Abstract
8506 Background: High-dose interferon alfa-2b regimen has been demonstrated as the standard of adjuvant therapy for resected melanoma. But the subgroup of mucosal melanoma seems more aggressive and insensitive to immunotherapy. So we conducted a phase II study (ChiCTR-TRC-11001798) to compare Interferon regimen with chemotherapy as adjuvant therapy for this particular subgroup pts. Methods: Resected mucosal melanoma pts were randomized to observation (Group A) or receive postoperative adjuvant Interferon (IFN) alfa2b 15 MU/m2/day for 5 days/week X 4 weeks followed by 9 MU/m2 three times each week for 48 weeks (Group B), or chemotherapy with temozolomide 200 mg/m2 d1-5 + cisplatin 25 mg/m2 d1-3, repeated every 3 Weeks X 6 cycles (Group C). Results: 189 patients were enrolled and 184 patients were eligible for survival analysis. With a median follow-up of 26.8 months, the median RFS for Group A, B and C were 5.4, 9.4 and 20.8 months, respectively (P<0.001). Estimated median OS for Group A, B and C were 21.2, 41.1 and 49.6 months (P<0.001), respectively. Toxicities were generally mild to moderate. Conclusions: Chemotherapy significantly improved RFS and OS as adjuvant therapy for mucosal melanoma pts over HDI regimen or observation. This trial suggests that different subgroup of melanoma may need different adjuvant therapy.
Published Version
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