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Poster lunch

1528 - S-1/oxaliplatin (SOX) plus bevacizumab (Bev) as first line followed by S-1/irinotecan (IRIS) plus cetuximab (Cmab) as second line therapy in metastatic colorectal cancer (mCRC) (SOBIC trial) (147P)


18 Nov 2017


Poster lunch


Cytotoxic Therapy;  Colon and Rectal Cancer


Yoshihiko Nakamoto


Annals of Oncology (2017) 28 (suppl_10): x42-x56. 10.1093/annonc/mdx659


Y. Nakamoto1, R. Mikami2, M. Umeki3, Y. Tokunaga4, T. Okumoto5, T. Kawamura6, H. Fujiwara7, S. Doi8, M. Noda9, N. Tomita9

Author affiliations

  • 1 Department Of Surgery, Meiwa Hospital, 663-8186 - Nishinomiya/JP
  • 2 Department Of Surgery, Kobe City Medical Center West Hospital, Kobe/JP
  • 3 Department Of Surgery, Hyogo Aonohara Hospital, Ono/JP
  • 4 Department Of Surgery, Japan Post Kyoto Teishin Hospital, Kyoto/JP
  • 5 Department Of Surgery, Himeji St.Mary’s Hospital, Himeji/JP
  • 6 Department Of Surgery, Kakogawa City Hospital, Kakogawa/JP
  • 7 Department Of Surgery, Sanda City Hospital, Sanda/JP
  • 8 Department Of Surgery, Kawanishi City Hospital, Kawanishi/JP
  • 9 Division Of Lower Gastrointestinal Surgery, Department Of Surgery, Hyogo College of Medicine, Nishinomiya/JP


Abstract 1528


S-1 combination therapy (SOX, IRIS) is expected to be promising and safe for mCRC. The SOBIC trial is a phase II trial designed to validate the effectiveness of first and second line oral combination chemotherapy (CT) in mCRC. This is the first report which evaluated the efficacy of S-1 combination CT for mCRC.


mCRC patients candidate were received first line SOX + Bev (7.5mg/kg of Bev, 130mg/m2 of oxaliplatin on day 1 and 80-120mg/day of S-1 for 2 weeks followed by a 1-week rest) followed by second line IRIS + Cmab (weekly Cmab 250 mg/m2 initial dose 400 mg/m2, 100 mg/m2 of irinotecan on day 1, 15 and 80-120mg/day of S-1 for 2 weeks followed by a 2-week rest) in KRAS wild patients, IRIS + Bev (5mg/kg of Bev on day 1, 15, 100 mg/m2 of irinotecan on day 1, 15 and 80-120mg/day of S-1 for 2 weeks followed by a 2-week rest) or IRIS (125 mg/m2 of irinotecan on day 1, 15 and 80-120mg/day of S-1 for 2 weeks followed by a 2-week rest) in KRAS mutant patients. The primary endpoint was second progression-free survival (PFS). The secondary endpoint included overall survival (OS), response rate (RR) in first and second line CT, R0 resection rate (R0-Rate) and safety. We estimated that a target sample size of 48 patients.


Among 52 patients were enrolled from May 2010 to March 2013 in HCCSG hospitals. 50 (male gender 60%, median age 65: 38 to 77) patients were included in the efficacy analysis. Second PFS was 24.2 months (95%CI: 17.7 to 35.2), OS was 35.2 months (95%CI: 27.8 to not reached). RR was 46.3% in first line CT, 20% in second line CT, respectively. In first line CT 10 (20%) patients underwent surgery, and R0 resection was achieved in all of the operable cases (R0-Rate was 20%). Surgery rate in second line CT was 12.5%. The main grade 3-4 adverse events were sensory neuropathy (18%), fatigue (10%), and anorexia (8%).


First line SOX+Bev, second line IRIS+Bev or IRIS+Cmab or IRIS was considered to be beneficial for mCRC patients.

Clinical trial identification

SOBIC trial

Legal entity responsible for the study

Yoshihiko Nakamoto




All authors have declared no conflicts of interest.

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