Phase II trial of docetaxel combined with nedaplatin for patients with recurrent and metastatic nasopharyngeal carcinoma
Authors Peng P, Lv B, Tang C, Liao H, Lin Z, Liu Y, Wang Z, Wang S, Cheng Z
Received 7 September 2015
Accepted for publication 6 November 2015
Published 10 December 2015 Volume 2015:9 Pages 6401—6405
Checked for plagiarism Yes
Review by Single anonymous peer review
Peer reviewer comments 4
Editor who approved publication: Prof. Dr. Wei Duan
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
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