title: Activity and safety of oxaliplatin with weekly 5-fluorouracil bolus and low-dose leucovorin as first-line treatment for advanced colorectal cancer.
abstract: This study was designed to evaluate the safety and tolerability of oxaliplatin combined with weekly boluses of 5-fluorouracil (5-FU) and low doses of leucovorin (LV) and to determine objective response, progression-free survival, and overall survival of patients with previously untreated advanced colorectal cancer. Seventy-nine patients enrolled in an observational, multicenter, prospective, open-label phase II study received intravenous (I.V.) infusions of oxaliplatin 85 mg/m2 over the course of 2 hours on days 1 and 14 and LV 20 mg/m2 over the course of 2 hours and 5-FU 500 mg/m2 as a bolus on days 1, 7, and 14 every 4 weeks until disease progression or unacceptable toxicity occurred. Seventy-nine patients were evaluable for safety, and data from 70 patients were used for efficacy analysis. The objective response rate was 51.4%. Complete responses occurred in 7 patients (10%), and partial responses occurred in 29 patients (41.4%). Disease control, defined as response or stable disease, was obtained in 56 of 70 patients (80%). The median duration of response was 8.34 weeks (range, 7.3-11.5 weeks). The median time to progression was 7.13 months (range, 6.28-7.72 months), and median overall survival time was 15 months (range, 12.32-18.37 months). Acute dose-limiting toxicities were grade 3/4 diarrhea and neutropenia, which occurred in 10.5% and 3.9% of patients, respectively. Among the 70 patients who experienced neurosensory toxicity, it was estimated that only 1.3% had grade 3 symptoms. Preliminary data showed that the regimen is at least as active as other regimens combining oxaliplatin and infusional schedules of 5-FU and might be more convenient for patients because it avoids the need for I.V. catheter implantation.
authors.affiliation: Hospital General Universitario de Guadalajara, c/ Donantes de Sangre, s/n, 19002- Guadalajara, Spain. javiercasinello@terra.es
authors.forename: Javier
authors.initials: J
authors.lastname: Cassinello
authors.forename: Pilar
authors.initials: P
authors.lastname: Escudero
authors.forename: Antonieta
authors.initials: A
authors.lastname: Salud
authors.forename: Fernando
authors.initials: F
authors.lastname: Marcos
authors.forename: Eduardo
authors.initials: E
authors.lastname: Pujol
authors.forename: Ramón
authors.initials: R
authors.lastname: Pérez-Carrión
authors.forename: Antonio
authors.initials: A
authors.lastname: Colmenarejo
authors.forename: Ricardo
authors.initials: R
authors.lastname: González del Val
authors.forename: José
authors.initials: J
authors.lastname: Valero
authors.forename: Mauro J
authors.initials: MJ
authors.lastname: Oruezábal
authors.forename: Vicente
authors.initials: V
authors.lastname: Guillem
authors.forename: Inés
authors.initials: I
authors.lastname: García
authors.forename: Alberto
authors.initials: A
authors.lastname: Arcediano
authors.forename: Xavier
authors.initials: X
authors.lastname: Marfà
mesh_terms: D000230:Adenocarcinoma / Q000188:drug therapy* / Q000473:pathology; D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D015179:Colorectal Neoplasms / Q000188:drug therapy* / Q000473:pathology; D003967:Diarrhea / Q000139:chemically induced; D018450:Disease Progression; D004334:Drug Administration Schedule; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage; D006801:Humans; D007262:Infusions, Intravenous; D007275:Injections, Intravenous; D002955:Leucovorin / Q000008:administration & dosage; D008297:Male; D008875:Middle Aged; D009503:Neutropenia / Q000139:chemically induced; D009944:Organoplatinum Compounds / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology*; D000077150:Oxaliplatin; D016896:Treatment Outcome
chemical_list: D000970:Antineoplastic Agents; D009944:Organoplatinum Compounds; D000077150:Oxaliplatin; D002955:Leucovorin; D005472:Fluorouracil