Characteristics of nausea and its impact on health-related quality of life in cisplatin-treated patients receiving dexamethasone-sparing prophylaxis: an analysis of the LUNG-NEPA study.

Abstract

We investigated the intensity and duration of nausea as well as its impact on health-related quality of life among cisplatin-treated patients who participated in a study of dexamethasone (DEX)-sparing regimens based on NEPA (netupitant/palonosetron). This retrospective analysis included chemo-naive patients from a trial evaluating non-inferiority of DEX on day 1 (DEX1 arm) combined with NEPA, compared with the same regimen with DEX administered on days 1-4 (DEX4; reference arm) following cisplatin (≥ 70mg/m2) administration. Nausea intensity was self-rated using a four-point Likert scale. Extended nausea duration was considered ≥ 3days within the 5days post-chemotherapy. Patients completed the Functional Living Index-Emesis (FLIE) questionnaire on day 6. In the DEX1 arm, more patients (20/76) experienced acute nausea, influencing the outcome of delayed nausea (38/76). During days 1 to 5, 51.3% (39/76) and 39.5% (30/76) of patients experienced nausea in the DEX1 and DEX4 arms, respectively (P = 0.192). Of these, 43.6% and 60% reported moderate-to-severe nausea, respectively, in the DEX1 and DEX4 arms (P = 0.200), while 74.4% and 56.7% of patients experienced extended nausea duration (P = 0.122). Similar between-arm rates of nauseated patients reported an impact on daily life (79.5% vs. 70%; P = 0.408). In analyses stratified for antiemetic regimen, moderate-to-severe nausea or extended nausea duration was associated with an impact on daily life (P ≤ 0.001). Despite the higher incidence, there was no suggestion of any strong adverse effect of NEPA plus single-dose DEX on the characteristics of nausea as well as its impact on daily life in patients with cisplatin-induced nausea. Further prospective controlled study is warranted. ClinicalTrials.gov identifier: NCT04201769. Registration date: 17/12/2019.