Management of chronic myeloid leukaemia in clinical practice in France: results of the French subset of patients from the UNIC study

Abstract

Objective:

To assess real-life treatment practices with imatinib for chronic-phase chronic myeloid leukaemia (CP-CML) in France.

Research design and methods:

In the observational ‘Unmet Needs in CML’ (UNIC) study of CML management in Europe, case report forms were completed retrospectively for eligible patients (≥18 years of age, currently treated for CML) during enrolment (September 2006–March 2007). Results from the subset of patients from France are presented.

Main outcome measures:

Primary objectives were to estimate from the collected data the proportions of patients ever treated with imatinib and those experiencing imatinib resistance and/or intolerance as determined by physicians’ diagnoses of resistance/intolerance leading to a change in imatinib use. Collected data were analysed descriptively. Secondary descriptive measures included imatinib dose modifications and methods for treatment response monitoring.

Results:

Of the 654 French CP-CML patients, 95.9% had received imatinib. Of these, 15% were judged by physicians as imatinib-resistant and 31% as imatinib-intolerant (not mutually exclusive) during treatment, 44% required dose modification and 23% discontinued imatinib. In the 12 months preceding the last observation, 65% had a cytogenetic features analysis and 93% had a polymerase chain reaction (PCR) assessment of molecular response. Importantly, and contrasting with European recommendations, 46% of imatinib-resistant patients had never been assessed for BCR-ABL mutations.

Limitations:

The observational study design limits data collection and interpretation. The findings are specific to the French healthcare system and may not apply to other countries.

Conclusion:

This observational study of CP-CML management in France confirmed that most patients are treated with imatinib, a treatment widely recognised as efficacious. The study highlights opportunities for optimising CML management, as a proportion of patients may require alternative treatment strategies due to imatinib resistance/intolerance. Response monitoring rates differ from recommendations, representing another opportunity for improving care for CP-CML patients through early identification of patients failing current therapy.

Key words::

• Chronic myeloid leukaemia
• Disease management
• Drug resistance
• Health resources
• Imatinib
• Toxicity

Transparency

Declaration of funding

This study was supported by Bristol-Myers Squibb.

Declaration of financial/other relationships

M.M., Principal Investigator for France, has disclosed that she received an honorarium from Bristol-Myers Squibb for the coordination of the UNIC study in France. S.C. has disclosed that he received an honorarium from Bristol-Myers Squibb for collecting patient data for the UNIC study. A.O. and B.B. have disclosed that they are employees of Bristol-Myers Squibb. The other authors have no conflicts of interest to declare.

Acknowledgement

Editorial assistance was provided by Ogilvy Healthworld Medical Education, funded by Bristol-Myers Squibb.

The authors thank the investigators from each participating centre in France involved in this study: M.-A. Bichoffe/D. Denizon (CHG de Montluçon, Montluçon); O. Boulat (Centre Hospitalier Henri Duffaut, Avignon); S. Cailleres (Centre Hospitalier du Pays d'Aix, Aix en Provence); N. Cambier (Centre Hospitalier Saint Vincent, Lille); M. Carreiro (CH Montauban, Montauban); C. Chaleteix (Hôtel Dieu, Clermont Ferrand); D. Christian (Hôpital du Bon Secours, Metz); S. Corm (Hôpital Claude Huriez, Lille); J.-C. Eisenmann (Hôpital Emile Muller, Mulhouse Cédex); M. Gardembas (Centre Hospitalier Universitaire d'Angers, Angers); K. Ghomari (Centre Hospitalier de Beauvais, Beauvais); A. Guerci-Bresler (CHU Brabois, Vandoeuvre les Nancy); M. Hacini (Centre Hospitalier, Chambery); F. Huguet (CHU Purpan, Toulouse); F. Maloisel (Hôpital Civil, Strasbourg); B. Pignon (CHU Reims, Reims); J. Reiffers (Institut Bergonié, Bordeaux); F. Teillet (Hôpital Louis Mourier, Colombes); P. Tuilliez (Hôpital Henri Mondor, Creteil); X. Vallantin (Hôpital Saint Jean, Perpignan); A. Vekhoff (Hotel Dieu Paris, Paris).

They also thank Patricia Hines, Bristol-Myers Squibb, for support with data analysis.

Data on the French cohort of patients from the UNIC study have been presented as an abstract and poster at the European Hematology Association Annual Meeting, Copenhagen, Denmark, 12–15 June 2008. Data pertaining to the original study detailing the results of the entire European patient sample have been presented as abstracts and posters at the American Society of Hematology Annual Meeting, Atlanta, GA, USA, 8–10 December 2007.