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  • Comparative Effectiveness and Safety of Radiotherapy Treatments for Head and Neck CancerThis slide set is based on a comparative effectiveness review (CER) titled, Comparative Effectiveness and Safety of Radiotherapy Treatments for Head and Neck Cancer, that was developed by the Blue Cross and Blue Shield Association Technology Evaluation Center Evidence-based Practice Center for the Agency for Healthcare Research and Quality (AHRQ Contract No. 290-02-0026) and is available online at effectivehealthcare.ahrq.gov. CERs represent comprehensive systematic reviews of the literature and usually compare two or more types of treatment, such as different drugs, for the same disease. For the CER on radiotherapy treatment for head and neck cancer, primaryclinical trials were identified from searches of MEDLINE® (January 1, 1990 through September 28, 2009), EMBASE® (January 1, 1990 through September 28, 2009), and the Cochrane Central Register of Controlled Trials (no date restriction). This CER included 35 comparative studies: 32 observational nonrandomized studies and three head-to-head randomized trials of intensity-modulated radiation therapy (IMRT), three-dimensional conformal radiation therapy (3DCRT), and two-dimensional radiation therapy (2DCT). Fifty-one single-arm studies were analyzed separately from the comparative studies (51 for IMRT, 18 for 3DCRT). Reference:Samson DJ, Ratko TA, Rothenberg BM, et al. Comparative Effectiveness and Safety of Radiotherapy Treatments for Head and Neck Cancer, Comparative Effectiveness Review No. 20 (Prepared by the Blue Cross and Blue Shield Association Technology Evaluation Center Evidence-based Practice Center under Contract No. 290-02-0026). Rockville, MD: Agency for Healthcare Research and Quality; May 2010. AHRQ Publication No. 10-EHC014-EF. Available at: http://www.effectivehealthcare.ahrq.gov/index.cfm/search-for-guides-reviews-and-reports/?pageaction=displayproduct&productID=447.
  • Head and Neck Cancer: AnatomyHead and neck cancer is generally considered to be a cancer that arises in the head or neck region—in the lips, oral cavity, pharynx, larynx, paranasal sinuses, and salivary glands.
  • Health Impact of Head and Neck Cancer in the United StatesHead and neck cancer arising in the oral cavity, salivary glands, larynx, hypopharynx, oropharynx, nasopharynx, nasal cavity, and paranasal sinuses accounts for 3 to 5 percent of all cancer in the United States. Since the comparative effectiveness review was published in May 2010, new estimates of head and neck cancer incidence and mortality have been reported. Estimates of new cases of head and neck cancer have increased from 47,560 in 2008 to 49,260 in 2010. The estimated number of deaths related to head and neck cancer have also increased, from 11,260 in 2008 to 11,480 in 2010.References:National Comprehensive Cancer Care Network Web site. NCCN Clinical Practice Guidelines in Oncology: Head and Neck Cancers (V.2.2010). Available at: http://www.nccn.org/professionals/physician_gls/f_guidelines.asp. Accessed August 25, 2010. American Cancer Society. Cancer Facts and Figures 2010. Atlanta, GA: American Cancer Society; 2010. Available at: http://www.cancer.org/acs/groups/content/@nho/documents/document/acspc-024113.pdf.
  • Classification and Staging of Head and Neck CancerThe majority of head and neck cancers arise from a noninvasive precursor in surface squamous epithelium that progresses to become squamous carcinoma. Other less common head and neck tumors arise from other structures, including the major and minor salivary glands, and give rise to a variety of other tumor types, such as adenocarcinomas.References:National Comprehensive Cancer Care Network Web site. NCCN Clinical Practice Guidelines in Oncology: Head and Neck Cancers (V.2.2010). Available at: http://www.nccn.org/professionals/physician_gls/f_guidelines.asp. Accessed August 25, 2010. Samson DJ, Ratko TA, Rothenberg BM, et al. Comparative Effectiveness and Safety of Radiotherapy Treatments for Head and Neck Cancer, Comparative Effectiveness Review No. 20 (Prepared by the Blue Cross and Blue Shield Association Technology Evaluation Center Evidence-based Practice Center under Contract No. 290-02-0026). Rockville, MD: Agency for Healthcare Research and Quality; May, 2010. AHRQ Publication No. 10-EHC014-EF. Available at: http://www.effectivehealthcare.ahrq.gov/index.cfm/search-for-guides-reviews-and-reports/?pageaction=displayproduct&productID=447.
  • Classification and Staging of Head and Neck Cancer (Continued)The staging of head and neck cancer varies slightly by anatomic site, but in general, early stage (stages I and II) disease, which comprises approximately 40 percent of cases, defines a small primary tumor without lymph node involvement. Locally advanced tumors (stages III and IV), which represents approximately 60 percent of cases, includes large primary tumors thatmay invade adjacent structures and/or spread to regional lymph nodes. Metastatic disease is uncommon at the time of diagnosis of a head and neck cancer, with the exception of certain subsites (e.g., nasopharynx and hypopharynx).References:National Comprehensive Cancer Care Network Web site. NCCN Clinical Practice Guidelines in Oncology: Head and Neck Cancers (V.2.2010). Available at: http://www.nccn.org/professionals/physician_gls/f_guidelines.asp. Accessed August 25, 2010. Samson DJ, Ratko TA, Rothenberg BM, et al. Comparative Effectiveness and Safety of Radiotherapy Treatments for Head and Neck Cancer, Comparative Effectiveness Review No. 20 (Prepared by the Blue Cross and Blue Shield Association Technology Evaluation Center Evidence-based Practice Center under Contract No. 290-02-0026). Rockville, MD: Agency for Healthcare Research and Quality; May, 2010. AHRQ Publication No. 10-EHC014-EF. Available at: http://www.effectivehealthcare.ahrq.gov/index.cfm/search-for-guides-reviews-and-reports/?pageaction=displayproduct&productID=447.
  • Risk Factors for Head and Neck CancerMajor risk factors for the development of head and neck cancer include tobacco and alcohol abuse. Other less-common risk factors include: occupational exposures, nutritional deficiencies, and poor oral health. Viral etiologies have also been established, with human papillomavirus infection appearing to be a risk factor, particularly within the oropharynx, in younger people without a history of tobacco or alcohol abuse. In addition, an association has been made between Epstein-Barr virus and nasopharyngeal cancer.Reference:Samson DJ, Ratko TA, Rothenberg BM, et al. Comparative Effectiveness and Safety of Radiotherapy Treatments for Head and Neck Cancer, Comparative Effectiveness Review No. 20 (Prepared by the Blue Cross and Blue Shield Association Technology Evaluation Center Evidence-based Practice Center under Contract No. 290-02-0026). Rockville, MD: Agency for Healthcare Research and Quality; May, 2010. AHRQ Publication No. 10-EHC014-EF. Available at: http://www.effectivehealthcare.ahrq.gov/index.cfm/search-for-guides-reviews-and-reports/?pageaction=displayproduct&productID=447.
  • Clinical Management of Head and Neck CancerThe management of head and neck cancer (HNC) is complex and usually involves a multidisciplinary team. In general, the approach to managing this type of cancer is dictated by the site and extent of the disease, as well as by the histologic type and grade of tumor. Early stage disease may be treated with a single modality (surgery or radiation); whereas, locally advanced disease is generally treated with combined modalities. Depending upon the extent of disease spread, a cervical lymph node dissection may be performed. Most patients with locally advanced HNC receive chemotherapy in addition to radiotherapy (chemoradiation) as a part of initial curative treatment. The integration of chemotherapy into the treatment of HNC has resulted in improvements in overall survival and local-regional control, has reduced the incidence of distant metastases, and has provided the opportunity for organ preservation in certain settings. Radiotherapy is associated with early and late toxicities, which can have a profound effect on a patient’s quality of life. Chemoradiation may be associated with enhancement of these toxicities, particularly mucositis and xerostomia. Therapy-related toxicities are particularly relevant in the treatment of HNC because of the close proximity of many important dose-limiting normal tissues. Treatment effect can impact basic functions like chewing, swallowing, and breathing; the senses (e.g., taste, smell, hearing); and significantly alter appearance and voice. References:National Comprehensive Cancer Care Network Web site. NCCN Clinical Practice Guidelines in Oncology: Head and Neck Cancers (V.2.2010). Available at: http://www.nccn.org/professionals/physician_gls/f_guidelines.asp. Accessed August 25, 2010. Forastiere AA. Chemotherapy in the treatment of locally advanced head and neck cancer. J Surg Oncol 2008;97:701-7.http://www.ncbi.nlm.nih.gov/pubmed/18493921Samson DJ, Ratko TA, Rothenberg BM, et al. Comparative Effectiveness and Safety of Radiotherapy Treatments for Head and Neck Cancer, Comparative Effectiveness Review No. 20 (Prepared by the Blue Cross and Blue Shield Association Technology Evaluation Center Evidence-based Practice Center under Contract No. 290-02-0026). Rockville, MD: Agency for Healthcare Research and Quality; May, 2010. AHRQ Publication No. 10-EHC014-EF. Available at: http://www.effectivehealthcare.ahrq.gov/index.cfm/search-for-guides-reviews-and-reports/?pageaction=displayproduct&productID=447.
  • Radiation Delivery TechnologyAdvances in treatment delivery technologies have been developed as an attempt to improve the conformality of the radiation being delivered. In other words, getting radiation just to the tumor and not to the normal surrounding tissue that could be harmed during treatment. Reference: Samson DJ, Ratko TA, Rothenberg BM, et al. Comparative Effectiveness and Safety of Radiotherapy Treatments for Head and Neck Cancer, Comparative Effectiveness Review No. 20 (Prepared by the Blue Cross and Blue Shield Association Technology Evaluation Center Evidence-based Practice Center under Contract No. 290-02-0026). Rockville, MD: Agency for Healthcare Research and Quality; May, 2010. AHRQ Publication No. 10-EHC014-EF. Available at: http://www.effectivehealthcare.ahrq.gov/index.cfm/search-for-guides-reviews-and-reports/?pageaction=displayproduct&productID=447.
