Summary of disease responses (efficacy analysis set)
| . | IRC-assessed by PET and/or CT (n = 66)∗ . | IRC-assessed by CT only (n = 66)∗ . | Investigator-assessed by PET and/or CT (n = 66)∗ . |
|---|---|---|---|
| ORR, % (95% CI)† | 68.2 (55.6-79.1) | 66.7 (54.0-77.8) | 75.8 (63.6-85.5) |
| Best overall response, n (%) | |||
| CR | 17 (25.8) | 16 (24.2) | 19 (28.8) |
| PR | 28 (42.4) | 28 (42.4) | 31 (47.0) |
| Stable disease | 13 (19.7) | 16 (24.2) | 10 (15.2) |
| Progressive disease | 6 (9.1) | 5 (7.8) | 5 (7.8) |
| Nonprogressive disease‡ | 1 (1.5) | 0 | 0 |
| Discontinued study before first assessment, n (%) | 1 (1.5) | 1 (1.5) | 1 (1.5) |
| Median time to response, mo (range) | 2.8 (1.7-11.1) | 3.0 (1.8-22.2) | 2.8 (1.7-16.6) |
| . | IRC-assessed by PET and/or CT (n = 66)∗ . | IRC-assessed by CT only (n = 66)∗ . | Investigator-assessed by PET and/or CT (n = 66)∗ . |
|---|---|---|---|
| ORR, % (95% CI)† | 68.2 (55.6-79.1) | 66.7 (54.0-77.8) | 75.8 (63.6-85.5) |
| Best overall response, n (%) | |||
| CR | 17 (25.8) | 16 (24.2) | 19 (28.8) |
| PR | 28 (42.4) | 28 (42.4) | 31 (47.0) |
| Stable disease | 13 (19.7) | 16 (24.2) | 10 (15.2) |
| Progressive disease | 6 (9.1) | 5 (7.8) | 5 (7.8) |
| Nonprogressive disease‡ | 1 (1.5) | 0 | 0 |
| Discontinued study before first assessment, n (%) | 1 (1.5) | 1 (1.5) | 1 (1.5) |
| Median time to response, mo (range) | 2.8 (1.7-11.1) | 3.0 (1.8-22.2) | 2.8 (1.7-16.6) |
Two patients were excluded from the efficacy analysis set because central review determined their diagnosis as diffuse large B-cell lymphoma.
95% CIs were calculated using 2-sided Clopper-Pearson methodology.
One patient with FDG-avid disease who missed the PET scan at cycle 3 and was assessed as nonprogressive disease (CT scan showed stable disease).