Non-pegylated liposomal doxorubicin (NPLD, Myocet®) + carboplatin in patients with platinum sensitive ovarian cancers: A ARCAGY-GINECO phase IB-II trial

Abstract Background Carboplatinand pegylatedliposomal doxorubicincombination is a standard regimen in platinum-sensitive recurrent ovarian cancer patients. The pegylatedliposomal doxorubicinshortage from 2011 to 2013 urged assessment of the efficacy and tolerance of non- pegylatedliposomal doxorubicinin combination with carboplatin. Methods MYCA was a multicenter 2-step phase Ib-II single arm trial meant to assess the safety and efficacy of carboplatinAUC 5 mg/min.mL combined with non- pegylatedliposomal (dose escalation from 40 to 50 mg/m 2 during phase Ib step; and 50 mg/m2 during phase II step), every 4 weeks in patients with platinum-sensitive relapse. The primary objective was disease control rate (DCR) at 12 months. Results From 2012 to 2014, 87 patients were enrolled. They were treated as second (78%) or third line (22%) treatment. Total of 67 patients (78%) completed 6 cycles. G-CSF support was prescribed to 58% patients. The DCR at 12 months was 30.0% (95% CI, 20.3–39.7); the median PFS was 10.0 months (95% CI, 8.6–11.0). The median overall survival was 28.1 months (95% CI, 22.3–32.5); and the objective response rate was 58% (95% CI, 47–68). Grade 3–4 neutropenia, anemia and thrombocytopenia were observed in 17%, 13% and 1%, respectively; febrile neutropeniain 6%. One patient who did not receive GCSF support died from febrile neutropenia. Conclusion Non- pegylatedliposomal doxorubicin- carboplatincombination exhibits an acceptable safety profile, with GCSF prophylaxis. Acknowledging the lack of direct comparison, efficacy in terms of 12 month DCR was comparable with standard treatments.