Table 1.
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).