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A Mouse Model of Incompletely Resected Soft Tissue Sarcoma for Testing (Neo)adjuvant Therapies
Published on: July 28, 2020
A phase II trial of temozolomide in patients with unresectable or metastatic soft tissue sarcoma
Susan M Talbot1, Mary Louise Keohan, Mary Hesdorffer
1Department of Medicine, Columbia University, College of Physicians and Surgeons, New York, New York 10032, USA.
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.
Insights
Temozolomide showed modest activity and was well-tolerated in patients with advanced soft tissue sarcoma, particularly uterine leiomyosarcoma. Further research into temozolomide for sarcoma treatment is warranted.
Area of Science:
- Oncology
- Medical Pharmacology
Background:
- Soft tissue sarcomas are a heterogeneous group of rare cancers.
- Metastatic and unresectable soft tissue sarcomas present significant treatment challenges.
Purpose of the Study:
- To evaluate the efficacy and toxicity of temozolomide in patients with unresectable or metastatic soft tissue sarcoma.
- To determine response rates, progression-free survival, and overall survival.
- To identify specific sarcoma subtypes that may benefit from temozolomide treatment.
Main Methods:
- A phase II study involving 26 patients with unresectable or metastatic soft tissue sarcoma.
- Temozolomide administered orally at 200 mg/m(2) twice daily for 5 days, followed by 90 mg/m(2) every 4 weeks.
- Toxicity and response were assessed in 25 eligible patients.
Main Results:
- An overall objective response rate of 8% was observed (2 partial responses, 2 mixed responses, 3 stable disease > 6 months).
- Median progression-free survival was 2.0 months and median overall survival was 13.2 months.
- In a subset of 11 patients with leiomyosarcoma (uterine or nonuterine origin), the objective response rate was 18%, with 27% achieving disease stabilization.
Conclusions:
- Temozolomide demonstrated modest activity against previously treated unresectable or metastatic leiomyosarcoma.
- The treatment regimen was well-tolerated, with no treatment-related deaths or Grade 4 toxicities.
- Temozolomide shows potential as a treatment option for specific subtypes of soft tissue sarcoma.
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