  • External-Beam Radiation Therapy for Head and Neck CancerThe main challenge in using radiation therapy to treat cancer is to attain the highest probability of tumor control or cure with the least amount of morbidity and toxicity to normal surrounding tissues (sometimes referred to as organs at risk). The external-beam radiation therapy modalities used to treat head and neck cancer include two-dimensional radiation therapy, three-dimensional conformal radiation therapy, intensity-modulated radiation therapy, and proton beam therapy. Reference:Samson DJ, Ratko TA, Rothenberg BM, et al. Comparative Effectiveness and Safety of Radiotherapy Treatments for Head and Neck Cancer, Comparative Effectiveness Review No. 20 (Prepared by the Blue Cross and Blue Shield Association Technology Evaluation Center Evidence-based Practice Center under Contract No. 290-02-0026). Rockville, MD: Agency for Healthcare Research and Quality; May, 2010. AHRQ Publication No. 10-EHC014-EF. Available at: http://www.effectivehealthcare.ahrq.gov/index.cfm/search-for-guides-reviews-and-reports/?pageaction=displayproduct&productID=447.
  • Treatment PlanningBoth 2DRT and 3DCRT use forward planning to create radiation dose distributions, in which radiation treatment fields are designated and the number, direction, and shapes of the radiation beams are defined. The treatment plan dose distribution shows how much dose is delivered to the tumor and normal structures. IMRT uses CT simulation images like 3D-CRT; however, inverse planning is used to outline target volumes. Inverse planning requires the treatment planner to input the desired radiation dose to the tumor and the constraints for normal surrounding structures. Then, computer software is used to arrive at the radiation beam characteristics most likely to meet the requirements designated at the start of treatment planning. Proton beam therapy can be planned using 3D; the technology for using inverse planning with proton beam therapy, however, is just emerging.Reference:Samson DJ, Ratko TA, Rothenberg BM, et al. Comparative Effectiveness and Safety of Radiotherapy Treatments for Head and Neck Cancer, Comparative Effectiveness Review No. 20 (Prepared by the Blue Cross and Blue Shield Association Technology Evaluation Center Evidence-based Practice Center under Contract No. 290-02-0026). Rockville, MD: Agency for Healthcare Research and Quality; May, 2010. AHRQ Publication No. 10-EHC014-EF. Available at: http://www.effectivehealthcare.ahrq.gov/index.cfm/search-for-guides-reviews-and-reports/?pageaction=displayproduct&productID=447.
  • Two-Dimensional Radiation Therapy and Three-Dimensional Conformal Radiation TherapyModern advances in computers have led to parallel advances in imaging technologies, allowing for higher levels of complexity in radiation therapy (RT) treatment-planning systems. Over the last 20 years, RT designs have evolved from being based on two-dimensional (2D) images to being based on three-dimensional (3D) images. During this evolution, increasingly complex computer algorithms have been incorporated. 2DRT consists of one to four beams with the radiation fields designed on 2D fluoroscopic simulation images; whereas, 3D conformal RT (CRT) employs computed tomography simulation, which permits more precise tumor definition. 3DCRT represented a major advance over 2DRT, because it permitted more accurate dose calculations by taking into account axial anatomy and complex tissue contours. 3DCRT also permits the use of a greater number of beams than are typically used in 2DRT. References:Burri MK, Bevan A, Roach M 3rd. Advances in radiation therapy: conventional to 3D, to IMRT, to 4D, and beyond. CA Cancer J Clin 2005;55:117-34.http://www.ncbi.nlm.nih.gov/pubmed/15761080Lee NY, Terezakis SA. Intensity-modulated radiation therapy. J Surg Oncol 2008;97:691-6.http://www.ncbi.nlm.nih.gov/pubmed/18493919Samson DJ, Ratko TA, Rothenberg BM, et al. Comparative Effectiveness and Safety of Radiotherapy Treatments for Head and Neck Cancer, Comparative Effectiveness Review No. 20 (Prepared by the Blue Cross and Blue Shield Association Technology Evaluation Center Evidence-based Practice Center under Contract No. 290-02-0026). Rockville, MD: Agency for Healthcare Research and Quality; May, 2010. AHRQ Publication No. 10-EHC014-EF. Available at: http://www.effectivehealthcare.ahrq.gov/index.cfm/search-for-guides-reviews-and-reports/?pageaction=displayproduct&productID=447.
  • Intensity-Modulated Radiation TherapyIMRT, which has been implemented over the last decade, has further refined radiation dose delivery. IMRT allows the modulation of beam intensity within each field and also enables the use of inverse computer planning, thereby permitting greater control of the dose distribution to the target. With inverse computer planning, the treatment planner defines the tumor target and the normal tissue before a computer algorithm is used to determine beam orientation, the dose to give from each beam, and the amount of modulation to give within each beam. In other words, the computer generates the treatment plan, based on goals defined by the treatment planner. References:Ballivy O, Santamaria RG, Borbalas AL, et al. Clinical application of intensity-modulated radiotherapy for head and neck cancer. Clin Transl Oncol 2008;10:407-14. http://www.ncbi.nlm.nih.gov/pubmed/18628069Burri MK, Bevan A, Roach M 3rd. Advances in radiation therapy: conventional to 3D, to IMRT, to 4D, and beyond. CA Cancer J Clin 2005;55:117-34.http://www.ncbi.nlm.nih.gov/pubmed/15761080Mendenhall WM, Amdur RJ, Palta JR. Intensity-modulated radiotherapy in the standard management of head and neck cancer: promises and pitfalls. J Clin Oncol 2006;24:2618-23.http://www.ncbi.nlm.nih.gov/pubmed/16763274Samson DJ, Ratko TA, Rothenberg BM, et al. Comparative Effectiveness and Safety of Radiotherapy Treatments for Head and Neck Cancer, Comparative Effectiveness Review No. 20 (Prepared by the Blue Cross and Blue Shield Association Technology Evaluation Center Evidence-based Practice Center under Contract No. 290-02-0026). Rockville, MD: Agency for Healthcare Research and Quality; May, 2010. AHRQ Publication No. 10-EHC014-EF. Available at: http://www.effectivehealthcare.ahrq.gov/index.cfm/search-for-guides-reviews-and-reports/?pageaction=displayproduct&productID=447.
  • Potential Advantages and Disadvantages of IMRT When Compared With 2DRT and 3DCRTPotential advantages include the ability to deliver higher doses to the tumor, while sparing normal, surrounding tissues and, thereby,decreasing toxicity. Reducing the radiation dose to normal structures offers potential benefits, which include sparing of salivary gland tissue to reduce the severity of xerostomia (dryness of the mouth due to decreased salivary function) and reducing the dose to structures related to swallowing (e.g., pharyngeal constrictor muscles and the larynx). There are several disadvantages to IMRT. Patients receive a higher total-body dose of radiation. There also is an increased risk of a marginal miss; in which case, the eradication of the tumor may be unsuccessful. IMRT has been associated with decreased dose homogeneity. When compared to more conventional radiotherapy techniques, IMRT is more expensive and time consuming. Difficulties have also arisen in set-up reproducibility and patient immobilization, and it has been shown that variations in daily patient positioning and changes in patient anatomy (e.g., weight loss, tumor shrinkage) may result in significant dose perturbations when compared with the original treatment plan. Finally, there has been concern about variations in prescribed doses versus what doseis actually delivered to the patient, and variations between medical institutions have raised concerns about the validity of comparing clinical outcomes for IMRT. References:Ballivy O, Santamaria RG, Borbalas AL, et al. Clinical application of intensity-modulated radiotherapy for head and neck cancer. Clin Transl Oncol 2008;10:407-14. http://www.ncbi.nlm.nih.gov/pubmed/18628069Burri MK, Bevan A, Roach M III. Advances in radiation therapy: conventional to 3D, to IMRT, to 4D, and beyond. CA Cancer J Clin 2005;55:117-34.http://www.ncbi.nlm.nih.gov/pubmed/15761080Mendenhall WM, Amdur RJ, Palta JR. Intensity-modulated radiotherapy in the standard management of head and neck cancer: promises and pitfalls. J Clin Oncol 2006;24:2618-23. http://www.ncbi.nlm.nih.gov/pubmed/16763274Samson DJ, Ratko TA, Rothenberg BM, et al. Comparative Effectiveness and Safety of Radiotherapy Treatments for Head and Neck Cancer, Comparative Effectiveness Review No. 20 (Prepared by the Blue Cross and Blue Shield Association Technology Evaluation Center Evidence-based Practice Center under Contract No. 290-02-0026). Rockville, MD: Agency for Healthcare Research and Quality; May 2010. AHRQ Publication No. 10-EHC014-EF. Available at: http://www.effectivehealthcare.ahrq.gov/index.cfm/search-for-guides-reviews-and-reports/?pageaction=displayproduct&productID=447.
  • Proton Beam TherapyPhotons (as is used in 2DRT, 3DCRT, and IMRT) spare the skin and deposit dose along their entire path until the beam leaves the body. As each beam continues on its path beyond the tumor, the use of multiple beams means that a significant volume of normal tissue receives a low dose. Although proton beam therapy has been used to treat tumors for more than 50 years, it has been used mostly in the treatment of prostate cancer and brain tumors, including those in children. Charged particle beams, like protons, differ from photons in that they interact only modestly with tissue until they reach the end of their path, where they deposit most of their energy and stop. The ability to stop at a chosen depth offers the potential advantage of treating tumors close to critical structures, and with the potential to decrease regions of low dose, perhaps decreasing the chance of second malignancies. Reference:Samson DJ, Ratko TA, Rothenberg BM, et al. Comparative Effectiveness and Safety of Radiotherapy Treatments for Head and Neck Cancer, Comparative Effectiveness Review No. 20 (Prepared by the Blue Cross and Blue Shield Association Technology Evaluation Center Evidence-based Practice Center under Contract No. 290-02-0026). Rockville, MD: Agency for Healthcare Research and Quality; May 2010. AHRQ Publication No. 10-EHC014-EF. Available at: http://www.effectivehealthcare.ahrq.gov/index.cfm/search-for-guides-reviews-and-reports/?pageaction=displayproduct&productID=447.
