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Results of a phase II trial with second-line cystemustine at 60 mg/m2 in advanced soft tissue sarcoma: a trial of the
H Curé1, I Krakowski, A Adenis
1Centre Jean Perrin and Inserm U71, Clermont-Ferrand, France.
Abstract:
The aim of this phase II trial was to examine the efficacy of a new nitrosourea, cystemustine, in soft tissue sarcoma. Between January 1990 and March 1991, 32 pretreated patients with advanced soft tissue sarcoma were enrolled. Cystemustine was given every 2 weeks at 60 mg/m2 via a 15-min i.v. infusion. All eligible patients were considered evaluable for response and toxicity (WHO criteria). Of the 32 enrolled patients, 4 were ineligible, leaving 28 evaluable patients. All but 1 had been pretreated: 6 with adjuvant chemotherapy, 18 patients with first-line palliative chemotherapy without nitrosourea, 3 with both treatments, and 18 had received radiotherapy. Median age was 54 years (range 20-73) and median performance status was 1 (0-2). One partial response (PR, duration 12 weeks), 2 stable disease and 25 progressions were observed, giving an overall response rate of 3.57% (confidence interval: 0.1-18.4%). Toxicity was mild, and was mainly neutropenia (no grade 3 or 4), thrombocytopenia (3.57% grade 3 and grade 4) and nausea-vomiting (no grade 3 or 4). It should be noted that the treatment for the patient who obtained a PR was third line with no previous response. Cystemustine with this schedule appears to have a low clinical activity and toxicity in advanced soft tissue sarcoma.
Insights
This Phase II trial found cystemustine showed low clinical activity in advanced soft tissue sarcoma patients. The nitrosourea drug demonstrated a low response rate with mild toxicity in this patient group.
Area of Science:
- Oncology
- Pharmacology
Background:
- Soft tissue sarcoma is a rare cancer with limited treatment options for advanced stages.
- Nitrosoureas are a class of chemotherapy drugs used in cancer treatment.
- Evaluating novel agents like cystemustine is crucial for improving patient outcomes.
Purpose of the Study:
- To assess the efficacy and toxicity of cystemustine, a new nitrosourea, in pretreated patients with advanced soft tissue sarcoma.
- To determine the overall response rate (ORR) and safety profile of cystemustine in this population.
Main Methods:
- A Phase II clinical trial involving 32 pretreated patients with advanced soft tissue sarcoma.
- Cystemustine administered intravenously at 60 mg/m2 every two weeks.
- Response and toxicity evaluated using World Health Organization (WHO) criteria.
Main Results:
- An overall response rate of 3.57% was observed (1 partial response, 2 stable disease, 25 progressions).
- The single partial response lasted 12 weeks and occurred in a patient receiving third-line treatment.
- Toxicity was generally mild, primarily consisting of neutropenia and thrombocytopenia (3.57% grade 3/4), with no grade 3/4 nausea-vomiting.
Conclusions:
- Cystemustine, at the tested dose and schedule, exhibits limited clinical activity in advanced soft tissue sarcoma.
- The drug is associated with mild toxicity, suggesting potential for further investigation in specific contexts or combinations.
- Further research is warranted to explore alternative nitrosourea-based therapies for soft tissue sarcoma.