Research Article

A Pilot Study of Whether the Cold-Heat Syndrome Type is Associated with Treatment Response and Immune Status in Patients with Non-Small Cell Lung Cancer

Table 1

Demographic and clinical characteristics of 20 patients with non-cold or cold type.

Total (n = 20)Adenocarcinoma (n = 14)
Non-cold (n = 11)Cold (n = 9) valueNon-cold (n = 7)Cold (n = 7) value

Age (year)61.4 ± 12.161.1 ± 8.90.95958.1 ± 13.259.3 ± 7.50.846

Sex0.1480.193
 Female0 (0.0%)3 (33.3%)0 (0.0%)3 (42.9%)
 Male11 (100.0%)6 (66.7%)7 (100.0%)4 (57.1%)

Smoking status0.1410.214
 Current8 (72.7%)3 (33.3%)5 (71.4%)2 (28.6%)
 Ex-smoker2 (18.2%)2 (22.2%)1 (14.3%)1 (14.3%)
 Nonsmoker1 (9.1%)4 (44.4%)1 (14.3%)4 (57.1%)

Histologic type0.844
 Adenocarcinoma7 (63.6%)7 (77.8%)7 (100.0%)7 (100.0%)
 Squamous4 (36.4%)2 (22.2%)

Drug0.0470.091
 Pembrolizumab4 (36.4%)2 (22.2%)4 (57.1%)1 (14.3%)
 Nivolumab4 (36.4%)0 (0.0%)1 (14.3%)0 (0.0%)
 Atezolizumab3 (27.3%)7 (77.8%)2 (28.6%)6 (85.7%)

Line of therapy0.0590.013
 2nd line therapy9 (81.8%)2 (22.2%)6 (85.7%)0 (0.0%)
 3rd line therapy1 (9.1%)2 (22.2%)0 (0.0%)2 (28.6%)
 4th line therapy1 (9.1%)4 (44.4%)1 (14.3%)4 (57.1%)
 7th line therapy0 (0.0%)1 (11.1%)0 (0.0%)1 (14.3%)

No. of cyclea7.0 ± 5.73.3 ± 1.10.1107.0 ± 4.33.0 ± 1.20.106
 Ongoing3 (27.3%)2 (22.2%)2 (28.6%)2 (28.6%)

Clinical response0.6680.549
 Partial response3 (27.3%)1 (11.1%)2 (28.6%)1 (14.3%)
 Stable disease4 (36.4%)4 (44.4%)3 (42.9%)2 (28.6%)
 Progressive disease4 (36.4%)4 (44.4%)2 (28.6%)4 (57.1%)

 PFS (day)a102.0 (43.0; 172.5)44.0 (42.0; 76.0)0.332130.0 (74.0; 166.0)43.0 (42.0; 45.0)0.036

PD-L1 expressionb0.0500.110
 Negative1 (9.1%)4 (50.0%)1 (14.3%)4 (57.1%)
 >0%, ≤50%3 (27.3%)3 (37.5%)1 (14.3%)1 (14.3%)
 >50%7 (63.6%)1 (12.5%)5 (71.4%)1 (14.3%)

EGFR mutation0.1150.193
 Positive0 (0.0%)3 (33.3%)0 (0.0%)3 (42.9%)
 Negative7 (63.6%)4 (44.4%)7 (100.0%)4 (57.1%)
 Not done4 (36.4%)2 (22.2%)

ALK mutation0.6210.368
 Positive1 (9.1%)0 (0.0%)1 (14.3%)0 (0.0%)
 Negative6 (54.5%)6 (66.7%)6 (85.7%)6 (85.7%)
 Not done4 (36.4%)3 (33.3%)0 (0.0%)1 (14.3%)

KRAS mutation0.6380.247
 Positive2 (18.2%)1 (11.1%)2 (28.6%)1 (14.3%)
 Negative4 (36.4%)2 (22.2%)4 (57.1%)2 (28.6%)
 Not done5 (45.5%)6 (66.7%)1 (14.3%)4 (57.1%)

aData of 5 patients whose ICI treatment was not finished (ongoing) were excluded. bMissing data (not done) of one patient were excluded for the analysis.