Kosaka, Y., Tanino, H., Sengoku, N., Minatani, N., Kikuchi, M., Nishimiya, H., . . . Watanabe, M. (2015). Phase II randomized, controlled trial of 1 day versus 3 days of dexamethasone combined with palonosetron and aprepitant to prevent nausea and vomiting in Japanese breast cancer patients receiving anthracycline-based chemotherapy. Supportive Care in Cancer, 24, 1405–1411.
To investigate if the use of a second-generation 5-HT3 receptor antagonist (palonosetron) and a NK1 receptor agonist (aprepitant) could allow a decreased dose of dexamethasone based on nausea and vomiting in patients with breast cancer receiving highly emetogenic chemotherapy
Randomization was to Group A: palonosetron IV plus dexamethasone IV with oral aprepitant on day 1 followed by 8 mg dexamethasone IV and 80 mg aprepitant PO on days 2 and 3. Group B received a placebo instead of dexamethasone on days 2 and 3. Patients were treated in the hospital.
Phase-II, single-center, single-blind, placebo-controlled, parallel, randomized trial. Randomization was done on a one to one ratio using a minimization method.
This study showed that complete control and CR revealed equivalent findings in acute and delayed chemotherapy-induced nausea and vomiting (CINV) with 1 day or 3 days of dexamethasone. No statistical differences were noted between both groups. Subgroup analysis looked at patients younger than 50 years. This also did not show any differences.
Using one dose of dexamethasone is feasible in treating CINV.
Reducing the use of dexamethasone may be possible in treating CINV prospectively. This may be critical in uncontrolled diabetics.