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  • On behalf of my RTOG investigator colleagues it is my privilege to present the long term outcomes of the RTOG H&N fractionation trial. This trial was begun more than 15 years ago and represents one of the largest purely fractionation trials ever conducted.
  • As you know there were 4 arms: SFX HFX w/ dose escal to 81.6 Gy, split course and concom boost.
  • Prim Obj was to improve local-regional control and a number of the usual secondary objectives.
  • Results were 1st reported in in 2000 by Karen Fu. For this report we have 5 years of additional follow-up for a median f/u of 8 years.The longest follow-up on any patient is 13.5 years. We also changed the time-based defn of late events from 90 to 180 days from start of therapy due to some prolonged acute events.
  • For this report we have 1068 analyzable patients; mostly oropharynx patients with only 10% oral cavity patients. Only 3% were stage II. Mostly stage II-IV using the 1988 staging system.
  • Kaplan-Meier local regional control showing about 7 points higher local-regional control for HFX and AFX-C. We did not include the split course are in these curves because I was similar to the standard arm and leaving it out make it easier to read.
  • Kaplan-Meier
  • Kaplan-Meier
  • Kaplan-Meier risk of developing at least 1 grade 3 or better late effect. Slight trend for higher risk with con com boost, but not stat signif at 0.18.
  • Prevalence of high grade late effects at years 1, 2, 5, 8 and 10. They tend to diminish over time and range from 6-24 %, depending on the year you look.
  • Risk of developing a second primary
  • Transcript

    • 1. Radiation Therapy Oncology Group Trotti, Andy 1 ; Fu, Karen K2 ; Pajak, Thomas F3 ; Jones, Christopher U4 ; Spencer, Sharon A5 ; Phillips, Theodore L2 ; Garden, Adam S9 ; Ridge, John A7 ; Cooper, Jay S8 ; Ang, K Kian9 Scientific Session RTOG Semi-Annual Meeting Miami, Florida Saturday Jan 21, 2006 LONG TERM OUTCOMES OF RTOG 90-03: A COMPARISON OF HYPERFRACTIONATION AND TWO VARIANTS OF ACCELERATED FRACTIONATION TO STANDARD FRACTIONATION RADIOTHERAPY FOR HEAD AND NECK SQUAMOUS CELL CARCINOMA
    • 2. Radiation Therapy Oncology Group Schema Standard FractionationStandard Fractionation (SFX)(SFX) HyperfractionationHyperfractionation (HFX)(HFX) Accelerated Hyperfractionation with SplitAccelerated Hyperfractionation with Split (AHFX-S)(AHFX-S) Accelerated Fractionation ConcomitantAccelerated Fractionation Concomitant BoostBoost (AFX-C)(AFX-C) oral cavity vs. oropharynx vs. larynx/hypopharynx N- vs. N + KPS 90-100 vs. 60-80 S T R A T I F Y R
    • 3. Radiation Therapy Oncology Group PrimaryPrimary:: To determine whether hyperfractionation and/or acceleratedTo determine whether hyperfractionation and/or accelerated fractionation improve thefractionation improve the local-regional controllocal-regional control rate of advancedrate of advanced squamous cell carcinoma of the head and neck.squamous cell carcinoma of the head and neck. SecondarySecondary ::To evaluate the disease-free and overall survival ratesTo evaluate the disease-free and overall survival rates associated with patients treated by each of the different fractionationassociated with patients treated by each of the different fractionation schemes, and evaluate associated levels of acute and late treatmentschemes, and evaluate associated levels of acute and late treatment toxicities.toxicities. Objectives
    • 4. Radiation Therapy Oncology Group Analyzable patientsAnalyzable patients 10731073 10681068 Median follow-up 3.4 yrs 8.5Median follow-up 3.4 yrs 8.5 yrsyrs Late events >90 d from start >180 dLate events >90 d from start >180 d from startfrom start 2005 analysis Trotti (2005)Trotti (2005)Fu (2000)Fu (2000)
    • 5. Radiation Therapy Oncology Group 1113 patients entered; 1068 analyzable (96%)1113 patients entered; 1068 analyzable (96%) Well balanced by gender, race, age, primary site, KPS, T-stagWell balanced by gender, race, age, primary site, KPS, T-stag N-stage, stage groupN-stage, stage group Oral cavityOral cavity 10.3%10.3% OropharynxOropharynx 60.5%60.5% HypopharynxHypopharynx 13.1%13.1% SG LarynxSG Larynx 16.1%16.1% AJCC Stage IIAJCC Stage II 3.4 % (BOT and HPX)3.4 % (BOT and HPX) AJCC Stage IIIAJCC Stage III 28.3%28.3% AJCC Stage IVAJCC Stage IV 68.3%68.3% Patient characteristics
    • 6. Radiation Therapy Oncology Group Local-Regional Control Failed/Total SFX 149/266 HFX 132/261 p=0.080 AFX-C 127/267 p=0.044 %CONTROL 0 25 50 75 100 YEARSFROMRANDOMIZATION 0 1 2 3 4 5 6 7 8 9 10 49% at 5 years (HFX & AFX-C) 42% at 5 years (SFX)
