title: Irinotecan plus raltitrexed as first-line treatment in advanced colorectal cancer: a phase II study.
abstract: To evaluate the efficacy and toxicity of irinotecan (CPT-11) in combination with raltitrexed as first-line treatment of advanced colorectal cancer (CRC). A total of 91 previously untreated patients with advanced CRC and measurable disease were enrolled in this phase II study. The median age was 62 years (range 31-77); male/female 54/37; ECOG performance status was 0 in 50 patients (55%), one in 39 (43%) and two in two (2%). Treatment consisted of CPT-11 350 mg x m(-2) in a 30-min intravenous infusion on day 1, followed after 30 min by a 15-min infusion of raltitrexed 3 mg x m(-2). Measurements of efficacy included the following: response rate, time to disease progression and overall survival. Of the 83 evaluable patients valuable to objective response, there were five complete responses (6%) and 23 partial responses (28%), for an overall response rate of 34% (95% CI: 25.9-46.5%). In all, 36 patients (43%) had stable disease, whereas 19 (23%) had a progression. The median time to progression was 11.1 months and the median overall survival was 15.6 months. A total of 487 cycles of chemotherapy were delivered with a median of five per patient. Grade 3-4 WHO toxicities were as follows: diarrhoea in 13 patients (15%), nausea/vomiting in four (4%), transaminase increase in six (7%), stomatitis in two (2%), febrile neutropenia in three (3%), anaemia in five (6%) and asthenia in three (3%). The combination CPT-11-raltitrexed is an effective, well-tolerated and convenient regimen as front-line treatment of advanced CRC.
authors.affiliation: Medical Oncology Service, Hospital La Paz, P de la Castellana, 261-28046 Madrid, Spain. jaimefeliu@hotmail.com
authors.forename: J
authors.initials: J
authors.lastname: Feliu
authors.forename: A
authors.initials: A
authors.lastname: Salud
authors.forename: P
authors.initials: P
authors.lastname: Escudero
authors.forename: L
authors.initials: L
authors.lastname: López-Gómez
authors.forename: C
authors.initials: C
authors.lastname: Pericay
authors.forename: C
authors.initials: C
authors.lastname: Castañón
authors.forename: M R López
authors.initials: MR
authors.lastname: de Tejada
authors.forename: J M
authors.initials: JM
authors.lastname: Rodríguez-García
authors.forename: M P
authors.initials: MP
authors.lastname: Martínez
authors.forename: M Sanz
authors.initials: MS
authors.lastname: Martín
authors.forename: J J
authors.initials: JJ
authors.lastname: Sánchez
authors.forename: M González
authors.initials: MG
authors.lastname: Barón
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D002166:Camptothecin / Q000008:administration & dosage / Q000031:analogs & derivatives*; D015179:Colorectal Neoplasms / Q000188:drug therapy* / Q000473:pathology; D018450:Disease Progression; D005260:Female; D006801:Humans; D007262:Infusions, Intravenous; D000077146:Irinotecan; D008297:Male; D008875:Middle Aged; D011799:Quinazolines / Q000008:administration & dosage; D016019:Survival Analysis; D013876:Thiophenes / Q000008:administration & dosage; D016896:Treatment Outcome
chemical_list: D011799:Quinazolines; D013876:Thiophenes; D000077146:Irinotecan; C068874:raltitrexed; D002166:Camptothecin