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 Anti-Cancer Agents & Biologic Therapy
Colon Cancer
Rectal Cancer
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.