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

• Published in: Cancer 2003-11, Vol.98 (9), p.1942-1946
• Main Authors: Talbot, Susan M., Keohan, Mary Louise, Hesdorffer, Mary, Orrico, Russell, Bagiella, Emilia, Troxel, Andrea B., Taub, Robert N.
• Format: Article
• Language: English
• Subjects: Adult; Aged; Antineoplastic agents; Antineoplastic Agents, Alkylating - administration & dosage; Antineoplastic Agents, Alkylating - therapeutic use; Antineoplastic Agents, Alkylating - toxicity; Biological and medical sciences; Chemotherapy; Dacarbazine - administration & dosage; Dacarbazine - adverse effects; Dacarbazine - analogs & derivatives; Dacarbazine - therapeutic use; Female; Humans; Leiomyosarcoma - drug therapy; Leiomyosarcoma - secondary; Male; Medical sciences; Middle Aged; Pharmacology. Drug treatments; Phase II; Prognosis; Sarcoma - drug therapy; Sarcoma - secondary; soft tissue sarcoma; temozolomide; Treatment Outcome; Uterine Neoplasms - drug therapy; Uterine Neoplasms - secondary
• ISSN: 0008-543X; 1097-0142
• DOI: 10.1002/cncr.11730

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/m2 followed by 9 doses of 90 mg/m2 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. Cancer 2003. © 2003 American Cancer Society. Temozolomide, the imidazotetrazine derivative, has modest activity against unresectable or metastatic leiomyosarcoma of both uterine and nonuterine origin with acceptable toxicity.