Efficacy end points (efficacy-evaluable population)
| . | Patients aged ≥60 y . | Patients aged ≥65 y . | Patients aged ≥70 y . | Patients aged ≥75 y . | ||||
|---|---|---|---|---|---|---|---|---|
| Pola-R-CHP (n = 311) . | R-CHOP (n = 318) . | Pola-R-CHP (n = 231) . | R-CHOP (n = 236) . | Pola-R-CHP (n = 141) . | R-CHOP (n = 143) . | Pola-R-CHP (n = 60) . | R-CHOP (n = 60) . | |
| Clinical response rates,∗ n (%) | ||||||||
| ORR | 268 (86.2) | 270 (84.9) | 194 (84.0) | 200 (84.8) | 122 (86.5) | 120 (83.9) | 51 (85.0) | 49 (81.7) |
| CR | 251 (80.7) | 242 (76.1) | 181 (78.4) | 179 (75.9) | 115 (81.6) | 111 (77.6) | 47 (78.3) | 46 (76.7) |
| PR | 17 (5.5) | 28 (8.8) | 13 (5.6) | 21 (8.9) | 7 (5.0) | 9 (6.3) | 4 (6.7) | 3 (5.0) |
| SD | 3 (1.0) | 3 (1.0) | 3 (1.3) | 3 (1.3) | 2 (1.4) | 2 (1.4) | 1 (1.7) | 1 (1.7) |
| PD | 16 (5.1) | 17 (5.4) | 14 (6.1) | 12 (5.1) | 6 (4.3) | 10 (7.0) | 2 (3.3) | 6 (10.0) |
| NE | 6 (1.9) | 9 (2.8) | 4 (1.7) | 6 (2.5) | 2 (1.4) | 3 (2.1) | 1 (1.7) | 1 (1.7) |
| ND/missing | 18 (5.8) | 19 (6.0) | 16 (6.9) | 15 (6.4) | 9 (6.4) | 8 (5.6) | 5 (8.3) | 3 (5.0) |
| 2-y rates, % (95% CI) | ||||||||
| PFS | 77.9 (73.3-82.6) | 70.3 (65.1-75.4) | 76.5 (71.0-82.0) | 68.4 (62.4-74.5) | 77.3 (70.3-84.3) | 67.0 (59.2-74.8) | 78.9 (68.3-89.5) | 68.9 (57.0-80.8) |
| Difference, % | 7.6 | 8.1 | 10.3 | 10.0 | ||||
| OS | 88.6 (85.0-92.1) | 87.4 (83.7-91.1) | 85.9 (81.4-90.4) | 86.5 (82.0-90.9) | 86.3 (80.5-92.0) | 82.8 (76.5-89.1) | 83.1 (73.5-92.6) | 83.1 (73.5-92.6) |
| Difference, % | 1.2 | −0.6 | 3.5 | 0 | ||||
| EFS | 77.3 (72.6-82.0) | 69.7 (64.5-74.9) | 76.1 (70.5-81.6) | 67.7 (61.6-73.8) | 77.3 (70.3-84.3) | 66.3 (58.4-74.2) | 78.9 (68.3-89.5) | 67.2 (55.1-79.3) |
| Difference, % | 7.6 | 8.4 | 11.0 | 11.7 | ||||
| DFS† | 81.8 (77.2-86.4) | 75.4 (70.2-80.7) | 80.4 (74.9-85.9) | 74.4 (68.2-80.5) | 81.3 (74.4-88.2) | 73.0 (65.1-80.9) | 82.7 (72.4-93.0) | 72.8 (60.6-85.0) |
| Difference, % | 6.4 | 6.0 | 8.3 | 9.9 | ||||
| . | Patients aged ≥60 y . | Patients aged ≥65 y . | Patients aged ≥70 y . | Patients aged ≥75 y . | ||||
|---|---|---|---|---|---|---|---|---|
