Gastrointestinal tumours, colorectal Poster lunch Poster Display session

147P - 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) (ID 1528)

Presentation Number
147P
Presentation Topic
Gastrointestinal tumours, colorectal
Lecture Time
13:00 - 13:00
Speakers
  • Y. Nakamoto
Authors
  • Y. Nakamoto
  • R. Mikami
  • M. Umeki
  • Y. Tokunaga
  • T. Okumoto
  • T. Kawamura
  • H. Fujiwara
  • S. Doi
  • M. Noda
  • N. Tomita
Session Title
Session Room
Exhibition area, Singapore, Singapore, Singapore
Date
18.11.2017
Session Time
13:00 - 14:00

Abstract

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.

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