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. 2009 Jul 6;27(23):3778–3785. doi: 10.1200/JCO.2008.20.9007

Table 1.

Baseline Characteristics Among Eligible Patients

Characteristic Treatment
GEM (n = 275)
GEM FDR (n = 277)
GEMOX (n = 272)
No. % No. % No. %
Mean age, years* 63 62 63
    Standard deviation 11 11 11
    Median 64 61 63
    Range 31-88 36-87 29-96
    Under 55 57 20.7 88 31.8 59 21.7
    55-69 141 51.3 123 44.4 136 50.0
    70+ 77 28.0 66 23.8 77 28.3
Sex
    Male 155 56.4 160 57.8 124 45.6
    Female 120 43.6 117 42.2 148 54.4
Race
    Hispanic 9 3.3 12 4.4 12 4.4
    Non-Hispanic white 235 85.8 236 86.1 231 85.6
    Non-Hispanic black 24 8.8 22 8.0 23 8.5
    Other 6 2.2 4 1.5 4 1.5
Previous 6-month weight loss
    < 5% of body weight 100 36.6 100 36.8 107 39.8
    5-< 10% of body weight 71 26.0 64 23.5 65 24.2
    10-< 20% of body weight 78 28.6 79 29.0 65 24.2
    20% or more of body weight 24 8.8 29 10.7 32 11.9
Histology grade
    Well differentiated 14 5 16 6 22 8
    Moderately differentiated 82 30 71 26 56 21
    Poorly differentiated/undifferentiated 76 28 77 28 78 29
    Missing/unknown 103 38 113 41 116 43
Prior RT
    No 254 92.4 253 91.3 250 91.9
    Yes 21 7.6 23 8.3 21 7.7
Prior adjuvant chemotherapy
    No 260 94.5 259 93.5 261 96.0
    Yes 15 5.5 17 6.1 10 3.7
Prior surgery
    No 230 83.6 234 84.5 239 87.9
    Yes 43 15.6 42 15.2 32 11.8
History of DVT or prior embolus
    No 236 85.8 240 86.6 243 89.3
    Yes 39 14.2 36 13.0 28 10.3
Disease measurable or not
    Measurable only 70 25.5 67 24.2 84 30.9
    Nonmeasurable only 13 4.7 13 4.7 16 5.9
    Both 192 69.8 194 70.0 172 63.2
PS on study
    0 94 34.2 86 31.0 73 26.8
    1 147 53.5 157 56.7 168 61.8
    2 34 12.4 33 11.9 30 11.0
Disease status on study
    Locally advanced 27 9.8 30 10.8 29 10.7
    Metastatic 248 90.2 246 88.8 243 89.3
Median CA19-9, U/mL 1,961 1,148 1,077
    25%-75% quantile 167-12,024 136-9,651 90-9,301
Median CEA, ng/dL 5.7 5.9 6.3
    25%-75% quantile 2.3-30.9 2.4-30.1 2.4-35.5

Abbreviations: GEM, gemcitabine; GEM FDR, gemcitabine fixed-dose rate; GEMOX, gemcitabine 1,000 mg/m2/100 minutes/day 1 plus oxaliplatin 100 mg/m2/day 2 every 14 days; RT, radiotherapy; DVT, deep vein thrombosis; PS, performance status.

*

Age different among three treatment arms, P = .03 (Pearson's χ2 test).

Sex different among three treatment arms, P < .01 (Pearson's χ2 test).