Gemcitabine at fixed dose-rate in patients with advanced soft-tissue sarcomas: a mono-institutional phase II study.

Purpose: To explore the clinical activity and toxicity of gemcitabine infused at the fixed dose of 10 mg/m(2)/min over 100 min in patients with soft tissue sarcomas (STSs).

Patients And Methods: Fourteen patients with advanced locally unresectable and/or metastatic, pretreated STSs (seven leiomyosarcoma, three malignant schwannoma, one synovialsarcoma, one malignant fibrous histiocytoma, one endometrial stromal cell sarcoma, one undifferentiated) were treated with gemcitabine 10 mg/m(2)/min/week over 100 min given for 3 weeks out of 4. The median age was 52 years (range 27-77), male/female ratio was 3/11, and the median WHO performance status was 0 (range 0-1). The median number of previous medical treatments for advanced disease was 1 (range 1-2).

Results: A median number of three cycles (range 1-10 cycles) and a total of 151 weekly administrations (median 9, range 3-27) of gemcitabine were administered. Treatment was well tolerated and the main causes of dose-reduction or omission/delay were hematological and liver toxicities. One patient (7%; 95% confidence interval: 0.2-33.9%) with a metastatic uterine leiomyosarcoma obtained a partial response that lasted for 6.5 months. Three patients (two leiomyosarcoma and one schwannoma) (21%) obtained a stabilization of disease. The median time to progression was 3.1 months (range 1.0-9.5). The median overall survival was 11.8 months (range 1.0-54.5+).

Conclusions: Gemcitabine infused at the fixed dose of 10 mg/m(2)/min over 100 min shows a good tolerability but an overall modest activity in unselected STSs histotypes. Nevertheless, an interesting tumor growth control rate was observed in specific histological variants (i.e., leiomyosarcoma), thus confirming data from recent controlled clinical trials.