Phase III Randomized Placebo-Controlled Dexamethasone Sparing Trial with
Highly Emetic Chemotherapy (QAE)*:
NK1 Receptor Antagonist + Palonosetron + Dexamethasone
DEX: DAY 1 ONLY
DEX: DAY 1, 2 and 3
Number of Patients:
200
196
Complete Response (5 Days)
44%
47%
Complete Response (Acute)
65%
63%
Complete Response (Delayed)
52%
56%
*
Highly Emetic (QAE) = Cisplatin (≥ 50 mg / M2) or Anthracycline + Cyclophosphamide
Complete Response = No emesis + no rescue
Non-inferiority endpoint met in all comparisons
Reference: Ito et al.
J Clin Oncol
. 36. 1000-1006, 2018