表1.
EGFR-TKIs耐药后ICIs联合治疗部分研究汇总
| Item | Study | n | Phase | Primary end point | Treatment plan | ORR | mPFS (mon) | Security |
|---|---|---|---|---|---|---|---|---|
| ICIs+TKIs | CheckMate 012 | 20 | I | Security | Nivolumab+Erlotinib | 15% | 5.1 | ≥G3 TRAEs: 24%; ≥irAEs: 36.7%; TEAEs causes treatment interruption: 6.7% |
| GEFTREM terminate | 27 | I | Security | Tremelimumab+Gefitinib | 0 | 2.2 | ≥G3 TRAEs: 81% | |
| Tatton suspension of recruitment |
34 | IB | Security | Durvalumab+Osimertinib | / | / | ILD: 35% | |
| CAURAL suspension of recruitment |
29 | III | Security | Durvalumab+Osimertinib; Osimertinib |
80% vs 64% | / | ILD: 2% | |
| ICIs+ Chemotherapy |
2019 WCLC NCT03513666 |
40 | II | ORR | Pembrolizumab+PEM/CBP | 50.0% | 7.0 | ≥G3 TRAEs: 65%; ≥irAEs: 5.0%; TEAEs caused treatment interruption: 10.0% |
| 2021 ESMO | 32 | II | PFS | Tislelizumab+NAB-PTX+CBP | 59.4% (95%CI: 40.6%-76.3%) |
/ | ≥G3 TRAEs: 32.5%; SAEs: 17.5% |
|
| KEYNOTE789 be in progress |
/ | III | OS | Pembrolizumab+PEM+CBP; PEM+CBP |
/ | / | / | |
| CheckMate 722 be in progress |
/ | III | PFS | Nivolumab+Chemotherapy; Chemotherapy |
/ | / | / | |
| ICIs+ Chemotherapy+ Antiangiogenic therapy |
2020 ESMO IMpower150 |
79 ABCP vs BCP 34 vs 44 |
III subgroup |
OS | Atezolizumab+PTX+CBP+BEV; PTX+CBP+BEV |
73.5% vs 40.9% | 10.2 vs 7.1; HR=0.56 (95%CI: 0.34-0.91) |
≥G3 TRAEs: 66.7% vs 55.8%; SAEs: 42.4% vs 20.9% |
| 2020 WCLC NCT03083041 |
43 | IB/II | PFS | Camrelizumab+Apatinib | 18.6% (95%CI: 8.4%-33.4%) |
2.8 (95%CI: 1.9-5.5) |
/ | |
| 2021 ESMO ASIA ORIENT-31 |
299 148 vs 151 |
III | PFS | Sintilimab+PEM+DDP+BEV; PEM+DDP |
48.1% vs 29.4% | 7.2 vs 4.3; HR=0.464 (95%CI: 0.34-0.91) |
≥G3 TRAEs: 54.7% vs 51%; SAEs: 37.2% vs 35%; TEAEs caused treatment: 19.9% vs 6.6%; irAEs: 35.1% vs 15.2% | |
| BGB-A317-2001-IIT be in progress |
32 | II | PFS | Tislelizumab+NAB-PTX+BEV | / | / | / |
EGFR: epidermal growth factor receptor; TKIs: tyrosine kinase inhibitors; ICIs: immune checkpoint inhibitors; ORR: objective response rate; PFS: progression-free survival; OS: overall survival; TRAEs: treatment-related adverse events; WCLC: World Conference on Lung Cancer; ESMO: European Society of Medical Oncology; irAEs: immune-related adverse events; SAEs: serious adverse events; ILD: interstitial lung disease; PEM: Pemetrexed disodium; CBP: Carboplatin; NAB-PTX: Paclitaxel protein-bound; BEV: Bevacizumab; DDP: Cisplatin; /: no data.