Transcript European CML Registry

CML Registry
Joerg Hasford, MD
Ludwig-Maximilians University
Munich, Germany
Speaker disclosed relations to Novartis
European CML Registry
M. Baccarani
J. Guilhot
B. Simonsson
Joerg Hasford
IBE
Email:
Italy
France
Sweden
Germany
Department of Medical Informatics, Biometry and Epidemiology,
Ludwig-Maximilians-Universität München
[email protected]
Structure
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Objectives
Clinical Data
Epidemiological data
Treatment survey
Discussion
Conclusions
European CML Registry
OBJECTIVES
Clinical
 to develop and validate
 a comprehensive prognostic model which allows to optimise
individual treatment choices
 in particular a prognostic model for treatment with imatinib
 to evaluate
 the impact of therapeutic drug monitoring, pharmacokinetics
and patients’ compliance during the course of CML
 the sequelae of discontinuation of treatment after complete
cytogenetic remission (CCR)
 the mechanisms and sequelae of imatinib failure
European CML Registry
OBJECTIVES
Epidemiological
 to collect baseline and treatment data of representative
samples of CML patients of all European countries
 to estimate the incidence of CML stratified for age, sex and
region
 to evaluate the medical management of CML patients using
the ELN recommendations
(Blood 2006;108:1809-20)
European CML Registry
OBJECTIVES
General
 to promote quality controlled molecular monitoring
 to foster continued medical education and spread of
excellence
 to develop and keep updated a core data set for CML
 to provide a platform for the expedited evaluation of new
treatments
 to promote European trials, meta-analyses and pooled data
analyses
Data provided by the
cooperating study groups
Study
Type
Treatment options
I - ICSG CML 21
Phase II
imatinib 800 mg
I - ICSG CML 22
Phase III
imatinib 400 mg vs 800 mg
117
I - ICSG CML 23
Phase II
imatinib 400mg
365
Phase II
4 arms imatinib treatment
904
E - CML/PETHEMA
Phase III
imatinib treatment
200
E - RELMC
Registry
any imatinib therapy
318
Nordic CML001
Phase III
imatinib 400mg vs 800mg
103
Nordic CML002
Phase II
imatinib 400 mg vs 400mg+PEG-IFN
50
ROM – Registry
Registry
any imatinib therapy
33
F - Spirit
Phase III
4 arms imatinib treatment
370
PL - Registry
Registry
any imatinib therapy
267
German gr. CML IV
Total
n
82
2809
Inclusion criteria
according to the CML Guidelines (Baccarani et al. Blood 2006)
Patients with Philadelphia positive or BCR/ABL
positive CML in early chronic phase* treated with
a tyrosine kinase inhibitor (mainly imatinib)
No age limitations
2062** of 2809 patients were included in the
registry
* Early chronic phase: patients in chronic phase and therapy begin with tyrosine kinase
inhibitors within six months after diagnosis.
** the number of accepted patients may decrease or increase slightly as baseline and
follow up data are not available for all patients yet; therefore inclusion criteria are
sometimes still missing.
Study data expected for the
European CML-Registry
Cooperation with the Austrian study group,
the OSHO study group, a Russian study
group, and the CAMELIA / INFINITY are in
progress.
European CML-Registry:
Baseline characteristics
n Sex (% female)
country
n
Median age in years
France
370
52 (18-81)
370
39
German group 565
53 (16-83)
565
41
Italy
563
52 (18-84)
559
40
Nordic group
136
51 (17-82)
91
45
Poland
86
48 (18-72)
89
42
Romania
7
38 (27-57)
10
40
E-PETHEMA
197
44 (18-71)
197
45
E-RELMC
131
46 (19-87)
131
35
European CML-Registry:
Results
Cytogenetic remission at month 12
complete
partial
minor
minimal
no response
Registry* (n=802)
75.4 % 13.0 %
3.6 %
3.9 %
4.1 %
Female* (n=325)
76.6 % 10.8 %
3.1 %
4.6 %
4.9 %
Male*
74.6 % 14.5 %
3.9 %
3.4 %
3.6 %
IRIS
(n=477)
69.0 % 16.0 %
All patients treated with imatinib 400 mg with or without co-medication, and
data included if t > 2 months.
* data was available of the German, Italian and Nordic study group
CML-Incidence and
treatment survey
Joerg Hasford, Martin Tauscher
Population:
Bavaria ~12.4 million inhabitants
Data base:
The Bavarian Association
of SHI-Accredited Physicians (KVB)
Coverage:
83.5% of outpatient care in Bavaria
(10.4 million)
Time:
2003 - 2005
CML case definition:
ICD C92.1 Chronic myeloid leukemia
and treatment with either imatinib,
interferon alpha, hydroxyurea or
busulfan,
treatment > 1 year
Results - Incidence
2004
2005
201 new CML-patients → 1.93 / 100,000 / year
187 new CML-patients → 1.80 / 100,000 / year
Male:
50.7 %
Female: 49.3 %
Age (median)
63 years
65 years
Population (SHI): 10,387,207
Incidence of CML International Data (WSP)
Bavaria
UK 1
UK 2
Women
1.06
0.47
0.67
Men
1.36
0.72
1.00
All persons
Incidence per 100’000
1
2
Mc Nally RJQ et al. Hematol Oncol 1997;15:173-189.
Phekoo KJ et al. Hematologica 2006;91:1400-1404.
0.83
Conclusions
• The European CML Registry has been successfully
established.
• The cytogenetic remission rates 12 months after treatment
initiation with imatinib 400 mg/d have been successfully
reproduced.
• First epidemiological analyses indicate incidence estimates
similar to the US, but comparatively high for Europe.
• Clinical trials select considerably younger and preferably
male patients with a more benign prognosis.
• First results of the treatment survey indicate room for
improvement.
Thank you very much
for your cooperation!
Denmark / Finland / Israel /
Norway / Sweden:
Prof. B. Simonsson (Uppsala)
France:
Dr.
Czech Republic / Germany /
Switzerland:
Prof. R. Hehlmann (Mannheim)
Italy:
Prof. M. Baccarani (Bologna)
Poland:
Prof. A. Hellmann (Gdansk)
Romania:
Prof. A. Colita (Bucharest)
Spain:
Prof. F. Cervantes (Barcelona)
Spain:
Prof. J.L. Steegmann (Madrid)
The Bavarian Association
of SHI-Accredited Physicians (KVB)
M. Tauscher
J. Guilhot (Poitiers)
The European CML
Registry Group in Munich
D. Lindörfer
M. Pfirrmann, Dipl.Stat., M.Sc., Dr. rer.biol.hum.
J. Hasford, Prof. Dr.
Joerg Hasford, MD
Ludwig-Maximilians University
Munich, Germany