1Department of Thoracic Surgery, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea
2Merck & Co., Inc., Kenilworth, NJ, USA
3Department of Pathology and Translational Genomics, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea
4Division of Hematology-Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea
Copyright © 2018 by the Korean Cancer Association
This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/3.0/) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.
This study was supported by Merck & Co., Inc. (Kenilworth, NJ, USA). Editorial assistance was provided by Jennifer M. Kulak, PhD, of the ApotheCom oncology team (Yardley, PA, USA) and was funded by Merck & Co., Inc., Kenilworth, NJ, USA. Drs. Cho, Y.-L. Choi, Sun, H. Choi, T.-E. Kim, and J. Kim have no conflicts to disclose. Drs Zhou, Dolled-Filhart, Emancipator, and Rutkowski are employees of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA and own stock in the company. Dr. Emancipator also has stock in Bayer AG and Johnson and Johnson and his spouse is employed by and has stock ownership in Celgene.
Subgroup | No. |
PD-L1 expression status |
Chi-square p-value | ||
---|---|---|---|---|---|
TPS ≥ 50% | TPS 1%-49% | Negative | |||
Overall | 319 | 24 (8) | 139 (44) | 156 (49) | |
Sex | |||||
Male | 125 | 13 (10) | 64 (51) | 48 (38) | 0.008 |
Female | 194 | 11 (6) | 75 (39) | 108 (56) | |
Smoking status | |||||
Never | 205 | 11 (5) | 82 (40) | 112 (55) | 0.011 |
Smokers | 114 | 13 (11) | 57 (50) | 44 (39) | |
ECOG PS | |||||
0 | 202 | 12 (6) | 88 (44) | 102 (51) | 0.345 |
1 | 116 | 12 (10) | 50 (43) | 54 (47) | |
Disease stage at baseline | |||||
IA | 153 | 6 (4) | 61 (40) | 86 (56) | 0.006 |
IB | 48 | 1 (2) | 20 (42) | 27 (56) | |
II | 41 | 7 (17) | 20 (49) | 14 (34) | |
III | 61 | 9 (15) | 29 (48) | 23 (38) | |
IV | 16 | 1 (6) | 9 (56) | 6 (38) | |
EGFR mutation | |||||
Exon 19 deletion | 145 | 9 (6) | 67 (46) | 69 (48) | 0.001 |
Exon 21 L858R | 121 | 9 (7) | 38 (31) | 74 (61) | |
Othersa) | 53 | 6 (11) | 34 (64) | 13 (25) |
Values are presented as number (%). PD-L1, programmed death ligand 1; TPS, tumor proportion score; ECOG PS, Eastern Cooperative Oncology Group performance status; EGFR, epidermal growth factor receptor.
a) Exon 19, nondeletion (n=26); exon 21, non-L858R mutation (n=3); exon 18 (n=12); exon 20 (n=8); one patient had mutations in both exons 18 and 20, and three patients had other mutations. Among those (n=53), median age was 60.0 years (range, 44 to 84 years), 51% were women (n=27), 49% were men (n=26), 51% were never smokers (n=27), and 49% were smokers (n=26). Most patients had early-stage disease, including 57% (n=30) stage I, 9% (n=5) stage II, 32% (n=17) stage III, and 2% (n=1) were stage IV.
Survival |
HR (95% CI) |
|
---|---|---|
PD-L1 TPS ≥ 50% (n=24) | PD-L1 TPS 1%-49% (n=139) | |
RFS | ||
Unadjusted HR (95% CI) | 3.07 (1.74-5.42) | 1.89 (1.31-2.74) |
Adjusted for baseline prognostic factorsb) | 1.60 (0.88-2.93) | 1.49 (1.02-2.18) |
Adjusted for baseline prognostic factors plus treatmentc) | 1.52 (0.81-2.84) | 1.51 (1.02-2.21) |
OS | ||
Unadjusted HR (95% CI) | 2.70 (1.07-6.66) | 1.04 (0.57-1.89) |
Adjusted for baseline prognostic factorsb) | 1.25 (0.46-3.44) | 0.94 (0.5-1.76) |
Adjusted for baseline prognostic factors plus treatmentc) | 1.29 (0.45-3.72) | 0.93 (0.49-1.74) |
RFS, recurrence-free survival; OS, overall survival; HR, hazard ratio; CI, confidence interval; PD-L1, programmed death ligand 1; TPS, tumor proportion score.
a) PD-L1 negative was used as the reference population (n=156),
b) Baseline prognostic factors included age, sex, smoking status, stage, and Eastern Cooperative Oncology Group performance status (Cox model 1),
c) Included baseline prognostic factors and treatment (Cox model 2).