  • The Comparative Effectiveness Review Development ProcessThe topic of the comparative effectiveness review (CER) upon which this continuing medical education activity is based, Comparative Effectiveness and Safety of Radiotherapy Treatments for Head and Neck Cancer,was nominated through a public process. The Agency for Healthcare Research and Quality (AHRQ) commissioned the Blue Cross Blue Shield Association Technology Evaluation Center Evidence-based Practice Center to prepare the CER. The topic was refined with input from experts and stakeholders to develop the clinical questions that the CER would address. The clinical questions were posted for public comment on the Effective Health Care Program Web site and then finalized. Systematic literature review was conducted using methods approved by AHRQ and with input from a technical expert panel. A comprehensive systematic review of the literature was conducted using several well-known databases, including MEDLINE® (January 1, 1990 through September 28, 2009), EMBASE® (January 1, 1990 through September 28, 2009), and the Cochrane Controlled Trials Register (no date restriction). Based on the findings of the review, a draft CER was prepared and published on the Effective Health Care Program Web site for review by the public. Additionally, the draft underwent rigorous peer review to improve the final product. Revisions were made to the draft report based on the reviewers’ comments. After the CER was finalized, the complete report was published on the Effective Health Care Program Web site (available at: http://www.effectivehealthcare.ahrq.gov/index.cfm/search-for-guides-reviews-and-reports/?pageaction=displayproduct&productID=447).References:Guyatt GH, Oxman AD, Vist GE, et al, for the GRADE Working Group. GRADE: an emerging consensus on rating quality of evidence and strength of recommendations. BMJ 2008;336:924-6.http://www.ncbi.nlm.nih.gov/pubmed/18436948Owens DK, Lohr KN, Atkins D, et al. AHRQ series paper 5: grading the strength of a body of evidence when comparing medical interventions—Agency for Healthcare Research and Quality and the Effective Health Care Program. J Clin Epidemiol 2010;63:513-23.http://www.ncbi.nlm.nih.gov/pubmed/19595577Samson DJ, Ratko TA, Rothenberg BM, et al. Comparative Effectiveness and Safety of Radiotherapy Treatments for Head and Neck Cancer, Comparative Effectiveness Review No. 20 (Prepared by the Blue Cross and Blue Shield Association Technology Evaluation Center Evidence-based Practice Center under Contract No. 290-02-0026). Rockville, MD: Agency for Healthcare Research and Quality; May 2010. AHRQ Publication No. 10-EHC014-EF. Available at: http://www.effectivehealthcare.ahrq.gov/index.cfm/search-for-guides-reviews-and-reports/?pageaction=displayproduct&productID=447.
  • Rating the Strength of Evidence From the CER: A Modification of the GRADE MethodologyThe system used for rating the strength of the overall body of evidence was developed by AHRQ for the Methods Reference Guide for Effectiveness and Comparative Effectiveness Reviews (version 1.0; available at: http://effectivehealthcare.ahrq.gov/repFiles/2007_10DraftMethodsGuide.pdf) and was based on a method developed by the GRADE (Grading of Recommendations, Assessment, DEvelopment) Working Group. The system used four required domains—risk of bias, consistency, directness, and precision—for assessments. All assessments were made by two investigators who resolved disagreements through discussion. The strength of evidence pertaining to each key question was classified into three broad categories or grades: high, moderate, low, or insufficient. References:Guyatt GH, Oxman AD, Vist GE, et al, for the GRADE Working Group. GRADE: an emerging consensus on rating quality of evidence and strength of recommendations. BMJ 2008;336:924-6.http://www.ncbi.nlm.nih.gov/pubmed/18436948Owens DK, Lohr KN, Atkins D, et al. AHRQ series paper 5: grading the strength of a body of evidence when comparing medical interventions—Agency for Healthcare Research and Quality and the Effective Health Care Program. J Clin Epidemiol 2010;63:513-23.http://www.ncbi.nlm.nih.gov/pubmed/19595577Samson DJ, Ratko TA, Rothenberg BM, et al. Comparative Effectiveness and Safety of Radiotherapy Treatments for Head and Neck Cancer, Comparative Effectiveness Review No. 20 (Prepared by the Blue Cross and Blue Shield Association Technology Evaluation Center Evidence-based Practice Center under Contract No. 290-02-0026). Rockville, MD: Agency for Healthcare Research and Quality; May 2010. AHRQ Publication No. 10-EHC014-EF. Available at: http://www.effectivehealthcare.ahrq.gov/index.cfm/search-for-guides-reviews-and-reports/?pageaction=displayproduct&productID=447.
  • Interventions of InterestStudies that used a mix of radiotherapy modalities, such as 2DRT plus IMRT boost or 3DCRT plus brachytherapy, were excluded from the review. Boost techniques were allowed if they were of the same modality as the main technique (e.g., IMRT with an IMRT boost). Conventional 2DRT was addressed to the extent that comparative studies included groups of patients who received 2DRT. However, noncomparative studies of 2DRT were not sought. Data on other comparators, such as stereotactic radiosurgery or similar modalities, were also not sought. Reference:Samson DJ, Ratko TA, Rothenberg BM, et al. Comparative Effectiveness and Safety of Radiotherapy Treatments for Head and Neck Cancer, Comparative Effectiveness Review No. 20 (Prepared by the Blue Cross and Blue Shield Association Technology Evaluation Center Evidence-based Practice Center under Contract No. 290-02-0026). Rockville, MD: Agency for Healthcare Research and Quality; May 2010. AHRQ Publication No. 10-EHC014-EF. Available at: http://www.effectivehealthcare.ahrq.gov/index.cfm/search-for-guides-reviews-and-reports/?pageaction=displayproduct&productID=447.
  • Comparative Effectiveness Review: Outcomes of InterestPrimary (health) outcomes included: Radiation-induced toxicities; adverse events, both acute and chronic normal tissue toxicity, such as: xerostomia, dysphagia, mucositis, skin toxicity, osteoradionecrosis, or bone toxicity; effect on quality of life; and clinical effectiveness, including: local and locoregional control, time to any recurrence (disease-free survival), and patient (disease-specific and overall) survival. Secondary (intermediate) outcomes included: salivary flow and probability of completing treatment according to protocol.The greatest emphasis was given to health outcomes directly related to length of life, quality of life, function, symptoms, or harm. Intermediate outcomes that might reflect physiologic processes were considered important to the extent that they were related to health outcomes. The specific primary and secondary outcomes selected here were those for which more than five comparative studies provided data and clinical expert consensus indicated their importance.Reference:Samson DJ, Ratko TA, Rothenberg BM, et al. Comparative Effectiveness and Safety of Radiotherapy Treatments for Head and Neck Cancer, Comparative Effectiveness Review No. 20 (Prepared by the Blue Cross and Blue Shield Association Technology Evaluation Center Evidence-based Practice Center under Contract No. 290-02-0026). Rockville, MD: Agency for Healthcare Research and Quality; May 2010. AHRQ Publication No. 10-EHC014-EF. Available at: http://www.effectivehealthcare.ahrq.gov/index.cfm/search-for-guides-reviews-and-reports/?pageaction=displayproduct&productID=447.
  • Clinical Questions Addressed by the Comparative Effectiveness Review of Radiotherapy for Head and Neck CancerHead and neck cancer was defined as tumors of: the larynx; the pharynx (hypopharynx, oropharynx, and nasopharynx); the lips and oral cavity; the paranasal sinus and nasal cavity; the salivary glands; and occult primary of the head and neck. Excluded were: brain tumors; skull base tumors; uveal/choroidal melanoma, other ocular and eyelid tumors; otologic tumors; cutaneous tumors of the head and neck (including melanoma); thyroid cancer; parathyroid cancer; esophageal cancer; and tracheal tumors.Tumor site was not necessarily defined as occurring in one anatomic location. For example, for purposes of data abstraction, “oral cavity” was considered as one site, although it technically involves multiple anatomic sites (e.g., the buccal mucosa, the anterior two-thirds of the tongue, the lips, etc.).References:Lawrence TS, Ten Haken RK, Giaccia A. Principles of radiation oncology. In: DeVita VT, Lawrence TS and Rosenberg SA, eds. Cancer: principles and practice of oncology, 8th ed, Vol 1. Philadelphia: Lippincott Williams and Wilkins; 2008. p. 307-36.National Comprehensive Cancer Care Network Web site. NCCN Clinical Practice Guidelines in Oncology: Head and Neck Cancers (V.2.2010). Available at: http://www.nccn.org/professionals/physician_gls/f_guidelines.asp. Accessed August 25, 2010. Samson DJ, Ratko TA, Rothenberg BM, et al. Comparative Effectiveness and Safety of Radiotherapy Treatments for Head and Neck Cancer, Comparative Effectiveness Review No. 20 (Prepared by the Blue Cross and Blue Shield Association Technology Evaluation Center Evidence-based Practice Center under Contract No. 290-02-0026). Rockville, MD: Agency for Healthcare Research and Quality; May 2010. AHRQ Publication No. 10-EHC014-EF. Available at: http://www.effectivehealthcare.ahrq.gov/index.cfm/search-for-guides-reviews-and-reports/?pageaction=displayproduct&productID=447.
