A phase I/II study of second-line chemotherapy with fractionated docetaxel and nedaplatin for 5-FU/cisplatin-resistant esophageal squamous cell carcinoma

Background/Aims: There are few second-line regimens available for esophageal cancer. The use of fractionated docetaxel and nedaplatin as second-line chemotherapy was examined in this study. Methodology: Eligibility criteria were follows: histologically-proven squamous cell carcinoma, surgically unresectable disease, failure to respond to chemotherapy with 5-FU and cisplatin and no more than 2 prior chemotherapy regimens. A total of 12 patients were enrolled in this study. To reduce toxicities, fractionated docetaxel (50mg/m² in day 1 and 8) and nedaplatin (50mg/m² in day 8) were administered as second-line chemotherapy. Results: Stable disease (SD) was observed in 4 cases (33%) and the disease control rate was 33%. Regarding toxicities, leukopenia was the most frequently observed (8 cases, 67%); however, there were no cases of grade 4 non-hematological toxicity. The 1-year overall survival was 26.7% and the median survival time was 7.8 months (95% CI=3.328-12.272 months). The 1-year progression-free survival was 0% and the median progression-free time was 2.0 months (95% CI=1.319-2.681). Conclusions: Combination chemotherapy using fractionated docetaxel and nedaplatin is safe and effective and appears to be a feasible regimen to use as second-line chemotherapy for FP-resistant advanced esophageal squamous cell carcinoma.