A phase II trial of temozolomide in patients with unresectable or metastatic soft tissue sarcoma.

Abstract

BACKGROUND:

The objective of this study was to assess the efficacy and toxicity of the imidazotetrazine derivative temozolomide for patients with unresectable or metastatic soft tissue sarcoma.

METHODS:

Twenty-five of 26 patients were eligible and assessable for toxicity and response. Temozolomide was administered twice daily on a 12-hour schedule for 5 days as an oral bolus dose of 200 mg/m(2) followed by 9 doses of 90 mg/m(2) every 4 weeks.

RESULTS:

There were 2 partial responses, 2 mixed responses, and 3 patients with stable disease that lasted > 6 months, for an overall objective response rate of 8%. At a median follow-up of 13.2 months, the median progression-free survival and the median overall survival were 2.0 months (95% confidence interval [95% CI], 1.7-2.3) and 13.2 months (95% CI, 4.7-31.1), respectively. All responding patients had leiomyosarcoma of uterine or nonuterine origin; and, in a subset analysis of these patients, the objective response rate was 18% (2 of 11 patients), with disease stabilization occurring in 3 of 11 patients (27%). For this subgroup, at a median follow-up of 24.4 months, the median progression-free survival and the median overall survival were 3.9 months (95% CI, 1.9-21.9) and 30.8 months (lower-bound 95% CI, 7.8), respectively. There were no treatment-related deaths or National Cancer Institute Grade 4 toxicities. Grade 3 toxicities included nausea, anemia, fatigue, elevated alkaline phosphatase levels and nonneutropenic fever (1 patient each).

CONCLUSIONS:

Temozolomide at the dose schedule employed in the current study was tolerated well and had modest activity against previously treated unresectable or metastatic leiomyosarcoma of both uterine and nonuterine origin.

• Authors: Susan M Talbot, Mary Louise Keohan, Mary Hesdorffer, Russell Orrico, Emilia Bagiella, Andrea B Troxel, Robert N Taub
• Journal: Cancer (Cancer) Vol. 98 Issue 9 Pg. 1942-6 (Nov 01 2003) ISSN: 0008-543X [Print] United States
• PMID: 14584078 (Publication Type: Clinical Trial, Clinical Trial, Phase II, Journal Article, Research Support, Non-U.S. Gov't)
• Copyright: Copyright 2003 American Cancer Society.

Chemical References

• Antineoplastic Agents, Alkylating
• Dacarbazine
• Temozolomide

Topics

• Adult
• Aged
• Antineoplastic Agents, Alkylating (administration & dosage, therapeutic use, toxicity)
• Dacarbazine (administration & dosage, adverse effects, analogs & derivatives, therapeutic use)
• Female
• Humans
• Leiomyosarcoma (drug therapy, secondary)
• Male
• Middle Aged
• Prognosis
• Sarcoma (drug therapy, secondary)
• Temozolomide
• Treatment Outcome
• Uterine Neoplasms (drug therapy, secondary)