切除不能大腸癌に対するFTD/TPI+BEVの従来法と隔週法の実用的ランダム化第Ⅲ相試験における治療早期副作用の比較:PRABITAS試験初回報告

消化器疾患の中でも、消化器がんは困っている患者さんが多く、未解決の課題も多い領域であり、大きなやりがいを感じたためです。

JSMOは最新の研究や臨床の知見を共有し議論を深められる貴重な場だと感じています。

Early Safety Outcomes of Biweekly Versus Conventional FTD/TPI Plus Bevacizumab in Colorectal Cancer: PRABITAS Analysis

[Background]

PRABITAS is a pragmatic, randomized phase III trial comparing biweekly versus conventional trifluridine/tipiracil (FTD/TPI) + bevacizumab (BEV) in metastatic colorectal cancer. The pragmatic design minimizes eligibility restrictions and permits physician-directed initiation and dose modifications. This first report from PRABITAS focuses on early treatment-related adverse event (TRAE) profiles.

[Methods]

Baseline characteristics and TRAEs were assessed in patients treated with conventional FTD/TPI + BEV (Arm A: FTD/TPI on day 1-5 and 8-12 every 28 days) or biweekly FTD/TPI + BEV (Arm B: FTD/TPI on day 1-5 every 14 days). Eligibility was assessed based on typical explanatory trial criteria, and patients were categorized as eligible or ineligible. Safety analyses included Cycles 1-2 in Arm A and Cycles 1-4 in Arm B, with events graded by CTCAE v5.0.

[Results]

A total of 972 patients from 179 institutions were enrolled from December 2023 to May 2025. Baseline characteristics and initial FTD/TPI dose reductions were balanced. Overall, 15.3% were ineligible under the explanatory trial criteria, most commonly due to ECOG PS 2, organ dysfunction or comorbidities. Compared with Arm A, Arm B showed lower rates of grade ≥2 nausea (14.2% vs. 8.0%), diarrhea (7.0% vs. 1.7%), fatigue (19.7% vs. 10.9%), and grade ≥3 neutropenia (39.2% vs. 13.6%). Febrile neutro