Table 5.
Fine and Gray competing risk model for time to pneumonitis while on treatment by LOTa
| Parameter | During LOT 1 | During LOT 2 | During LOT 3 | |||
|---|---|---|---|---|---|---|
| Hazard ratio (95% CI) | P value | Hazard ratio (95% CI) | P value | Hazard ratio (95% CI) | P value | |
| Demographic characteristics | ||||||
| Age (≥ 65 vs. < 65) | 0.95 (0.86–1.05) | 0.3388 | 1.08 (0.93–1.25) | 0.3079 | 0.98 (0.79–1.21) | 0.8634 |
| Gender (male vs. female) | 1.15 (1.04–1.27) | 0.0051* | 1.2 (1.04–1.39) | 0.0143* | 1.02 (0.81–1.27) | 0.8916 |
| Race (African American vs. Caucasian) | 0.94 (0.79–1.11) | 0.4602 | 1.01 (0.79–1.28) | 0.9534 | 1.12 (0.8–1.58) | 0.5115 |
| Race (Asian vs. Caucasian) | 1.26 (0.88–1.81) | 0.2114 | 0.85 (0.48–1.53) | 0.5931 | 0.98 (0.49–1.96) | 0.9498 |
| Race (other/unknown vs. Caucasian) | 1.11 (0.87–1.41) | 0.4031 | 0.92 (0.61–1.38) | 0.6853 | 1.09 (0.56–2.12) | 0.8042 |
| Histology | ||||||
| Squamous vs. non-squamousb | 1.32 (1.18–1.47) | <0 .0001* | 1.16 (0.98–1.38) | 0.0901 | 1.28 (0.98–1.67) | 0.0694 |
| Unknown vs. non-squamous | 0.85 (0.66–1.09) | 0.1951 | 1.33 (0.94–1.9) | 0.1093 | 0.93 (0.42–2.03) | 0.8538 |
| Biomarker status | ||||||
| EGFRc (positive vs. negative) | 0.82 (0.69–0.98) | 0.0273* | 0.78 (0.62–0.99) | 0.0370* | 0.86 (0.63–1.16) | 0.3085 |
| EGFR (unknown vs. negative) | 0.82 (0.71–0.95) | 0.0072* | 0.83 (0.68–1.01) | 0.0645 | 0.84 (0.62–1.12) | 0.2315 |
| PD-L1 (positive vs. negative) | 1.16 (0.8–1.69) | 0.4410 | 0.89 (0.56–1.39) | 0.5984 | 0.71 (0.34–1.47) | 0.3538 |
| PD-L1 (unknown vs. negative) | 0.82 (0.58–1.16) | 0.2643 | 0.69 (0.46–1.03) | 0.0698 | 0.61 (0.32–1.17) | 0.1383 |
| History of adverse events | ||||||
| CCI score (1–4 vs. 0) | 0.98 (0.89–1.09) | 0.7420 | 0.89 (0.77–1.03) | 0.1046 | 1.02 (0.82–1.27) | 0.8500 |
| History of diabetes (yes vs. no) | 1.02 (0.91–1.14) | 0.7113 | 1.01 (0.86–1.19) | 0.9171 | 0.98 (0.76–1.25) | 0.8445 |
| History of pneumonitis (yes vs. no) | 2.91 (2.6–3.25) | <0 .0001* | 2.9 (2.51–3.36) | < 0.0001* | 2.91 (2.35–3.6) | <0 .0001* |
| Treatment category | ||||||
| Any ICI monotherapy (yes vs. no) | 1.64 (0.89–3.02) | 0.1104 | 1.92 (1.04–3.56) | 0.0375* | 1.45 (0.68–3.09) | 0.3302 |
| Any ICI combination therapy (yes vs. no) | 1.06 (0.78–1.44) | 0.6984 | 1.58 (1.04–2.4) | 0.0305* | 1.5 (0.77–2.95) | 0.2370 |
| EGFR TKI therapy (yes vs. no) | 0.95 (0.52–1.76) | 0.8729 | 0.94 (0.49–1.79) | 0.8443 | 1.04 (0.49–2.22) | 0.9149 |
| Other targeted therapy (yes vs. no) | 0.55 (0.43–0.71) | < .0001* | 0.58 (0.41–0.83) | 0.0027* | 0.73 (0.45–1.21) | 0.2247 |
| Any platinum-based chemotherapy (yes vs. no) | 0.92 (0.52–1.66) | 0.7909 | 0.98 (0.53–1.79) | 0.9395 | 0.76 (0.36–1.63) | 0.4856 |
| Any non-platinum-based chemotherapy (yes vs. no) | 0.9 (0.49–1.65) | 0.7342 | 1.12 (0.62–2.05) | 0.7069 | 0.73 (0.36–1.51) | 0.3957 |
| Radiation therapy | ||||||
| History of radiation therapy (yes vs. no) | 1.33 (1.19–1.49) | <0 .0001* | 1.14 (0.95–1.38) | 0.1647 | 1.46 (1.07–2) | 0.0181* |
CCI Charlson Comorbidity Index; EGFR epidermal growth factor receptor; ICI immune checkpoint inhibitor; LOT line of therapy; PD-L1 programmed death-ligand 1; TKI, tyrosine kinase inhibitor
aRegimens whose start dates were on or after January 1, 2008, were considered for the analysis. Assessment period is from start of LOT to 30 days after end of current LOT or day prior to start of next LOT, whichever is earlier, or (where no next LOT) up to end of follow-up for patient or end of LOT + 30, whichever is earlier. Shaded cells represent parameters that were significant at the 0.05 level
bPatients with squamous cell carcinoma were compared against patients with non-squamous cell carcinoma only. Non-squamous NSCLC includes adenocarcinoma and large cell lung cancer. Patients with unknown histology were excluded from this analysis