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Table 1 Patient demographics and baseline disease characteristics

From: Cetuximab plus platinum-based chemotherapy in head and neck squamous cell carcinoma: a randomized, double-blind safety study comparing cetuximab produced from two manufacturing processes using the EXTREME study regimen

Characteristic

US commercial cetuximab

Arm A

(N = 77)

BI-manufactured cetuximab

Arm B

(N = 71)

Sex, n (%)

  

 Male

68 (88.3)

55 (77.5)

Age, years

  

 Median (range)

57.8 (26.9–77.2)

61.3 (29.2–81.9)

KPS score, n (%)

  

 70

9 (11.7)

7 (9.9)

 80

28 (36.4)

22 (31.0)

 90

32 (41.6)

31 (43.7)

 100

8 (10.4)

11 (15.5)

Stage of disease, n (%)

  

 Local

8 (10.4)

12 (16.9)

 Locoregional

26 (33.8)

20 (28.2)

 Metastatic

43 (55.8)

38 (53.5)

Histologic type, n (%)

  

 Well differentiated

3 (3.9)

6 (8.5)

 Moderately differentiated

35 (45.5)

29 (40.8)

 Poorly differentiated

25 (32.5)

17 (23.9)

 Undifferentiated

3 (3.9)

1 (1.4)

 Unable to determine

11 (14.3)

15 (21.1)

 Missing/unknown

0

2 (2.8)

  1. Abbreviations: BI Boehringer Ingelheim, KPS Karnofsky Performance Status, US United States