Perioperative chemotherapy with S-1 plus oxaliplatin (SOX) for stage III colorectal cancer patients.

Abstract

603 Background: Neoadjuvant chemotherapy (NAC) has a potential to increase the curative resection rate and reduce the recurrence rate. The purpose of this study was to evaluate the safety and efficacy of S-1 plus oxaliplatin (SOX) regimen as neoadjuvant (4 courses) and adjuvant (4 courses) for the treatment of patients with Stage III colorectal cancer (anyT and N+). Methods: We have treated patients with Stage III colorectal cancer undergone operation after NAC (SOX 4 courses) and adjuvant chemotherapy (SOX 4 courses) at Fukuoka University Hospital. SOX regimen (S-1 80 mg/ m2 : day1~14 and oxaliplatin 130 mg/m2 : day1) was administrated every 3 weeks. The primary endpoint was response rate and safety. Results: Of the 21 patients enrolled between September 2012 and December 2014. The median age was 62 years (range, 43–87), and 57% were female. Eastern Cooperative Oncology Group performance status scores were 0, 1, and 2 in 50%, 40%, and 10% of the patients, respectively. The patients received median 4(1-4) courses of NAC and median 4(0-4) courses of adjuvant chemotherapy. The cumulative median dose of oxaliplatin was 1204 (210-1841) mg/body. In NAC, 4 patients required treatment interruption because of the toxicity [grade2 gastrointestinal bleeding (n = 1), grade 3 thrombocytopenia (n = 2), and grade4 ileus (n = 1)]. A complete response according to Response Evaluation Criteria in Solid Tumors ver.1.1 was observed in a patient (4.8%) and a partial response was observed in 15 patients (71.4%) and a stable disease was 5 patients (23.8%). The response rate and tumor control rate were 76.1% and 100%. Curative resection was performed in all patients. No perioperative complications more than grade3 as Clavien Dindo classification was observed in all patients. The observed adverse events of Grade 3 or higher were thrombocytopenia (n = 4), neutropenia (n = 3), diarrhea (n = 1), and ileus (n = 1). Conclusions: Perioperative chemotherapy with SOX is safe and effective. Further studies are warranted to confirm the safety and efficacy of this method. A single-arm phase II trial of perioperative chemotherapy (SOX) and operation for stage III colorectal cancer patients (FUTURE1104 SOS3).