TABLE II.
Phase iii maintenance trials with epidermal growth factor receptor tyrosine kinase inhibitors
Agent | Reference (study name) | Regimen | Screened (n) | Randomized (n) | pfs (months) | os (months) |
---|---|---|---|---|---|---|
Switch maintenance | ||||||
Erlotinib | ||||||
Miller et al., 200924 (atlas) | Platinum doublet–bev → bev–erlotinib | 1160 | 768 | 4.8 | 15.9 | |
Platinum doublet–bev → bev–placebo | 3.7 | 13.9 | ||||
(p=0.0012) | (p=0.27) | |||||
Cappuzzo et al., 201025 (saturn) | Platinum doublet × 4 → erlotinib | 1949 | 889 | 3.1 | 12 | |
Platinum doublet × 4 → placebo | 2.8 | 11 | ||||
(p<0.0001) | (p=0.01) | |||||
Perol et al., 201026 (ifct-gfpc 0502) | Cisplatin–gemcitabine → erlotinib | nr | 310 | 2.8 | nr | |
Cisplatin–gemcitabine → observation | 2.1 | nr | ||||
(p=0.002) | ||||||
Gefitinib | ||||||
Gaafar et al., 201027 (eortc 08021–ilcp 01/03) | Platinum doublet × 4 → gefitinib | 173 | 173 | 4.1 | 10.9 | |
Platinum doublet × 4 → placebo | 2.9 | 9.4 | ||||
(p=0.0015) | (p=0.2) | |||||
Takeda et al., 201028 (wjtog 0203) | Platinum doublet × 3 → gefitinib | 598 | 598 | 4.6 | 13.7 | |
Platinum doublet × 6 | 4.3 | 12.9 | ||||
(p<0.001) | (p=0.11) | |||||
Zhang et al., 201129 (inform) | Platinum doublet × 4 → gefitinib | 298 | 296 | 4.8 | 18.7 | |
Platinum doublet × 4 → placebo | 2.6 | 16.9 | ||||
(p<0.0001) | (p=0.26) | |||||
Continuation maintenance | ||||||
None designed |
pfs = progression-free survival; os = overall survival; bev = bevacizumab; nr = not reported.