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Hypopharynxmanagement

This document summarizes guidelines for the management of carcinoma of the hypopharynx and larynx. It covers topics like NCCN guidelines, treatment options including surgery, radiotherapy, chemotherapy and biological therapy. It describes TNM staging according to AJCC 7th edition and provides general treatment recommendations based on tumor stage. It discusses the benefits of radiotherapy over surgery and indications for primary radiotherapy. It also summarizes various studies comparing altered fractionation radiotherapy with or without chemotherapy to conventional radiotherapy for improved survival outcomes in advanced stage disease.

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Management of carcinoma hypopharynx & Larynx Dr Dinesh K Singh Senior Resident, BMCHRC
Topics to be covered: • NCCN guidelines • Treatment overview • Evidence based treatment • RT Technique  Surgery  Radiotherapy  Chemotherapy  Biological therapy
TNM STAGING- AJCC 7TH edition (2010)* T1: Tumour limited to one subsite of hypopharynx and ≤ 2 cm in greatest dimension. T2: Tumour invades more than one subsite or adjacent site or measures >2cm but ≤ 4 cm without fixation of hemilarynx. T3: Tumours > 4 cm or with fixation of hemilarynx or extension into esophagus T4a: Tumor invades thyroid/cricoid cartilage, hyoid bone, thyroid gland, central compartment of soft tissue. T4b: Tumor invades prevertebral fascia, encases the carotid artery or involves mediastinal structures. *Edge SB, Byrd DR, Compton CC, et al. AJCC cancer staging handbook, 7th ed. New York: Springer, 2010.*
TNM STAGING- AJCC 7TH edition (2010)* • N0: No regional LN • N1: Single ipsilateral LN ≤ 3cm • N2a: Single ipsilateral LN 3-6cm b: Multiple ipsilateral LNs ≤ 6cm c: Bilateral or contralateral LNs ≤ 6cm • N3: Any LN more than 6cm • M stage: • Mx- cannot be assessed, • M0- no distant metastasis, • M1- distant metastasis
Stage grouping Stage 0 Tis N0 M0 Stage I T1 N0 M0 Stage II T2 N0 M0 Stage III T1, T2 T3 T3 N1 N0 N1 M0 M0 M0 Stage IV A T1,T2,T3 T4a N2 N0,N1,N2 M0 M0 Stage IV B Any T T4b N3 Any N M0 M0 Stage IV C Any T Any N M1
Treatment options Surgery Types Indications Evidence  Targeted therapy Types Indications Evidence  Chemotherapy Types Indications Evidence  Radiotherapy Types Indication Evidence Multi modality treatment
General Treatment Recommendations Based On Hypopharynx Tumor Stage* *Perez & Brady's Principles and Practice of RadiationOncology
Single Modality: • – Surgery or RT Choice depends on • – Tumor: site, extension • – Patient: preference, comorbidities • – Expertise of the multidisciplinary team, available resources  Equally effective: however no randomised trials for surgery vs. RT.  Each modality can salvage the other if local recurrence. EARLY STAGE (I-II)(T1-T2, N0)
ADVANCED STAGE:(III/IV) T1-2, N1-3 / T3-4, N0-N+ Multi Modality: • Radiotherapy with altered fractionation schedules • Radiotherapy with chemotherapy • Radiotherapy with biological therapy • Neoadjuvant chemotherapy f/b surgery • Surgery f/b RT/CT-RT Choice depends on • Tumor: site, extension • Patient: preference, comorbidities • Expertise of the multidisciplinary team, available resources
Benefits of RT over surgery • Probability of functional morbidity or cosmetic defects is reduced. • Risk of a major postoperative complication is avoided • Elective neck RT can be included with little added morbidity. • Surgical salvage of RT failure is supposed to have better outcome than the RT salvage of a surgical failure. Indications for primary radiotherapy • small sized tumor • larynx/voice preservation • those who refuse surgery
CAUSE-SPECIFIC AND OVERALL SURVIVAL FOR CARCINOMA OF THE PYRIFORM SINUS TREATED WITH RADIATION ALONE 2001 As stage increases 5 years survival with RT alone decreases
Radiation treatment intensification 2. Addition of chemotherapy to RT 1. Altered fractionation RT 3.Chemotherapy +Altered fractionation RT 4. Addition of biological therapy to RT
2010 IAEA-ACC
1997
2010
. • Patients with stage III or IV SCC (n=1076) were randomized to 4 treatment arms: 2000
(1) Standard fractionation 70 Gy/35 daily fractions/7 weeks (2) Hyper fractionation 81.6 Gy/68 twice-daily fractions/7 weeks (3) Accelerated fractionation with split 67.2Gy(1.6bid)/42 fractions/6 weeks with a 2-week rest after 38.4 Gy (4) Accelerated fractionation with concomitant boost 72 Gy/42 fractions/6 weeks.(1.8Gy/f with 1.5 Gy /f boost on last 12 fractions)
RTO 90-03 Results: at 2years • LRC: • significant improvement in 2 yr locoregional control for the hyper fractionation and concomitant boost arms . • DFS: • trend toward improved disease-free survival (p = 0.067 and p = 0.054 respectively for the hyper fractionation and concomitant boost arms • OS: difference in overall survival was not significant. • TOXICITY: • altered fractionation regimens were associated with higher incidence of grade 3 or worse acute mucosal toxicity, but no significant difference in overall toxicity at 2 years following completion of treatment.
