Real-life patterns of use and effectiveness of bortezomib: the VESUVE cohort study

Abstract

In response to a regulatory request for real-life data on patterns of use and survival outcomes, 793 patients initiating bortezomib for multiple myeloma in France (May 2004–April 2006) were included in this observational study. Data were collected from medical files and patients were followed for 2 years, with vital status collected after 3 years. In total 779 patients were analyzed: 83.1% had immunoglobulin G (IgG) or IgA M-component, mean age was 65.7 years and 46.5% were female. Bortezomib was initiated as third-or-later line in 82.0%. For 75.9%, the starting dose was 1.3 mg/m²; 42.6% had bortezomib alone, 54.0% with dexamethasone. The mean number of bortezomib cycles was 5.0. Three-year overall survival from bortezomib initiation was 31.4% (95% confidence interval, CI [28.1; 34.7]) and median overall survival was 19.6 months. Two-year progression-free survival was 12.0% (95% CI [9.8; 14.4]), and median progression-free survival was 7.2 months. Overall best response was 44.0%. Survival outcomes during real-life use of bortezomib were within the range of those reported in clinical trials.

Keywords::

• Bortezomib
• multiple myeloma
• cohort studies
• survival analysis

Acknowledgements

The authors would like to thank all participating pharmacists and physicians, as well as the on-site clinical research assistants, ICTA France, for help in data collection, and Prof. Jean Soulier (Hôpital Saint-Louis, Paris) for help with cytogenetics data. The authors would also like to thank Dr. Sylvie Blazejewski, Alise Le Monies De Sagazan, Ludovic Liège, Dr. Patrick Bouex, Aurélie Balestra, Karelle Forest, Sophie Pichard, and all members of the data collection team for their work on the study (Université de Bordeaux).

Potential conflict of interest:

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