Adjuvant gemcitabine plus docetaxel followed by doxorubicin versus observation for uterus-limited, high-grade leiomyosarcoma: A phase III GOG study.

5505Background: We conducted a phase III trial to determine whether adjuvant chemotherapy with gemcitabine-docetaxel followed by doxorubicin improves survival compared to observation in women with resected, uterus-confined, high grade LMS. Methods: Women with uterus-confined high grade LMS, confirmed disease-free by post-resection imaging, were randomly assigned to treatment with gemcitabine-docetaxel x 4 cycles, followed by doxorubicin x 4 cycles (CHEMO) or to observation (OBS). All were followed by CT or MR imaging every 4 mos for 3 yrs, then every 6 mos for 2 yrs for recurrence. The primary endpoint was overall survival. Results: The study was opened with international collaboration. 38 of the target accrual of 216 patients (pts) were enrolled, after which the study was closed for National Cancer Institute-defined accrual futility. 20 pts were assigned to CHEMO and 18 to OBS. 3 pts assigned to CHEMO never received treatment. Among the 17 pts treated with at least one cycle of CHEMO grade 3 or 4 toxicit...