2006 GORTEC 9402
MARCH META-ANALYSIS 2006 2010 The Lancet, Volume 368, Issue 9538, Pages 843 - 854, 2 September 2006
15 Randomized Trials of Varied Fractionation (1970-1998) PATIENT CHARACTERISTICS 7073 patients Tumours sites: mostly oropharynx and larynx 74% patients had stage III—IV disease hyper fractionated accelerated accelerated with total dose reduction Overall survival was the main endpoint median follow up:6 yr
benefit Conventional vs Altered Hyper fractionation vs Accelerated fractionation Locoregional control Loco regional control 6.4 %times higher benefit was higher with hyper fractionated radiotherapy ( OS 8% at 5 years) than with accelerated radiotherapy (2% with accelerated fractionation without total dose reduction and 1·7% with total dose reduction at 5 years, p=0·02) Survival benefit absolute benefit of 3·4% at 5 years with altered fractionated radiotherapy,
RESULTS OF MARCH META-ANALYSIS: There was a significant survival benefit in altered fractionation.(3.4%at 5 years) There was a benefit on locoregional control in favour of altered fractionation versus conventional radiotherapy (6·4% at 5 years; p<0·0001 The benefit was significantly higher in the youngest patients Interpretation Altered fractionated radiotherapy improves survival in patients with head and neck squamous cell carcinoma. Comparison of the different types of altered radiotherapy suggests that hyperfractionation has the greatest benefit
CHEMOTHERAPY • NEOADJUVANT • CONCURRENT • ADJUVANT
1996 EORTC 24891 EORTC trial 24891 compared PF (cisplatin and 5-FU) induction chemotherapy followed by radiation therapy (RT) versus total laryngectomy, radical neck dissection, and postoperative RT in patients with hypopharyngeal cancer Role of NACT for larynx preservation NACT-RT Vs Surgery-RT
• Treatment failures occurred at approximately the same frequencies in both arms. • Fewer failures at distant sites in the induction- chemotherapy arm • The median duration of survival was 25 months in the immediate-surgery arm and 44 months in the induction-chemotherapy arm • The 3- and 5-year estimates of retaining a functional larynx in patients treated in the induction chemotherapy arm were 42% and 35% respectively. CONCLUSION OF EORTC 24891
Choice of chemotherapy regimen: 2 drug vs.3 drug regimen
2007: TAX323/EORTC 24971
PATIENT CHRACTERISTICS: 29%pts of ca hypopharynx Aim : compare TPF with PF as induction chemotherapy in patients with locoregionally advanced, unresectable disease. Primary end point :PFS 358 patients underwent randomization, with 177 assigned to the TPF group and 181 to the PF group ARM A (N=177) ARM B(N=181) TOTAL P value
CONCLUSION OF TAX 323  At a median follow-up of 32.5 months, the median PFS was 11.0 months in the TPF group and 8.2 months in the PF group .  There were more grade 3 or 4 events of leukopenia and neutropenia in the TPF group and more grade 3 or 4 events of thrombocytopenia, nausea, vomiting, stomatitis, and hearing loss in the PF group.
2007: TAX 324
15% patients of ca hypopharynx Aim: compare induction chemotherapy with docetaxel plus cisplatin and fluorouracil (TPF) with cisplatin and fluorouracil (PF), followed by chemoradiotherapy for treatment of SCCH& N
Results of TAX 324 more patients survived in the TPF group than in the PF group estimates of overall survival at 3 years were 62% in theTPF group and 48% in the PF group, median overall survival was 71 months and 30 months, respectively (P = 0.006). better locoregional control in the TPF group than in the PF group (P = 0.04)  incidence of distant metastases in the two groups did not differ significantly (P = 0.14) Rates of neutropenia and febrile neutropenia were higher in the TPF group; chemotherapy was more frequently delayed because of hematologic adverse events in the PF group
2009 GORTEC 2000-01
CONCURRENT CHEMORADIOTHERAPY
An Intergroup Phase III Comparison of Standard Radiation Therapy and Two Schedules of Concurrent Chemoradiotherapy in Patients With Unresectable Squamous Cell Head and Neck Cancer. J Clin David J. Adelstein Oncol 21:92-98. 20032003 CTRT VS RT ALONE which one is better in unresectable HNSCC?
ARM C CTRT of 2 Gy/d, was split between the first CT course (30 Gy) & third CT course (30 to 40 Gy). A total dose of 60 to 70 Gy was given The radiation therapy break was planned to allow for the possibility of surgical resection in those patients rendered resectable after the first two courses of chemotherapy and the first 30 Gy of radiation. Patients who had achieved a complete response after this induction or who remained unresectable proceeded, without surgery, to complete chemoradiotherapy.
2003, 2006,2012 Forastiere et al •RT Vs. CTRT Vs. NACT-RT which one is better? J Clin Oncol. 2013 Mar 1;31(7):845-52. doi: 10.1200/JCO.2012.43.6097. Epub 2012 Nov 2 Journal of Clinical Oncology, 2006 ASCO Annual Meeting Proceedings Vol 24, No 18S (June 20 Supplement), 2006: 5517
2012 Radiotherapy Alone Vs. Concurrent CTRT Vs. Sequential NACT-RT J Clin Oncol. 2013 Mar 1;31(7):845-52. doi: 10.1200/JCO.2012.43.6097. Epub 2012 Nov 2
Loco regional control Overall survival Larynx preservation 2012 UPDATE
No Published Phase 3 Trial Study Have Tested Induction Chemotherapy f/b chemoradiotherapy Vs Upfront Chemoradiotherapy
ALTERED FRACTIONATION ± CHEMO-RADIOTHERAPY
Lancet Oncol. 2012 Feb;13(2):145-53. doi: 10.1016/S1470-2045(11)70346-1. Epub 2012 Jan 18 2012 aimed to assess the efficacy and safety of a combination of approaches.
