Bibliographic Details
| 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 |
| Authors: |
Ramón Salazar, Jaume Capdevila, Jose Luis Manzano, Carles Pericay, Mercedes Martínez-Villacampa, Carlos López, Ferrán Losa, María José Safont, Auxiliadora Gómez-España, Vicente Alonso-Orduña, Pilar Escudero, Javier Gallego, Beatriz García-Paredes, Amalia Palacios, Sebastiano Biondo, Cristina Grávalos, Enrique Aranda, on behalf of the Spanish Cooperative Group for the Treatment of Digestive Tumors (TTD) |
| Source: |
BMC Cancer, Vol 20, Iss 1, Pp 1-11 (2020) |
| Publisher Information: |
BMC, 2020. |
| Publication Year: |
2020 |
| Collection: |
LCC:Neoplasms. Tumors. Oncology. Including cancer and carcinogens |
| Subject Terms: |
Locally-advanced rectal cancer, Bevacizumab, Neoadjuvant, Chemoradiotherapy, Neoplasms. Tumors. Oncology. Including cancer and carcinogens, RC254-282 |
| More Details: |
Abstract 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 . |
| Document Type: |
article |
| File Description: |
electronic resource |
| Language: |
English |
| ISSN: |
1471-2407 |
| Relation: |
https://doaj.org/toc/1471-2407 |
| DOI: |
10.1186/s12885-020-07661-z |
| Access URL: |
https://doaj.org/article/a4aa7e2c60b44e39af5cbf4a269301f7 |
| Accession Number: |
edsdoj.4aa7e2c60b44e39af5cbf4a269301f7 |
| Database: |
Directory of Open Access Journals |
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