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
| Autor: | 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, Spanish Cooperative Group for the Treatment of Digestive Tumors (TTD) |
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| Přispěvatelé: | Institut Català de la Salut, [Salazar R, Martínez-Villacampa M] Medical Oncology. Oncobell Program IDIBELL Institut Català d’Oncologia Hospital Duran i Reynals, CIBERONC, Barcelona, Spain. [Capdevila J] Servei d’Oncologia Mèdica, Vall d’Hebron Hospital Universitari, Barcelona, Spain. [Manzano JL] Medical Oncology, ICO. Hospital Germans Trias i Pujol, Barcelona, Spain. [Pericay C] Medical Oncology, C. S. Parc Taulí, Barcelona, Spain. [López C] Hospital Marqués de Valdecilla, Santander, Spain, Vall d'Hebron Barcelona Hospital Campus |
| Jazyk: | angličtina |
| Rok vydání: | 2020 |
| Předmět: |
0301 basic medicine
Male Cancer Research Colorectal cancer medicine.medical_treatment law.invention Recte - Càncer - Quimioteràpia Neoplasms::Neoplasms by Site::Digestive System Neoplasms::Gastrointestinal Neoplasms::Intestinal Neoplasms::Colorectal Neoplasms::Rectal Neoplasms [DISEASES] 0302 clinical medicine Randomized controlled trial law Surgical oncology Quimioteràpia Antineoplastic Combined Chemotherapy Protocols Rectal Adenocarcinoma Chemoradiotherapy lcsh:Neoplasms. Tumors. Oncology. Including cancer and carcinogens Recte - Càncer - Radioteràpia Progression-Free Survival Bevacizumab Oncology terapéutica::tratamiento combinado::quimiorradioterapia::quimiorradioterapia complementaria [TÉCNICAS Y EQUIPOS ANALÍTICOS DIAGNÓSTICOS Y TERAPÉUTICOS] 030220 oncology & carcinogenesis Female Neoadjuvant medicine.drug Research Article medicine.medical_specialty Urology Radioteràpia Adenocarcinoma lcsh:RC254-282 Locally-advanced rectal cancer neoplasias::neoplasias por localización::neoplasias del sistema digestivo::neoplasias gastrointestinales::neoplasias intestinales::neoplasias colorrectales::neoplasias del recto [ENFERMEDADES] Capecitabine 03 medical and health sciences Càncer colorectal Genetics medicine Chemotherapy Humans Radiotherapy business.industry Rectal Neoplasms Therapeutics::Combined Modality Therapy::Chemoradiotherapy::Chemoradiotherapy Adjuvant [ANALYTICAL DIAGNOSTIC AND THERAPEUTIC TECHNIQUES AND EQUIPMENT] medicine.disease Radiation therapy 030104 developmental biology business |
| Zdroj: | Dipòsit Digital de la UB Universidad de Barcelona Scientia BMC Cancer BMC Cancer, Vol 20, Iss 1, Pp 1-11 (2020) r-FISABIO: Repositorio Institucional de Producción Científica Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana (FISABIO) |
| ISSN: | 1471-2407 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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