Table 3.
Cycle 1 Efficacy of NEPA + DEX compared with oral palonosetron + DEX.
| Patients (%) | Study 1 (Cisplatin HEC) | Study 2 (AC) | ||||
|---|---|---|---|---|---|---|
| NEPA + DEX (N = 136) |
Oral PALO + DEX (N = 135) |
P value1 | NEPA + DEX (N = 724) |
Oral PALO + DEX (N = 725) |
P value2 | |
| No emesis | ||||||
| Acute (0–24 h) | 98.5 | 89.7 | 0.007 | 90.9 | 87.3 | 0.025 |
| Delayed (25–120 h) | 91.9 | 80.1 | 0.006 | 81.8 | 75.6 | 0.004 |
| Overall (0–120 h) | 91.1 | 76.5 | 0.001 | 79.8 | 72.1 | <0.001 |
| No significant nausea | ||||||
| Acute | 98.5 | 93.4 | 0.050 | 87.3 | 87.9 | 0.747 |
| Delayed | 90.4 | 80.9 | 0.027 | 76.9 | 71.3 | 0.014 |
| Overall | 89.6 | 79.4 | 0.021 | 74.6 | 69.1 | 0.020 |
| Complete protection | ||||||
| Acute | 97.0 | 87.5 | 0.006 | 82.3 | 81.1 | 0.528 |
| Delayed | 84.4 | 73.5 | 0.027 | 67.3 | 60.3 | 0.005 |
| Overall | 83.0 | 69.9 | 0.010 | 63.8 | 57.9 | 0.020 |
1 P value from logistic regression versus oral palonosetron; not adjusted for multiple comparisons.
2 P value from two-sided Cochran-Mantel-Haenszel test including treatment, age class, and region as strata.
HEC: highly emetogenic chemotherapy; AC: anthracycline cyclophosphamide; NEPA: netupitant/palonosetron; PALO: palonosetron; DEX: dexamethasone.