• Naohito Beppu, Hidenori Yoshie, Fumihiko Kimura, Tsukasa Aihara, Hiroshi Doi, Norihiko Kamikonya, Nagahide Matsubara, Naohiro Tomita, Hidenori Yanagi, and Naoki Yamanaka.
• Department of Surgery, Meiwa Hospital, 4-31 Agenaruo-cho, Nishinomiya, Hyogo, 663-8186, Japan. beppu-n@hyo-med.ac.jp.
• Surg. Today. 2016 Oct 1; 46 (10): 1123-31.

PurposeTo evaluate the safety and efficacy of induction SOX (S-1 + oxaliplatin) ± cetuximab chemotherapy followed by short-course chemoradiotherapy and surgery in patients with poor-risk locally advanced rectal cancer.MethodsWe enrolled eligible patients with poor-risk rectal cancer defined as T3 lower rectal cancer with mesorectal fascia involvement, T4a or T4b tumors or cases with lateral lymph node swelling. The primary endpoint was a pathological complete response (pCR), and the secondary endpoints were the objective response rate (ORR) and the pathological high response rate (Grade 2 plus 3).ResultsTwenty eligible patients were enrolled. The majority (75.0 %, 15/20) of the patients completed four cycles of induction chemotherapy, and all patients completed the radiotherapy (25 Gy/10 fractions/5 days). The global rate of Grade 3-4 toxicities was 30.0 % (6/20 patients). The ORRs were 85.0 % (17/20) and 95.0 % (19/20) in the patients who underwent R0 and R1 resection, respectively. The pathological high response rate was 70.0 % (14/20) and the pCR was 10.0 % (2/20).ConclusionThe regimen of induction SOX (S-1 + oxaliplatin) ± cetuximab chemotherapy followed by short-course chemoradiotherapy is safe and is associated with good tumor regression in patients with poor-risk locally advanced rectal cancer.

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