A phase II trial of imatinib mesylate in merkel cell carcinoma (neuroendocrine carcinoma of the skin): A Southwest Oncology Group study (S0331).

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.

• Authors: Wolfram E Samlowski, 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
• Journal: American journal of clinical oncology (Am J Clin Oncol) Vol. 33 Issue 5 Pg. 495-9 (Oct 2010) ISSN: 1537-453X [Electronic] United States
• PMID: 20019577 (Publication Type: Clinical Trial, Phase II, Journal Article, Multicenter Study, Research Support, U.S. Gov't, P.H.S.)

Chemical References

• Benzamides
• Piperazines
• Protein Kinase Inhibitors
• Pyrimidines
• Imatinib Mesylate

Topics

• Aged
• Aged, 80 and over
• Benzamides
• Carcinoma, Merkel Cell (drug therapy)
• Drug-Related Side Effects and Adverse Reactions
• Feasibility Studies
• Female
• Humans
• Imatinib Mesylate
• Male
• Middle Aged
• Piperazines (adverse effects, therapeutic use)
• Protein Kinase Inhibitors (adverse effects, therapeutic use)
• Pyrimidines (adverse effects, therapeutic use)
• Skin Neoplasms (drug therapy)
• Survival Analysis