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 journalArticle

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
JournalInternational Journal of Clinical Oncology
DOIs
Publication statusAccepted/In press - Jan 1 2019

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Trifluridine
Colorectal Neoplasms
Survival
Proportional Hazards Models
regorafenib
Drug Therapy

All Science Journal Classification (ASJC) codes

  • Surgery
  • Hematology
  • Oncology

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

In: International Journal of Clinical Oncology, 01.01.2019.

Research output: Contribution to journalArticle

Moriwaki, T, Fukuoka, S, Masuishi, T, Takashima, A, Kumekawa, Y, Kajiwara, T, Yamazaki, K, Esaki, T, Makiyama, A, Denda, T, Hatachi, Y, Suto, T, Sugimoto, N, Enomoto, M, Ishikawa, T, Kashiwada, T, Oki, E, Komatsu, Y, Tsuji, A, Tsuchihashi, K, Sakai, D, Ueno, H, Tamura, T, Yamashita, K & Shimada, Y 2019, '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', International Journal of Clinical Oncology. https://doi.org/10.1007/s10147-019-01600-0
Moriwaki, Toshikazu ; Fukuoka, Shota ; Masuishi, Toshiki ; Takashima, Atsuo ; Kumekawa, Yosuke ; Kajiwara, Takeshi ; Yamazaki, Kentaro ; Esaki, Taito ; Makiyama, Akitaka ; Denda, Tadamichi ; Hatachi, Yukimasa ; Suto, Takeshi ; Sugimoto, Naotoshi ; Enomoto, Masanobu ; Ishikawa, Toshiaki ; Kashiwada, Tomomi ; Oki, Eiji ; Komatsu, Yoshito ; Tsuji, Akihito ; Tsuchihashi, Kenji ; Sakai, Daisuke ; Ueno, Hideki ; Tamura, Takao ; Yamashita, Kimihiro ; Shimada, Yasuhiro. / 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. In: International Journal of Clinical Oncology. 2019.
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title = "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",
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.",
author = "Toshikazu Moriwaki and Shota Fukuoka and Toshiki Masuishi and Atsuo Takashima and Yosuke Kumekawa and Takeshi Kajiwara and Kentaro Yamazaki and Taito Esaki and Akitaka Makiyama and Tadamichi Denda and Yukimasa Hatachi and Takeshi Suto and Naotoshi Sugimoto and Masanobu Enomoto and Toshiaki Ishikawa and Tomomi Kashiwada and Eiji Oki and Yoshito Komatsu and Akihito Tsuji and Kenji Tsuchihashi and Daisuke Sakai and Hideki Ueno and Takao Tamura and Kimihiro Yamashita and Yasuhiro Shimada",
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TY - JOUR

T1 - Prognostic scores for evaluating the survival benefit of regorafenib or trifluridine/tipiracil in patients with metastatic colorectal cancer

T2 - an exploratory analysis of the REGOTAS study

AU - Moriwaki, Toshikazu

AU - Fukuoka, Shota

AU - Masuishi, Toshiki

AU - Takashima, Atsuo

AU - Kumekawa, Yosuke

AU - Kajiwara, Takeshi

AU - Yamazaki, Kentaro

AU - Esaki, Taito

AU - Makiyama, Akitaka

AU - Denda, Tadamichi

AU - Hatachi, Yukimasa

AU - Suto, Takeshi

AU - Sugimoto, Naotoshi

AU - Enomoto, Masanobu

AU - Ishikawa, Toshiaki

AU - Kashiwada, Tomomi

AU - Oki, Eiji

AU - Komatsu, Yoshito

AU - Tsuji, Akihito

AU - Tsuchihashi, Kenji

AU - Sakai, Daisuke

AU - Ueno, Hideki

AU - Tamura, Takao

AU - Yamashita, Kimihiro

AU - Shimada, Yasuhiro

PY - 2019/1/1

Y1 - 2019/1/1

N2 - 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.

AB - 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.

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UR - http://www.scopus.com/inward/citedby.url?scp=85076264940&partnerID=8YFLogxK

U2 - 10.1007/s10147-019-01600-0

DO - 10.1007/s10147-019-01600-0

M3 - Article

AN - SCOPUS:85076264940

JO - International Journal of Clinical Oncology

JF - International Journal of Clinical Oncology

SN - 1341-9625

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