THE USE OF HTA AS A DECISION TOOL- CASE STUDY WITH DEXRAZOXANE (DZR).
Author(s)
ABSTRACT WITHDRAWN
OBJECTIVES : Dexrazoxane (DZR) is an approved drug for reducing the risk of anthracycline-induced cardiotoxicity. However, its benefits for the pediatric population are not clear. This systematic review evaluated the evidences of DZR use in patients with childhood cancer and the prevention of anthracycline-induced cardiotoxicity, and other possible effects regarding safety of its use. Five databases were searched for randomized controlled trials (RCTs) and nonrandomized studies (NRSs) that compared dexrazoxane to placebo or no cardioprotection among children. METHODS : Systematic review RESULTS : Thirteen publications from five RCTs and five NRSs were eligible. Among these, eight reported results regarding cardiomyopathy; nine reported toxicity, cardiotoxicity or second malignant neoplasms, and ten (data from seven studies) presented results about morbidity or mortality. DZR was associated with a statistically significant risk reduction of subclinic cardiotoxicity in studies with long term follow up, although the definition of cardiotoxicity was different among them. The advantages of DZR on clinical cardiotoxicity could not be evaluated, since a small number of events were reported. No study reported quality of life as an outcome. Regarding cardiovascular morbidity and mortality, some studies favor DZR use before doxorubicin administration. The mortality rate and event free survival were not affected by DZR in most studies. Even thought some results diverge, there is insufficient evidence to link the use of DZR and development of second malignant neoplasm or relapse. Evidence indicates that DZR brings some level of cardioprotection in pediatric population treating with anthracicline. CONCLUSIONS : It is unclear how relevant are the benefits and therefore the effectiveness of it is not clear. The use of HTA tools in this context was not able to aid in the definition of the use of the drug or not. However, it is important to continue long-term follow up studies with this population to determine the effects of DZR over time.
Conference/Value in Health Info
2019-11, ISPOR Europe 2019, Copenhagen, Denmark
Code
PCN332
Disease
Oncology