Treatment of malignant, non-resectable, epithelial origin esophageal tumours with the humanized anti-epidermal growth factor antibody nimotuzumab combined with radiation therapy and chemotherapy.

Figures & data

Table 1. Patients demographic and tumor characteristics

Characteristic		Nimotuzumab			Control
		Mean	intervals		Mean	intervals
Aged		58.5	(54.8–62.2)		58.9	(54.9–62.8)
Sex	Femele	21.2%		16.7%
	Male	78.8%		83.3%
Race	White	66.7%		50.0%
	Black	9.1%		20.0%
	Mix	21.2%		30.0%
	Asian	3.0%		0%
ECOG	0	38.4%		38%
	1	52.5%		41.4%
	2	9.1%		17.2%
	3	0%		3.4%
Primary Tumor localization	Cervical	6.7%		3.6%
	Medium/ Thoracic	93.3%		89.3%
Clinical Stage	II	3.3%		0%
	III	76.7%		76.7%
	IV	20.0%		23.3%
Differentiation Epidermal Carcinoma	Poor	15.1%		20.0%
	Moderate	39.1%		33.3%
	Well	15.2%		26.7%
	Indetermined	18.2%		13.3%
	Others	12.2%		6.7%

No statistically significant differences between the two groups so that the populations studied are balanced (p = 0.64.)

Table 2. . Safety profile in a Phase II nimotuzumab clinical trial as CTC Version 3.0

CTC AE	nimotuzumab					control
	Grade 3	Grade 4	Grade 5	Total	%	Grade 3	Grade 4	Grade 5	Total	%
Diarrhea	5	1	0	6	26,09	1	1	0	2	8
Nauseas	0	0	0	0	0	0	0	0	0	0
Asthenia	1	0	0	1	4,35	2	0	0	2	8
Vomiting	2	0	0	2	8,7	0	0	0	0	0
Fever	0	0	0	0	0	0	0	0	0	0
Couth	0	0	0	0	0	0	0	0	0	0
Anorexia	2	0	0	2	8,7	2	0	0	2	8
Insomnia	0	0	0	0	0	0	0	0	0	0
Retroesternal pain	0	1	0	1	4,34	0	0	0	0	0
Anemia	0	0	0	0	0	0	0	0	0	0
Headache	0	0	0	0	0	0	0	0	0	0
Radiodermitis	0	0	0	0	0	1	0	0	1	4
Others	7	2	2	11	47,82	9	5	4	18	72
Total	17	4	2	23	100	15	6	4	25	100

Figure 1. Baseline representative EGFR tumor staining, EGFR expression was classified as high in 14 of 18 evaluated patients. A negative expression of EGFR. positive anti EGFR staining 2+, c.3+. All of them at 40x