Introduction
Materials and methods
Patients
Treatment strategy
Data records and assessment
Statistical analysis
Results
Patient characteristics
Characteristic | Before matching | Characteristic | After matching | ||||
---|---|---|---|---|---|---|---|
TRT Group (n = 117) | non-TRT Group (n = 159) | P value | TRT Group (n = 99) | non-TRT Group (n = 98) | P value | ||
Age, years | 0.363 | Age, years | 0.939 | ||||
< 60 | 55(47.0%) | 66(41.5%) | < 60 | 46(46.5%) | 45(45.9%) | ||
≥60 | 62(53.0%) | 93(58.5%) | ≥60 | 53(53.5%) | 53(54.1%) | ||
Gender | 0.135 | Gender | 0.492 | ||||
Male | 92(78.6%) | 136(85.5%) | Male | 78(78.8%) | 81(82.7%) | ||
Female | 25(21.4%) | 23(14.5%) | Female | 21(21.2%) | 17(17.3%) | ||
Smoking history | 0.486 | Smoking history | 0.821 | ||||
Yes | 65(55.6%) | 95(59.7%) | Yes | 56(56.6%) | 57(58.2%) | ||
No | 52(44.4%) | 64(40.3%) | No | 43(43.4%) | 41(41.8%) | ||
ECOG PS | 0.08 | ECOG PS | 0.418 | ||||
0–1 | 92(78.6%) | 110(69.2%) | 0–1 | 74(74.7%) | 78(79.6%) | ||
2 | 25(21.4%) | 49(30.8%) | 2 | 25(25.3%) | 20(20.4%) | ||
T stage | 0.909 | T stage | 0.832 | ||||
T1-T2 | 61(52.1%) | 84(52.8%) | T1-T2 | 48(48.5%) | 49(50.0%) | ||
T3-T4 | 56(47.9%) | 75(47.2%) | T3-T4 | 51(51.5%) | 49(50.0%) | ||
N stage | 0.387 | N stage | 0.434 | ||||
N0-N2 | 61(52.1%) | 73(45.9%) | N0-N2 | 53(53.5%) | 47(48.0%) | ||
N3 | 56(47.9%) | 86(54.1%) | N3 | 46(46.5%) | 51(52.0%) | ||
M stage | 0.002 | M stage | 0.665 | ||||
M1a | 24 (20.5%) | 21 (13.2%) | M1a | 19 (19.2%) | 17 (17.4%) | ||
M1b | 72 (61.5%) | 80 (50.3%) | M1b | 60 (60.6%) | 56 (57.1%) | ||
M1c | 21 (18.0%) | 58 (36.5%) | M1c | 20 (20.2%) | 25 (25.5%) | ||
Type of ICIs | 0.652 | Type of ICIs | 0.793 | ||||
PD-1 | 36(30.8%) | 53(33.3%) | PD-1 | 31(31.3%) | 29(29.6%) | ||
PD-L1 | 81(69.2%) | 106(66.7%) | PD-L1 | 68(68.7%) | 69(70.4%) | ||
NO. of metastatic sites | 0.004 | NO. of metastatic sites | 0.837 | ||||
≤ 2 | 106(90.6%) | 123(77.4%) | ≤ 2 | 88(88.9%) | 88(89.8%) | ||
> 2 | 11(9.4%) | 36(22.6%) | > 2 | 11(11.1%) | 10(10.2%) | ||
Brain metastases | 0.295 | Brain metastases | 0.725 | ||||
Yes | 40(34.2%) | 45(28.3%) | Yes | 33(33.3%) | 35(35.7%) | ||
No | 77(65.8%) | 114(71.7%) | No | 66(66.7%) | 63(64.3%) | ||
Liver metastases | < 0.001 | Liver metastases | 0.899 | ||||
Yes | 24(20.5%) | 66 (41.5%) | Yes | 24(24.2%) | 23(23.5%) | ||
No | 93(79.5%) | 93(58.5%) | No | 75(75.8%) | 75(76.5%) | ||
Bone metastases | 0.039 | Bone metastases | 0.596 | ||||
