Chemotherapy-induced nausea and vomiting (CINV) adversely affects patients' quality of life
and may affect patients' treatment decisions. The emetogenicity of the chemotherapy
administered and specific patient characteristics such as female gender, age, and history of
low alcohol intake can increase a patients' risk for CINV.
Table 1. Patient-Related Risk Factors for Emesis Following Chemotherapy Major Factors Minor
Factors Female History of Motion Sickness Age < 50 years Emesis during past pregnancy History
of prior low chronic alcohol intake (<1 ounce of alcohol/day) Anxiety History of previous
chemotherapy-induced emesis
Significant and uncontrolled CINV may result in patients returning to the chemotherapy
treatment facility one to three days post-chemotherapy for rehydration, or emesis or nausea
control. If CINV cannot be controlled in an outpatient facility, patients may subsequently be
treated in an emergency department or require hospitalization. Patients who have an
electrolyte imbalance or those who have recently undergone surgery or radiation therapy, are
at greater risk of experiencing serious complications from CINV.
The use of 5-hydroxytryptamine-3 (5-HT3) receptor antagonists has improved the control of
CINV Additional improvement in the control of CINV has occurred with the use of neurokinin-1
(NK-1) receptor antagonists, and olanzapine, an antipsychotic which blocks multiple
neurotransmitters in the central nervous system.
The primary endpoint used for studies evaluating various agents for the control of CINV has
been complete response (CR) (no emesis, no use of rescue medication) over the acute (24 hours
post-chemotherapy), delayed (24-120 hours), and overall (0-120 hours) periods. The
combination of a 5-HT3 receptor antagonist, dexamethasone, and a NK-1 receptor antagonist
have improved the control of emesis in patients receiving either highly emetogenic
chemotherapy (HEC) or moderately emetogenic chemotherapy (MEC) over a 120-hour period
following chemotherapy administration
The use of effective antiemetic agents in various clinical settings has been described in
established guidelines from the Multinational Association of Supportive Care in Cancer
(MASCC) and the European Society of Medical Oncology (ESMO), the American Society of Clinical
Oncology (ASCO)], and the National Comprehensive Cancer Network (NCCN).
The purpose of the proposed is to provide a clinical approach to CINV prophylaxis in cycle 2
of MEC or HEC for patients who developed breakthrough CINV after cycle 1 based on the
available data in the literature as well as the recommendations provided by established
guidelines.