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Poster display session

1701 - A Retrospective Cohort Study Evaluating the Safety and Efficacy of TAS-102 in Patients with Metastatic Colorectal Cancer [HGCSG1503]: Updated analysis


09 Sep 2017


Poster display session


Cytotoxic Therapy;  Colon and Rectal Cancer


Satoshi Yuki


Annals of Oncology (2017) 28 (suppl_5): v158-v208. 10.1093/annonc/mdx393


S. Yuki1, Y. Komatsu2, M. Yagisawa2, Y. Tsuji3, K. Harada4, K. Hatanaka5, H. Okuda6, A. Hosokawa7, K. Ogawa8, K. Furukawa9, S. Minami10, A. Ishiguro11, T. Honda12, T. Ohta13, M. Dazai14, K. Eto15, T. Sasaki16, J. Nakajima17, N. Sakamoto1, Y. Sakata18

Author affiliations

  • 1 Gastroenterology And Hepatology, Hokkaido University Hospital, 060-8638 - Sapporo/JP
  • 2 Cancer Center, Hokkaido University Hospital, 060-8638 - Sapporo/JP
  • 3 Medical Oncology, Tonan Hospital, 060-0004 - Sapporo/JP
  • 4 Medical Oncology, Kushiro Rosai Hospital, Kushiro/JP
  • 5 Gastroenterology, Hakodate Municipal Hospital, 041-8680 - Hakodate/JP
  • 6 Medical Oncology, Keiyukai Sapporo Hospital, 003-0027 - Sapporo/JP
  • 7 Gastroenterology And Hematology, Toyama University Hospital, 930-0194 - Toyama/JP
  • 8 Gastroenterology, Kouseiren Takaoka Hospital, Takaoka/JP
  • 9 Gastroenterology, Niigata City General Hospital, Niigata/JP
  • 10 Gastroenterology, Oji General Hospital, Tomakomai/JP
  • 11 Medical Oncology, Teine Keijinkai Hospital, Sapporo/JP
  • 12 Gastroenterology And Hepatology, Nagaski University Hospital, 852-8501 - Nagasaki/JP
  • 13 Gastroenterology, Sapporo Higashi Tokushukai Hospital, Sapporo/JP
  • 14 Gastroenterology, Sapporo Medical Center NTT EC, 060-0061 - Sapporo/JP
  • 15 Gastroenterology, Tomakomai City Hospital, Tomakomai/JP
  • 16 Internal Medicine, Hokkaido Gastroenterology Hospital, Sapporo/JP
  • 17 Gastroenterology, Obihiro Kosei Hospital, Obihiro/JP
  • 18 Ceo, Misawa City Hospital, 033-0022 - Misawa/JP


Abstract 1701


The J003 trial and RECOURSE trial revealed the safety and efficacy of TAS-102 for patients with metastatic colorectal cancer (mCRC). In March 2014, TAS-102 was approved in Japan, however, there are few studies exploring the efficacy and safety of TAS-102, particularly in the daily practice use. Therefore, we performed this retrospective analysis in order to investigate the real-world clinical practice of TAS-102 for patients with mCRC.


We retrospectively analyzed the clinical data of 411 patients who received TAS-102 in the multi-institutional retrospective study (HGCSG1503). This study was analyzed by CTCAE v4.0 for adverse events (AEs), RECIST v1.1 for response rate (RR)/disease control rate (DCR), and Kaplan-Meier method for progression free survival (PFS) and overall survival (OS).


Patients characteristics were as follows; male/female 218/193, median age 66 (range 33-88), ECOG PS (0/1/2/3) 170/190/43/8, KRAS Exon2 wild/mutant 210/187 (14 patients; KRAS Exon2 was not tested). The initial starting dose was 70 mg/m2 (n = 326, 79.3%) and reduced dose (n = 85, 20.7%). Dose reductions were required in 101 patients (24.6%). The common ≥grade 3 AEs were neutrophil count decreased (48.1%), white blood cell decreased (34.8%), and anemia (28.7%). RR and DCR were 0.5% and 37.2%, respectively. Median PFS and OS were 2.2 and 7.3 months. In analysis on the relationship between ECOG PS 0-1 and PS 2-3, DCR was 38.7% vs. 26.7% (p = 0.140), median PFS was 2.3 vs. 1.5 months (HR 2.000, p 


In this analysis, TAS-102 in the real-world clinical practice showed slightly higher anemia to the previous pivotal clinical trials. Although the efficacy in patients with PS 0–1 was similar to the previous reports, TAS-102 did not show the efficacy for patients with PS 2-3.

Clinical trial identification

UMIN000020551, 2016/02/02

Legal entity responsible for the study

Non-profit organization: Hokkaido Gastrointestinal Cancer Study Group


Non-profit organization: Hokkaido Gastrointestinal Cancer Study Group


S. Yuki: Honoraria: Taiho Pharmaceutical, Takeda Pharmaceutical, Merck Serono, Eli Lilly Japan, Chugai Pharmaceutical, Bayer Yakuhin, Bristol-Myers Squibb. Y. Komatsu: Speakers’ Bureau, research funding: Taiho Pharmaceutical. T. Sasaki: Honoraria: Chugai Pharmaceutical, Yakult Honsha. Y. Sakata: Consultant fee from Taiho Pharmaceutical Co., Ltd. All other authors have declared no conflicts of interest.

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