Yes | 27(23.1%) | 55(34.6%) | Yes | 24(24.2%) | 27(27.6%) | ||
No | 90(76.9%) | 104(65.4%) | No | 75(75.8%) | 71(72.4%) | ||
Response evaluation* | 0.794 | Response evaluation* | 0.758 | ||||
CR/PR | 81(69.2%) | 107(67.3%) | CR/PR | 67(67.7%) | 69(70.4%) | ||
SD | 36(30.8%) | 52(32.7%) | SD | 32(32.3%) | 29(29.6%) |
Survival outcomes and treatment response
Survival estimated | TRT Group (n = 99) | non-TRT Group (n = 98) | P value |
---|---|---|---|
1-year PFS, % | 41.9 | 30.6 | 0.030 |
1-year OS, % | 78.2 | 64.8 | 0.033 |
2-year OS, % | 41.5 | 24.5 | 0.019 |
Subgroup analysis of survival outcomes
Univariate and multivariate cox analyses of PFS and OS
Variables | Univariate analysis | Multivariate analysis | ||
---|---|---|---|---|
HR (95% CI) | P value | HR (95% CI) | P value | |
Gender | ||||
Male | ||||
Female | 0.608 (0.390–0.946) | 0.027* | 0.586 (0.374–0.917) | 0.019* |
Age | ||||
≥ 60 | ||||
< 60 | 0.999 (0.707–1.410) | 0.994 | ||
Smoking History | ||||
Yes | ||||
No | 0.785 (0.552–1.116) | 0.177 | ||
ECOG PS | ||||
2 | ||||
≥ 2 | 1.266 (0.845–1.898) | 0.253 | ||
T stage | ||||
≤ 2 | ||||
> 2 | 1.603 (1.132–2.272) | 0.008* | 1.778 (1.240–2.550) | 0.002* |
N stage | ||||
≤ 2 | ||||
> 2 | 1.596 (1.121–2.270) | 0.009* | 1.436 (0.998–2.066) | 0.051 |
M stage | ||||
M1a | ||||
M1b | 1.096 (0.681–1.764) | 0.705 | ||
M1c | 1.866 (1.706–3.293) | 0.026* | 1.956 (1.117–3.424) | 0.019* |
Type of ICIs | ||||
PD-1 | ||||
PD-L1 | 1.718 (1.156–2.554) | 0.007* | 1.684 (1.120–2.533) | 0.012* |
Receiving TRT | ||||
No | ||||
Yes | 0.651 (0.460–0.920) | 0.015* | 0.599(0.420–0.854) | 0.005* |
NO. of metastatic sites | ||||
< 3 | ||||
≥ 3 | 1.605 (0.917–2.808) | 0.098 | ||
Liver metastases | ||||
No | ||||
Yes | 1.192 (0.798–1.780) | 0.391 | ||
Bone metastases | ||||
No | ||||
Yes | 1.409 (0.964–2.060) | 0.077 | ||
Brain metastases | ||||
No | ||||
Yes | 1.039 (0.719–1.502) | 0.838 |
Variables | Univariate analysis | Multivariate analysis | ||
---|---|---|---|---|
HR (95% CI) | P value | HR (95% CI) | P value | |
Gender | ||||
Male | ||||
Female | 0.802 (0.507–1.266) | 0.343 | ||
Age | ||||
≥ 60 | ||||
< 60 | 0.661 (0.457–0.956) | 0.028* | 0.593 (0.408–0.862) | 0.006* |
Smoking History | ||||
Yes | ||||
No | 0.835 (0.580–1.202) | 0.332 | ||
ECOG PS | ||||
< 2 | ||||
≥ 2 | 1.208 (0.791–1.845) | 0.382 | ||
T stage | ||||
≤ 2 | ||||
> 2 | 1.335 (0.929–1.920) | 0.118 | ||
N stage | ||||
