2019 ASCO: Paclitaxel/Carboplatin vs Paclitaxel/Ifosfamide in Carcinosarcoma of the Uterus or Ovary
Results from the phase III NRG Oncology clinical trial GOG 0261 comparing paclitaxel plus carboplatin to paclitaxel plus ifosfamide in women with stage I–IV recurrent carcinosarcoma of the uterus or ovary found that treatment with paclitaxel/carboplatin was not inferior to paclitaxel/ifosfamide based on the primary objective overall survival, and paclitaxel/carboplatin was associated with longer progression-free survival outcomes when compared with paclitaxel/ifosfamide. These results were presented by Powell et al at the 2019 ASCO Annual Meeting (Abstract 5500).
“While they are rare, gynecologic carinosarcomas are extremely aggressive, and there has been a great deal of debate surrounding what the ideal or optimal treatment regimen would be for the women who have these malignancies,” stated lead study author Matthew A. Powell, MD, of the Washington University School of Medicine, St. Louis. “Previous phase II research suggested that paclitaxel combined with carboplatin may improve outcomes for this patient population in terms of safety and convenience of treatment, so we tested this against a treatment regimen that included paclitaxel and ifosfamide.”
Study Results
The trial included 449 eligible patients. In the primary uterine carcinosarcoma cohort, median overall survival was 37 months for those who received paclitaxel/carboplatin compared to 29 months for the paclitaxel/ifosfamide treatment arm (hazard ratio [HR] = 0.87; 90% confidence interval [CI] = 0.70–1.075; P < .01 for noninferiority, P > .1 for superiority). Additionally, the median progression-free survival was 16 months for women who received paclitaxel/carboplatin and 12 months for women who received paclitaxel/ifosfamide (HR = 0.73; P = < .01 for noninferiority, P < .01 for superiority).
The investigators found increased toxicity for the paclitaxel/carboplatin treatment, which was mostly hematologic, but confusion and genitourinary hemorrhage were significantly worse with paclitaxel/ifosfamide (rates of toxicity grade 1, 2, 3, 4, and 5 were 1%, 8%, 40%, 48%, 2%, respectively, for paclitaxel/carboplatin; 1%, 32%, 39%, 25%, 1%, respectively, for paclitaxel/ifosfamide). During treatment, both groups experienced a similar decline in quality of life and increased neurotoxicity symptoms.
There was a similar trend in results noted for the women who participated in the smaller, secondary cohort of patients with ovarian carcinosarcoma, with a 30-month median overall survival in the paclitaxel/carboplatin arm vs 25 months in the paclitaxel/ifosfamide arm and 15-month median progression-free survival for the paclitaxel/carboplatin arm vs 10 months for the paclitaxel/ifosfamide arm.
“The hope is to continue to improve survival and quality-of-life outcomes for women who experience this rare malignancy,” concluded Dr. Powell.
Disclosure: This project was supported by the National Cancer Institute. For full disclosures of the study authors, visit coi.ascopubs.org.
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