  • Planned ComparisonsThe CER on which this CME activity is based considered the comparative effectiveness and safety of four types of external-beam radiotherapies: three-dimensional conformal radiotherapy (3DCRT), two-dimensional radiotherapy (2DRT), intensity modulated radiotherapy (IMRT), and proton beam therapy. Of 2,679 records found through an electronic literature search, 354 articles were retrieved for further screening. Thirty-eight articles that described comparative studies were abstracted. Of the 38 comparative studies, 5 were three-arm designs, so there were 48 total comparisons. Interventions in comparative studies included IMRT, 3DCRT and 2DRT; none included proton beam therapy. Reference: Samson DJ, Ratko TA, Rothenberg BM, et al. Comparative Effectiveness and Safety of Radiotherapy Treatments for Head and Neck Cancer, Comparative Effectiveness Review No. 20 (Prepared by the Blue Cross and Blue Shield Association Technology Evaluation Center Evidence-based Practice Center under Contract No. 290-02-0026). Rockville, MD: Agency for Healthcare Research and Quality; May 2010. AHRQ Publication No. 10-EHC014-EF. Available at: http://www.effectivehealthcare.ahrq.gov/index.cfm/search-for-guides-reviews-and-reports/?pageaction=displayproduct&productID=447.
  • Overview of Available LiteratureThe available literature featured a small body of randomized, controlled trials, accompanied by a larger body of poor-quality observational, nonrandomized studies. Study quality was assessed according to principles described in a reference guide for conducting comparative effectiveness reviews produced by AHRQ. In this context, poor-quality study refers to studies that have high potential for bias of results (e.g., single institution case series). The observational studies included in the review were clinically diverse with respect to patient characteristics and treatment setting, thereby creating uncertainty about whether results should be attributed to confounding rather than treatment differences. Details were often lacking among observational studies about patient characteristics and treatments, and it was not clear for any study whether well-done multivariable analyses were performed to adjust for differences. Reference:Agency for Healthcare Research and Quality. Methods Reference Guide for Effectiveness and Comparative Effectiveness Reviews, Version 1.0. Rockville, MD: Agency for Healthcare Research and Quality; Draft Posted October 2007. Available at: http://effectivehealthcare.ahrq.gov/repFiles/2007_10DraftMethodsGuide.pdf.Samson DJ, Ratko TA, Rothenberg BM, et al. Comparative Effectiveness and Safety of Radiotherapy Treatments for Head and Neck Cancer, Comparative Effectiveness Review No. 20 (Prepared by the Blue Cross and Blue Shield Association Technology Evaluation Center Evidence-based Practice Center under Contract No. 290-02-0026). Rockville, MD: Agency for Healthcare Research and Quality; May 2010. AHRQ Publication No. 10-EHC014-EF. Available at: http://www.effectivehealthcare.ahrq.gov/index.cfm/search-for-guides-reviews-and-reports/?pageaction=displayproduct&productID=447.
  • Clinical Bottom Line: Comparative Evidence for 2DRT, 3DCRT, and IMRTThis slide summarizes the most pertinent results, regarding tumor control, survival, and adverse events, from the comparative effectiveness review (CER) titled, Comparative Effectiveness and Safety of Radiotherapy Treatments for Head and Neck Cancer. The next several slides (24–33) will discuss these data in greater detail. When considered together, the results indicate that there may be a clinical benefit from IMRT for some patients with head and neck cancer in terms of the occurrence of late xerostomia and quality of life related to xerostomia. Reference:Samson DJ, Ratko TA, Rothenberg BM, et al. Comparative Effectiveness and Safety of Radiotherapy Treatments for Head and Neck Cancer, Comparative Effectiveness Review No. 20 (Prepared by the Blue Cross and Blue Shield Association Technology Evaluation Center Evidence-based Practice Center under Contract No. 290-02-0026). Rockville, MD: Agency for Healthcare Research and Quality; May 2010. AHRQ Publication No. 10-EHC014-EF. Available at: http://www.effectivehealthcare.ahrq.gov/index.cfm/search-for-guides-reviews-and-reports/?pageaction=displayproduct&productID=447.
  • Clinical Bottom Line: Comparative Evidence for 2DRT, 3DCRT, and IMRT (continued)This slide summarizes the most pertinent results, regarding quality of life and treatment team experience, from the comparative effectiveness review (CER) titled, Comparative Effectiveness and Safety of Radiotherapy Treatments for Head and Neck Cancer. The next several slides (24–33) will discuss these data in greater detail. When considered together, the results indicate that there may be a clinical benefit from IMRT for some patients with head and neck cancer in terms of the occurrence of late xerostomia and quality of life related to xerostomia. Reference:Samson DJ, Ratko TA, Rothenberg BM, et al. Comparative Effectiveness and Safety of Radiotherapy Treatments for Head and Neck Cancer, Comparative Effectiveness Review No. 20 (Prepared by the Blue Cross and Blue Shield Association Technology Evaluation Center Evidence-based Practice Center under Contract No. 290-02-0026). Rockville, MD: Agency for Healthcare Research and Quality; May 2010. AHRQ Publication No. 10-EHC014-EF. Available at: http://www.effectivehealthcare.ahrq.gov/index.cfm/search-for-guides-reviews-and-reports/?pageaction=displayproduct&productID=447.
  • Clinical Bottom Line: Comparative Evidence for Proton Beam versus 2DRT, 3DRT, and IMRTThis slide summarizes the evidence, regarding comparisons of proton beam therapy to 2DRT, 3DCRT, and IMRT, reported in the comparative effectiveness review (CER) titled Comparative Effectiveness and Safety of Radiotherapy Treatments for Head and Neck Cancer. The next several slides (24–33) will discuss these data in greater detail. Since no studies compared the domains of tumor control, survival, adverse effects, quality of life, or experience of the treatment team between proton beam therapy and the other external-beam radiation therapy modalities considered in the report, no conclusions could be drawn about their comparative effectiveness and safety.Reference:Samson DJ, Ratko TA, Rothenberg BM, et al. Comparative Effectiveness and Safety of Radiotherapy Treatments for Head and Neck Cancer, Comparative Effectiveness Review No. 20 (Prepared by the Blue Cross and Blue Shield Association Technology Evaluation Center Evidence-based Practice Center under Contract No. 290-02-0026). Rockville, MD: Agency for Healthcare Research and Quality; May 2010. AHRQ Publication No. 10-EHC014-EF. Available at: http://www.effectivehealthcare.ahrq.gov/index.cfm/search-for-guides-reviews-and-reports/?pageaction=displayproduct&productID=447.
  • Comparative Effectiveness Regarding Improved Tumor Control or SurvivalBecause of insufficient levels of evidence related to this key question, no conclusions on tumor control or survival could be drawn from the body of evidence comparing IMRT vs. 3DCRT, IMRT vs. 2DRT, or 2DRT vs. 3DCRT. Reference:Samson DJ, Ratko TA, Rothenberg BM, et al. Comparative Effectiveness and Safety of Radiotherapy Treatments for Head and Neck Cancer, Comparative Effectiveness Review No. 20 (Prepared by the Blue Cross and Blue Shield Association Technology Evaluation Center Evidence-based Practice Center under Contract No. 290-02-0026). Rockville, MD: Agency for Healthcare Research and Quality; May 2010. AHRQ Publication No. 10-EHC014-EF. Available at: http://www.effectivehealthcare.ahrq.gov/index.cfm/search-for-guides-reviews-and-reports/?pageaction=displayproduct&productID=447.
  • Evidence on the Comparative Effectiveness Regarding Quality of Life and Adverse EventsThere were 38 comparative studies. Of these, four were randomized, controlled trials of IMRT, 3DCRT, or 2DRT. Three were studies of patients with nasopharyngeal cancer, while one was of patients with oropharyngeal or hypopharyngeal cancer. One unpublished, randomized, controlled trial, reported by Nutting et al. at the 2009 annual meeting of the American Society of Clinical Oncology, could not be clearly rated because a manuscript was unavailable, one was rated fair and two were rated poor due to lack of intention-to-treat analyses. The remaining 34 studies were observational, with significant flaws such as: lack of comparable groups at baseline; comparing radiotherapy technologies at different points in time, that is, the study arms were not contemporaneous; and poorly done multivariable analyses. Reference: Samson DJ, Ratko TA, Rothenberg BM, et al. Comparative Effectiveness and Safety of Radiotherapy Treatments for Head and Neck Cancer, Comparative Effectiveness Review No. 20 (Prepared by the Blue Cross and Blue Shield Association Technology Evaluation Center Evidence-based Practice Center under Contract No. 290-02-0026). Rockville, MD: Agency for Healthcare Research and Quality; May 2010. AHRQ Publication No. 10-EHC014-EF. Available at: http://www.effectivehealthcare.ahrq.gov/index.cfm/search-for-guides-reviews-and-reports/?pageaction=displayproduct&productID=447.
  • Evidence on the Comparative Effectiveness Regarding Quality of Life and Adverse EventsOne unpublished, randomized, controlled trial, reported by Nutting, et al. at the 2009 annual meeting of the American Society of Clinical Oncology, showed a large advantage for IMRT in the frequency of late xerostomia of grade 2 or higher. The risk difference was 35 percentage points with a 95 percent confidence interval (95% CI) between 12.6 and 55.5 percentage points.• Six observational studies favored IMRT. Of the five studies that reported frequencies, the reported range of differences is 7 to 79 percentage points.• Quality of life was reported in three observational studies and generally favored IMRT over 3DCRT, although not all of the domains that were measured were statistically significant. Significant advantages for IMRT were found in these domains: dry mouth, sticky saliva, taste/smell, fatigue, and feeling ill.• Acute xerostomia, acute mucositis, late mucositis, acute dysphagia, late skin toxicity, and late osteoradionecrosis and bone toxicity were reported in some studies and typically favored IMRT over 3DCRT. These differences, however, were not consistently statistically significant. Among studies of acute skin toxicity, neither the size of the difference nor the direction was consistent.Reference: Samson DJ, Ratko TA, Rothenberg BM, et al. Comparative Effectiveness and Safety of Radiotherapy Treatments for Head and Neck Cancer, Comparative Effectiveness Review No. 20 (Prepared by the Blue Cross and Blue Shield Association Technology Evaluation Center Evidence-based Practice Center under Contract No. 290-02-0026). Rockville, MD: Agency for Healthcare Research and Quality; May 2010. AHRQ Publication No. 10-EHC014-EF. Available at: http://www.effectivehealthcare.ahrq.gov/index.cfm/search-for-guides-reviews-and-reports/?pageaction=displayproduct&productID=447.
