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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 1 st 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

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  • 1. Trotti, Andy 1 ; Fu, Karen K 2 ; Pajak, Thomas F 3 ; Jones, Christopher U 4 ; Spencer, Sharon A 5 ; Phillips, Theodore L 2 ; Garden, Adam S 9 ; Ridge, John A 7 ; Cooper, Jay S 8 ; Ang, K Kian 9 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. Standard Fractionation (SFX) Hyperfractionation (HFX) Accelerated Hyperfractionation with Split (AHFX-S) Accelerated Fractionation Concomitant Boost (AFX-C) Schema 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. Primary : To determine whether hyperfractionation and/or accelerated fractionation improve the local-regional control rate of advanced squamous cell carcinoma of the head and neck. Secondary : To evaluate the disease-free and overall survival rates associated with patients treated by each of the different fractionation schemes, and evaluate associated levels of acute and late treatment toxicities. Objectives
  • 4. Analyzable patients 1073 1068 Median follow-up 3.4 yrs 8.5 yrs Late events >90 d from start >180 d from start 2005 analysis Trotti (2005) Fu (2000)
  • 5. 1113 patients entered; 1068 analyzable (96%) Well balanced by gender, race, age, primary site, KPS, T-stage, N-stage, stage group Oral cavity 10.3% Oropharynx 60.5% Hypopharynx 13.1% SG Larynx 16.1% AJCC Stage II 3.4 % (BOT and HPX) AJCC Stage III 28.3% AJCC Stage IV 68.3% Patient characteristics
  • 6. Local-Regional Control Failed/Total SFX 149/266 HFX 132/261 p=0.080 AFX-C 127/267 p=0.044 49% at 5 years (HFX & AFX-C) 42% at 5 years (SFX)
  • 7. Disease-Free Survival Failed/Total SFX 236/266 HFX 227/261 p=0.082 AFX-C 223/267 p=0.057
  • 8. Overall Survival Dead/Total SFX 214/266 HFX 204/261 p=0.14 AFX-C 209/267 p=0.46
  • 9. 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. 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
  • 11. Prevalence of Grade 3+ Late Effects YEARS FROM START OF RT % WITH TOXICITY 1 2 5 8 10 n=218/arm* n=136/arm* n=76/arm * n=36/arm* n=16/arm* * Avg. No. Pts per arm SFX HFX RR=0.97 p=0.39 AFX-C RR=1.10 p=0.82 AHFX-S RR=1.04 p=0.72
  • 12. Time to Second Primary Failed/Total Any 182/1068 H&N 36/1068 Non-H&N 150/1068 25% at 5 years 40% at 10 years
  • 13. 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. 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. THANK YOU
  • 16. 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. LRC, DFS, DM and OS Locoregional Control 2yr 5yr 10yr   AFX-C SFX 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