Table 3. Multivariate Analysis of Factors Associated With Progression-Free Survivala.
Risk factor | Effect | HR (95% CI) | P value |
---|---|---|---|
Baseline LDH level | Elevated vs normal | 1.45 (1.27-1.65) | <.001 |
ECOG PS at screening | 1 vs 0 | 1.20 (1.06-1.36) | .004 |
Ipilimumab exposureb | Ipilimumab exposed vs ipilimumab naive | 1.13 (1.00-1.28) | .042 |
PD-L1 status | Negative vs positive | 1.58 (1.35-1.84) | <.001 |
Baseline tumor size | >93 mm vs ≤93 mmc | 1.44 (1.26-1.65) | <.001 |
Prior systemic BRAFi therapy | Yes vs no | 1.31 (1.14-1.52) | <.001 |
Sex | Female vs male | 1.23 (1.09-1.38) | <.001 |
Albumin | ≤0.834 vs >0.834 | 1.23 (1.08-1.40) | <.001 |
Abbreviations: BRAFi, BRAF inhibitor; ECOG PS, Eastern Cooperative Oncology Group performance status; HR, hazard ratio; LDH, lactate dehydrogenase; PD-L1, programmed death ligand 1.
Analysis included all patients, regardless of BRAF mutation status. Progression-free survival was determined by Response Evaluation Criteria in Solid Tumors, version 1.1, per investigator review.
The clinical study and prior ipilimumab exposure were highly correlated, and only 1 could be included in the model. See eTable 3 in the Supplement for multivariate analysis with study included as a covariate instead of ipilimumab exposure.
Cutoff chosen based on the value that showed the most significant difference in response.