Table 4. Adverse effects of combined therapy in major clinical trials.
| Study | Neutropenia | Anemia | Thrombocytopenia | Diarrhea | Rash | Paronychia | Stomatitis | AST/ALT elevation | LD | Hypertension |
|---|---|---|---|---|---|---|---|---|---|---|
| ≥ Grade3 (%) | ≥ Grade3 (%) | ≥ Grade3 (%) | ≥ Grade3 (%) | ≥ Grade3 (%) | ≥ Grade3 (%) | ≥ Grade3 (%) | ≥ Grade3 (%) | ≥ Grade3 (%) | ≥ Grade3 (%) | |
| NEJ 0051, 2 | 48.8 | 34.1 | 41.5 | 9.8 | 2.4 | 2.4 | 4.9 | 9.8 | 0.0 | NA |
| 46.2 | 12.8 | 28.2 | 0.0 | 0.0 | 2.6 | 0.0 | 20.5 | NAa | NA | |
| FASTACT-23 | 29 | 11 | 14 | 1 | 5 | NA | 0.0 | NA | NAb | NA |
| JMIT4 | 5 | 3 | NA | 1 | NA | NA | 4 | 22 | 1 | NA |
| JO255675 | NA | NA | NA | 1 | 25 | 3 | 1 | NAc | 0 | 60 |
1Gefitinib + chemotherapy Concurrent regimen.
2Gefitinib + chemotherapy Sequential alternating regimen.
3Erlotinib + chemotherapy.
4Gefitinib + Pemetrexed.
5Erlotinib + Bevacizumab.
AST = Aspartate Aminotransferase.
ALT = Alanine AminotransferaseT.
ILD = Interstitial Lung Disease.
NA = Not Available
aA total of 4 interstitial lung diseases (5% of all patients) occurred (grade 1 and 2 events in the concurrent, and grade 2 and 4 events in the sequential alternating regimen group).
bOne interstitial lung disease event occurred.
C5% incidences of liver function disorder or abnormal hepatic function were noted.