title: Carboplatin plus paclitaxel in extensive small cell lung cancer: a multicentre phase 2 study.
abstract: A multicentre phase 2 trial (single-stage design) was undertaken to test the efficacy and toxicity of carboplatin (AUC 6 according to Calvert) plus paclitaxel (175 mg/m(2)3-h infusion) every 4 weeks in the first line treatment of patients affected by extensive small cell lung cancer. The primary end-point of the trial was the objective response rate. 31 objective responses among 50 patients were considered necessary to proceed to a phase 3 trial. 48 patients were enrolled (median age 59 years). Treatment was very well tolerated. 3 patients (6.2%) had a complete response and 23 (47.9%) a partial response, for an overall response rate of 54.2% (95% CI: 39.2-68.6). Median time to progression was 5.7 months (95% CI: 5.2-6.2). Median survival was 9.6 months (95% CI: 7.2-14.6), with a median follow-up time of alive patients of 12 months. At 1 year, the probability of being progression-free or alive was 0.16 and 0.43, respectively. In conclusion, carboplatin plus paclitaxel as given in the present study is very well tolerated but not sufficiently active to warrant phase 3 comparison with standard chemotherapy regimens.
authors.affiliation: Oncologia Medica B, Istituto Nazionale Tumori, Naples.
authors.forename: C
authors.initials: C
authors.lastname: Gridelli
authors.forename: L
authors.initials: L
authors.lastname: Manzione
authors.forename: F
authors.initials: F
authors.lastname: Perrone
authors.forename: E
authors.initials: E
authors.lastname: Veltri
authors.forename: R
authors.initials: R
authors.lastname: Cioffi
authors.forename: M G
authors.initials: MG
authors.lastname: Caprio
authors.forename: L
authors.initials: L
authors.lastname: Frontini
authors.forename: A
authors.initials: A
authors.lastname: Rossi
authors.forename: E
authors.initials: E
authors.lastname: Barletta
authors.forename: M L
authors.initials: ML
authors.lastname: Barzelloni
authors.forename: D
authors.initials: D
authors.lastname: Bilancia
authors.forename: C
authors.initials: C
authors.lastname: Gallo
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D016190:Carboplatin / Q000008:administration & dosage; D018288:Carcinoma, Small Cell / Q000188:drug therapy* / Q000473:pathology; D018572:Disease-Free Survival; D004334:Drug Administration Schedule; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000473:pathology; D008297:Male; D008875:Middle Aged; D017239:Paclitaxel / Q000008:administration & dosage
chemical_list: D016190:Carboplatin; D017239:Paclitaxel