Vincenzo Valentini1, Maria Antonietta Gambacorta1, Francesco Cellini2, Cynthia Aristei3, Claudio Coco4, Brunella Barbaro5, Sergio Alfieri6, Domenico D'Ugo7, Roberto Persiani8, Francesco Deodato9, Antonio Crucitti10, Marco Lupattelli11, Giovanna Mantello12, Federico Navarria13, Claudio Belluco14, Angela Buonadonna15, Caterina Boso16, Sara Lonardi17, Luciana Caravatta18, Maria Cristina Barba19, Fabio Maria Vecchio20, Ernesto Maranzano21, Domenico Genovesi18, Giovanni Battista Doglietto6, Alessio Giuseppe Morganti22, Giuseppe La Torre23, Salvatore Pucciarelli24, Antonino De Paoli13. 1. Department Radiation Oncology, Fondazione Policlinico Universitario A. Gemelli IRCCS, Università Cattolica del Sacro Cuore, Roma, Italy. 2. Department Radiation Oncology, Fondazione Policlinico Universitario A. Gemelli IRCCS, Roma, Italy. Electronic address: francesco.cellini@policlinicogemelli.it. 3. Radiation Oncology Section, Department of Surgery and Biomedical Science, University of Perugia and Perugia General Hospital, Perugia, Italy. 4. Chirurgia Generale Presidio Columbus, Fondazione Policlinico Universitario A. Gemelli IRCCS, Università Cattolica del Sacro Cuore, Roma, Italy. 5. Department of Bioimaging and Radiological Sciences, Fondazione Policlinico Universitario A. Gemelli IRCCS, Università Cattolica del Sacro Cuore, Roma, Italy. 6. Istituto di Clinica Chirurgica, Fondazione Policlinico Universitario A. Gemelli IRCCS, Università Cattolica del Sacro Cuore, Roma, Italy. 7. Abdominal Surgery Area, General Surgery Unit, Fondazione Policlinico Universitario A. Gemelli IRCCS, Università Cattolica del Sacro Cuore, Roma, Italy. 8. Department of Surgery, Fondazione Policlinico Universitario A. Gemelli IRCCS, Università Cattolica del Sacro Cuore, Roma, Italy. 9. Radiotherapy Department, Fondazione Ricerca e Cura Giovanni Paolo II, Università Cattolica del Sacro Cuore, Campobasso, Italy. 10. Department of Surgery, Università Cattolica del Sacro Cuore, Rome, Italy. 11. Radiation Oncology Centre - S. Maria Misericordia Hospital, Perugia, Italy. 12. Radiotherapy Unit, Azienda Ospedaliero Universitaria, Ospedali Riuniti Ancona, Italy. 13. Radiation Oncology Department, Centro di Riferimento Oncologico, IRCCS, Aviano, Italy. 14. Surgical Oncology Department, Centro di Riferimento Oncologico, IRCCS, Aviano, Italy. 15. Medical Oncology Department, Centro di Riferimento Oncologico, IRCCS, Aviano, Italy. 16. Radiotherapy and Nuclear Medicine Unit, IOV-IRCCS, Padova , Italy. 17. Medical Oncology Unit 1, IOV-IRCCS, Padova, Italy. 18. Radiotherapy Unit, SS Annunziata Hospital, G. D'Annunzio University, Chieti, Italy. 19. Radiation Oncology Centre, V. Fazzi Hospital, Lecce, Italy. 20. Department of Pathology, Fondazione Policlinico Universitario A. Gemelli IRCCS, Università Cattolica del Sacro Cuore, Roma, Italy. 21. Radiotherapy Oncology Centre, S. Maria Hospital, Terni, Italy. 22. Radiation Oncology Center, Department of Experimental, Diagnostic and Speciality Medicine, DIMES, University of Bologna, S. Orsola-Malpighi Hospital, Italy. 23. Department of Public Health and Infectious Diseases, Sapienza University of Rome, Italy. 24. Department of Surgical, Oncological and Gastroenterological Sciences, University of Padova, Italy.
Abstract
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.
RCT Entities:
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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