Table 2.
Summary of efficacy results of the Japanese subgroup of the A.R.R.O.W. study
| Once-weekly Kd 20/70 mg/m2 (N = 26) |
Twice-weekly Kd 20/27 mg/m2 (N = 14) |
|
|---|---|---|
| Best overall response, n (%)a | ||
| Stringent complete response (sCR) | 0 (0.0) | 0 (0.0) |
| Complete response (CR) | 3 (11.5) | 0 (0.0) |
| Very good partial response (VGPR) | 8 (30.8) | 4 (28.6) |
| Partial response (PR) | 8 (30.8) | 4 (28.6) |
| Minimal response (MR) | 3 (11.5) | 0 (0.0) |
| Stable disease | 0 (0.0) | 5 (35.7) |
| Progressive disease | 1 (3.8) | 1 (7.1) |
| Not evaluable (NE) | 3 (11.5) | 0 (0.0) |
| Duration of responseb | ||
| Number of events, n (%) | 8 (30.8) | 3 (21.4) |
| Median (95% CI) (months)a | 15.1 (11.1, NE) | NE (2.8, NE) |
| Clinical benefit rate (CBR)c | ||
| Number of subjects who achieved clinical benefit | 22 | 8 |
| CBR (95% CI) (%)d | 84.6 (65.1, 95.6) | 57.1 (28.9, 82.3) |
| Overall survival | ||
| Number of subjects who died, n (%) | 3 (11.5) | 1 (7.1) |
| Median (95% CI) (months)e | NE (NE, NE) | NE (NE, NE) |
Stratification factors: ISS stage at study entry (Stage 1 vs. Stage 2 or 3), refractory to bortezomib treatment (yes vs. no), and age (< 6 vs. ≥ 65 years)
CI confidence interval, Kd carfilzomib (Kyprolis) plus dexamethasone, NE not estimable
aBest overall response is defined as a subject's best response during the study
bMedian and percentiles were estimated using the Kaplan–Meier method. Corresponding CIs were estimated using the method by Klein and Moeschberger (1997) with log–log transformation
cClinical benefit is defined as achieving a best overall response of MR, PR, VGPR, CR or sCR
dClopper–Pearson interval
eMedian was estimated using the Kaplan–Meier method. Corresponding CIs were estimated using the method by Klein and Moeschberger (1997) with log–log transformation