Table 2. Phase III Trials comparing EGFR-inhibitors to chemotherapy in maintenance and adjuvant settings.
| Trial [year] (Ref) | Patient selection | Targeted therapy (TT) | Comparator (C) | Median PFS TT vs. C (mo.) | HR | P value |
|---|---|---|---|---|---|---|
| Maintenance | ||||||
| WJTOG0203 [2010] (61) | n=604, unselected, Adc + SCC (EGFR predictive biomarker not known) | Gefitinib (in those without PD after 3× cycles platinum doublet) | Platinum doublet (up to 6 cycles) | 4.6 (Gefitinib) vs. 4.3 (chemo) | 0.68 | <0.001 |
| SATURN [2010] (62) | n=884, unselected for entry, Adc + SCC, 7% EGFR mutant | Erlotinib (in those without PD after 4× cycles platinum doublet) | Placebo | 2.8 vs. 2.6 (12.3 vs. 11.1 wks.) | 0.71 | <0.0001 |
| INFORM [2012] (63) | n=296, unselected, Adc + SCC (known EGFR status excluded) | Gefitinib (in those without PD after 4× cycles platinum doublet) | Placebo | 4.8 vs. 2.6 | 0.42 | <0.0001 |
| IFCT-GFPC 0502 [2012] (64) | n=464, unselected, Adc + SCC | Erlotinib or Gemcitabine maintenance (in those without PD after 4× cycles cisplatin gemcitabine) | Observation | 2.9 vs. 1.9 (Erlotinib) | 0.69 | 0.003 |
| 3.8 vs. 1.9 (Gemcitabine) | 0.56 | <0.001 | ||||
| SWOG S0023 [2008] (65) | n=243, unselected, Adc + SCC, closed after unplanned interim analysis after ISEL trial | Gefitinib (after chemoradiation and docetaxel in inoperable stage III) | Placebo | 8.3 vs. 11.7 | 0.8 | 0.17 |
| Adjuvant | ||||||
| BR.19 [2013] (66) | n=503, unselected, Adc + SCC, closed after unplanned interim analysis after ISEL trial | Gefitinib (after completely resected stage IB, II or IIIA NSCLC) | Placebo | 50.4 vs. not yet reached (4.2 years vs. not yet reached) | 1.22 | 0.15 |
Adc, adenocarcinoma; SCC, squamous cell carcinoma; PFS, progression-free survival; HR, hazard ratio; EGFR, epidermal growth factor receptor; TKI, tyrosine kinase inhibitor; mo, months; wks, weeks.