• Radiother Oncol · May 2019

    Randomized Controlled Trial

    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.

    • Vincenzo Valentini, Maria Antonietta Gambacorta, Francesco Cellini, Cynthia Aristei, Claudio Coco, Brunella Barbaro, Sergio Alfieri, Domenico D'Ugo, Roberto Persiani, Francesco Deodato, Antonio Crucitti, Marco Lupattelli, Giovanna Mantello, Federico Navarria, Claudio Belluco, Angela Buonadonna, Caterina Boso, Sara Lonardi, Luciana Caravatta, Maria Cristina Barba, Fabio Maria Vecchio, Ernesto Maranzano, Domenico Genovesi, Giovanni Battista Doglietto, Alessio Giuseppe Morganti, Giuseppe La Torre, Salvatore Pucciarelli, and Antonino De Paoli.
    • Department Radiation Oncology, Fondazione Policlinico Universitario A. Gemelli IRCCS, Università Cattolica del Sacro Cuore, Roma, Italy.
    • Radiother Oncol. 2019 May 1; 134: 110-118.

    Background And PurposeCapecitabine-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 Objectivepathological outcome (TRG 1-2) among arms.Materials And MethodsLow-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.ResultsFrom 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).ConclusionXelac 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.Copyright © 2018. Published by Elsevier B.V.

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