الفهرس 
Acknowledgement
EpidemiologyOnly 14 pages are availabe for public view
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Abstract
This prospective study was aiming to evaluate the efficacy and toxicity of neo-adjuvant short course radiation therapy concurrently with continuous infusion 5-fluorouracil in the management of locally advanced rectal cancer patients treated at Clinical Oncology Department, Assiut University Hospital between October 2020 and October 2021 to assess the safety and feasibility of 5-FU when given concurrently with5 Gy x 5 fractions by measuring DLT which is defined as toxicities occurring during chemoradiation or within 21 days from the completion of chemoradiation as a primary endpoint and to assess 2 years EFS and OS after short course radiotherapy concurrent with dose escalation infusion 5-FU followed by mFOLFOX and delayed surgery.
The study included 20 patients with 10 males (50%) and 10 females (50%) patients, and the mean age at the time of diagnosis was 49.05 ± 12.137 years. There were 9 patients (45%) with middle rectal cancer, 6 patients (30%) with lower rectal cancer and 5 patients (25%) with upper rectal cancer. There were 4 patients (20%) with cT2, 13 patients (65%) with cT3, and 3 patients (15%) with cT4. Regarding the nodal status, 3 patients were with clinical N0 (15%) and 17 patients with clinical N+ (85%).
The most common grade III and III-IV toxicities in the study group were diarrhea (10%) and abdominal pain (5%). The most common grade I and II toxicities included diarrhea (25%), abdominal pain (20%), and anaemia (10%). There were only 2 patients (10%) developed grade I and II anaemia and 1 patient (5%) developed grade I and II neutropenia with no grade III and IV hematological or investigational toxicities. Regarding non-hematological toxicities, 4 patients (20%) complain of grade I, II abdominal pain versus 1 patient (5%) with grade III, IV, and pain was related to acute appendicitis developed 1 week after the end of radiotherapy. Diarrhea was the commonest side effect as 5 patients (25%) developed grade I and II, and 2 patients (10%) developed grade III and IV.
The clinical response in the study group assessed by MRI pelvis with 4 patients (20%) had a clinical complete response, 2 patients having middle rectal tumors and 2 patients having lower rectal tumors who underwent radical surgery with sphincteric preservation. 14 patients (70%) showed good subjective response with significant tumor regression on MRI according to RECIST criteria, but 3 of them died before undergoing surgery, one of them with acute appendicitis, one with pulmonary embolism and one without any apparent cause with their age range between 65 and 75. There were 2 patients (10%) with progressive disease, and surgery could not be done and proceeded to second-line chemotherapy.
4 patients (26.7%) out of 15 patients who underwent surgery had pCR with R0 resection, 11 patients (73.3%) had a pathological PR with R0 resection with only one patient with positive margin despite down-staging due to fibrosis, and no patient with stationary disease.
The mean for EFS±SE in the study group was 19.623±1.686 month (95% confidence interval 16.318-22.928) and the mean OS±SE in the study group was 21.100± 1.537 month (95% confidence interval 18.088-24.112). Regarding 2 years EFS rate and 2 years OS rate in the study, it was 75% and 85% respectively. Regarding EFS and OS according to the site of the tumor, it was19.083±2.850 and 21.167±2.586 for lower rectal tumors, 22.000±1.826 and 24.000 for middle rectal tumors, and 16.600±1.686 and 16.600±4.075 for upper rectal tumors with insignificant P value.