Several other clinical trials: Dutch-Belgium NELSON trial, final results 2015-compares CT screening with usual careIn addition, on going trials in Italy, Germany and the United Kingdom. The task force is hoping to bring all this data together and have some answers in the next 3-4 years.
It is the key to saving livesIt is evidence based practice which will soon be standard of careScreening is the “Meat and Potatoes” of a Thoracic ProgramWhen guidelines for screening are established patients will be looking to their community hospitals for screening programs
1970 – 1980: Studies of chest x-rays disappointing for people considered high risk for lung cancer; computed tomography introducedCT scanners gradually become widely availableIn 1991, radiology researchers led by Claudia Henschke, MD, began investigating the potential of CT scans to provide the screening benefit that chest x-rays failed to show
Initially started in New York State, this ongoing observational study and research program, the International Early Lung Cancer Action Program (I-ELCAP), now has over 50,000 participants in thirteen states and eight other countriesThe purpose is twofold: assess the impact of CT screening on high risk patients and to continuously upgrade and improve the comprehensive I-ELCAP protocol - the standards and precise regimen for screening and diagnosis - as imaging advances and new findings become available Results published in the New England Journal of Medicine in 2006 indicated …participants with clinical stage I cancer who underwent surgical resection within 1 month of diagnosis, the survival rate was 92% (Henschke et al., 2006). This trial was criticized because it did not address a mortality benefit from lung cancer screening.For more information on I-ELCAP visit: http://www.ielcap.org/
In 2002, the National Cancer Institute launched the National Lung Screening Trial (NLST) The endpoint was to see if CT screening could reduce the number of lung cancer deaths by at least 20%. recruited over 53,000 people, current and former smokers between the ages of 55 and 74 who smoked for 30 pack-years. Half were screened with chest x-rays and the other half with CT scans. Each participant received three annual screens starting in 2005 and ending in 2007.The trial was to go through 2012November 2010 the trial was stopped20.3% fewer lung cancer deaths with those screened with CT scan.In fact, “The rate of death from any cause was reduced in the low-dose CT group, as compared with the radiology group…(NLST, 2011)
To put the 20.3% figure in context, the overall mortality benefit of mammography screening for breast cancer is 15%. PSA testing for prostate cancer failed to show any mortality benefit in US based randomized controlled trials but did show a 20% benefit in a Swedish trialThe actual mortality benefit of CT screening could be much greater. Recent modeling studies by I-ELCAP and others suggest that it could range from 37-65%.
A false positive can result in further testing, additional radiation exposure, cost and possibly unnecessary biopsies or surgeries which entail additional risks….”a comparison of the numbers of cancers diagnosed in the two trial groups [X-ray vs. CT] suggests that the magnitude of over diagnosis with low-dose CT as compared with radiographic screening is not large (2011, NLST research team). Complications from invasive diagnostic evaluation procedures were uncommon… (2011, NLST research team).10-30% of those screened for cancer by mammography, colonoscopy, PSA testing, or CT scans will have a positive screen requiring further testingOn average 13% of those screened using the I-ELCAP protocol will have a positive screen requiring further workup
The potential problems can be safely managed with adherence to a well developed protocol for the screening, diagnosis and treatment of early lung cancer
State your purpose and visionLet them catch your passion and vision so that they want to be involvedDevelop Ownership by “brain storming”Let the key players suggest how they would implement their “piece” in the processCommitment is fostered
You are the glue that holds the program together
CT Lung screening is “value added.” This program will increase awareness of your TOP through advertising, word of mouth, patient satisfaction and PCP referrals
We have a cash pay program. No insurance is billedPatient is aware of this upon enrollment
The USPSTF task force is a panel of non-Federal experts in prevention and evidence-based medicine and is composed of mostly PCP’s.
The new data will be reviewed by the U.S. Preventative Services Task Force (USPSTF) in 2012 The USPSTF task force is a panel of non-Federal experts in prevention and evidence-based medicine and is composed of mostly PCP’s.ASCO developing clinical practice guideline on lung cancer screening with the NCCN, ACS and the American College of Chest PhysiciansWhen the NCCN guidelines are established criteria within your screening program can be adjusted accordingly
Follow-up with a thank you letter to the PCPEncourage the PCP to call us if they have a suspicious nodule and we will present the case at multidisciplinary conference Let PCP’s know that after work-up, diagnosis and treatment the patient will be returned to them (PCP’s will not lose their patients) Advertise your TOP program; VATS, multidisciplinary program, CT lung screening, smoking cessationEmphasize- “We want to find lung cancer early; when it is treatable and possibly curable”
There were significant challenges with patient compliance to repeat scans at 3, 6 or 12 months. Interventional tactics to encourage patient compliance need to be implemented. Strategic planning should include expansion and flexibility to modify screening programs as evidence points toward National screening guidelines
Mayo Clinic Nicotine Dependence Center1 week training in Rochester MNBrings evidence based credibility to your smoking cessation programYour smoking cessation curriculum can be developed using the Mayo Clinic and the RX For Change (UCSF) info at rxforchange.comwww.becomeanex.org Purchase a CO monitor www.testbreath.comShould measure CO in ppmCost around $1200.00The CO assessment is reimbursable with CPT code 94720
Class consists of an initial consultation with the Tobacco Treatment Specialist (45-60 min)followed by 5 weekly group classes (2 hours each)Sense of community develops within the groupGraduation ceremonyF/U at 1,3,6 months through e-mailCessation percentage essentialDevelop brochures or flyersClasses are free but charge for consultationBilled as “incident to”Use ICD 9 code 305.1 Tobacco Use Disorder CPT code 99407 Tobacco behavior change >10 minutes Develop an Excel data base to keep statistics such as; cessation method, quit rate at 1, 3 and 6 months
Lung cancer is the leading cause of worldwide cancer mortality and is responsible for more deaths annually in the United States than the combination of breast, colorectal, and prostate cancer combined. IN 2010, according to the CDC, there were 222, 520 new cases of combined NSCL and SCL with 157,300 deaths.
Pie chart of the incidence of lung cancer types, sorted by histological subtypes, in turn sorted into how many are non-smokers versus smokers – “smokers” by definition are current or formerly smoked more than/longer than 1 year. Kenfield SA, Wei EK, Stampfer MJ, Rosner BA, Colditz GA (2008). "Comparison of aspects of smoking among the four histological types of lung cancer.". Tob Control17 (3): 198-204. DOI:10.1136/tc.2007.022582. PMID18390646. PMC:PMC3044470.Raw data:“Lung cancer is a unique disease in that the etiologic agent is actually an industry.” Journal of National Comprehensive Cancer Network. Non-Small Cell Lung Cancer Version 1:2010. Vol8, No7. pg:742. July 2010.The highest incidence of lung cancer (nonsmall cell, which includes adenocarcinoma as well as squamous, is found in African American men and women.Adenocarcinoma represents 40% of all lung cancer in smokers in the U.S. and is also the most common cell type seen in non-smokers.Adenoca usually is seen peripherally in the lungs, as opposed to small cell lung cancer and squamous cell lung cancer, which both tend to be more centrally located, although it may also occur as central lesions.
