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Japanese Journal of Clinical Oncology Advance Access originally published online on June 9, 2009
Japanese Journal of Clinical Oncology 2009 39(9):582-587; doi:10.1093/jjco/hyp058
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© The Author (2009). Published by Oxford University Press. All rights reserved

A Phase II Study of Paclitaxel and Nedaplatin as First-line Chemotherapy in Patients with Advanced Esophageal Cancer

Weiguo Cao, Chun Xu, Guying Lou, Jinsong Jiang, Shunguang Zhao, Mei Geng, Wenqi Xi, Hao Li and Yening Jin

Department of Oncology, Shanghai Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, PR China

* For reprints and all correspondence: Yening Jin, Department of Oncology, Shanghai Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, No. 197, Rui Jin Er Lu, Shanghai 200025, PR China. E-mail: rjyyzlk{at}gmail.com

Received March 29, 2009; accepted May 1, 2009

Objective: The aim of this study was to assess the efficacy and toxicity of the combination of paclitaxel and nedaplatin as a first-line chemotherapy for patients with advanced esophageal cancer.

Methods: Patients with advanced esophageal cancer received 175 mg/m2 of paclitaxel over a 3 h infusion, followed by nedaplatin 80 mg/m2 in a 1 h infusion on day 1 every 3 weeks until the documented disease progression, unacceptable toxicity or patient's refusal.

Results: Between March 2005 and December 2007, 48 patients entered in the study. Forty-six (95.8%) of the 48 patients were assessable for response. The overall response rate was 41.7% (95% CI, 27.8–55.7%) with 2 complete responses and 18 partial responses. The median follow-up period was 20.5 months (range, 12.5–27.2 months). The median overall time to progression and overall survival (OS) were 6.1 months (95% CI, 4.8–7.4 months) and 11.5 months (95% CI, 9.1–13.9 months), respectively. The estimate of OS at 12 and 24 months was 43.8% (95% CI, 29.7–77.8%) and 10.4% (95% CI, 1.8–19.1%), respectively. Most patients experienced anemia, during their course of therapy with 6 (13.0%) patients for grade 3/4 anemia, and grade 1 or 2 anemia was detected in 23 (50%) patients. Grade 3 leucopenia, neutropenia and thrombocytopenia were documented in 8 (17.4%), 9 (17.4%) and 2 (4.3%) patients, respectively. Grade 3 nausea and vomiting were detected in 3 (6.5%) and 2 (4.3%) patients, respectively. Two patients (4.3%) were hospitalized because of treatment-related complications. The treatment was well tolerated and no toxic death occurred.

Conclusions: Combination of paclitaxel and nedaplatin is a tolerated treatment modality with promising activity in previously untreated advanced esophageal cancer.

Key Words: advanced esophageal cancer • paclitaxel • nedaplatin


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