P-244 - Prospective study of S-1 + Irinotecan plus bevacizumab as second-line therapy in Japanese patients with metastatic colorectal cancer (KSCC1102)

Date 04 July 2015
Event WorldGI 2015
Session Posters
Topics Anticancer agents
Colon and Rectal Cancer
Biological Therapy
Presenter H. Satake
Citation Annals of Oncology (2015) 26 (suppl_4): 1-100. 10.1093/annonc/mdv233
Authors H. Satake1, A. Tsuji1, Y. Emi2, M. Shimokawa3, Y. Miyamoto1, H. Saeki1, E. Oki1, S. Maekawa4, H. Tanioka5, Y. Akagi6, H. Baba1, Y. Ogata7, Y. Maehara1
  • 1Kobe City Medical Center General Hospital, Kobe/JP
  • 2Saiseikai Fukuoka General Hospital, Fukuoka/JP
  • 3National Kyushu Cancer Center, Fukuoka/JP
  • 4Munakata Medical Association Hospital, Munakata/JP
  • 5Okayama Rosai Hospital, Okayama/JP
  • 6Kurume University School of Medicine, Kurume/JP
  • 7Kurume University Medical Center, Kurume/JP



S-1 + irinotecan (IRIS) plus bevacizumab (Bev) is a standard therapy for metastatic colorectal cancer (mCRC) in Japan. However, few clinical data on its use in second line therapy are available.


The study was conducted under a multicenter, single-arm, open-label prospective design. Major inclusion criteria were previously treated mCRC with an oxaliplatin containing regimen; presence of measurable lesions; age > 20 years; ECOG performance status (PS) 0–1; and adequate organ function. Patients received Bev 7.5 mg/kg d1 and IRIS (irinotecan 150 mg/m2 d1 plus S-1 80 mg/m2 bid d1-14) q3w, repeated until unacceptable toxicity or disease progression occurred. Primary endpoint was progression-free survival (PFS). A sample size of 37 was planned for a threshold PFS of 3.0 months (M) and expected value of 5.0 M, with one-sided alpha of 0.05 and beta of approximately 0.1.


Thirty-seven patients were enrolled from Nov. 2011 to May 2013, of whom male/female, 23/14; median age, 62.0 years (range 33-76); and PS 0/1, 33/4. Two patients did not fulfill the eligibility criteria, and one was not treated. 34 patients were assessed for response and 36 for safety: CR + PR, 7 patients; confirmed ORR, 20.6%. Response rate across all time points without confirmation was 26.5%. Median PFS was 5.6M (90% CI, 3.8-7.0M) and mOS was 16.4M (95% CI, 8.1–20.0M) The most common grade 3/4 adverse events were neutropenia 25.0%, thrombocytopenia 8.4%, anorexia 22.2%, fatigue 16.7%, hypertension 30.6%, hand-foot syndrome 0%, bleeding 5.6% and febrile neutropenia 5.6%.


Second-line treatment with IRIS + Bev showed a promising response rate, PFS and OS, and an acceptable tolerability profile in clinical care of Japanese patients with mCRC.