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The INTERACT Trial: Long-term results of a randomised trial on preoperative capecitabine-based radiochemotherapy intensified by concomitant boost or oxaliplatin, for cT2 (distal)-cT3 rectal cancer.
Valentini, Vincenzo; Gambacorta, Maria Antonietta; Cellini, Francesco; Aristei, Cynthia; Coco, Claudio; Barbaro, Brunella; Alfieri, Sergio; D'Ugo, Domenico; Persiani, Roberto; Deodato, Francesco; Crucitti, Antonio; Lupattelli, Marco; Mantello, Giovanna; Navarria, Federico; Belluco, Claudio; Buonadonna, Angela; Boso, Caterina; Lonardi, Sara; Caravatta, Luciana; Barba, Maria Cristina; Vecchio, Fabio Maria; Maranzano, Ernesto; Genovesi, Domenico; Doglietto, Giovanni Battista; Morganti, Alessio Giuseppe; La Torre, Giuseppe; Pucciarelli, Salvatore; De Paoli, Antonino.
Afiliación
  • Valentini V; Department Radiation Oncology, Fondazione Policlinico Universitario A. Gemelli IRCCS, Università Cattolica del Sacro Cuore, Roma, Italy.
  • Gambacorta MA; Department Radiation Oncology, Fondazione Policlinico Universitario A. Gemelli IRCCS, Università Cattolica del Sacro Cuore, Roma, Italy.
  • Cellini F; Department Radiation Oncology, Fondazione Policlinico Universitario A. Gemelli IRCCS, Roma, Italy. Electronic address: francesco.cellini@policlinicogemelli.it.
  • Aristei C; Radiation Oncology Section, Department of Surgery and Biomedical Science, University of Perugia and Perugia General Hospital, Perugia, Italy.
  • Coco C; Chirurgia Generale Presidio Columbus, Fondazione Policlinico Universitario A. Gemelli IRCCS, Università Cattolica del Sacro Cuore, Roma, Italy.
  • Barbaro B; Department of Bioimaging and Radiological Sciences, Fondazione Policlinico Universitario A. Gemelli IRCCS, Università Cattolica del Sacro Cuore, Roma, Italy.
  • Alfieri S; Istituto di Clinica Chirurgica, Fondazione Policlinico Universitario A. Gemelli IRCCS, Università Cattolica del Sacro Cuore, Roma, Italy.
  • D'Ugo D; Abdominal Surgery Area, General Surgery Unit, Fondazione Policlinico Universitario A. Gemelli IRCCS, Università Cattolica del Sacro Cuore, Roma, Italy.
  • Persiani R; Department of Surgery, Fondazione Policlinico Universitario A. Gemelli IRCCS, Università Cattolica del Sacro Cuore, Roma, Italy.
  • Deodato F; Radiotherapy Department, Fondazione Ricerca e Cura Giovanni Paolo II, Università Cattolica del Sacro Cuore, Campobasso, Italy.
  • Crucitti A; Department of Surgery, Università Cattolica del Sacro Cuore, Rome, Italy.
  • Lupattelli M; Radiation Oncology Centre - S. Maria Misericordia Hospital, Perugia, Italy.
  • Mantello G; Radiotherapy Unit, Azienda Ospedaliero Universitaria, Ospedali Riuniti Ancona, Italy.
  • Navarria F; Radiation Oncology Department, Centro di Riferimento Oncologico, IRCCS, Aviano, Italy.
  • Belluco C; Surgical Oncology Department, Centro di Riferimento Oncologico, IRCCS, Aviano, Italy.
  • Buonadonna A; Medical Oncology Department, Centro di Riferimento Oncologico, IRCCS, Aviano, Italy.
  • Boso C; Radiotherapy and Nuclear Medicine Unit, IOV-IRCCS, Padova , Italy.
  • Lonardi S; Medical Oncology Unit 1, IOV-IRCCS, Padova, Italy.
  • Caravatta L; Radiotherapy Unit, SS Annunziata Hospital, G. D'Annunzio University, Chieti, Italy.
  • Barba MC; Radiation Oncology Centre, V. Fazzi Hospital, Lecce, Italy.
  • Vecchio FM; Department of Pathology, Fondazione Policlinico Universitario A. Gemelli IRCCS, Università Cattolica del Sacro Cuore, Roma, Italy.
