Vinorelbine and gemcitabine vs vinorelbine and carboplatin as first-line treatment of advanced NSCLC. A phase III randomised controlled trial by the Norwegian Lung Cancer Study Group.

Détails

ID Serval
serval:BIB_36C2BD9D5E0A
Type
Article: article d'un périodique ou d'un magazine.
Collection
Publications
Titre
Vinorelbine and gemcitabine vs vinorelbine and carboplatin as first-line treatment of advanced NSCLC. A phase III randomised controlled trial by the Norwegian Lung Cancer Study Group.
Périodique
British journal of cancer
Auteur⸱e⸱s
Fløtten Ø., Grønberg B.H., Bremnes R., Amundsen T., Sundstrøm S., Rolke H., Hornslien K., Wentzel-Larsen T., Aasebø U., von Plessen C.
ISSN
1532-1827 (Electronic)
ISSN-L
0007-0920
Statut éditorial
Publié
Date de publication
24/07/2012
Peer-reviewed
Oui
Volume
107
Numéro
3
Pages
442-447
Langue
anglais
Notes
Publication types: Clinical Trial, Phase III ; Journal Article ; Multicenter Study ; Randomized Controlled Trial
Publication Status: ppublish
Résumé
Platinum-based doublet chemotherapy is the standard first-line treatment for advanced non-small cell lung cancer (NSCLC), but earlier studies have suggested that non-platinum combinations are equally effective and better tolerated. We conducted a national, randomised study to compare a non-platinum with a platinum combination.
Eligible patients had stage IIIB/IV NSCLC and performance status (PS) 0-2. Patients received up to three cycles of vinorelbine 60 mg m(-2) p.o.+gemcitabine 1000 mg m(-2) i.v. day 1 and 8 (VG) or vinorelbine 60 mg m(-2) p.o. day 1 and 8+carboplatin area under the curve=5 (Calvert's formula) i.v. day 1 (VC). Patients ≥75 years received 75% of the dose. Endpoints were overall survival, health-related quality of life (HRQoL), toxicity, and the use of radiotherapy.
We randomised 444 patients from September 2007 to April 2009. The median age was 65 years, 58% were men and 25% had PS 2. Median survival was VG: 6.3 months; VC: 7.0 months, P=0.802. Vinorelbine plus carboplatin patients had more grade III/IV nausea/vomiting (VG: 4%, VC: 12%, P=0.008) and grade IV neutropenia (VG: 7%, VC: 19%, P<0.001). Infections, HRQoL and the use of radiotherapy did not differ significantly between the treatment groups.
The two regimens yielded similar overall survival. The VG combination had only a slightly better toxicity profile.
Mots-clé
Adult, Aged, Aged, 80 and over, Antineoplastic Combined Chemotherapy Protocols/therapeutic use, Carboplatin/administration & dosage, Carboplatin/adverse effects, Carcinoma, Non-Small-Cell Lung/drug therapy, Carcinoma, Non-Small-Cell Lung/pathology, Deoxycytidine/administration & dosage, Deoxycytidine/adverse effects, Deoxycytidine/analogs & derivatives, Female, Follow-Up Studies, Humans, Lung Neoplasms/drug therapy, Lung Neoplasms/pathology, Male, Middle Aged, Neoplasm Staging, Organoplatinum Compounds/administration & dosage, Organoplatinum Compounds/adverse effects, Quality of Life, Vinblastine/administration & dosage, Vinblastine/adverse effects, Vinblastine/analogs & derivatives, Vinorelbine, Gemcitabine
Pubmed
Web of science
Open Access
Oui
Création de la notice
10/03/2023 13:43
Dernière modification de la notice
28/04/2023 6:54
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