Abstract
8505 Background: To assess the benefit of 4 weeks of HDI compared with observation (obs) in relation to the relapse free survival (RFS) and overall survival (OS) of patients (pts) with resectable intermediate and high-risk melanoma Methods: Pts with intermediate and high-risk melanoma defined as T3 (AJCC 6th ed. >Breslow thickness 1.5mm (AJCC 7th ed. >2.0mm) or any thickness with microscopically positive node disease (N1a-N2a) were randomized to receive postoperative adjuvant Interferon (IFN) alfa2b 20 MU/m2/day for 5 days/week X 4 weeks or observation. Primary endpoints of the trial were RFS and OS. A sample size of 1420 pts was chosen to detect a 15% relative increase in the median time-to-event for those not cured and a 7.5% absolute increase in the cure rate with 88% power at a 5% level of significance, using a two-sided log-rank test. Results: Between December 1998 and October 2010, 1150 pts were enrolled – 581 assigned to HDI and 596 to obs. The breakdown of stage at entry was as follows: T2N0: 22%, T3N0: 45%, T4N0: 14%, T1-4, N1a-2a:19%. Primary ulceration was present in 36% of pts. A third interim analysis of this trial was carried out in August 2010 with RFS data in 838 and OS data in 1091 pts. The 234 RFS events correspond to 69.0% information time, while the 134 OS events correspond to 74% information time. Median RFS for Obs was 7.3 years (95% CI 5.3, 9.8; n=413) while for IFN, RFS was 6.8 years (95% CI 5.1, 9.0; n=425). The 5-year survival rate for OBS was 0.85 (95% CI .81, .89; n=535) while for IFN induction-only the 5-year survival rate was 0.82 with (95% CI .78, .86; n=556). Accrual to the trial has therefore been terminated. Conclusions: Adjuvant HDI induction with only 4 weeks therapy neither improved RFS nor OS over observation for pts with intermediate and high-risk melanoma. This trial supports the importance of HDI treatment duration and argues that the approved 1 year Interferon regimen of induction followed by maintenance remains the standard of care for pts with T4N0 or node positive disease.
Published Version
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