title: A modern regimen of pre-operative concurrent chemo-radiation therapy in locally advanced rectal cancer.
abstract: OBJECTIVE
  To evaluate the efficacy and toxicity of preoperative concurrent capecitabine and radiotherapy in the treatment of resectable locally advanced rectal cancer (LARC).
  
  
  METHODS
  We conducted a phase II trial to assess pathological complete response, tumor downstaging, toxicity and survival of capecitabine (825 mg/m(2) orally, twice daily) with radiotherapy (50.4 Gy/28 fractions) in 31 patients with LARC (cT3/T4 or N+) staged by endoscopic ultrasound (EUS).
  
  
  RESULTS
  Median age was 53 years; with M:F ratio of 1:1.58; 77.4% had Eastern Cooperative Oncology Group performance status of 1. EUS showed that 67.7% of tumors were T3, 19.4% were T4, and 58% were node positive. Of 30 patients who had surgery, 6.5% achieved pathological complete remission (pCR). Tumor and nodal downstaging were achieved in 53.9% and 50% of patients, respectively. Grade 3/4 toxicities were mainly diarrhea (35.5%) and proctitis (32.3%). Sphincter preservation was achieved in 4/21 (15%) of patients initially planned for abdominoperineal resection. The median follow-up was 46 months (Range: 1.47-63.9), and the 3-year disease-free and overall survival were 59.8% and 76.6%, respectively.
  
  
  CONCLUSIONS
  Capecitabine given concurrently with radiation therapy is generally well tolerated, and proved to be an effective radiosensitizer in the neoadjuvant treatment of locally advanced rectal cancer, yielding results comparable to those reported with 5-FU.
authors.affiliation: Department of Medical Oncology, King Faisal Specialist Hospital and Research Center, Riyadh, Kingdom of Saudi Arabia.
authors.forename: Shouki
authors.initials: S
authors.lastname: Bazarbashi
authors.forename: Mazen
authors.initials: M
authors.lastname: El-Bassiouni
authors.forename: Mahmoud
authors.initials: M
authors.lastname: Abdelsalam
authors.forename: Hussein
authors.initials: H
authors.lastname: Soudy
authors.forename: Nasser Al
authors.initials: NA
authors.lastname: Sanea
authors.forename: Alaa Abdul
authors.initials: AA
authors.lastname: Jabbar
authors.forename: Mohamed
authors.initials: M
authors.lastname: Manji
authors.forename: Mosa
authors.initials: M
authors.lastname: Fagih
authors.forename: Dahish
authors.initials: D
authors.lastname: Ajarim
mesh_terms: D000328:Adult; D000368:Aged; D000964:Antimetabolites, Antineoplastic / Q000627:therapeutic use*; D000069287:Capecitabine; D017024:Chemotherapy, Adjuvant; D003131:Combined Modality Therapy; D003841:Deoxycytidine / Q000031:analogs & derivatives* / Q000627:therapeutic use; D018572:Disease-Free Survival; D005260:Female; D005472:Fluorouracil / Q000031:analogs & derivatives* / Q000627:therapeutic use; D006801:Humans; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000175:diagnosis; D009367:Neoplasm Staging; D011355:Prodrugs; D011879:Radiotherapy Dosage; D012004:Rectal Neoplasms / Q000188:drug therapy / Q000473:pathology / Q000532:radiotherapy / Q000628:therapy*; D012074:Remission Induction; D015996:Survival Rate; D016896:Treatment Outcome
chemical_list: D000964:Antimetabolites, Antineoplastic; D011355:Prodrugs; D003841:Deoxycytidine; D000069287:Capecitabine; D005472:Fluorouracil