title: Capecitabine initially concomitant to radiotherapy then perioperatively administered in locally advanced rectal cancer.
abstract: OBJECTIVE
  To evaluate the impact of neoadjuvant capecitabine, concomitant to radiotherapy, followed by capecitabine monotherapy, in operable locally advanced rectal cancer (LARC) by measuring pathologic response and conservative surgery rate, toxicity profile, and disease-free survival (DFS).
  
  
  METHODS
  From October 2002 to July 2006, a total of 51 patients affected by LARC (T3-T4 or any node positive tumor), received capecitabine (825 mg/m(2), orally, twice daily continuously) concomitant to radiotherapy on the pelvis (50.4 Gy/ 28 fractions), followed by two cycles of capecitabine (1,250 mg/m(2), orally, twice daily, 14 days on 7 days off) up until 2 weeks before surgery. Tailored adjuvant systemic treatment was discussed according to pathologic stage.
  
  
  RESULTS
  Of 51 patients, (median age 61 years, range 38-82 years; 19 women and 32 men; ECOG performance status 0/1/2: 46/4/1), 50 were evaluable for response: 18% complete pathologic remission; 12% T-downstaging, and 30% N-downstaging. One patient died before surgery from mesenteric stroke. Grade 3 acute toxicities were 2% diarrhea, 8% dermatitis, 2% liver function test elevation, and 2% hand-foot syndrome. Sphincter preservation rates for tumors < or =6 cm from the anal verge were 62% and 80% for the whole population. Median follow up was 43.0 months (range 0.8-68.6 months). Five-years DFS was 85.4% (95% CI = 75.3-95.4%).
  
  
  CONCLUSIONS
  Based on our study results, we conclude that this regimen is well tolerated and active and compares favorably with existing capecitabine-based approaches.
authors.affiliation: Medical Care Unit, Department of Medicine, European Institute of Oncology, Milan, Italy. maria.zampino@ieo.it
authors.forename: Maria Giulia
authors.initials: MG
authors.lastname: Zampino
authors.forename: Elena
authors.initials: E
authors.lastname: Magni
authors.forename: Maria Cristina
authors.initials: MC
authors.lastname: Leonardi
authors.forename: Elena
authors.initials: E
authors.lastname: Petazzi
authors.forename: Luigi
authors.initials: L
authors.lastname: Santoro
authors.forename: Fabrizio
authors.initials: F
authors.lastname: Luca
authors.forename: Antonio
authors.initials: A
authors.lastname: Chiappa
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Petralia
authors.forename: Cristina
authors.initials: C
authors.lastname: Trovato
authors.forename: Nicola
authors.initials: N
authors.lastname: Fazio
authors.forename: Roberto
authors.initials: R
authors.lastname: Orecchia
authors.forename: Franco
authors.initials: F
authors.lastname: Nolè
authors.forename: Filippo
authors.initials: F
authors.lastname: de Braud
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000964:Antimetabolites, Antineoplastic / Q000008:administration & dosage*; D000069287:Capecitabine; D003131:Combined Modality Therapy / Q000009:adverse effects / Q000379:methods; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives*; D018572:Disease-Free Survival; D004334:Drug Administration Schedule; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000031:analogs & derivatives*; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D020360:Neoadjuvant Therapy / Q000379:methods*; D011446:Prospective Studies; D012004:Rectal Neoplasms / Q000188:drug therapy* / Q000473:pathology / Q000532:radiotherapy*; D012074:Remission Induction
chemical_list: D000964:Antimetabolites, Antineoplastic; D003841:Deoxycytidine; D000069287:Capecitabine; D005472:Fluorouracil