- Compared to the standard carboplatin/gemcitabine/bevacizumab (CG-BEV) regimen, the combination treatment with carboplatin/pegylated liposomal doxorubicin/bevacizumab (CD-BEV) significantly improves progression-free survival (PFS) in patients with recurrent ovarian cancer (ROC), and might be an important addition to the therapeutic options even in patients pretreated with anti-angiogenic drugs.
Why this matters
- CG-BEV significantly increases PFS over CG alone whilst CD has one of the best therapeutic indices for ROC.
- New effective and safe treatments for this patient setting are needed.
- Median PFS in the CG-BEV arm was 11.7 months vs 13.3 months in the CD-BEV (HR: 0.80, P=0.0128).
- In the subgroup pretreated with anti-angiogenic drugs (N=309), median PFS was 10.1 months for CG-BEV vs 11.3 months for CD-BEV arm (HR: 0.73, P=0.0126).
- No new safety concerns arose.
- Global quality of life (QoL) was slightly superior with CD-BEV compared with CG-BEV.
- The trial included 682 patients with ROC-PBT, randomised to standard CG-BEV (n=337) or experimental CD-BEV (n=345).
- 41.5% of the women included in the study population were pre-treated with BEV as part of first-line treatment.
- The primary endpoint was the PFS by RECIST 1.1.
- Secondary objectives included biological progression-free survival (PFSbio) by serum CA125, overall survival (OS; study not powered for OS), QoL assessed by EORTC-QLQ-C30 and QLQ-OV28, safety, and tolerability.
- The trial was designed to test the superiority of CD-BEV over CG-BEV, with 80% power (two-sided log rank-test, alpha level 5%) to show a 26.6% change in PFS (HR 0.79; 564 PFS events).
- The study was not powered for OS.
- Hoffman La Roche.
- “New combination strategies based on agents with innovative effects are needed in this population, together with a wider investigation of possible molecular biomarkers like BRCA and HRD.” Sandro Pignata, IRCCS National Cancer Institute “Fondazione G. Pascale”, Naples, Italy.