Brief Article
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World J Gastroenterol. Sep 21, 2013; 19(35): 5910-5916
Published online Sep 21, 2013. doi: 10.3748/wjg.v19.i35.5910
A phase II study of paclitaxel and nedaplatin as front-line chemotherapy in Chinese patients with metastatic esophageal squamous cell carcinoma
Yi-Fu He, Chu-Shu Ji, Bing Hu, Ping-Sheng Fan, Chang-Lu Hu, Feng-Shou Jiang, Jian Chen, Lei Zhu, Yi-Wei Yao, Wei Wang
Yi-Fu He, Chu-Shu Ji, Bing Hu, Chang-Lu Hu, Feng-Shou Jiang, Jian Chen, Yi-Wei Yao, Wei Wang, Department of Medical Oncology, Anhui Provincial Hospital affliated to Anhui Medical University, Hefei 230001, Anhui Province, China
Ping-Sheng Fan, Lei Zhu, Department of Medical Oncology, Anhui Provincial Cancer Hospital, Hefei 230031, Anhui Province, China
Author contributions: He YF, Ji CS, Fan PS, Hu CL, Chen J, Zhu L and Yao YW performed the majority of experiments; Jiang FS and Wang W provided analytical tools and were also involved in editing the manuscript; Hu B designed the study and provided financial support for this work; He YF and Hu B wrote the manuscript.
Supported by Natural Science Foundation of Anhui Province No. 070413256X; and Medical Research Foundation of Anhui Provincial Health Department No. 2010B001 and No. 13zc012
Correspondence to: Bing Hu, Professor, Department of Medical Oncology, Anhui Provincial Hospital affliated to Anhui Medical University, 17 Lujiang Road , Hefei 230001, Anhui Province, China. hubing3756@hotmail.com
Telephone: +86-551-62283337 Fax: +86-551-62283864
Received: June 2, 2013
Revised: August 1, 2013
Accepted: August 12, 2013
Published online: September 21, 2013
Processing time: 110 Days and 14.3 Hours
Abstract

AIM: To evaluate the efficacy and safety of paclitaxel-nedaplatin combination as a front-line regimen in Chinese patients with metastatic esophageal squamous cell carcinoma (ESCC).

METHODS: A two-center, open-label, single-arm phase II study was designed. Thirty-nine patients were enrolled and included in the intention-to-treat analysis of efficacy and adverse events. Patients received 175 mg/m2 of paclitaxel over a 3 h infusion on 1 d, followed by nedaplatin 80 mg/m2 in a 1 h infusion on 2 d every 3 wk until the documented disease progression, unacceptable toxicity or patient’s refusal.

RESULTS: Of the 36 patients assessable for efficacy, there were 2 patients (5.1%) with complete response and 16 patients (41.0%) with partial response, giving an overall response rate of 46.1%. The median progression-free survival and median overall survival for all patients were 7.1 mo (95%CI: 4.6-9.7) and 12.4 mo (95%CI: 9.5-15.3), respectively. Toxicities were moderate and manageable. Grade 3/4 toxicities included neutropenia (15.4%), nausea (10.3%), anemia (7.7%), thrombocytopenia (5.1%), vomiting (5.1%) and neutropenia fever (2.6%).

CONCLUSION: The combination of paclitaxel and nedaplatin is active and well tolerated as a first-line therapy for patients with metastatic ESCC.

Keywords: Esophageal squamous cell cancer; Front-line chemotherapy; Paclitaxel; Nedaplatin

Core tip: Esophageal cancers are among the most aggressive tumors with a poor prognosis. Till now, there has been no standard chemotherapy regimen for advanced esophageal cancer. In this paper, we conducted a phase II study on combination chemotherapy consisting of paclitaxel and nedaplatin in previously untreated patients with metastatic esophageal squamous cell carcinoma (ESCC). Our results demonstrated that the combination of two drugs is active and well tolerated as a first-line therapy for patients with recurrent or metastatic ESCC.