Hensley ML, et al. - Researchers performed a randomized phase III trial to determine the efficacy of adjuvant chemotherapy for improving survival in women with uterine leiomyosarcoma. Owing to accrual futility, this study was closed despite international collaboration to test the role of adjuvant chemotherapy in uterine-confined leiomyosarcoma. Although robust statistical comparison could not be made in view of the sample size, observed overall survival (OS) and recurrence-free survival data do not exhibit superior outcomes with adjuvant chemotherapy.

Methods

• Researchers randomly assigned women with uterus-confined, high-grade leiomyosarcoma who were confirmed disease free by imaging either to four cycles of gemcitabine plus docetaxel, followed by four cycles of doxorubicin, or to observation.
• They followed all the patients for evidence of recurrence.
• OS was assessed as the primary end point.

Results

• Enrollment of 38 of the targeted accrual of 216 patients was performed with international collaboration, after which the study was closed by the National Cancer Institute for accrual futility.
• Researchers assigned 20 patients to chemotherapy and 18 to observation.
• Among the 17 patients treated with at least one cycle of chemotherapy, 47% displayed grade 3 or 4 toxicities; among the 18 patients assigned to observation, one had grade 3 hypertension.
• Six deaths (chemotherapy, n = 5; observation, n = 1) all due to disease were identified.
• The restricted mean survival time for OS was estimated as 34.3 months (95% CI, 25.3 to 43.3 months) and 46.4 months (95% CI, 43.6 to 49.1 months) in the chemotherapy arm and the observation arm, respectively.
• Each arm displayed eight recurrences.
• The restricted mean survival time for recurrence-free survival was estimated as 18.1 (95% CI, 14.2 to 22.0) months and 14.6 months (95% CI, 10.3 to 19.0 months) in the chemotherapy arm and observation arm, respevtively.
• Owing to the small sample size, neither survival outcome comparison was considered statistically robust.