STAGE III/IV, M0 HNSCC n=840 R A N D O M I Z E D Arm A Conventional chemo radiotherapy
RT – 70Gy/6w 1st 40Gy  2Gy/#/d, 5#/w Next 30Gy (off the spinal cord)  1.5Gy/#/BD CT – 2 cycles of 5days each, 4w apart. Carboplatin 70mg/sqm/d + 5FU 600mg/sqm/d RT – 70Gy/35#/7w at 2Gy/#, 5#/w CT – 3 cycles of 4days each, 3w apart. Carboplatin 70mg/sqm/d + 5FU 600mg/sqm/d RT – 64.8Gy/3.5w at 1.8Gy/#/BD, 5#/w Arm A Conventional chemoradiotherapy Arm B Accelerated RT with concomitant CT Arm C Very Accelerated RT . Median follow-up was 5·2 years
 Accelerated radiotherapy-chemotherapy offered no PFS benefit compared with conventional chemoradiotherapy or very accelerated radiotherapy  conventional chemoradiotherapy improved PFS compared with very accelerated chemoradiotherapy  More patients in the very accelerated radiotherapy group had RTOG grade 3-4 acute mucosal toxicity (226 [84%] of 268 patients) compared with accelerated radiotherapy-chemotherapy (205 [76%] of 271 patients) or conventional chemoradiotherapy (180 [69%] of 262; p=0·0001).  (60%) of patients in the conventional chemoradiotherapy group, (64%) of patients in the accelerated radiotherapy-chemotherapy group, and (70%) of patients in the very accelerated radiotherapy group were intubated with feeding tubes during treatment (p=0·045). Results of GORTEC 9902
CONCLUSION OF GORTEC 9902 1. Chemotherapy has a substantial treatment effect given concomitantly with radiotherapy. • 2. Acceleration of radiotherapy cannot compensate for the absence of chemotherapy. • 3. Acceleration of radiotherapy is probably not beneficial in concomitant chemo- radiotherapy schedules.
Role of biological therapy •Cetuximab with RT • Bonner et al- • 424 patients • Locally advanced SCCHN • 15% pt : Ca hypopharynx
Bonner et al, 2006 Drawback: in control arm RT alone given (not a standard treatment for stage III and IV HNSCC)
• LOCOREGIONAL CONTROL • OVERALL SURVIVAL
Bonner et al 2010 update: 5 years follow up
subgroups analysis demonstrated effect of cetuximab was pronounced in patients with oropharyngeal carcinoma,  T1-T3 disease, concomitant boost radiation, N1-N3, KPS 90-100 , male patients, EGFR expression ≤ 50%, ≤65 years.
Surgical options in operable Ca hypopharynx Voice preservation surgery in early hypopharynx cancer Supraglottic laryngectemy Hemilaryngectomy Partial laryngopharyngectomy Radical Laryngectomy in advanced stages  Total laryngectomy Total laryngopharyngectomy
Primary Surgery • T1 and T2 Tumors: voice conservation surgery • INDICATIONS • CONTRAINDICATIONS  voice conservation approaches possible  refuse radiation  vocal fold fixation,  cartilage invasion,  postcricoid invasion,  deep pyriform sinus invasion,  extension beyond the larynx • T3 / T4 Tumors • INDICATIONS dysfunctional larynx pt. with bulky destructive tumor that severely compromise airway or destroy cartilage, bone, soft tissue undergo immediate laryngopharyngectomy and post op radiation
operation indication parts removed contraindication hemilaryngectomy horizontal partial supraglottic laryngectomy(SGL)  T1/T2 pyriform sinus tumor  voice preservation for early supraglottic extension  epiglottis  aryepiglottic fold  false cords  upper 1/3-1/2 of thyroid cartilage  ±hyoid bone  preserves one or both arytenoids & true vc  thyroid,cricoid cartilage invasion  arytenoid involvement  vocal fold fixation  postcricoid invasion  deep pyriform sinus invasion  extension beyond the larynx  fixed neck nodes  inadequate pulmonary function extended supraglottic laryngectomy  supraglottic lesion with<1cm base of tongue invasion  same as SGL with removal of i/l bot upto circumvallete papillae
operation indications removes contraindication  partial laryngophary ngectomy  used for small medial and anterior pyriform sinus lesion  false vocal cord  epiglottis  aryepiglottic fold  pyriform sinus,  tvc are preserved  transglottic extension,  cartilage invasion  vocal cord paralysis,  pyriform apex invasion,  postcricoid invasion  extralaryngeal spread  poor pulmonary reserve  total laryngectomy  Advanced pyriform sinus lesion  cartilage invasion  removes hyoid, thyroid, cricoid cartilage, epiglottis strap muscle. Patient left with a permanent tracheostoma and pharynx reconstruction  total laryngophary ngectomy  for more advanced hypopharyngeal lesion  total laryngectomy  plus removal of varying amount of pharyngeal wall
Advances in surgery • In recent years, advancements in organ preservation surgery have included the use of • Transoral laser microsurgery • Transoral robotic surgery. • Advantage Less morbidity avoiding tracheostomy and the use of feeding tubes
ADJUVANT RADIOTHERAPY IN OPERATED HNSCC
Preoperative RT Vs postoperative RT: RTOG 73-03 Phase III study of preoperative radiation therapy (50.0 Gy) versus postoperative radiation therapy (60.0 Gy) for supraglottic larynx and hypopharynx primaries duration of follow-up was 9-15 years, Loco-regional control& absolute survival was estimated & compared 1987
N=277 patients. Operable stage T2-T4 /N±  oral cavity(14%)  Oropharynx(17%)  Supraglottic larynx(26%)  Hypopharynx(43%) Postoperative stage III or IV SCCHN R A N D O M I Z E Arm 2:Post-op RT 60 Gy. n= 141 Arm 1: Pre-op RT 50 Gy n=136
Long-term Follow-up Of RTOG Study 73-03 *(Tupchong L et al. Int J Radiat Oncol Biol Phys. 1991 Jan;20(1):21-8.) outcome preopRT postopRT LRC 58% 70% LRF within 2 years 59% 58% LRF after 2years 27% 8% Overall survival similar toxicity similar • Post op RT is better than preop RT for LRC 1991
Indications for post operative radiotherapy Primary:  Large primary - T4 or T3 with soft tissue infiltration  Close or positive margins of excision  Deep infiltrative tumour  High grade tumour  Lympho-vascular and perineural invasion Lymph nodes:  Bulky nodal disease N2 / N3  Extra nodal extension  Multiple level involvement
POSTOPERATIVE RADIOTHERAPY Is PO CTRT better than PORT alone?
