British journal of cancer · 2026
A prospective observational study of treatment sequencing with regorafenib and FTD/TPI in metastatic colorectal cancer: The OSERO study.
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Kawakami Takeshi, Masuishi Toshiki, Hamano Tetsutaro, Chida Akihiko, Mitani Seiichiro, Yasui Hisateru, Ishiguro Atsushi, Ando Takayuki, Sawada Kentaro, Harada Kazuaki, Takahashi Naoki, Boku Shogen, Kashiwada Tomomi, Esaki Taito, Yoshikawa Ayumu, Sugiyama Keiji, Yamamoto Kouji, Satake Hironaga, Yuki Satoshi, Yamazaki Kentaro, Oki Eiji
Аннотация
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.
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.