Table 2.
Randomized phase III trials with a neoadjuvant surgical treatment approach in stage III NSCLC before the introduction of immune checkpoint inhibitors
| Trial Recruitment Number of enrolled/surgery/resected patients |
Phase | Stage TNM | Treatment arms | R0a | pCRa | OSb (number of patients included in the OS analysis per arm) | OSc |
|---|---|---|---|---|---|---|---|
|
SAKK 16 trials 1997-2016 n = 431/342 |
II-III | IIIA-N2 IIIB TNM seventh |
RCT > S CT > S |
272/342 (80%) | 66/342 (19%) | 5-year OS: 37% mOS: 27.1 months | |
|
Rosell et al.22 1989-1991 n = 60/50/50 |
III | IIIA-N2 Mountain 1986 |
S CT > S |
27/30 (90%) 23/27 (85%) |
0/30 (0%) 1/27 (4%) |
5-year OS: 0% versus 17% mOS: 10 versus 22 months | |
|
RTOG 89-0123 1990-1994 n = 73/26/23 |
III | IIIA-N2 Mountain 1986 |
CT > S > CT CT > RT > CT |
19/26 (73%) | 4-year OS: 22% versus 22% mOS: 19.4 versus 17.4 months (N = 29/N = 32) | ||
|
Stephens et al.24 1995-1999 n = 48/7/4 |
III | IIIA IIIA-N2 Mountain 1986 |
RT CT > S |
2-year OS: 16% versus 15% mOS: 11.2 versus 13.8 months | |||
|
Intergroup 013925 1994-2001 n = 396/164/155 |
III | IIIA-N2 Mountain 1986 |
RCT > S RCT |
144/164 (88%) | 29/164 (18%) | 5-year OS: 27% versus 20% mOS: 23.6 versus 22.2 months | |
|
EORTC 0894126 1994-2002 n = 579/154/131 |
III | IIIA-N2 TNM fifth |
CT > RT CT > S |
77/154 (50%) | 8/154 (5%) | 5-year OS: 14% versus 16% mOS: 17.5 versus 16.4 months (N = 165/N = 167) | mOS: 15.4 months |
|
GLCCG27 1995-2003 n = 524/296/272 |
III | IIIA-N2 IIIB Mountain 1986 |
CT > RCT > S CT > S > RT |
182/296 (62%) | 76/296 (26%)d | 5-year OS: 21% versus 18% mOS: 15.7 versus 17.6 months | |
|
WJTOG990318 2000-2005 n = 60/51/49 |
III | IIIA-N2 TNM sixth |
RCT > S CT > S |
3/51 (6%) | 3-year OS: 52% versus 39% mOS: 39.6 versus 29.9 months | ||
|
ESPATUE20 2004-2013 n = 246/70/70 |
III | IIIA-N2 IIIB TNM sixth |
CT > RCT > RCT CT > RCT > S |
66/70 (94%) | 27/70 (39%) | 5-year OS: 40% versus 44% (N = 80/N = 81) | 5-year OS: 34% |
Comparison with pooled analysis of SAKK 16 trials.
CT, chemotherapy; mOS, median overall survival; NSCLC, non-small-cell lung cancer; OS, overall survival; pCR, pathological complete remission; R0, complete surgical resection; RCT, chemoradiation; RT, radiotherapy; S, surgery; SAKK, Swiss Group for Clinical Cancer Research; TNM, tumor–node–metastasis.
a
Proportion of patients who had surgery.
b
Patients who were randomized.
c
Intention-to-treat population.
d
>90% regression.