  • Studies Regarding Quality of Life and Adverse Events: IMRT vs. 3DCRTConsistent results favoring IMRT over 3DCRT were observed for late xerostomia and quality of life domains related to xerostomia. Adverse event comparisons that reported numerical differences in incidence of late xerostomia (≥ grade 2) are presented graphically in this slide. Four studies found large (greater than 15 percentage points) significant differences favoring IMRT over 3DCRT in the frequency of late xerostomia. The results of one unpublished, randomized, controlled trial, presented at the 2009 annual meeting of the American Society of Clinical Oncology, showed a large advantage for IMRT in the frequency of late xerostomia of grade 2 or higher (risk difference, 35 percentage points; 95% CI, 12.6–55.5). Six observational studies that reported late xerostomia all favored IMRT. Of the five studies that reported frequencies, the reported range of differences was 7 to 79 percentage points. Data not shown:• Quality of life was reported in three observational studies and generally favored IMRT. Significant advantages for IMRT included these domains: dry mouth, sticky saliva, taste/smell, fatigue, and feeling ill. • Acute xerostomia, acute mucositis, late mucositis, acute dysphagia, late skin toxicity, and late osteoradionecrosis and bone toxicity were reported in some and typically favored IMRT but differences were not consistently statistically significant. Among studies of acute skin toxicity, neither the size of the difference nor the direction was consistent. Reference: Samson DJ, Ratko TA, Rothenberg BM, et al. Comparative Effectiveness and Safety of Radiotherapy Treatments for Head and Neck Cancer, Comparative Effectiveness Review No. 20 (Prepared by the Blue Cross and Blue Shield Association Technology Evaluation Center Evidence-based Practice Center under Contract No. 290-02-0026). Rockville, MD: Agency for Healthcare Research and Quality; May 2010. AHRQ Publication No. 10-EHC014-EF. Available at: http://www.effectivehealthcare.ahrq.gov/index.cfm/search-for-guides-reviews-and-reports/?pageaction=displayproduct&productID=447.
  • Conclusions on the Comparative Effectiveness Regarding Quality of Life and Adverse Events: IMRT vs. 3DCRTPatients who receive IMRT have reduced late xerostomia and better quality of life, when compared with those who receive 3DCRT. While the evidence is consistent enough to suggest a true effect in favor of IMRT, it does not permit the creation of a pooled effect estimate with a confidence interval.Reference: Samson DJ, Ratko TA, Rothenberg BM, et al. Comparative Effectiveness and Safety of Radiotherapy Treatments for Head and Neck Cancer, Comparative Effectiveness Review No. 20 (Prepared by the Blue Cross and Blue Shield Association Technology Evaluation Center Evidence-based Practice Center under Contract No. 290-02-0026). Rockville, MD: Agency for Healthcare Research and Quality; May 2010. AHRQ Publication No. 10-EHC014-EF. Available at: http://www.effectivehealthcare.ahrq.gov/index.cfm/search-for-guides-reviews-and-reports/?pageaction=displayproduct&productID=447.
  • Evidence on the Comparative Effectiveness Regarding Quality of Life and Adverse Events: IMRT vs. 2DRTNine studies reported on late xerostomia; the results of eight of those studies were statistically significant in favor of IMRT. Among the studies that reported frequency of late xerostomia, the range of differences between IMRT and 2DRT was 43 to 62 percentage points.• Quality of life was reported in one randomized controlled trial and two observational studies and generally favored IMRT, although not all domains measured were statistically significant. Domains significantly favoring IMRT included dry mouth and sticky saliva.• Indirect evidence from the comparison of IMRT vs. 3DCRT shows that greater conformality of radiation reduces late xerostomia and improves quality of life. Thus, inference from the comparison of IMRT vs. 3DCRT provides additional support for this conclusion.• Acute and late mucositis, acute and late dysphagia, acute and late skin toxicity, and late osteoradionecrosis and bone toxicity were reported in some studies. Few studies reported significant results; these studies tended to be small or reported 2DRT data were from an earlier time period than IMRT. Reference:Samson DJ, Ratko TA, Rothenberg BM, et al. Comparative Effectiveness and Safety of Radiotherapy Treatments for Head and Neck Cancer, Comparative Effectiveness Review No. 20 (Prepared by the Blue Cross and Blue Shield Association Technology Evaluation Center Evidence-based Practice Center under Contract No. 290-02-0026). Rockville, MD: Agency for Healthcare Research and Quality; May 2010. AHRQ Publication No. 10-EHC014-EF. Available at: http://www.effectivehealthcare.ahrq.gov/index.cfm/search-for-guides-reviews-and-reports/?pageaction=displayproduct&productID=447.
  • Studies Regarding Late Xerostomia: IMRT vs. 2DRTAdverse event comparisons that reported numerical differences in incidence of late xerostomia for patients receiving either IMRT or 2DRT are presented graphically in this slide. Consistent between-group differences were found for two outcomes: late xerostomia and health-related quality of life domains related to xerostomia. Nine studies reported on late xerostomia, and eight were statistically significant in favor of IMRT. Among the six studies that reported frequency, shown above, the range of differences between IMRT and 2DRT was 43 to 62 percentage points. Data not shown: Because of the variation in the proportion of studies with statistically significant between-group differences for each adverse event or outcome considered and the quality or limitations of the specific studies involved, conclusions could be drawn only regarding the impact of IMRT versus 2DRT on late xerostomia incidence and quality of life domains related to xerostomia. No between-group differences were statistically significant for the following outcomes: late mucositis, acute skin toxicity, late osteoradionecrosis and bone toxicity, and locoregional control.Reference:Samson DJ, Ratko TA, Rothenberg BM, et al. Comparative Effectiveness and Safety of Radiotherapy Treatments for Head and Neck Cancer, Comparative Effectiveness Review No. 20 (Prepared by the Blue Cross and Blue Shield Association Technology Evaluation Center Evidence-based Practice Center under Contract No. 290-02-0026). Rockville, MD: Agency for Healthcare Research and Quality; May 2010. AHRQ Publication No. 10-EHC014-EF. Available at: http://www.effectivehealthcare.ahrq.gov/index.cfm/search-for-guides-reviews-and-reports/?pageaction=displayproduct&productID=447.
  • Conclusions on the Comparative Effectiveness Regarding Quality of Life and Adverse Events: IMRT vs. 2DRTPatients who receive IMRT have reduced late xerostomia and better quality of life (as it relates to late xerostomia) compared with those who receive 2DRT [Level of Evidence: Moderate]. There is insufficient evidence to permit conclusions about other outcomes related to adverse events and quality of life. Reference:Samson DJ, Ratko TA, Rothenberg BM, et al. Comparative Effectiveness and Safety of Radiotherapy Treatments for Head and Neck Cancer, Comparative Effectiveness Review No. 20 (Prepared by the Blue Cross and Blue Shield Association Technology Evaluation Center Evidence-based Practice Center under Contract No. 290-02-0026). Rockville, MD: Agency for Healthcare Research and Quality; May 2010. AHRQ Publication No. 10-EHC014-EF. Available at: http://www.effectivehealthcare.ahrq.gov/index.cfm/search-for-guides-reviews-and-reports/?pageaction=displayproduct&productID=447.
  • Evidence on the Comparative Effectiveness Regarding Quality of Life and Adverse Events: 3DCRT vs. 2DRTFour studies reported on late xerostomia with a range of differences between 3DCRT and 2DRT of 15 to 48 percentage points, except one study that favored 2DRT by 10 percentage points. Only one result was statistically significant.• One study compared quality of life outcomes between 3DCRT and 2DRT but did not report a statistical comparison.• Acute xerostomia, acute mucositis, late mucositis, acute dysphagia, acute skin toxicity, late skin toxicity, and late osteoradionecrosis and bone toxicity were reported in a few studies; differences between 3DCRT and 2DRT were small and not statistically significant, not exceeding a difference of 9 percentage points.• The available literature is of insufficient quantity and quality to ascertain whether there are differences in quality of life or adverse events, including late xerostomia, between 3DCRT and 2DRT.Reference:Samson DJ, Ratko TA, Rothenberg BM, et al. Comparative Effectiveness and Safety of Radiotherapy Treatments for Head and Neck Cancer, Comparative Effectiveness Review No. 20 (Prepared by the Blue Cross and Blue Shield Association Technology Evaluation Center Evidence-based Practice Center under Contract No. 290-02-0026). Rockville, MD: Agency for Healthcare Research and Quality; May 2010. AHRQ Publication No. 10-EHC014-EF. Available at: http://www.effectivehealthcare.ahrq.gov/index.cfm/search-for-guides-reviews-and-reports/?pageaction=displayproduct&productID=447.
