Dose-finding study of oxaliplatin associated to capecitabinebased preoperative chemoradiotherapy in locally advanced rectal cancer

// Gemma Bruera 1, 2 , Mario Di Staso 3 , Pierluigi Bonfili 3 , Antonio Galvano 4 , Rosa Manetta 5 , Gino Coletti 6 , Roberto Vicentini 7 , Stefano Guadagni 2, 8 , Corrado Ficorella 2, 9 , Ernesto Di Cesare 2, 3 , Antonio Russo 4 and Enrico Ricevuto 1, 2 1 Oncology Territorial Care, S. Salvatore Hospital, Oncology Network ASL1 Abruzzo, University of L'Aquila, L'Aquila, Italy 2 Department of Biotechnological and Applied Clinical Sciences, University of L’Aquila, L’Aquila, Italy 3 Radiotherapy, S. Salvatore Hospital, Oncology Network ASL1 Abruzzo, University of L’Aquila, L’Aquila, Italy 4 Medical Oncology, Department of Surgical, Oncological and Stomatological Sciences, University of Palermo, Palermo, Italy 5 Radiology, S. Salvatore Hospital, L’Aquila, Oncology Network ASL1 Abruzzo, Italy 6 Pathology, S. Salvatore Hospital, L’Aquila, Oncology Network ASL1 Abruzzo, Italy 7 Hepatobiliar-pancreatic Surgery, S. Salvatore Hospital, L’Aquila, Oncology Network ASL1 Abruzzo, Italy 8 Universitary General Surgery, S. Salvatore Hospital, Oncology Network ASL1 Abruzzo, University of L’Aquila, L’Aquila, Italy 9 Medical Oncology, S. Salvatore Hospital, Oncology Network ASL1 Abruzzo, University of L’Aquila, L’Aquila, Italy Correspondence to: Antonio Russo, email: antonio.russo@usa.net Keywords: capecitabine; chemoradiotherapy; dose-finding; locally advanced rectal cancer; oxaliplatin Received: December 07, 2017 Accepted: February 27, 2018 Published: April 03, 2018 ABSTRACT Introduction: Proper administration timing, dose-intensity, efficacy/toxicity ratio of oxaliplatin added to fluoropyrimidin should be improved to safely perform two-drugs intensive preoperative chemoradiotherapy in locally advanced rectal cancer (LARC). This dose-finding study investigated recommended oxaliplatin dose, safety of oxaliplatin/capecitabine regimen and preliminary activity. Methods: Schedule: oxaliplatin dose-levels, 35-40 mg/m 2 /week; capecitabine 825 mg/m 2 / twice daily, radiotherapy on rectum/nodes, 50/45 Gy, 45 and 9 boost/45 Gy, in first 5 and subsequent patients, 5 days/week, respectively; for 5 weeks. Pathologic complete response (pCR) 10% was projected in order to positively affect clinical outcome. Results: Seventeen fit