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Abstract Background: Purpose: Metformin may have antineoplastic effects in several malignancies and may improve response to radiotherapy in locally advanced rectal cancer. Objective: Aim of the Work: Evaluating the potential effect of metformin use on pathologic complete response (PCR) to radiotherapy and assessing its toxicity in diabetic patients with locally advanced rectal cancer. Methods: This phase II comparative randomized prospective study was conducted at Ain Shams University hospitals, Damanhour Oncology Centre and Ayadi El Mostakbal Oncology Centre, on a sample of 50 patients with type II diabetes and, locally advanced rectal cancer, and who are planned to be treated by neoadjuvant CCRT followed by surgical resection from June 2018 to June 2020. Patients were divided into two groups: metformin group (n = 25) and non metformin group (n = 25). Tumor response was compared between the two groups. Toxicity of metformin and concurrent chemoradiotherapy was also assessed. Tumour response was also compared in relation to multiple predictive factors. Results: Metformin use had significant correlation with pCR (Pvalue=0.025) but metformin dose did not have any significant impact on pCR (Pvalue=0.206). In addition decreased BMI, pre T-x blood glucose level, and interval of radiotherapy to surgey, had high a significant impact on increased pCR (Pvalue=0.021, 0.005, and 0.001, respectively). There was no significant correlation between pCR and age, pre-Tx HbA1c level, pretreatment CEA, tumor distance from anal verge, tumour circumferential extent, clinical tumor stage, clinical nodal stage, and tumour grade (Pvalue=0.94, 0.303, 0.533, 0.094, 0.061, 0.197, 0.074, and 0.129, respectively). Nausea and diarrhea are common side effects of concurrent chemoradiotherapy and metformin hydrochloride (Pvalue=<0.0001, 0.039, respectively). Conclusion: Metformin use, BMI, pre T-x blood glucose level, and interval of radiotherapy to surgey, are associated with higher tumor response rates to radiotherapy in rectal cancer in patients with diabetes. However, larger scale studies including higher number of patients are needed to verify the validity of this drug as an adjunct to radiotherapy in rectal cancer patients. |