Table 1.
Time to progression (TTP) and progression‐free survival (PFS) per investigator assessment (sensitivity analysis), time‐to‐next therapy (TTNT) and overall survival (OS) in the VTD and VTDC arms, based on Kaplan–Meier product limit estimates
| Outcome | VTD (n = 49) | VTDC (n = 49) | HR (95% CI) | P a |
|---|---|---|---|---|
| TTP (sensitivity analysis) | ||||
| Events, n (%) | 27 (55) | 35 (71) | ||
| Median (95% CI), months |
35·7 (23·9–NE) |
34·5 (23·5 –50·6) |
1·26 (0·76–2·09) |
0·370 |
| 3‐year rate, % (95% CI) |
48·8 (33·9–62·1) |
47·9 (33·3–61·1) |
NA | NA |
| 5‐year rate, % (95% CI) |
41·8 (27·5–55·5) |
27·1 (15·5–40·0) |
NA | NA |
| PFS (sensitivity analysis) | ||||
| Events, n (%) | 29 (59) | 36 (74) | ||
| Median (95% CI), months |
34·1 (23·5–NE) |
34·2 (23·5–48·2) |
1·20 (0·74–1·97) |
0·461 |
| 3‐year rate, % (95% CI) |
46·8 (32·4–59·9) |
46·9 (32·6–60·0) |
NA | NA |
| 5‐year rate, % (95% CI) |
40·1 (26·2–53·5) |
26·5 (15·2 –39·3) |
NA | NA |
| TTNT | ||||
| Events, n (%) | 26 (53) | 30 (61) | ||
| Median (95% CI), months |
51·8 (31·9–NE) |
47·9 (28·7–NE) |
1·21 (0·71–2·05) |
0·484 |
| OS | ||||
| Events, n (%) | 15 (31) | 19 (39) | ||
| Median (95% CI), months |
NE (NE–NE) |
NE (64·3–NE) |
1·15 (0·58–2·27) |
0·692 |
| 3‐year rate, % (95% CI) |
79·6 (65·4–88·5) |
83·7 (70·0–91·5) |
NA | NA |
| 5‐year rate, % (95% CI) |
69·1 (54·1–80·1) |
65·3 (50·3–76·8) |
NA | NA |
HR, hazard ratio; CI, confidence interval; NE: not estimable; NA: not applicable; VTD, bortezomib‐thalidomide‐dexamethasone; VTDC, bortezomib‐thalidomide‐dexamethasone plus cyclophosphamide.
a
Based on a stratified log‐rank test.