GOG-0261: paclitaxel-carboplatin versus paclitaxel-ifosfamide in uterine carcinosarcoma
For uterine carcinosarcoma, the standard breast and ovarian regimen carboplatin-paclitaxel was as effective as the older, more toxic paclitaxel-ifosfamide combination, simplifying treatment of this rare aggressive cancer.
Overview
Phase 3 non-inferiority trial of 536 patients with stage I to IV, persistent or recurrent uterine carcinosarcoma (with a small ovarian carcinosarcoma cohort) randomised to paclitaxel-carboplatin or paclitaxel-ifosfamide.
Median overall survival was 37 versus 29 months (hazard ratio 0.87, non-inferior) and progression-free survival 16 versus 12 months, with more haematological toxicity but less confusion and genitourinary toxicity with carboplatin.
- Median overall survival 37 vs 29 months; hazard ratio 0.87 (non-inferior).
- Median progression-free survival 16 vs 12 months.
Carboplatin-paclitaxel is the chemotherapy standard for uterine carcinosarcoma in all stages, now combined with dostarlimab in advanced disease following RUBY, which included carcinosarcoma.
- Non-inferiority design; the trend favouring carboplatin was not tested for superiority.
- Adjuvant radiotherapy was not standardised.
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