| Pola-R-CHP (n = 311) . | R-CHOP (n = 318) . | Pola-R-CHP (n = 231) . | R-CHOP (n = 236) . | Pola-R-CHP (n = 141) . | R-CHOP (n = 143) . | Pola-R-CHP (n = 60) . | R-CHOP (n = 60) . | |
| Clinical response rates,∗ n (%) | ||||||||
| ORR | 268 (86.2) | 270 (84.9) | 194 (84.0) | 200 (84.8) | 122 (86.5) | 120 (83.9) | 51 (85.0) | 49 (81.7) |
| CR | 251 (80.7) | 242 (76.1) | 181 (78.4) | 179 (75.9) | 115 (81.6) | 111 (77.6) | 47 (78.3) | 46 (76.7) |
| PR | 17 (5.5) | 28 (8.8) | 13 (5.6) | 21 (8.9) | 7 (5.0) | 9 (6.3) | 4 (6.7) | 3 (5.0) |
| SD | 3 (1.0) | 3 (1.0) | 3 (1.3) | 3 (1.3) | 2 (1.4) | 2 (1.4) | 1 (1.7) | 1 (1.7) |
| PD | 16 (5.1) | 17 (5.4) | 14 (6.1) | 12 (5.1) | 6 (4.3) | 10 (7.0) | 2 (3.3) | 6 (10.0) |
| NE | 6 (1.9) | 9 (2.8) | 4 (1.7) | 6 (2.5) | 2 (1.4) | 3 (2.1) | 1 (1.7) | 1 (1.7) |
| ND/missing | 18 (5.8) | 19 (6.0) | 16 (6.9) | 15 (6.4) | 9 (6.4) | 8 (5.6) | 5 (8.3) | 3 (5.0) |
| 2-y rates, % (95% CI) | ||||||||
| PFS | 77.9 (73.3-82.6) | 70.3 (65.1-75.4) | 76.5 (71.0-82.0) | 68.4 (62.4-74.5) | 77.3 (70.3-84.3) | 67.0 (59.2-74.8) | 78.9 (68.3-89.5) | 68.9 (57.0-80.8) |
| Difference, % | 7.6 | 8.1 | 10.3 | 10.0 | ||||
| OS | 88.6 (85.0-92.1) | 87.4 (83.7-91.1) | 85.9 (81.4-90.4) | 86.5 (82.0-90.9) | 86.3 (80.5-92.0) | 82.8 (76.5-89.1) | 83.1 (73.5-92.6) | 83.1 (73.5-92.6) |
| Difference, % | 1.2 | −0.6 | 3.5 | 0 | ||||
| EFS | 77.3 (72.6-82.0) | 69.7 (64.5-74.9) | 76.1 (70.5-81.6) | 67.7 (61.6-73.8) | 77.3 (70.3-84.3) | 66.3 (58.4-74.2) | 78.9 (68.3-89.5) | 67.2 (55.1-79.3) |
| Difference, % | 7.6 | 8.4 | 11.0 | 11.7 | ||||
| DFS† | 81.8 (77.2-86.4) | 75.4 (70.2-80.7) | 80.4 (74.9-85.9) | 74.4 (68.2-80.5) | 81.3 (74.4-88.2) | 73.0 (65.1-80.9) | 82.7 (72.4-93.0) | 72.8 (60.6-85.0) |
| Difference, % | 6.4 | 6.0 | 8.3 | 9.9 | ||||
BICR, blinded independent central review; ND, not done; NE, not evaluable; ORR, objective response rate; PD, progressive disease; PR, partial response; SD, stable disease.
BICR assessed at the end of treatment.
The DFS-evaluable population for Pola-R-CHP and R-CHOP was 276 and 271, respectively, in patients aged ≥60 years; 204 and 201, in patients aged ≥65 years; 125 and 125, in patients aged ≥70 years; and 52 and 53, in patients aged ≥75 years.