title: Oxaliplatin as single agent in previously untreated colorectal carcinoma patients: a phase II multicentric study.
abstract: BACKGROUND
  Oxaliplatin is a new cytotoxic agent from the diaminocyclohexane family with proven antitumor activity against colon cancer cell lines. Activity in patients with colorectal carcinoma previously treated with 5-fluorouracil has been studied in three single-agent phase II trials, showing a reproducible response rate of 10%. Here we report a phase II trial with oxaliplatin as a first-line chemotherapy for metastatic colorectal cancer.
  
  
  METHODS
  Twenty-five patients were entered in the study. All of them had metastatic disease without previous chemotherapy, and at least one lesion had to be measurable by computed tomography (CT). Therapy consisted of a two-hour infusion of oxaliplatin at a dose of 130 mg/m2 every 21 days.
  
  
  RESULTS
  The overall response rate determined by investigators was 20% (95% CI, 6.8%-40.7%). Eight patients (32%) had stable disease. The median time to disease progression in responders was six months (range four to nine). The median progression-free survival was four months and median overall survival 14.5 months (95% CI, 10-20 months). The main toxic effects were peripheral neuropathy (92%) and laryngopharyngeal dysesthesia (75%). No severe grade 3-4 neurotoxicities (NCI-CTC) were found. Gastrointestinal and hematological toxicities were mild.
  
  
  CONCLUSIONS
  Oxaliplatin is an active agent in first-line chemotherapy for advanced colorectal cancer. It was well tolerated, caused no toxic deaths, had low hematotoxicity, well controlled gastrointestinal toxicity, and frequent but mild peripheral neurological symptoms. Therefore, it is of interest to associate oxaliplatin with other active compounds.
authors.affiliation: Hospital Clínico San Carlos, Madrid, Spain.
authors.forename: E
authors.initials: E
authors.lastname: Díaz-Rubio
authors.forename: J
authors.initials: J
authors.lastname: Sastre
authors.forename: A
authors.initials: A
authors.lastname: Zaniboni
authors.forename: R
authors.initials: R
authors.lastname: Labianca
authors.forename: H
authors.initials: H
authors.lastname: Cortés-Funes
authors.forename: F
authors.initials: F
authors.lastname: de Braud
authors.forename: C
authors.initials: C
authors.lastname: Boni
authors.forename: M
authors.initials: M
authors.lastname: Benavides
authors.forename: G
authors.initials: G
authors.lastname: Dallavalle
authors.forename: M
authors.initials: M
authors.lastname: Homerin
mesh_terms: D000230:Adenocarcinoma / Q000188:drug therapy* / Q000556:secondary; D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D015179:Colorectal Neoplasms / Q000188:drug therapy*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009944:Organoplatinum Compounds / Q000009:adverse effects / Q000627:therapeutic use*; D000077150:Oxaliplatin; D015203:Reproducibility of Results
chemical_list: D000970:Antineoplastic Agents; D009944:Organoplatinum Compounds; D000077150:Oxaliplatin