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 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

    54 Citations (Scopus)

    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

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    interferon alfa-2b
    Dacarbazine
    Vinblastine
    Interferons
    Cisplatin
    Interleukin-2
    Melanoma
    Leukemia
    Survival
    Neoplasms
    Recurrence
    Biological Therapy

    ASJC Scopus subject areas

    • Cancer Research
    • Oncology

    Cite this

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

    In: Journal of Clinical Oncology, Vol. 32, No. 33, 20.11.2014, p. 3771-3778.

    Research output: Contribution to journalArticle

    Flaherty, Lawrence E. ; Othus, Megan ; Atkins, Michael B. ; Tuthill, Ralph J. ; Thompson, John A. ; Vetto, John ; Haluska, Frank G. ; Pappo, Alberto S. ; Sosman, Jeffrey A. ; Redman, Bruce G. ; Moon, James ; Ribas, Antoni ; Kirkwood, John M. ; Sondak, Vernon K. / 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. In: Journal of Clinical Oncology. 2014 ; Vol. 32, No. 33. pp. 3771-3778.
    @article{99ede46c292146d1b8008a64083f1a2f,
    title = "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",
    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).",
    author = "Flaherty, {Lawrence E.} and Megan Othus and Atkins, {Michael B.} and Tuthill, {Ralph J.} and Thompson, {John A.} and John Vetto and Haluska, {Frank G.} and Pappo, {Alberto S.} and Sosman, {Jeffrey A.} and Redman, {Bruce G.} and James Moon and Antoni Ribas and Kirkwood, {John M.} and Sondak, {Vernon K.}",
    year = "2014",
    month = "11",
    day = "20",
    doi = "10.1200/JCO.2013.53.1590",
    language = "English (US)",
    volume = "32",
    pages = "3771--3778",
    journal = "Journal of Clinical Oncology",
    issn = "0732-183X",
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    TY - JOUR

    T1 - Southwest oncology group S0008

    T2 - 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

    AU - Flaherty, Lawrence E.

    AU - Othus, Megan

    AU - Atkins, Michael B.

    AU - Tuthill, Ralph J.

    AU - Thompson, John A.

    AU - Vetto, John

    AU - Haluska, Frank G.

    AU - Pappo, Alberto S.

    AU - Sosman, Jeffrey A.

    AU - Redman, Bruce G.

    AU - Moon, James

    AU - Ribas, Antoni

    AU - Kirkwood, John M.

    AU - Sondak, Vernon K.

    PY - 2014/11/20

    Y1 - 2014/11/20

    N2 - 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).

    AB - 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).

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    U2 - 10.1200/JCO.2013.53.1590

    DO - 10.1200/JCO.2013.53.1590

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    JO - Journal of Clinical Oncology

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