Table 3.
| a: Cox proportional hazards models were created for progression-free survival (PFS) with number of treatment related adverse events (trAEs) included as a time-varying covariate. Listed are results from both unadjusted model and adjusted models. Hazard ratio estimates marked ‘(+1)’ correspond to the incremental effect of a unit increase in the relevant predictor. | ||
|---|---|---|
| Progression-Free Survival (Unadjusted Model) | ||
| Effect | HR (95% CI) | P |
| Number of trAEs (+1) | 0.81 (0.65, 1.01) | 0.067 |
| Progression-Free Survival (Adjusted Model) | ||
|---|---|---|
| Effect | HR (95% CI) | P |
| Number of trAEs (+1) | 0.75 (0.56, 0.99) | 0.043 |
| Female | 0.80 (0.48, 1.35) | 0.409 |
| Age at Trial Start (+1y) | 0.97 (0.95, 1.00) | 0.036 |
| Number of Previous Lines of Therapy (+1) | 1.03 (0.86, 1.24) | 0.760 |
| PD-L1 Proportion Score (Ref: ≤1) | ||
| 1–49 | 1.13 (0.63, 2.02) | 0.686 |
| ≥50 | 1.03 (0.46, 2.28) | 0.948 |
| EGFR Mutations | 1.51 (0.80, 2.84) | 0.204 |
| Ever Smoker | 0.93 (0.48, 1.80) | 0.820 |
| Squamous | 1.01 (0.52, 1.95) | 0.972 |
| b: Cox proportional hazards models were created for overall survival (OS) with number of treatment related adverse events (trAEs) included as a time-varying covariate. Listed are results from both unadjusted model and adjusted models. Hazard ratio estimates marked ‘(+1)’ correspond to the incremental effect of a unit increase in the relevant predictor. | ||
|---|---|---|
| Overall Survival (Unadjusted Model) | ||
| Effect | HR (95% CI) | P |
| Number of trAEs (+1) | 0.77 (0.63, 0.94) | 0.011 |
| Overall Survival (Adjusted Model) | ||
|---|---|---|
| Effect | HR (95% CI) | P |
| Number of trAEs (+1) | 0.75 (0.58, 0.96) | 0.021 |
| Female | 0.92 (0.56, 1.51) | 0.738 |
| Age at Trial Start (+1y) | 0.99 (0.96, 1.01) | 0.285 |
| Number of Previous Lines of Therapy (+1) | 1.08 (0.91, 1.28) | 0.363 |
| PD-L1 Proportion Score (Ref: ≤1) | ||
| 1–49 | 1.18 (0.67, 2.06) | 0.566 |
| ≥50 | 1.38 (0.63, 3.02) | 0.420 |
| EGFR Mutations | 0.74 (0.40, 1.38) | 0.345 |
| Ever Smoker | 0.72 (0.39, 1.34) | 0.302 |
| Squamous | 0.98 (0.49, 1.96) | 0.950 |
| c: Logistic regression models were created for objective response with number of treatment related adverse events (trAEs) included as a covariate. To control for guarantee bias, only the 65 patients on trial ≥9wks were included and only those trAEs that occurred ≤9wks after initiating therapy were considered. Listed are results from both unadjusted model and adjusted models. ORRs are compared with odds ratios and odds ratio estimates marked ‘(+1)’ correspond to the incremental effect of a unit increase in the relevant predictor. | ||
|---|---|---|
| Objective Response Rate (Unadjusted Model) | ||
| Effect | OR (95% CI) | P |
| Number of trAEs (+1) | 1.27 (0.81, 1.99) | 0.306 |
| Objective Response Rate (Adjusted Model) | ||
|---|---|---|
| Effect | OR (95% CI) | P |
| Number of trAEs (+1) | 2.02 (0.87, 4.69) | 0.101 |
| PD-L1 Proportion Score (Ref: ≤1) | ||
| 1–49 | 3.94 (0.67, 23.10) | 0.129 |
| ≥50 | 26.64 (2.85, 249.00) | 0.004 |
| EGFR Mutations | 1.07 (0.18, 6.47) | 0.937 |