As demonstrated on the previous graph, nearly 85% of lung cancers are classified as non-small-cell lung cancer (NSCLC), and up to 70% of NSCLC present as locally advanced (stage III) which means that it has spread to nearby tissues or lymphnodes, or metastatic disease (stage IV). Treatment approaches are rapidly advancing on personalized medicine, utilizing targeted therapies based on and tumorimmunohistochemistries, and specialized markers---all of which represent a significant advance in the treatment of NSCLC. There is a significant push forward to educate nurses and oncologists on molecular markers in the pathogenesis of NSCLC, as well as the role of histology in treatment response to various agents for patients with advanced NSCLC. We’re going to focus here on two patients who came to lung cancer by very different pathways.
He feels well, is active, not yet retired. Denies shortness of breath, etc.Still smoking, multiple attempts to quit, stopped once for 2 years. Wife does not smoke.Never been diagnosed as COPD, but recounts chronic bouts of bronchitis and morning cough productive of whitish sputum which is not new.Number of Pack Years = (Packs smoked per day) x (years as a smoker)orNumber of pack years = (number of cigarettes smoked per day x number of years smoked)/20 (1 pack has 20 cigarettes).For example: a patient who has smoked 15 cigarettes a day for 40 years has a (15x40)/20 = 30 pack year smoking history.The degree of exposure to tobacco is closely related to risk of disease.
Non small cell vs small cell: this picture shows the relative findings of nonsmall cell which tend to be at the periphery rather than in the central portions of the chest as is mostly seen with small cell…in our patient, Joe, his mass is in the right LOWER lobe.
The hilum is the wedge-shaped area on the central portion of each lung where the bronchi, arteries, veins, and nerves enter and exit the lungs.Lymph nodes of the lungs: Metastasis to regional lymph nodes is of major importance in determining treatment and ultimately survival. Regional lymph nodes are classified as follows. N0=no lymph node metastasis; N1=metastasis to lymph nodes in the peribronchial or the ipsilateral hilar region or both, including direct extension; N2=metastasis to ipsilateral mediastinal lymph nodes and subcarinal lymph nodes, and N3=metastasis to contralateral mediastinal lymph nodes, contralateral hilar lymph nodes, ipsilateral or contralateral scalene or supraclavicular lymph nodes. Lymph Node Map:Fourteen numbered nodal stations are illustrated in the diagram. N2 nodes are numbered 1 through 9. Ipsilateral nodes are designated right or left (depending on location of primary tumor), midline prevascular and retrotracheal lymph nodes are considered ipsilateral. The lymph is drained from the lung tissue through subsegmental, segmental, lobar and interlobar lymph nodes to the hilar lymph nodes, which are located around the hilum (the pedicle, which attaches the lung to the mediastinal structures, containing the pulmonary artery, the pulmonary veins, the main bronchus for each side, some vegetative nerves and the lymphatics) of each lung. The lymph flows subsequently to the mediastinal lymph nodes.Mediastinal lymph nodes: They consist of several lymph node groups, especially along the trachea (5 groups), along the esophagus and between the lung and the diaphragm. In the mediastinal lymph nodes arises lymphatic ducts, which drains the lymph to the left subclavianvein (to the venous angle in the confluence of the subclavian and deep jugular veins).
http://chestjournal.chestpubs.org/content/136/1/260/F6.large.jpgStaging: the TNM staging guidelines were updated and adopted by the American Joint Committee on Cancer (AJCC), this 7th edition went into effect in Jan. 2010.We use two kinds of staging as we are evaluating a patient for lung cancer: Clinical Staging and Pathologic staging.Clinical Staging is non-invasive and includes medical hx, physical exam, and imaging. We are at the T clinical staging with our patient Joe via CT scan.His tumor is 4cm…what Tumor stage is he?We can arrive at a clinical N and M stage using PET imagingN1 ipsilateralparabronchial nodes and/or ipsilateralhilar and intrapulmonary nodes.N2 ipsilateralmediastinal and/or subcarinal nodesN3 contralateral mediastinal, contralateral hilar, ipsalateral or contralateral scalene or supraclavicular nodesOK, so we know Joe has, at least by CT scan, enlarged right hilar nodes…what is his N stage? (N1)M staging is determined by the involvement of pericardial nodes or pericardial effusions. So Joe’s M stage is 0.
Based on what we know so far about staging, what is Joe’s stage considered at this point in time?T2N1M0…Stage IIa under the new staging. Tumor is >3cm which makes it T2…At this point, Joe appears to be resectable. Surgery for stages I and II provide the best option for cure.What testing is next and why?The goal of imaging is to determine resectability and whether that should be a lobectomy, a wedge resection or a pneumonectomy.The purpose of pathologic staging is to classify the lung cancer, determine the extent of invasion, determine the specific immunohistological and molecular data for treatment planning.
We bring Joe in to clinic to discuss the implications of his scan
Meds diovan, ASA, albuterol, MVIFor the sake of brevity, I did not include all parameters…labs were within normal limits; previous surgeries included an old gunshot wound to the right shoulder, no involvement with the physiology of the current situation.Recall that he smokes at least 1ppd of cigarettes and is not especially interested in quitting.
Good node exam essential for all forms of cancer…Preauricular - In front of the ear Postauricular - Behind the ear Occipital - At the base of the skull Tonsillar - At the angle of the jaw Submandibular - Under the jaw on the side Submental - Under the jaw in the midline Superficial (Anterior) Cervical - Over and in front of the sternomastoid muscle Supraclavicular - In the angle of the sternomastoid and the clavicle
How big is my tumor? At this point, b/c it appears that Joe has a solitary 4cm mass with at least one hilar node, he is thought to still be resectable, at a stage IIA .Surgery provides the best chance of cure in Stage I and II disease.
Mod differentiated---response to cisplatin-based therapies is correlated to some degree with differentiation.Moderatedly to well-differentiated tumors fiar better than poorly differentiated tumors.TTF-1 (thyroid transcription factor 1) is a transcription factor that regulates surfactant proteins and T1 alpha proteins which are secreted by the alveolar epithelium. It should be positive in primary lung and negative in metastatic tumors to the lung such as colon or breast cancer.The CK markers are highly specific markers for colon cancer, therefore metastatic adenoca from the colorectum would read as CK7 – and CK20 (+).Finally chromogranin and synaptophysin help define neuroendocrine tumors in the lung…all carcinoid tumors stain positive and some Small Cell Lung ca may stain positive if there are neuroendocrine features.At the time that Joe was diagnosed, there was only a beginning buzz about newer studies and the tumor was not sent out for EGFR or KRAS.
Pathologic staging: includes clinical parameters/imaging plus tissue (no meat, no treat) and staging studies which include PET and MRI of brain with/without contrast. We would have actually gathered the PET and the MRI studies before meeting with Joe again.
