Background
Methods
Eligibility criteria
Study design
Central review
Drug administration
Analysis
Results
Patient characteristics
FAS (n = 39) | PPS (n = 36) | |
---|---|---|
Gender, M/F | 33 (84.6 %)/6 (15.4 %) | 30 (83.3 %)/6 (16.7 %) |
Median age, years (range) | 68.0 (52–75) | 68.0 (52–74) |
Smoking history, ex/never | 38 (97.4 %)/1 (2.6 %) | 35 (97.2 %)/1 (2.8 %) |
Pack years | 61.09 ± 32.07 | 61.85 ± 33.01 |
Body mass index | 24.35 ± 3.43 | 24.41 ± 3.57 |
Activity | ||
Hugh-Jones I | 29 (74.4 %) | 26 (72.2 %) |
Hugh-Jones II | 9 (23.1 %) | 9 (25.0 %) |
Hugh-Jones III | 1 (2.6 %) | 1 (2.8 %) |
Hugh-Jones IV | 0 (0.0 %) | 0 (0.0 %) |
Hugh-Jones V | 0 (0.0 %) | 0 (0.0 %) |
Fine crackle (audible) | 17 (43.6 %) | 16 (44.4 %) |
Vital capacity (%predicted) | 96.51 ± 15.21 | 97.25 ± 15.25 |
FEV1.0 (% predicted) | 92.31 ± 16.74 | 92.81 ± 17.24 |
DLCO (% predicted) | 73.71 ± 23.11 | 73.88 ± 24.45 |
KL-6(U/mL) | 1012.3 ± 891.9 | 1022.4 ± 924.7 |
Surgical procedure | FAS (n = 38) | PPS (n = 36) |
Operation time (hours) | 3.36 ± 1.23 | 3.37 ± 1.25 |
Blood loss (g) | 138.6 ± 126.2 | 127.7 ± 114.6 |
Surgical procedure | ||
Lobectomy | 26 (68.4 %) | 24 (66.7 %) |
Segmentectomy | 7 (18.4 %) | 7 (19.4 %) |
Wedge resection | 7 (18.4 %) | 7 (19.4 %) |
Combined resection | 3 (7.9 %) | 3 (8.3 %) |
Residual tumor | ||
R0 | 36 (94.7 %) | 34 (94.4 %) |
R1 | 1 (2.6 %) | 1 (2.8 %) |
R2 | 1 (2.6 %) | 1 (2.8 %) |
Cancer pathology | FAS (n = 38) | PPS (n = 36) |
Pathological type | ||
Squamous cell carcinoma | 18 (47.4 %) | 18 (50.0 %) |
Adenocarcinoma | 16 (42.1 %) | 14 (38.9 %) |
Large cell carcinoma | 0 (0.0 %) | 0 (0.0 %) |
Adenosquamous carcinoma | 1 (2.6 %) | 1 (2.8 %) |
Other | 3 (7.9 %) | 3 (8.3 %) |
Pathological stage | ||
IA | 10 (26.3 %) | 10 (27.8 %) |
IB | 12 (31.6 %) | 10 (27.8 %) |
IIA | 8 (21.1 %) | 8 (22.2 %) |
IIB | 4 (10.5 %) | 4 (11.1 %) |
IIIA | 2 (5.3 %) | 2 (5. %) |
IIIB | 0 (0.0 %) | 0 (0.0 %) |
IV | 1 (2.6 %) | 1 (2.8 %) |
(non-cancer) | 1 (2.6 %) | 1 (2.8 %) |
Preoperative complications (n = 43) | Postoperative complications (n = 37) | |||||
---|---|---|---|---|---|---|
Grade 1, 2 | Grade 3–5 | Grade 1, 2 | Grade 3–5 | |||
Photosensitivity | 1 | 0 | 0.0 % | 0 | 0 | 0.0 % |
Anorexia | 4 | 0 | 0.0 % | 5 | 1 | (Grade 4, 2.7 %) |
Nausea | 4 | 0 | 0.0 % | 3 | 0 | 0.0 % |
Diarrhea | 0 | 0 | 0.0 % | 1 | 0 | 0.0 % |
Somnolence | 1 | 0 | 0.0 % | 0 | 0 | 0.0 % |
Dizziness | 2 | 0 | 0.0 % | 1 | 0 | 0.0 % |
Malaise | 2 | 0 | 0.0 % | 2 | 0 | 0.0 % |
Respiratory failure | 0 | 0 | 0.0 % | 0 | 1 | (Grade 4, 2.7 %) |
Dyspnea | 0 | 0 | 0.0 % | 5 | 1 | (Grade 4, 2.7 %) |
Pulmonary fistula | 0 | 0 | 0.0 % | 2 | 0 | 0.0 % |
Postoperative hemorrhage | 0 | 0 | 0.0 % | 1 | 0 | 0.0 % |
Cough | 0 | 0 | 0.0 % | 1 | 0 | 0.0 % |
Atrial fibrillation | 0 | 0 | 0.0 % | 1 | 0 | 0.0 % |
Wound dehiscence | 0 | 0 | 0.0 % | 1 | 0 | 0.0 % |
Pneumonitis | 0 | 0 | 0.0 % | 0 | 1 | (Grade 5, 2.7 %) |
Dysgeusia | 0 | 0 | 0.0 % | 1 | 0 | 0.0 % |
White blood cell decreased | 0 | 0 | 0.0 % | 2 | 0 | 0.0 % |
Neutrophil count decreased | 0 | 0 | 0.0 % | 1 | 0 | 0.0 % |
Anemia | 2 | 0 | 0.0 % | 4 | 0 | 0.0 % |
Hypoalbuminemia | 2 | 0 | 0.0 % | 19 | 0 | 0.0 % |
ALP increased | 2 | 0 | 0.0 % | 8 | 0 | 0.0 % |
Blood bilirubin increased | 0 | 0 | 0.0 % | 1 | 0 | 0.0 % |
AST increased | 3 | 0 | 0.0 % | 8 | 1 | (Grade 3, 2.7 %) |
ALT increased | 3 | 0 | 0.0 % | 6 | 0 | 0.0 % |
GGT increased | 5 | 0 | 0.0 % | 6 | 0 | 0.0 % |
Creatinine increased | 1 | 0 | 0.0 % | 0 | 0 | 0.0 % |
Hyponatremia | 3 | 0 | 0.0 % | 8 | 1 | (Grade 3, 2.7 %) |
Hyperkalemia | 1 | 0 | 0.0 % | 0 | 0 | 0.0 % |
Hypokalemia | 0 | 0 | 0.0 % | 3 | 0 | 0.0 % |
Hypocalcemia | 0 | 0 | 0.0 % | 3 | 0 | 0.0 % |
Group | N | AE-IPF occurred within the 30th POD | Non–AE rate within the 30th POD | 95 % CI |
p-value |
---|---|---|---|---|---|
FAS | 39 | 2 | 94.90 % | 82.7–99.4 |
p = 0.010 |
PPS | 36 | 1 | 97.20 % | 85.5–99.9 |
p = 0.004 |
PPS-IPF | 32 | 1 | 96.90 % | 83.8–99.9 |
p = 0.008 |