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Phase II study of exatecan mesylate (DX-8951f) as first line therapy for advanced non-small cell lung cancer.

Journal Article


Abstract


  • BACKGROUND:Exatecan mesylate (DX-8951f) is a water soluble analogue of camptothecin that inhibits topoisomerase I. This multi-centre phase II study evaluated the activity of single agent exatecan in previously untreated patients with advanced non-small cell lung cancer (NSCLC). PATIENTS AND METHODS:Patients with histologically or cytologically proven stage IIIb or IV NSCLC were treated with exatecan 0.5 mg/m(2) per day by 30 min intra-venous (i.v.) infusion for 5 days every 3 weeks to a maximum of six cycles. Measurable disease was documented prior to study entry and patients were re-staged every two cycles. Pharmacokinetic (PK) sampling was performed during cycle one. RESULTS:39 patients (32 patients ECOG performance status 0 or 1; 29 male and ten female; mean age 63 years) were entered into the study. Thirty-three completed at least two cycles of exatecan and 11 completed six cycles. Two patients (5.1%, 95% C.I. 0.3-21.3%) had a partial response, 7 (18.0%) minor response and 8 (20.5%) stable disease. Median time to tumour progression (TTP) was 88 days and median overall survival 262 days. The main toxicity was reversible neutropenia. PK analysis of exatecan demonstrated a mean clearance of 2.28 l/h per m(2), volume of distribution 18.2 l/m(2) and mean elimination half-life of 7.9 h. CONCLUSIONS:Exatecan mesylate has limited activity in advanced NSCLC and is not recommended for further evaluation as a single agent in this tumour type. PK data from this trial supports results established in phase I studies.

UOW Authors


  •   Ranson, Marie (external author)

Publication Date


  • 2003

Citation


  • Braybrooke, J. P., Ranson, M., Manegold, C., Mattson, K., Thatcher, N., Cheverton, P., . . . Talbot, D. C. (2003). Phase II study of exatecan mesylate (DX-8951f) as first line therapy for advanced non-small cell lung cancer.. Lung cancer (Amsterdam, Netherlands), 41(2), 215-219. doi:10.1016/s0169-5002(03)00190-9

Web Of Science Accession Number


Start Page


  • 215

End Page


  • 219

Volume


  • 41

Issue


  • 2

Abstract


  • BACKGROUND:Exatecan mesylate (DX-8951f) is a water soluble analogue of camptothecin that inhibits topoisomerase I. This multi-centre phase II study evaluated the activity of single agent exatecan in previously untreated patients with advanced non-small cell lung cancer (NSCLC). PATIENTS AND METHODS:Patients with histologically or cytologically proven stage IIIb or IV NSCLC were treated with exatecan 0.5 mg/m(2) per day by 30 min intra-venous (i.v.) infusion for 5 days every 3 weeks to a maximum of six cycles. Measurable disease was documented prior to study entry and patients were re-staged every two cycles. Pharmacokinetic (PK) sampling was performed during cycle one. RESULTS:39 patients (32 patients ECOG performance status 0 or 1; 29 male and ten female; mean age 63 years) were entered into the study. Thirty-three completed at least two cycles of exatecan and 11 completed six cycles. Two patients (5.1%, 95% C.I. 0.3-21.3%) had a partial response, 7 (18.0%) minor response and 8 (20.5%) stable disease. Median time to tumour progression (TTP) was 88 days and median overall survival 262 days. The main toxicity was reversible neutropenia. PK analysis of exatecan demonstrated a mean clearance of 2.28 l/h per m(2), volume of distribution 18.2 l/m(2) and mean elimination half-life of 7.9 h. CONCLUSIONS:Exatecan mesylate has limited activity in advanced NSCLC and is not recommended for further evaluation as a single agent in this tumour type. PK data from this trial supports results established in phase I studies.

UOW Authors


  •   Ranson, Marie (external author)

Publication Date


  • 2003

Citation


  • Braybrooke, J. P., Ranson, M., Manegold, C., Mattson, K., Thatcher, N., Cheverton, P., . . . Talbot, D. C. (2003). Phase II study of exatecan mesylate (DX-8951f) as first line therapy for advanced non-small cell lung cancer.. Lung cancer (Amsterdam, Netherlands), 41(2), 215-219. doi:10.1016/s0169-5002(03)00190-9

Web Of Science Accession Number


Start Page


  • 215

End Page


  • 219

Volume


  • 41

Issue


  • 2