A phase II trial of imatinib mesylate in merkel cell carcinoma (Neuroendocrine carcinoma of the skin): A Southwest oncology group study (S0331)

Wolfram E. Samlowski, James Moon, Ralph J. Tuthill, Michael Heinrich, Naomi S. Balzer-Haas, Stuart A. Merl, Ronald C. DeConti, John A. Thompson, Merle T. Witter, Lawrence E. Flaherty, Vernon K. Sondak

    Research output: Contribution to journalArticle

    58 Citations (Scopus)

    Abstract

    Background: Imatinib mesylate (Gleevec) was evaluated as a treatment for Merkel cell carcinoma (MCC, neuroendocrine carcinoma of the skin) based on the identification of strong c-KIT staining of these neoplasms. Methods: Eligibility included patients with measurable metastatic or unresectable MCC, c-KIT (CD117) expression and a Zubrod performance status of 0 to 2. Imatinib 400 mg daily was administered orally in 28-day cycles to 23 patients. Results: Overall, imatinib was well tolerated with grade 1 or 2 nausea, diarrhea, and hematologic toxicity as the most frequent side effects. A partial response was seen in 1 patient (4%; 95% CI: 0%-22%). Median progression- free survival was 1 month (95% CI: 1-2 months). Median overall survival was 5 months (95% CI: 2-8 months). One patient achieved a partial response and another had prolonged disease stabilization while receiving treatment. Conclusions: The majority of patients progressed rapidly within 1 to 2 cycles of treatment. The observed progression-free survival and overall survival were not adequate to conclude that this agent was active in advanced MCC, and thus the planned second stage of patient accrual was not opened.

    Original languageEnglish (US)
    Pages (from-to)495-499
    Number of pages5
    JournalAmerican Journal of Clinical Oncology: Cancer Clinical Trials
    Volume33
    Issue number5
    DOIs
    StatePublished - Oct 2010

    Fingerprint

    Merkel Cell Carcinoma
    Neuroendocrine Carcinoma
    Skin
    Disease-Free Survival
    Survival
    Nausea
    Imatinib Mesylate
    Diarrhea
    Therapeutics
    Staining and Labeling
    Neoplasms

    Keywords

    • C-KIT
    • Imatinib mesylate
    • Merkel cell carcinoma
    • Neuroendocrine carcinoma of the skin

    ASJC Scopus subject areas

    • Oncology
    • Cancer Research
    • Medicine(all)

    Cite this

    A phase II trial of imatinib mesylate in merkel cell carcinoma (Neuroendocrine carcinoma of the skin) : A Southwest oncology group study (S0331). / Samlowski, Wolfram E.; Moon, James; Tuthill, Ralph J.; Heinrich, Michael; Balzer-Haas, Naomi S.; Merl, Stuart A.; DeConti, Ronald C.; Thompson, John A.; Witter, Merle T.; Flaherty, Lawrence E.; Sondak, Vernon K.

    In: American Journal of Clinical Oncology: Cancer Clinical Trials, Vol. 33, No. 5, 10.2010, p. 495-499.

    Research output: Contribution to journalArticle

    Samlowski, Wolfram E. ; Moon, James ; Tuthill, Ralph J. ; Heinrich, Michael ; Balzer-Haas, Naomi S. ; Merl, Stuart A. ; DeConti, Ronald C. ; Thompson, John A. ; Witter, Merle T. ; Flaherty, Lawrence E. ; Sondak, Vernon K. / A phase II trial of imatinib mesylate in merkel cell carcinoma (Neuroendocrine carcinoma of the skin) : A Southwest oncology group study (S0331). In: American Journal of Clinical Oncology: Cancer Clinical Trials. 2010 ; Vol. 33, No. 5. pp. 495-499.
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    abstract = "Background: Imatinib mesylate (Gleevec) was evaluated as a treatment for Merkel cell carcinoma (MCC, neuroendocrine carcinoma of the skin) based on the identification of strong c-KIT staining of these neoplasms. Methods: Eligibility included patients with measurable metastatic or unresectable MCC, c-KIT (CD117) expression and a Zubrod performance status of 0 to 2. Imatinib 400 mg daily was administered orally in 28-day cycles to 23 patients. Results: Overall, imatinib was well tolerated with grade 1 or 2 nausea, diarrhea, and hematologic toxicity as the most frequent side effects. A partial response was seen in 1 patient (4{\%}; 95{\%} CI: 0{\%}-22{\%}). Median progression- free survival was 1 month (95{\%} CI: 1-2 months). Median overall survival was 5 months (95{\%} CI: 2-8 months). One patient achieved a partial response and another had prolonged disease stabilization while receiving treatment. Conclusions: The majority of patients progressed rapidly within 1 to 2 cycles of treatment. The observed progression-free survival and overall survival were not adequate to conclude that this agent was active in advanced MCC, and thus the planned second stage of patient accrual was not opened.",
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    author = "Samlowski, {Wolfram E.} and James Moon and Tuthill, {Ralph J.} and Michael Heinrich and Balzer-Haas, {Naomi S.} and Merl, {Stuart A.} and DeConti, {Ronald C.} and Thompson, {John A.} and Witter, {Merle T.} and Flaherty, {Lawrence E.} and Sondak, {Vernon K.}",
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    AU - Moon, James

    AU - Tuthill, Ralph J.

    AU - Heinrich, Michael

    AU - Balzer-Haas, Naomi S.

    AU - Merl, Stuart A.

    AU - DeConti, Ronald C.

    AU - Thompson, John A.

    AU - Witter, Merle T.

    AU - Flaherty, Lawrence E.

    AU - Sondak, Vernon K.

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    AB - Background: Imatinib mesylate (Gleevec) was evaluated as a treatment for Merkel cell carcinoma (MCC, neuroendocrine carcinoma of the skin) based on the identification of strong c-KIT staining of these neoplasms. Methods: Eligibility included patients with measurable metastatic or unresectable MCC, c-KIT (CD117) expression and a Zubrod performance status of 0 to 2. Imatinib 400 mg daily was administered orally in 28-day cycles to 23 patients. Results: Overall, imatinib was well tolerated with grade 1 or 2 nausea, diarrhea, and hematologic toxicity as the most frequent side effects. A partial response was seen in 1 patient (4%; 95% CI: 0%-22%). Median progression- free survival was 1 month (95% CI: 1-2 months). Median overall survival was 5 months (95% CI: 2-8 months). One patient achieved a partial response and another had prolonged disease stabilization while receiving treatment. Conclusions: The majority of patients progressed rapidly within 1 to 2 cycles of treatment. The observed progression-free survival and overall survival were not adequate to conclude that this agent was active in advanced MCC, and thus the planned second stage of patient accrual was not opened.

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