Adjuvant temozolomide plus cisplatin versus high-dose interferon versus observation in resected mucosal melanoma
In this Chinese randomised trial, chemotherapy with temozolomide and cisplatin after surgery for mucosal melanoma lengthened relapse-free and overall survival compared with interferon or observation, the only positive adjuvant trial specific to mucosal disease.
Overview
Phase 2 randomised trial of 189 patients with resected mucosal melanoma assigned to observation, high-dose interferon alfa-2b for one year, or six cycles of temozolomide plus cisplatin.
Median relapse-free survival was 5.4 months with observation, 9.4 months with interferon and 20.8 months with chemotherapy, and median overall survival 21.2, 40.4 and 48.7 months respectively.
- Median relapse-free survival 20.8 months (chemotherapy) vs 9.4 (interferon) vs 5.4 (observation).
- Median overall survival 48.7 vs 40.4 vs 21.2 months.
Adjuvant temozolomide-cisplatin is used in China for resected mucosal melanoma; elsewhere anti-PD-1 therapy is extrapolated from cutaneous disease, and the two have since been compared directly.
- Single-country phase 2 trial in a largely Asian population.
- Predates adjuvant immunotherapy.
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