Table 1.
Characteristic | Total patients (n=189) | Cisplatin (n=126) | Gemcitabine (n=63) | p-value |
---|---|---|---|---|
Age (yr) a) | 56.3±11.5 | 55.4±10.9 | 57.9±12.5 | 0.668b) |
Performance status c) | ||||
ECOG 0 | 77 (40.7) | 47 (37.3) | 30 (47.6) | 0.348d) |
ECOG 1 | 107 (56.6) | 76 (60.3) | 31 (49.2) | |
ECOG 2 | 5 (2.6) | 3 (2.4) | 2 (3.2) | |
Clinical stage e) | ||||
IB2 | 12 (6.3) | 8 (6.3) | 4 (6.3) | 0.975d) |
IIA | 6 (3.2) | 4 (3.2) | 2 (3.2) | |
IIB | 108 (57.1) | 72 (57.1) | 36 (57.1) | |
IIIA | 1 (0.5) | 1 (0.8) | 0 | |
IIIB | 59 (31.2) | 39 (31.0) | 20 (31.7) | |
IVB | 3 (1.6) | 2 (1.6) | 1 (1.6) | |
Hemoglobin (g/dL) | 12.8±2.04 | 12.9±2.02 | 12.7±2.05 | 0.574b) |
Histology | ||||
Squamous cell carcinoma | 157 (83.1) | 102 (81.0) | 55 (87.3) | 0.536d) |
Adenocarcinoma | 23 (12.2) | 17 (13.5) | 6 (9.5) | |
Adenosquamous carcinoma | 9 (4.8) | 7 (5.6) | 2 (3.2) | |
Comorbidities | ||||
Number | 1.24±0.48 | 1.23±0.50 | 1.26±0.44 | 0.051b) |
Comorbidities=1 | 148 (78.3) | 102 (80.9) | 46 (73.9) | 0.212d) |
Comorbidities ≥ 2 | 41 (21.6) | 24 (19.0) | 17 (26.9) | |
T2DM | 89 (46.8) | 57 (45.2) | 32 (50.8) | < 0.001d) |
SAH | 112 (58.9) | 81 (64.3) | 31 (49.2) | |
Acute kidney injury | 19 (10.0) | 14 (11.1) | 5 (7.9) | |
Other | 15 (7.9) | 3 (2.4) | 12 (19.0) | |
Response rates f) | ||||
Complete response | 165 (87.3) | 109 (86.5) | 56 (88.9) | 0.094d) |
Partial response | 9 (4.7) | 4 (3.2) | 5 (7.9) | |
Disease progression | 15 (7.9) | 13 (10.3) | 2 (3.2) | |
Pattern of failure | ||||
Local | 12 (6.3) | 7 (5.5) | 5 (7.9) | 0.917d) |
Locoregional | 9 (4.7) | 6 (4.7) | 3 (4.7) | |
Distant metastasis | 35 (18.5) | 22 (17.4) | 13 (20.6) | |
Locoregional+distant metastasis | 16 (8.4) | 14 (11.1) | 2 (3.1) | |
Persistent disease | 13 (6.8) | 10 (7.9) | 3 (4.7) |
Values are presented as mean±SD or number (%). SAH, systemic arterial hypertension; SD, standard deviation; T2DM, type 2 diabetes mellitus.
Kolmogorov-Smirnov test (normal distribution is assumed),
Student T test for independent samples,
Assessed according to the Eastern Cooperative Oncology Group (ECOG),
Chi-square test,
According to the International Federation of Gynecology and Obstetrics (2008),
Assessed by Response Evaluation Criteria in Solid Tumors (v1.1).