A prospective study on treatment of recurrent epithelial ovarian cancer with gemcitabine and pegylated liposomal doxorubicin

ABSTRACT

Background: Rechallenge of a platinum-based chemotherapy is the most common approach for a recurrent platinumsensitive epithelial carcinoma ovary. However, this carries a substantial risk of cumulative neurotoxicity. Objectives: In the present study, we tried to compare the efficacy and toxicities of gemcitabine pegylated liposomal doxorubicin combination regimen to rechallenge of paclitaxel-carboplatin in this setting. Materials and Methods: A total of 30 patients were included in the study. The patients were randomized into two groups each containing 15 patients. The study group received injection gemcitabine at the dose of 1 g/m2 injection intravenously on day 1 and day 8 and liposomal doxorubicin 30 mg/m2 on day 1 in a 3 weekly cycle up to a total of six cycles in absence of disease progression or unacceptable toxicities. The control group patients were treated with injection paclitaxel at a dose of 175 mg/m2 I/V infusion and injection carboplatin at a dose considering area under the curve 6 in a 3 weekly for six cycles. Results: In the study arm, out of 14 patients, 4 (28.57%) patients had complete response, 6 (42.85%) had partial response, 3 (21.42%) had stable disease, and 1 (7.14%) showed disease progression. In the control arm, 6 (40%) patients out of 15 showed complete response, and 4 (26.66%) partial response. Disease progression was noted in 1 (6.66%) patient. There was less incidence of neurotoxicity compared to the control arm. Conclusion: Chemotherapy with a combination of gemcitabine and pegylated liposomal doxorubicin shows equivalent efficacy in platinum-sensitive recurrent ovarian cancer when compared to rechallenge of platinum-based chemotherapy. The regimen has an acceptable toxicity profile with lesser incidence of neuropathy than rechallenge of paclitaxel-carboplatin combination.