Gefitinib, Methotrexate and Methotrexate plus 5-Fluorouracil as palliative treatment in recurrent head and neck squamous cell carcinoma

Figures & data

Table 1. Patient's demographic and clinical characteristics of 3 groups

Variables	GEFITINIB (n = 39) (%)	MTX (n = 40) (%)	MTX + 5FU (n = 38) (%)	P value
Age (yrs):
Mean ± SD	47.00 ± 10.68	46.90 ± 10.55	46.95 ± 11.87	0.999
Range (min to max)	(33 to 70)	(32 to 75)	(22 to 74)
Gender:
Females	3 (7.7)	2 (5.0)	1 (2.6)	0.602
Males	36 (92.3)	38 (95.0)	37 (97.4)
ECOG PS:
0	9 (23.1)	8 (20.0)	9 (23.7)	0.994
1	21 (53.8)	23 (57.5)	21 (55.3)
2	9 (23.1)	9 (22.5)	8 (21.1)
Primary disease site:
Hypopharynx	5 (12.8)	2 (5.0)	3 (7.9)	0.253
Larynx	4 (10.3)	4 (10.0)	7 (18.4)
Oral cavity	16 (41.0)	20(50.0)	13 (34.2)
Oropharynx	12 (30.8)	14 (35.0)	10 (26.3)
Others	2 (5.1)	0 (0.0)	5 (13.2)
Site of recurrence:
Lymph node	23 (59.0)	24 (60.0)	22 (57.9)	0.993
Primary site	12 (30.8)	11 (27.5)	11 (28.9)
Both	4 (10.3)	5 (12.5)	5 (13.2)
Prior chemotherapy:
No Chemotherapy	7 (17.9)	6 (15.0)	8 (21.1)	0.900
Platin + Nontaxane	10 (25.6)	13 (32.5)	12 (31.6)
Platin + Taxane	22 (56.4)	21 (52.5)	18 (47.4)
Drug exposure duration (mths):	8.89 ± 6.15	6.42 ± 4.59	6.50 ± 4.26	0.054
Mean ± SD	8.89 ± 6.15	6.42 ± 4.59	6.50 ± 4.26	0.054

Abbreviations: MTX, Methotrexate; 5FU, 5-Fluorouracil; ECOG PS, Eastern Cooperative Oncology Group Performance Status.

Table 2. Treatments response of 3 groups

Variables	GEFITINIB (n = 39) (%)	MTX (n = 40) (%)	MTX + 5FU (n = 38) (%)	P value
Tumor response:
Partial response	2 (5.1)	2 (5.0)	2 (5.3)	1.000
Progressive disease	4 (10.3)	4 (10.0)	4 (10.5)
Stable disease	10 (25.6)	10 (25.0)	10 (26.3)
Not applicable	23 (59.0)	24 (60.0)	22 (57.9)
Node response:
Partial response	1 (2.6)	0 (0.0)	1 (2.6)	0.934
Progressive disease	9 (23.1)	13 (32.5)	10 (26.3)
Stable disease	17 (43.6)	16 (40.0)	16 (42.1)
Not applicable	12 (30.8)	11 (27.5)	11 (28.9)
Overall response:
Partial response	3 (7.7)	2 (5.0)	3 (7.9)	0.924
Progressive disease	13 (33.3)	17 (42.5)	14 (36.8)
Stable disease	23 (59.0)	21 (52.5)	21 (55.3)

Abbreviations: MTX, Methotrexate; 5FU, 5-Fluorouracil.

Table 3. Treatments related adverse events of 3 groups

Adverse events	GEFTINIB (n = 39) (%)	MTX (n = 40) (%)	MTX + 5FU (n = 38) (%)	P value
Rash maculo-papular:
0	33 (84.6)	39 (97.5)	37 (97.4)	0.114
1	4 (10.3)	1 (2.5)	1 (2.6)
2	2 (5.1)	0 (0.0)	0 (0.0)
Rash acneiform:
0	37 (94.9)	40 (100.0)	38 (100.0)	0.397
1	1 (2.6)	0 (0.0)	0 (0.0)
2	1 (2.6)	0 (0.0)	0 (0.0)
Mucositis oral:
0	35 (89.7)	30 (75.0)	25 (65.8)	0.377
1	2 (5.1)	5 (12.5)	6 (15.8)
2	1 (2.6)	3 (7.5)	4 (10.5)
3	1 (2.6)	2 (5.0)	3 (7.9)
Nausea:
0	34 (87.2)	30 (75.0)	27 (71.1)	0.617
1	4 (10.3)	6 (15.0)	6 (15.8)
2	1 (2.6)	3 (7.5)	3 (7.9)
3	0 (0.0)	1 (2.5)	2 (5.3)
Vomiting:
0	37 (94.9)	35 (87.5)	33 (86.8)	0.695
1	2 (5.1)	4 (10.0)	3 (7.9)
2	0 (0.0)	1 (2.5)	1 (2.6)
3	0 (0.0)	0 (0.0)	1 (2.6)
Diarrhea:
0	31 (79.5)	36 (90.0)	32 (84.2)	0.462
1	5 (12.8)	4 (10.0)	3 (7.9)
2	3 (7.7)	0 (0.0)	2 (5.3)
3	0 (0.0)	0 (0.0)	1 (2.6)
Alanine aminotransferase:
0	37 (94.9)	38 (95.0)	35 (92.1)	0.833
1	2 (5.1)	2 (5.0)	3 (7.9)
Aspartate aminotransferase:
0	36 (92.3)	38 (95.0)	35 (92.1)	0.851
1	3 (7.7)	2 (5.0)	3 (7.9)
Alkaline phosphatase:
0	38 (97.4)	40 (100.0)	38 (100.0)	0.365
1	1 (2.6)	0 (0.0)	0 (0.0)
Anemic:
0	35 (89.7)	33 (82.5)	29 (76.3)	0.626
1	3 (7.7)	3 (7.5)	3 (7.9)
2	1 (2.6)	2 (5.0)	3 (7.9)
3	0 (0.0)	2 (5.0)	3 (7.9)
Leucopenia:
0	38 (97.4)	37 (92.5)	34 (89.5)	0.376
1	1 (2.6)	3 (7.5)	4 (10.5)
Thrombocytopenia:
0	38 (97.4)	38 (95.0)	35 (92.1)	0.569
1	1 (2.6)	2 (5.0)	3 (7.9)
Tumor haemmorage:
0	35 (89.7)	38 (95.0)	36 (94.7)	0.584
1	4 (10.3)	2 (5.0)	2 (5.3)

Abbreviations: MTX, Methotrexate; 5FU, 5-Fluorouracil.

Figure 1. Cumulative survival proportions of 3 groups.

Figure 2. QOL of 3 groups over the periods.

Figure 3. Microphotograph showing Immunohistochemical expression of EGFR in SCCHN (a) showing negative cytoplasmic and membranous staining (b) showing positive cytoplasmic and membranous staining (DAB × 125 × digital magnification).