Abstract
Abstract 4267
This multicenter, international, prospective registry is a longitudinal (5 year) assessment of diagnosis methods, management strategies, and outcomes for CML patients (pts) under ‘real world’ conditions. Pts were enrolled from Latin America (LA), United States (US), Asia Pacific (AP), Middle East and Africa (MEA), and Russia and Turkey (RT). This first, interim data summary reports baseline characteristics on the first 1001 enrolled pts.
Eligible pts were ≥ 16 yrs of age and entered the Registry within 6 months of CML diagnosis. Demographics, medical history, current disease status and management information are collected at baseline. Follow up data are collected at approximately 6-month intervals. Center practices in disease detection and monitoring are collected annually.
1001 patients from 148 sites worldwide were enrolled with a data cut-off of May 2009. Represented in this dataset: 165 (16.5%) from LA, 179 (17.9%) from US, 372 (37.2%) from AP, 84 (8.4%) from MEA, and 201 (20.1%) from RT. The majority of patients in LA (50%) were from government hospitals, US from private hospitals/practices (61.1%), AP and MEA from academic institutions (54.8% and 64.7% respectively), and RT from regional/community hospitals (55%). Overall, 953 (95.2%) pts were in chronic phase CML, with little variation across regions. Overall, 58.4% of pts were male (LA, 51.5%; US, 57.0%; AP, 67.7%; MEA, 53.6%; RT, 50.2%) and median age was 46 yrs (range, 15–91). Notably, median age in the AP region was just 40 yrs (LA, 48; US, 53; MEA, 41.5; RT, 52). Hematologic, bone marrow, and cytogenetic (Cy) assessments were used for CML diagnosis in most pts (88.7%, 84.4%, 82.6%, respectively). For Cy assessment, the method used varied widely by region. Most centers appeared to use both karyotype and fluorescence in situ hybridization (FISH), with FISH being used in a greater proportion of pts in the US and MEA (Table 1).
Cytogenetic Assessment, n (%) . | LA (n = 165) . | US (n = 179) . | AP (n = 372) . | MEA (n = 84) . | RT (n = 201) . | Overall (n = 1001) . |
---|---|---|---|---|---|---|
Overall | 148 (89.7) | 146 (81.6) | 320 (86.0) | 64 (76.2) | 149 (74.1) | 827 (82.6) |
Karyotype | 140 (94.6) | 91 (62.3) | 281 (87.8) | 38 (59.4) | 118 (79.2) | 668 (80.8) |
FISH | 14 (9.5) | 113 (77.4) | 98 (30.6) | 45 (70.3) | 37 (24.8) | 307 (37.1) |
Cytogenetic Assessment, n (%) . | LA (n = 165) . | US (n = 179) . | AP (n = 372) . | MEA (n = 84) . | RT (n = 201) . | Overall (n = 1001) . |
---|---|---|---|---|---|---|
Overall | 148 (89.7) | 146 (81.6) | 320 (86.0) | 64 (76.2) | 149 (74.1) | 827 (82.6) |
Karyotype | 140 (94.6) | 91 (62.3) | 281 (87.8) | 38 (59.4) | 118 (79.2) | 668 (80.8) |
FISH | 14 (9.5) | 113 (77.4) | 98 (30.6) | 45 (70.3) | 37 (24.8) | 307 (37.1) |
Only 51.6% of pts had molecular assessments at diagnosis, ranging from 27.4% in RT to 70.2% in MEA. The majority (54.3%) of pts had no risk score assigned at diagnosis. Sokal score, assessed in 39.1% of pts, was the most common risk score used in all regions (LA, 46.7%; US, 5.6%; AP, 36.0%; MEA, 50.0%; RT, 63.7%). The most common comorbidity was cardiac disorders, in 211 (21.1%) pts, followed by diabetes in 74 (7.4%) pts. Pulmonary disorders were present in 33 (3.3%) patients. At the time of Registry enrollment, imatinib was the most commonly prescribed therapy. Most centers (83.1%) were not performing plasma drug monitoring of anti-leukemic therapy, primarily due to lack of availability (58.5%); 89.2% of those centers would consider performing plasma drug level testing if it were readily available.
The first interim results of this Registry reveal some regional differences in CML diagnosis and management. Notably, not all pts appear to be treated according to published disease management guidelines. For example, although only karyotyping can detect additional chromosomal abnormalities in Philadelphia chromosome-positive CML, approximately 20% of patients overall and 40% of patients in the US and MEA did not have karyotyping performed at diagnosis. Furthermore, molecular assessments were not universally performed at diagnosis. As these data mature, ongoing interim summaries from the WORLD CML Registry will continue to assess global trends in CML diagnostic methods, treatment approaches, adherence to disease management guidelines and response to treatment. Educational initiatives can thus be regionally tailored to optimize patient care in CML. Additional data summaries by center setting (private hospitals/practices, academic, etc) will also be available.
Cortes-Franco:Novartis: Honoraria, Research Funding, Speakers Bureau; Wyeth: Honoraria, Research Funding, Speakers Bureau; BMS: Honoraria, Research Funding, Speakers Bureau. Joske:Novartis Australia: Membership on an entity's Board of Directors or advisory committees; Novartis Pharma AG: Membership on an entity's Board of Directors or advisory committees. Mongay:Novartis: Employment. Eng:Novartis: Employment. Wang:Novartis: Employment. Hughes:Bristol-Myers Squibb: Advisor, Honoraria, Research Funding; Novartis: Advisor, Honoraria, Research Funding. Kim:Novartis: Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; BMS: Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; Wyeth: Research Funding.
Author notes
Asterisk with author names denotes non-ASH members.