R A N D O M IZ E Cisplatin 100 mg/m2 d 1, 22, 43 XRT XRT Cooper et al, 2004; Bernier et al, 2004. S U R G E R Y RTOG 95-01 459 patients EORTC 22931 334 patients EORTC (66 Gy over 6 ½ wks) RTOG (60–66 Gy over 6-6 ½ wks) Postoperative Chemoradiotherapy
• RESULTS OF POSTOP CHEMORADIATION TRIAL
EORTC 22931 only Bernier et al N=334 EORTC 22931 and RTOG 9501 RTOG 9501 only Cooper et al.2004 N=459 stage III/IV disease margin+ ≥2positive l.n ECE+ ECE + ECE + margin + margin+ PNI+ embolism
RT Techniques in Hypopharynx • CTV for curative radiotherapy T1/T2 N0 • GTV is defined using • Endoscopy • EUA reports and diagrams • Diagnostic imaging • There is no evidence on which to base GTV-CTV margins at the primary site but submucosal spread is common and can extend at least 10 mm from the GTV • GTV is grown by a 10mm axial margin and a 15 mm longitudinal margin to create a CTV70 • Edited to take account of patterns of spread and natural barriers to tumour progression (e.g. bone) • CTV70 is also edited to include adjacent lymph nodes (usually level III but occasionally part of levels II and IV) on the same axial slices as the CTV70
RT Techniques in Hypopharynx • For lateral pyriform fossa tumours these high risk nodes will be ipsilateral • For other hypopharyngeal tumours they will be bilateral • The CTV44 is edited to include other lymph node groups at risk of micrometastases • For lateral pyriform fossa tumours this will include ipsilateral levels II–IV • For other tumours with bilateral lymph node drainage, bilateral nodes are include • Retropharyngeal nodes are included for tumours involving the posterior pharyngeal wall
RT Techniques in Hypopharynx • Target volume definition • CTV for curative radiotherapy T1/T2 N0 • The GTV is defined using endoscopy, EUA reports and diagrams, and diagnostic imaging • There is no evidence on which to base GTV-CTV margins at the primary site but submucosal spread is common and can extend at least 10 mm from the GTV • GTV is grown by a 10mm axial margin and a 15 mm longitudinal margin to create a CTV70 • This is then edited to take account of patterns of spread and natural barriers to tumour progression (e.g. bone) • The CTV70 is also edited to include adjacent lymph nodes (usually level III but occasionally part of levels II and IV) on the same axial slices as the CTV70 • For lateral pyriform fossa tumours these high risk nodes will be ipsilateral; for other hypopharyngeal tumours they will be bilateral
RT Techniques in Hypopharynx
RT Techniques in Hypopharynx • CTV for curative radiotherapy T 3/4 or N • Post induction chemotherapy • CTVs should therefore be based on the initial pattern of disease as well as on the residual tumour seen on the planning CT • GTV should be defined on the planning CT from the residual volume but should include any nodes that were involved at diagnosis even if they are not now enlarged
RT Techniques in Hypopharynx • To allow for submucosal spread, the GTV is enlarged by 10 mm axially and 15mm longitudinally to form the CTV70 • The CTV70 is edited to take account of natural barriers to tumour progression and to include all sites of primary disease at presentation. • For example • A pyriform fossa cancer invading the tongue base at diagnosis may respond to induction chemotherapy to leave residual tumour in the pyriform fossa alone • The tongue base should be included in the CTV70 • CTV is further edited to include sites of high risk nodal disease • For N disease the CTV70 includes level II–IV nodes adjacent to the primary GTV, any involved nodes at other levels and any nodes in between
RT Techniques in Hypopharynx
RT Techniques in Hypopharynx • CTV for adjuvant radiotherapy • After careful discussion with the surgeon and pathologist, the CTV60 is defined as sites of possible residual microscopic disease • The CTV60 should include the margins of resection and sites of any dissected nodal levels where there was tumour. • Sites of positive resection margins or where there was extracapsular nodal spread should be further defined as CTV66. • When the patient has had a laryngectomy • Stoma should be included in the CTV60 if subglottic extension was present or if the surgeon is concerned about the risk of parastomal recurrence
RT Techniques in Hypopharynx • CTV for adjuvant radiotherapy • If a clinically node negative tumour has been excised with an elective neck dissection and there is unexpected tumour in the neck nodes, a CTV44 can also be defined • This should ensure that the nodal levels have been treated either surgically or with radiotherapy • For example • If surgery for a T2 pyriform fossa tumour included an ipsilateral level II–IV neck dissection at which multiple involved nodes were identified (pN2b), the CTV44 should include ipsilateral levels Ib and V, contralateral levels II–IV and bilateral retropharyngeal nodes
RT Technique of Carcinoma Larynx
RT Technique of Carcinoma Larynx • Target volume definition • T1 N0 glottic larynx • Conventional treatment with small lateral beams is usually successful and well tolerated • Records and pictures from nasal endoscopy and EUA should be available as small primary vocal cord tumours are difficult to see on CT scan • GTV is defined as the site of primary tumour • CTV is the glottic larynx with a border at least 10 mm superiorly and inferiorly from the GTV. • Axially the bilateral mucosal laryngeal surface is included • PTV is CTV with a 3–5 mm isotropic margin depending on local assessment of random and systematic errors assuming tumour movement is minimal • Motion can be assessed by watching laryngeal movement with fluoroscopy in the simulator to ensure that the vocal cords remain within the PTV on swallowing
RT Technique of Carcinoma Larynx • In practice, it can be easier to define • Superior (mid-body of hyoid) • Inferior (inferior margin of cricoid) beam borders • On the lateral DRR from the planning CT scan and then check on the axial slices that the whole glottic larynx is included within the CTV, assuming a 5 mm penumbra from PTV to beam edge • Using smaller beams defined solely on the basis of GTV-CTV-PTV definition has little therapeutic advantage and increases the possibility of a geographical tumour miss due to intra-fractional motion from swallowing
Thank You
Hypopharynxmanagement
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Hypopharynxmanagement

  • 1.
