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Prospective study of daily low-dose nedaplatin and continuous 5-fluorouracil infusion combined with radiation for the treatment of esophageal squamous cell carcinoma
BMC Cancer, 12/04/2009
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Osawa S et al. – 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.The treatment used in our study may yield a high complete response rate and better survival for each stage of esophageal squamous cell carcinoma.
Methods- Between January 2003 and June 2008, 33 patients with clinical stage I to IVB esophageal squamous cell carcinoma enrolled
- Nedaplatin (10 mg/body/day) administered daily and 5-FU (500 mg/body/day) was administered continuously for 20 days
- Fractionated radiotherapy for total dose of 50.4-66 Gy administered together with chemotherapy
- Additional chemotherapy with nedaplatin and 5-FU optionally performed for maximum of 5 courses after chemoradiotherapy
- Additional chemotherapy with nedaplatin and 5-FU optionally performed for maximum of 5 courses after chemoradiotherapy
- Primary end-point of study was to evaluate the tumor response, and the secondary end-points were to evaluate the toxicity and the overall survival
- 22 patients (72.7%) completed regimen of chemoradiotherapy
- 20 (60.6%) achieved a complete response, 10 patients (30.3%) a partial response
- One patient (3.0%) had stable disease, and 2 (6.1%) progressive disease
- Overall response rate was 90.9% (95% confidence interval: 75.7%-98.1%)
- For grade 3-4 toxicity, leukopenia observed in 75.8% of 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%
- 1- and 2-year survival rates 94.7% and 88.4% in patients with T1-3 M0 disease, and 66.2% and 55.2% in patients with T4/M1 disease
