Tolerability, complications, and toxicity
The primary aim of this study was to describe the complications and
toxicity associated with this treatment plan. Data were abstracted from
the record, described categorically, and graded using the common
terminology criteria for adverse events version 5 (CTCAE v5.0).
Information abstracted included: unplanned hospitalizations and
admissions to the intensive care unit (ICU), unplanned ambulatory clinic
or emergency department (ED) visits (not for scheduled chemotherapy,
routine examinations, or restaging); significant infections, such as
central line-associated bloodstream infection, and treatment delays. A
treatment delay was defined as an interval of greater than four weeks
between chemotherapy cycles (one week longer than expected) or greater
than five weeks if surgery was performed (two weeks longer than expected
without surgery). Organ toxicity (except for hematopoietic and transient
minor elevation of liver function tests), admissions for fever and
neutropenia, uncontrolled nausea, and vomiting were recorded and graded.
Long-term toxicities (organ toxicities grades 3 and 4) and impact on
growth were noted in follow-up until the last contact at the time of
record abstraction.