165P - Neutropenia as a predictive factor in patients with metastatic colorectal cancer treated with TAS-102

Date 19 December 2015
Event ESMO Asia 2015 Congress
Session Poster presentation 1
Topics Anticancer Agents
Complications/Toxicities of Treatment
Colon and Rectal Cancer
Biological Therapy
Presenter Satoshi Hamauchi
Citation Annals of Oncology (2015) 26 (suppl_9): 42-70. 10.1093/annonc/mdv523
Authors S. Hamauchi1, K. Yamazaki1, T. Masuishi2, Y. Kito1, A. Komori2, T. Tsushima1, A. Todaka1, T. Yokota1, N. Machida1, A. Fukutomi1, Y. Onozawa3, K. Muro2, H. Yasui1, K. Mori4, H. Taniguchi2
  • 1Division Of Gastrointestinal Oncology, Shizuoka Cancer Center, 411-8777 - Shizuoka/JP
  • 2Division Of Clinical Oncology, Aichi Cancer Center Hospital, Nagoya/JP
  • 3Division Of Clinical Oncology, Shizuoka Cancer Center, Shizuoka/JP
  • 4Clinical Trial Coordination Office, Shizuoka Cancer Center, Shizuoka/JP



TAS-102 significantly improved overall survival in patients (pts) with refractory metastatic colorectal cancer (mCRC). The most common treatment-related adverse event of TAS-102 is bone marrow suppression, such as neutropenia. Potential predictive value of neutropenia caused by cytotoxic drugs has been reported in various types of cancer.


We retrospectively analyzed 86 consecutive refractory mCRC pts who received TAS-102 at two Japanese institutions between May 2014 and March 2015. To evaluate the association between survival and neutropenia, pts were divided into four categories according to the grade of neutropenia during the first course (4 weeks) of TAS-102: Category A (grade 0-1, n = 48), B (grade 2–4, n = 38), C (grade 0-2, n = 65), and D (grade 3-4, n = 21).


Pts characteristics were as follows: median age 64 years old (range 32–90); male 59%; PS 0-1 90%; primary site colon 56%; KRAS exon2 wild 58%; number of metastatic site ≥3 55%. With a median follow up time of 7.6 months (m) (range 3.8- 12.6), median progression free survival (mPFS) was 2.1 m, disease control rate (DCR) was 36.3%, and median overall survival (mOS) was 5.7 m. The association between neutropenia and efficacy is shown in the table below. Multivariate analysis in both Category A vs B and C vs D showed that neutropenia was the only significant predictive factor of DCR and mPFS.

The association between neutropenia and efficacy of TAS-102

Category A vs B Category C vs D
DCR % 25.0 vs 50.0 29.5 vs 57.9
OR, p value 2.96, 0.03 3.23, 0.03
mPFS m 1.8 vs 2.9 1.9 vs 4.8
HR, p value 0.50, 0.003 0.40, 0.002
mOS m 4.4 vs 6.4 5.3 vs 6.7
HR, p value 0.66, 0.11 0.49, 0.04


Neutropenia during the first course caused by TAS-102 was associated with better efficacy. Neutropenia may be a surrogate marker for adequate antitumor doses of TAS-102.

Clinical trial identification


S. Hamauchi, K. Yamazaki, H. Taniguchi: lecture fees from Taiho Pharmaceutical. All other authors have declared no conflicts of interest.