209P - Efficacy and safety of SOX as an adjuvant therapy for stage 2/3 colon cancer in a group at high risk of recurrence in prospective study

Date 17 December 2016
Event ESMO Asia 2016 Congress
Session Poster lunch
Topics Cytotoxic agents
Colon and Rectal Cancer
Presenter Hiroshi Osawa
Citation Annals of Oncology (2016) 27 (suppl_9): ix53-ix67. 10.1093/annonc/mdw581
Authors H. Osawa
  • Oncology And Hematology, EDOGAWA HOSPITAL, 133-0052 - TOKYO/JP



A number of large scale clinical trials have demonstrated that using a combination of oxaliplatin(L-OHP) and oral-fluoropyrimidines as an adjuvant chemotherapy for stage 2/3 colon cancer improved the prognosis. However, there is no experience in Japanese patients with using SOX therapy, in which S-1 and oxaliplatin are used in combination. Therefore, our objective was to evaluate the efficacy and safety of SOX in Japanese patients as an adjuvant chemotherapy for colon cancer in a single institute prospective study.


The efficacy and safety of SOX as an adjuvant chemotherapy for patients with stage 3 colon cancer and stage 2 patients who had a signature for high risk of recurrence were evaluated in patients who had undergone surgery at our institution between July, 2012 and January, 2015. In principle, the first cycle was given as an in-patient treatment. After the oxaliplatin was dissolved to 130 mg/m2 in 500 ml saline, it was intravenously infused for 120 mins on the first day. S-1, 80mg/m2, was orally administered twice per day, from the evening of day 1 through morning of day 15. The above was, in principle, repeated at 3-week intervals for a total of eight cycles.


Thirty-two patients received SOX therapy during the study period: 19 men and 13 women with median age of 65.5 years (32–78 years). Performance status was 0 for 27 patients, and PS 1 for 5 patients. The clinical stages were stage 2 in 5 patients, stage 3A in 19 patients, and stage 3B in 8 patients. The median number of SOX cycles was 8 (2-8 courses). The treatment completion rate was 68.8%. Three-year disease free survival rates were 78.1%. Three-year overall survival rates were 93.8%. In terms of adverse events, the serious adverse events of grade 3 or higher seen among all patients were neutropenia in three patients, thrombocytopenia in two patient, bronchospasm of L-OHP in two patients, interstitial pneumonia and diarrhea in one patient and peripheral sensory neuropathy in six patients. However, corneal epithelial disorders, which is characteristic of S-1, was not observed.


Efficacy and safety of SOX in Japanese patients as an adjuvant chemotherapy after colon cancer surgery was demonstrated in the latest prospective study report.

Clinical trial indentification


Legal entity responsible for the study



IRB of Edogawa Hospital


All authors have declared no conflicts of interest.