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Poster display - Cocktail

806 - HGCSG1401 : A retrospective cohort study evaluating the safety and efficacy of regorafenib in patients with metastatic colorectal cancer : Analysis of risk factors for liver dysfunction.


24 Nov 2018


Poster display - Cocktail


Tumour Site

Colon and Rectal Cancer


Atsushi Ishiguro


Annals of Oncology (2018) 29 (suppl_9): ix28-ix45. 10.1093/annonc/mdy431


A. Ishiguro1, S. Yuki2, S. Nakano2, Y. Kawamoto2, K. Sawada3, Y. Tsuji4, T. Honda5, T. Miyagishima6, S. Yoshida7, K. Hatanaka8, T. Sasaki9, O. Muto10, H. Ohnuma11, S. Kato12, A. Sato13, M. Abe14, K. Kato15, T. Amano16, Y. Sakata17, Y. Komatsu3

Author affiliations

  • 1 Medical Oncology, Teine Keijinkai Hospital, 006-8555 - Sapporo/JP
  • 2 Gastroenterology And Hepatology, Hokkaido University Hospital, 060-8638 - Sapporo/JP
  • 3 Cancer Center, Hokkaido University Hospital, 060-8638 - Sapporo/JP
  • 4 Medical Oncology, Tonan Hospital, 060-0001 - Sapporo/JP
  • 5 Clinical Oncology Center, Nagaski University Hospital, 852-8501 - Nagasaki/JP
  • 6 Medical Oncology, Kushiro Rosai Hospital, 085-8533 - Kushiro/JP
  • 7 Gastroenterology, The University of Tokyo Hospital, 113-8654 - Tokyo/JP
  • 8 Gastroenterology, Hakodate Municipal Hospital, 041-8680 - Hakodate/JP
  • 9 Internal Medicine, Hokkaido Gastroenterology Hosipital, Sapporo/JP
  • 10 Medical Oncology, Japan Red Cross Akita Hospital, 101495 - Akita/JP
  • 11 Medical Oncology And Hematology, Sapporo Medical University, Sapporo/JP
  • 12 Gastroenterology, Sapporo Hokuyu Hospital, Sapporo/JP
  • 13 Medical Oncology, Hirosaki University Graduate School of Medicine, Hirosaki/JP
  • 14 Medical Oncology, Sapporo-Kosei General Hospital, Sapporo/JP
  • 15 Gastroenterology, Iwamizawa Municipal General Hospital, Iwamizawa/JP
  • 16 Clinical Research And Medical Innovation Center, Hokkaido University Hospital, 060-8638 - Sapporo/JP
  • 17 Ceo, Misawa City Hospital, 033-0022 - Misawa/JP


Abstract 806


Regorafenib (REG) prolongs overall survival (OS) and progression-free survival (PFS) for patients (pts) with metastatic colorectal cancer (mCRC) in RCTs. However, there is a problem with REG-induced severe liver dysfunction (≥Grade 3) which occurs in 5-11% of treated Japanese pts. Therefore, we analyzed the incidence, therapeutic efficacy, and potential risk factors for REG-induced severe liver dysfunction in a community-based retrospective study (HGCSG1401) of pts treated with REG.


173 pts treated with REG were retrospectively registered from 22 centers in Japan. Survival analyses were performed with Kaplan-Meier method. Log-rank test and Cox-proportional hazard model were used to compare Grade 0-2 and 3-5. To identify risk factors for REG-induced severe liver dysfunction, a multivariate analysis was performed using the logistic regression analysis with backward elimination for variables with p < 0.10 in univariate analysis.


In 173 eligible pts, 24 (13.9%) experienced REG-induced severe liver dysfunction. The median PFS of Grade 0-2 and 3-5 were 2.2 and 1.6 months, respectively. The median OS of Grade 0-2 and 3-5 were 6.9 and 3.4 months, respectively. In the analysis of PFS and OS, there were significant difference between Grade 0-2 and 3-5 (PFS: HR 1.578, p = 0.045, OS: HR 1.799, p = 0.010). Univariate analyses showed that high AST, LDH, ALP, and GGT level at baseline were associated with REG-induced severe liver dysfunction. In multivariate analyses, high baseline AST level (≥ 50 U/L) was significantly associated with increased risk of REG-induced severe liver dysfunction (odds ratio=3.458, p = 0.032).


Compared with previous reports, this analysis showed the slightly higher incidence of REG-induced severe liver dysfunction. In multivariate analysis, it was inferred that high AST level (≥ 50 U/L) at baseline might be an independent risk factor. Grade 3-5 patients significantly showed shorter OS than Grade 0-2 patients. It is presumed that this patient population could not receive TAS-102 as post regorafenib therapy. Since this is an exploratory analysis, we consider it necessary to verify in large data set.

Editorial acknowledgement

Clinical trial identification

UMIN000020861, 2016/02/03.

Legal entity responsible for the study

Non-profit Organization: Hokkaido Gastrointestinal Cancer Study Group.


Non-profit Organization: Hokkaido Gastrointestinal Cancer Study Group.


S. Yuki, Y. Komatsu: Honoraria: Bayer. All other authors have declared no conflicts of interest.

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