Combined treatment with pegylated interferon–α‐2a and dacarbazine in patients with advanced metastatic melanoma

Abstract

AbstractBACKGROUND.Dacarbazine (DTIC) and pegylated interferon (IFN)–α‐2a have both demonstrated some efficacy as single agents in metastatic melanoma. To the authors' knowledge, the current study is the first to test a combination of these 2 agents in a phase 2 trial.METHODS.Twenty–eight patients with stage IV melanoma without brain metastases were treated with DTIC (at a dose of 850 mg/m2 every 3 weeks) combined with weekly pegylated IFN–α‐2a at a dose of 180 μg. The study was initiated to evaluate the efficacy and tolerability of the combination. The primary study endpoint was objective response.RESULTS.Twenty–five patients were evaluable for response. Two patients (8.0%) achieved a complete response that continued for >480 days and 746 days, respectively. Four patients (16.0%) demonstrated a partial response, and another patient experienced stable disease. Six of 7 nonprogressive patients had either not received treatment or had not developed disease progression during adjuvant IFN treatment for stage II/III disease. The median duration of response was 236 days, the median progression‐free survival was 56 days, and the overall survival time was 403 days. Few grade 3 toxicities and only 1 grade 4 toxicity were observed (according to National Cancer Institute Common Toxicity Criteria).CONCLUSIONS.The combination of DTIC and pegylated IFN–α‐2a was found to be well tolerated in patients with metastatic melanoma. The response rate of 24%, including 2 long‐lasting complete responses, is encouraging, but must be confirmed in larger trials. Cancer 2008. © 2008 American Cancer Society.