Table 2.
Patient 1a | Patient 2 | Patient 3 | Patient 4 | |
---|---|---|---|---|
Tumor diameter | ||||
At baseline, mm | 17 | 26.8 | 48 | 24.5 |
At study end, mm | 41 | 22.3 | 50.9 | 26 |
Change from baseline, % | 141 | –16.8 | 6.0 | 6.1 |
Tumor volume | ||||
At baseline, mm3 | 4862 | 7618 | 20 262 | 1717 |
At study end, mm3 | 20 313 | 4461 | 23 762 | 1890 |
Change from baseline, % | 318 | –41.4 | 17.3 | 10.0 |
PRL level | ||||
At baseline, µ/L | 11748 | 238 | 1347 | 113.7 |
Nadir, µ/L | 11753 | 123.1 | 1258.2 | 141.9 |
Change from baseline to nadir, % | 0.04 | –48.2 | –6.6 | 24.8 |
At study end, µ/L | 23 850 | 137.5 | 1725.5 | 181 |
Change from baseline to study end, % | 103 | –42 | 28 | 59 |
Safety | ||||
Transaminitis | No | Yes (grade 1) | No | Yes (grade 1) |
Rash | No | No | Yes (grade 2) | Yes (grade 2) |
Bradycardia | No | No | Yes (grade 1) | Yes (grade 1) |
Diarrhea | No | No | No | Yes (grade 1) |
Abbreviation: PRL, prolactin.
a Patient 1 withdrew after 3 months of treatment. Values given are from the final study visit.