Table 5 Comparison of baseline patient characteristics, treatment outcomes and selected toxicity profiles after afatinib as 2nd TKI therapy in LUX-Lung1 and current study
| Â | LUX-Lung1 study | Current study | ||
|---|---|---|---|---|
Number of patients | 390 | 25 | ||
Age (range) | 58 (30–85) | 63 (42–85) | ||
Male/female (%) | 159 (40.8)/231 (59.2) | 11 (44.0)/14 (56.0) | ||
ECOG performance status (%) | Â | Â | ||
  0 | 92 (23.6) | 1 (4.0) | ||
  1 | 268 (68.7) | 12 (48.0) | ||
  2 | 30 (7.7) | 12 (48.0) | ||
Prior EGFR-TKI therapy (%) | Â | Â | ||
  Erlotinib | 215 (55.1) | 14 (56.0) | ||
  Gefitinib | 152 (39.0) | 11 (44.0) | ||
  Both | 23 (5.9) | 0 (0) | ||
Number of lines of prior chemotherapy (%) | Â | Â | ||
  1 | 231 (59.2) | 14 (56) | ||
  2 | 156 (40.0) | 11 (44) | ||
  3 | 3 (0.8) | 0 (0) | ||
Objective response (%) | Â | Â | ||
  Partial response | 29 (7.4) | 5 (20.0) | ||
  Stable disease | 198 (50.8) | 12 (48.0) | ||
Disease control (%) | 227 (58.2) | 17 (68.0) | ||
Median progression-free survival in months (range) | 3.3 (2.8–4.4) | 4.1 (2.7–5.5) | ||
Median overall survival in months (range) | 10.8 (10.0–12.0) | 10.3 (7.5–13.0) | ||
Selected toxicity profiles (%) | All grades (%) | ≥Grade 3 (%) | All grades (%) | ≥Grade 3 (%) |
  Rash | 305 (78.2) | 56 (14.4) | 15 (60.0) | 0 (0) |
  Diarrhea | 339 (86.9) | 66 (16.9) | 15 (60.0) | 7 (28.0) |
  Mucositis/stomatitis | 237 (60.8) | 12 (3.1) | 1 (4.0) | 0 (0) |
  Paronychia/nail effect | 153 (39.2) | 20 (5.1) | 2 (8.0) | 0 (0) |
  Hypokalemia | 34 (8.7) | 11 (2.8) | 2 (8.0) | 2 (8.0) |