Paclitaxel plus carboplatin was noninferior to paclitaxel plus cisplatin in extending overall survival in incurable metastatic or recurrent cervical cancer in a multicenter open-label randomized phase III clinical trial published online March 3 in Journal of Clinical Oncology.
Given that carboplatin induces less toxicity than does cisplatin, doesn’t require 24-hour hospitalization when administered, and doesn’t require monitored hydration to prevent nephrotoxicity as cisplatin does, the paclitaxel-plus-carboplatin therapy should be a standard treatment option for this patient population, said Dr. Ryo Kitagawa of NTT Medical Center, Tokyo, and associates.
Worldwide, cisplatin plus paclitaxel is considered the standard cytotoxic treatment for metastatic or recurrent cervical cancer. Carboplatin has been reported to be less effective in three studies, but the two agents have never been compared against each other in a phase III trial. Dr. Kitagawa and her associates performed such a comparison study in 253 women whose disease was not amenable to curative surgery or radiotherapy. These patients were randomly assigned to receive either paclitaxel plus carboplatin (126 patients) or standard paclitaxel plus cisplatin (127 patients) and were followed for a median of 18 months.
The carboplatin regimen, with a median overall survival of 17.5 months, proved to be noninferior to the cisplatin regimen, which had a median OS of 18.3 months. The carboplatin regimen also was either noninferior or superior to the cisplatin regimen for the secondary outcomes of progression-free survival (6.2 months vs. 6.9 months), complete response rate (7.1% vs. 3.9%), and complete or partial response rate (62.6% vs. 58.8%), the investigators said (J. Clin. Oncol. 2015 March 3 [doi:10.1200/JCO.2014.58.4391]).
The percentages of patients who completed the treatment protocol were nearly the same in both study groups (72% and 71%), and the patients who discontinued treatment because of adverse effects also was similar (9.5% and 11.8%). Quality of life was judged to be significantly better with the carboplatin regimen because the percentage of nonhospitalization time was much greater (61.9% vs 46.4%). The carboplatin regimen also induced markedly less grade 4 neutropenia, grade 3-4 febrile neutropenia, creatinine elevation, and nausea/vomiting, but thrombocytopenia and reversible neuropathy tended to be more frequent with carboplatin than with cisplatin.