Salazar, RamónCapdevila, JaumeManzano, Jose LuisPericay, CarlesMartínez-Villacampa, MercedesLópez, CarlosLosa, FerránSafont, María JoséGómez-España, AuxiliadoraAlonso-Orduña, VicenteEscudero, PilarGallego, JavierGarcía-Paredes, BeatrizPalacios, AmaliaBiondo, SebastianoGrávalos, CristinaAranda, EnriqueSpanish Cooperative Group for the Treatment of Digestive Tumors (TTD)2023-02-092023-02-092020-11-27http://hdl.handle.net/10668/16681Preoperative chemoradiotherapy with capecitabine is considered as a standard of care for locally advanced rectal cancer. The "Tratamiento de Tumores Digestivos" group (TTD) previously reported in a randomized Ph II study that the addition of Bevacizumab to capecitabine-RT conferred no differences in the pre-defined efficacy endpoint (pathological complete response). We present the follow-up results of progression-free survival, distant relapse-free survival, and overall survival data at 3 and 5 years. Patients (pts) were randomized to receive 5 weeks of radiotherapy (45 Gy/25 fractions) with concurrent Capecitabine 825 mg/m2 twice daily, 5 days per week with (arm A) or without (arm b) bevacizumab (5 mg/kg once every 2 weeks). In our study, the addition of bevacizumab to capecitabine and radiotherapy in the neoadjuvant setting shows no differences in pathological complete response (15.9% vs 10.9%), distant relapse-free survival (81.0 vs 80.4 and 76.2% vs 78.2% at 3 and 5 years respectively), disease-free survival (75% vs 71.7 and 68.1% vs 69.57% at 3 and 5 years respectively) nor overall survival at 5-years of follow-up (81.8% vs 86.9%). the addition of bevacizumab to capecitabine plus radiotherapy does not confer statistically significant advantages neither in distant relapse-free survival nor in disease-free survival nor in Overall Survival in the short or long term. EudraCT number: 2009-010192-24 . Clinicaltrials.gov number: NCT01043484 .enAttribution 4.0 Internationalhttp://creativecommons.org/licenses/by/4.0/BevacizumabChemoradiotherapyLocally-advanced rectal cancerNeoadjuvantAdenocarcinomaAntineoplastic Combined Chemotherapy ProtocolsBevacizumabCapecitabineChemoradiotherapyFemaleHumansMaleProgression-Free SurvivalRectal Neoplasmsresearch article33246428open access10.1186/s12885-020-07661-z1471-2407PMC7694337https://doi.org/10.1186/s12885-020-07661-zhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC7694337/pdf