title: Multicenter phase II clinical trial of preoperative capecitabine with concurrent radiotherapy in patients with locally advanced rectal cancer.
abstract: BACKGROUND
  To assess pathologic complete response, sphincter preservation rates and toxicity profile of preoperative chemoradiation with capecitabine in resectable locally advanced rectal cancer.
  
  
  METHODS
  Fifty-eight patients from six Spanish centers were included (March 2004 to June 2005) with histological/cytological diagnosis of locally advanced rectal cancer, age between 18 and 80 years, ECOG 0-2, adequate bone marrow, renal and hepatic functions. Prior chemotherapy/radiotherapy was not allowed. Preoperative treatment was capecitabine 825 mg/m(2) bid concomitant to radiotherapy (45 + 5.4 Gy boost over 5.5 weeks). Surgery was performed 4-8 weeks after completion of chemoradiotherapy.
  
  
  RESULTS
  Fifty-eight patients were enrolled in this study: 60.3 % males, median age of 64.5 (30.9-78.7) years, 28.6 % with ECOG 0 and 71.4 % with ECOG 1. Median distance of tumor from the anal verge was 7 (1-12) cm. Fifty-two (89.6. %) patients completed preoperative chemoradiotherapy. Primary tumor and node downstaging occurred in 61.1 and 69.6 % of patients, respectively. Surgery was performed in 55 patients (94.8 %): 80 % had negative lymph nodes and 72.7 % underwent sphincter-preserving procedures. A pathologic complete response was observed in 10.5 % (95 % CI 2.5-18.5) of the patients. Main grade I-II toxicities were leucopenia (43.1 %), neutropenia (24.1 %), anemia (36.2 %), diarrhea (32.8 %) and skin disorders (5.1 %), from which diarrhea (6.9 %), leucopenia (1.7 %) and skin disorders (1.7 %) reached grade III. There were no grade IV toxicities.
  
  
  CONCLUSIONS
  Preoperative capecitabine-based chemoradiation is a well-tolerated and effective neoadjuvant treatment for locally advanced rectal cancer that achieves encouraging rates of tumor downstaging.
authors.affiliation: Department Radiation Oncology, Hospital Clínico Universitario San Carlos, c/Profesor Martín Lagos, S/N, 28040 Madrid, Spain. mherasg.hcsc@salud.madrid.org
authors.forename: Manuel
authors.initials: M
authors.lastname: de las Heras
authors.forename: Fernando
authors.initials: F
authors.lastname: Arias
authors.forename: Rosario
authors.initials: R
authors.lastname: del Moral-Avila
authors.forename: Jaime
authors.initials: J
authors.lastname: Gómez-Millán
authors.forename: Encarnación
authors.initials: E
authors.lastname: Jiménez
authors.forename: Amadeo
authors.initials: A
authors.lastname: Wals
authors.forename: Jose Luis
authors.initials: JL
authors.lastname: Tisaire
authors.forename: Ma Pino
authors.initials: MP
authors.lastname: Alcantara
mesh_terms: D000230:Adenocarcinoma / Q000473:pathology / Q000532:radiotherapy / Q000628:therapy*; D000328:Adult; D000368:Aged; D000964:Antimetabolites, Antineoplastic / Q000008:administration & dosage / Q000009:adverse effects; D000069287:Capecitabine; D059248:Chemoradiotherapy / Q000009:adverse effects / Q000379:methods*; D003841:Deoxycytidine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D018450:Disease Progression; D004334:Drug Administration Schedule; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D006801:Humans; D008297:Male; D008875:Middle Aged; D057234:Preoperative Period; D012004:Rectal Neoplasms / Q000473:pathology / Q000532:radiotherapy / Q000628:therapy*; D016896:Treatment Outcome
chemical_list: D000964:Antimetabolites, Antineoplastic; D003841:Deoxycytidine; D000069287:Capecitabine; D005472:Fluorouracil