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A trial of the Eastern Cooperative Oncology Group
Article first published online: 1 APR 2003
Copyright © 2003 American Cancer Society
Volume 97, Issue 8, pages 1969–1973, 15 April 2003
How to Cite
Okuno, S., Ryan, L. M., Edmonson, J. H., Priebat, D. A. and Blum, R. H. (2003), Phase II trial of gemcitabine in patients with advanced sarcomas (E1797). Cancer, 97: 1969–1973. doi: 10.1002/cncr.11290
This study was conducted by the Eastern Cooperative Oncology Group (Robert L. Comis, M.D., Chair).
The contents of this article are solely the responsibility of the authors and do not necessarily represent the official views of the National Cancer Institute.
- Issue published online: 1 APR 2003
- Article first published online: 1 APR 2003
- Manuscript Accepted: 12 DEC 2002
- Manuscript Revised: 25 NOV 2002
- Manuscript Received: 12 JUN 2002
- Public Health Service Grants from the National Cancer Institute, National Institutes of Health, Department of Health and Human Services. Grant Numbers: CA23318, CA66636, CA21115, CA13650, CA59307
- antitumor activity;
The current study was conducted to evaluate the antitumor activity and toxicity of gemcitabine in patients with advanced sarcoma.
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.
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.
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.