Multicenter randomised trial of two versus three courses of preoperative cisplatin and fluorouracil plus docetaxel for locally advanced oesophageal squamous cell carcinoma
Multicenter randomised trial of two versus three courses of preoperative cisplatin and fluorouracil plus docetaxel for locally advanced oesophageal squamous cell carcinoma
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DOI：
10.1038/s41416-022-01726-5
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发表时间：
2022-02-09
影响因子：
8.8
通讯作者：
Yasuda, Takushi
中科院分区：
文献类型：
--
作者：
Makino, Tomoki;Yamasaki, Makoto;Yasuda, Takushi
背景：新辅助化疗(NAC)治疗食道鳞状细胞癌(ESCC)的最佳周期数尚未确定。在一项多机构、随机、II期试验中，我们比较了两个疗程的NAC和三个疗程的NAC治疗局部晚期ESCC。方法将180例局部晚期食管癌患者随机分为2个疗程(91例)和3个疗程(89例)，静脉注射多西紫杉醇70 mg/m(2)，顺铂70 mg/m(2)。第1天，氟尿嘧啶700 mg/m(2)，连续输注5天)，每3周一次，术前给予。主要终点是两年无进展生存(PFS)，并进行意向治疗分析。结果患者的背景参数是平衡的。两个疗程组和三个疗程组的R0切除率分别为98.9%和96.5%(P=0.830)。在切除的病例中，两个疗程组和三个疗程组的pN0率(P=0.225)和组织学反应(P=0.898)相似。两组的2年PFS率也相当(71.4%vs.71.1%，P=0.669)。在基于基线特征的亚组中，只有65岁以下的患者使用三个疗程的治疗显示出更好的生存趋势(危险比=2.612，95%可信区间：1.012-7.517)。结论两个疗程的DCF方案可作为局部晚期ESCC的一种可选NAC治疗方案。
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.