Intensified neoadjuvant radio-chemotherapy for locally advanced rectal cancer: mono-istitutional experience and long-term results

The purpose of our study is to demonstrate that intensified neoadjuvant chemo-radiotherapy (CRT) treatment in locally advanced rectal cancer (LARC), aimed at further enhancing the complete pathological response and local disease control, is feasible and well tolerated.  From January 2011 to December 2015, 62 patients (women 21, men 41, mean age 61,5, range 36-84) with LARC (cT2-3 cN0-2) were enrolled in our institution. All patients performed an intensified neo-adjuvant CRT treatment according to the following scheme: FOLFOX4 induction chemotherapy for 3 cycles, followed by a concomitant radio-chemotherapy, with concomitant boost pelvic radiotherapy to a total dose to the primary of 54 Gy and daily continuous infusion of 5-Fluorouracil. After 6-8 weeks pts were re-evaluated by means of colonoscopy, body TC and pelvic MRI. Intensified CRT compliance was 90%. Grade I-II proctitis according to CTCAE v4.0 was 43%, grade III diarrhea was 10%, grade I-II genito-urinary toxicity was 29%. Eleven patients (19%) had a complete pathological response (pCR), 37 patients had a partial response. Sixty patients received surgery, two refused it: sphincter-saving procedure was performed in 85% of patients, Miles’ surgery in 15% of them. Fifty-nine patients are alive, after a median follow-up time of 43 months. Six patients experienced a distant metastatic disease, and two patients a local relapse. This study has shown that the intensification of preoperative systemic therapy, together with intensification of radiotherapy, was feasible, well tolerated and has obtained high rates of local disease control (96,5%), with 19% of pCR rate.