    Management of carcinoma hypopharynx& Larynx Dr Dinesh K Singh Senior Resident, BMCHRC
  • 2.
    Topics to becovered: • NCCN guidelines • Treatment overview • Evidence based treatment • RT Technique  Surgery  Radiotherapy  Chemotherapy  Biological therapy
  • 3.
    TNM STAGING- AJCC7TH edition (2010)* T1: Tumour limited to one subsite of hypopharynx and ≤ 2 cm in greatest dimension. T2: Tumour invades more than one subsite or adjacent site or measures >2cm but ≤ 4 cm without fixation of hemilarynx. T3: Tumours > 4 cm or with fixation of hemilarynx or extension into esophagus T4a: Tumor invades thyroid/cricoid cartilage, hyoid bone, thyroid gland, central compartment of soft tissue. T4b: Tumor invades prevertebral fascia, encases the carotid artery or involves mediastinal structures. *Edge SB, Byrd DR, Compton CC, et al. AJCC cancer staging handbook, 7th ed. New York: Springer, 2010.*
  • 4.
    TNM STAGING- AJCC7TH edition (2010)* • N0: No regional LN • N1: Single ipsilateral LN ≤ 3cm • N2a: Single ipsilateral LN 3-6cm b: Multiple ipsilateral LNs ≤ 6cm c: Bilateral or contralateral LNs ≤ 6cm • N3: Any LN more than 6cm • M stage: • Mx- cannot be assessed, • M0- no distant metastasis, • M1- distant metastasis
  • 5.
    Stage grouping Stage 0Tis N0 M0 Stage I T1 N0 M0 Stage II T2 N0 M0 Stage III T1, T2 T3 T3 N1 N0 N1 M0 M0 M0 Stage IV A T1,T2,T3 T4a N2 N0,N1,N2 M0 M0 Stage IV B Any T T4b N3 Any N M0 M0 Stage IV C Any T Any N M1
  • 14.
    Treatment options Surgery Types Indications Evidence  Targetedtherapy Types Indications Evidence  Chemotherapy Types Indications Evidence  Radiotherapy Types Indication Evidence Multi modality treatment
  • 15.
    General Treatment RecommendationsBased On Hypopharynx Tumor Stage* *Perez & Brady's Principles and Practice of RadiationOncology
  • 16.
    Single Modality: • –Surgery or RT Choice depends on • – Tumor: site, extension • – Patient: preference, comorbidities • – Expertise of the multidisciplinary team, available resources  Equally effective: however no randomised trials for surgery vs. RT.  Each modality can salvage the other if local recurrence. EARLY STAGE (I-II)(T1-T2, N0)
  • 17.
    ADVANCED STAGE:(III/IV) T1-2, N1-3/ T3-4, N0-N+ Multi Modality: • Radiotherapy with altered fractionation schedules • Radiotherapy with chemotherapy • Radiotherapy with biological therapy • Neoadjuvant chemotherapy f/b surgery • Surgery f/b RT/CT-RT Choice depends on • Tumor: site, extension • Patient: preference, comorbidities • Expertise of the multidisciplinary team, available resources
  • 18.
    Benefits of RTover surgery • Probability of functional morbidity or cosmetic defects is reduced. • Risk of a major postoperative complication is avoided • Elective neck RT can be included with little added morbidity. • Surgical salvage of RT failure is supposed to have better outcome than the RT salvage of a surgical failure. Indications for primary radiotherapy • small sized tumor • larynx/voice preservation • those who refuse surgery
  • 19.
    CAUSE-SPECIFIC AND OVERALLSURVIVAL FOR CARCINOMA OF THE PYRIFORM SINUS TREATED WITH RADIATION ALONE 2001 As stage increases 5 years survival with RT alone decreases
  • 20.
    Radiation treatment intensification 2.Addition of chemotherapy to RT 1. Altered fractionation RT 3.Chemotherapy +Altered fractionation RT 4. Addition of biological therapy to RT
  • 23.
  • 24.
  • 25.
  • 26.
    . • Patients withstage III or IV SCC (n=1076) were randomized to 4 treatment arms: 2000
  • 27.
    (1) Standard fractionation 70Gy/35 daily fractions/7 weeks (2) Hyper fractionation 81.6 Gy/68 twice-daily fractions/7 weeks (3) Accelerated fractionation with split 67.2Gy(1.6bid)/42 fractions/6 weeks with a 2-week rest after 38.4 Gy (4) Accelerated fractionation with concomitant boost 72 Gy/42 fractions/6 weeks.(1.8Gy/f with 1.5 Gy /f boost on last 12 fractions)
  • 28.
    RTO 90-03 Results:at 2years • LRC: • significant improvement in 2 yr locoregional control for the hyper fractionation and concomitant boost arms . • DFS: • trend toward improved disease-free survival (p = 0.067 and p = 0.054 respectively for the hyper fractionation and concomitant boost arms • OS: difference in overall survival was not significant. • TOXICITY: • altered fractionation regimens were associated with higher incidence of grade 3 or worse acute mucosal toxicity, but no significant difference in overall toxicity at 2 years following completion of treatment.
  • 29.
  • 30.
    MARCH META-ANALYSIS 2006 2010 The Lancet,Volume 368, Issue 9538, Pages 843 - 854, 2 September 2006
  • 31.
    15 Randomized Trialsof Varied Fractionation (1970-1998) PATIENT CHARACTERISTICS 7073 patients Tumours sites: mostly oropharynx and larynx 74% patients had stage III—IV disease hyper fractionated accelerated accelerated with total dose reduction Overall survival was the main endpoint median follow up:6 yr
  • 32.
    benefit Conventional vsAltered Hyper fractionation vs Accelerated fractionation Locoregional control Loco regional control 6.4 %times higher benefit was higher with hyper fractionated radiotherapy ( OS 8% at 5 years) than with accelerated radiotherapy (2% with accelerated fractionation without total dose reduction and 1·7% with total dose reduction at 5 years, p=0·02) Survival benefit absolute benefit of 3·4% at 5 years with altered fractionated radiotherapy,
  • 33.