In general, stage I (confined to the lung without nodal or distant metastases), II (involvement of only lymph nodes within the lung or the hilum, the area where blood vessels enter the lung, on the same side as the tumor), and IIIA (involvement of nodes in the mediastinum, the area between the lungs, on the same side as the tumor) (Table 2) are considered potentially resectable for cure with a survival following complete resection of 76%, 47%, and 26-56% (4). Stage IIIB (involvement of the mediastinal organs, between the lungs, or lymph node metastases on the side opposite from the tumor) and IV (distant metastases) are generally considered surgically incurable although a “gray zone” exists with some advocating resection of limited N2 disease (involvement of mediastinal nodes on the same side as the tumor), stage IIIB without N2 disease or with a squamous cell histology, and stage IV with a solitary brain metastasis. To be curative, all areas invaded by
Joe is referred to medical oncology. Let’s discuss each of the choices:Even with surgical resection, Joe most likely would have needed adjuvant therapy with chemo and possibly radiation.Duration of treatment with chemotherapy is 4-6 cycles.Patients with disemminated disease with a good performance status benefit from chemotherapy with a platinum based regimen.In spite of advancements in the prognosis for stage IV remains poor.Carboplatin , paclitaxel and bevacizumab (approved 2006) non-squamous, no hemoptysis…We now know that Erlotinib can be given as first line therapy in patient with metastatic or advanced NSCL with an EGFR gene mutation…but at that time, it was not yet approved for first line and we were not yet routinely testing for EGFR.Joe is recommended for concurrent chemo/radiation.
In medically fit patients with locally advanced non-small-cell lung cancer (NSCLC), concurrent chemoradiotherapy improves survival compared with radiotherapy alone or sequential chemotherapy followed by radiotherapy.[1–3] However, chemoradiotherapy is also associated with significantly higher rates of toxicities.Carboplatin, paclitaxel, weekly regimen with radiation to 63Gy 6-7 weeks. After the first cycle, bevacizumab was added on an every 3 week basis. Aninternational randomized phase III trial, called the AVAIL trial observed that when bevacizumab was added to chemotherapy containing a platinum agent, there was a significan improvement in rate of recurrence (RR) and Progression-free suvival, it did not improve OS.Carboplatin was chosen b/c of the impact of less severe side-effects. We were concerned about Joe’s weight loss.2006, the FDA granted approval of bevacizumab (Avastin®, Genentech, Inc.), in combination with carboplatin and paclitaxel, for the initial systemic treatment of patients with unresectable, locally advanced, recurrent, or metastatic, non-squamous, non-small cell lung cancer, based on the demonstration of a statistically significant improvement in overall survival (OS) of 12.3 mos in patients receiving bevacizumab with carboplatin and paclitaxel compared to vs 10.3mos for pts receiving carboplatin and paclitaxel alone.
A never smoker is defined as a person who has not smoked more than 100 cigarettes in their lifetime.Getting reliable data on the occurrence of lung cancer amongst non-smokers is difficult because most cancer registries (population-based), including the National Cancer Institute's Surveillance, Epidemiology and End Results (SEER) database, generally do not gather information related to the patient’s smoking habits. Data available with SEER has been associated with tobacco use information (population-based), but it can only be used to determine occurrence of lung cancer amongst never smokers within wide geographic areas.
However, not all lung cancer cases are linked to cigarette smoking. There are other risk factors as well such as exposure to haloethers, asbestos, arsenic, nickel, and polycyclic aromatic hydrocarbons. PAHs are Researchers are also trying to identify the potential role of exposure to radon and environmental tobacco smoke, i.e. second hand smoke or passive smoking. The list of probable risk factors include genetic factors, dietary factors, and the existence of underlying benign types of parenchymal lung disease such as pulmonary fibrosis and chronic obstructive lung disease.
Stage IIIb : T3 b/c of extension into pleura & mediastinum ; N2 or N3 d/t multiple ipsilateral nodal involvement
Discuss support systems.
Discuss pathology in never smokers.EGFR mutation is negative and she was FISH positive for EML4-ALK gene alteration. There is a study with crizotinib and we work to get her enrolled. She reads everything she can about the new molecular studies and the impact that these studies will eventually have on treatment…she fixates on having one of those drugs available for her. All her eggs are now in one basket.Options of a platinum doublet plus either bevacizumab or pemetrexed is discussed…there are multiple options available…cisplatin and etoposide is one of the concurrent chemoradiation regimens; carboplatin is yet another NCCN regimen recommended as a radiosensitizer combination with xrt.Treatment is d
At our facility in Richmond, we currently perform PET/CT imaging which combines PET with CT within a single scanner. Published literature has shown improved diagnostic correlation and accuracy with combined modality PET/CT compared to PET alone. The most commonly used PET radiotracer is currently a glucose analog called F-18-fluoro-deoxyglucose or (FDG). Molecular derangements in malignant cells, increased glycolytic rates, and increased glucose membrane receptors, result in increased cellular uptake of FDG. Our radiology oncologist feels she can safely and adequately encompass the bulk of the mediastinal mass, the RUL mass as well as several small nodules that are also in the field.The patient then undergoes an MRI of the brain…Brain metastases are the most common type of brain tumors, the total number diagnosed annually outnumber all other intracranial tumors combined . as pts live longer with extracranial cancers d/t the continued improvement in therapies, the incidence of brain mets is expected to also increase. Men make up the largest number of metastatic brain lesions due lung cancer while breast cancer is the most common source for women, but with the increasing frequency of lung cancer in women, it is expected that for females this too will be the primary cause of metastatic brain tumors .
PET reflects the spiculated lesion in the right upper lung along with bulkymediastinal and rthilaradenopathy.
Due to her hemoptysis, bevacizumab (avastin) which was discussed, is no longer an option: (discuss hemorrhage). Her plan is altered even though she has had no more than one small episode of blood. After discussion with the PI for crizotinib, it is decided to offer her cisplatin & pemetrexed (alimta) and hope for release of the drug…Discuss psychosocial issues, depression.She has a relentless spirit and finds an for her anxiety by engaging in support groups and fighting to have her job moved closer to home instead of driving 2 hours to D.C.
