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Clinical Trial
. 2012 Jul 24;107(3):442-7.
doi: 10.1038/bjc.2012.284. Epub 2012 Jul 3.

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

Ø Fløtten  1 , B H Grønberg, R Bremnes, T Amundsen, S Sundstrøm, H Rolke, K Hornslien, T Wentzel-Larsen, U Aasebø, C von Plessen
Affiliations
Clinical Trial

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

Ø Fløtten et al. Br J Cancer. .

Abstract

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.+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.

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=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.

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

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Figures

Figure 1
Figure 1
CONSORT diagram.
Figure 2
Figure 2
Kaplan–Meier survival plots according to the treatment arms.
See this image and copyright information in PMC

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