    RESULTS OF MARCHMETA-ANALYSIS: There was a significant survival benefit in altered fractionation.(3.4%at 5 years) There was a benefit on locoregional control in favour of altered fractionation versus conventional radiotherapy (6·4% at 5 years; p<0·0001 The benefit was significantly higher in the youngest patients Interpretation Altered fractionated radiotherapy improves survival in patients with head and neck squamous cell carcinoma. Comparison of the different types of altered radiotherapy suggests that hyperfractionation has the greatest benefit
  • 34.
  • 35.
    1996 EORTC 24891 EORTC trial24891 compared PF (cisplatin and 5-FU) induction chemotherapy followed by radiation therapy (RT) versus total laryngectomy, radical neck dissection, and postoperative RT in patients with hypopharyngeal cancer Role of NACT for larynx preservation NACT-RT Vs Surgery-RT
  • 37.
    • Treatment failuresoccurred at approximately the same frequencies in both arms. • Fewer failures at distant sites in the induction- chemotherapy arm • The median duration of survival was 25 months in the immediate-surgery arm and 44 months in the induction-chemotherapy arm • The 3- and 5-year estimates of retaining a functional larynx in patients treated in the induction chemotherapy arm were 42% and 35% respectively. CONCLUSION OF EORTC 24891
  • 38.
    Choice of chemotherapyregimen: 2 drug vs.3 drug regimen
  • 39.
  • 41.
    PATIENT CHRACTERISTICS: 29%pts ofca hypopharynx Aim : compare TPF with PF as induction chemotherapy in patients with locoregionally advanced, unresectable disease. Primary end point :PFS 358 patients underwent randomization, with 177 assigned to the TPF group and 181 to the PF group ARM A (N=177) ARM B(N=181) TOTAL P value
  • 42.
    CONCLUSION OF TAX323  At a median follow-up of 32.5 months, the median PFS was 11.0 months in the TPF group and 8.2 months in the PF group .  There were more grade 3 or 4 events of leukopenia and neutropenia in the TPF group and more grade 3 or 4 events of thrombocytopenia, nausea, vomiting, stomatitis, and hearing loss in the PF group.
  • 43.
  • 44.
    15% patients ofca hypopharynx Aim: compare induction chemotherapy with docetaxel plus cisplatin and fluorouracil (TPF) with cisplatin and fluorouracil (PF), followed by chemoradiotherapy for treatment of SCCH& N
  • 48.
    Results of TAX324 more patients survived in the TPF group than in the PF group estimates of overall survival at 3 years were 62% in theTPF group and 48% in the PF group, median overall survival was 71 months and 30 months, respectively (P = 0.006). better locoregional control in the TPF group than in the PF group (P = 0.04)  incidence of distant metastases in the two groups did not differ significantly (P = 0.14) Rates of neutropenia and febrile neutropenia were higher in the TPF group; chemotherapy was more frequently delayed because of hematologic adverse events in the PF group
  • 49.
  • 53.
  • 54.
    An Intergroup PhaseIII Comparison of Standard Radiation Therapy and Two Schedules of Concurrent Chemoradiotherapy in Patients With Unresectable Squamous Cell Head and Neck Cancer. J Clin David J. Adelstein Oncol 21:92-98. 20032003 CTRT VS RT ALONE which one is better in unresectable HNSCC?
  • 55.
    ARM C CTRT of2 Gy/d, was split between the first CT course (30 Gy) & third CT course (30 to 40 Gy). A total dose of 60 to 70 Gy was given The radiation therapy break was planned to allow for the possibility of surgical resection in those patients rendered resectable after the first two courses of chemotherapy and the first 30 Gy of radiation. Patients who had achieved a complete response after this induction or who remained unresectable proceeded, without surgery, to complete chemoradiotherapy.
  • 57.
    2003, 2006,2012 Forastiere etal •RT Vs. CTRT Vs. NACT-RT which one is better? J Clin Oncol. 2013 Mar 1;31(7):845-52. doi: 10.1200/JCO.2012.43.6097. Epub 2012 Nov 2 Journal of Clinical Oncology, 2006 ASCO Annual Meeting Proceedings Vol 24, No 18S (June 20 Supplement), 2006: 5517
  • 60.
    2012 Radiotherapy Alone Vs.Concurrent CTRT Vs. Sequential NACT-RT J Clin Oncol. 2013 Mar 1;31(7):845-52. doi: 10.1200/JCO.2012.43.6097. Epub 2012 Nov 2
  • 61.
    Loco regional controlOverall survival Larynx preservation 2012 UPDATE
  • 62.
    No Published Phase3 Trial Study Have Tested Induction Chemotherapy f/b chemoradiotherapy Vs Upfront Chemoradiotherapy
  • 63.
  • 64.
    Lancet Oncol. 2012Feb;13(2):145-53. doi: 10.1016/S1470-2045(11)70346-1. Epub 2012 Jan 18 2012 aimed to assess the efficacy and safety of a combination of approaches.
  • 65.
  • 66.
    RT – 70Gy/6w 1st40Gy  2Gy/#/d, 5#/w Next 30Gy (off the spinal cord)  1.5Gy/#/BD CT – 2 cycles of 5days each, 4w apart. Carboplatin 70mg/sqm/d + 5FU 600mg/sqm/d RT – 70Gy/35#/7w at 2Gy/#, 5#/w CT – 3 cycles of 4days each, 3w apart. Carboplatin 70mg/sqm/d + 5FU 600mg/sqm/d RT – 64.8Gy/3.5w at 1.8Gy/#/BD, 5#/w Arm A Conventional chemoradiotherapy Arm B Accelerated RT with concomitant CT Arm C Very Accelerated RT . Median follow-up was 5·2 years
  • 67.
