Multicenter Randomized Trial of Dacarbazine Alone or in Combination With Two Different Doses and Schedules of Interferon Alfa-2a in the Treatment of Advanced Melanoma

作者: E Bajetta , A Di Leo , M G Zampino , M R Sertoli , G Comella

DOI: 10.1200/JCO.1994.12.4.806

关键词: SurgeryRandomized controlled trialOncologyClinical trialAlpha interferonMedicineDacarbazineInterferon alfaRandomizationMelanomaChemotherapyInternal medicine

摘要: PURPOSESome phase II studies have suggested that the combination of interferons (IFNs) with dacarbazine (DTIC) in treatment malignant melanoma (MM) increases antitumor activity DTIC alone. In an attempt to confirm this hypothesis, a randomized study was performed further intent observing whether low doses recombinant interferon alfa-2a (rIFN alpha 2a) could be as effective intermediate doses.PATIENTS AND METHODSTwo hundred sixty-six patients were onto three different arms: 800 mg/m2 intravenously (IV) days 1 and 21; plus rIFN 2a 9 mIU intramuscularly (IM) daily; 3 IM times per week. Major prognostic factors well balanced among arms. Chemotherapy administered for maximum eight cycles. After 6 months therapy, continued until disease progression at week responding who had received combined treatment.RESULTSThe percentage ...

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