Oops, you're using an old version of your browser so some of the features on this page may not be displaying properly.

MINIMAL Requirements: Google Chrome 24+Mozilla Firefox 20+Internet Explorer 11Opera 15–18Apple Safari 7SeaMonkey 2.15-2.23

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)

Date

18 Nov 2017

Session

Poster lunch

Topics

Cytotoxic Therapy;  Colon and Rectal Cancer

Presenters

Yoshihiko Nakamoto

Citation

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

Authors

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
More

Resources

Abstract 1528

Background

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.

Methods

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.

Results

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%).

Conclusions

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

Funding

None

Disclosure

All authors have declared no conflicts of interest.

This site uses cookies. Some of these cookies are essential, while others help us improve your experience by providing insights into how the site is being used.

For more detailed information on the cookies we use, please check our Privacy Policy.

Customise settings
  • Necessary cookies enable core functionality. The website cannot function properly without these cookies, and you can only disable them by changing your browser preferences.