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
N1 - Funding Information:
This work was supported by funding from the JSCCR. We would like to thank Editage ( https://www.editage.jp ) for English language editing.
Funding Information:
Atsuo Takashima received a research grant from Takeda, MSD, LSK, and Sumitomo Dainippon. Kentaro Yamazaki received honoraria from Taiho and Bayer, and a research grant from Taiho. Taito Esaki received honoraria from Lilly, and a research grant from Astellas, MSD, Dai-ichi-Sankyo, Ono, Merck Serono, Dainippon Sumitomo, Novartis, Taiho, and Lilly, and scholarship donations from Ono. Naotoshi Sugimoto received a research grant from MSD, Ono, Astellas, Dai-ichi Sankyo. Eiji Oki received honoraria from Taiho and Bayer. Yoshito Komatsu received honoraria from Lilly, Taiho, Chugai, Takeda, Bayer, Bristol Myers, Sanofi, Merck Serono, Yakult, and MSD, and a research grant from NanoCarrier, Baxter, Linical, QuintilesIMS, Sysmex, Mediscience, Ono, Dainippon Sumitomo, MSD, Taiho, Dai-ichi-Sankyo, and Yakult, and scholarship donations from Taiho, Chugai, Kyowa Kirin, Takeda, and Ono. Akihito Tsuji received honoraria from Taiho, Chugai, Takeda, Merck Serono, Lilly, Sanofi, and Bristol, and a research grant from Bristol Meyer, Ono, Taiho, and Sanofi. Daisuke Sakai received honoraria from Chugai, and a research grant from Lilly, Ono, Dai-ichi-Sankyo, and Astellas, and endowed chairs from Yakult, Chugai, and Ono. Hideki Ueno received a research grant from Taiho, Yakult, Bayer, Chugai, and Sysmex. Yasuhiro Shimada received a research grant from Taiho, MSD, and Lilly. All other authors declare no potential conflict of interest.
Publisher Copyright:
© 2019, Japan Society of Clinical Oncology.
PY - 2020/4/1
Y1 - 2020/4/1
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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U2 - 10.1007/s10147-019-01600-0
DO - 10.1007/s10147-019-01600-0
M3 - Article
C2 - 31838590
AN - SCOPUS:85076264940
SN - 1341-9625
VL - 25
SP - 614
EP - 621
JO - International Journal of Clinical Oncology
JF - International Journal of Clinical Oncology
IS - 4
ER -
