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Relative survival in patients with chronic-phase chronic myeloid leukaemia in the tyrosine-kinase inhibitor era: analysis of patient data from six prospective clinical trials.

ABSTRACT: Tyrosine-kinase inhibitors improve overall survival in patients with chronic myeloid leukaemia in chronic phase (CML-CP). Survival compared with the general population by age, response, and type of tyrosine-kinase inhibitor is not known. With use of data from trials of tyrosine kinase inhibitors, we compared overall survival in patients with newly diagnosed CML-CP to that of general population.In this cohort analysis, we included data from patients with CML-CP enrolled in six consecutive or parallel prospective clinical trials of tyrosine-kinase inhibitors at a single institution from July 30, 2000, to Sept 17, 2012. We analysed data for response and survival with the Kaplan-Meier method. For estimated overall survival in the general population, we obtained data from national vital statistics reports and matched to patients with CML-CP by age, sex, ethnicity, and year at diagnosis. We assessed numbers and causes of death within 1 year of beginning treatment by age group and by response to therapy. We then did univariate analysis and multivariate analysis to investigate factors associated with survival probability.Our analysis included 483 patients, 271 received imatinib, 105 received nilotinib, and 107 received dasatinib. Most patients were younger than 65 years, and no patients were older than 85 years. Median follow-up was 99·4 months (IQR 44·9-121·6), by which time 53 (11%) patients had died. The most common causes of death were progression to advanced disease stage, including complications of stem-cell transplantation (17 [4%] patients), secondary malignancies (nine [2%] patients), and cardiovascular causes (nine [2%] patients). 5-year overall survival in patients with CML-CP decreased in older age categories. For the whole population of patients with CML-CP, 5-year survival was only slightly lower than that of the matched general population (relative survival 94·7% [95% 92·1-97·4]). Individuals of all ages with a report of complete cytogenetic response to treatment or deeper within 1 year had a 5-year survival similar to that of the general population.In the era of treatment with tyrosine-kinase inhibitors, patients diagnosed with CML-CP can expect a 5-year survival that is only slightly lower than that of the general population. With access to tyrosine-kinase inhibitors, most patients with chronic myeloid leukaemia could enjoy a near normal life expectancy.MD Anderson Cancer Center, National Cancer Institute.

SUBMITTER: Sasaki K

PROVIDER: S-EPMC4884053 | biostudies-literature | 2015 May

REPOSITORIES: biostudies-literature

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Relative survival in patients with chronic-phase chronic myeloid leukaemia in the tyrosine-kinase inhibitor era: analysis of patient data from six prospective clinical trials.

Sasaki Koji K Strom Sara S SS O'Brien Susan S Jabbour Elias E Ravandi Farhad F Konopleva Marina M Borthakur Gautam G Pemmaraju Naveen N Daver Naval N Jain Preetesh P Pierce Sherry S Kantarjian Hagop H Cortes Jorge E JE

The Lancet. Haematology 20150420 5

<h4>Background</h4>Tyrosine-kinase inhibitors improve overall survival in patients with chronic myeloid leukaemia in chronic phase (CML-CP). Survival compared with the general population by age, response, and type of tyrosine-kinase inhibitor is not known. With use of data from trials of tyrosine kinase inhibitors, we compared overall survival in patients with newly diagnosed CML-CP to that of general population.<h4>Methods</h4>In this cohort analysis, we included data from patients with CML-CP ...[more]

PMID: 26688093

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Project description:IntroductionIn the earliest cases of COVID-19, a higher percentage of severe and fatal cases was observed in patients with cancer, including those with haematological malignancies. However, patients with chronic myeloid leukaemia (CML) had better prognoses, suggesting that tyrosine kinase inhibitors (TKIs) may have a therapeutic effect against SARS-CoV-2. This study describes the clinical and epidemiological characteristics of patients with CML receiving the TKIs tested for SARS-CoV-2 in Tegucigalpa, Honduras.MethodologyAn Analytical cross-sectional study was conducted. The sample included patients with Philadelphia chromosome-positive (Ph+) CML, who had been tested at least once for COVID-19 at the Emma Romero de Callejas Cancer Centre (CCERC). Sociodemographic and clinical variables were both analysed. Epi Info 7.2.4.0 and Stata/MP 16.0 were used to collect and analyse data. The COVID-19 positivity percentage and the association between severity and the TKI used were determined using Fisher's exact test and odds ratio (OR). Data were gathered from clinical records with approval of CCERC institutional management.ResultsOne hundred and forty-nine patients with Ph+ CML were included; 20.1% were COVID-19-positive; 56% were male; mean age was 46 years; 81% were receiving imatinib, with a mean treatment duration of 6 years; 55% achieved a BCR -ABL molecular response ≤ 0.1% (IS). Twenty-one percent had comorbidities. COVID-19 was asymptomatic in 38.7% of patients, mild in 35.5% and severe in 9.7%. One patient died, a fatality rate of 3.2%. No statistical association was found between disease severity and treatment with imatinib versus second-line TKI (OR: 0.833, p: 0.8493, 95% CI: 0.098-10.998).ConclusionDespite high COVID-19 positivity in CML when compared with the literature, this study found a lower fatality rate. The type of TKI used or molecular response at the time of infection was not associated with case severity. Determining the effectiveness of imatinib or other TKIs as a COVID-19 treatment requires randomised clinical trials.

Project description:BackgroundDose reduction of tyrosine kinase inhibitors (TKI) in patients with chronic myeloid leukaemia (CML) with an optimal response to TKIs may support cost-effective medication use by maintaining therapeutic effectiveness while reducing adverse events and medication costs. As the choice for dose reduction depends on patients' individual needs and preferences, a patient-centred approach is warranted. Therefore, a study to evaluate the effectiveness of patient-guided dose reduction in patients with CML who are in a major or deep molecular response is designed.MethodsThis study is a prospective, multicentre, single-arm study. 147 patients with CML (aged ≥ 18 years) in chronic phase, who are treated with imatinib, bosutinib, dasatinib, nilotinib or ponatinib, and have reached at least major molecular response (defined as having BCR-ABL levels < 0.1% for an uninterrupted period of 6 months) are eligible. Patients will use an online patient decision aid and a shared decision making consultation will be held, after which patients who choose to will receive a personalised, lower TKI dose. Primary outcome is the proportion of patients with intervention failure at 12 months after dose reduction, defined as patients who have restarted their initial dose due to (expected) loss of major molecular response. For this, BCR-ABL1 levels will be analysed from blood samples drawn at baseline, 6 weeks after dose reduction and 3-monthly thereafter. Secondary outcomes include the proportion of patients with intervention failure at 6 and 18 months after dose reduction. Other outcomes include differences before and after dose reduction regarding the number and severity of patient-reported side effects; quality of life; beliefs about medicines; and medication adherence. Patients' level of decisional conflict and regret after choosing dose reduction will be assessed, as will the decisional process experienced by patients and healthcare providers.DiscussionOutcomes of this trial using a personalised approach will provide clinical and patient-reported data to guide future dose reduction of TKIs in CML. If the strategy appears to be effective, it may be implemented as another valid option to offer next to standard of care to prevent potential unnecessary exposure to higher TKI doses in this selected group of patients.Trial registrationEudraCT number 2021-006581-20.

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Relative survival in patients with chronic-phase chronic myeloid leukaemia in the tyrosine-kinase inhibitor era: analysis of patient data from six prospective clinical trials.

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Relative survival in patients with chronic-phase chronic myeloid leukaemia in the tyrosine-kinase inhibitor era: analysis of patient data from six prospective clinical trials.

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