Multicenter randomised trial of two versus three courses of preoperative cisplatin and fluorouracil plus docetaxel for locally advanced oesophageal squamous cell carcinoma

Background The optimal number of neoadjuvant chemotherapy (NAC) cycles remains to be established for treating oesophageal squamous cell carcinoma (ESCC). We compared two versus three courses of NAC for treating locally advanced ESCC in a multi-institutional, randomised, Phase II trial. Methods We randomly assigned 180 patients with locally advanced ESCC at 6 institutions to either two ( N = 91) or three ( N = 89) courses of DCF (docetaxel 70 mg/m 2 , cisplatin 70 mg/m 2 i.v. on day 1, fluorouracil 700 mg/m 2 continuous infusion for 5 days) every 3 weeks, prior to surgery. The primary endpoint was 2-year progression-free survival (PFS) with an intention-to-treat analysis. Results Patient background parameters were well-balanced. The R0 resection rates were 98.9 and 96.5% in the two- and three-course groups, respectively ( P = 0.830). In resected cases, the two- and three-course groups had comparable pN0 rates ( P = 0.225) and histological responses ( P = 0.898). The 2-year PFS rate was also comparable between the two groups (71.4 vs. 71.1%, P = 0.669). Among subgroups based on baseline characteristics, only patients aged under 65 years old showed a tendency for better survival with the three-course treatment (hazard ratio = 2.612, 95% confidence interval: 1.012–7.517). Conclusions Two courses of a DCF regimen showed potential as an optional NAC treatment for locally advanced ESCC. Clinical trial registration University Hospital Medical Information Network Clinical Trials Registry of Japan (identification number UMIN 000015788).