Southwest oncology group S0008: A Phase III trial of high-dose interferon alfa-2b versus cisplatin, vinblastine, and dacarbazine, plus interleukin-2 and interferon in patients with high-risk melanoma-an intergroup study of cancer and leukemia group B, children's oncology group, eastern cooperative oncology group, and southwest oncology group

Lawrence E. Flaherty, Megan Othus, Michael B. Atkins, Ralph J. Tuthill, John A. Thompson, John T. Vetto, Frank G. Haluska, Alberto S. Pappo, Jeffrey A. Sosman, Bruce G. Redman, James Moon, Antoni Ribas, John M. Kirkwood, Vernon K. Sondak

    Research output: Contribution to journalArticle

    58 Scopus citations

    Abstract

    Results In all, 432 patients were enrolled. Grade 3 and 4 adverse events occurred in 57% and 7% of HDI patients and 36% and 40% of biochemotherapy patients, respectively. At a median follow-up of 7.2 years, biochemotherapy improved RFS (hazard ratio [HR], 0.75; 95% CI, 0.58 to 0.97; P = .015), with a median RFS of 4.0 years (95% CI, 1.9 years to not reached [NR]) versus 1.9 years for HDI (95% CI, 1.2 to 2.8 years) and a 5-year RFS of 48% versus 39%. Median OS was not different (HR, 0.98; 95% CI, 0.74 to 1.31; P = .55), with a median OS of 9.9 years (95% CI, 4.62 years to NR) for biochemotherapy versus 6.7 years (95% CI, 4.5 years to NR) for HDI and a 5-year OS of 56% for both arms.

    Conclusion Biochemotherapy is a shorter, alternative adjuvant treatment for patients with high-risk melanoma that provides statistically significant improvement in RFS but no difference in OS and more toxicity compared with HDI.

    Purpose High-dose interferon (IFN) for 1 year (HDI) is the US Food and Drug Administration-approved adjuvant therapy for patients with high-risk melanoma. Efforts to modify IFN dose and schedule have not improved efficacy. We sought to determine whether a shorter course of biochemotherapy would be more effective.

    Patients and Methods S0008 (S0008: Chemotherapy Plus Biological Therapy in Treating Patients With Melanoma) was an Intergroup phase III trial that enrolled high-risk patients (stage IIIA-N2a through IIIC-N3), randomly assigning them to receive either HDI or biochemotherapy consisting of dacarbazine, cisplatin, vinblastine, interleukin-2, IFN alfa-2b (IFN-α-2b) and granulocyte colony-stimulating factor given every 21 days for three cycles. Coprimary end points were relapse-free survival (RFS) and overall survival (OS).

    Original languageEnglish (US)
    Pages (from-to)3771-3778
    Number of pages8
    JournalJournal of Clinical Oncology
    Volume32
    Issue number33
    DOIs
    StatePublished - Nov 20 2014

    ASJC Scopus subject areas

    • Oncology
    • Cancer Research

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