Table 3.
Treatment course and outcome
| Alisertib dose level | Patient | ≥ grade 3 toxicity, all cycles | Progression-free survival (months) | Overall survival (months) |
|---|---|---|---|---|
| 40 mg | 1 | None | 3.8 | 19.2 |
| 2 | None | 13.8 | 31.5 | |
| 3 | None | 32.5 | 32.5+ | |
| 50 mg | 1 | None | 1.8 | 6.4 |
| 2 | Grade 4 neutropenia with grade 3 leukopenia and lymphopenia | 6.7 | 7.6+ | |
| 3 | None | 11.1 | 11.7+ | |
| 4 | Grade 3 fatigue and then grade 4 hypertension with grade 3 dyspnea and hypoxia | 13.3+a | 13.3+ | |
| 5 | None | 25.9 | 27.6 | |
| 6 | Grade 4 neutropenia with grade 3 leukopenia | 31.8+ | 31.8+ |
a One subject discontinued study participation due to grade 4 hypertension with grade 3 dyspnea and hypoxia (considered unlikely related to treatment) after 13.3 months of therapy. As of the data lock, the patient had maintained stable disease on fulvestrant monotherapy