A Worldwide Observational Registry Collecting Longitudinal Data on Management of Chronic Myeloid Leukemia Patients (The WORLD CML Registry) – 2nd Annual Interim Analysis

This ongoing international, prospective registry provides 5-year longitudinal data on diagnosis methods, management strategies, and outcomes for CML patients (pts) worldwide. Deviations from published disease management recommendations and differences by region or center setting were examined.

Pts (≥ 16 yrs of age) within 6 months of CML diagnosis were enrolled from Latin America (LA), United States (US), Asia Pacific (AP), Middle East and Africa (MEA), and Russia and Turkey (RT). Baseline demographics, medical history, current disease status and management information were collected at approximately 6-month intervals or with a change in disease status or management.

With a cut-off of May 10, 2010, data were reported on 1667 patients from 175 centers, including 456 (27.4%) from LA, 287 (17.2%) from US, 462 (27.7%) from AP, 175 (10.5%) from MEA, and 287 (17.2%) from RT. Most (62%) sites participated in CML studies within the past 5 yrs. The majority (93.7%) of patients were in chronic phase CML, similar across all regions, although more pts were diagnosed in accelerated phase or blast crisis (9.9%) in LA than in any other region (US, 4.5%; AP, 4.3%; MEA, 5.7%; RT, 5.9%). Centers most commonly described themselves as government hospitals in LA (42.1%), private hospitals/practices in US (62.7%), academic institutions in AP and MEA (57.9% and 66.7%) and regional/community hospitals in RT (50%). Median age was 47 yrs, with the lowest median age in AP (41) and the highest in US (53). Overall, 57.4% of pts were male and 9.3% of pts with a cytogenetic (Cy) assessment at diagnosis had an additional chromosomal abnormality detected in the Philadelphia chromosome-positive cell. Hematologic (91.2%) and Cy (85.6%) assessments were used for CML diagnosis in most pts. For Cy assessment, the method used varied widely by region and center (Table 1). Molecular assessments at diagnosis were performed in 63.2%, 50.5%, 60.6%, 62.9%, and 32.4% of pts in LA, US, AP, MEA, and RT, respectively, and were most common at regional/community hospitals (65.9%) and least common at private hospitals/practice (34.9%). Only 23.4% of centers utilizing molecular assessments at diagnosis reported results using the international scale. The most common co-morbidities at baseline were cardiac disorders in 377 (22.6%) pts, including hypertension in 329 (19.7%) pts, and diabetes in 134 (8.0%) pts. Pulmonary disorders were present at baseline in 49 (2.9%) pts. While imatinib was the most widely used therapy, hydroxyurea was being used as primary CML treatment (not merely for leukocyte reduction) in 401 (24.1%) pts prior to registry entry.

The WORLD registry has included over 1,600 pts worldwide. In a ‘real world' setting, many patients are not managed according to published disease recommendations or guidelines. For example, a substantial percentage of pts did not have karyotyping or molecular assessments performed at diagnosis, even though karyotyping can detect additional chromosomal abnormalities in Philadelphia chromosome-positive CML and molecular monitoring is the most sensitive means of disease detection. Furthermore, hydroxyurea is still used as primary therapy in a significant proportion of pts. The WORLD CML Registry will continue to assess global trends in the diagnosis and management of CML, particularly as new frontline therapies become available.

Pasquini: Novartis: Consultancy, Honoraria; Bristol-Myers Squibb: Consultancy, Honoraria. Cortes: Novartis: Research Funding; Bristol Myers Squibb: Research Funding; Pfizer: Consultancy, Research Funding. Kantarjian: Novartis: Consultancy, Research Funding; Bristol Myers Squibb: Research Funding; Pfizer: Research Funding. Joske: Novartis: Honoraria, Membership on an entity's Board of Directors or advisory committees. Meillon: Novartis: Speakers Bureau; Bristol-Myers Squibb: Speakers Bureau. Mongay: Novartis: Employment. Reynolds: Novartis Oncology: Employment, Equity Ownership. Hughes: Novartis: Honoraria, Research Funding, Speakers Bureau; Bristol-Myers Squibb: Honoraria, Research Funding; Ariad: Honoraria. Kim: Novartis: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; Bristol-Myers Squibb: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding.