title: A randomized controlled pilot study to compare capecitabine-oxaliplatin with 5-FU-leucovorin as neoadjuvant concurrent chemoradiation in locally advanced adenocarcinoma of rectum.
abstract: BACKGROUND
  Established as an adjuvant chemotherapy, CapeOX has recently been shown to have radiosensitizer property in a phase I and II studies, with appreciable downstaging and tolerable toxicities.
  
  
  OBJECTIVE
  The study was designed to evaluate whether the capecitabine-oxaliplatin combination was superior to 5-fluorouracil (5-FU)-leucovorin as radiosensitizer for neoadjuvant chemoradiation in downstaging locally advanced rectal adenocarcinoma and to compare the toxicities between the two arms.
  
  
  METHODS
  Single institutional, double blinded, prospective, noncrossover, randomized control pilot study.
  
  
  METHODS
  In arm A (n = 21), patients received capecitabine (1,000 mg/m(2) daily) in twice dailydoseon days 1-14 and 25-38 and oxaliplatin (85 mg/m(2)) intravenous ( IV) over 2 h, on D1 and D29. In arm B (n = 21), patients received leucovorin (20 mg/m(2)) and 5-FU (350 mg/m(2)) from D1-5 and D29-33. Patient in both the arms received concurrent radiation (50.4 Gy in 28 #, in conventional fractionation of 1.8 Gy per fraction). Six to eight weeks after concurrent chemoradiation, patients underwent assessment and surgery with total mesorectal resection. Postoperatively, adjuvant chemotherapy with m-FOLFOX 6 of 4 months was given to all patients.
  
  
  METHODS
  Chi-square test was used to compare categorical variables between the groups.
  
  
  RESULTS
  Objective response rate (ORR) in arm A was 80.95% compared to arm B which had 66.66% (P = 0.3055). Pathological complete response (pCR) rate of arm A was comparable to arm B (23.8 vs 14.28%, P value = 0.6944). Surgery with R0 resection was possible in 80.95% cases of arm A compared to 66.66% cases of arm B (P = 0.4827). Grade III toxicities were quite comparable between two treatment arms.
  
  
  CONCLUSIONS
  In terms of ORR, pCR rate, R0 resection, and toxicity profile; both the arms were comparable.
authors: Department of Radiotherapy, Institute of Post Graduate Medical Education and Research, Kolkata, India.
authors: Animesh
authors: A
authors: Saha
authors: Sajal Kumar
authors: SK
authors: Ghosh
authors: Chhaya
authors: C
authors: Roy
authors: Makhan Lal
authors: ML
authors: Saha
authors: Krishnangshu Bhanja
authors: KB
authors: Choudhury
authors: Koushik
authors: K
authors: Chatterjee
mesh_terms: D000230:Adenocarcinoma / Q000188:drug therapy* / Q000473:pathology / Q000532:radiotherapy*; D000293:Adolescent; D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D000069287:Capecitabine / Q000008:administration & dosage; D059248:Chemoradiotherapy / Q000009:adverse effects; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage; D006801:Humans; D002955:Leucovorin / Q000008:administration & dosage; D008297:Male; D008875:Middle Aged; D020360:Neoadjuvant Therapy; D060787:Neoplasm Grading; D009362:Neoplasm Metastasis; D009367:Neoplasm Staging; D009944:Organoplatinum Compounds / Q000008:administration & dosage; D000077150:Oxaliplatin; D010865:Pilot Projects; D012004:Rectal Neoplasms / Q000188:drug therapy* / Q000473:pathology / Q000532:radiotherapy*; D012307:Risk Factors; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D009944:Organoplatinum Compounds; D000077150:Oxaliplatin; D000069287:Capecitabine; D002955:Leucovorin; D005472:Fluorouracil