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Poster display session: Basic science, Endocrine tumours, Gastrointestinal tumours - colorectal & non-colorectal, Head and neck cancer (excluding thyroid), Melanoma and other skin tumours, Neuroendocrine tumours, Thyroid cancer, Tumour biology & pathology

1977 - Randomized phase II study of FOLFIRI plus ramucirumab (Rmab) versus FOLFOXIRI plus Rmab as first-line treatment for patients with metastatic colorectal cancer (mCRC): WJOG9216G


21 Oct 2018


Poster display session: Basic science, Endocrine tumours, Gastrointestinal tumours - colorectal & non-colorectal, Head and neck cancer (excluding thyroid), Melanoma and other skin tumours, Neuroendocrine tumours, Thyroid cancer, Tumour biology & pathology


Cytotoxic Therapy

Tumour Site

Colon and Rectal Cancer


Yosuke Kito


Annals of Oncology (2018) 29 (suppl_8): viii150-viii204. 10.1093/annonc/mdy281


Y. Kito1, T. Yamada2, T. Matsumoto3, H. Yasui4, K. Murata5, A. Makiyama6, H. Hara7, E. Baba8, K. Nishio9, K. Yoshimura10, S. Hironaka11, K. Muro12, K. Yamazaki13

Author affiliations

  • 1 Medical Oncology, Ishikawa Prefectural Central Hospital, 920-8530 - Kanazawa/JP
  • 2 Gastroenterology, University of Tsukuba Hospital, 305-0005 - Tsukuba, ibaraki/JP
  • 3 Internal Medicine, Himeji Red Cross Hospital, 670-8540 - Himeji Hyogo Pref/JP
  • 4 Department Of Medical Oncology, Kobe City Medical Center General Hospital, 650-0047 - Kobe/JP
  • 5 Department Of Colorectal Surgery, Kansai Rosai Hospital, Amagasaki/JP
  • 6 Department Of Hematology/oncology, Japan Community Healthcare Organization Kyushu Hospital, FUKUOKA/JP
  • 7 Department Of Gastroenterology, Saitama Cancer Center, Ina/JP
  • 8 Comprehensive Clinical Oncology, Kyushu University Hospital, 8128582 - FUKUOKA/JP
  • 9 Department Of Genome Biology, Kindai University, 589-8511 - Osaka/JP
  • 10 Innovative Clinical research Center, Kanazawa University, 920-8641 - Kanazawa/JP
  • 11 Medical Oncology & Hepatology, Oita University Faculty of Medicine, 879-5593 - Yufu/JP
  • 12 Department Of Clinical Oncology, Aichi Cancer Center Hospital, 464-8681 - Nagoya/JP
  • 13 Division Of Gastrointestinal Oncology, Shizuoka Cancer Center, 411-8777 - Shizuoka/JP


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Abstract 1977


Rmab, an anti-VEGFR-2 antibody, inhibits VEGF-A, -C, -D binding and endothelial cell proliferation, while bevacizumab (Bmab) binds to and blocks circulating VEGF-A. The RAISE trial showed the survival benefit of FOLFIRI plus Rmab compared with FOLFIRI plus placebo as second-line treatment for patients with mCRC. The TRIBE trial demonstrated that FOLFOXIRI plus Bmab improved overall response rate (ORR), progression-free survival and overall survival compared with FOLFIRI plus Bmab as induction therapy followed by maintenance therapy with fluorouracil (5-FU), l-leucovorin (l-LV) and Bmab. However, little is known about the role of Rmab in first-line setting and the comparison of induction followed by maintenance therapy with continuous therapy continued until progressive disease (PD) or unacceptable toxicity.

