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- Title
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.
- Authors
Celio, Luigi; Cortinovis, Diego; Cogoni, Alessio Aligi; Cavanna, Luigi; Martelli, Olga; Carnio, Simona; Collovà, Elena; Bertolini, Federica; Petrelli, Fausto; Cassano, Alessandra; Chiari, Rita; Zanelli, Francesca; Pisconti, Salvatore; Vittimberga, Isabella; Letizia, Antonietta; Misino, Andrea; Gernone, Angela; Bonizzoni, Erminio; Pilotto, Sara; De Placido, Sabino
- Abstract
<bold>Background: </bold>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).<bold>Methods: </bold>Chemotherapy-naïve patients undergoing cisplatin (≥70 mg/m2), 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.<bold>Results: </bold>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.112.4 [±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.<bold>Conclusion: </bold>Reducing DEX, when administered with NEPA, does not seem to adversely impact the daily functioning in patients undergoing cisplatin.<bold>Trial Registration: </bold>ClinicalTrials.gov NCT04201769 . Registration date: 17/12/2019 - Retrospectively registered.
- Publication
BMC Cancer, 2022, Vol 22, Issue 1, p1
- ISSN
1471-2407
- Publication type
journal article
- DOI
10.1186/s12885-022-10018-3