Long-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)

Keijiro Sugimura, Makoto Yamasaki, Takushi Yasuda, Masahiko Yano, Motohiro Hirao, Kazumasa Fujitani, Yutaka Kimura, Hiroshi Miyata, Masaaki Motoori, Atsushi Takeno, Osamu Shiraishi, Tomoki Makino, Takayuki Kii, Koji Tanaka, Taro Satoh, Masaki Mori, Yuichiro Doki

Research output: Contribution to journalArticlepeer-review

Abstract

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/m2 of Adriamycin, 70 mg/m2 of cisplatin intravenously on day 1, and 700 mg/m2 of fluorouracil infusion for 7 days) every 4 weeks or DCF (70 mg/m2 of docetaxel, 70 mg/m2 of cisplatin intravenously on day 1, and 700 mg/m2 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.

Original languageEnglish
Pages (from-to)75-82
Number of pages8
JournalAnnals of Gastroenterological Surgery
Volume5
Issue number1
DOIs
Publication statusPublished - Jan 2021

All Science Journal Classification (ASJC) codes

  • Surgery
  • Gastroenterology

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