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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

2182 - BRAVERY study: A multicenter phase II study of eribulin in patients with BRAF V600E mutant metastatic colorectal cancer (EPOC1701).

Date

21 Oct 2018

Session

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

Topics

Cytotoxic Therapy;  Targeted Therapy

Tumour Site

Colon and Rectal Cancer

Presenters

Toshiki Masuishi

Citation

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

Authors

T. Masuishi1, H. Taniguchi1, D. Kotani2, H. Bando2, Y. Komatsu3, K. Yamaguchi4, T.E. Nakajima5, T. Satoh6, T. Nishina7, T. Esaki8, M. Wakabayashi9, S. Nomura9, S. Sakamoto9, H. Ono9, N. Hirano9, N. Fujishiro9, N. Fuse10, A. Sato10, A. Ohtsu2, T. Yoshino2

Author affiliations

  • 1 Department Of Clinical Oncology, Aichi Cancer Center Hospital, 464-8681 - Nagoya/JP
  • 2 Department Of Gastroenterology And Gastrointestinal Oncology, National Cancer Center Hospital East, 277-8577 - Kashiwa/JP
  • 3 Department Of Cancer Chemotherapy, Hokkaido University Hospital Cancer Center, 060-8638 - Sapporo/JP
  • 4 Department Of Gastrointestinal Oncology, Cancer Institute Hospital of JFCR, 135-8550 - Tokyo/JP
  • 5 Department Of Clinical Oncology, St Marianna University School of Medicine, 216-8511 - Kawasaki city/JP
  • 6 Department Of Frontier Science For Cancer And Chemotherapy, Osaka University, 565-0871 - Osaka/JP
  • 7 Department Of Gastrointestinal Medical Oncology, National Hospital Organization Shikoku Cancer Center, 791-0280 - Matsuyama/JP
  • 8 Department Of Gastrointestinal And Medical Oncology, National Kyushu Cancer Center, Fukuoka/JP
  • 9 Clinical research Support Office, National Cancer Center Hospital East, Kashiwa/JP
  • 10 Clinical research Support Office, National Cancer Center Hospital East, 277-8577 - Kashiwa/JP
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Resources

Abstract 2182

Background

BRAF V600E mutations are present in 5-10% of metastatic colorectal cancer (mCRC) patients, associated with aggressive biology and limited response to standard chemotherapy, especially in second line and beyond. BRAF V600E mutant CRCs have different patterns of gene expression from the BRAF wild-type, and preclinical evidence suggests that microtubule inhibitors have a potential antitumor effect on xenograft models of BRAF V600E mutant CRC; among them, eribulin has greater growth inhibitory activity than either vinblastine or paclitaxel in vitro. In addition, we have experienced a hint of activity for BRAF V600E mutant CRC patients with tumor shrinkage following eribulin treatment (Masuishi T, et al. Ann Oncol, 2018).

Trial design

BRAVERY study is a multicenter phase II study to evaluate the efficacy and safety of eribulin in patients with BRAF V600E mutant mCRC detected in either tumor tissue (primary analysis cohort) or circulating tumor DNA (ctDNA) assay (liquid biopsy cohort). Key eligibility criteria are refractory or intolerant to at least one regimen (including irinotecan or oxaliplatin) containing fluoropyrimidine, an age of 20 years or older, and ECOG performance status of 0–1. Eribulin is administered intravenously at a dose of 1.4 mg/m2 on Days 1 and 8, repeated every 21 days. Primary endpoint is confirmed objective response rate (ORR) by investigator’s assessment. A sample size of the primary analysis cohort is calculated 27 using two-stage design with ORR of 25% deemed promising and 5% unacceptable (one-sided α, 0.05; β, 0.1). Secondary endpoints include progression-free survival, time to treatment failure, disease control rate, overall survival and adverse events. Furthermore, pretreated tissue and serial blood samples are collected for biomarker analysis; especially focused on gene expression associated with BRAF mutant-like CRC as a predictive marker, BRAF mutant allele frequency in ctDNA as early detection of efficacy, and acquired gene alteration as resistant mechanism to eribulin. At the end of April 2018, four patients have been enrolled in primary analysis cohort since March 2018. Clinical trial information: UMIN000031221 and 000031552.

Clinical trial identification

UMIN000031221 and 000031552. 26/March/2018.

Legal entity responsible for the study

Hiroya Taniguchi.

Funding

Japan Agency for Medical Research and Development.

Editorial Acknowledgement

Disclosure

T. Esaki: Grant and personal fees: Eisai. All other authors have declared no conflicts of interest.

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