    • 7. Radiation Therapy Oncology Group Disease-Free Survival Failed/Total SFX 236/266 HFX 227/261 p=0.082 AFX-C 223/267 p=0.057 %ALIVEWITHOUTDISEASE 0 25 50 75 100 YEARSFROMRANDOMIZATION 0 1 2 3 4 5 6 7 8 9 10 / / / / / / / / // / / / //// // / / / / / / / / / / / ////// / / // / / / / / / / /// / / ///// // / / / // // / / / ///
    • 8. Radiation Therapy Oncology Group Overall Survival Dead/Total SFX 214/266 HFX 204/261 p=0.14 AFX-C 209/267 p=0.46 %ALIVE 0 25 50 75 100 YEARSFROMRANDOMIZATION 0 1 2 3 4 5 6 7 8 9 10 / / / / / / / / / / / / / / / ///// / / / ///// / / // / / /// / // // / / / / / / /// // / // ////// //// // /// / / / // / / / / /// / /// ///// // // / / / ///// // / / / / ////
    • 9. Radiation Therapy Oncology Group Causes of death Total dead Study cancer Second malignancy Complications of protocol treatment Other causes & unknown AFX-C 209 58.4% 10.5% 1.0% 30.1% SFX 214 57.0% 8.4% 0.5% 34.1% HFX 204 61.3% 8.8% 0.5% 29.4% AHFX-S 219 56.6% 12.3% 0.5% 30.6%
    • 10. Radiation Therapy Oncology Group Time to Late Grade 3+ Toxicity Failed/Total SFX 63/233 HFX 63/232 HR=0.97 p=0.88 AFX-C 81/232 HR=1.25 p=0.18 AHFX-S 65/239 HR=0.98 p=0.92 %FAILED 0 25 50 75 100 YEARSFROMSTARTOFRT 0 1 2 3 4 5 6 7 8 9 10
    • 11. Radiation Therapy Oncology Group Prevalence of Grade 3+ Late Effects YEARS FROM START OF RT %WITHTOXICITY SFX HFX RR=0.97 p=0.39 AFX-C RR=1.10 p=0.82 AHFX-S RR=1.04 p=0.72 1 2 5 8 10 21.4 11.3 8.5 9.4 5.9 20.7 19.9 9.5 5.3 13.3 24.3 13.5 16.3 14.3 20 22 12.7 17.1 18 14.2 0 25 50 75 100 n=218/arm* n=136/arm* n=76/arm * n=36/arm* n=16/arm* * Avg. No. Pts per arm
    • 12. Radiation Therapy Oncology Group Time to Second Primary Failed/Total Any 182/1068 H&N 36/1068 Non-H&N 150/1068 %FAILED 0 25 50 75 100 YEARSFROMRANDOMIZATION 0 1 2 3 4 5 6 7 8 9 10 25% at 5 years 40% at 10 years
    • 13. Radiation Therapy Oncology Group Conclusions • AFX-C (p=0.044) and HFX (p=0.080) are assoc w/ modestly higher loco-regional control (HR ~0.80; ~7 points). • There is a trend for better disease-free survival in AFX-C and HFX. • There are no differences in overall survival.
    • 14. Radiation Therapy Oncology Group Conclusions • The risk of ever developing a grade 3+ late event ranges from 33-44% at 5 years and 36-56% at 10 years. • The rate of late events is slightly higher with concomitant boost but not statistically significant (p=0.18). • Late event prevalence rates are similar among arms; rates tend to decrease over time. • The risk of developing a second malignancy is 25% at 5 years and 40% at 10 years (1/5 are H&N; 4/5 are non-H&N sites).
    • 15. Radiation Therapy Oncology Group THANK YOUTHANK YOU
    • 16. Radiation Therapy Oncology Group University of South Florida Radiological Associates of Sacramento U. of Alabama at Birmingham Medical Center University of California San Francisco U. of Texas-MD Anderson Cancer Center Fox Chase Cancer Center New York University Hospital McGill University Medical College of Wisconsin Washington University Montefiore Medical Center University of Western Ontario Akron City Hospital SUNY Health Science Cntr/Brooklyn Wayne State University University of Pennsylvania Medical Center Dartmouth Hitchcock Medical Center Albert Einstein Medical Center University of Puerto Rico/Med Sciences Ca Emory University Affiliated Hospitals University Of Alberta Thomas Jefferson University Hospital 103 83 82 75 56 54 50 49 44 42 37 37 37 32 30 28 25 23 21 19 19 19 University of Rochester LDS Hospital Loyola Univ Medical Center Johns Hopkins Hospital University of Miami Hamilton Regional Cancer Centre Mayo Clinic University of Kentucky Hospital South Jersey Oncology Group CCOP Wake Forest University Baptist Medical Center Kansas City CCOP S. Nevada Cancer Research Foundation CCOP North Shore University Hospital CCOP University of California Davis Medical Center Greenville S.C. CCOP West Michigan Cancer Center CCOP Atlanta Regional CCOP Dayton CCOP Main Line Health CCOP Christiana Care Health Services, Inc. Columbia River CCOP Upstate Carolina CCOP 18 14 12 12 12 11 10 10 8 8 5 5 3 3 3 3 2 2 2 1 1 1 Participating Institutions
    • 17. Radiation Therapy Oncology Group LRC, DFS, DM and OSLRC, DFS, DM and OS Locoregional Control 2yr 5yr 10yr  AFX-CSFX HFX AFX-S Disease Free Survival 2yr 5yr 10yr Distant Metastasis 2yr 5yr 10yr Overall Survival 2yr 5yr 10yr 46 42 39 53 49 40 48 42 40 55 49 49 31 20 11 38 26 11 34 23 15 38 25 13 22 29 31 20 29 33 24 27 29 21 27 29 55 37 18 47 29 19 49 34 19 46 30 17

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