Single NEPA Dose NonInferior To Aprepitant-Based Regimen For CINV Prevention

A single fixed dose of a combination netupitant and palonosetron agent may be as effective as a 3-day regimen of aprepitant plus granisetron for prevention of cisplatin-induced nausea and vomiting

  • Date: 02 Nov 2017
  • Author: By Lynda Williams, Senior medwireNews Reporter
  • Topic: Supportive Measures

medwireNews: A fixed single oral dose of netupitant plus palonosetron (NEPA) has been at least as effective at preventing chemotherapy-induced nausea and vomiting (CINV) as a 3-day regimen of aprepitant and granisetron in a phase III trial.

The study participants, aged an average of 54.5 years, were all undergoing a highly emetogenic, cisplatin-based chemotherapy regimen, most commonly for lung cancer (58.3%) or head and neck cancer (6.6%).

Patients randomly assigned to receive the study protocol were given a single dose of NEPA on day 1, consisting of a 300 mg dose of the highly selective NK1 receptor agonist netupitant and a 0.5 mg dose of the 5-HT3 receptor antagonist palonosetron, plus dexamethasone 12 mg on day 1 and 8 mg on days 2–4.

And patients in the comparator group were given aprepitant 125 mg on day 1, alongside granisetron 3 mg and dexamethasone 12 mg, followed by aprepitant 80 mg on days 2 and 3 and dexamethasone 8 mg on days 2–4.

The primary endpoint of a complete response – defined as no emesis and no requirement for rescue medicine – was achieved by 73.8% of NEPA-treated patients and this rate was noninferior to the 72.4% rate achieved among those given aprepitant plus granisetron.

Indeed, NEPA was noninferior to aprepitant plus granisetron during both the acute (0–24 h) and delayed (25–120 h) phases and this was reflected in the overall rates for no emesis (75.0 vs 74.0%) and no significant nausea (75.7 vs 70.4%). In addition, NEPA was significantly superior to the comparator regimen with regard to the number of patients not requiring rescue medication in the delayed phase (97.6 vs 94.7%) and this was reflected in the overall rate (96.6 vs 93.5%).

“The slightly higher response rates for NEPA were reflected in a quality of life benefit, with acorrespondingly greater proportion of patients with no impact on their functioning due to nausea during the delayed phase, when CINV control is most challenging”, say Li Zhang, from Sun Yat-sen University Cancer Center in Guangzhou, China, and co-investigators.

“While this difference is small, it is encouraging that NEPA demonstrated some potential to improve quality of life”, they add.

Writing in the Annals of Oncology, the researchers describe NEPA as “well tolerated with a comparable adverse event profile to [aprepitant plus granisetron].” The most common treatment-related adverse events for both groups were constipation (8.0 vs 6.3%) and hiccups (2.7 vs 1.4%), and most side effects were of mild or moderate intensity.

The authors conclude: “NEPA conveniently packages two classes of antiemetics recommended by guidelines in the HEC/high risk MEC settings in a single oral dose administered 60 minutes prior to chemotherapy.

“In clinical practice NEPA could either be taken at home or at the clinic/hospital prior to chemotherapy.”

Reference

Zhang L, Lu S, Feng J, et al. A randomized phase 3 study evaluating the efficacy of single-dose NEPA, a fixed antiemetic combination of netupitant and palonosetron, versus an aprepitant regimen for prevention of chemotherapy-induced nausea and vomiting (CINV) in patients receiving highly emetogenic chemotherapy (HEC). Ann Oncol; Advance online publication 28 October 2017. https://doi.org/10.1093/annonc/mdx698

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