Trial design

WJOG9216G is an open-label, randomized phase II study evaluating FOLFIRI plus Rmab until PD (arm A) versus FOLFOXIRI plus Rmab for 8 to 12 cycles followed by maintenance therapy with 5-FU, l-LV and Rmab (arm B) for patients with mCRC. Eligibility criteria include histologically confirmed unresectable colorectal adenocarcinoma, age of 20-75 years, ECOG PS of 0 or 1, without UGT1A1 *6/ *6, *28/ *28 or *6/ *28, no history of prior chemotherapy for mCRC, and adequate organ function. Stratification criteria are institution, RAS status, history of adjuvant chemotherapy, and primary tumor location. Arm A comprises Rmab 8 mg/kg, irinotecan (IRI) 180 mg/m2, l-LV 200 mg/m2, and bolus 5-FU 400 mg/m2 followed by a 46-hour continuous infusion (ci) of 5-FU 2400 mg/m2 every 2 weeks until PD. Arm B consists of 8 to 12 cycles of FOLFOXIRI plus Rmab (Rmab 8 mg/kg, IRI 165 mg/m2, oxaliplatin 85 mg/m2, l-LV 200 mg/m2, and 5-FU ci 3200 mg/m2) as induction therapy followed by 5-FU/l-LV plus Rmab until PD. Primary endpoint is ORR, and main secondary endpoints are PFS, PFS2, OS and safety. Sample size was calculated to be 120 (60 patients per arm), with a one-sided alpha of 10% and a power of 80%, assuming ORR of 50% in arm A and of 70% in arm B. This study has enrolled 23 patients as of April 28th, 2018.

Clinical trial identification

UMIN000026527 (Release date: March 13th, 2017).

Legal entity responsible for the study

West Japan Oncology Group.


Eli Lilly Japan K.K.

Editorial Acknowledgement


H. Yasui: Honoraria: Taiho Pharmaceutical, Chugai Pharma, Yakult Honsha, Bristol-Myeres Squibb Japan, Takeda, Kyowa Hakko Kirin, Medicon, Ono Pharmaceutical, Daiichi Sankyo, Lilly Japan, Merk Serono, Terumo, Becton Dickinson, Nihonkayaku. H. Hara: Consulting or advisory role: Ono Pharmaceutical, Chugai Pharma, Merck Serono, and MSD; Honoraria from Chugai Pharma, Taiho Pharmaceutical, Merck Serono, Yakult Honsha, Lilly, Ono Pharmaceutical, Takeda; Author's institution has received research funding: AstraZeneca, Chugai Pharma, Merck Serono, MSD, Ono Pharmaceutical, Taiho Pharmaceutical, Takeda, Boehringer Ingelheim, Dainippon Sumitomo Pharma, Daiichi Sankyo, Lilly, Pfizer, LSK BioPharma, Eisai, Incyte. E. Baba: Honoraria: Chugai Pharma, Lilly Pharma; Author's institution has received research funding: Chugai Pharma, Lilly Pharma, Ono Pharmaceutical, Taiho Pharmaceutical, Takeda, Merck Serono Ltd. K. Yoshimura: Honoraria: Chugai Pharma, Lilly, Astra Zeneca, Taiho Pharmaceutical, Boehringer Ingelheim, Takeda, Eisai. S. Hironaka: Consulting or advisory role: Astra Zeneca; Honoraria: Lilly, Bristol-Myers Squibb Japan, Ono Pharmaceutical, Taiho Pharmaceutical, Yakult Honsha, Daiichi Sankyo. K. Muro: Honoraria: Takeda, Chugai Pharma, Yakult Honsha, Merck Serono, Taiho Pharmaceutical, Lilly, Ono Pharmacutical; Research funding: Ono Pharmaceutical, MSD, Daiichi Sankyo, Shionogi Pharma, Kyowa Hakko Kirin, Gilead Sciences. K. Yamazaki: Honoraria: Chugai Pharma, Daiichi Sankyo, Yakult Honsha, Takeda, Bayer, Merck Serono, Bristol-Myers Squibb Japan, Taiho Pharmaceutical, and Lilly; Author's institution has received research funding: Taiho Pharmaceutical. All other authors have declared no conflicts of interest.

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