RT Journal Article
T1 Phase II randomized trial of capecitabine with bevacizumab and external beam radiation therapy as preoperative treatment for patients with resectable locally advanced rectal adenocarcinoma: long term results.
A1 Salazar, Ramón
A1 Capdevila, Jaume
A1 Manzano, Jose Luis
A1 Pericay, Carles
A1 Martínez-Villacampa, Mercedes
A1 López, Carlos
A1 Losa, Ferrán
A1 Safont, María José
A1 Gómez-España, Auxiliadora
A1 Alonso-Orduña, Vicente
A1 Escudero, Pilar
A1 Gallego, Javier
A1 García-Paredes, Beatriz
A1 Palacios, Amalia
A1 Biondo, Sebastiano
A1 Grávalos, Cristina
A1 Aranda, Enrique
A1 Spanish Cooperative Group for the Treatment of Digestive Tumors (TTD), 
K1 Bevacizumab
K1 Chemoradiotherapy
K1 Locally-advanced rectal cancer
K1 Neoadjuvant
AB Preoperative 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 .
YR 2020
FD 2020-11-27
LK http://hdl.handle.net/10668/16681
UL http://hdl.handle.net/10668/16681
LA en
DS RISalud
RD Apr 12, 2025