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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
BACKGROUND: 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 di...
Autores principales: | , , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
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BioMed Central
2020
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7694337/ https://www.ncbi.nlm.nih.gov/pubmed/33246428 http://dx.doi.org/10.1186/s12885-020-07661-z |
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author | Salazar, Ramón Capdevila, Jaume Manzano, Jose Luis Pericay, Carles Martínez-Villacampa, Mercedes López, Carlos Losa, Ferrán Safont, María José Gómez-España, Auxiliadora Alonso-Orduña, Vicente Escudero, Pilar Gallego, Javier García-Paredes, Beatriz Palacios, Amalia Biondo, Sebastiano Grávalos, Cristina Aranda, Enrique |
author_facet | Salazar, Ramón Capdevila, Jaume Manzano, Jose Luis Pericay, Carles Martínez-Villacampa, Mercedes López, Carlos Losa, Ferrán Safont, María José Gómez-España, Auxiliadora Alonso-Orduña, Vicente Escudero, Pilar Gallego, Javier García-Paredes, Beatriz Palacios, Amalia Biondo, Sebastiano Grávalos, Cristina Aranda, Enrique |
author_sort | Salazar, Ramón |
collection | PubMed |
description | BACKGROUND: 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. METHODS: 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). RESULTS: 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%). CONCLUSIONS: 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. TRIAL REGISTRATION: EudraCT number: 2009–010192-24. Clinicaltrials.gov number: NCT01043484. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s12885-020-07661-z. |
format | Online Article Text |
id | pubmed-7694337 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2020 |
publisher | BioMed Central |
record_format | MEDLINE/PubMed |
spelling | pubmed-76943372020-11-30 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 Salazar, Ramón Capdevila, Jaume Manzano, Jose Luis Pericay, Carles Martínez-Villacampa, Mercedes López, Carlos Losa, Ferrán Safont, María José Gómez-España, Auxiliadora Alonso-Orduña, Vicente Escudero, Pilar Gallego, Javier García-Paredes, Beatriz Palacios, Amalia Biondo, Sebastiano Grávalos, Cristina Aranda, Enrique BMC Cancer Research Article BACKGROUND: 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. METHODS: 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). RESULTS: 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%). CONCLUSIONS: 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. TRIAL REGISTRATION: EudraCT number: 2009–010192-24. Clinicaltrials.gov number: NCT01043484. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s12885-020-07661-z. BioMed Central 2020-11-27 /pmc/articles/PMC7694337/ /pubmed/33246428 http://dx.doi.org/10.1186/s12885-020-07661-z Text en © The Author(s) 2020 Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data. |
spellingShingle | Research Article Salazar, Ramón Capdevila, Jaume Manzano, Jose Luis Pericay, Carles Martínez-Villacampa, Mercedes López, Carlos Losa, Ferrán Safont, María José Gómez-España, Auxiliadora Alonso-Orduña, Vicente Escudero, Pilar Gallego, Javier García-Paredes, Beatriz Palacios, Amalia Biondo, Sebastiano Grávalos, Cristina Aranda, Enrique 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 |
title | 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 |
title_full | 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 |
title_fullStr | 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 |
title_full_unstemmed | 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 |
title_short | 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 |
title_sort | 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 |
topic | Research Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7694337/ https://www.ncbi.nlm.nih.gov/pubmed/33246428 http://dx.doi.org/10.1186/s12885-020-07661-z |
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