title: Three-week schedule of irinotecan and cisplatin in advanced non-small cell lung cancer: a multicentre phase II study.
abstract: A phase II multicentre study of a 3-week schedule of irinotecan (CPT-11) and cisplatin providing the highest recommended dose intensity of both agents in combination, was conducted in patients with advanced non-small cell lung cancer (NSCLC). Seventy-four stage IIIB (not suitable for radiotherapy) or stage IV NSCLC patients were enrolled to receive CPT-11 200 mg/m(2) i.v. and cisplatin 80 mg/m(2) i.v. on day 1 every 3 weeks. Relative dose-intensities for CPT-11 and cisplatin were 92 and 95%, respectively. No complete responses were observed. Twenty-five patients out of 73 obtained a partial response (34.2%). Partial responses were confirmed in 18 patients (24.7%: 95% CI, 15.3-36.1%). Median survival overall was 8.2 months, 9.7 months for patients with baseline performance status (PS) 0 and 1, and 4 months for patients with PS 2. The 1-year survival rate was 31%. Major clinical toxicities were grade 3 and 4 delayed diarrhoea (29% of patients) and febrile neutropenia (14% of patients). In conclusion, the present once-every-3-week schedule of CPT-11 and cisplatin is feasible and active in PS 0-1 advanced NSCLC patients, but results do not seem superior to those reported with other schedules.
authors.affiliation: Medical Oncology Department, Institut Català d'Oncologia, Av. Gran Via s/n, km 2.7, 08907 L'Hospitalet, Barcelona, Spain. fcardenal@csub.scs.es
authors.forename: F
authors.initials: F
authors.lastname: Cardenal
authors.forename: M
authors.initials: M
authors.lastname: Domine
authors.forename: B
authors.initials: B
authors.lastname: Massutí
authors.forename: A
authors.initials: A
authors.lastname: Carrato
authors.forename: E
authors.initials: E
authors.lastname: Felip
authors.forename: P
authors.initials: P
authors.lastname: Garrido
authors.forename: O
authors.initials: O
authors.lastname: Juan
authors.forename: A
authors.initials: A
authors.lastname: Artal
authors.forename: I
authors.initials: I
authors.lastname: Barneto
authors.forename: G
authors.initials: G
authors.lastname: López-Vivanco
authors.forename: M
authors.initials: M
authors.lastname: Balcells
authors.forename: R
authors.initials: R
authors.lastname: Rosell
mesh_terms: D000230:Adenocarcinoma / Q000188:drug therapy / Q000473:pathology / Q000556:secondary; D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D002166:Camptothecin / Q000008:administration & dosage / Q000031:analogs & derivatives*; D018287:Carcinoma, Large Cell / Q000188:drug therapy / Q000473:pathology / Q000556:secondary; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000473:pathology; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy / Q000473:pathology / Q000556:secondary; D002945:Cisplatin / Q000008:administration & dosage; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D000077146:Irinotecan; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000473:pathology; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D015996:Survival Rate; D016896:Treatment Outcome
chemical_list: D000077146:Irinotecan; D002945:Cisplatin; D002166:Camptothecin