title: The combination of carboplatin and weekly paclitaxel: a safe and active regimen in advanced non small-cell lung cancer patients. A phase I-II study.
abstract: The combination of carboplatin and paclitaxel given every three weeks is a tolerated and reasonably active regimen in advanced non-small cell lung cancer (NSCLC). This study was designed to evaluate the maximum tolerated dose (MTD) of a fixed dose of carboplatin with an area under the curve (AUC) of 6 and escalating doses of weekly paclitaxel with an initial dose of 50 mg/m2 with 10 mg/m2 increments at each level in untreated NSCLC patients (phase I study). The study continued with a phase II study. Thirty patients entered the phase I study. The MTD was: carboplatin AUC = 6 on days 1 and 28 plus paclitaxel 100 mg/m2 (1 hour) on days 1, 8,15, 28. The dose-limiting toxicity (DLT) was severe neutropenia and cardiological toxicity. Subsequently, 42 patients entered the phase II study with the same treatment schedule. The 2-drug combination was globally well tolerated. The overall response rate (RR) was 42% [CI 95%: 26.3-57.7], stable disease (SD) 29% and progression (PD) 29%. The median duration of response was 8.0 mos (range: 1.0-19.0). The median time to progression was 8.0 mos (range: 7.0-19.0) and the median survival was 14.0 months (range: 9.0-19.0). The association of carboplatin AUC = 6 and weekly paclitaxel 100 mg/m2 proved to be manageable, active and extremely safe even in elderly patients (one third of all patients in our cohort). The survival results were interesting: the median survival time was 14 months (9-19 months) and the 1- and 2-year survival was 59% and 16%, respectively.
authors.affiliation: Dept. of Medical Oncology, Regina Elena National Cancer Institute, Rome, Italy. alessandra.fabi@virgilio.it
authors.forename: A
authors.initials: A
authors.lastname: Fabi
authors.forename: M
authors.initials: M
authors.lastname: Barduagni
authors.forename: V
authors.initials: V
authors.lastname: Ferraresi
authors.forename: E
authors.initials: E
authors.lastname: Cortesi
authors.forename: T
authors.initials: T
authors.lastname: Gamucci
authors.forename: F
authors.initials: F
authors.lastname: De Marinis
authors.forename: R
authors.initials: R
authors.lastname: Saltarelli
authors.forename: A
authors.initials: A
authors.lastname: Gabriele
authors.forename: M
authors.initials: M
authors.lastname: Pellicciotta
authors.forename: A
authors.initials: A
authors.lastname: Ceribelli
authors.forename: S
authors.initials: S
authors.lastname: De Marco
authors.forename: F
authors.initials: F
authors.lastname: Facciolo
authors.forename: F
authors.initials: F
authors.lastname: Cognetti
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D019540:Area Under Curve; D016190:Carboplatin / Q000008:administration & dosage*; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000401:mortality; D015331:Cohort Studies; D018450:Disease Progression; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000401:mortality; D008297:Male; D020714:Maximum Tolerated Dose; D008875:Middle Aged; D009362:Neoplasm Metastasis; D017239:Paclitaxel / Q000008:administration & dosage*; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D016190:Carboplatin; D017239:Paclitaxel