Prognostic scores for evaluating the survival benefit of regorafenib or trifluridine/tipiracil in patients with metastatic colorectal cancer: an exploratory analysis of the REGOTAS study

Toshikazu Moriwaki, Shota Fukuoka, Toshiki Masuishi, Atsuo Takashima, Yosuke Kumekawa, Takeshi Kajiwara, Kentaro Yamazaki, Taito Esaki, Akitaka Makiyama, Tadamichi Denda, Yukimasa Hatachi, Takeshi Suto, Naotoshi Sugimoto, Masanobu Enomoto, Toshiaki Ishikawa, Tomomi Kashiwada, Eiji Oki, Yoshito Komatsu, Akihito Tsuji, Kenji TsuchihashiDaisuke Sakai, Hideki Ueno, Takao Tamura, Kimihiro Yamashita, Yasuhiro Shimada

Research output: Contribution to journalArticlepeer-review

Abstract

Background: Although regorafenib or trifluridine/tipiracil (FTD/TPI) has been recognized as a later-line standard treatment in patients with metastatic colorectal cancer (mCRC), not all patients have beneficial outcomes. This study aimed to develop a prognostic scoring system for evaluating the overall survival (OS) benefit. Methods: Patients included in the REGOTAS study, which comprised 489 patients (regorafenib group: 199; FTD/TPI group: 290 patients), were evaluated. OS was analyzed using multivariate Cox proportional model. The prognostic score was calculated using the worst four individual factors weighted by hazard ratio, and the total scores were categorized as low-, moderate-, and high-OS benefit. Results: The worst four factors in the regorafenib group were AST > 40 IU/dL (point, + 3), CRP ≥ 1.0 mg/dL (+ 2), number of metastatic organ site ≥ 3 (+ 2), and duration from initiation of 1st-line chemotherapy < 18 months (+ 2), while they were AST (+ 2), CRP (+ 2), CA19-9 > 37.0 U/mL (+ 2), and ECOG PS ≥ 1 (+ 2) in the FTD/TPI group. These corresponded to a total prognostic score of > 5, 2–4, and 0 points in the regorafenib group and 8, 2–6, and 0 points in the FTD/TPI group. The median OS in the low, moderate, and high OS benefit group was 3.3 (95% CI 3.0–3.7), 8.1 (95% CI 6.4–9.7), and 12.6 months (95% CI 10.6–14.6) in the regorafenib group and 2.8 (95% CI 2.0–3.5), 7.5 (95% CI 6.6–8.3), and 15.4 months (95% CI 9.7–21.2) in the FTD/TPI group. Conclusion: These prognostic scores are useful for identifying patients with mCRC who will obtain survival benefits from these drugs.

Original languageEnglish
Pages (from-to)614-621
Number of pages8
JournalInternational Journal of Clinical Oncology
Volume25
Issue number4
DOIs
Publication statusPublished - Apr 1 2020
Externally publishedYes

All Science Journal Classification (ASJC) codes

  • Surgery
  • Hematology
  • Oncology

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