We have gamma knife technology in my facility…this is actual knifeless, intracranial stereotactic radiation. After MRI mapping, the hundreds of individual beams are delivered as extremely focused radiation to a precise target in the brain.Many advantages for patients:Little residual side effects compared to whole brain radiation no shaved heads, usually same day OP procedure rather than week or more post brain surgeryLess complications, more precisionMay be repeated as more lesions appear.We are the areas only community hospital
Eloise is followed monthly by her neuro-oncologist who re-scans her brain and finds resolution of the treated areas and no change in the two suspect areas, one of which was believed to be a small meningioma. After 3 months of scanning, she is moved out to 6 mos, than 1 year of MRI scanning.She completes 4 cycles of chemotherapy with a platinum based agent. She has significant reduction of all masses, and her symptoms are resolved with the exception of some fatigue…she continued to work all through her treatment regimen.The SATURN trial involved 889 patients who had not progressed after 4 cycles of platinum-based chemotherapy. Maintenance therapy with erlotinib (150 mg/day) resulted in an increase in progression-free survival time, from 41% to 45%, compared with placebo, (hazard ratio [HR], 0.71; P = .000003), rBased on her EGFR status, she is to start maintenance therapy with erlotinib 150mg. but the day before she is to start, crizotinib is approved and made publicly available.SATURN trial:
Skin dryness ; cream better than lotion; no dyes or fragrances. If your patient is undergoing a different regimen that includesradiation, this cream must go on after radiation.Avoid the sun; does patient have to work in the sun, sit near a window? Truck driver?Nurses should also be aware of concomitant medications that the patient is taking. Erlotinib is metabolized via the CYP3A4 pathway in the liver. CYP3A4 inhibitors (antifungals like ketoconazole, clarithromycin, and grapefruit juice) dramatically increases the plasma levels of erlotinib, which can in turn worsen the side effects. .STEPP trial compared preventive prohylaxis of rash with oral doxycycline and topical hydrocortisone 1% cream versus treating the acute/reactive EGFR inhibitor rash in patients receiving panitumumab for metastatic colorectal cancer. Patients who received the prophylactic therapy had a 50% reduction in grade 2 or higher rash compared to the patients who were treated reactively. Patients in the preventive therapy arm also had improved quality of life compared to those in the reactive arm. More studies are underway…especially since in some EGFR trials there seems to be a correlation of rash with disease response and survival. Questions arise as to whether preventing the rash would make the drug less effective.Oncology nurses caring for patients on EGFR-inhibitor therapy need to become competent in treatment of these common dermatologic toxicities. Because rash indicates a probable response to therapy, it is incumbent on the oncology nurse to implement care strategies for these toxicities, helping patients to maintain therapy for longer periods. Education of the patient regarding the characteristics and time course of the rash and associated toxicities is crucial. Care strategies should be instituted early and be based on current expert recommendations and clinical trial results for treatment of EGFR inhibitor rash. Although steroids were originally not recommended in product package inserts, short-term oral steroids or steroid creams have shown clinical use in reducing inflammation associated with EGFR inhibitor therapy.
Limitations with the National Cancer Institute Common Toxicity Criteria scales10 had prompted consensus panels of experts to revise grading of EGFR rash, as the third version was subject to variable interpretation and called for involvement of body surface area in calculating grades of rash.11,12 Recommendations for simplifying the approach to grading, for ease of patient care and more accuracy, now exist. This simplified approach (as illustrated below) calls for 3 categories: mild, moderate, and severe (Figure 3). The mild reaction is considered to be a generalized localized papulopustular reaction with minimal symptoms; the moderate reaction is a generalized papulopustular rash that is pruritic or tender, but minimally affects the activities of daily living (or ADLs); and the severe reaction is a generalized papulopustular rash with severe pruritus or tenderness that affects ADLs significantly and may possibly be infected. It is worth noting, however, that the NCI Common Terminology Criteria for Adverse Events Version 4 (NCI-CTC v.4) was released in May of 2009 and has a more specific descriptive grading scale for the EGFR rash and associated nail toxicities. Mild rash may not require intervention; if needed, clindamycin gel and/or topical hydrocortisone may be adequate. Moderate rash may require the previous treatments, or consideration of pimecrolimus 1%, plus a tetracycline analogue agent, such as oral doxycycline 100 mg twice daily or minocycline 100 mg twice daily. Severe rash requires dose interruption of the EGFR agent, tetracycline analogue treatment, plus application of hydrocortisone cream, clindamycin gel, or pimecrolimus, plus an oral steroid dose pack.11 Each tier of care requires careful assessment of patient response to strategies for treatment of rash. Dermatologic consultation is advisable in uncontrolled or severe cases.
Crizotinib has an aminopyridine structure, and functions as a protein kinase inhibitor by competitive binding within the ATP-binding pocket of target kinases. About 4% of patients with non-small cell lung carcinoma have a chromosomal rearrangement that generates a fusion gene between EML4 (echinoderm microtubule-associated protein-like 4) and ALK, which results in constitutive kinase activity that contributes to carcinogenesis.  The kinase activity of the fusion protein is also inhibited by crizotinib. . Patients with this gene fusion are typically non-smokers who do not have mutations in the epidermal growth factor receptor gene (EGFR) or in the KRAS gene.[In studies, most deaths were attributed to pulmonary related events: pneumonia, ARDS, empyema, sepsis
Joe had much difficulty with his treatment…he was noncompliant with his pre and post treatment medications in the first 2 cycles and became extremely ill with N/V and dehydration (importance of antiemetics). While he had only mild elevation in blood pressure with bevacizumab,this was corrected with an alteration in his antiypertensives. He did however ultimately experience Grade 2 proteinuria and bevacizumab was stopped (due to threat of nephrotic syndrome which can occur with urine protein levels of more than 3.5g/24 hrs. He completed 4 cycles of carbotplatin and paclitaxel and had a 50% reduction in his tumors, reduction of adenopathy but her refused to continue on any other chemotherapy, opting to take a break and “get my strength back”…Pt experiences ds progression 5 mos s/p treatment. A follow-up CT scan shows growth of the primary tumor in his RLL plus additional adenopathy.Grade 0=normal; Grade 1= loss of deep tendon reflexes or paresthesia (including tingling) but not interfering with function; Grade 2= objective sensory loss or paresthesia (including tingling), interfering with function but not with activities of daily living; and Grade 3= sensory loss or paresthesia interfering with activities of daily living; Grade 4= permanent sensory loss that interferes with function. Of note is that that the severity of pain is not included in this measure.Pemetrexed or docetaxelas second line or maintenance.Since Joe’s initial diagnosis, the NCCN guidelines have recommended tumor typing for EGFR mutations…. previous biopsy was retreived and sent for EGFR and KRAS mutation analysis that was only just beginning to be discussed at the time of his diagnosis. We now know that there is a a close association in adencarcinoma with EGFR--- and the results return as “wild-type” EGFR-KRAS.The wild-type EGFR receptor typically sends a downstream signal that ultimately stimulates the growth of the NSCLC cells that are dependent on the receptor & TKIs like erlotinib can modestly inhibit this relatively weak signal . Kras mutation is associated with smokers and is prognostic of survival, although wild-type confers a little better survival advantage for reasons still unknown. K-ras does not affect therapeutic efficacy for chemotherapy, but it does predict efficacy of EGFR tyrosine kinase inhibitors. The SATURN trial involving erlotinib, did show a statistically significant benefit for EGFR wild-type tumor, so erlotinib was chosen as the option to discuss with Joe and his family. Approximately 90% of all NSCLC contains wildtypeEGFR (no mutation detected within the EGFR gene) (Lynch, 2004; Paez, 2004; Pao, 2004).Compared to lung cancer patients harboring tumor-associated EGFR activating mutations, patients with tumors containing a wildtypeEGFR gene are less sensitive to the EGFR TKIs, erlotinib (Tarceva) and gefitinib (Iressa) (Mok, 2009). However, erlotinib was approved for use in the second/third-line setting for unselected NSCLC, based upon a 2 month survival benefit vs. placebo (Shepherd, 2005). The mutated EGFR receptor is constitutively activated with a prominent downstream signal that can be dramatically inhibited by gefitinib and erlotinib.
Joe chooses not to have any further treatment .During his treatment he met regularly with the Oncology Social Worker to discuss his quality of life issues, organize his advance planning and directives, and also with his Nurse Navigator for active symptom management.This time he carefully considered all options offered and decided that he would seek only supportive care. His family was supportive, having watched him struggle with his treatment regimen and lose all interest in life.The patient is referred for hospice services.
