title: Phase II study of preoperative radiotherapy and concomitant weekly intravenous oxaliplatin combined with oral capecitabine for stages II-III rectal cancer.
abstract: BACKGROUND
  A prospective phase II study was conducted to assess the clinical activity and tolerability of oxaliplatin, capecitabine, and radiotherapy (RT) for neoadjuvant therapy of stages II-III rectal cancer.
  
  
  METHODS
  Patients with histologically confirmed stages II-III (T3-T4 and/or N+) resectable rectal adenocarcinoma were eligible. Capecitabine was administered at 825 mg/m(2) twice daily for 5 days/week and oxaliplatin at 50 mg/m(2) on day 1 weekly for 5 weeks starting the first day of RT (before RT). RT consisted of a total dose of 45 Gy delivered in 25 fractions of 1.8 Gy, 5 days per week, for 5 weeks.
  
  
  RESULTS
  A total of 46 patients were included (35 male, 10 female, median age 62 years). TNM Stage was T3 in 43 patients and T4 in 2. Twenty-eight patients had suspected nodal involvement. The intended chemoradiation treatment was completed in 94 % patients. Grade 3/4 toxicity included lymphocytopenia (6 patients), diarrhea (4 patients), emesis (2 patients), asthenia (3 patients), anorexia (1 patient), and hepatic toxicity (1 patient). Grade 1 neurotoxicity occurred in 18 patients, Grade 2 neurotoxicity in 3, and Grade 1 palmoplantar erythrodysesthesia in 2. Forty-two patients underwent surgery (complete resection 95 %, sphincter-saving operation 55 %). The overall pathologic response rate was 83 %, with a pathologic complete response (pCR) rate of 11.9 % (95 % CI 4.0-25.6).
  
  
  CONCLUSIONS
  The pCR rate observed with oxaliplatin plus capecitabine and RT did not reach the pre-specified criteria of efficacy in this trial, which is in line with recent results of randomized phase III trials.
authors.affiliation: Department of Medical Oncology, Institut Català d'Oncologia/IDIBELL, L'Hospitalet de Llobregat, Barcelona, Autovía Castelldefels, Barcelona, Spain. ramonsalazar@iconcologia.net
authors.forename: Ramon
authors.initials: R
authors.lastname: Salazar
authors.forename: Matilde
authors.initials: M
authors.lastname: Navarro
authors.forename: Ferran
authors.initials: F
authors.lastname: Losa
authors.forename: Vicente
authors.initials: V
authors.lastname: Alonso
authors.forename: Manel
authors.initials: M
authors.lastname: Gallén
authors.forename: Fernando
authors.initials: F
authors.lastname: Rivera
authors.forename: Manuel
authors.initials: M
authors.lastname: Benavides
authors.forename: Pilar
authors.initials: P
authors.lastname: Escudero
authors.forename: Encarnación
authors.initials: E
authors.lastname: González
authors.forename: Bartomeu
authors.initials: B
authors.lastname: Massutí
authors.forename: Auxiliadora
authors.initials: A
authors.lastname: Gómez
authors.forename: Margarita
authors.initials: M
authors.lastname: Majem
authors.forename: Enrique
authors.initials: E
authors.lastname: Aranda
mesh_terms: D061605:Administration, Intravenous; D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D000069287:Capecitabine; D059248:Chemoradiotherapy; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives; D004334:Drug Administration Schedule; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000031:analogs & derivatives; D006801:Humans; D008297:Male; D008875:Middle Aged; D020360:Neoadjuvant Therapy; D009944:Organoplatinum Compounds / Q000008:administration & dosage; D000077150:Oxaliplatin; D012004:Rectal Neoplasms / Q000473:pathology / Q000628:therapy*
chemical_list: D009944:Organoplatinum Compounds; D000077150:Oxaliplatin; D003841:Deoxycytidine; D000069287:Capecitabine; D005472:Fluorouracil