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

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• 作者：Munetaka Takekuma ; Yasuyuki Hirashima ; Kimihiko Ito ; Hiroshi Tsubamoto ; Tsutomu Tabata ; Atsushi Arakawa ; Yoshio Itani ; Naoto Furukawa ; Homare Murakoshi ; Satoshi Takeuchi
• 关键词：Phase II trial ; Advanced or recurrent cervical cancer ; Paclitaxel ; Nedaplatin
• 刊名：Gynecologic Oncology
• 出版年：2012
• 出版时间：September, 2012
• 年：2012
• 卷：126
• 期：3
• 页码：341-345
• 全文大小：228 K

文摘

Objective

A 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.

Methods

Patients 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.

Results

Fifty 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).

Conclusions

Paclitaxel 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.