Neoadjuvant short-course radiotherapy followed by camrelizumab and chemotherapy in locally advanced rectal cancer (UNION): early outcomes of a multicenter randomized phase III trial

• DOI: 10.1016/j.annonc.2024.06.015
• Publication Date: 2024-07-03T00:28:02Z
• Authors: Z.Y. Lin; P. Zhang; P. Chi; Y. Xiao; X.M. Xu; A.M. Zhang; X.F. Qiu; J.X. Wu; Y. Yuan; Z.N. Wang; X.J. Qu; X. Li; X. Nie; M. Yang; K.L. Cai; W.K. Zhang; Y. Huang; Z. Sun; Z.G. Hou; C. Ma; F.Z. Cheng; K.X. Tao; T. Zhang
• Keywords: Clinical endpoint; Chemoradiotherapy; Neoadjuvant Therapy

•This is the first phase III trial comparing SCRT followed by immunochemotherapy to LCRT chemotherapy in LARC.•Neoadjuvant CAPOX and camrelizumab significantly improved pCR versus neoadjuvant CAPOX.•Neoadjuvant demonstrated promising efficacy LARC patients with pMMR/MSS.•The treatment arm provides opportunity for organ preservation a watch-and-wait strategy.•No unexpected toxicities were observed, safety profile of was manageable. BackgroundNeoadjuvant short-course radiotherapy (SCRT) (a programmed cell death protein 1 monoclonal antibody) has shown potential clinical activity locally advanced rectal cancer (LARC) II trial. This study aimed further confirm compared long-course chemoradiotherapy (LCRT) alone as LARC.Patients methodsIn this randomized, trial, T3-4/N+ adenocarcinoma randomly assigned (1 : 1) receive or (LCRT), two cycles alone, respectively. After surgery, each underwent either six CAPOX, up 17 doses camrelizumab, CAPOX. The primary endpoint pathological complete response (pCR) rate (ypT0N0) assessed blinded independent review committee. Key secondary endpoints tested hierarchically 3-year event-free survival (EFS) overall (OS).ResultsBetween July 2021 March 2023, intention-to-treat population comprised 113 experimental 118 control arm, surgery carried out 92% 83.9%, At data cut-off (11 2023), rates 39.8% [95% confidence interval (CI) 30.7% 49.5%] 15.3% (95% CI 9.3% 23.0%) (difference, 24.6%; odds ratio, 3.7; 95% 2.0-6.9; P < 0.001). In surgical complication 40.0% 40.8%, grade ≥3 treatment-related adverse events 29.2% 27.2%. Three-year EFS OS continue mature.ConclusionsIn patients, plus higher than well-tolerated profile. can be recommended modality these patients. Neoadjuvant LARC. (OS). Between mature.