Table 5.
Comparison of the interstitial lung disease (ILD) analysis from the interim and final analysis results for Post-Launch All-patient-Registration Surveillance in Tarceva®-treated non-small-cell lung cancer patients (POLARSTAR)
| Endpoint | Interim analysis (safety, n = 3488) (efficacy, n = 3453) | Final analysis (safety, n = 9909) (efficacy, n = 9663) |
|---|---|---|
| ILD analysis | ||
| Patients with confirmed ILD, n (%) | 158 (4.5) | 429 (4.3) |
| ILD-related mortality rate, % | 1.6 | 1.5 |
| ILD-related mortality rate in ILD patients | 34.8 | 35.7 |
| Risk factors for ILD development, HR | ||
| Previous/concurrent ILD | 4.1 | 3.2 |
| Previous/concurrent Emphysema or COPD | – | 1.9 |
| Previous/concurrent lung infection | 2.0 | 1.6 |
| Smoking history | 3.0 | 2.2 |
| ECOG PS 2–4 | 1.6 | 1.4 |
| <360 days from diagnosis to treatment | – | 0.58 |
COPD, chronic obstructive pulmonary disease; ECOG PS, Eastern Cooperative Oncology Group performance status; HR, hazard ratio.