Phase II trial of docetaxel combined with nedaplatin for patients with recurrent and metastatic nasopharyngeal carcinoma

• Main Authors: Peng PJ, Lv BJ, Tang C, Liao H, Lin Z, Liu YM, Wang ZH, Wang SY, Cheng ZB
• Format: Article
• Language: English
• Published: Dove Medical Press 2015-12-01
• Series: Drug Design, Development and Therapy
• Subjects: Docetaxel; Nedaplatin; Nasopharyngeal Carcinoma
• Online Access: https://www.dovepress.com/phase-ii-trial-of-docetaxel-combined-with-nedaplatin-for-patients-with-peer-reviewed-article-DDDT

Pei-Jian Peng,1,* Bao-Jun Lv,2,* Con Tang,2,* Hai Liao,3 Zhong Lin,1 Yu-Meng Liu,4 Zhi-Hui Wang,1 Si-Yang Wang,5 Zhi-Bin Cheng5 1Department of Medical Oncology, 2Department of Surgical Oncology, The Fifth Affiliated Hospital of Sun Yat-sen University, Zhuhai, 3Department of Medical Oncology, Cancer Centre, Sun Yat-sen University, Guangzhou, 4Department of Oncology, People’s Hospital of Zhongshan City, Zhongshan, 5Department of Radiation Oncology, The Fifth Affiliated Hospital of Sun Yat-sen University, Zhuhai, Guangdong Province, People’s Republic of China *These authors contributed equally to this work Purpose: This Phase II trial was designed to evaluate the efficacy and safety of docetaxel combined with nedaplatin as first-line treatment for patients with recurrent or metastatic nasopharyngeal carcinoma. Methods: In this multicenter Phase II trial, the patients were treated with intravenous docetaxel (75 mg/m2, day 1) and nedaplatin (80 mg/m2, day 1), each cycle repeated every 3 weeks for two cycles at least. Results: From January 2010 to November 2013, a total of 78 patients were recruited in this trial. Among them, 73 patients were assessable for response. The treatment was well tolerated. The main hematological adverse event was neutropenia. A total of 12 patients (15.4%) had grade 3 or grade 4 neutropenia. Grade 3 anemia was observed in six patients (7.7%) and no grade 3/4 thrombocytopenia was observed. No Grade 3/4 non-hematological toxicity was observed. There were five complete response (6.8%), 43 partial responses (58.9%), and the overall response rate was 65.8% (95% confidence interval [CI], 48.7%–81.2%). With a median follow-up period of 18.6 months, the median time to progression was 7.9 months (95% CI, 4.2–10.8 months), median overall survival was 15.7 months (95% CI, 11.6–18.5 months). Conclusion: Docetaxel combined with nedaplatin offers a satisfactory clinical activity and an acceptable safety profile as first-line chemotherapy for patients with recurrent and metastatic nasopharyngeal carcinoma. Keywords: docetaxel, nedaplatin, nasopharyngeal carcinoma