Exploratory analysis of the effect of a dexamethasone-sparing regimen for prophylaxis of cisplatin-induced emesis on food intake (LUNG-NEPA study)

• Published in: Scientific reports Vol. 13; no. 1; pp. 1257 - 9
• Main 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, Bria, Emilio
• Format: Journal Article
• Language: English
• Published: England Nature Publishing Group 23.01.2023; Nature Publishing Group UK; Nature Portfolio
• Subjects: Antiemetics; Antineoplastic Agents - therapeutic use; Body weight loss; Chemotherapy; Cisplatin; Cisplatin - therapeutic use; Dexamethasone; Dexamethasone - therapeutic use; Eating; Food; Food intake; Humans; Lung; Nausea - chemically induced; Palonosetron; Patients; Prophylaxis; Steroids; Vomiting; Vomiting - chemically induced
• ISSN: 2045-2322; 2045-2322
• DOI: 10.1038/s41598-023-28464-9

We demonstrated the non-inferiority of a dexamethasone (DEX)-sparing (single-dose) regimen with NEPA, a netupitant/palonosetron fixed combination, for preventing chemotherapy-induced nausea and vomiting (CINV) caused by cisplatin. This pre-planned exploratory analysis assessed the effect of the DEX-sparing regimen on a patient's food intake. Chemotherapy-naïve patients undergoing cisplatin (≥ 70 mg/m ) were given NEPA and DEX (12 mg) on day 1 and randomized to receive either no further DEX (DEX1), or oral DEX (4 mg BID) on days 2-4 (DEX4). Patient-reported endpoint maintenance of usual daily food intake was assessed during the 5-days post-chemotherapy. The relationship between usual daily food intake and CINV control, pre-chemotherapy self-rated food intake and BMI-adjusted weight loss (WL) were evaluated. One-hundred fifty-two patients (76/group) were assessable. The proportion of patients reporting maintenance of usual daily food intake was similar in both groups: 69.7% (95% CI, 58.6-78.9) for DEX1 vs. 72.4% (95% CI, 61.4-81.2) for DEX4. Only CINV control was significantly associated with maintenance of usual daily food intake (P ≤ 0.001) during the overall phase. The DEX-sparing regimen does not adversely affect patient-reported daily food intake post-chemotherapy. The current analysis adds further insights into antiemetic efficacy of DEX sparing beyond day 1 in the challenging setting of cisplatin.Trial registration: The parent study was registered on ClinicalTrials.gov (NCT04201769).