Phase II trial of paclitaxel and nedaplatin in patients with advanced/recurrent uterine cervical cancer: A Kansai Clinical Oncology Group study

ObjectiveA multicenter phase II trial was conducted to evaluate the activity and toxicity of paclitaxel and nedaplatin (cis-diammineglycolatoplatonum) in patients with advanced/recurrent uterine cervical cancer.MethodsPatients were required to have measurable disease. Histologic confirmation of the primary diagnosis as uterine cervical cancer was mandatory. The treatment consisted of paclitaxel 175 mg/m2 over 3 hours and nedaplatin 80 mg/m2 intravenously over 1 hour on day 1 every 28 days until progressive disease or adverse effects prohibited further therapy.ResultsFifty patients were enrolled into the study protocol from October 2007 to February 2010. 45 patients(90%) were eligible for assessment of response (RECIST version 1.0) to treatment; 31 patients (62%) received prior radiotherapy and 23 patients (46%) received prior chemotherapy. The overall response rate was 44.4% (11 complete responses and 8 partial responses) with 22.2% of patients having stable disease. Grades 3 or 4 adverse events (NCI-CTCAE ver 3) included neutropenia (n = 16, 32.7%), febrile neutropenia (n = 1, 2.0%), anemia (n = 9, 18.4%), but there was no significant thrombocytopenia. Non-hematologic toxicity was generally not serious and without a dominant pattern. The median progression-free survival was 7.5 months (95% C.I., 5.7, 9.4) and overall survival was 15.7 months (95% C.I., 9.4, 21.9).ConclusionsPaclitaxel 175 mg/m2 and nedaplatin 80 mg/m2 intravenously on day 1 every 28 days in patients with advanced/recurrence uterine cervical cancer demonstrated easy administration, favorable antitumor activity, and the toxicity profile of this regimen would be decreased compared with cisplatin-containing combinations. Evaluation of this regimen in phase III trials is warranted.

► We conducted phase II trial in patients with advanced or recurrent cervical cancer
► The overall response rate o paclitaxel and nedaplatin was 44.4%.
► The administration of this regimen is easy.
► The toxicity profile of this regimen would be decreased compared with cisplatin-containing combinations.
► Phase III trials of this regimen with advanced or recurrent cervical cancer are warranted.