Methods
This was a single-center, retrospective, cohort study of pediatric hematology and oncology patients at Cleveland Clinic Children’s from July 2016 to December 2020. Approval for the study was obtained through the Institutional Review Board at the Cleveland Clinic in Cleveland, Ohio. Eligible patients were admitted to an inpatient pediatric unit and scheduled to receive HEC defined per Children’s Oncology Group CINV guidelines. Patients were included in the chemotherapy block numbers up to 4 times. Patients who received oral olanzapine for the purpose of CINV control were identified from pharmacy dispensing records. Patients receiving conditioning chemotherapy for a hematopoietic stem cell transplant or who received four-drug CINV prophylaxis were excluded.
A chemotherapy block was defined as a series of consecutive days that chemotherapy was administered. The period of time prior to initiation, during, and up to 24 hours after completion of chemotherapy was defined as acute phase. Delayed phase was defined as greater than 24 hours after completion of chemotherapy to 120 hours after or until discharge, whichever occurred first.
The primary objective was to compare complete response (CR) between the groups in the acute, delayed and overall phases. Patients were considered to have a CR when no emesis and no use of rescue medication occurred during the respective periods. Secondary objectives olanzapine prescribing practices and safety.
Descriptive statistics were used to summarize the demographic and clinical characteristics of the participants. Comparison between categorical values was performed using the chi-squared test or Fishers exact test. A level of significance was set at 0.05.