NEPA (Netupitant/Palonosetron) for the Prevention of Chemotherapy-Induced Nausea and Vomiting (CINV) in Patients Receiving Highly or Moderately Emetogenic Chemotherapy Who Experienced Breakthrough CINV in Cycle 1 of Chemotherapy: A Phase II Clinical Trial.

BACKGROUND

Although control of chemotherapy-induced nausea and vomiting (CINV) is substantially improved with guideline-directed antiemetic prophylaxis, breakthrough CINV remains a significant clinical patient problem. In subsequent cycles after breakthrough occurs, antiemetic guidelines recommend adding agents not used in the initial cycle. This study was designed to evaluate the use of NEPA (netupitant/palonosetron) plus dexamethasone with or without olanzapine for the prevention of CINV in the second cycle of chemotherapy for patients receiving highly (HEC) or moderately emetogenic chemotherapy (MEC) who developed breakthrough CINV in their first cycle despite guideline-directed prophylactic antiemetics.

METHODS

This was a Phase 2, single center, open-label study. Patients received guideline-recommended prophylactic antiemetics in Cycle 1 based on the chemotherapy emetogenicity. Patients who experienced breakthrough CINV in Cycle 1 received intravenous (IV) NEPA (Day 1) plus dexamethasone (Days 1-4) and olanzapine (Days 1-4) for HEC or IV NEPA (Day 1) plus dexamethasone (Days 1-4) for MEC in Cycle 2.

RESULTS

Of the 227 patients enrolled in Cycle 1, 100 patients (n = 37 HEC, 63 MEC) experienced breakthrough CINV and received the NEPA-based treatments in Cycle 2. The complete response (no emesis/no rescue use) rates [95% confidence intervals] during the overall (0-120 h) phase were 76% [59%, 88%] and 79% [67%, 89%] in the HEC and MEC groups, respectively.

CONCLUSION

These results show that NEPA with or without olanzapine is an effective approach for CINV prevention for patients receiving HEC or MEC who develop breakthrough CINV after their first course of chemotherapy. The results support the antiemetic guideline recommendations.

TRIAL REGISTRATION

clinicaltrials.gov identifier: NCT06065722.