Lung Cancer Navigation
Enhance Your Thoracic Oncology Program Through Prevention and Screening<br />Pamela Matten, RN, BSN, OCN<br />Nurse Navigator Thoracic Oncology Program<br />The Center for Cancer Prevention & Treatment<br />St. Joseph Hospital<br />
Why Lung Cancer Research is Needed<br /><ul><li>Estimated deaths by cancer type in the U.S. for 2009 are from the American Cancer Society Facts and Figures, 2009
Annual funding figures represent the National Cancer Institute (NCI) and Department of Defense estimated 2009 spending</li></li></ul><li>
Objectives<br />Purpose and history of lung screening<br />Findings of the National Lung Screening Trial (NLST)<br />Navigators’ role in screening<br />Developing a successful computed tomography (CT) lung screening program<br />Role of the multidisciplinary conferences and screening<br />Prevention; smoking cessation<br />
Why Is CT Lung Screening So Important?<br />Lung cancer, as the most lethal cancer in the world, presents an enormous health care challenge. However, the key to reversing the situation may be in embracing a public health sensibility in harnessing the power of CT imaging in a carefully validated approach to the early management of lung cancer. <br /> - AK Ganti, 2006<br />
National Lung Screening Trial<br />New clinical evidence from the NLST indicates “Screening with the use of low-dose CT reduces mortality from lung cancer. The rate of death from any cause was reduced in the low-dose CT group, as compared with the radiology group.”<br />National Lung Screening Trial. 2011.<br />
14th World Conference on Lung Cancer<br />“This is the most important publication in lung cancer in a decade.…We can expect to see a shift in lung cancer, with changes in management that hail a new era in lung cancer treatment.…We are on the crest of a wave of an enormous change in lung cancer.”<br /> - Dr. John Field, Chair, International Association for the Study of Lung Cancer CT Screening Task Force<br />
Pertinence for Today<br />When guidelines for screening are established, patients will be looking to their community hospitals for screening programs<br />The thoracic nurse navigators’ role, experience and ability to act as liaison between patient and physicians, makes them ideal candidates to implement and manage a CT screening program<br />
Purpose for Screening<br />Key to saving lives<br />Find lung cancer early<br />Surveillance of suspicious nodules<br />Lung cancer screening provides a teachable moment for promoting smoking cessation and relapse prevention1<br />Helps grow your thoracic oncology program<br />1ParkER, et al. Ann Behav Med. 2009;37(3):268-279.<br />
History of CT Lung Screening<br />1970-1980: Studies of chest x-rays disappointing for people considered high risk for lung cancer; CT introduced<br />CT scanners gradually became widely available<br />In 1991, radiology researchers led by Claudia Henschke, MD, began investigating the potential of CT scans to provide the screening benefit that chest x-rays failed to show<br />
International Early Lung Cancer Action Program (I-ELCAP)<br />Ongoing observational study and research program initially started in New York state<br />50,000+ participants/13 states/8 countries<br />Purpose: Assess impact of CT lung screening and improve protocol<br />Results: Participants with stage I cancer with surgical resection within 1 month of diagnosis had survival rate of 92%<br />Criticized because it did not address a mortality benefit from lung cancer screening<br />www.ielcap.org/<br />
National Lung Screening Trial<br />Launched in 2002 by National Cancer Institute<br />Goal to determine if CT scan could reduce number of lung cancer deaths by at least 20%<br />Recruited 53,000+ current and former smokers aged 55 to 74 who smoked for 30 pack-years<br />Half screened with chest x-ray, half with CT scans<br />Trial stopped 2 years early in 2010 when observers discovered there were already 20.3% fewer lung cancer deaths with CT scan<br />www.cancer.gov/clinicaltrials/noteworthy-trials/nlst.<br />
NLST Results in Perspective: A Comparison of Mortality Benefit<br />NLST results: 20.3%<br />This is extremely significant<br />Mammography screening: 15%<br />PSA testing: 0% in US trials; 20% in Swedish trial<br />www.cancer.gov/clinicaltrials/noteworthy-trials/nlst.<br />
What About False Positives?<br />A comparison of x-ray vsCT suggests the magnitude of over diagnosis with low-dose CT compared with radiographic screening is not large <br />10% to 30% of those screened for cancer will have a positive screen requiring further testing<br />13% of those screened using the I-ELCAP protocol will have a positive screen <br />
What About Other Screening Methods?<br />Blood, urine, breath, or sputum or genetic link?<br />Research is ongoing to find biomarkers that could uncover a genetic clue that a person is predisposed to lung cancer <br />This is harder than we thought and may take decades to realize<br />Currently no other method of screening for lung cancer has been found to be effective<br />
What About Radiation Exposure?<br />“…the decrease in the rate of death from any cause with the use of low-dose CT screening suggests that such screening is not on the whole deleterious”1<br />Screening CT delivers exposure to 0.3 to 0.55 mSvof radiation, which is the equivalent of 2 chest x-rays2 or 1-2 mammograms3<br />The potential problems can be safely managed with adherence to a well developed protocol for the screening, diagnosis and treatment of early lung cancer<br />1NLST Research Team. N Engl J Med. 2011;365:395-409. 2Diederich S, et al. Cancer. 2000;89:2457-2460. 3Brenner DJ, et al. Radiology. 2004;232:735-738. <br />..<br />
Multidisciplinary Conference: A Great Venue for Presenting Abnormal Screening CTs<br />
Case Study<br />64-year-old woman with chronic smoking history >20 pack-years<br />Referred by primary care physician (PCP) for CT screening<br />Screening revealed a 2.13-mm spiculated nodule<br />Radiologist recommends follow-up with diagnostic scan in 1 year<br />
Presented at Multidisciplinary Conference<br />Nodule increased to 5 mm<br />Recommendations – surgical consult<br />Surgeon is cautious since nodule is so small – wait 3 months then repeat CT<br />
Case Study Conclusions<br />Minimally invasive video-assisted thoracoscopic surgery (VATS)<br />3 days in hospital<br />Pathology; 7 mm adenocarcinoma<br />Patient referred to postoperative physical and respiratory rehabilitation 3x times 3 weeks<br />Surveillance CT every 6 months for 1 year and every year thereafter<br />
Developing a CT Screening Program<br />The thoracic nurse navigators’ role, experience and ability to act as liaison between patient and physicians, makes them ideal candidates to implement and manage a CT screening program<br />Nurse navigators are directly involved in development and enhancement processes aimed at improving clinical outcomes for oncology patients. The nurse navigator educates patients about cancer prevention, screening, diagnosis, treatment options, and the importance of early detection of cancer <br />
How Do You Start?<br />Build your team<br />Determine the costs<br />Set screening guidelines<br />Capture the data<br />Market the program<br />Overcome challenges<br />
