Evaluating the impact of chemotherapy-induced nausea and vomiting on daily functioning in patients receiving dexamethasone-sparing antiemetic regimens with NEPA (netupitant/palonosetron) in the cisplatin setting: results from a randomized phase 3 study

Background: The non-inferiority of dexamethasone (DEX) on day 1, with or without low-dose DEX on days 2 and 3, combined with oral NEPA (netupitant/palonosetron), compared with the guideline-consistent use of DEX was demonstrated in cisplatin. Here, we complete the analysis by assessing the impact of emesis on daily lives of patients receiving DEX-sparing regimens using the Functional Living Index-Emesis (FLIE).Methods: Chemotherapy-naive patients undergoing cisplatin (>= 70 mg/m(2)), were given NEPA and DEX (12 mg) on day 1 and randomized to receive either 1) no further DEX (DEX1), 2) oral DEX (4 mg daily) on days 2-3 (DEX3), or 3) DEX (4 mg twice daily) on days 2-4 (DEX4; control). Patients completed the FLIE questionnaire on day 6 of cycle 1. Endpoints included the FLIE nausea domain, vomiting domain, and overall combined domain scores, as well as the proportion of patients with no impact on daily life (NIDL; overall score > 108). This was a protocol-planned analysis.Results: In the DEX1 group, no significant differences were observed in the FLIE nausea score (48.9 [+/- 1.8; SE] vs. 53.7 [+/- 1.5]), vomiting score (56.6 [+/- 1.4] vs. 58.7 [+/- 0.8]) and overall score (105.6 [+/- 2.8] vs.1 12.4 [+/- 1.9]) versus DEX4 control; similar results were observed in the DEX3 group for nausea score (49.6 [+/- 1.7]), vomiting score (58.2 [+/- 1]) and overall score (107.8 [+/- 2.4]) versus control. There were no significant between-group differences in the proportion of patients reporting NIDL.Conclusion: Reducing DEX, when administered with NEPA, does not seem to adversely impact the daily functioning in patients undergoing cisplatin.