≤ 2 | ||||
> 2 | 1.249 (0.869–1.794) | 0.230 | ||
M stage | ||||
M1a | ||||
M1b | 1.994 (1.153–3.449) | 0.014 | 2.051 (1.163–3.620) | 0.013* |
M1c | 3.516 (1.878–6.583) | < 0.001* | 2.818 (1.437–5.527) | 0.003* |
Type of ICIs | ||||
PD-1 | ||||
PD-L1 | 0.996 (0.676–1.466) | 0.983 | ||
Receiving TRT | ||||
No | ||||
Yes | 0.618 (0.428–0.892) | 0.010* | 0.670 (0.464–0.966) | 0.032* |
NO. of metastatic sites | ||||
≤ 2 | ||||
> 2 | 1.883 (1.070–3.314) | 0.028* | 1.836 (0.939–3.592) | 0.076 |
Liver metastases | ||||
No | ||||
Yes | 2.007 (1.364–2.953) | < 0.001 | 1.722 (1.160–2.558) | 0.007* |
Bone metastases | ||||
No | ||||
Yes | 1.094 (0.726–1.648) | 0.669 | ||
Brain metastases | ||||
No | ||||
Yes | 1.247 (0.849–1.829) | 0.260 |
Safety
Adverse Events | TRT Group (n = 99) | non-TRT Group (n = 98) | P value |
---|---|---|---|
Any Grades | 82 (82.8%) | 82 (83.7%) | 0.874 |
G1-2 Totally | 78 (78.8%) | 78 (79.6%) | 0.889 |
Leucopenia /White-cell count decreased | 44 (44.4%) | 34 (34.7%) | 0.190 |
Neutropenia /Neutrophil count decreased | 23 (23.2%) | 21 (21.4%) | 0.864 |
Thrombocytopenia /Platelet count decreased | 7 (7.1%) | 2 (2.0%) | 0.170 |
Anaemia | 5 (5.1%) | 13 (13.3%) | 0.051 |
Nausea | 27 (27.3%) | 25 (25.5%) | 0.872 |
Decreased appetite | 17 (17.2%) | 28 (28.6%) | 0.063 |
Constipation | 9 (9.1%) | 14 (14.3%) | 0.276 |
Diarrhea | 6 (6.1%) | 7 (7.1%) | 0.783 |
Radiation esophagitis | 38 (38.4%) | / | / |
Pneumonitis | 16 (16.2%) | 9 (9.2%) | 0.199 |
Myocarditis | 0 (0%) | 0 (0%) | / |
Hypothyroid | 1 (1.0%) | 1 (1.0%) | 1.000 |
Atrial fibrillation | 0 (0%) | 0 (0%) | / |
Adverse Events | TRT Group (n = 99) | non-TRT Group (n = 98) | P value |
---|---|---|---|
Any Grades | 81 (81.8%) | 82 (83.7%) | 0.874 |
G3-4 Totally | 28 (28.3%) | 27 (27.6%) | 0.909 |
Leucopenia /White-cell count decreased | 4 (4.0%) | 2 (2.0%) | 0.683 |
Neutropenia /Neutrophil count decreased | 8 (8.1%) | 12(12.2%) | 0.356 |
Thrombocytopenia /Platelet count decreased | 1 (1.0%) | 2 (2.0%) | 0.621 |
Anaemia | 1 (1.0%) | 2 (2.0%) | 0.621 |
Nausea | 4 (4.0%) | 7 (7.1%) | 0.373 |
Decreased appetite | 1 (1.0%) | 3 (3.1%) | 0.369 |
Constipation | 0 (0%) | 0 (0%) | / |
Diarrhea | 0 (0%) | 2 (2.0%) | 0.246 |
Radiation esophagitis | 4 (4.0%) | / | / |
Pneumonitis | 6 (6.1%) | 3 (3.1%) | 0.498 |
Myocarditis | 3 (2.0%) | 0 (0%) | 0.497 |
Hypothyroid | 1 (1.0%) | 0 (0%) | 1.000 |
Atrial fibrillation | 0 (0%) | 1 (1.0%) | 0.497 |