Subgroup | No. | PD-L1 expression status |
Chi-square p-value | ||
---|---|---|---|---|---|
TPS ≥ 50% | TPS 1%-49% | Negative | |||
Overall | 319 | 24 (8) | 139 (44) | 156 (49) | |
Sex | |||||
Male | 125 | 13 (10) | 64 (51) | 48 (38) | 0.008 |
Female | 194 | 11 (6) | 75 (39) | 108 (56) | |
Smoking status | |||||
Never | 205 | 11 (5) | 82 (40) | 112 (55) | 0.011 |
Smokers | 114 | 13 (11) | 57 (50) | 44 (39) | |
ECOG PS | |||||
0 | 202 | 12 (6) | 88 (44) | 102 (51) | 0.345 |
1 | 116 | 12 (10) | 50 (43) | 54 (47) | |
Disease stage at baseline | |||||
IA | 153 | 6 (4) | 61 (40) | 86 (56) | 0.006 |
IB | 48 | 1 (2) | 20 (42) | 27 (56) | |
II | 41 | 7 (17) | 20 (49) | 14 (34) | |
III | 61 | 9 (15) | 29 (48) | 23 (38) | |
IV | 16 | 1 (6) | 9 (56) | 6 (38) | |
EGFR mutation | |||||
Exon 19 deletion | 145 | 9 (6) | 67 (46) | 69 (48) | 0.001 |
Exon 21 L858R | 121 | 9 (7) | 38 (31) | 74 (61) | |
Others |
53 | 6 (11) | 34 (64) | 13 (25) |
Survival | HR (95% CI) |
|
---|---|---|
PD-L1 TPS ≥ 50% (n=24) | PD-L1 TPS 1%-49% (n=139) | |
RFS | ||
Unadjusted HR (95% CI) | 3.07 (1.74-5.42) | 1.89 (1.31-2.74) |
Adjusted for baseline prognostic factors |
1.60 (0.88-2.93) | 1.49 (1.02-2.18) |
Adjusted for baseline prognostic factors plus treatment |
1.52 (0.81-2.84) | 1.51 (1.02-2.21) |
OS | ||
Unadjusted HR (95% CI) | 2.70 (1.07-6.66) | 1.04 (0.57-1.89) |
Adjusted for baseline prognostic factors |
1.25 (0.46-3.44) | 0.94 (0.5-1.76) |
Adjusted for baseline prognostic factors plus treatment |
1.29 (0.45-3.72) | 0.93 (0.49-1.74) |
Values are presented as number (%). PD-L1, programmed death ligand 1; TPS, tumor proportion score; ECOG PS, Eastern Cooperative Oncology Group performance status; Exon 19, nondeletion (n=26); exon 21, non-L858R mutation (n=3); exon 18 (n=12); exon 20 (n=8); one patient had mutations in both exons 18 and 20, and three patients had other mutations. Among those (n=53), median age was 60.0 years (range, 44 to 84 years), 51% were women (n=27), 49% were men (n=26), 51% were never smokers (n=27), and 49% were smokers (n=26). Most patients had early-stage disease, including 57% (n=30) stage I, 9% (n=5) stage II, 32% (n=17) stage III, and 2% (n=1) were stage IV.
RFS, recurrence-free survival; OS, overall survival; HR, hazard ratio; CI, confidence interval; PD-L1, programmed death ligand 1; TPS, tumor proportion score. PD-L1 negative was used as the reference population (n=156), Baseline prognostic factors included age, sex, smoking status, stage, and Eastern Cooperative Oncology Group performance status (Cox model 1), Included baseline prognostic factors and treatment (Cox model 2).