Total neoadjuvant approach with FOLFOXIRI plus bevacizumab followed by chemoradiotherapy plus bevacizumab in locally advanced rectal cancer: the TRUST trial.

摘要: Abstract Background Neoadjuvant chemoradiotherapy (CRT) in locally advanced rectal cancer (LARC) does not achieve effective control of distant metastases. Induction chemotherapy is a promising strategy, and bevacizumab (BV) could improve the results CRT. 5-Fluorouracil, oxaliplatin irinotecan (FOLFOXIRI) plus BV treatment option metastatic colorectal cancer. We evaluate feasibility efficacy neoadjuvant comprising induction FOLFOXIRI followed by CRT with fluoropyrimidines BV. Methods In this phase II single-arm trial, patients node-positive or clinical T4 high-risk T3 LARC underwent 6 cycles BV, (50.4 Gy concomitant capecitabine) (5 mg/kg on days 1, 15 28). Surgery was planned 8 weeks after completion Primary end-point 2-year disease-free survival (DFS). Results enrolled 49 patients: All but one (withdrewing consent enrolment) were included per-protocol analyses. The study met its primary end-point: 36 free recurrence at 2 years (2-y DFS: 80.45%, 95% confidence interval [CI]: 78.79–82.10). Forty-four underwent surgery; pathologic complete response rate 36.4%. Forty-six completed induction: neutropenia (41.6%) diarrhoea (12.5%) main G3/4 toxicities. Forty-five received CRT, protocol amended capecitabine schedule during slightly modified 13 due to incidence G3 hand-foot syndrome proctitis (23.1%). After amendment, no severe events reported. Conclusions feasible active. terms DFS suggest that strategy may disease LARC.