Table 2.
Complete response (%) 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) | 77.9 vs 77.8 | 0.963 | 76.0 vs 76.7 | 0.835 | 91.5 vs 73.0 | 0.025 | 88.9 vs 80.0 | 0.212 | 88.4 vs 81.7 | 0.014 |
| Delayed phase (24–120 h) | 66.7 vs 59.8 | 0.039 | 66.7 vs 58.8 | 0.034 | 74.5 vs 54.1 | 0.052 | 72.2 vs 48.0 | 0.012 | 77.4 vs 65.1 | <0.001 |
| Overall phase (0–120 h) | 62.8 vs 55.1 | 0.023 | 62.5 vs 53.9 | 0.024 | 74.5 vs 48.6 | 0.016 | 72.2 vs 48.0 | 0.012 | 75.4 vs 63.1 | <0.001 |
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.