Table 5.
Comparisons between Phase 3 trial and Phase 4 trial of icotinib
| Study | Phase | Specific population | Number of Cases | ORR | DCR | Rash | Diarrhea | Dysfunction of liver |
|---|---|---|---|---|---|---|---|---|
| Shi et al12 | III | All patients | 200 | 27.6% | 75.4% | 41% | 22% | 11% |
| Sun43 | IV | All patients | 5,549 | 30% | 80.6% | 17.4% | 8.5% | 0.8% |
| >70 years old | 1,571 | – | – | 16.7% | 8.1% | – | ||
| EGFR mutated | ||||||||
| First-line | 144 | 56.3%* | 95.2%* | – | – | – | ||
| Second-line and above | 521 | 47.1% | 91.5% | – | – | – | ||
| EGFR wild | 214 | 17.8% | 75.7% | – | – | – |
Notes: *ORR and DCR in first-line therapy were significantly higher than those in second-line therapy and above in Phase IV trial; “–”, not available.
Abbreviations: DCR, disease control rate; EGFR, epidermal growth factor receptor; ORR, objective response rate.