Table 6.
Study | Phase | Patients | Immunotherapy | RT/ChT | Primary Outcome |
---|---|---|---|---|---|
Maasilta et al., 1992 | II | 20 | Alpha-INT with RT vs. RT alone |
66 Gy, 1.25 Gy/fx tw | Moderate/severe pneumonitis and/or oesophagitis in experimental arm |
McDonald et al., 1993 | I/II | 39 | Beta-INF with RT | 54–59.4 Gy, 1.8 Gy/fx | ORR: 81% CR: 44% 5-y OS 51% No serious AE |
Shaw et al., 1995 | I | 18 | Gamma-INF with RT | 60 Gy, 1.5 Gy/fx tw | 50% life threatening or fatal AE mOS: 7.8 m |
RTOG 93-04 Bradley et al., 2002 |
III | 123 | Beta-INF with RT vs. RT |
60 Gy, 2 Gy/fx | G3-4 AE higher on beta-INF arm p = 0.024 1-y OS: 44% vs. 42% (p = ns) |
DETERRED Lin et al., 2018 |
II | 40 | Atezolizumab + CRT | 60–66 Gy, 30–33 fx, concurrently with ChT | ≥G3 atezo-related toxicity in 6 pts 30%; G5 fistula (n = 1) 5%. G3 radiation pneumonitis (n = 1) |
NICOLAS Peters et al., 2019 |
IA/II | 79 | Nivolumab with CRT | 66 Gy/33 fx, concurrently with ChT | No ≥G3 post-RT pneumonitis 1-y PFS 50% and 1-y OS 79% |
KEYNOTE 779 Jabbour et al., 2021 |
II | 185 | Pembrolizumab with CRT | 60 Gy, 2 Gy/fx/carboplatin–paclitaxel (A) or cisplatin-pemetrexed (B) | G ≧ 3:AE A: 64.3; B: 41, pneumonitis > 3 A: 8%, B: 5.5% |
2020 AFT-16 Ross et al. |
II | 64 | Atezolizumab before and after CRT | 60 Gy, 2 Gy/fx+ carboplatin–paclitaxel | AE ≧ 3: 20% 12-week-DCR: 77.4% |
Lemmon et al., 2020 | I | 9 | Pembrolizumab with CRT + Surgery | 45 Gy, 1.8 fx with cisplatin-etoposide | pCR 67% 2 G5 AE Trial halted |
RT = radiotherapy; ChT = chemotherapy; CRT = chemoradiotherapy; AE = adverse event; INF = interferon; ns = not significant; Gy = grays; fx = fraction-s; ORR = overall response rate; CR = complete response; DCR = disease control rate; pCR = pathologic complete response; OS = overall survival; PFS = progression-free survival; tw = twice; G = grade; m = months.