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

Emilio Bajetta, Angelo Di Leo, Maria Giulia Zampino, Mario Roberto Sertoli, Giuseppe Comella, Mario Barduagni, Benvenuto Giannotti, Paola Queirolo, Giuliana Tribbia, Maria Grazia Bernengo, Ettore Tito Menichetti, Sergio Palmeri, Anna Russo, Mario Cristofolini, Anna Erbazzi, Camilla Fowst, Domenico Criscuolo, Rosaria Bufalino, Nicoletta Zilembo, Natale Cascinelli

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Abstract

Purpose: Some phase II studies have suggested that the combination of interferons (IFNs) with dacarbazine (DTIC) in the treatment of malignant melanoma (MM) increases the antitumor activity of DTIC alone. In an attempt to confirm this hypothesis, a randomized study was performed with the further intent of observing whether low doses of recombinant interferon alfa-2a (rIFNα2a) could be as effective as intermediate doses. Patients and Methods: Two hundred sixty-six patients were randomized onto three different treatment arms: DTIC 800 mg/m 2 intravenously (IV) days 1 and 21; DTIC plus rIFNα2a 9 mIU intramuscularly (IM) daily; and DTIC plus rIFNα2a 3 mIU IM three times per week. Major prognostic factors were well balanced among the three arms. Chemotherapy was administered for a maximum of eight cycles. After 6 months of therapy, rIFNα2a was continued until disease progression at 3 mIU three times per week in responding patients who had received the combined treatment. Results: The percentage of objective responses did not differ among the three groups (20%, 28%, and 23%, respectively), although a significant prolongation of response duration was observed when rIFNα2a was added to DTIC (2.6 v 8.4 v 5.5 months, respectively). However, this improvement in response duration did not translate into an amelioration of overall survival. The addition of rIFNα2a led to the onset of flu-like syndrome, but in no case was it necessary to withdraw the treatment program and no toxic deaths or life-threatening toxicities were reported. Conclusion: In this study, rIFNα2a significantly prolonged response duration, whereas no effects on response rate and survival were observed; rIFNα2a 3 mIU appeared to be equally effective and better tolerated than 9 mIU.

Original languageEnglish
Pages (from-to)806-811
Number of pages6
JournalJournal of Clinical Oncology
Volume12
Issue number4
Publication statusPublished - Apr 1994

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ASJC Scopus subject areas

  • Cancer Research
  • Oncology

Cite this

Bajetta, E., Di Leo, A., Zampino, M. G., Sertoli, M. R., Comella, G., Barduagni, M., Giannotti, B., Queirolo, P., Tribbia, G., Bernengo, M. G., Menichetti, E. T., Palmeri, S., Russo, A., Cristofolini, M., Erbazzi, A., Fowst, C., Criscuolo, D., Bufalino, R., Zilembo, N., & Cascinelli, N. (1994). 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. Journal of Clinical Oncology, 12(4), 806-811.