Building Your Team<br />Identify a physician champion<br />Nurse navigator is a key element<br />Meet with key players: radiology, reimbursement, billing, administration, legal<br />Give evidence-based facts: Screening Saves Lives<br />Have a clear purpose and vision<br />Develop ownership through brainstorming<br />Each key player implements their piece<br />
Nurse Navigator’s Role<br />Act as liaison between patient and physician<br />Implement & manage CT lung screening program<br />Directly involved in program development and enhancement<br />Educates patients about:<br />Smoking cessation<br />Screening results<br />Further work-up/diagnosis<br />Treatment options<br />Importance of early detection<br />
Worth the Cost<br />CT lung screening is value added for your program<br />“…the cost of surgery for stage I lung cancer is less than half that of late-stage treatment…”1<br />St. Joseph Hospital increased analytical cases by 10% each year since starting CT lung screening<br />1HenschkeCI, et al.ThoracSurgClin. 2007;17(2):137-142.<br />
Worth the Cost (cont.)<br />CT lung screening is not covered by most insurance plans, including Medicare<br />Screening needs to be affordable for your patient demographics<br />Consider setting a low cash pay price ($125)<br />No insurance billed<br />Develop a CPT code for the procedure<br />Determine if you will provide financial aid to uninsured<br />
Screening Guidelines<br />No national screening guidelines<br />The new data will be reviewed by the US Preventive Services Task Force (USPSTF) in 2012 <br />The American Society of Clinical Oncology (ASCO) is developing clinical practice guidelines on lung cancer screening with the National Comprehensive Cancer Network (NCCN), American Cancer Society (ACS), and the American College of Chest Physicians<br />
Screening Guidelines (cont.)<br />Set your criteria for screening based on your demographics<br />Pool the resources of the NLST, I-ELCAP, or other international studies<br />This will help you develop a protocol that will provide patients the maximum benefits from screening with the lowest possible risks<br />When the NCCN guidelines are established, criteria within your screening program can be adjusted accordingly<br />
St. Joseph Hospital (SJH) Criteria<br />TOP criteria is similar to the I-ECLAP protocol:<br />Patient must be ≥50 years of age<br />Smoked for ≥20 years<br />Patients should be asymptomatic<br />Have a PCP<br />Have a PCP in Orange County<br />
Data Capture<br />Absolutely necessary<br />Develop a CT screening access database <br />Need administrative assistance<br />Letters are generated at 3, 6, or 12 months, as recommended by the radiologist<br />Follow up for 2 years<br />
Marketing<br />Develop screening brochures/referral pads<br />See 100 PCPs within first year <br />Educate on importance of early diagnosis for lung cancer and smoking cessation<br />Offer your services<br />Call with suspicious nodule<br />Put them at ease on issue of care<br />Advertise your TOP program<br />Emphasize: “We want to find lung cancer early; when it is treatable and possibly curable”<br />
SJH Retrospective Review<br />526 patients screened from November 2004 through 2008; 3% were diagnosed with cancer <br />458 patients had abnormal lung findings; 3.5% diagnosed with cancer <br />16 cancers were identified; 13 were lung primaries and 3 non-lung (B-cell lymphoma, liposarcoma, and metastatic melanoma) <br />
SJH Retrospective Review<br />Of the 13 primary lung cancers identified by screening:<br />77% (10) were stage IA <br />17% (2) were stage III <br /> 8% (1) were stage IV<br />Over 75% were early-stage lung cancer, treated with surgical resection and potential cure<br />
Challenges<br />Patient compliance to repeat scans at 3, 6, or 12 months<br />Implement interventional tactics to encourage patient compliance <br />Strategic planning should include expansion and flexibility <br />Ability to modify screening programs as evidence points toward national screening guidelines <br />
Screening and Prevention Go Hand-in-Hand<br />
Smoking Cessation<br />A cancer diagnosis provides an important window of opportunity for promoting tobacco cessation<br />
Why Promote Cessation?<br />A large proportion of cancer patients are current or former smokers at the time of diagnosis <br />Prevalence of ever smoking is highest among patients with tobacco-related cancers <br />20% to 50% of patients with cancer continue to smoke after diagnosis<br />By not addressing the issue, it sends the message, “It’s too late” or “I don’t care”<br />
Further Reasons to Promote Cessation<br />Smoking negatively impacts cancer treatment response<br />Surgery<br />Radiation<br />Chemotherapy<br />Increases odds for development of second primary tumors <br />Negatively impacts survival outcomes<br />Reduces quality of life <br />
Develop a Smoking Cessation Program<br />Obtain a Tobacco Treatment Specialist (TTS) certification: http://ndc.mayo.edu <br />Develop curriculum: Mayo Clinic and Rx for Change (UCSF)<br />Purchase CO monitor<br />Resources:<br />www.rxforchange.com<br />www.becomeanex.org <br />www.testbreath.com <br />
Classes<br />Initial consultation with the Tobacco Treatment Specialist (45-60 minutes)<br />Follow up at 1, 3, and 6 months through e-mail<br />Billed as “incident to”: ICD-9 code 305.1 <br />Tobacco Use Disorder, CPT code 99407 <br />Tobacco behavior change >10 minutes <br />5 weekly group classes (2 hours each) - free<br />Develop an Excel database to keep statistics, such as cessation method, quit rate at 1, 3, and 6 months<br />
Questions?<br />Pamela Matten, RN, BSN, OCN<br />1100 W La Veta<br />Orange, CA 92867<br />714-734-6236<br />email@example.com<br />
References<br />Brenner D.J., Elliston C.D. (2004), Estimated radiation risks potentially associated with full-body CT screening. Radiology, 232:735-8. <br />Diederich S, Lenzen H., (2000). Radiation exposure associated with imaging of the chest: comparison of different radiographic, and computed tomography techniques,. Cancer. 2000;89:2457-60. <br />Fleischner Society Guidelines: Radiology 2005 Nov; 237:395-400<br />Henschke C.I., Yankelevitz D.F., Altorki N.K. (2007); The role of ct screening for lung cancer. J.thorsurg.2007.03.004(141) <br />Ganti A.K.,(2006);Lung cancer screening..The Oncologist.2006.11 (5) 487<br />MacMahon, H., et al., Guidelines for management of small pulmonary nodules detected on CT scans; A statement from the Fleischner Society. Radiology 2005; 237: 395-400<br />NLST research team, Reduced lung cancer mortality with low-dose computed tomographic screening. NEJM 2011; 10.1056; 13. <br />NLST research team, Reduced lung cancer mortality with low-dose computed tomographic screening. NEJM 2011; 10.1056; 9-10.<br />NLST research team, Reduced lung cancer mortality with low-dose computed tomographic screening. NEJM 2011; 10.1056; 11.<br />NLST research team, Reduced lung cancer mortality with low-dose computed tomographic screening. NEJM 2011; 10.1056; 1 <br />Park E.R. et al., Risk perceptions among participants undergoing lung cancer screening: baseline results from the national lung screening trial. ANN Behav Med 2009; 37 (3): 268-279.<br />