  • Maranzano E; Radiotherapy Oncology Centre, S. Maria Hospital, Terni, Italy.
  • Genovesi D; Radiotherapy Unit, SS Annunziata Hospital, G. D'Annunzio University, Chieti, Italy.
  • Doglietto GB; Istituto di Clinica Chirurgica, Fondazione Policlinico Universitario A. Gemelli IRCCS, Università Cattolica del Sacro Cuore, Roma, Italy.
  • Morganti AG; Radiation Oncology Center, Department of Experimental, Diagnostic and Speciality Medicine, DIMES, University of Bologna, S. Orsola-Malpighi Hospital, Italy.
  • La Torre G; Department of Public Health and Infectious Diseases, Sapienza University of Rome, Italy.
  • Pucciarelli S; Department of Surgical, Oncological and Gastroenterological Sciences, University of Padova, Italy.
  • De Paoli A; Radiation Oncology Department, Centro di Riferimento Oncologico, IRCCS, Aviano, Italy.
Radiother Oncol ; 134: 110-118, 2019 05.
Article en En | MEDLINE | ID: mdl-31005204
BACKGROUND AND PURPOSE: Capecitabine-based radiochemotherapy (cbRCT) is standard for preoperative long-course radiochemotherapy of locally advanced rectal cancer. This prospective, parallel-group, randomised controlled trial investigated two intensification regimens. cT4 lesions were excluded. PRIMARY OBJECTIVE: pathological outcome (TRG 1-2) among arms. MATERIALS AND METHODS: Low-located cT2N0-2M0, cT3N0-2M0 (up to 12 cm from anal verge) presentations were treated with cbRCT randomly intensified by either radiotherapy boost (Xelac arm) or multidrug concomitant chemotherapy (Xelox arm). Xelac: concomitant boost to bulky site (45 Gy/1.8 Gy/die, 5 sessions/week to the pelvis, +10 Gy at 1 Gy twice/week to the bulky) plus concurrent capecitabine (1650 mg/mq/die). Xelox: 45 Gy to the pelvis + 5.4 Gy/1.8 Gy/die, 5 sessions/week to the bulky site + concurrent capecitabine (1300 mg/mq/die) and oxaliplatin (130 mg/mq on days 1,19,38). Surgery was planned 7-9 weeks after radiochemotherapy. RESULTS: From June 2005 to September 2013, 534 patients were analysed: 280 in Xelac, 254 in Xelox arm. Xelox arm presented higher G ≥ 3 haematologic (p = 0.01) and neurologic toxicity (p < 0.001). Overall, 98.5% patients received curative surgery. The tumour regression grade distribution did not differ between arms (p = 0.102). TRG 1+2 rate significantly differed: Xelac arm 61.7% vs. Xelox 52.3% (p = 0.039). Pathological complete response (ypT0N0) rates were 24.4 and 23.8%, respectively (p non-significant). Median follow-up:5.62 years. Five-year disease-free survival rate were 74.7% (Xelac) and 73.8% (Xelox), respectively (p = 0.444). Five-year overall survival rate were 80.4% (Xelac) and 85.5% (Xelox), respectively (p = 0.155). CONCLUSION: Xelac arm significantly obtained higher TRG1-2 rates. No differences were found about clinical outcome. Because of efficacy on TRG, inferior toxicity and good compliance, Xelac schedules or similar radiotherapy dose intensification schemes could be considered as reference treatments for cT3 lesions.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Oxaloacetatos / Neoplasias del Recto / Protocolos de Quimioterapia Combinada Antineoplásica / Quimioradioterapia / Capecitabina Tipo de estudio: Clinical_trials / Observational_studies / Risk_factors_studies Límite: Adult / Aged / Aged80 / Female / Humans / Male / Middle aged Idioma: En Revista: Radiother Oncol Año: 2019 Tipo del documento: Article País de afiliación: Italia Pais de publicación: Irlanda

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Oxaloacetatos / Neoplasias del Recto / Protocolos de Quimioterapia Combinada Antineoplásica / Quimioradioterapia / Capecitabina Tipo de estudio: Clinical_trials / Observational_studies / Risk_factors_studies Límite: Adult / Aged / Aged80 / Female / Humans / Male / Middle aged Idioma: En Revista: Radiother Oncol Año: 2019 Tipo del documento: Article País de afiliación: Italia Pais de publicación: Irlanda