Carboplatin and Vinorelbine Combined with Subcutaneous Interleukin-2 in Metastatic Melanoma with Poor Prognosis

Background: The treatment results of metastatic melanoma are miserable if the tumor has spread beyond the soft tissue and lung, in particular, if dacarbazine (DTIC)based therapy has failed. Platinum analogs and vinca alkaloids have shown some activity in melanoma. Interleukin-2 (IL-2) may augment the efficacy of chemotherapy. Patients and Methods: A prospective phase II pilot study was conducted to evaluate the efficacy and tolerability of a regimen which contained carboplatin (450 mg/m(2) on day 1), vinorelbine (30 mg/m(2) on day 1) and IL-2 (9 MU subcutaneously once daily on days 2-5 and 9-12) in metastatic melanoma. Twenty-two patients (11 men, 11 women; median age 56 years) were eligible, of whom 13 had cutaneous, 6 ocular and 3 unknown primary melanoma. Seventeen patients (77%) had liver metastases and an equal number had received prior chemotherapy and/or interferon-alfa for recurrent disease. Results: One partial response was recorded, yielding a response rate of 4.5%. Nine patients had stable disease for a median of 6.0 months (range 3.0-8.6 months). The median time to progression for all patients was 1.8 months (range 0.7-8.6 months) and the median survival was 7.2 months (range 1.4-42.0 months). Toxicity was moderate but manageable. Myelosuppression was the most significant adverse event. Conclusion: This regimen may offer clinical benefit for melanoma patients with poor prognosis as second- line therapy after DTIC has failed.