Cb + pegylated liposomal doxorubicin (PLD) is standard in OCLR. Because of recurrent PLD shortage, we explored the efficacy and tolerance of Cb-NPLD
From 11/2012 to 07/2014, 86 pts with OCLR received Cb AUC 5 mg.min/ml and NPLD 50 mg/m2, day 1 q4weeks with prophylactic G-CSF support. Primary objective was disease control rate (DCR) at 12 mos. Disease progression was defined according to GCIG criteria including RECIST, CA125 or clinical deterioration.
A total of 69 pts (80%) completed 6 cycles and 7 (9%) continued up to 9 cycles, with G-CSF support (96%). Pts characteristics were: median age 67 years (range 60-75); serous histology (90%); prior platinum (100%), taxane (94%) and bevacizumab (33%); platinum-free interval 6-12 (PFI) (44%) or > 12 mos (56%); 67 (78%) pts had 1 previous line of chemotherapy (CT) and 19 (22%) had 2. DCR at 12 mos was 40%. Median PFS was 11.4 mos (95% CI: 10.2-13.1). OS is not mature (33% events). Complete response rate was 21% and objective response rate was 58% (95% CI: 47-68), 49% (95% CI: 32-65) and 64% (95% CI: 50-78) in the global population, in pts with 6-12 or > 12 mos PFI, respectively. Grade (G) 3/4 neutropenia, thrombocytopenia and anemia were observed in 23, 13 and 11% respectively with febrile neutropenia in 6%. Non hematological toxicities were the followings: G3 fatigue (13%), nausea (8%), vomiting (6%), hand-foot syndrome (1%), pulmonary embolism (1%); G2 alopecia (39%). Junctional tachycardia (JT) in a pt with JT history was the only cardiac event observed. One pt who did not receive prophylactic G-CSF support died from febrile neutropenia.
Cb + NPLD is an alternative carboplatin-based regimen for OC in late relapse. Activity and toxicity profile are in the range of other regimens, but prophylactic G-CSF support is required.
Clinical trial identification
Legal entity responsible for the study
F. Joly: For consulting or advisory role : Roche, Sanofi, Pfizer For Research funding : Astellas, Pfizer For travel, accomodations, expenses : Roche, Janssen, Novartis. I.L. Ray-Coquard: For consulting or advisory role: Pharmamar, Roche, AstraZeneca, MSD For travel, accomodations, expenses: Pharmamar, Roche. A-C. Hardy-Bessard: For Travel, accomodation, expenses: Astrazeneca, Novartis, Roche G. Freyer: For consulting or advisory role: Teva. All other authors have declared no conflicts of interest.