Randomized phase II study of cetuximab plus cisplatin/vinorelbine compared with cisplatin/vinorelbine alone as first-line therapy in EGFR-expressing advanced non-small-cell lung cancer.

2.50
Hdl Handle:
http://hdl.handle.net/10541/55819
Title:
Randomized phase II study of cetuximab plus cisplatin/vinorelbine compared with cisplatin/vinorelbine alone as first-line therapy in EGFR-expressing advanced non-small-cell lung cancer.
Authors:
Rosell, Rafael; Robinet, G; Szczesna, A; Ramlau, R; Constenla, M; Mennecier, B C; Pfeifer, W; O'Byrne, Kenneth J; Welte, T; Kolb, R; Pirker, R; Chemaissani, A; Perol, M; Ranson, Malcolm R; Ellis, Paul A; Pilz, K; Reck, Martin
Abstract:
BACKGROUND: The Lung Cancer Cetuximab Study is an open-label, randomized phase II pilot study of cisplatin and vinorelbine combined with the epidermal growth factor receptor (EGFR)-targeted monoclonal antibody cetuximab versus cisplatin and vinorelbine alone, in patients with advanced EGFR-expressing, non-small-cell lung cancer (NSCLC). End points of the study are activity, safety and pharmacokinetics. PATIENTS AND METHODS: Following randomization, for a maximum of eight cycles, patients received three-weekly cycles of cisplatin (80 mg/m(2), day 1) and vinorelbine (25 mg/m(2) on days 1 and 8) alone or following cetuximab treatment (initial dose 400 mg/m(2), followed by 250 mg/m(2) weekly thereafter). RESULTS: Eighty-six patients were randomly allocated to the study (43 per arm). Confirmed response rates were 28% in the cisplatin/vinorelbine arm (A) and 35% in the cetuximab plus cisplatin/vinorelbine arm (B). Median progression-free survival (PFS) was 4.6 months in arm A and 5.0 months in arm B, with PFS rates at 12 months of 0% and 15%, respectively. Median survival was 7.3 months in arm A and 8.3 months in arm B. The 24-month survival rates were 0% and 16%, respectively. The cetuximab combination was well tolerated. CONCLUSION: In the first-line treatment of advanced NSCLC, the combination of cetuximab plus cisplatin/vinorelbine demonstrated an acceptable safety profile and the potential to improve activity over cisplatin/vinorelbine alone.
Affiliation:
Catalan Institute of Oncology, Hospital Germans Trias i Pujol, Badalona, Barcelona, Spain. rrosell@ico.scs.es
Citation:
Randomized phase II study of cetuximab plus cisplatin/vinorelbine compared with cisplatin/vinorelbine alone as first-line therapy in EGFR-expressing advanced non-small-cell lung cancer. 2008, 19 (2):362-9 Ann. Oncol.
Journal:
Annals of Oncology
Issue Date:
Feb-2008
URI:
http://hdl.handle.net/10541/55819
DOI:
10.1093/annonc/mdm474
PubMed ID:
17947225
Type:
Article
Language:
en
ISSN:
1569-8041
Appears in Collections:
All Christie Publications ; Medical Oncology

