• Nobutoshi Ando, Hoichi Kato, Hiroyasu Igaki, Masayuki Shinoda, Soji Ozawa, Hideaki Shimizu, Tsutomu Nakamura, Hiroshi Yabusaki, Norio Aoyama, Akira Kurita, Kenichiro Ikeda, Tatsuo Kanda, Toshimasa Tsujinaka, Kenichi Nakamura, and Haruhiko Fukuda.
• Department of Surgery, Tokyo Dental College Ichikawa General Hospital, Ichikawa, Japan. nando@tdc.ac.jp
• Ann. Surg. Oncol. 2012 Jan 1;19(1):68-74.

BackgroundPatients with esophageal carcinoma receiving postoperative chemotherapy showed superior disease-free survival than those receiving surgery alone in a Japan Clinical Oncology Group trial (JCOG9204). The purpose of this study was to evaluate optimal perioperative timing-that is, before or after surgery-for providing chemotherapy in patients with locally advanced esophageal squamous cell carcinoma.MethodsEligible patients with clinical stage II or III, excluding T4, squamous cell carcinoma were randomized to undergo surgery followed (group 1) or preceded (group 2) by chemotherapy consisting of two courses of cisplatin plus 5-fluorouracil. The primary end point was progression-free survival.ResultsWe randomized 330 patients, with 166 assigned to group 1 and 164 to group 2, between May 2000 and May 2006. The planned interim analysis was conducted after completion of patient accrual. Progression-free survival did not reach the stopping boundary, but overall survival in group 2 was superior to that of group 1 (P = 0.01). Therefore, the Data and Safety Monitoring Committee recommended early publication. Updated analyses showed the 5-year overall survival to be 43% in group 1 and 55% in group 2 (hazard ratio 0.73, 95% confidence interval 0.54-0.99, P = 0.04), where the median follow-up of censored patients was 61.6 months. Concerning operative morbidity, renal dysfunction after surgery in group 2 was slightly higher than in group 1.ConclusionsPreoperative chemotherapy with cisplatin plus 5-fluorouracil can be regarded as standard treatment for patients with stage II/III squamous cell carcinoma.

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