ワカバヤシ　ムネヒロ   Wakabayashi Munehiro   若林　宗弘    所属   東邦大学  医学部 医学科（大森病院）    職種   助教
言語種別	英語
発表タイトル	A phase Ⅱ study of intrapatient dose escalation of biweekly trifluridine/tipiracil plus bevacizumab for colorectal cancer (E-BiTS study)
会議名	European Society of Medical Congress 2024
学会区分	国際学会
発表形式	ポスター掲示
講演区分	一般
発表者・共同発表者	◎Munehiro Wakabayashi, Hiroya Taniguchi, Satoshi Yuki, Hiroyuki Takeda, Seiichiro Mitani, Yuta Okumura, Naoya Akazawa, Akitaka Makiyama, Toshihiro Kudo, Chiho Kudo, Keita Mori, Kei Muro
発表年月日	2024/09/16
国名	スペイン
開催地 （都市, 国名）	Balcelona
開催期間	2024/09/13～2024/09/17
学会抄録	ANNALS OF ONCOLOGY 35(Supplement 2),S441
概要	Background: Trifluridine/tipiracil (FTD/TPI) plus bevacizumab (BEV) is a standard treatment for refractory metastatic colorectal cancer (mCRC). The biweekly regimen has shown promise, especially in reducing neutropenia. However, the optimal biweekly dosage of FTD/TPI remains undetermined. Methods: The E-BiTS study was an open-label, single-arm, multicenter, phase II study for mCRC, involving ECOG PS 0–1 patients who had prior treatment with standard therapies. Specific requirements included serum creatinine ≤1.5 mg/dL and creatinine clearance ≥60 ml/min. Patients received biweekly FTD/TPI (35 mg/m2 twice daily on days 1–5, q2w) plus BEV (5 mg/kg on day 1, q2w). Based on specific criteria, the FTD/TPI dose could be escalated by +10 mg/day per cycle, up to +30 mg/day, from level 0 to level +3 during cycles 2–4. The primary endpoint was the disease control rate (DCR) with a threshold of 60%. Results: Thirty-four patients met the eligibility criteria. Patient characteristics (n = 34) included a median age of 65 years (range: 39–75), 76% with ECOG PS 0, 82% with left-sided cancer, 59% with RAS mutation, and 74% with 2 or more metastatic organs. Dose escalation of FTD/TPI at least 1 level was feasible in 91% of the patients. The maximum FTD/TPI levels of +1, +2, and +3 were achieved in 41%, 29%, and 21% of patients, respectively. The median relative dose intensity of FTD/TPI during the first 4 cycles was 98.9% among those who received ≥4 cycles (n = 29). The DCR was 72.7% (80% confidence interval: 60.4–82.8). Median progression-free survival was 5.8 months (95% CI: 2.7–6.5). Any grade and grade ≥3 neutropenia rates were 74% and 24%, respectively. Other adverse events were in line with previous studies. Conclusions: The E-BiTS study achieved its primary endpoint with a DCR of 72.7%. Intrapatient dose escalation of biweekly FTD/TPI plus BEV was well-tolerated and effective in patients with mCRC.