Gemcitabine plus vinorelbine in advanced non-small cell lung cancer: a phase II study of three different doses View Full Text


Ontology type: schema:ScholarlyArticle      Open Access: True


Article Info

DATE

2000-08-17

AUTHORS

C Gridelli, L Frontini, F Perrone, C Gallo, M Gulisano, S Cigolari, F Castiglione, S F Robbiati, G Gasparini, G P Ianniello, A Farris, M C Locatelli, R Felletti, E Piazza, ,

ABSTRACT

Our aim was to study the activity and toxicity of the gemcitabine plus vinorelbine (Gem Vin) combination and to identify the optimal dose. Previously untreated patients aged < 70 years, with stage IV or IIIb (not candidates for radiotherapy) non-small cell lung cancer were eligible. Studied dose-levels of Gem Vin, administered on days 1 and 8 every 3 weeks, were (mg m(-2)): level I = 1000/25; level II = 1200/25; level III = 1000/30; level IV = 1200/30. A feasibility study was performed at each dose-level, followed by a single-stage phase II study. Dose-level IV was unfeasible because of grade 4 neutropenia. Overall, out of 126 patients enrolled in phase II studies, there were one complete and 32 partial responses (response rate 26%: 95% CI 18-34%). Response rates were 27.9%, 21.4% and 29.3% at levels I, II and III, respectively. The treatment was well tolerated. Toxicity was less frequent and severe at level I. Overall median survival was 33 weeks (95% CI 28-40). Descriptive quality of life analysis showed that patients with a worse baseline global health status score tended to drop out of the study earlier than those with a better score. Gem Vin is feasible at different doses. It is sufficiently active and well tolerated. A phase III study to compare the effect on quality of life of Gem Vin (level I) vs cisplatin-based chemotherapy is ongoing. More... »

PAGES

707-714

References to SciGraph publications

Identifiers

URI

http://scigraph.springernature.com/pub.10.1054/bjoc.2000.1341

DOI

http://dx.doi.org/10.1054/bjoc.2000.1341

DIMENSIONS

https://app.dimensions.ai/details/publication/pub.1048815074

PUBMED

https://www.ncbi.nlm.nih.gov/pubmed/10952772


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