Responses at week 23 in the ITT population according to either local investigators or IRR
| . | Local investigators, n (%) . | IRR, n (%)* . | ||
|---|---|---|---|---|
| R (n = 77) . | RL (n = 77) . | R (n = 77) . | RL (n = 77) . | |
| CR/CRu | 19 (25) | 28 (36) | 28 (36) | 47 (61) |
| 95% CI, % | 16-36 | 26-48 | 26-48 | 49-72 |
| PR | 28 (36) | 35 (45) | 16 (21) | 13 (17) |
| SD | 6 (8) | 4 (5) | 7 (9) | 2 (3) |
| PD | 2 (3) | 3 (4) | 3 (4) | 1 (1) |
| NE† | 22 (29) | 7 (9) | 23 (30) | 14 (18) |
| . | Local investigators, n (%) . | IRR, n (%)* . | ||
|---|---|---|---|---|
| R (n = 77) . | RL (n = 77) . | R (n = 77) . | RL (n = 77) . | |
| CR/CRu | 19 (25) | 28 (36) | 28 (36) | 47 (61) |
| 95% CI, % | 16-36 | 26-48 | 26-48 | 49-72 |
| PR | 28 (36) | 35 (45) | 16 (21) | 13 (17) |
| SD | 6 (8) | 4 (5) | 7 (9) | 2 (3) |
| PD | 2 (3) | 3 (4) | 3 (4) | 1 (1) |
| NE† | 22 (29) | 7 (9) | 23 (30) | 14 (18) |
NE, not evaluable; PD, progressive disease; PR, partial response; SD, stable disease.
On imaging only.
Patients NE at week 23 included those already showing PD or not achieving at least an MR at week 10 and those who discontinued before week 23 because of unacceptable toxicity or any other reason, as indicated in the CONSORT diagram (Figure 1). These patients were counted as nonresponders. In 8 patients, CT scan imaging was not available for IRR.