Hensley ML, et al. - In women with uterine leiomyosarcoma, whether a survival benefit results from adjuvant chemotherapy was determined in this randomized phase 3 trial. With adjuvant chemotherapy, no superior outcomes were seen in terms of overall survival (OS) and recurrence-free survival, although the sample size precluded robust statistical comparison. This investigation was closed for accrual futility, despite international collaboration to test the role of adjuvant chemotherapy in uterine-confined leiomyosarcoma.

Methods

• Participants were women with uterus-confined, high-grade leiomyosarcoma who were confirmed disease free by imaging.
• These patients were randomly assigned to four cycles of gemcitabine plus docetaxel, followed by four cycles of doxorubicin, or to observation.
• Recurrence was examined in all participants; OS was assessed as primary end point.

Results

• Enrollment of 38 of the targeted accrual of 216 patients was done with international collaboration, after which the study was closed by the National Cancer Institute for accrual futility.
• Chemotherapy was received by 20 patients and 18 were assigned to observation.
• At least one cycle of chemotherapy was received by 17 patients, of these, grade 3 or 4 toxicities were observed in 47%; grade 3 hypertension was reported in a single patient among the 18 patients assigned to observation.
• Six deaths were attributed to disease (chemotherapy, n = 5; observation, n = 1).
• In the chemotherapy arm and in the observation arm, the estimated restricted mean survival time for OS was 34.3 months (95% CI, 25.3 to 43.3 months) and 46.4 months (95% CI, 43.6 to 49.1 months), respectively.
• In each arm, 8 recurrences were noted.
• In the chemotherapy arm and in the observation arm, the estimated restricted mean survival time for recurrence-free survival was 18.1 (95% CI, 14.2 to 22.0) months and 14.6 months (95% CI, 10.3 to 19.0 months), respectively.
• Because of small sample size, neither survival outcome comparison was considered statistically robust.