Lung Cancer Case Discussion<br />Karen Overmeyer, MS, RN, ANP<br />Thoracic Oncology Nurse Navigator<br />Henrico Doctors’ Hospital<br />Cancer Center Specialty Clinics<br />Richmond, Virginia<br />
Cancer Center Specialty Clinics at Henrico Doctors’ Hospital<br />
Objectives<br />Identify 3 risk factors for NSCL cancer.<br />Discuss the implications of molecular studies in treatment planning.<br />Define the difference in prognostic biomarkers v.s. predictive biomarkers.<br />Describe the Nurse Navigator role in the delivery of care to the thoracic oncology patient.<br />Discuss the advantages of multidisciplinary care for the lung cancer patient.<br />
Overview of Lung Cancer Today<br />Leading cause of cancer worldwide.<br />> 170,00 death in the U.S.<br />More deaths than breast, colorectal, and prostate combined.<br />5-yr survival rate for all NSCL stages combined 16%.<br />5-yr survival rates of unresectable disease in stages IIIB and IV: < 5%<br />American Cancer Society: Cancer Facts & Figures 2010<br />
Case Studies<br /> 65 year old African American, male, smoker.<br />45 year old, Caucasian, female, non-smoker.<br />
Case Study #1<br />Joe<br />65 y/o <br />African American, married, brick mason.<br />PS = O<br />40 pack year smoking history, hypertension well controlled, prostate cancer 2008 with post brachytherapy PSA of 0.5 (ng/ml)<br />Presented to PCP w/ bacterial pneumonia visible on CXR w/ dense consolidation RLL.<br />Symptoms do not totally resolve with antibiotics.<br />Repeat CXR 8 weeks later residual opacity.<br />
Staging for Lung Cancer<br />What is Joe’s clinical stage? ____________<br />What is the next step?________________<br />PET<br />Bronchoscopy<br />Mediastinoscopy<br />EBUS<br />CT guided biopsy<br />Right lower lobectomy<br />Notes: _______________________________________<br />______________________________________________________________________________________________<br />
Chest Tumor Multidisciplinary Clinic<br />Provides a team approach with disease specific specialists meeting together at one place and time to decide on a comprehensive treatment plan.<br />Goal is to expedite the pathway from suspicion to diagnosis, & diagnosis to treatment, and through survivorship or palliative/hospice while collaborating with PCPs and all involved clinicians.<br />Patient and family remain at the helm of decision-making.<br />Visit to discuss options for further treatment, or proceed on to further testing and come to MDC for diagnosis & treatment planning.<br />
History & Physical Exam<br />Review of Systems:<br />HTN well controlled on valsartran /hydrochlorthiazide 160/12.5 No hx of MI or notable CAD.<br />ASA 80mg daily, MVI, Vitamin E<br />Colonoscopy age 55, 2 benign polyps<br />Prostate cancer, annual PSA & exam<br />Denies fever, chills, night-sweats, but admits to intermittent cough, feeling “more winded” , c/o low level fatigue and 3-6# weight loss over the past 4 months. Denies GI, GU, MS, Neuro changes no headaches, visual changes, changes in mentation, falls, lightheadedness.<br />
Lungs clear on left with few rhonchi on the right, no wheezing. No palpable neck, chest, axillary nodes; no pinpoint tenderness over thorax, bony prominences. Skin, extremities unremarkable for bruising, rashes, edema, other.
Pathology for Joe<br />CT-guided needle biopsy of RLL mass:<br />Non-small cell lung, adencarcinoma type<br />Moderately differentiated<br />Immunostains –differentiate primary lung from metastatic adenocarcinoma<br />TTF- 1 (+), CK7 (+) , and CK20 (– )<br />Chromogranin and synaptophysin are negative.<br />Notes: ___________________________<br />___________________________________<br />
Case #1 Staging<br />Final diagnosis: _____________________<br />What’s next?_______________________<br />MRI of brain w/without contrast<br />PET/CT <br />Pulmonary Function Studies/Pulmonary Consult.<br />Cardiology consult.<br />Tobacco addiction counseling.<br />Supportive services (follow up of Distress Screening Tool, PsychoSocioSpiritual, Financial advisor)<br />
Final Staging Results<br />PET shows expected FDG avidity in RLL mass with SUV 9. 4, plus 2 right hilar nodes with SUV of 6. Also several mildly positive right and left paratracheal nodes with SUV ranging from 1.5 to 2.8.<br />No extra-nodal or distant metastatic sites evident.<br />MRI is w/o evidence of metastasis.<br />PFTs : FEV1 = 2.48 /FVC % = 58% DLCO =70<br />What is Joe’s final stage?_______________<br />
Joe’s Final Plan of Care<br />Chemo Regimen:_____________________<br />Rationale __________________________<br />____________________________________<br />____________________________________<br />Radiation: __________________________<br />Rationale: __________________________<br />____________________________________<br />
Nursing Interventions<br />Knowledge deficit regarding lung cancer<br />Support & ongoing teaching throughout treatment.<br />Assess for depression.<br />Assessment of treatment related toxicities<br />Chemotherapy (nausea/vomiting, oral mucositis, low blood counts, fatigue, neutropenia, thrombocytopenia, anemia, constipation/diarrhea, anorexia.)<br />Radiation – dysphagia, mucositis, pharyngitis, thrush,wt loss, cough increase, skin changes. <br />Monitor side-effects of bevacizumab<br />Hypertension – instruct on home monitoring<br />Infusion reactions – fluid management<br />Cardiotoxicity- chest pain, peripheral edema, CHF<br />
Case #2 Patient History <br />Eloise<br />45 y/o<br />Caucasian, divorced, no children.<br />Never-smoker, active lifestyle, no PMH other than seasonal allergies. PSH: hysterectomy at age 38 for fibroids, no other adult surgeries. <br />3 month hx of cough, rhinitis, slight fatigue and by month 3, cough worse, experiencing slight shortness of breath, chest pressure with coughing.<br />PS= O<br />
Incidence in Never-Smokers<br />Risk factors:<br />Environmental (haloethers, asbestos, arsenic, radon, nickel, polycyclic aromatic hydrocarbons (PAH), secondhand smoke)<br />Genetic, dietary, association w/ other benign lung disease (pulmonary fibrosis, COPD<br />Globally – 15% in men & 53% in women<br />In Asia, 60-70% of cancers in non-smokers are women.<br />
CT scan Results -Case Study #2<br />CT of chest, abdomen, & pelvis revealed a right upper lobe mass, 1.4cm x 1.4cm extending into the pleura. Right hilar mass 4.5cm x 4.3cm, bulky mediastinal adenopathy measuring 3.3 cm x 2cm x2cm, precarinal and pretracheal nodes measuring 5.1cm x 3.5cm x 3.2 cm.<br />
Staging for Lung Cancer<br />What is Eloise’s clinical stage? ____________<br />What is the next step?__________________<br />PET<br />Bronchoscopy<br />Mediastinoscopy<br />EBUS<br />CT guided biopsy<br />Surgical resection<br />Notes: _____________________________________<br />__________________________________________________________________________________________<br />
