Table 5. Subgroup analysis of clinical response among evaluable phase I/II patients receiving RP2D.
|
Phase I/II at RP2D |
|||||
|---|---|---|---|---|---|
|
Bortezomib |
Lenalidomide |
||||
| All (n=79) | Naive (n=43) | Pretreated (n=36) | Naive (n=55) | Pretreated (n=24) | |
|
Response, n (%) | |||||
| sCR | 0 | 0 | 0 | 0 | 0 |
| CR | 3 (3.8) | 3 (7.0) | 0 | 3 (5.5) | 0 |
| VGPR | 10 (12.7) | 5 (11.6) | 5 (13.9) | 7 (12.7) | 3 (12.5) |
| PR | 18 (22.8) | 11 (25,6) | 7 (19.4) | 15 (27.3) | 3 (12.5) |
| MR | 10 (12.7) | 4 (9.3) | 6 (16,7) | 9 (16.4) | 1 (4.2) |
| SD | 35 (40.5) | 18 (41.9) | 14 (38.9) | 18 (32.7) | 14 (58.3) |
| PD | 6 (7.6) | 2 (4.7) | 4 (11.1) | 3 (5.5) | 3 (12.5) |
| ORRa, n (%) (95% CI) | 31 (39.2) (28.4–50.9) | 19 (44.2) (29.1–60.1) | 12 (33.3) (18.6–51.0) | 25 (45.5) (32.0–59.4) | 6 (25.0) (9.8–46.7) |
| CBRb, n (%) (95% CI) | 41 (51.9) (40.4–63.3) | 23 (53.5) (37.7–68.8) | 18 (50.0) (32.9–67.1) | 34 (61.8) (47.7–74.6) | 7 (29.2) (12.6–51.1) |
| Median PFS, months (95% CI) | 6.8 (5.5-NR) | 7.0 (5.5–10.4) | 6.2 (4.1–7.8) | 7.7 (6.2–10.4) | 4.8 (3.6–7.1) |
| Median duration of response, months (95% CI) | 5.6 (4.9-NR) | 9.8 (4.9–10.1) | 6.7 (4.3-NA) | 9.8 (5.6–10.1) | 5.9 (2.4-NA) |
Abbreviations: CBR=clinical benefit rate; CI=confidence interval; CR=complete response; MR=minimal response; NR=not reached; ORR=overall response rate; PD=progressive disease; PFS=progression-free survival; PR=partial response; RP2D=recommended phase II dose; sCR=stringent complete response; SD=stable disease; VGPR=very good partial response.
a
ORR=sCR+CR+VGPR+PR.
b
CBR=sCR+CR+VGPR+PR+MR.