Is neoadjuvant chemoradiation a gold standard for carcinoma rectum? a comprehensive analysis of outcomes and prognostic factors from a tertiary care centre from India

Introduction: The management of rectal cancer has changed over the years with an emphasis on neoadjuvant chemoradiation (NACRT) followed by surgery. Multiple western studies had shown better local control and sphincter preservation with preoperative chemoradiation in carcinoma rectum. However, data from India is lacking. Thus, we conducted the retrospective study in our institution to show the impact of neoadjuvant chemoradiation on sphincter preservation in carcinoma rectum. Aims: Down staging, local control and sphincter preservation in carcinoma rectum. Materials and Methods: The retrospective study was conducted in our institution which enrolled 126 patients with histologically confirmed diagnosis of carcinoma rectum (stage I-III) treated with neoadjuvant chemoradiation followed by surgery from Jan2009-Dec2013. Total dose of 45Gy in 25 fractions over 5weeks was delivered using 3D-CRT technique. All patients received 5-FU/LV(5-Fluorouracil/Leucovorin) weekly with 5-FU 325mg/m2 and LV 30mg/m2 on D1 of every week. 4-8weeks after completion of NACRT, patients were assessed for disease response, sphinchter preservation possibility and resectability of tumour. Pathologic assessment of response was seen in the resected tumours. Impact of different prognostic factors on clinical outcome was analysed. Results: Median age of presentation was 48 years (range 18-77 years). Out of 126 patients, 86 were males and 40 were females. Most of the patients presented with bleeding per rectum (94.4%). Mean duration of symptoms was 9 months. Most of the patients presented with T3 disease (50.8%) followed by T2 (43.6%) and T4 (5.6%). Out of 126 patients, 83(65.9%) had N1 disease and 10(7.9%) had N2 disease. Lymph nodes were not involved in 33(26.2%). Most of our patients presented with stage III disease (73.8%). Mean distance of tumor was 4.2cm from anal verge. All the patients had histologically proven adenocarcinoma with signet ring cell and mucinous variety seen in 9.5% and 7.1% respectively. Most of the patients had moderately differentiated adenocarcinoma (43.7%). Well differentiated and poorly differentiated variety were seen in 6 and 5 patients respectively. With NACRT 82(65.07%) patients out of 126 were down staged and were amenable for surgery. Among 126 patients, 63(50.0%) underwent LAR(low anterior resection) and thus 50% of the patients had sphincter preserved and 53(42.1%) underwent APR(abdomino-perineal resection). Pathological complete response was seen in 14(11.9%) patients. Local control was seen in 60% of the patients. Patients with Hb>12gm//dl and tumours more than 3 cm from anal verge showed better sphincter preservation (p=0.018,p=0.011 respectively). Though grade of the tumour did not have impact on sphincter preservation however survival was improved in low grade tumours. Type of histology, lymph node positivity, pre op CEA did not have any significant impact on outcome. Conclusion: This study represents the largest Indian experience with standard neoadjuvant chemoradiation followed by surgery in rectal cancer. Down staging of tumor, improved local control and increased sphincter preservation was seen in our study. Pretreatment Hemoglobin status, distance from anal verge and grade of the tumour came out to be the important prognostic factors.