  • Other Issues ConsideredKey Question 3 of the CER asked: Are there differences in comparative effectiveness of IMRT, 3DCRT, 2DRT, and proton beam therapy for specific patient characteristics?Upon review of the literature, it was determined that no comparative studies addressing this key question exist, thus no conclusions could be reached.Level of evidence: InsufficientKey Question 4 of the CER asked: Are there differences in comparative effectiveness of IMRT, 3DCRT, 2DRT, and proton beam therapy for user experience, target volume delineation, or dosimetric parameters? Upon review of the literature, it was determined that no comparative studies addressed this key question, thus no conclusions could be reached.Level of evidence: InsufficientReference:Samson DJ, Ratko TA, Rothenberg BM, et al. Comparative Effectiveness and Safety of Radiotherapy Treatments for Head and Neck Cancer, Comparative Effectiveness Review No. 20 (Prepared by the Blue Cross and Blue Shield Association Technology Evaluation Center Evidence-based Practice Center under Contract No. 290-02-0026). Rockville, MD: Agency for Healthcare Research and Quality; May 2010. AHRQ Publication No. 10-EHC014-EF. Available at: http://www.effectivehealthcare.ahrq.gov/index.cfm/search-for-guides-reviews-and-reports/?pageaction=displayproduct&productID=447.
  • What To Discuss With Your Patients About Radiotherapy Treatments for Head and Neck CancerRadiation is associated with early and late toxicities, which can have a profound effect on a patient’s quality of life, and chemoradiation may be associated with enhancement of these toxicities (particularly mucositis and xerostomia). Therapy related toxicities are particularly relevant in the treatment of head and neck cancer because of the close proximity of many important dose-limiting normal tissues. Treatment effects can affect basic functions like chewing, swallowing, and breathing, and the senses (e.g., taste, smell, and hearing), and can significantly alter appearance and voice. Most of the studies in this review were based on the results of patients treated at academic medical centers. However, an informal survey estimates that 30 to 60 percent of all cancer patients in the U.S. are treated with IMRT. Whether similar results will be achieved as the technology diffuses to less-experienced settings has not been addressed in the comparative studies available for this review.Reference:Samson DJ, Ratko TA, Rothenberg BM, et al. Comparative Effectiveness and Safety of Radiotherapy Treatments for Head and Neck Cancer, Comparative Effectiveness Review No. 20 (Prepared by the Blue Cross and Blue Shield Association Technology Evaluation Center Evidence-based Practice Center under Contract No. 290-02-0026). Rockville, MD: Agency for Healthcare Research and Quality; May 2010. AHRQ Publication No. 10-EHC014-EF. Available at: http://www.effectivehealthcare.ahrq.gov/index.cfm/search-for-guides-reviews-and-reports/?pageaction=displayproduct&productID=447.
  • Gaps in Knowledge: Radiotherapy Treatments for Head and Neck CancerThe available literature to assess the relative effectiveness of different techniques of radiotherapy in head and neck cancer on the whole consisted of poor-quality studies and, with the exception of late xerostomia and quality of life, a low or insufficient level of evidence. The challenges of conducting research in head and neck cancer need to be acknowledged. Head and neck cancers are not common, so the pace of patient accrual may be slow; this may be accompanied by changes in practices, both for the technology of radiotherapy itself and other aspects of management and treatment. Also, head and neck cancer patients are likely to be clinically diverse in terms of tumor site, histology, stage, prior and co-interventions, and other factors. On the other hand, the length of followup needed to study head and neck cancer treatments is relatively short when compared to some common cancers, such as breast or colon cancer. A further challenge to evaluating radiotherapy techniques for head and neck cancer concerns the rapid pace at which these technologies are evolving. Reference:Samson DJ, Ratko TA, Rothenberg BM, et al. Comparative Effectiveness and Safety of Radiotherapy Treatments for Head and Neck Cancer, Comparative Effectiveness Review No. 20 (Prepared by the Blue Cross and Blue Shield Association Technology Evaluation Center Evidence-based Practice Center under Contract No. 290-02-0026). Rockville, MD: Agency for Healthcare Research and Quality; May 2010. AHRQ Publication No. 10-EHC014-EF. Available at: http://www.effectivehealthcare.ahrq.gov/index.cfm/search-for-guides-reviews-and-reports/?pageaction=displayproduct&productID=447.

Head and Neck Cancer Head and Neck Cancer Presentation Transcript

  • Comparative Effectiveness and Safety of Radiotherapy Treatments for Head and Neck Cancer Prepared for: Agency for Healthcare Research and Quality (AHRQ) www.ahrq.gov
  • Head and Neck Cancer: Anatomy
  • Health Impact of Head and Neck Cancerin the United States Head and neck cancer accounts for approximately 3 to 5 percent of cancers in the United States. The estimated new cases of head and neck cancer in the U.S. have increased from 47,560 in 2008 to 49,260 in 2010. The estimated deaths from head and neck cancer in the U.S. have increased from 11,260 in 2008 to 11,450 in 2010. National Comprehensive Cancer Network Web site. Available at: http://www.nccn.org/professionals/ physician_gls/f_guidelines.asp; American Cancer Society. Cancer Facts and Figures 2010. Available at: http://www.cancer.org/acs/groups/content/@nho/documents/document/acspc-024113.pdf.
  • Classification and Staging ofHead and Neck Cancer Most types of head and neck cancer arise from a noninvasive precursor in the surface squamous epithelium that progresses to become squamous cell carcinoma. Approximately 40 percent of head and neck cancers are early stage, and the remaining 60 percent are locally advanced. Metastatic disease is uncommon at the time of diagnosis. National Comprehensive Cancer Network Web site. Available at: http://www.nccn.org/professionals/ physician_gls/f_guidelines.asp; Samson DJ, et al. AHRQ Comparative Effectiveness Review No. 20. Available at: http://www.effectivehealthcare.ahrq.gov/ index.cfm/search-for-guides-reviews-and-reports/?pageaction= displayproduct&productID=447.
  • Classification and Staging of Head and Neck Cancer (Continued) Early Stage Locally Advanced (Stages I and II) (Stages III and IV)Representation at 40% 60%diagnosisDefinition Small primary tumor Large primary tumors, without lymph node which may invade involvement adjacent structures and/or spread to regional lymph nodesTypical treatment plan Single modality Combined modality (surgery or radiation) Samson DJ, et al. AHRQ Comparative Effectiveness Review No. 20. Available at: http://www.effectivehealthcare.ahrq.gov/index.cfm/search-for-guides-reviews-and-reports/ ?pageaction=displayproduct&productID=447.
  • Risk Factors for Head and Neck Cancer Tobacco and alcohol abuse Viral infection (e.g., human papillomavirus, Epstein-Barr virus) Occupational exposures Nutritional deficiencies Poor oral health Behavioral factors Family history Samson DJ, et al. AHRQ Comparative Effectiveness Review No. 20. Available at: http://www.effectivehealthcare.ahrq.gov/index.cfm/search-for-guides-reviews-and-reports/ ?pageaction=displayproduct&productID=447.
  • Clinical Management of Head and NeckCancer Treatment of head and neck cancer is complex and usually involves a multidisciplinary team. The type of treatment used is dictated by the site and extent of the disease. Nearly all patients with locally advanced disease receive radiation, and many of those also get chemotherapy as part of initial curative treatment. Patients are subject to early and late treatment-related toxicities, which can profoundly affect their quality of life. Forastiere AA. J Surg Oncol 2008;97:701-7; National Comprehensive Cancer Network Web site. Available at: http://www.nccn.org/professionals/ physician_gls/f_guidelines.asp; Samson DJ, et al. AHRQ Comparative Effectiveness Review No. 20. Available at: http://www.effectivehealthcare.ahrq.gov/index.cfm/search-for-guides-reviews-and-reports/ ?pageaction=displayproduct&productID=447.
  • Radiation Delivery Technology  The main goals of improvements in advancing treatment delivery technology have been to maximize disease control and minimize toxicity.  One of the principle technologies used to accomplish this to date has been conformal therapy.  Conformal Therapy  An attempt to deliver radiation to the tumor target while not delivering radiation to nontumor targets (normal tissues). Samson DJ, et al. AHRQ Comparative Effectiveness Review No. 20. Available at: http://www.effectivehealthcare.ahrq.Gov/index.cfm/search-for-guides-reviews-and-reports/ ?pageaction=displayproduct&productID=447.
  • External-Beam Radiation Therapy forHead and Neck Cancer Delivery Methods  Two-dimensional radiation therapy  Three-dimensional conformal radiation therapy  Intensity-modulated radiation therapy  Proton beam therapy Samson DJ, et al. AHRQ Comparative Effectiveness Review No. 20. Available at: http://www.effectivehealthcare.ahrq.Gov/index.cfm/search-for-guides-reviews-and-reports/ ?pageaction=displayproduct&productID=447.
  • Treatment Planning Forward Planning  This type of planning is used in 2DRT and 3DCRT.  Planner designs the beams and then calculates dose given by beam. Inverse Planning  This type of planning is used in IMRT.  Planner sets goal for dose first (defines goals of dose to tumor and normal tissue); computer algorithms then calculate beam intensity and dose from each beam, based on those goals. IMRT = intensity-modulated radiation therapy; 2DRT = two-dimensional radiation therapy; 3DCRT = three-dimensional conformal radiation therapy Samson DJ, et al. AHRQ Comparative Effectiveness Review No. 20. Available at: http://www.effectivehealthcare.ahrq.gov/index.cfm/search-for-guides-reviews-and-reports/ ?pageaction=displayproduct&productID=447.
  • Two-Dimensional Radiation Therapy andThree-Dimensional Conformal Radiation Therapy 2DRT consists of radiation fields designed on 2D fluoroscopic simulation images; typically consists of one to four beams. 3DCRT employs computed tomography simulation, which allows more precise tumor definition. 3DCRT allows the use of a greater number of beams than typically used in 2DRT. 3DCRT allows more accurate dose calculation by accounting for axial anatomy and complex tissue contours. RT = radiation therapy; 2D = two-dimensional; 3D = three-dimensional; CRT = conformal RT Burri MK, et al. CA Cancer J Clin 2005;55:117-34; Lee NY, Terezakis SA. J Surg Oncol 2008;97:691;-6; Samson DJ, et al. AHRQ Comparative Effectiveness Review No. 20. Available at: http://www.effectivehealthcare.ahrq.gov/index.cfm/search-for-guides-reviews-and-reports/ ?pageaction=displayproduct&productID=447.
