As reported in the Journal of Clinical Oncology by Powell et al, the phase III NRG Oncology GOG-0261 trial has shown that paclitaxel/carboplatin is noninferior to paclitaxel/ifosfamide in terms of overall survival among chemotherapy-naive patients with uterine carcinosarcoma.

Study Details

The open-label trial enrolled 449 eligible women with uterine carcinosarcoma and 90 eligible women with ovarian carcinosarcoma from sites in the United States and Korea between August 2009 and March 2014. A total of 228 patients with uterine carcinosarcoma and 44 with ovarian carcinosarcoma were randomly allocated to receive paclitaxel at 175 mg/m² plus carboplatin at area under the curve = 6 once on day 1 of each 3-week cycle for 6 to 10 cycles. A total of 221 patients with uterine carcinosarcoma and 46 with ovarian carcinosarcoma were randomly assigned to receive ifosfamide at 1.6 g/m² daily on days 1 to 3 and mesna plus paclitaxel at 135 mg/m² once on day 1 plus granulocyte colony–stimulating factor support on days 4 to 6 of each 3-week cycle for 6 to 10 cycles.

The primary endpoint was overall survival in the uterine carcinosarcoma cohort.

Overall Survival

At data cutoff (February 2019), median follow-up was 61 months.

In the uterine carcinosarcoma cohort, median overall survival was 37 months in the paclitaxel/carboplatin group vs 29 months in the paclitaxel/ifosfamide group (adjusted hazard ration [HR] = 0.87, 90% confidence interval [CI] = 0.70–1.075, P < .01 for noninferiority, P = .1 for superiority). Median progression-free survival was 16 months vs 12 months (adjusted HR = 0.73, 95% CI = 0.58–0.93, P < .01 for noninferiority, P < .01 for superiority).

In the ovarian carcinosarcoma cohort, median overall survival was 30 months in the paclitaxel/carboplatin group vs 25 months in the paclitaxel/ifosfamide group (adjusted HR =1.15, 95% CI = 0.67–1.95); neither inferiority nor noninferiority was ruled out. Median progression-free survival was 15 months vs 10 months (adjusted HR = 1.01, 95% CI = 0.61–1.67); inferiority of paclitaxel/carboplatin could not be ruled out due to small sample size.

Adverse Events

In the uterine carcinosarcoma cohort, toxicities were similar in the two groups, except that patients in the paclitaxel/carboplatin group had a higher rate of grade ≥ 3 hematologic toxicity (82% vs 50%, P < .01). Grade ≥ 3 neurologic toxicity occurred in 7% vs 12% of patients (P = .10). Other common grade 3 or 4 adverse events consisted of metabolic events (13% vs 16%) and gastrointestinal events (9% vs 9%).

The investigators concluded, “Paclitaxel/carboplatin was not inferior to the active regimen paclitaxel/ifosfamide and should be standard treatment for uterine carcinosarcoma.”

Matthew A. Powell, MD, of the Division of Gynecologic Oncology, Washington University School of Medicine in St. Louis, is the corresponding author for the Journal of Clinical Oncology article.

Disclosure: The study was supported by grants from the National Cancer Institute. For full disclosures of the study authors, visit ascopubs.org.