الفهرس 
Patient and methodsOnly 14 pages are availabe for public view
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Abstract
The present study included 463 patients with pathologically proven rectal cancer. All patients underwent neoadjuvant chemradiation followed by definitive surgery.
All the patients had either 5-FU or Capecitabine concomitant with radiotherapy. The aim of this work is to compare the treatment outcomes and acute toxicity of preoperative radiotherapy (RT) with capecitabine vs. preoperative RT with intermittent 5-fluorouracil (55FU) i·lfusion in rectal cancer. The aim of the comparison is to show equiv;-.Ient efficacy between capecitabine and 5-FU infusion plus leucovorin in neoadjuvant chemoradiation for locally adv3i Iced rectal cancer Capecitabine was the standard drug used in neoadj’o vant rectal chemoradiation in our study with 5-FU group represent 1 historical control. Capecitabine dose throughout the study protocol was 825 mg/m2 twice daily administered for 5 days (Monda:’ to Friday) throughout the, course of preoperative pelvic irradiation. Time interval for capecitabine dose used was mainly 1 hour interval before radiation treatment with 12 hour interval between capecitabine doses.
Primary outcome measure was pathological complete response. Secondary outcome measures included local recurrence (LR), disease free survival (DFS) and overall survival (OS), a negative circumferential margin, node positivity following chemoradiation. Toxicity was examined both qualitatively and quantitatively as acute and late morbidity, surgical complications and late functional results. Acute toxicity was defined as Grade 3 or 4 toxicity (haematological,
gastro-intestinal and genitourinary) experienced up to four weeks post chemoradiation according to the National Cancer Institute Canada common toxicity criteria (CTC) revised 1999 definitions.
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Patients enrolled in our study show greater compliance to the treatment protocol ( more than 90 % ).
Analysis of the treatment results revealed that capecitabine is equally effective to 5-FU with less side effects. Pathological complete remi’ssion was significantly higher for capecitabine compared to 5-FU. Incidence of diarrhea was also less in capecitabine group compared to that in 5-FU.
. Our study represent a follow up period ranged from 1 : 144 month.for 5-FU group versus 1: 73 month for capecitabine group.
Surgical morbidity was in the range of ( 45 % & 56 % ) for 55FU and Capecitabine respectively. Data regarding ranastomotic leakage was poorly documented in our study.
complete ecurrence a negative )radiation. ly as acute nal results. ,ological,
IThis study proves feasibility and effecacy Q)f capecitabine as an oral drug to its IV counterpart 5-FU with less side’effects like diarrhea but increase in hand and foot syndrome incidence’!!