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Clinical Trial
. 2010 Oct;33(5):495-9.
doi: 10.1097/COC.0b013e3181b9cf04.

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

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 et al. Am J Clin Oncol. 2010 Oct.

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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Figures

Figure 1
Figure 1
A: Progression free survival B: Overall Survival
Figure 1
Figure 1
A: Progression free survival B: Overall Survival
See this image and copyright information in PMC

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