Gemcitabine and docetaxel in patients with unresectable leiomyosarcoma: results of a phase 2 trial
The combination of gemcitabine and docetaxel produced responses in more than half of patients with leiomyosarcoma, most of them uterine and many previously treated with doxorubicin, establishing a widely used second regimen for the disease.
Overview
Phase 2 study of 34 patients with unresectable leiomyosarcoma (29 uterine) treated with fixed-dose-rate gemcitabine followed by docetaxel every three weeks with growth factor support.
Objective response was 53 percent including three complete responses, with responses in patients previously treated with doxorubicin; median time to progression was 5.6 months and myelosuppression was the main toxicity.
- Objective response 53 percent (18 of 34).
- Responses in patients with prior doxorubicin exposure.
Gemcitabine-docetaxel is a standard first- or second-line option for leiomyosarcoma, especially uterine, and remains in use alongside doxorubicin-based regimens.
- Single-arm study; randomised trials (GeDDiS) later found gemcitabine-docetaxel no better than doxorubicin first line.
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