  • Intensity-Modulated Radiation Therapy Intensity-modulated radiation therapy has been implemented over the last decade. Further refines dose delivery by allowing the modulation of beam intensity within each treatment field and by permitting inverse treatment planning. Ballivy O, et al. Clin Transl Oncol 2008;10:407-14; Burri MK, et al. CA Cancer J Clin 2005;55:117-34; Mendenhall WM, et al. J Clin Oncol 2006;24:2618-23; Samson DJ, et al. AHRQ Comparative Effectiveness Review No. 20. Available at: http://www.effectivehealthcare.ahrq.gov/index.cfm/search-for-guides-reviews-and-reports/ ?pageaction= displayproduct&productID=447.
  • Potential Advantages and Disadvantagesof IMRT When Compared With 2DRT and3DCRT Potential Advantages Potential DisadvantagesHigher dose delivered to tumor Higher total body doseSparing of normal, surrounding Increased risk of marginal misstissue from radiation damage and dose perturbationDecreased toxicity Time and expenseIMRT = intensity-modulated radiation therapy; 2DRT = two-dimensional radiation therapy;3DCRT = three-dimensional conformal radiation therapyBallivy O, et al. Clin Transl Oncol 2008;10:407-14; Burri MK, et al. CA Cancer J Clin 2005;55:117-34; Mendenhall WM,et al. J Clin Oncol 2006;24:2618-23; Samson DJ et al. AHRQ Comparative Effectiveness Review No. 20. Available at:http://www.effectivehealthcare.ahrq.gov/index.cfm/search-for-guides-reviews-and-reports/?pageaction=displayproduct&productID=447.
  • Proton Beam Therapy A different type of radiation, as opposed to the standard type that uses photons. At present, it typically uses 1 to 3 beams. Proton beams can essentially stop at a target, as opposed to photons that continue to travel through tissue. Proton beam therapy can be planned using 3D images; the technology for using inverse planning with proton beam therapy is just coming into use. Samson DJ, et al. AHRQ Comparative Effectiveness Review No. 20. Available at: http://www.effectivehealthcare.ahrq.gov/index.cfm/search-for-guides-reviews-and- reports/?pageaction=displayproduct&productID=447.
  • The Comparative Effectiveness ReviewDevelopment Process The topic of the comparative effectiveness review (CER) was nominated in a public process. Input from experts and stakeholders was used to refine the topic and to develop the clinical questions that the CER would address. The clinical questions were made available for public comment on the Effective Health Care (EHC) Program Web site and then finalized. The systematic literature review was conducted using approved AHRQ methods and with input from a technical expert panel. The draft CER was made available for public comment on the EHC Program Web site and underwent a rigorous peer-review process to improve the final product. The final CER was published on the EHC Web site. Guyatt GH, et al. BMJ 2008;336:924-6; Owens DK, et al. J Clin Epidemiol 2010;63:513-23; Samson DJ, et al. AHRQ Comparative Effectiveness Review No. 20. Available at: http://www.effectivehealthcare.ahrq.gov/ index.cfm/search-for-guides-reviews-and-reports/?pageaction=displayproduct&productID=447.
  • Rating the Strength of Evidence From theCER:A Modification of the GRADE Methodology The strength of the overall body of evidence was rated using a system adapted from the method of the GRADE Working Group. The modified system uses four domains—risk of bias, consistency, directness, and precision—for assessment. The strength of evidence pertaining to each key question was classified into three broad categories or grades: High confidence that the evidence reflects the true effect. Further research High is very unlikely to change our confidence in the estimate of effect. Moderate confidence that the evidence reflects the true effect. Further Moderate research may change our confidence in the estimate of effect and may change the estimate. Low confidence that the evidence reflects the true effect. Further research Low is likely to change our confidence in the estimate of effect and is likely to change the estimate. Insufficient Evidence is either unavailable or does not permit estimation of an effect. Guyatt GH, et al. BMJ 2008;336:924-6; Owens DK, et al. J Clin Epidemiol 2010;63:513-23; Samson DJ, et al. AHRQ Comparative Effectiveness Review No. 20. Available at: http://www.effectivehealthcare.ahrq.gov/ index.cfm/search-for-guides-reviews-and-reports/?pageaction=displayproduct&productID=447.
  • Interventions of Interest 2DRT: any treatment plan in which only two-dimensional projection radiographs are used to delineate radiation beams and target volumes. 3DCRT: any treatment plan in which computerized tomography-based treatment planning is used to delineate radiation beams and target volumes in three dimensions. IMRT: any treatment plan in which intensity-modulated radiation beams and computerized inverse treatment planning is used. Proton beam therapy: any treatment plan in which proton beam radiation is used. IMRT = intensity-modulated radiation therapy; 2DRT = two-dimensional radiation therapy; 3DCRT = three-dimensional conformal radiation therapy Samson DJ, et al. AHRQ Comparative Effectiveness Review No. 20. Available at: http://www.effectivehealthcare. ahrq.gov/index.cfm/search-for-guides-reviews-and-reports/?pageaction=displayproduct&productID=447.
  • Comparative Effectiveness Review:Outcomes of Interest Primary Outcomes*: Health  Secondary Outcomes*: Intermediate  Radiation-induced toxicities  Salivary flow  Adverse events, both acute  Probability of completing and chronic normal treatment according to protocol tissue toxicity  Effect on quality of life  Clinical effectiveness  Local and locoregional control  Disease-free & overall survival *The specific primary and secondary outcomes selected here were those for which more than five comparative studies provided data and clinical expert consensus indicated their importance. Samson DJ, et al. AHRQ Comparative Effectiveness Review No. 20. Available at: http://www.effectivehealthcare.ahrq.gov/index.cfm/search-for-guides-reviews-and- reports/?pageaction=displayproduct&productID=447.
  • Key Clinical Questions Addressed by the Comparative Effectiveness Review of Radiotherapy for Head and Neck Cancer What is the comparative effectiveness of IMRT, 3DCRT, 2DRT, and proton beam therapy regarding tumor control and patient survival? What is the comparative effectiveness of IMRT, 3DCRT, 2DRT, and proton beam therapy regarding adverse events and quality of life? Are there differences in the comparative effectiveness of IMRT, 3DCRT, 2DRT, and proton beam therapy for specific patient and tumor characteristics? Is there variation in comparative effectiveness of IMRT, 3DCRT, 2DRT, and proton beam therapy because of differences in user experience, target volume delineation, or dosimetric parameters? IMRT = intensity-modulated radiation therapy; 2DRT = two-dimensional radiation therapy; 3DCRT = three-dimensional conformal radiation therapy Lawrence TS, et al. In: Cancer. principles and practice of oncology. 8th ed, Vol 1. 2008. p. 307-36; National Comprehensive Cancer Network Web site. Available at: http://www.nccn.org/professionals/ physician_gls/f_guidelines.asp; Samson DJ, et al. AHRQ Comparative Effectiveness Review No. 20. Available at: http://www.effectivehealthcare.ahrq.gov/index.cfm/search-for-guides- reviews-and-reports/?pageaction=displayproduct&productID=447.
  • Planned Comparisons IMRT vs. 3DCRT IMRT vs. 2DRT 3DCRT vs. 2DRT Proton beam therapy vs. 2DRT, 3DCRT, and IMRT IMRT = intensity-modulated radiation therapy; 2DRT = two-dimensional radiation therapy; 3DCRT = three-dimensional conformal radiation therapy Samson DJ, et al. AHRQ Comparative Effectiveness Review No. 20. Available at: http://www.effectivehealthcare.ahrq.gov/index.cfm/search-for-guides-reviews-and- reports/?pageaction=displayproduct&productID=447.
  • Overview of Available Literature Small body of randomized, controlled trials. Larger body of observational, nonrandomized studies that have high potential for bias of results (e.g., single institution case series). Clinical diversity of observational studies, with respect to patient characteristics and treatment setting, created uncertainty about significance of confounding. AHRQ. Methods Reference Guide for Effectiveness and Comparative Effectiveness Reviews. Available at: http://effectivehealthcare.ahrq.gov/repFiles/2007_10DraftMethodsGuide.pdf; Samson DJ, et al. AHRQ Comparative Effectiveness Review No. 20. Available at: http://www.effectivehealthcare.ahrq. gov/index.cfm/search-for-guides-reviews-and-reports/ ?pageaction=displayproduct&productID=447.
  • Clinical Bottom Line: Comparative Evidence for2DRT, 3DCRT, and IMRT Tumor Control or Survival: There is insufficient evidence to determine whether 2DRT, 3DCRT, or IMRT confers any advantages when compared with each other.  Level of evidence: insufficient Adverse Effects: IMRT is associated with a lower incidence of late xerostomia, when compared with 3DCRT or 2DRT.  Level of evidence: moderate Adverse Effects: For adverse events other than xerostomia, there is insufficient evidence to permit conclusions about the comparative effects of 2DRT, 3DCRT, or IMRT.  Level of evidence: insufficient IMRT = intensity-modulated radiation therapy; 2DRT = two-dimensional radiation therapy; 3DCRT = three-dimensional conformal radiation therapy Samson DJ, et al. AHRQ Comparative Effectiveness Review No. 20. Available at: http://www.effectivehealthcare.ahrq.gov/index.cfm/search-for-guides-reviews-and- reports/?pageaction=displayproduct&productID=447.
