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  • 1
    Electronic Resource
    Electronic Resource
    Oxford, UK : Blackwell Publishing Ltd
    Annals of the New York Academy of Sciences 154 (1968), S. 0 
    ISSN: 1749-6632
    Source: Blackwell Publishing Journal Backfiles 1879-2005
    Topics: Natural Sciences in General
    Type of Medium: Electronic Resource
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  • 2
    Publication Date: 2013-11-15
    Description: Background Availability of the tyrosine kinase inhibitors (TKIs) has revolutionized the outcome of patients with CML, with a 10-year overall survival rate of approximately 90%. This long-term benefit is highly dependent upon adherence; patients with less than 90% TKI adherence have been shown to have poor outcomes. The primary aim of this retrospective observational study is to determine the association between adherence to first-line TKIs and response in community-based CML patients. The secondary aim is to describe the real-world effectiveness of first-line TKIs by evaluating rates of response and disease progression. Methods The McKesson Specialty Health/US Oncology Network (USON) iKnowMed (iKM) electronic health record (EHR) database and medical charts were used to identify newly diagnosed CML patients who received first-line TKIs between July 2007 and March 2011. Adherence to TKI was measured as proportion of days covered (PDC). PDC was computed as the actual number of days of TKI therapy divided by the number of follow-up days after TKI initiation. Adherence was defined as PDC ≥90%. Response assessment included complete hematologic response (CHR) at 3 and 6 months (mo), complete cytogenetic response [CCyR (FISH or karyotype)] at 12 and 18 mo, and major molecular response [MMR (BCR-ABLIS ≤0.1% or ≥3 log reduction)] at 12 and 18 mo. Disease progression was defined as transformation to accelerated phase (AP) or blast phase (BP) CML, bone marrow transplant (BMT), or all-cause of death during follow-up. Descriptive analysis was conducted to summarize baseline patient characteristics and progression. Fisher's exact test will be used to determine univariate association between adherence and response. Here we report the interim results for imatinib adherence and treatment response. Data collection for dasatinib/nilotinib is ongoing and will be presented. Results Three-hundred newly diagnosed CML patients were identified within the iKM database (195 imatinib, 54 dasatinib, and 51 nilotinib). Among 218 patients evaluated thus far, 155 (71.1%) received imatinib, 28 (12.8%) received dasatinib, and 35 (16.1%) received nilotinib. Baseline patient characteristics were well balanced across the TKIs. Mean PDC for imatinib was 80%; 58% (n=117) were adherent (PDC≥90%). Imatinib treatment response data is presented in Table 1 according to adherence status. Low frequency of response monitoring limited the number of patients for analysis (47% evaluable for cytogenetic response and 67% for molecular response within the first 18 mo of treatment). Within a median follow-up of 38 mo, 25 (16%) imatinib patients progressed during the follow-up period (9 transformed to AP/BP, 4 BMT, 12 deaths). Overall, there were 14 deaths among imatinib treated patients. Conclusion Among newly diagnosed CML patients who received imatinib in a community practice setting, the rates of 12-mo CCyR and MMR were 51% and 22%, respectively. In addition, 16% of imatinib-treated patients progressed during a median follow-up period of 38 mo. Fifty-eight percent of imatinib patients were adherent; these patients were observed to have higher cytogenetic and molecular responses compared to non-adherent patients. Response assessment within this study was limited by the low frequency of cytogenetic and molecular monitoring within clinical practice; USON is initiating measures to improve compliance to response monitoring guidelines. Disclosures: Bhowmik: McKesson Specialty Health/US Oncology Network: Employment. Bhor:McKesson Specialty Health/US Oncology Network: Employment. Yap:McKesson Specialty Health/US Oncology Network: Employment. Middlebrook:McKesson Specialty Health/US Oncology Network: Employment. Rembert:McKesson Specialty Health/US Oncology Network: Employment. Cain:Bristol-Myers Squibb: Employment. Okoro:Bristol-Myers Squibb: Employment. Bolinder:Bristol-Myers Squibb: Employment. Jabbour:Bristol-Myers Squibb: Honoraria; Novartis: Honoraria; Pfizer: Honoraria; Ariad: Honoraria.
    Print ISSN: 0006-4971
    Electronic ISSN: 1528-0020
    Topics: Biology , Medicine
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  • 3
    Publication Date: 2009-11-20
    Description: Abstract 4531 Introduction According to the Surveillance, Epidemiology, and End Results (SEER) database 12,810 patients will be diagnosed with acute myeloid leukemia (AML) in 2009 with an incidence rate of 3.5 per 100,000 persons in the United States. The SEER data estimates that 55% of those diagnosed are 65 years or older. Standard first line therapy for the treatment of AML consists of at least one round of chemotherapy commonly referred to as induction. A significant portion of those patients who receive standard induction chemotherapy will have leukemia that fails to show a complete response as defined by less than 5% leukemia blasts in the bone marrow with normal tri-lineage hematopoiesis and peripheral blood count recovery (Mueller S, et al. BMC Cancer 2006, 6:143). Age, patient performance status, the presence of secondary AML, cytogenetics, and molecular markers are prognostic for particular cohorts of patients, however, there is currently no means to predict whether an individual's leukemia will or will not undergo a complete response (CR) after the administration of standard AML induction chemotherapy. Methods A budget impact model was designed to assess the incremental societal cost and incremental cost to a typical national health plan of treating patients who will fail induction therapy. The analysis only evaluated elderly patients over the age of sixty five. Data were gathered from the peer reviewed literature. All costs have been updated to 2009 dollars using the medical care component of the consumer price index. The patient population was determined to be 6,981 patients in 2009 with 30% receiving induction therapy (Menzin J, et al. Arch Intern Med. 2002; 162:1597-1603) and only 38% demonstrating a CR (Appelbaum FR, et al. Blood 2006 107:3481-5) resulting in 1,303 patients failing during induction therapy. The costs were taken from Menzin et al., which used Medicare claims data to determine the associated costs of AML patients during the first two years post diagnosis. In the model Medicare payments are used as a proxy for direct costs to society and a national health plan. These reimbursements are able to capture the costs of the initial hospital visit, lab/diagnostic/radiology, supportive care, drugs, and adverse events through the observation of payments across all appropriate settings of care (inpatient hospitalization, skilled nursing facility, outpatient hospital/clinical, physician's office, home health, and hospice). A patient undergoing chemotherapy incurred costs of $120,468 over two years, while a patient avoiding chemotherapy only incurred costs of $40,720. Results The incremental cost of a patient receiving induction therapy was calculated to be $79,748. For a national health care plan with an assumed average of one million members results in a cost of $283,856 to treat patients whose leukemia would not respond to induction chemotherapy. The overall societal impact of treating this patient population with ineffective therapy is $104 million. Conclusions Patients who are subjected to ineffective chemotherapy face the cytotoxic effects of the treatment, none of the benefits of treatment response, and impose a significant cost burden to themselves and the healthcare payment system. Diagnostics currently in development that can identify patients at the time of diagnosis with disease unresponsive to therapy may have the ability to alleviate unnecessary costs, while steering patients to better tailored and more effective therapies. Disclosures: Cleary Cohen: Nodality, Inc: Employment. Middlebrook:Nodality Inc: Employment.
    Print ISSN: 0006-4971
    Electronic ISSN: 1528-0020
    Topics: Biology , Medicine
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