TY - JOUR
T1 - Fixed-Dose Netupitant and Palonosetron for Chronic Nausea in Cancer Patients
T2 - A Double-Blind, Placebo Run-in Pilot Randomized Clinical Trial
AU - Hui, David
AU - Puac, Veronica
AU - Shelal, Zeena
AU - Liu, Diane
AU - Maddi, Rama
AU - Kaseb, Ahmed
AU - Javle, Milind
AU - Overman, Michael
AU - Yennurajalingam, Sriram
AU - Gallagher, Colleen
AU - Bruera, Eduardo
N1 - Publisher Copyright:
© 2020 American Academy of Hospice and Palliative Medicine
PY - 2021/8
Y1 - 2021/8
N2 - Context: No clinical trials have examined the effect of netupitant/palonosetron (NEPA) on chronic nausea in patients with cancer. Objectives: In this pilot randomized trial, we assessed the efficacy of NEPA and placebo on chronic nausea. Methods: This double-blind, parallel, randomized trial enrolled patients with cancer and chronic nausea for at least 1 month, intensity ≥4/10 and not on moderately or highly emetogenic systemic therapies. Patients started with a placebo run-in period from days 1 to 5; those without a placebo response proceeded to the double-blinded phase between days 6 to 15 (NEPA: placebo 2:1 ratio). The primary outcome was within-group change in average nausea over the 24 hours on a 0–10 numeric rating scale between day 5 and 15. Results: Among the 53 enrolled patients, 46 proceeded to placebo run-in and 33 had blinded treatment (22 NEPA and 11 placebo). We observed a statistically significant within-group improvement in nausea numeric rating scale between day 5 and 15 in the NEPA group (mean change, −2.0; 95% CI, −3.1 to −0.8) and the placebo group (mean change, −2.3; 95% CI, −3.9 to −0.7). A complete response was achieved in 8 (38%) patients in the NEPA group and 2 (20%) in the placebo group by day 15. No grade 3–4 toxicities were attributed to NEPA. There were no statistically significant between-group differences for the primary/secondary outcomes. Conclusions: NEPA and placebo were associated with similar magnitude of within-group improvement in chronic nausea without significant between-group differences (Clinicaltrials.gov NCT03040726).
AB - Context: No clinical trials have examined the effect of netupitant/palonosetron (NEPA) on chronic nausea in patients with cancer. Objectives: In this pilot randomized trial, we assessed the efficacy of NEPA and placebo on chronic nausea. Methods: This double-blind, parallel, randomized trial enrolled patients with cancer and chronic nausea for at least 1 month, intensity ≥4/10 and not on moderately or highly emetogenic systemic therapies. Patients started with a placebo run-in period from days 1 to 5; those without a placebo response proceeded to the double-blinded phase between days 6 to 15 (NEPA: placebo 2:1 ratio). The primary outcome was within-group change in average nausea over the 24 hours on a 0–10 numeric rating scale between day 5 and 15. Results: Among the 53 enrolled patients, 46 proceeded to placebo run-in and 33 had blinded treatment (22 NEPA and 11 placebo). We observed a statistically significant within-group improvement in nausea numeric rating scale between day 5 and 15 in the NEPA group (mean change, −2.0; 95% CI, −3.1 to −0.8) and the placebo group (mean change, −2.3; 95% CI, −3.9 to −0.7). A complete response was achieved in 8 (38%) patients in the NEPA group and 2 (20%) in the placebo group by day 15. No grade 3–4 toxicities were attributed to NEPA. There were no statistically significant between-group differences for the primary/secondary outcomes. Conclusions: NEPA and placebo were associated with similar magnitude of within-group improvement in chronic nausea without significant between-group differences (Clinicaltrials.gov NCT03040726).
KW - Nausea
KW - neoplasms
KW - neurokinin-1 receptor antagonists
KW - randomized controlled trials
KW - serotonin 5-HT3 receptor antagonists
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U2 - 10.1016/j.jpainsymman.2020.12.023
DO - 10.1016/j.jpainsymman.2020.12.023
M3 - Article
C2 - 33388382
AN - SCOPUS:85099812988
SN - 0885-3924
VL - 62
SP - 223-232.e1
JO - Journal of pain and symptom management
JF - Journal of pain and symptom management
IS - 2
ER -