  • Clinical Bottom Line: Comparative Evidence for 2DRT,3DCRT, and IMRT Quality of Life: Patients who received IMRT had improved quality of life in domains related to late xerostomia when compared with those who received 3DCRT or 2DRT.  Level of evidence: moderate Quality of Life: There is insufficient evidence to determine the comparative effects of IMRT, 3DCRT, and 2DRT on other quality of life indicators.  Level of evidence: insufficient Experience of Treatment Team: The data is insufficient to determine whether the experience of the clinical team confers an advantage, as no comparative studies addressed this issue.  Level of evidence: insufficient IMRT = intensity-modulated radiation therapy; 2DRT = two-dimensional radiation therapy; 3DCRT = three-dimensional conformal radiation therapy Samson DJ, et al. AHRQ Comparative Effectiveness Review No. 20. Available at: http://www.effectivehealthcare.ahrq.gov/index.cfm/search-for-guides-reviews-and-reports/ ?pageaction=displayproduct&productID=447.
  • Clinical Bottom Line: ComparativeEvidence for Proton Beam vs. 2DRT,3DCRT, and IMRT No comparative studies addressed the domains of tumor control, survival, adverse effects, quality of life, or experience of the treatment team. The data, therefore, are insufficient to permit conclusions about proton beam therapy when compared with the other modalities.  Level of evidence: insufficient Samson DJ, et al. AHRQ Comparative Effectiveness Review No. 20. Available at: http://www.effectivehealthcare.ahrq.gov/index.cfm/search-for-guides-reviews-and- reports/?pageaction=displayproduct&productID=447.
  • Comparative Effectiveness RegardingImproved Tumor Control or Survival Evidence on Tumor Control Comparison or Survival IMRT vs. 3DCRT Insufficient IMRT vs. 2DRT Insufficient 2DRT vs. 3DCRT InsufficientIMRT = intensity-modulated radiation therapy; 2DRT = two-dimensional radiation therapy;3DCRT = three-dimensional conformal radiation therapySamson DJ, et al. AHRQ Comparative Effectiveness Review No. 20. Available at:http://www.effectivehealthcare.ahrq.gov/index.cfm/search-for-guides-reviews-and-reports/?pageaction=displayproduct&productID=447.
  • Effectiveness Regarding Quality of Lifeand Adverse Events The review considered 38 comparative studies.  Of these, four were randomized, controlled trials (RCT).  One RCT could not be clearly rated because a manuscript was unavailable.  One RCT was rated fair.  Two RCTs were rated poor because they lacked intention-to-treat analysis. The remaining 34 studies were observational, with significant flaws such as: lacking comparable groups at baseline; making comparisons of radiotherapy technologies at different points in time (i.e., the study arms were not contemporaneous); and including poorly performed multivariable analyses. Samson DJ, et al. AHRQ Comparative Effectiveness Review No. 20. Available at: http://www.effectivehealthcare.ahrq.gov/index.cfm/search-for-guides-reviews-and-reports/ ?pageaction=displayproduct&productID=447.
  • Evidence on the Comparative Effectiveness RegardingQuality of Life and Adverse Events: IMRT vs. 3DCRT Based on 14 comparative studies of IMRT vs. 3DCRT. One was an unpublished, randomized, controlled trial that was assessed a quality rating of good. Thirteen were observational studies, of which all were assessed poor quality ratings. IMRT = intensity-modulated radiation therapy; 3DCRT = three-dimensional conformal radiation therapy Samson DJ, et al. AHRQ Comparative Effectiveness Review No. 20. Available at: http://www.effectivehealthcare.ahrq.gov/index.cfm/search-for-guides-reviews-and-reports/ ?pageaction=displayproduct&productID=447.
  • Studies Regarding Quality of Life andAdverse Events: IMRT vs. 3DCRT NS = not significant; NR = not reportedSamson DJ, et al. AHRQ Comparative Effectiveness Review No. 20. Available at:http://www.effectivehealthcare.ahrq.gov/index.cfm/search-for-guides-reviews-and-reports/?pageaction=displayproduct&productID=447.
  • Conclusions on the Comparative Effectiveness RegardingQuality of Life and Adverse Events: IMRT vs. 3DCRT IMRT results in less late xerostomia and better quality of life as it relates to xerostomia, when compared with 3DCRT.  Level of Evidence: Moderate IMRT = intensity-modulated radiation therapy; 3DCRT = three-dimensional conformal radiation therapy Samson DJ, et al. AHRQ Comparative Effectiveness Review No. 20. Available at: http://www.effectivehealthcare.ahrq.gov/index.cfm/search-for-guides-reviews-and-reports/ ?pageaction=displayproduct&productID=447.
  • Evidence on the Comparative Effectiveness RegardingQuality of Life and Adverse Events: IMRT vs. 2DRT Twenty-two comparative studies addressing IMRT and 2DRT: 2 randomized controlled trials (RCTs) and 20 observational studies, of which 5 were prospective designs. Nine studies reported on late xerostomia; 5 studies reported on acute xerostomia; quality of life was reported in 1 RCT and 2 observational studies. Studies not well designed to control for bias and confounding. All studies, with the exception of one RCT (which was considered to be of fair quality), were of poor quality. IMRT = intensity-modulated radiation therapy; 2DRT = two-dimensional radiation therapy Samson DJ, et al. AHRQ Comparative Effectiveness Review No. 20. Available at: http://www.effectivehealthcare.ahrq.gov/index.cfm/search-for-guides-reviews-and-reports/ ?pageaction=displayproduct&productID=447.
  • Studies Regarding Late Xerostomia: IMRT vs. 2DRT IMRT = intensity-modulated radiation therapy; 2DRT = two-dimensional radiation therapy; RT = radiation therapySamson DJ, et al. AHRQ Comparative Effectiveness Review No. 20. Available at:http://www.effectivehealthcare.ahrq.gov/index.cfm/search-for-guides-reviews-and-reports/?pageaction=displayproduct&productID=447.
  • Conclusions on the Comparative Effectiveness RegardingQuality of Life and Adverse Events: IMRT vs. 2DRT The body of evidence suggests less late xerostomia and better quality of life, as it relates to xerostomia, with IMRT.  Level of evidence: Moderate  Eight of nine studies reporting on late xerostomia were statistically significant in favor of IMRT over 2DRT (range of difference, 43–62%) .  Quality of life measurements generally favored IMRT over 2DRT, although not all domains measured were statistically significant.  The magnitude of difference reported in the studies is uncertain due to poor quality. IMRT = intensity-modulated radiation therapy; 2DRT = two-dimensional radiation therapySamson DJ, et al. AHRQ Comparative Effectiveness Review No. 20. Available at: http://www.effectivehealthcare.ahrq.gov/index.cfm/search-for-guides-reviews-and-reports/ ?pageaction=displayproduct&productID=447.
  • Evidence on the Comparative Effectiveness RegardingQuality of Life and Adverse Events: 3DCRT vs. 2DRT Twelve comparative studies addressed 3DCRT and 2DRT: 1 RCT and 11 observational, of which 2 were prospective observational studies. Studies were of poor quality, were not well designed for control of bias and confounding, and had other weaknesses. Conclusion: The available literature is of insufficient quantity and quality to ascertain whether there are differences in quality of life or adverse events between 3DCRT and 2DRT. 2DRT = two-dimensional radiation therapy; 3DCRT = three-dimensional conformal radiation therapy Samson DJ, et al. AHRQ Comparative Effectiveness Review No. 20. Available at: http://www.effectivehealthcare.ahrq.gov/index.cfm/search-for-guides-reviews-and-reports/ ?pageaction=displayproduct&productID=447.
  • Other Issues Considered Level of evidence is insufficient to determine whether:  Specific patient characteristics influence the comparative effectiveness of IMRT, 3DCRT, 2DRT, or proton beam therapy for patients with head and neck cancers.  User experience, target volume delineation, or dosimetric parameters influence the comparative effectiveness of IMRT, 3DCRT, 2DRT or proton beam therapy for patients with head and neck cancers. IMRT = intensity-modulated radiation therapy; 2DRT = two-dimensional radiation therapy; 3DCRT = three-dimensional conformal radiation therapy Samson DJ, et al. AHRQ Comparative Effectiveness Review No. 20. Available at: http://www.effectivehealthcare.ahrq.gov/index.cfm/search-for-guides-reviews-and-reports/ ?pageaction=displayproduct&productID=447.
  • What To Discuss With Your Patients AboutRadiotherapy Treatments for Head and Neck Cancer Whether critical normal structures are present in the field to be irradiated (e.g., salivary glands, the pituitary gland, optic nerve) and potential resulting adverse events. The potential benefits and the acute and late harms of the proposed radiation treatment for the individual patient— given the type, location, and stage of his or her cancer. The potential long-term adverse effects of radiation on quality of life—given the patient’s individual lifestyle and values. The level of skill and experience of the cancer treatment team in planning and delivering various forms of radiation therapy. Samson DJ, et al. AHRQ Comparative Effectiveness Review No. 20. Available at: http://www.effectivehealthcare.ahrq.gov/index.cfm/search-for-guides-reviews-and-reports/ ?pageaction=displayproduct&productID=447.
  • Gaps in Knowledge:Radiotherapy Treatments for Head and Neck Cancer High-quality studies are needed to determine the comparative effectiveness of IMRT, 3DCRT, 2DRT, and proton beam radiation therapy:  In achieving tumor control and improving patient survival.  In reducing adverse events and improving quality of life indicators.  In understanding how outcomes are affected by the characteristics of the tumor, the patient, and the physician/radiotherapy team (e.g., experience), or by radiation treatment planning (e.g., target volume delineation, dosimetric parameters). IMRT = intensity-modulated radiation therapy; 2DRT = two-dimensional radiation therapy; 3DCRT = three-dimensional conformal radiation therapy Samson DJ, et al. AHRQ Comparative Effectiveness Review No. 20. Available at: http://www.effectivehealthcare.ahrq.gov/index.cfm/search-for-guides-reviews-and-reports/ ?pageaction=displayproduct&productID=447.