Table 3.
Endpoint of no nausea (%) by cancer population, phase, and chemotherapy treatment following oral administration of rolapitant
| Breast cancer population52
|
GI/colorectal cancer population53,*
|
Lung cancer population54
|
||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| MEC plus AC, %
|
P-value | AC only, %
|
P-value | MEC; non-AC, %
|
P-value | Cisplatin-baseda, %
|
P-value | Carboplatin or cisplatin-basedb, %
|
P-value | |
| ROL (n=417) vs CON (n=428) | ROL (n=333) vs CON (n=347) | ROL (n=47) vs CON (n=37) | ROL (n=54) vs CON (n=50) | ROL (n=337) vs CON (n=350) | ||||||
| Acute phase (0–24 h) | 56.8 vs 62.1 | 0.116 | 54.1 vs 59.1 | 0.187 | 74.5 vs 56.8 | 0.089 | 75.9 vs 58.0 | 0.053 | 75.7 vs 70.9 | 0.155 |
| Delayed phase (24–120 h) | 38.8 vs 40.4 | 0.641 | 36.9 vs 38.9 | 0.597 | 61.7 vs 35.1 | 0.016 | 48.1 vs 30.0 | 0.060 | 63.5 vs 51.1 | 0.001 |
| Overall phase (0–120 h) | 35.3 vs 37.4 | 0.520 | 33.6 vs 35.2 | 0.676 | 57.4 vs 35.1 | 0.043 | 48.1 vs 28.0 | 0.036 | 60.5 vs 48.6 | 0.002 |
Notes:
a
Pooled analysis of the two HEC phase 3 trials;
b
pooled analysis of the two HEC and the MEC plus AC trials.
*
(Tesaro, Inc., data on file, 2016).
Abbreviations: AC, anthracycline and cyclophosphamide; CON, control; GI, gastrointestinal; h, hours; HEC, highly emetogenic chemotherapy; MEC, moderately emetogenic chemotherapy; ROL, rolapitant.