Open AccessLong‐term results of a randomized controlled trial comparing neoadjuvant Adriamycin, cisplatin, and 5‐fluorouracil vs docetaxel, cisplatin, and 5‐fluorouracil followed by surgery for esophageal cancer (OGSG1003)
Author(s) -
Sugimura Keijiro,
Yamasaki Makoto,
Yasuda Takushi,
Yano Masahiko,
Hirao Motohiro,
Fujitani Kazumasa,
Kimura Yutaka,
Miyata Hiroshi,
Motoori Masaaki,
Takeno Atsushi,
Shiraishi Osamu,
Makino Tomoki,
Kii Takayuki,
Tanaka Koji,
Satoh Taro,
Mori Masaki,
Doki Yuichiro
Publication year - 2021
Publication title -
annals of gastroenterological surgery
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.308
H-Index - 15
ISSN - 2475-0328
DOI - 10.1002/ags3.12388
Subject(s) - docetaxel , medicine , fluorouracil , cisplatin , hazard ratio , clinical endpoint , confidence interval , chemotherapy , esophageal cancer , randomized controlled trial , gastroenterology , surgery , urology , oncology , cancer
Aim The aim is to report the long‐term outcomes of preoperative cisplatin and fluorouracil plus docetaxel (DCF) vs Adriamycin (ACF) for resectable esophageal squamous cell carcinoma (ESCC). Previously, this trial showed that DCF is associated with prolonged recurrence‐free survival (RFS). Methods Patients were randomly assigned to two cycles of ACF (35 mg/m 2 of Adriamycin, 70 mg/m 2 of cisplatin intravenously on day 1, and 700 mg/m 2 of fluorouracil infusion for 7 days) every 4 weeks or DCF (70 mg/m 2 of docetaxel, 70 mg/m 2 of cisplatin intravenously on day 1, and 700 mg/m 2 of fluorouracil infusion for 5 days) every 3 weeks, followed by surgery. The primary endpoint was RFS. The secondary endpoint was overall survival (OS). Results Between October 2011 and October 2013, 162 patients at 10 institutions were enrolled in the study, 162 of whom were eligible and randomly assigned to the two groups. The median follow‐up for surviving patients was 69.8 months. The 5‐year RFS was significantly better in the DCF group than in the ACF group (59.9% vs 40.7%, hazard ratio [HR] 0.55; 95% confidence interval [CI], 0.35‐0.86; P = .009) and the 5‐year OS was significantly better in the DCF group than in the ACF group (63.5% vs 49.4%, HR, 0.61; 95% CI, 0.38‐0.96; P = .03). The benefit of DCF chemotherapy on survival was significantly greater in the subgroups with more advanced clinical T and N stage. Conclusions Cisplatin and fluorouracil plus docetaxel are associated with better RFS and OS than ACF in resectable ESCC patients.