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

Background: Purpose: 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.  Materials and Methods: 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. Results: 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. Conclusion: 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.