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Randomized Controlled Trial
. 2023 Jan 23;13(1):1257.
doi: 10.1038/s41598-023-28464-9.

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

Luigi Celio  1 , Diego Cortinovis  2 , Alessio Aligi Cogoni  3 , Luigi Cavanna  4 , Olga Martelli  5 , Simona Carnio  6 , Elena Collovà  7 , Federica Bertolini  8 , Fausto Petrelli  9 , Alessandra Cassano  10   11 , Rita Chiari  12 , Francesca Zanelli  13 , Salvatore Pisconti  14 , Isabella Vittimberga  15 , Antonietta Letizia  16 , Andrea Misino  17 , Angela Gernone  18 , Erminio Bonizzoni  19 , Sara Pilotto  20 , Sabino De Placido  21 , Emilio Bria  10   11
Affiliations
Randomized Controlled Trial

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

Luigi Celio et al. Sci Rep. .

Abstract

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/m2) 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).

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Conflict of interest statement

Luigi Celio has received consulting fees from Italfarmaco SpA, and Kyowa Kirin; speaker’s fee from Berlin-Chemie AG, and Helsinn. Diego Cortinovis has received speaker’s bureau and scientific advisor fees from Roche, AstraZeneca, BMS, MSD, Boehringer, Amgen, Novartis, and Lilly. Federica Bertolini has received speaker’s fee from MSD, AstraZeneca, and BMS; advisory board fees from MSD, Eli-Lilly, and Sanofi. Rita Chiari has declared speaker's fee - advisory boards from Astrazeneca, Roche, BMS, MSD, Pfizer, and Takeda. Erminio Bonizzoni received consulting fees from Helsinn. Sara Pilotto has received fees for consulting, advisory role and lectures from AstraZeneca, BMS, Boehringer, Eli-Lilly, Merck, Novartis, Roche, Amgen, Takeda. Emilio Bria received speakers’ and travels’ fees from MSD, AstraZeneca, Celgene, Pfizer, Helsinn, Eli-Lilly, BMS, Novartis and Roche, as well as institutional research grants from AstraZeneca and Roche. All remaining authors have declared no conflicts of interest.

Figures

Figure 1
Figure 1
Proportion of patients reporting usual daily food intake in acute, delayed, and overall phases. Error bars represent 95% confidence interval. NEPA, fixed combination of netupitant and palonosetron; DEX1, dexamethasone day 1; DEX4, dexamethasone day 1 to 4.
Figure 2
Figure 2
Time course of complete response (a), no significant nausea (b), and usual daily food intake (c) in each treatment group (by 24-h period). Error bars represent 95% confidence interval. NEPA, fixed combination of netupitant and palonosetron; DEX1, dexamethasone day 1; DEX4, dexamethasone day 1 to 4.
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