Diminished dose nedaplatin combined with low-dose cisplatin as first-line therapy for advanced esophageal carcinoma: A randomized clinical trial / 肿瘤

ABSTRACT

Objective: To investigate the safety and efficacy of the combination of diminished dose of nedaplatin (NDP) and low dose of cisplatin (PDD) for advanced esophageal carcinoma. Methods: The patients who had no indications for surgery or radiotherapy were recruited in our study. They were divided into the three groups randomly. Group A were given NDP (25 mg/m2, iv) and PDD (15 mg/m2, iv) on day 1 and day 8 and continuously infused with 5-FU (300 mg/m2) for 24 h on days 1-5 and days 8-12. Group B were given NDP (40 mg/m2, iv) on days 1-2 and continuously infused with 5-FU (500 mg/m2, iv) on days 1-5. Group C were administered PDD (40 mg/m2, iv) on days 1-2 and infused with 5-FU (500 mg/m2, iv) on days 1-5. All the patients were given folic acid tablet 60 mg/d following infusion of 5-FU. The therapeutic regimens were repeated every 22 days (one cycle). The effect was evaluated after two cycles. Results: The total response ratio (complete response and partial response) and median remission time were 60.00% and 5.5 months for group A. respectively; 54.54% and 5.0 months for group B, respectively; 41.18% and 3.0 months for group C, respectively. The difference was not significant between group A and group B (P>0.05). The clinical efficacy in groups A and B was significantly different compared with group C (P<0.05). The main toxicities included leucopenia and thrombocytopenia. The incidence rate of III to IV grade leucopenia was 14.29%, 27.27%, and 8.82% in groups A, B, and C, respectively; and that of thrombocytopenia was 11.43%, 39.39%, and 5.88%, respectively. The difference was significant (P<0.05). Conclusion: Diminished dose of NDP combined with low dose of cisplatin has definite effects on advanced esophageal carcinoma with less hematological toxicity.