     Accelerated radiotherapy-chemotherapyoffered no PFS benefit compared with conventional chemoradiotherapy or very accelerated radiotherapy  conventional chemoradiotherapy improved PFS compared with very accelerated chemoradiotherapy  More patients in the very accelerated radiotherapy group had RTOG grade 3-4 acute mucosal toxicity (226 [84%] of 268 patients) compared with accelerated radiotherapy-chemotherapy (205 [76%] of 271 patients) or conventional chemoradiotherapy (180 [69%] of 262; p=0·0001).  (60%) of patients in the conventional chemoradiotherapy group, (64%) of patients in the accelerated radiotherapy-chemotherapy group, and (70%) of patients in the very accelerated radiotherapy group were intubated with feeding tubes during treatment (p=0·045). Results of GORTEC 9902
  • 69.
    CONCLUSION OF GORTEC9902 1. Chemotherapy has a substantial treatment effect given concomitantly with radiotherapy. • 2. Acceleration of radiotherapy cannot compensate for the absence of chemotherapy. • 3. Acceleration of radiotherapy is probably not beneficial in concomitant chemo- radiotherapy schedules.
  • 70.
    Role of biologicaltherapy •Cetuximab with RT • Bonner et al- • 424 patients • Locally advanced SCCHN • 15% pt : Ca hypopharynx
  • 71.
    Bonner et al, 2006 Drawback:in control arm RT alone given (not a standard treatment for stage III and IV HNSCC)
  • 73.
    • LOCOREGIONAL CONTROL• OVERALL SURVIVAL
  • 75.
    Bonner et al2010 update: 5 years follow up
  • 76.
    subgroups analysis demonstrated effectof cetuximab was pronounced in patients with oropharyngeal carcinoma,  T1-T3 disease, concomitant boost radiation, N1-N3, KPS 90-100 , male patients, EGFR expression ≤ 50%, ≤65 years.
  • 77.
    Surgical options inoperable Ca hypopharynx Voice preservation surgery in early hypopharynx cancer Supraglottic laryngectemy Hemilaryngectomy Partial laryngopharyngectomy Radical Laryngectomy in advanced stages  Total laryngectomy Total laryngopharyngectomy
  • 78.
    Primary Surgery • T1and T2 Tumors: voice conservation surgery • INDICATIONS • CONTRAINDICATIONS  voice conservation approaches possible  refuse radiation  vocal fold fixation,  cartilage invasion,  postcricoid invasion,  deep pyriform sinus invasion,  extension beyond the larynx • T3 / T4 Tumors • INDICATIONS dysfunctional larynx pt. with bulky destructive tumor that severely compromise airway or destroy cartilage, bone, soft tissue undergo immediate laryngopharyngectomy and post op radiation
  • 79.
    operation indication partsremoved contraindication hemilaryngectomy horizontal partial supraglottic laryngectomy(SGL)  T1/T2 pyriform sinus tumor  voice preservation for early supraglottic extension  epiglottis  aryepiglottic fold  false cords  upper 1/3-1/2 of thyroid cartilage  ±hyoid bone  preserves one or both arytenoids & true vc  thyroid,cricoid cartilage invasion  arytenoid involvement  vocal fold fixation  postcricoid invasion  deep pyriform sinus invasion  extension beyond the larynx  fixed neck nodes  inadequate pulmonary function extended supraglottic laryngectomy  supraglottic lesion with<1cm base of tongue invasion  same as SGL with removal of i/l bot upto circumvallete papillae
  • 80.
    operation indications removescontraindication  partial laryngophary ngectomy  used for small medial and anterior pyriform sinus lesion  false vocal cord  epiglottis  aryepiglottic fold  pyriform sinus,  tvc are preserved  transglottic extension,  cartilage invasion  vocal cord paralysis,  pyriform apex invasion,  postcricoid invasion  extralaryngeal spread  poor pulmonary reserve  total laryngectomy  Advanced pyriform sinus lesion  cartilage invasion  removes hyoid, thyroid, cricoid cartilage, epiglottis strap muscle. Patient left with a permanent tracheostoma and pharynx reconstruction  total laryngophary ngectomy  for more advanced hypopharyngeal lesion  total laryngectomy  plus removal of varying amount of pharyngeal wall
  • 81.
    Advances in surgery •In recent years, advancements in organ preservation surgery have included the use of • Transoral laser microsurgery • Transoral robotic surgery. • Advantage Less morbidity avoiding tracheostomy and the use of feeding tubes
  • 82.
  • 83.
    Preoperative RT Vspostoperative RT: RTOG 73-03 Phase III study of preoperative radiation therapy (50.0 Gy) versus postoperative radiation therapy (60.0 Gy) for supraglottic larynx and hypopharynx primaries duration of follow-up was 9-15 years, Loco-regional control& absolute survival was estimated & compared 1987
  • 84.
    N=277 patients. Operable stageT2-T4 /N±  oral cavity(14%)  Oropharynx(17%)  Supraglottic larynx(26%)  Hypopharynx(43%) Postoperative stage III or IV SCCHN R A N D O M I Z E Arm 2:Post-op RT 60 Gy. n= 141 Arm 1: Pre-op RT 50 Gy n=136
  • 85.
    Long-term Follow-up OfRTOG Study 73-03 *(Tupchong L et al. Int J Radiat Oncol Biol Phys. 1991 Jan;20(1):21-8.) outcome preopRT postopRT LRC 58% 70% LRF within 2 years 59% 58% LRF after 2years 27% 8% Overall survival similar toxicity similar • Post op RT is better than preop RT for LRC 1991
  • 86.
    Indications for postoperative radiotherapy Primary:  Large primary - T4 or T3 with soft tissue infiltration  Close or positive margins of excision  Deep infiltrative tumour  High grade tumour  Lympho-vascular and perineural invasion Lymph nodes:  Bulky nodal disease N2 / N3  Extra nodal extension  Multiple level involvement
  • 87.
    POSTOPERATIVE RADIOTHERAPY Is POCTRT better than PORT alone?
  • 88.
    R A N D O M IZ E Cisplatin 100 mg/m2d 1, 22, 43 XRT XRT Cooper et al, 2004; Bernier et al, 2004. S U R G E R Y RTOG 95-01 459 patients EORTC 22931 334 patients EORTC (66 Gy over 6 ½ wks) RTOG (60–66 Gy over 6-6 ½ wks) Postoperative Chemoradiotherapy
  • 89.
