Carboplatin/gemcitabine alternating with carboplatin/pegylated liposomal doxorubicin and carboplatin/cyclophosphamide in platinum-refractory/resistant paclitaxel — pretreated ovarian carcinoma

ObjectiveIn this phase II study the efficacy and toxicity of an alternating chemotherapy regimen was examined in platinum-resistant relapsed epithelial ovarian cancer (EOC) patients.MethodsForty-five patients with platinum-refractory/resistant relapsed EOC, previously treated with carboplatin + paclitaxel +/− epirubicin were included. The regimen was consisted of gemcitabine 800 mg/m2 (days 1 + 8) and carboplatin AUC 5, alternating with pegylated liposomal doxorubicin 30 mg/m2 and carboplatin AUC 5, alternating with carboplatin AUC 5 and cyclophosphamide 600 mg/m2, every 3 weeks for a total of 9 cycles.ResultsAmong 38 patients with measurable disease, 39.4% (95% CI: 23.2–55.7) responded (five complete response and 10 partial response), while 30 out of 40 (75%) patients assessable by CA125 criteria had a serological response. Responses were more frequent in patients with platinum-free interval (PFI) 3–6 months than in those with PFI 0–3 months, but this was not statistically-significant. After a median follow-up of 19.5 months (range, 1.0–37+ months) the median progression-free survival was 7.1 months (95% CI: 3.4–10.8) and the median survival (OS) was 18.8 months (95% CI: 15.6–22.0). For patients with PFI 0–3 months PFS was 4.3 (95% CI: 0.8–7.8) months, while for those with PFI 3–6 months PFS was 8.9 (95% CI: 5.3–12.4) months (p = 0.062). The regimen was well-tolerated and the main grade 3–4 toxicity was myelosuppression, palmar–plantar erythrodysesthesia, allergy and fatigue.ConclusionThis alternating regimen, including carboplatin, gemcitabine, liposomal doxorubicin and cyclophosphamide, is an active and well-tolerated treatment in platinum relapsed/refractory EOC patients.