Phase II Randomized Trial Comparing High-dose Interferon Alfa-2b with Temozolomide plus Cisplatin as Systemic Adjuvant Therapy for Resected Mucosal Melanoma
Mené sur 189 patients atteints d'un mélanome des muqueuses ayant fait l'objet d'une résection, cet essai de phase II compare l'efficacité et la toxicité de deux traitements adjuvants, l'interféron alpha2b à haute dose et une chimiothérapie à base de temolozomide
Purpose: Mucosal melanoma is rare and associated with extremely poor prognosis. However, standard adjuvant therapy for mucosal melanoma has not been established. We conducted a randomized phase II clinical trial in resected mucosal melanoma (MM) patients to compare the efficacy and safety of high-dose IFN-α2b (HDI) and temozolomide-based chemotherapy as adjuvant therapy. Experimental Design: MM patients in stage II/III after surgery were randomized into three groups: observation group (Group A, surgery alone), HDI group (Group B, treated with 15×106 Unit/m2/day IFN-α2b, followed by 9×106 Unit IFN-α2b), and temozolomide (200 mg/m2/day) plus cisplatin (75 mg/m2) group (Group C). The endpoints were relapse-free survival (RFS), overall survival (OS) and toxicities. Results: 189 patients were enrolled and finally analyzed. With a median follow-up of 26.8 months, the median RFS were 5.4, 9.4 and 20.8 months for Group A, B and C, respectively. Estimated median OS for Group A, B and C were 21.2, 40.4 and 48.7 months, respectively. Patients treated with temozolomide plus cisplatin demonstrated significant improvements in RFS (P < 0.001) and OS (P < 0.01) than those treated with either HDI or surgery alone. Toxicities were generally mild to moderate. Conclusion: Both temozolomide-based chemotherapy and HDI are effective and safe as adjuvant therapies for resected MM as compared to observation alone. However, HDI tends to be less effective than temozolomide-based chemotherapy for resected MM patients in respect to RFS. The temozolomide plus cisplatin regimen might be a better choice for resected MM patients.