    • RESULTS OFPOSTOP CHEMORADIATION TRIAL
  • 90.
    EORTC 22931 only Bernier etal N=334 EORTC 22931 and RTOG 9501 RTOG 9501 only Cooper et al.2004 N=459 stage III/IV disease margin+ ≥2positive l.n ECE+ ECE + ECE + margin + margin+ PNI+ embolism
  • 92.
    RT Techniques inHypopharynx • CTV for curative radiotherapy T1/T2 N0 • GTV is defined using • Endoscopy • EUA reports and diagrams • Diagnostic imaging • There is no evidence on which to base GTV-CTV margins at the primary site but submucosal spread is common and can extend at least 10 mm from the GTV • GTV is grown by a 10mm axial margin and a 15 mm longitudinal margin to create a CTV70 • Edited to take account of patterns of spread and natural barriers to tumour progression (e.g. bone) • CTV70 is also edited to include adjacent lymph nodes (usually level III but occasionally part of levels II and IV) on the same axial slices as the CTV70
  • 93.
    RT Techniques inHypopharynx • For lateral pyriform fossa tumours these high risk nodes will be ipsilateral • For other hypopharyngeal tumours they will be bilateral • The CTV44 is edited to include other lymph node groups at risk of micrometastases • For lateral pyriform fossa tumours this will include ipsilateral levels II–IV • For other tumours with bilateral lymph node drainage, bilateral nodes are include • Retropharyngeal nodes are included for tumours involving the posterior pharyngeal wall
  • 94.
    RT Techniques inHypopharynx • Target volume definition • CTV for curative radiotherapy T1/T2 N0 • The GTV is defined using endoscopy, EUA reports and diagrams, and diagnostic imaging • There is no evidence on which to base GTV-CTV margins at the primary site but submucosal spread is common and can extend at least 10 mm from the GTV • GTV is grown by a 10mm axial margin and a 15 mm longitudinal margin to create a CTV70 • This is then edited to take account of patterns of spread and natural barriers to tumour progression (e.g. bone) • The CTV70 is also edited to include adjacent lymph nodes (usually level III but occasionally part of levels II and IV) on the same axial slices as the CTV70 • For lateral pyriform fossa tumours these high risk nodes will be ipsilateral; for other hypopharyngeal tumours they will be bilateral
  • 95.
    RT Techniques inHypopharynx
  • 96.
    RT Techniques inHypopharynx • CTV for curative radiotherapy T 3/4 or N • Post induction chemotherapy • CTVs should therefore be based on the initial pattern of disease as well as on the residual tumour seen on the planning CT • GTV should be defined on the planning CT from the residual volume but should include any nodes that were involved at diagnosis even if they are not now enlarged
  • 97.
    RT Techniques inHypopharynx • To allow for submucosal spread, the GTV is enlarged by 10 mm axially and 15mm longitudinally to form the CTV70 • The CTV70 is edited to take account of natural barriers to tumour progression and to include all sites of primary disease at presentation. • For example • A pyriform fossa cancer invading the tongue base at diagnosis may respond to induction chemotherapy to leave residual tumour in the pyriform fossa alone • The tongue base should be included in the CTV70 • CTV is further edited to include sites of high risk nodal disease • For N disease the CTV70 includes level II–IV nodes adjacent to the primary GTV, any involved nodes at other levels and any nodes in between
  • 98.
    RT Techniques inHypopharynx
  • 99.
    RT Techniques inHypopharynx • CTV for adjuvant radiotherapy • After careful discussion with the surgeon and pathologist, the CTV60 is defined as sites of possible residual microscopic disease • The CTV60 should include the margins of resection and sites of any dissected nodal levels where there was tumour. • Sites of positive resection margins or where there was extracapsular nodal spread should be further defined as CTV66. • When the patient has had a laryngectomy • Stoma should be included in the CTV60 if subglottic extension was present or if the surgeon is concerned about the risk of parastomal recurrence
  • 100.
    RT Techniques inHypopharynx • CTV for adjuvant radiotherapy • If a clinically node negative tumour has been excised with an elective neck dissection and there is unexpected tumour in the neck nodes, a CTV44 can also be defined • This should ensure that the nodal levels have been treated either surgically or with radiotherapy • For example • If surgery for a T2 pyriform fossa tumour included an ipsilateral level II–IV neck dissection at which multiple involved nodes were identified (pN2b), the CTV44 should include ipsilateral levels Ib and V, contralateral levels II–IV and bilateral retropharyngeal nodes
  • 101.
    RT Technique ofCarcinoma Larynx
  • 102.
    RT Technique ofCarcinoma Larynx • Target volume definition • T1 N0 glottic larynx • Conventional treatment with small lateral beams is usually successful and well tolerated • Records and pictures from nasal endoscopy and EUA should be available as small primary vocal cord tumours are difficult to see on CT scan • GTV is defined as the site of primary tumour • CTV is the glottic larynx with a border at least 10 mm superiorly and inferiorly from the GTV. • Axially the bilateral mucosal laryngeal surface is included • PTV is CTV with a 3–5 mm isotropic margin depending on local assessment of random and systematic errors assuming tumour movement is minimal • Motion can be assessed by watching laryngeal movement with fluoroscopy in the simulator to ensure that the vocal cords remain within the PTV on swallowing
  • 103.
    RT Technique ofCarcinoma Larynx • In practice, it can be easier to define • Superior (mid-body of hyoid) • Inferior (inferior margin of cricoid) beam borders • On the lateral DRR from the planning CT scan and then check on the axial slices that the whole glottic larynx is included within the CTV, assuming a 5 mm penumbra from PTV to beam edge • Using smaller beams defined solely on the basis of GTV-CTV-PTV definition has little therapeutic advantage and increases the possibility of a geographical tumour miss due to intra-fractional motion from swallowing
  • 106.