Oral Akynzeo® vs Standard of Care in Preventing CINV in High-risk MEC Patients (MyRisk)
Status:
Recruiting
Trial end date:
2023-08-31
Target enrollment:
Participant gender:
Summary
MyRisk: Efficacy and safety evaluation of oral Akynzeo® in patients receiving MEC at high
risk of developing CINV based on a prediction tool. A multinational and multicenter study.
Antiemetic guidelines recommendations are based on the emetogenic potential of the
chemotherapy. Chemotherapy (CT) agents are divided in Highly, Moderately, Low and Minimally
Emetogenic potential.
In addition to type of chemotherapy, several patient-related risk factors can increase the
risk of CINV (chemotherapy-induced nausea and vomiting). Currently, there is limited
consensus surrounding the most relevant patient risk factors that may predict the risk of
CINV. Based on a recent study by Dranitsaris et al. (Dranitsaris et al. Ann Oncol. 2017 Jun
1; 28(6):1260-1267.), eight (8) predictive factors have been identified and an algorithm has
been developed to incorporate these factors into the optimal selection of prophylactic
antiemetics:
1. nausea and/or vomiting in the prior cycle of chemotherapy
2. use of non-prescribed antiemetics at home in the prior cycle of chemotherapy
3. platinum or anthracycline-based chemotherapy
4. age < 60 years
5. expectations for (anticipating) nausea and/or vomiting
6. <7 h of sleep the night before chemotherapy
7. history of morning sickness during previous pregnancy
8. cycle of chemotherapy (A negative association between risk and number of cycles was
identified where the hazard for CINV was highest in cycles 1 and 2, with a gradual
decline and plateau from cycle 3 onward).
The clinical application of this prediction tool has the potential to be an important
resource for clinicians and may help to enhance patient care by optimizing the use of the
antiemetics in a proactive manner.