Table 2.
Response rates, progression-free survival, and overall survival for the intent-to-treat population based on independent radiological assessment
| Blinded radiology assessment | nab-Paclitaxel (N = 264) | Dacarbazine (N = 265) | Response rate ratioa (Pnab-P/PDTIC) | P b |
|---|---|---|---|---|
| ORR, n (%) | 39 (15) | 30 (11) | 1.305 (0.837–2.035) | 0.239 |
| 95% CI | 10.5–19.1 | 7.5–15.1 | ||
| DCR,cn (%) | 102 (39) | 71 (27) | 1.442 (1.123–1.852) | 0.004 |
| 95% CI | 32.8–44.5 | 21.5–32.1 | ||
| PR, n (%) | 39 (15) | 30 (11) | ||
| SD ≥16 weeks, n (%) | 63 (24) | 41 (15) | ||
| Best response, n (%) | 0.0017d | |||
| PR | 39 (15) | 30 (11) | ||
| SD | 67 (25) | 41 (16) | ||
| PD | 93 (35) | 128 (48) | ||
| Not evaluablee | 65 (25) | 65 (25) | 0.005f | |
| HR (HRnab-P/DTIC) | ||||
| PFS, median (95% CI) based on independent radiology review (months) | 4.8 (3.7–5.5) | 2.5 (2.0–3.6) | 0.792 (0.631–0.992)g | 0.044 |
| BRAF mutant | 5.3 (3.5–7.5) | 3.5 (1.9–5.5) | 0.883 (0.515–1.513) | 0.656 |
| BRAF wild type | 5.4 (3.5–5.7) | 2.5 (1.9–3.7) | 0.715 (0.492–1.040) | 0.088 |
| BRAF unknown | 3.7 (2.8–5.6) | 2.2 (1.9–3.6) | 0.684 (0.457–1.024) | 0.066 |
| PFS, median (95% CI) based on investigator review (months) | 3.7 (3.1–3.9) | 2.1 (1.9–2.5) | 0.845 (0.696–1.025) | 0.086 |
| OS, median (95% CI) (months) | 12.6 (11.1–14.2) | 10.5 (9.5–12.4) | 0.897 (0.738–1.089)h | 0.271 |
aThe 95% CI for response rate ratios is calculated according to the asymptotic 95% CI of the relative risk of nab-paclitaxel to dacarbazine.
bThe P values are based on the χ2 test.
cDCR includes CR + PR + stable disease (SD) ≥16 weeks.
dIncludes confirmed PR, SD, and PD.
eNonassessable patients had (i) scans that were not done, (ii) scans that were done but not fully evaluable, or (iii) scans that were done and evaluable but a single response of CR, PR, or SD was not confirmed at a later assessment.
fComparison of PD rate between arms.
g95.1% CI is provided given that two-sided type I error of 0.049 was allocated for final PFS analysis.
h95.1% CI is provided given that two-sided type I error of 0.049 was allocated for final OS analysis.
DCR, disease control rate; DTIC, dacarbazine; HR, hazard ratio; nab-P, nab-paclitaxel; ORR, objective response rate; OS, overall survival; P, proportion of improved patients; PD, progressive disease; PFS, progression-free survival; PR, partial response; SD, stable disease.