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

2.50
Hdl Handle:
http://hdl.handle.net/10541/78181
Title:
Phase II study of exatecan mesylate (DX-8951f) as first line therapy for advanced non-small cell lung cancer.
Authors:
Braybrooke, J P; Ranson, Malcolm R; Manegold, Christian; Mattson, K; Thatcher, Nick; Cheverton, P; Sekiguchi, M; Suzuki, M; Oyama, R; Talbot, D C
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.
Affiliation:
Cancer Research UK Medical Oncology Unit, Churchill Hospital, Oxford OX3 7LJ, UK.
Citation:
Phase II study of exatecan mesylate (DX-8951f) as first line therapy for advanced non-small cell lung cancer. 2003, 41 (2):215-9 Lung Cancer
Journal:
Lung Cancer
Issue Date:
Aug-2003
URI:
http://hdl.handle.net/10541/78181
PubMed ID:
12871785
Type:
Article
Language:
en
ISSN:
0169-5002
Appears in Collections:
All Christie Publications

Full metadata record

DC FieldValue Language
dc.contributor.authorBraybrooke, J P-
dc.contributor.authorRanson, Malcolm R-
dc.contributor.authorManegold, Christian-
dc.contributor.authorMattson, K-
dc.contributor.authorThatcher, Nick-
dc.contributor.authorCheverton, P-
dc.contributor.authorSekiguchi, M-
dc.contributor.authorSuzuki, M-
dc.contributor.authorOyama, R-
dc.contributor.authorTalbot, D C-
dc.date.accessioned2009-08-21T12:09:52Z-
dc.date.available2009-08-21T12:09:52Z-
dc.date.issued2003-08-
dc.identifier.citationPhase II study of exatecan mesylate (DX-8951f) as first line therapy for advanced non-small cell lung cancer. 2003, 41 (2):215-9 Lung Canceren
dc.identifier.issn0169-5002-
dc.identifier.pmid12871785-
dc.identifier.urihttp://hdl.handle.net/10541/78181-
dc.description.abstractBACKGROUND: 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.en
dc.language.isoenen
dc.subjectLung Canceren
dc.subjectCancer Metastasisen
dc.subjectCancer Stagingen
dc.subject.meshAdult-
dc.subject.meshAged-
dc.subject.meshAntineoplastic Agents, Phytogenic-
dc.subject.meshCamptothecin-
dc.subject.meshCarcinoma, Non-Small-Cell Lung-
dc.subject.meshDrug Administration Schedule-
dc.subject.meshFemale-
dc.subject.meshFinland-
dc.subject.meshGermany-
dc.subject.meshGreat Britain-
dc.subject.meshHumans-
dc.subject.meshInfusions, Intravenous-
dc.subject.meshJapan-
dc.subject.meshLung Neoplasms-
dc.subject.meshMale-
dc.subject.meshMiddle Aged-
dc.subject.meshNeoplasm Metastasis-
dc.subject.meshNeoplasm Staging-
dc.subject.meshSurvival Analysis-
dc.subject.meshTreatment Outcome-
dc.titlePhase II study of exatecan mesylate (DX-8951f) as first line therapy for advanced non-small cell lung cancer.en
dc.typeArticleen
dc.contributor.departmentCancer Research UK Medical Oncology Unit, Churchill Hospital, Oxford OX3 7LJ, UK.en
dc.identifier.journalLung Canceren

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