Table 1.
Patients' Characteristics by Treatment Arm and Biomarker Analysis
| Characteristic | Gemcitabine and Carboplatin (n = 85) |
Gemcitabine (n = 85) |
P | Nonbiomarker Group (n = 101) |
Biomarker Group (n = 69) |
P | ||||
|---|---|---|---|---|---|---|---|---|---|---|
| No. | % | No. | % | No. | % | No. | % | |||
| Age, years | .820* | .718* | ||||||||
| Median | 72.9 | 75.0 | 73.8 | 75.0 | ||||||
| Range | 46.3-88.4 | 45.2-89.7 | 45.2-89.7 | 49.4-85.5 | ||||||
| Sex | 1.000† | .275† | ||||||||
| Male | 47 | 48 | 60 | 35 | ||||||
| Female | 38 | 37 | 41 | 34 | ||||||
| Histology | .311† | .609† | ||||||||
| Adenocarcinoma | 53 | 45 | 55 | 43 | ||||||
| Squamous carcinoma | 14 | 22 | 23 | 13 | ||||||
| Other | 18 | 18 | 23 | 13 | ||||||
| Stage | .035† | .180† | ||||||||
| IV | 70 | 80 | 86 | 64 | ||||||
| IIIB | 13 | 5 | 14 | 4 | ||||||
| Unknown | 2 | 0 | 1 | 1 | ||||||
| Best measurable response by CT§ | .003† | .977† | ||||||||
| CR | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | ||
| PR | 29 | 43.9 | 10 | 16.4 | 21 | 31.3 | 18 | 30.0 | ||
| SD | 23 | 34.8 | 35 | 57.4 | 30 | 44.8 | 28 | 46.7 | ||
| PD | 14 | 21.2 | 16 | 26.2 | 16 | 23.9 | 14 | 23.3 | ||
| Best measurable response by CT | < .001† | 1.000† | ||||||||
| CR and PR | 29 | 43.9 | 10 | 16.4 | 21 | 31.3 | 18 | 30.0 | ||
| 95% CI | 24.2 to 54.2 | 8.2 to 28.1 | 20.6 to 43.8 | 18.9 to 43.2 | ||||||
| Best confirmed response category‖ | .050† | .668† | ||||||||
| CR | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | ||
| PR | 16 | 21.1 | 5 | 6.3 | 10 | 11.5 | 11 | 15.9 | ||
| SD | 34 | 44.7 | 38 | 47.5 | 39 | 44.8 | 33 | 47.8 | ||
| PD | 20 | 26.3 | 25 | 31.3 | 25 | 28.7 | 20 | 29.1 | ||
| Unknown | 6 | 7.9 | 12 | 15.0 | 13 | 14.9 | 5 | 7.2 | ||
| Best confirmed response | .010† | .240† | ||||||||
| CR and PR | 16 | 21.1 | 5 | 6.3 | 10 | 12.7 | 11 | 17.2 | ||
| 95% CI | 12.5 to 31.9 | 2.1 to 14.0 | 4.8 to 17.5 | 8.2 to 26.7 | ||||||
| OS, months | .242‡ | .312‡ | ||||||||
| Median | 6.7 | 5.1 | 4.9 | 6.0 | ||||||
| 95% CI | 4.9 to 10.0 | 3.9 to 6.3 | 3.9 to 6.7 | 5.1 to 8.4 | ||||||
| PFS, months | .143‡ | .698‡ | ||||||||
| Median | 3.8 | 2.7 | 2.6 | 3.1 | ||||||
| 95% CI | 2.6 to 4.6 | 1.9 to 3.6 | 2.0 to 4.1 | 2.8 to 4.3 | ||||||
Abbreviations: CT, computed tomography; CR, complete response; PR, progressive disease; SD, stable disease; PD, progressive disease; OS, overall survival; PFS, progression-free survival.
*
Wilcoxon rank-sum test.
†
Fisher's exact test.
‡
Log-rank test.
§
Best measurable response by CT was available in 66 patients treated with gemcitabine and carboplatin and 61 patients treated with gemcitabine.
‖
Best confirmed response was available in 70 patients treated with gemcitabine and carboplatin and 68 patients treated with gemcitabine.