Background: Nedaplatin, a new analog of cisplatin, has been developed and marketed in recent years in Japan. In this study, we evaluated the efficacy and toxicity of a regimen of nedaplatin and 5-FU with radiation in patients with advanced esophageal carcinomas.
Materials and methods: Between June 1999 and December 2002, 42 patients with advanced and unresectable thoracic esophageal squamous cell carcinomas (SCCs) were enrolled into this study. Twenty-five of these 42 patients were considered to have inoperable tumors due to distant organ metastasis, distant lymph node metastasis, severe organ dysfunction and rejection of surgery by the patients. The remaining 17 patients received neoadjuvant treatment followed by surgery. The clinical responses of the primary tumors were evaluated.
Results: Response and toxicity could be assessed in 22 of the 25 patients with unresectable esophageal SCCs. Two of these 22 achieved a complete response (CR), 15 had a partial response (PR) and 5 showed no change (NC). The overall response rate (CR + PR) was 77%. The one- and 2-year survival rates were 30.7% and 10.2%, respectively, with a median survival time (MST) of 10.1 months. Of the 17 patients who received neoadjuvant treatment, 14 underwent subsequent surgery. Preoperatively, 2 of these 17 patients achieved a CR, 10 had a PR and 5 showed NC. The overall response rate for all 39 patients was 74%. The pathological complete response (pCR) rate of the 14 patients who underwent surgery was 28.6%. Their one- and 2-year survival rates were 48.2% and 12.1%, respectively, with an MST of 12.2 months. Toxicity was evaluated in the 39 patients whose responses were assessed. Toxicity higher than grade 3 occurred in 8 out of 39 (20.5%) patients, and 6 (15.4%), 3 (7.7%) and one (2.6%) had grade 3 leukopenia, thrombocytopenia and anemia, respectively.
Conclusion: In conclusion, this study indicates that combination chemoradiotherapy with nedaplatin and 5-FU is safe and efficacious for patients with advanced esophageal carcinomas. We recommend further evaluation of this treatment regimen in such patients.