Phase II trial of gemcitabine in patients with advanced sarcomas (E1797)

Abstract

BACKGROUND The current study was conducted to evaluate the antitumor activity and toxicity of gemcitabine in patients with advanced sarcoma. METHODS Twenty‐five patients with advanced sarcomas, who previously were untreated for metastatic disease, were treated on an Eastern Cooperative Oncology Group Phase II study. Patients ranged in age from 27 to 79 years, with a median age of 59 years. The most common histology was leiomyosarcoma (54%). The grades of the tumors were high in 40%, moderate in 24% and low in 12%. Gemcitabine was given at a dose of 1250 mg/m² as a 30‐minute infusion weekly for 3 weeks followed by 1 week of rest. RESULTS One of the 25 patients (4%) (90% confidence interval [90% CI], 0–18%) achieved a partial response lasting 8 months. The estimated overall median survival was 15 months. The 1‐year estimated survival rate was 63% (90% CI, 47–84%). The estimated median progression‐free survival (PFS) was 13 months with a 1‐year PFS rate of 56% (90% CI, 41–76%). Grade 3–4 toxicities (by CTC criteria) were observed in all 25 patients. No lethal toxicity (Grade 5) related to treatment was found. CONCLUSIONS The results of the current study demonstrated that gemcitabine given at this schedule and dose in this population of patients with advanced sarcoma had limited activity. Cancer 2003;97:1969–73. © 2003 American Cancer Society. DOI 10.1002/cncr.11290