Table 1.

Baseline Characteristics of Patients, overall study population and by MLH1 Nuclear expression including patients from Both Arms of study

	Entire population for whom MLH1 was evaluated (n=117)		< median (n=58)		≥ median (n=59)
Age
Median	63	63	63
Min-Max	35–80	37–80	35–80
	n	%	n	%	n	%	p-value†
Gender							0.31
Male	62	53.0	28	48.3	34	57.6
Female	55	47.0	30	51.7	25	42.4
Race							0.21
White	105	89.7	50	86.2	55	93.2
African-American/Other	12	10.3	8	13.8	4	6.8
Primary Tumor Location							0.48
Head	98	83.8	50	86.2	48	81.4
Everything Else	19	16.2	8	13.8	11	18.6
KPS							0.65
60,70,80	42	35.9	22	37.9	20	33.9
90,100	75	64.1	36	62.1	39	66.1
T-stage (surgical)							0.96
T1,T2	28	23.9	14	24.1	14	23.7
T3,T4	89	76.1	44	75.9	45	76.3
N-stage (surgical)							0.51
N0	37	31.6	20	34.5	17	28.8
N1	80	68.4	38	65.5	42	71.2
AJCC Stage (5th Edition)							0.64
I,II	36	30.8	19	32.8	17	28.8
III,IV	81	69.2	39	67.2	42	71.2
Largest tumor dimension of primary							0.52
<3 cm	47	40.2	25	43.1	22	37.3
≥ 3cm	70	59.8	33	56.9	37	62.7
Surgical Margins							0.12
Complete resection/negative margins	47	40.2	21	36.2	26	44.1
Complete resection/positive margins	40	34.2	25	43.1	15	25.4
Complete resection/unknown margins	30	25.6	12	20.7	18	30.5
RX							0.23
RT + 5-FU	60	51.3	33	56.9	27	45.8
RT + Gemcitabine	57	48.7	25	43.1	32	54.2

^†p-value from Chi-square or Fisher’s exact test

Abbreviations: KPS= Karnofsky Performance Status; RX= treatment; RT= radiation therapy; 5-FU=5-Fluorouracil; AJCC= American Joint Committee on Cancer