Pharmacoepidemiology and drug safety · 2025
Effectiveness and Safety of Reduced and Standard Initial Doses of Regorafenib in Patients With Metastatic Colorectal Cancer: A Multicenter Retrospective Study in Taiwan.
СтатьяМногоцентровое исследованиеНаблюдательное исследованиеСравнительное исследованиеНазвание и аннотация: Перевод в очереди
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Kuo Yu-Hsuan, Kuo Chun-Nan, Chang Chia-Lun, Ko Yu
Аннотация
PURPOSE: This study aims to compare the effectiveness and safety of standard and reduced initial doses of regorafenib in patients with metastatic colorectal cancer (mCRC).
MATERIALS AND METHODS: This retrospective observational study was conducted using the Taipei Medical University Clinical Research Database. Patients aged 20 years or older who received regorafenib for mCRC between January 2014 and December 2021 were included. Patients were divided into standard initial dose (160 mg) and reduced initial dose (< 160 mg) groups. Time-to-treatment discontinuation (TTD), overall survival (OS), and the incidence of five common adverse events were compared between groups.
RESULTS: Among 266 patients, 58 received the standard initial dose and 208 received the reduced initial dose; the median TTD was 68.0 days and 64.5 days, respectively (p = 0.25). The median OS was 9.7 months for the standard-dose group and 6.7 months for the reduced-dose group (p = 0.01). In the multivariate Cox analysis, the reduced initial dose was associated with shorter survival (hazard ratio 1.66 [95% confidence interval 1.22-2.30]). Hand-foot skin reaction and total bilirubin elevation were less common in the reduced-dose group (p = 0.01 and 0.03, respectively). Excluding concurrent anti-cancer drug users led to a similar median OS between the two dosing groups (p = 0.12).
CONCLUSION: No difference in TTD was observed between the dosing groups. The reduced-dose group had a shorter OS but fewer adverse events. For patients who can tolerate standard doses of regorafenib, a combination of regorafenib and other anti-cancer drugs may be beneficial but would require further investigation.
MATERIALS AND METHODS: This retrospective observational study was conducted using the Taipei Medical University Clinical Research Database. Patients aged 20 years or older who received regorafenib for mCRC between January 2014 and December 2021 were included. Patients were divided into standard initial dose (160 mg) and reduced initial dose (< 160 mg) groups. Time-to-treatment discontinuation (TTD), overall survival (OS), and the incidence of five common adverse events were compared between groups.
RESULTS: Among 266 patients, 58 received the standard initial dose and 208 received the reduced initial dose; the median TTD was 68.0 days and 64.5 days, respectively (p = 0.25). The median OS was 9.7 months for the standard-dose group and 6.7 months for the reduced-dose group (p = 0.01). In the multivariate Cox analysis, the reduced initial dose was associated with shorter survival (hazard ratio 1.66 [95% confidence interval 1.22-2.30]). Hand-foot skin reaction and total bilirubin elevation were less common in the reduced-dose group (p = 0.01 and 0.03, respectively). Excluding concurrent anti-cancer drug users led to a similar median OS between the two dosing groups (p = 0.12).
CONCLUSION: No difference in TTD was observed between the dosing groups. The reduced-dose group had a shorter OS but fewer adverse events. For patients who can tolerate standard doses of regorafenib, a combination of regorafenib and other anti-cancer drugs may be beneficial but would require further investigation.