Chronic Myeloid Leukemia Clinical Trial
Official title:
A Multi-centre Study of Epidemiology, Characteristics, Treatment and Outcome of Chronic Myeloid Leukaemia in Adults in Hong Kong
Chronic myeloid leukaemia (CML) is a malignant disorder of the haematopoietic system. It is characterized by the chromosomal translocation between chromosomes 9 and 22, resulting in the formation of the Philadelphia chromosome which contains the BCRABL1 fusion gene. The projected prevalence of CML is rising steadily, due to the significantly improved survival of CML patients and that the incidence rate increases with age. The efficacious yet costly tyrosine kinase inhibitors pose a significant financial burden to both patients and the health care system, while they carry their own side effects and long-term risks. This study aims to set up a local disease registry of CML to improve the knowledge concerning this disease, including epidemiology,characteristics and treatment outcome of CML in Hong Kong,as well as long-term safety and toxicities of therapeutic agents.
Chronic myeloid leukaemia (CML) is a malignant disorder of the haematopoietic system
characterized by the presence of the Philadelphia chromosome arising from t(9;22)(q34;q
11).The annual incidence of CML is reported to be around 1-2 cases per 100,000 population.In
Hong Kong, the age-standardised incidence rate of CML has remained static in recent years.
However, as the incidence of CML increases with age and Hong Kong has an ageing population,
the crude incidence rate is expected to follow a rising trend. On the other hand, the
prognosis of CML patients has improved significantly since the advent of tyrosine kinase
inhibitors (TKis) more than two decades ago. With the efficacious TKis, CML has changed from
a deadly cancer to a treatable chronic condition. It has been shown that life expectancy of
CML patients is approaching that of the general population now.The prevalence of CML is
expected to rise considerably in view of the increasing incidence in an ageing population and
improved prognosis. The Hong Kong Cancer Registry only provides data on the incidence rates
of cancers but it has yet to provide cancer prevalence data. A clinical registry is "an
organized system that uses observational study methods to collect uniform data to evaluate
specific outcomes". A disease registry specifically designed for CML would provide more
accurate and comprehensive data and allow an in-depth study of the epidemiology and
characteristics of CML in Hong Kong.
At present,there are three TKis approved for front-line treatment of newly diagnosed
chronic-phase CML,viz.,imatinib, nilotinib and dasatinib.lmatinib is a first-generation TKI
while nilotinib and dasatinib are second-generation TKis (2G-TKI) . Nilotinib and dasatinib
demonstrate better in vitro efficacy and achieve molecular responses faster and deeper than
imatinib,but these drugs not been proven superior to imatinib in conventional clinical
endpoints including overall survival and progression-free survival.Besides, nilotinib and
dasatinib are not without side effects and their long-term safety profiles are unclear. For
example, nilotinib is associated with increased cardiovascular risk while dasatinib often
leads to pleural effusion and less frequently,pulmonary hypertension.The safety of imatinib
has been well established over the past 15 years and its side effects are generally
considered tolerable. However, the generic formulation of imatinib has been recently
introduced to public hospitals and substituted for branded imatinib in CML patients. There
have been reports that patient switching to generic imatinib develop adverse drug reactions
not experienced with branded imatinib. Other less commonly used therapeutic agents include
bosutinib and ponatinib, which still play an important role in the management of CML.
Therefore, it is important to determine the "real-world" clinical effectiveness of various
drugs, and monitor their side effects and long-term toxicities in a population-based
approach.
As physicians in Hong Kong are facing a growing patient population on long-term TKI,the
demand on health care services and financial burden of drug costs will escalate accordingly.
lt is pivotal for the investigators to understand the disease and patients in the locality
better by systematic data collection, in order to improve quality of care, allow service
planning and facilitate medical research and advances .
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