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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

Permanent lenke
https://hdl.handle.net/10037/25325
DOI
https://doi.org/10.1038/bjc.2012.284
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article.pdf (245.5Kb)
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Dato
2012-07-03
Type
Journal article
Tidsskriftartikkel
Peer reviewed

Forfatter
Fløtten, Øystein; Grønberg, Bjørn Henning; Bremnes, Roy M.; Amundsen, Tore; Sundstrøm, Stein Harald; Rolke, Heidi; HORNSLIEN, KJERSTI; Wentzel-Larsen, Tore; Aasebø, Ulf; von Plessen, Christian
Sammendrag
BACKGROUND: 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.

METHODS: 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. þ gemcitabine 1000 mg m -2 i.v. day 1 and 8 (VG) or vinorelbine 60 mg m-2 p.o. day 1 and 8 þ carboplatin area under the curve ¼ 5 (Calvert’s formula) i.v. day 1 (VC). Patients X75 years received 75% of the dose. Endpoints were overall survival, health-related quality of life (HRQoL), toxicity, and the use of radiotherapy.

RESULTS: 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 ¼ 0.802. Vinorelbine plus carboplatin patients had more grade III/IV nausea/vomiting (VG: 4%, VC: 12%, P ¼ 0.008) and grade IV neutropenia (VG: 7%, VC: 19%, Po0.001). Infections, HRQoL and the use of radiotherapy did not differ significantly between the treatment groups.

CONCLUSION: The two regimens yielded similar overall survival. The VG combination had only a slightly better toxicity profile.

Forlag
Springer Nature
Sitering
Fløtten Ø, Grønberg BH, Bremnes RM, Amundsen T, Sundstrøm SH, Rolke H, HORNSLIEN K, Wentzel-Larsen T, Aasebø U, von Plessen C. 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. British Journal of Cancer. 2012;107(3):442-447
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Copyright 2012 The Author(s)

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