A randomized trial of individualized versus standard of care antiemetic therapy for breast cancer patients at high risk for chemotherapy-induced nausea and vomiting
M. Clemons,
G. Dranitsaris,
M. Sienkiewicz,
S. Sehdev,
T. Ng,
A. Robinson,
M. Mates,
T. Hsu,
S. McGee,
O. Freedman,
V. Kumar,
D. Fergusson,
B. Hutton,
L. Vandermeer,
J. Hilton
Affiliations
M. Clemons
Department of Medicine and Division of Medical Oncology, The Ottawa Hospital and the University of Ottawa, Ottawa, Ontario, Canada; Cancer Research Program, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada; Clinical Epidemiology Program, The Ottawa Hospital Research Institute and University of Ottawa, Ottawa, Canada; Corresponding author. Division of Medical Oncology, the Ottawa Hospital Cancer Centre 501 Smyth Road, Ottawa, Canada.
Cancer Research Program, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada
S. Sehdev
Department of Medicine and Division of Medical Oncology, The Ottawa Hospital and the University of Ottawa, Ottawa, Ontario, Canada
T. Ng
Department of Medicine and Division of Medical Oncology, The Ottawa Hospital and the University of Ottawa, Ottawa, Ontario, Canada
A. Robinson
Cancer Centre of Southeastern Ontario, Kingston General Hospital, Kingston, ON, Canada
M. Mates
Cancer Centre of Southeastern Ontario, Kingston General Hospital, Kingston, ON, Canada
T. Hsu
Department of Medicine and Division of Medical Oncology, The Ottawa Hospital and the University of Ottawa, Ottawa, Ontario, Canada
S. McGee
Department of Medicine and Division of Medical Oncology, The Ottawa Hospital and the University of Ottawa, Ottawa, Ontario, Canada
O. Freedman
Division of Medical Oncology, Durham Regional Cancer Centre, Oshawa, Ontario, Canada
V. Kumar
Markham Stouffville Hospital, Shakir Rehmatullah Cancer Clinic, Markham, Ontario, Canada
D. Fergusson
Clinical Epidemiology Program, The Ottawa Hospital Research Institute and University of Ottawa, Ottawa, Canada
B. Hutton
Clinical Epidemiology Program, The Ottawa Hospital Research Institute and University of Ottawa, Ottawa, Canada
L. Vandermeer
Cancer Research Program, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada
J. Hilton
Department of Medicine and Division of Medical Oncology, The Ottawa Hospital and the University of Ottawa, Ottawa, Ontario, Canada; Cancer Research Program, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada
Purpose: Despite triple antiemetic therapy use for breast cancer patients receiving emetogenic chemotherapy, nausea remains a clinical challenge. We evaluated adding olanzapine (5 mg) to triple therapy on nausea control in patients at high personal risk of chemotherapy-induced nausea and vomiting (CINV). Methods: This multi-centre, placebo-controlled, double-blind trial randomized breast cancer patients scheduled to receive neo/adjuvant chemotherapy with anthracycline-cyclophosphamide or platinum-based chemotherapy to olanzapine (5 mg, days 1–4) or placebo. Primary endpoint was frequency of self-reported significant nausea, repeated for all cycles of chemotherapy. Secondary endpoints included: duration of nausea, overall total control of CINV, Health Related Quality of Life (HRQoL) using FLIE questionnaire, use of rescue mediation and treatment-related adverse events. Results: 218 eligible patients were randomised to placebo (105) or olanzapine (113). From days 0–5 following each cycle of chemotherapy, 41.3% (95%CI: 36.1–46.7%) of patients in the placebo group reported significant nausea compared to 27.7% (95%CI: 23.2–32.4%) in the olanzapine group (p = 0.001). Across all cycles of chemotherapy, patients receiving olanzapine experienced a statistically significant improvement in HRQoL (p < 0.001). Grade 1/2 sedation was the most commonly side effect reported at 40.8% in the placebo group vs. 54.1% with olanzapine (p < 0.001). Conclusion: In patients at high personal risk of CINV, the addition of olanzapine 5 mg daily to standard antiemetic therapy significantly improves the control of nausea, HRQoL, with no unexpected toxicities.
