title: A multicenter phase II study of irinotecan in patients with advanced colorectal cancer previously treated with 5-fluorouracil.
abstract: This multicenter, open-label, phase II study was performed to assess the efficacy and toxicity of irinotecan 350 mg/m2 intravenously every 3 weeks in patients with advanced colorectal cancer (CRC) previously treated with 5-fluorouracil (5-FU). The study enrolled 115 patients and a total of 558 cycles (median, 6 per patient) were administered. The overall objective response rate on an intent-to-treat basis was 18% (with 1 complete response and 20 partial responses), whereas 42 patients (37%) showed stable disease. Median time to progression was 4.8 months and median survival was 13.6 months. Grade 3/4 toxicities included delayed diarrhea (19.1%), nausea/vomiting (10.4%), and neutropenia (8.7%). There were 2 toxic deaths, 1 from delayed diarrhea and 1 from hemorrhage and grade 4 mucositis. In conclusion, the present study confirms the antitumor efficacy of irinotecan monotherapy in patients with CRC pretreated with 5-FU.
authors.affiliation: Hospital de Móstoles, Madrid, Spain.
authors.forename: Miguel
authors.initials: M
authors.lastname: Méndez
authors.forename: Antonieta
authors.initials: A
authors.lastname: Salut
authors.forename: Carlos
authors.initials: C
authors.lastname: García-Girón
authors.forename: Marta
authors.initials: M
authors.lastname: Navalon
authors.forename: Pilar
authors.initials: P
authors.lastname: Diz
authors.forename: Maria José
authors.initials: MJ
authors.lastname: García López
authors.forename: Pilar
authors.initials: P
authors.lastname: España
authors.forename: Ascensión
authors.initials: A
authors.lastname: de la Torre
authors.forename: Purificación
authors.initials: P
authors.lastname: Martínez del Prado
authors.forename: Isabel
authors.initials: I
authors.lastname: Duarte
authors.forename: Eduardo
authors.initials: E
authors.lastname: Pujol
authors.forename: Alberto
authors.initials: A
authors.lastname: Arizcun
authors.forename: Juan Jesús
authors.initials: JJ
authors.lastname: Cruz
mesh_terms: D000328:Adult; D000368:Aged; D000972:Antineoplastic Agents, Phytogenic / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D002166:Camptothecin / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000627:therapeutic use*; D015179:Colorectal Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D004334:Drug Administration Schedule; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000627:therapeutic use; D006801:Humans; D007262:Infusions, Intravenous; D000077146:Irinotecan; D008297:Male; D008875:Middle Aged; D009362:Neoplasm Metastasis; D009367:Neoplasm Staging; D013030:Spain; D016019:Survival Analysis; D016896:Treatment Outcome
chemical_list: D000972:Antineoplastic Agents, Phytogenic; D000077146:Irinotecan; D005472:Fluorouracil; D002166:Camptothecin