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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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References

    1. Aaronson NK, Ahmedzai S, Bergman B, Bullinger M, Cull A, Duez NJ, Filiberti A, Flechtner H, Fleishman SB, de Haes JC (1993) The European Organization for Research and Treatment of Cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology. J Natl Cancer Inst 85: 365–376 - PubMed
    1. Alberola V, Camps C, Provencio M, Isla D, Rosell R, Vadell C, Bover I, Ruiz-Casado A, Azagra P, Jimenez U, Gonzales-Larriba JL, Diz P, Cardenal F, Artal A, Carrato A, Morales S, Sanches JJ, de Las PR, Felip E, Lopez-Vivanco G (2003) Cisplatin plus gemcitabine versus a cisplatin-based triplet versus nonplatinum sequential doublets in advanced non-small-cell lung cancer: a Spanish Lung Cancer Group phase III randomized trial. J Clin Oncol 21: 3207–3213 - PubMed
    1. Alberti W (1995) Chemotherapy in non-small cell lung cancer: a meta-analysis using updated data on individual patients from 52 randomised clinical trials. Non-small Cell Lung Cancer Collaborative Group. BMJ 311: 899–909 - PMC - PubMed
    1. Ardizzoni A, Tiseo M, Boni L, Rosell R, Fossella FV, Schiller JH, Paesmans M, Radosavljevic A, Paccagnella A, Mazzanti P, Bisset D (2006) CISCA (cisplatin vs carboplatin) meta-analysis: an individual patient data meta-analysis comparing cisplatin versus carboplatin-based chemotherapy in first-line treatment of advanced non-small cell lung cancer (NSCLC). J Clin Oncol 24: 18S [Abstract]
    1. Bergman B, Aaronson NK, Ahmedzai S, Kaasa S, Sullivan M (1994) The EORTC QLQ-LC13: a modular supplement to the EORTC Core Quality of Life Questionnaire (QLQ-C30) for use in lung cancer clinical trials. EORTC Study Group on Quality of Life. Eur J Cancer 30A: 635–642 - PubMed

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