Full metadata record

DC FieldValue Language
dc.contributor.authorRosell, Rafael-
dc.contributor.authorRobinet, G-
dc.contributor.authorSzczesna, A-
dc.contributor.authorRamlau, R-
dc.contributor.authorConstenla, M-
dc.contributor.authorMennecier, B C-
dc.contributor.authorPfeifer, W-
dc.contributor.authorO'Byrne, Kenneth J-
dc.contributor.authorWelte, T-
dc.contributor.authorKolb, R-
dc.contributor.authorPirker, R-
dc.contributor.authorChemaissani, A-
dc.contributor.authorPerol, M-
dc.contributor.authorRanson, Malcolm R-
dc.contributor.authorEllis, Paul A-
dc.contributor.authorPilz, K-
dc.contributor.authorReck, Martin-
dc.date.accessioned2009-03-16T17:15:22Z-
dc.date.available2009-03-16T17:15:22Z-
dc.date.issued2008-02-
dc.identifier.citationRandomized phase II study of cetuximab plus cisplatin/vinorelbine compared with cisplatin/vinorelbine alone as first-line therapy in EGFR-expressing advanced non-small-cell lung cancer. 2008, 19 (2):362-9 Ann. Oncol.en
dc.identifier.issn1569-8041-
dc.identifier.pmid17947225-
dc.identifier.doi10.1093/annonc/mdm474-
dc.identifier.urihttp://hdl.handle.net/10541/55819-
dc.description.abstractBACKGROUND: The Lung Cancer Cetuximab Study is an open-label, randomized phase II pilot study of cisplatin and vinorelbine combined with the epidermal growth factor receptor (EGFR)-targeted monoclonal antibody cetuximab versus cisplatin and vinorelbine alone, in patients with advanced EGFR-expressing, non-small-cell lung cancer (NSCLC). End points of the study are activity, safety and pharmacokinetics. PATIENTS AND METHODS: Following randomization, for a maximum of eight cycles, patients received three-weekly cycles of cisplatin (80 mg/m(2), day 1) and vinorelbine (25 mg/m(2) on days 1 and 8) alone or following cetuximab treatment (initial dose 400 mg/m(2), followed by 250 mg/m(2) weekly thereafter). RESULTS: Eighty-six patients were randomly allocated to the study (43 per arm). Confirmed response rates were 28% in the cisplatin/vinorelbine arm (A) and 35% in the cetuximab plus cisplatin/vinorelbine arm (B). Median progression-free survival (PFS) was 4.6 months in arm A and 5.0 months in arm B, with PFS rates at 12 months of 0% and 15%, respectively. Median survival was 7.3 months in arm A and 8.3 months in arm B. The 24-month survival rates were 0% and 16%, respectively. The cetuximab combination was well tolerated. CONCLUSION: In the first-line treatment of advanced NSCLC, the combination of cetuximab plus cisplatin/vinorelbine demonstrated an acceptable safety profile and the potential to improve activity over cisplatin/vinorelbine alone.en
dc.language.isoenen
dc.subjectCetuximaben
dc.subjectCisplatinen
dc.subjectEpidermal Growth Factor Receptoren
dc.subjectLung Canceren
dc.subject.meshAdult-
dc.subject.meshAged-
dc.subject.meshAntibodies, Monoclonal-
dc.subject.meshAntineoplastic Combined Chemotherapy Protocols-
dc.subject.meshCarcinoma, Non-Small-Cell Lung-
dc.subject.meshCisplatin-
dc.subject.meshConfidence Intervals-
dc.subject.meshDose-Response Relationship, Drug-
dc.subject.meshDrug Administration Schedule-
dc.subject.meshFemale-
dc.subject.meshFollow-Up Studies-
dc.subject.meshHumans-
dc.subject.meshLung Neoplasms-
dc.subject.meshMale-
dc.subject.meshMaximum Tolerated Dose-
dc.subject.meshMiddle Aged-
dc.subject.meshNeoplasm Invasiveness-
dc.subject.meshNeoplasm Staging-
dc.subject.meshProbability-
dc.subject.meshReference Values-
dc.subject.meshRisk Assessment-
dc.subject.meshSurvival Analysis-
dc.subject.meshTreatment Outcome-
dc.subject.meshVinblastine-
dc.titleRandomized phase II study of cetuximab plus cisplatin/vinorelbine compared with cisplatin/vinorelbine alone as first-line therapy in EGFR-expressing advanced non-small-cell lung cancer.en
dc.typeArticleen
dc.contributor.departmentCatalan Institute of Oncology, Hospital Germans Trias i Pujol, Badalona, Barcelona, Spain. rrosell@ico.scs.esen
dc.identifier.journalAnnals of Oncologyen

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