Prospective study of daily low-dose nedaplatin and continuous 5-fluorouracil infusion combined with radiation for the treatment of esophageal squamous cell carcinoma
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, and 10 patients (30.3%) a partial response. One patient (3.0%) had a stable disease, and 2 patients (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 T1-3M0 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 registrationClinicalTrials.gov Identifier: NCT00197444
Author: Satoshi OsawaTakahisa FurutaKen SugimotoTakashi KosugiTomohiro TeraiMihoko YamadeYasuhiro TakayanagiMasafumi NishinoYasushi HamayaChise KodairaTakanori YamadaMoriya IwaizumiKosuke TakagakiKen-ichi YoshidaShigeru KanaokaMutsuhiro Ikuma
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Published on: 2009-11-22
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