Table 2.
Investigator-evaluated assessment of response
| ITT population | Cohort A n = 15 (%) | Cohort B n = 17 (%) | Cohort C n = 66 (%) |
|---|---|---|---|
| Best response,a n (%) | 0 | 0 | 4 (6.1) |
| CR | 0 | 0 | 0 |
| PR | 0 | 0 | 4 (6.1) |
| SD | 6 (40) | 6 (35.3) | 26 (39.4) |
| PD | 7 (46.7) | 7 (41.2) | 26 (39.4) |
| Nonevaluableb | 2 (13.3) | 4 (23.5) | 10 (15.2) |
| DCR (≥8 wk)c | 4 (26.7) | 5 (29.4) | 28 (42.4) |
| PFS rate at 16 wk | 2 (13.3) | 1 (5.9) | 13 (19.7) |
| PFS, median (95% CI), mo | 1.9 (1.6–3.6) | 1.9 (1.6–3.7) | 1.8 (1.8–2.9) |
| OS, median (95% CI), mo | 7.1 (5.2–14.3) | 11.0 (3.9–17.1) | 8.8 (4.4–10.5) |
a
Initial assessment at 8 weeks from treatment start with confirmation assessment at least 4 weeks later.
b
Patients discontinuing treatment before the first posttreatment scans were considered nonevaluable. Reasons were: AEs (n = 4); death (n = 3); investigator decision (n = 2), protocol violation (n = 2); symptomatic deterioration (n = 1); and withdrawal of informed consent (n = 4).
c
DCR: CR and PR and SD ≥ 8 weeks.