Single-day regimen of palonosetron (PALO) and dexamethasone (DEX) for the prevention of emesis associated with moderately emetogenic chemotherapy (MEC): Subgroup analysis from a randomized phase III trial

9620 Background: We have recently shown non-inferiority in preventing acute and delayed nausea and vomiting associated with MEC between the PALO plus 1-day DEX and PALO plus 3-day DEX regimens. Planned analysis stratified by type of chemotherapy (anthracycline + cyclophosphamide [AC] group or patients receiving at least one moderately emetogenic agent according to modified Hesketh classification) has been performed. Methods: A total of 332 chemo-naive patients with solid tumors were randomized to receive a single IV dose of PALO 0.25 mg plus DEX 8 mg IV on day 1 of chemotherapy (arm A; n=166) or the same regimen followed by DEX 8 mg orally on days 2 and 3 (arm B; n=166). Endpoints included complete response rates (CR: no emetic episodes [EE], no rescue antiemetics; primary endpoint) and proportion of patients with no EE throughout the 5 days after the first cycle of chemotherapy. Subgroups were analyzed by two-sided chi-square test. Results: Per-protocol population included 324 patients (65% women; median...