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Open Access Research article

Prospective study of daily low-dose nedaplatin and continuous 5-fluorouracil infusion combined with radiation for the treatment of esophageal squamous cell carcinoma

Satoshi Osawa1*, Takahisa Furuta2, Ken Sugimoto1, Takashi Kosugi3, Tomohiro Terai1, Mihoko Yamade1, Yasuhiro Takayanagi1, Masafumi Nishino1, Yasushi Hamaya14, Chise Kodaira1, Takanori Yamada1, Moriya Iwaizumi1, Kosuke Takagaki1, Ken-ichi Yoshida4, Shigeru Kanaoka4 and Mutsuhiro Ikuma1

Author Affiliations

1 First Department of Medicine, Hamamatsu University School of Medicine, Hamamatsu, Japan

2 Center for Clinical Research, Hamamatsu University School of Medicine, Hamamatsu, Japan

3 Department of Radiology, Hamamatsu University School of Medicine, Hamamatsu, Japan

4 Department of Molecular Diagnosis, Hamamatsu University School of Medicine, Hamamatsu, Japan

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BMC Cancer 2009, 9:408  doi:10.1186/1471-2407-9-408

Published: 22 November 2009

Abstract

Background

Protracted low-dose concurrent chemotherapy combined with radiation has been proposed for enhanced treatment results for esophageal cancer. We evaluated the efficacy and the toxicity of a novel regimen of daily low-dose nedaplatin (cis-diammine-glycolatoplatinum) and continuous infusion of 5-fluorouracil (5-FU) with radiation in patients with esophageal squamous cell carcinoma.

Methods

Between January 2003 and June 2008, 33 patients with clinical stage I to IVB esophageal squamous cell carcinoma were enrolled. Nedaplatin (10 mg/body/day) was administered daily and 5-FU (500 mg/body/day) was administered continuously for 20 days. Fractionated radiotherapy for a total dose of 50.4-66 Gy was administered together with chemotherapy. Additional chemotherapy with nedaplatin and 5-FU was optionally performed for a maximum of 5 courses after chemoradiotherapy. The primary end-point of this study was to evaluate the tumor response, and the secondary end-points were to evaluate the toxicity and the overall survival.

Results

Twenty-two patients (72.7%) completed the regimen of chemoradiotherapy. Twenty patients (60.6%) achieved a complete response, 10 patients (30.3%) a partial response. One patient (3.0%) had a stable disease, and 2 (6.1%) a progressive disease. The overall response rate was 90.9% (95% confidence interval: 75.7%-98.1%). For grade 3-4 toxicity, leukopenia was observed in 75.8% of the cases, thrombocytopenia in 24.2%, anemia in 9.1%, and esophagitis in 36.4%, while late grade 3-4 cardiac toxicity occurred in 6.1%. Additional chemotherapy was performed for 26 patients (78.8%) and the median number of courses was 3 (range, 1-5). The 1-, 2- and 3-year survival rates were 83.9%, 76.0% and 58.8%, respectively. The 1- and 2-year survival rates were 94.7% and 88.4% in patients with T1-3 M0 disease, and 66.2% and 55.2% in patients with T4/M1 disease.

Conclusion

The treatment used in our study may yield a high complete response rate and better survival for each stage of esophageal squamous cell carcinoma.

Trial registration

ClinicalTrials.gov Identifier: NCT00197444