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[Gemcitabine in advanced stage soft tissue sarcoma: a phase II study].
A Amodio1, S Carpano, C Manfredi
1Istituto Regina Elena per lo Studio e la Cura dei Tumori, Roma, Italia.
La Clinica Terapeutica
|June 15, 1999
Summary
This study found gemcitabine showed limited activity in advanced soft tissue sarcoma patients. The treatment was well-tolerated, but did not demonstrate significant efficacy for this patient population.
Area of Science:
- Oncology
- Medical Oncology
- Pharmacology
Background:
- Soft tissue sarcoma is a rare and heterogeneous group of tumors.
- Treatment options for advanced or metastatic soft tissue sarcoma are limited.
- Gemcitabine is a chemotherapy agent with activity in various solid tumors.
Purpose of the Study:
- To evaluate the efficacy and safety of gemcitabine in patients with locally advanced or metastatic soft tissue sarcoma.
- To determine the optimal dose and schedule for gemcitabine in this patient population.
Main Methods:
- A phase II clinical trial was conducted.
- Gemcitabine was administered at doses of 1,000 or 1,250 mg/m2 on days 1, 8, and 15 of each 4-week cycle.
- Patients included those previously treated or not treated with anthracyclines and ifosfamide.
Main Results:
- Eighteen patients were enrolled in the trial.
- One patient achieved a partial response (fibrous malignant histiocytoma).
- Disease stabilization was observed in 7 patients, with a median time to progression of 4 months.
- The treatment was generally well-tolerated, with no grade 4 toxicity reported.
Conclusions:
- Gemcitabine, at the dose and schedule tested, demonstrated limited clinical activity in patients with advanced soft tissue sarcoma.
- Further investigation with different dosing or in combination therapies may be warranted.
- The observed toxicity profile suggests gemcitabine can be safely administered in this setting.