Multidisciplinary Clinic<br />ROS negative in all systems except for notable cough and chest discomfort described as tightness all over.<br />The patient works for a local government agency, but drives to a satellite office I hr away each day; works out at the gym 3 days a week, maintains healthy diet and annual checkups.<br />She is divorced x 8 yrs, has a dog, owns her own home, loves gardening, has a sister who is her support system.<br />She is “devastated” and in shock over initial CT findings.<br />Distress screening:___________<br />
Multidisciplinary Clinic<br />Physical Exam:<br />VS: 120/72 P78 R18 T98 Ht: 5’6” Wt: 138#<br /> Pain: 0/10 ECOG: 0 Pulse Ox: 98%<br />Ambulatory, oriented, talkative, well-developed, well-nourished cauc. Female.<br />HEENT unremarkable; Chest: Bilateral breath sounds diminished toward bases bilaterally with intermittent wheeze; cough induced by deep breathing. HRRR, no murmurs, rubs. No palpable head, neck, chest lymphnodes; no areas of tenderness or masses noted. GI: active bowel sounds, flat abd. , no tenderness, masses, pain to palpation. GU deferred. Skin unremarkable, w/o bruises, rashes; no peripheral edema.<br />
A Diagnosis & Next Steps<br />Eloise’s path returns as NSCL, type______<br />Immunohistochemistry_______________<br />Molecular profiling: __________________<br />Chemotherapy + Radiation is planned.<br />What therapy would you offer this patient?<br />Paclitaxel/carboplatin<br />Bevacizumab/pemetrexed/cisplatin<br />Gemcitabine/carboplatin<br />Cisplatin/etoposide<br />
Predictive vs Prognostic Markers<br />Predictive – indicates therapeutic efficacy<br />Prognostic – indicates survival independent of treatment received.<br />
PET & MRI Results<br />PET: RUL mass has moderate uptake w/ SUV 2.9. Left upper tracheal node has an SUV of 8.6; midline mediastinal nodes are 14.7; right hilar adenopathy SUV is 25. No focal uptake below the diaphragm.<br />
MRI of brain w/ without contrast shows 3 areas of metastasis: right frontal 0.1cm, temporal-occipital lobe demonstrates two lesions 0.9cm and 0.5cm.<br />
Staging <br />Now what is Eloise’s Stage?____________<br />How does this affect treatment?__________<br />Eloise was holding out hope for consideration in a clinical study, but late one evening she has one episode of hemoptysis which she describes as a teaspoonful of blood mixed with sputum. She is seen and evaluated in the ED and discharged home.<br />She is disqualified for any clinical studies.<br />How does hemoptysis change the planned Tx?______<br />What should our next first step be?__________<br />
Navigator Interventions<br />Knowledge deficit regarding lung cancer<br />Support & ongoing teaching throughout treatment. Patient and family.<br />Assessment of treatment related toxicities<br />Chemotherapy (nausea/vomiting, oral mucositis, low blood counts, fatigue, neutropenia, thrombocytopenia, anemia, constipation/diarrhea, anorexia.)<br />Monitor side-effects of pemetrexed<br />Maintain folic acid and B12 levels to reduce GI/hematologic side effects<br />-folic acid daily for 5 of 7 days of cycle 1, then daily w/ treatment, and for 21 days post last treatment. B12 one week prior to first cycle, then every 9 weeks thereafter.<br />
Additional Interventions:<br />Nurse Navigator promotes ongoing collaboration:<br />Between care providers, referring physician<br />Scheduling follow up testing, appointments <br />Nutritional assessment.<br />Counsel regarding long distance driving<br />No history of seizures<br />Energy conserving daily routines<br />Delegating or hiring assistance with home and yard maintenance.<br />Psychosocial and financial support<br />LINC (legal information network for cancer) local pro-bono defense for workplace rights.<br />
Effectiveness of Therapy/Maintenance<br />Eloise is rescanned good response.<br />Single agent erlotinib is selected for maintenance.<br />Which of the following are associated side effects?<br />Paronychia<br />Keratoconjunctivitis<br />Acneform rash<br />Diarrhea<br />Interstitial lung disease<br />a, c, d<br />all of the above<br />
Nursing Interventions<br />Potential disruption of skin integrity r/t side effect of tyrosine kinase inhibitor.<br />Prevent dry skin (adequate hydration, avoid hot baths, protect skin from the elements/injury).<br />Thick emollient to face/body 2-3 x/day.<br />Stay out of the sun; SPF 30 or > sunscreen.<br />Exercise caution with concomitant medications d/t CYP3A4 inhibitors.<br />Consider prophylaxis regimen <br />Doxycycline, topical hydrocortisone 1%<br />STEPP trial 50% reduction of grade 2 or > skin toxicities.<br />
The Good News – New Directions<br />Several days prior to Eloise starting erlotinib, crizotinib is released with FDA approval.<br />250mg twice per day <br />Reduce to 200mg tab twice per day for side effects<br />Take with or without food<br />Is a CYP3A pathway drug alterations.<br />Monthly CBC, liver enzymes, bilirubin<br />Monitor for:<br />Visual disturbance, nausea, vomiting, diarrhea or constipation.<br />QT interval prolongation<br />Signs of pneumonitis<br />Edema<br />
Case #1 revisited <br />Joe, 68 y/o African American <br />Treatment stopped d/t poor tolerance.<br />Presents with dyspnea, cough 5 mos. s/p completion of four cycles of chemotherapy & radiation.<br />Hospitalized during treatment for intractable nausea & for febrile neutropenia. He has Grade III chemotherapy induced neuropathy.<br />What is most appropriate next step?<br />Hospice/supportive care<br />EGFR inhibitor (erlotinib or gefitinib)<br />Docetaxel<br />Pemetrexed<br />
Palliative Care: Early Intervention<br />Medical care & Palliative care not mutually exclusive<br />Impact on quality of life and survival<br />Role of nursing as advocates<br />Promote early initiation, at diagnosis<br />Offer patient and family access to resources for advanced symptom control<br />Utilize psycho-social-spiritual support as needs, concerns arise.<br />Poised to assist with the transition to end of life care so that it is not a surprise to arrive at that door.<br />
Current & Future Directions<br />“Personalized” therapies – expanding opportunities for growth & development<br />Novel targets in lung cancer<br />Prognostic vs. predictive biomarkers<br />Molecular diagnostics and genomics<br />Prevention and Intervention<br />Tobacco in all forms<br />Environmental controls<br />
References<br />Dienstmann, D., Martinez, P., Felip, E. (2011). Personalizing therapy with targeted agents in non-small cell lung cancer. Oncotarget 2011; 2:165 -177. Retreived from: www.impactjournals.com/oncotarget.<br />Subramanian J, Govindan R (February 2007). "Lung cancer in never smokers: a review". Journal of Clinical Oncology25 (5): 561–70. doi:10.1200/JCO.2006.06.8015. PMID 17290066.<br />Malloy P, Virani R, Kelly K, Munevar C. Beyond bad news – commmunication skills of nurses in palliative care. J. Hospice Palliative Nurs. 2010; 12:166 -174.<br />VonHoff, D, Stephenson, J, Loesch, D, et. al. (October 28, 2010). Pilot study using molecular profiling of patients’ tumors to find potential targets and select treatments for their refractory cancers. Journal of Clinical Oncology. http://jco.ascopubs.org/cgi/doi/10.1200/JCO.2009.26.5983<br />Clinical Practice Guidelines in Oncology:non-small cell lung cancer. (July 2010). Journal of the Comprehensive Cancer Network. Vol 8, Number 7; pp739-832.<br />