Phase II and pharmacologic study of weekly oral paclitaxel plus cyclosporine in patients with advanced non-small-cell lung cancer

C. M.F. Kruijtzer, J. H.M. Schellens, J. Mezger, M. E. Scheulen, U. Keilholz, J. H. Beijnen, H. Rosing, R. A.A. Mathôt, S. Marcus, H. Van Tinteren, P. Baas

Onderzoeksoutput: Bijdrage aan tijdschriftArtikelpeer review

52 Citaten (Scopus)


Purpose: A phase II study was performed to assess the efficacy and toxicity of oral cyclosporine (CsA) plus paclitaxel in advanced non-small-cell lung cancer (NSCLC). Patients and Methods: Chemotherapy-naive or previously treated patients (one regimen) with measurable disease and World Health Organization performance status ≤ 2 were eligible. Oral paclitaxel was given weekly in a dose of 90 mg/m2 bid. CsA (10 mg/kg) was given 30 minutes before each dose of oral paclitaxel. Results: Twenty-six patients with a median age of 54 years (range, 32 to 77 years) were entered onto this study. Eighteen patients (69%) had received one prior chemotherapy regimen. The most frequently recorded toxicities were as follows: National Cancer Institute common toxicity criteria grade 3 neutropenia, eight patients (31%); grade 4, six patients (23%); grade 4 febrile neutropenia, three patients (12%); grade 2/3 neurotoxicity, three patients (12%); and grade 2 nail changes, four patients (15%). The overall response rate (ORR) of the 23 assessable patients was 26% (95% confidence interval [CI], 10% to 48%). In the intention-to-treat population, the ORR was 23% (95% CI, 9% to 44%). The median time to progression was 3.5 months (95% CI, 1.2 to 3.9 months), and median overall survival was 6.0 months (95% CI, 2.3 months to not available). Pharmacokinetics revealed that the mean area under the concentration-time curve (AUC) of oral paclitaxel was 5.0 ± 2.3 μmol/L/h in week 1 and 4.6 ± 2.0 μmol/L/h in week 2, with interpatient variabilities (coefficient of variation [%CV]) of 45% and 42%, respectively. The intrapatient variability (%CV) of the AUC was 14.5%. Conclusion: Oral paclitaxel plus CsA is active and safe in advanced NSCLC, including in patients previously treated with chemotherapy.

Originele taal-2Engels
Pagina's (van-tot)4508-4516
Aantal pagina's9
TijdschriftJournal of Clinical Oncology
Nummer van het tijdschrift23
StatusGepubliceerd - 1 dec. 2002
Extern gepubliceerdJa


Duik in de onderzoeksthema's van 'Phase II and pharmacologic study of weekly oral paclitaxel plus cyclosporine in patients with advanced non-small-cell lung cancer'. Samen vormen ze een unieke vingerafdruk.

Citeer dit