A prospective observational study of treatment sequencing with regorafenib and FTD/TPI in metastatic colorectal cancer: The OSERO study.

IF 7.8 1区医学 Q1 ONCOLOGY

British Journal of Cancer Pub Date : 2026-09-29 DOI:10.1038/s41416-026-03620-w

Takeshi Kawakami, Toshiki Masuishi, Tetsutaro Hamano, Akihiko Chida, Seiichiro Mitani, Hisateru Yasui, Atsushi Ishiguro, Takayuki Ando, Kentaro Sawada, Kazuaki Harada, Naoki Takahashi, Shogen Boku, Tomomi Kashiwada, Taito Esaki, Ayumu Yoshikawa, Keiji Sugiyama, Kouji Yamamoto, Hironaga Satake, Satoshi Yuki, Kentaro Yamazaki, Eiji Oki

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引用次数: 0

Abstract

Background: Regorafenib (REG) monotherapy and trifluridine/tipiracil (FTD/TPI), with or without bevacizumab (BEV), are standard later-line treatments for metastatic colorectal cancer (mCRC). However, the optimal treatment sequence remains uncertain.

Methods: The OSERO study was a prospective observational study in patients with mCRC scheduled for later-line treatment with REG or FTD/TPI, with or without BEV (UMIN000040586). Patients were categorized into REG (A), FTD/TPI (B), and FTD/TPI plus BEV (C). The primary endpoint was overall survival (OS). To adjust for imbalances in baseline characteristics, stabilized inverse probability of treatment weights (IPTWs) derived from a propensity score model were applied.

Results: Among 468 patients, (A, n = 154; B, n = 82; C, n = 232), scheduled second-line treatment rates were 65.6%, 37.8%, and 62.9%. Median overall survival (mOS) was 12.2, 7.5, and 10.6 months, respectively. After IPTW adjustment, mOS was 12.2 (A) and 10.6 months (C) (hazard ratio, 1.03; 95% confidence interval, 0.81-1.30; P = 0.837). Grade ≥ 3 adverse events ( > 10%) included hand-foot syndrome, proteinuria, and hypertension in (A), and neutropenia and anemia (B, C).

Conclusion: Sequential treatment with REGO and FTD/TPI plus BEV therapy yielded comparable survival, suggesting that treatment selection may depend on safety profiles of each drug.

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瑞非尼和FTD/TPI治疗转移性结直肠癌的前瞻性观察研究：OSERO研究。

背景：瑞非尼（REG）单药治疗和trifluridine/tipiracil (FTD/TPI)，联合或不联合贝伐单抗（BEV），是转移性结直肠癌（mCRC）的标准后期治疗。然而，最佳治疗顺序仍不确定。方法：OSERO研究是一项前瞻性观察性研究，在有或没有BEV的mCRC患者中计划接受REG或FTD/TPI的后期治疗（UMIN000040586）。患者分为REG (A)、FTD/TPI (B)和FTD/TPI + BEV (C)。主要终点是总生存期（OS）。为了调整基线特征的不平衡，应用了来自倾向评分模型的稳定治疗权重逆概率（IPTWs）。结果：468例患者（A, n = 154； B, n = 82； C, n = 232），计划二线治疗率分别为65.6%、37.8%和62.9%。中位总生存期（mOS）分别为12.2、7.5和10.6个月。经IPTW调整后，mOS分别为12.2 (A)和10.6个月(C)（风险比1.03；95%可信区间0.81-1.30;P = 0.837）。≥3级不良事件（bbb10 %）包括手足综合征、蛋白尿和高血压(A)，中性粒细胞减少症和贫血（B， C）。结论：REGO和FTD/TPI加BEV治疗的顺序治疗获得了相当的生存率，这表明治疗选择可能取决于每种药物的安全性。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

British Journal of Cancer 医学-肿瘤学

CiteScore

15.10

自引率

1.10%

发文量

383

审稿时长

6 months

期刊介绍： The British Journal of Cancer is one of the most-cited general cancer journals, publishing significant advances in translational and clinical cancer research.It also publishes high-quality reviews and thought-provoking comment on all aspects of cancer prevention,diagnosis and treatment.