title: Phase II study of capecitabine (Xeloda) and concomitant boost radiotherapy in patients with locally advanced rectal cancer.
abstract: OBJECTIVE
  The aim of this study was to determine the efficacy of capecitabine (Xeloda), an oral fluoropyrimidine, as a radiosensitizer in the neoadjuvant treatment of locally advanced rectal cancer (LARC).
  
  
  METHODS
  We conducted a phase II study of capecitabine (825 mg/m2 orally, twice daily continuous) with radiotherapy (52.5 Gy/30 fractions to the primary tumor and perirectal nodes) in 54 patients with LARC (node-negative > or = T3 or any node-positive tumor) staged by endoscopic ultrasound (EUS). The primary endpoint was pathologic response rate; secondary endpoints included toxicity profiles and survival parameters.
  
  
  RESULTS
  Of the 54 patients (median age, 56.7 years; range, 21.3-78.7 years; male:female ratio, 1.7; Eastern Cooperative Oncology Group performance status 0-1: 100%), 51 patients (94%) had T3N0 or T3N1 disease by EUS. Surgery was not performed in 3 patients; 2 of these patients had metastatic disease, and the third patient refused after a complete clinical response. Of the 51 patients evaluable for pathologic response, 9 patients (18%) achieved complete response, and 12 patients (24%) had microscopic residual disease (< 10% viable cells). In addition, 26 patients of all 54 patients (51%) achieved T-downstaging, and 15 patients of 29 patients (52%) achieved N-downstaging. Grade 3/4 toxicities were radiation dermatitis (9%) and diarrhea (2%). Sphincter preservation rate for tumor < or = 5 cm from the anal verge was 67% (18/27).
  
  
  CONCLUSIONS
  This regimen of radiotherapy plus capecitabine is well tolerated and is more convenient than protracted venous infusion of 5-FU. The pathologic response rate is comparable to our previous experience using protracted venous infusion 5-FU for LARC.
authors.affiliation: Department of Radiation Oncology, The University of Texas, M.D. Anderson Cancer Center, Houston, TX, USA.
authors.forename: Sunil
authors.initials: S
authors.lastname: Krishnan
authors.forename: Nora A
authors.initials: NA
authors.lastname: Janjan
authors.forename: John M
authors.initials: JM
authors.lastname: Skibber
authors.forename: Miguel A
authors.initials: MA
authors.lastname: Rodriguez-Bigas
authors.forename: Robert A
authors.initials: RA
authors.lastname: Wolff
authors.forename: Prajnan
authors.initials: P
authors.lastname: Das
authors.forename: Marc E
authors.initials: ME
authors.lastname: Delclos
authors.forename: George J
authors.initials: GJ
authors.lastname: Chang
authors.forename: Paulo M
authors.initials: PM
authors.lastname: Hoff
authors.forename: Cathy
authors.initials: C
authors.lastname: Eng
authors.forename: Thomas D
authors.initials: TD
authors.lastname: Brown
authors.forename: Christopher H
authors.initials: CH
authors.lastname: Crane
authors.forename: Barry W
authors.initials: BW
authors.lastname: Feig
authors.forename: Jeffrey
authors.initials: J
authors.lastname: Morris
authors.forename: Saroj
authors.initials: S
authors.lastname: Vadhan-Raj
authors.forename: Stanley R
authors.initials: SR
authors.lastname: Hamilton
authors.forename: Edward H
authors.initials: EH
authors.lastname: Lin
mesh_terms: D000328:Adult; D000368:Aged; D000069287:Capecitabine; D017024:Chemotherapy, Adjuvant; D003131:Combined Modality Therapy; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000627:therapeutic use; D005260:Female; D005472:Fluorouracil / Q000031:analogs & derivatives; D006801:Humans; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D011838:Radiation-Sensitizing Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D011879:Radiotherapy Dosage; D012004:Rectal Neoplasms / Q000188:drug therapy / Q000473:pathology / Q000532:radiotherapy* / Q000601:surgery
chemical_list: D011838:Radiation-Sensitizing Agents; D003841:Deoxycytidine; D000069287:Capecitabine; D005472:Fluorouracil