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.