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Clinical Trial
. 2007 Aug 6;97(3):283-9.
doi: 10.1038/sj.bjc.6603869. Epub 2007 Jun 26.

Vinorelbine/carboplatin vs gemcitabine/carboplatin in advanced NSCLC shows similar efficacy, but different impact of toxicity

N Helbekkmo  1 , S H Sundstrøm, U Aasebø, P Fr Brunsvig, C von Plessen, H H Hjelde, O K Garpestad, A Bailey, R M Bremnes; Norwegian Lung Cancer Study Group
Affiliations
Clinical Trial

Vinorelbine/carboplatin vs gemcitabine/carboplatin in advanced NSCLC shows similar efficacy, but different impact of toxicity

N Helbekkmo et al. Br J Cancer. .

Abstract

This randomised phase III study in advanced non-small cell lung cancer (NSCLC) patients was conducted to compare vinorelbine/carboplatin (VC) and gemcitabine/carboplatin (GC) regarding efficacy, health-related quality of life (HRQOL) and toxicity. Chemonaive patients with NSCLC stage IIIB/IV and WHO performance status 0-2 were eligible. No upper age limit was defined. Patients received vinorelbine 25 mg m(-2) or gemcitabine 1000 mg m(-2) on days 1 and 8 and carboplatin AUC4 on day 1 and three courses with 3-week cycles. HRQOL questionnaires were completed at baseline, before chemotherapy and every 8 weeks until 49 weeks. During 14 months, 432 patients were included (VC, n=218; GC, n=214). Median survival was 7.3 vs 6.4 months, 1-year survival 28 vs 30% and 2-year survival 7 vs 7% in the VC and GC arm, respectively (P=0.89). HRQOL, represented by global QOL, nausea/vomiting, dyspnoea and pain, showed no significant differences. More grade 3-4 anaemia (P<0.01), thrombocytopenia (P<0.01) and transfusions of blood (P<0.01) or platelets (P<0.01) were observed in the GC arm. There was more grade 3-4 leucopoenia (P<0.01) in the VC arm, but the rate of neutropenic infections was the same (P=0.87). In conclusion, overall survival and HRQOL are similar, while grade 3-4 toxicity requiring interventions are less frequent when VC is compared to GC in advanced NSCLC.

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Figures

Figure 1
Figure 1
Flow of patients through each stage of the study.
Figure 2
Figure 2
Overall survival according to treatment arms. (A) Survival for all study patients; VC (n=218, censored n=12) and GC (n=214, censored=11). (B) Survival for PS 0/1 patients; VC (n=156, censored n=11) and GC (n=153, censored n=9).
Figure 3
Figure 3
Health-related quality of life scores (weeks 0–17) for global QOL, nausea/vomiting, pain, and dyspnoea according to treatment arm.
See this image and copyright information in PMC

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