Update on gemcitabine and docetaxel combination therapy for primary and metastatic sarcomas

The combination of fixed-dose-rate gemcitabine and docetaxel has become an established treatment option for advanced uterine leiomyosarcoma and has demonstrated efficacy in nonleiomyosarcoma histology soft-tissue sarcomas. The activity of this regimen in advanced uterine leiomyosarcoma, other soft-tissue sarcomas, and pediatric sarcomas is discussed.

Fixed-dose-rate gemcitabine and docetaxel achieved high objective response rates in three prospective phase II studies as first-line or second-line therapy for advanced uterine leiomyosarcoma. In a randomized trial, the combination of gemcitabine and docetaxel was superior to gemcitabine alone in terms of objective response, progression-free, and overall survival among patients with soft-tissue sarcoma, most of whom had received at least one prior cytotoxic regimen. In a prospective phase II trial, four of 10 pediatric patients with sarcomas achieved complete responses with this regimen. In a small, prospective phase II trial for women with completely resected stage I, II, III, or IV high-grade uterine leiomyosarcoma, adjuvant treatment with gemcitabine-docetaxel was associated with a 2-year progression-free survival rate that appears superior to that of historical controls.

Fixed-dose-rate gemcitabine and docetaxel is a reasonable treatment option for patients with advanced soft-tissue sarcoma. The regimen is a good choice as first-line or second-line therapy for advanced uterine leiomyosarcoma. The role of adjuvant gemcitabine-docetaxel in completely resected, uterine-limited, high-grade leiomyosarcoma is under investigation.