TABLE 3.
Characteristic | All | Schedule A | Schedule B |
---|---|---|---|
Induction cycles | |||
Median | 4 | 4 | 4 |
Range | 1–9 | 1–8 | 1–9 |
Maintenance cycles | |||
No of patients (%) | 16 (37.2) | 12 (52.2) | 4 (20) |
Talazoparib/carboplatin | |||
No of patients (%) a | 6 (13.9) | 4 (17.4) | 2 (10) |
Median cycles | 2 | 3.5 | 2 |
Range | 2–9 | 2–9 | 2–2 |
Talazoparib monotherapy | |||
No of patients (%) a | 13 (30.2) | 9 (39.1) | 2 (10) |
Median cycles | 8 | 15 | 10 |
Range | 1–63 | 1–63 | 2–18 |
Dose modification at MTD (No of patients, %) |
|||
Ever | 27 (96.4) | 14 (93) | 13 (100) |
During induction | 27 (96.4) | 14 (93) | 13 (100) |
Chemotherapy dose reduction | 27 (96.4) | 14 (93) | 13 (100) |
BMN dose reduction | 1 (3.5) | 1 (7) | 0 (0) |
Induction % dose intensity at MTD (mean, SD) b | |||
Carboplatin | 91 (9) | 93 (7) | 89 (10) |
Paclitaxel | 68 (17) | 69 (18) | 68 (17) |
BMN | 92 (20) | 89 (24) | 94 (14) |
Supportive care (No of patients, %) |
|||
Growth factor | 15 (34.8) | 11 (47.8) | 4 (20) |
Any transfusion | 14 (32.5) | 6 (26.1) | 8 (40) |
pRBC transfusion | 12 (27.9) | 6 (26.1) | 6 (30) |
Platelet transfusion | 2 (4.6) | 0 (0) | 2 (10) |
Reason for treatment discontinuation (No of patients, %) | |||
Disease progression | 26 (60.4) | 14 (60.8) | 12 (60) |
Adverse event | 5 (11.6) | 3 (13) | 2 (10 |
Intercurrent illness | 3 (6.9) | 1 (4.3) | 2 (10) |
Death on study | 1 (2.3) | 0 (0) | 1 (5) |
Study completion/transition to commercial drug | 2 (4.66) | 2 (8.7) | 0 (0) |
Other | 6 (13.9) | 3 (13) c | 3 (15) d |
Patients who received both talazoparib/carboplatin and subsequent talazoparib monotherapy maintenance are reported in both groups.
Percent of full dose based on number of induction cycles.
Schedule A (one patient each): Physician's decision, Patient not tolerating therapy, and Switched to alternative treatment.
Schedule B (one patient each): Refused further treatment, late determination of eligibility, and treatment held for more than 3 weeks.