Carboplatin plus paclitaxel versus carboplatin plus pegylated liposomal doxorubicin as first-line treatment for patients with ovarian cancer: The Mito-2 Randomized Phase III Trial Full Text
Journal of Clinical Oncology, 08/18/2011
Clinical Article
Pignata S et al. – Carboplatin/PLD was not superior to carboplatin/paclitaxel, which remains the standard first-line chemotherapy for advanced ovarian cancer. Given the observed CIs and the different toxicity, carboplatin/PLD could be considered an alternative to standard therapy.
Methods- Chemotherapy-naive patients with stage IC to IV ovarian cancer (age ≤ 75 years; Eastern Cooperative Oncology Group performance status ≤ 2) were randomly assigned to carboplatin area under curve (AUC) 5 plus paclitaxel 175 mg/m2 or to carboplatin AUC 5 plus PLD 30 mg/m2, every 3 weeks for 6 cycles
- Primary end point was PFS
- With 632 events in 820 enrolled patients, study would have 80% power to detect 0.80 HR of PFS
- 820 patients were randomly assigned
- Disease stages III and IV were prevalent
- Occurrence of PFS events substantially slowed before obtaining the planned number
- Therefore, in concert with the Independent Data Monitoring Committee, final analysis was performed with 556 events, after median follow-up of 40 months
- Median PFS times were 19.0 and 16.8 months with carboplatin/PLD and carboplatin/paclitaxel, respectively (HR, 0.95; 95% CI, 0.81 to 1.13; P = .58)
- Median OS times 61.6 and 53.2 months with carboplatin/PLD and carboplatin/paclitaxel, respectively (HR, 0.89; 95% CI, 0.72 to 1.12; P = .32)
- Carboplatin/PLD produced similar response rate but different toxicity (less neurotoxicity and alopecia but more hematologic AEs)
- No relevant difference in global QOL after 3 and 6 cycles
