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Table 1 Patient demographics and clinical characteristics

From: Adjuvant therapy with gemcitabine and stereotactic body radiation therapy versus gemcitabine alone for resected stage II pancreatic cancer: a prospective, randomized, open-label, single center trial

 

GEM arm

(n = 20)

GEM + SBRT arm

(n = 18)

P

Age, y, median (IQR)

58.5 (50.3–67.3)

63.0 (58.8–66.0)

0.176

Sex, male, n (%)

12 (60.0%)

13 (72.2%)

 

BMI, Kg/m2, median (IQR)

22.2 (20.4–25.0)

23.3 (22.0–24.8)

0.361

ECOG, n (%)

  

0.825

0

14 (70.0%)

12 (66.7%)

 

1

6 (30.0%)

6 (33.3%)

 

Preoperative CA19-9, U/L, median (IQR)

267.9 (38.8–737.3)

575.3 (105.8–1921.0)

0.305

CA19-9 on randomization, U/L, median (IQR)

24.4 (5.3–105.5)

126 (7.2–375.5)

0.160

Post-operative complications (Clavien-Dido ≥ grade III), n (%)

5 (25.0%)

7 (38.9%)

0.358

Surgery to adjuvant chemotherapy, d, median (IQR)

41.5 (35.5 – 45.0)

62.5 (51.0 – 69.3)

 < 0.001

Number of dissected lymph nodes, median (IQR)

20.0 (12.3 – 23.8)

20.5 (16.5 – 29.3)

0.276

Number of positive lymph nodes, median (IQR)

1.00 (0–3.0)

2.00 (0.8 – 4.0)

0.534

Number of node-positive patients, n (%)

12 (60.0%)

13 (72.2%)

0.428

Maximum tumor size, mm, median (IQR)

3 (2.3–3.9)

3 (2.4–3.7)

0.828

Procedure, n (%)

  

0.084

Pancreaticoduodenectomy

13 (65.0%)

16 (88.9%)

 

Distal pancreatectomy

7 (35.0%)

2 (11.1%)

 

Combined vascular resection, n (%)

5 (25.0%)

6 (33.3%)

0.572

Combined organ resection, n (%)

1 (5.0%)

0

0.336

  1. BMI Body-mass index, ECOG Eastern Cooperative Oncology Group, GEM Gemcitabine, IQR Interquartile range, SBRT, stereotactic body radiation therapy