apy, and a maximum nausea visual analogue scale [VAS] score <25 mm on a 0 to 100 mm scale)
complete response during the acute and delayed phases.
A summary of the key results from this study is shown in Table 3.
Table 3: Percent of Patients Receiving Moderately Emetogenic Chemotherapy Responding by Treatment Group and Phase — Cycle 1 ENDPOINTS Aprepitant
Regimen
(N = 433)*
% Standard
Therapy
(N = 424)*
% p-Value
N: Number of patients included in the primary analysis of complete response.
Overall: 0 to 120 hours post-chemotherapy treatment.
NS when adjusted for prespecified multiple comparisons rule; unadjusted p-value <0.001.
PRIMARY ENDPOINT
Complete Response † 51 42 0.015
OTHER PRESPECIFIED ENDPOINTS
No Emesis 76 59 NS‡
No Nausea 33 33 NS
No Significant Nausea 61 56 NS
No Rescue Therapy 59 56 NS
Complete Protection 43 37 NS
In this study, a statistically significantly (p=0.015) higher proportion of patients receiving the aprepitant regimen (51%) in Cycle 1 had a complete response (primary endpoint) during the overall phase compared with patients receiving standard therapy (42%). The difference between treatment groups was primarily driven by the “No Emesis Endpoint”, a principal component of this composite primary endpoint. In addition, a higher proportion of patients receiving the aprepitant regimen in Cycle 1 had a complete response during the acute (0-24 hours) and delayed (25-120 hours) phases compared with patients receiving standard therapy; however, the treatment group differences failed to reach statistical significance, after multiplicity adjustments.
Patient-Reported Outcomes: In a phase III study in patients receiving moderately emetogenic chemotherapy, the impact of nausea and vomiting on patients’ daily lives was assessed in Cycle 1 using the FLIE. A higher proportion of patients receiving the aprepitant regimen reported minimal or no impact on daily life (64% versus 56%). This difference between treatment groups was primarily driven by the “No Vomiting Domain” of this composite endpoint.
Multiple-Cycle Extension: Patients receiving moderately emetogenic chemotherapy were permitted to continue into the Multiple-Cycle extension of the study for up to 3 additional cycles of chemotherapy. Antiemetic effect for patients receiving the aprepitant regimen is maintained during all cycles.
INDICATIONS AND USAGE
EMEND for Injection, in combination with other antiemetic agents, is indicated for the:
prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy including high-dose cisplatin.
prevention of nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (see DOSAGE AND ADMINISTRATION).
CONTRAINDICATIONS
EMEND for Injection is contraindicated in patients who are hypersensitive to EMEND for Injection, aprepitant, polysorbate 80 or any other components of the product.
Aprepitant, when administered orally, is a moderate cytochrome P450 isoenzyme 3A4 (CYP3A4) inhibitor following the 3-day antiemetic dosing regimen for CINV. Since fosaprepitant is rapidly converted to aprepitant, fosaprepitant should not be used conc |
