title: Two Doses of oxaliplatin with capecitabine (XELOX) in metastatic colorectal cancer.
abstract: OBJECTIVE
  Phase II/III studies have shown XELOX to be as effective as FOLFOX in patients with advanced colorectal cancer (CRC). The study was designed to evaluate the activity and tolerability of XELOX in CRC. In August 2002, we began a prospective study of XELOX as first-line therapy for patients with metastatic CRC. Twenty-two patients were enrolled between November 2002 and August 2003 (series I). An interim analysis performed in August 2003 revealed that 32% of patients required a dose reduction of oxaliplatin because of toxicity. From August 2003 to April 2005, an additional 20 patients were included (series II). This second group of patients received oxaliplatin at a lower dose.
  
  
  METHODS
  The first 22 patients (series I) included received oxaliplatin 130 mg/m(2) on day 1 plus capecitabine 2000 mg/m(2) daily on days 1-15 (3-week cycle). The second set of 20 patients (series II) received oxaliplatin 85 mg/m(2) on day 1; the dose of capecitabine and the frequency of administration were not modified.
  
  
  RESULTS
  Patient characteristics were well balanced in the 2 series. Overall response (series I vs. II): 41% vs. 65%; median time to progression was similar: 10.51 vs. 10.92 (log-rank test, P = .79). Median survival was similar in the 2 series: 19.55 vs. 21.18 months (log-rank test, P = .61). Grade 3/4 toxicity (series I vs. II): peripheral neuropathy, 14% vs. 0 (P = .23).
  
  
  CONCLUSIONS
  In patients with advanced CRC, in combination with capecitabine, oxaliplatin 85 mg/m(2) is as effective with lower toxicity when compared with oxaliplatin 130 mg/m(2).
authors.affiliation: Servicio de Oncologia, Hospital Municipal de Badalona-BSA, Badalona, Barcelona, Spain. imoreno@bsa.gs
authors.forename: Isabel
authors.initials: I
authors.lastname: Moreno-Solórzano
authors.forename: Rafael
authors.initials: R
authors.lastname: Ibeas-Rollan
authors.forename: Mariano
authors.initials: M
authors.lastname: Monzó-Planella
authors.forename: José
authors.initials: J
authors.lastname: Moreno-Solórzano
authors.forename: Francisco
authors.initials: F
authors.lastname: Martínez-Ródenas
authors.forename: Edmon
authors.initials: E
authors.lastname: Pou-Sanchis
authors.forename: Raquel
authors.initials: R
authors.lastname: Hernández-Borlan
authors.forename: Marta
authors.initials: M
authors.lastname: Navarro-Vigo
authors.forename: Silvia
authors.initials: S
authors.lastname: Ortigosa-Rodríguez
authors.forename: Bernat
authors.initials: B
authors.lastname: Gel-Moreno
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use*; D000069287:Capecitabine; D015179:Colorectal Neoplasms / Q000188:drug therapy* / Q000473:pathology; D003841:Deoxycytidine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives / Q000494:pharmacology; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D004338:Drug Combinations; D064420:Drug-Related Side Effects and Adverse Reactions; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives / Q000494:pharmacology; D006801:Humans; D008297:Male; D008875:Middle Aged; D009362:Neoplasm Metastasis; D009944:Organoplatinum Compounds / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology; D010071:Oxaloacetates; D016019:Survival Analysis
chemical_list: D004338:Drug Combinations; D009944:Organoplatinum Compounds; D010071:Oxaloacetates; D003841:Deoxycytidine; D000069287:Capecitabine; D005472:Fluorouracil