Table 5.
Endpoint of no nausea (%) by age, phase, and chemotherapy treatment following oral administration of rolapitant55,56
| Patients <65 years old
|
Patients ≥65 years old
|
|||||||
|---|---|---|---|---|---|---|---|---|
| MEC plus AC, %
|
P-value | Cisplatin-baseda, %
|
P-value | MEC plus AC, %
|
P-value | Cisplatin-baseda, %
|
P-value | |
| ROL (n=495) vs CON (n=470) | ROL (n=397) vs CON (n=393) | ROL (n=171) vs CON (n=196) | ROL (n=138) vs CON (n=142) | |||||
| Acute phase (0–24 h) | 60.4 vs 61.9 | 0.630 | 67.3 vs 62.8 | 0.194 | 78.4 vs 75.5 | 0.519 | 79.7 vs 68.3 | 0.030 |
| Delayed phase (24–120 h) | 44.6 vs 42.1 | 0.430 | 54.7 vs 42.5 | <0.001 | 59.6 vs 51.5 | 0.119 | 58.7 vs 49.3 | 0.115 |
| Overall phase (0–120 h) | 41.2 vs 38.5 | 0.392 | 50.9 vs 39.9 | 0.002 | 57.9 vs 50.5 | 0.157 | 56.5 vs 46.5 | 0.093 |
Note:
a
Pooled analysis of the two HEC phase 3 trials.
Abbreviations: AC, anthracycline and cyclophosphamide; CON, control; h, hours; HEC, highly emetogenic chemotherapy; MEC, moderately emetogenic chemotherapy; ROL, rolapitant.