Table 1. Characteristics of the Patients at Baseline*.
| Characteristic | nab-Paclitaxel plus Gemcitabine (N = 431) |
Gemcitabine Alone (N = 430) |
Total (N = 861) |
|---|---|---|---|
| Age | |||
| No. of yr | |||
| Median | 62 | 63 | 63 |
| Range | 27–86 | 32–88 | 27–88 |
| Distribution — no. (%) | |||
| <65 yr | 254 (59) | 242 (56) | 496 (58) |
| ≥65 yr | 177 (41) | 188 (44) | 365 (42) |
| Sex — no. (%) | |||
| Female | 186 (43) | 173 (40) | 359 (42) |
| Male | 245 (57) | 257 (60) | 502 (58) |
| Race or ethnic group — no.(%)† | |||
| Asian | 8 (2) | 9 (2) | 17 (2) |
| Black | 16 (4) | 16 (4) | 32 (4) |
| White | 378 (88) | 375 (87) | 753 (87) |
| Hispanic | 25 (6) | 26 (6) | 51 (6) |
| Other | 4 (1) | 4 (1) | 8 (1) |
| Region — no. (%) | |||
| Australia | 61 (14) | 59 (14) | 120 (14) |
| Eastern Europe | 64 (15) | 62 (14) | 126 (15) |
| North America | 268 (62) | 271 (63) | 539 (63) |
| Western Europe | 38 (9) | 38 (9) | 76 (9) |
| Karnofsky performance-status score — no./total no. (%)‡ | |||
| 100 | 69/429 (16) | 69/429 (16) | 138/858 (16) |
| 90 | 179/429 (42) | 199/429 (46) | 378/858 (44) |
| 80 | 149/429 (35) | 128/429 (30) | 277/858 (32) |
| 70 | 30/429 (7) | 33/429 (8) | 63/858 (7) |
| 60 | 2/429 (<1) | 0/429 | 2/858 (<1) |
| Pancreatic tumor location — no. (%) | |||
| Head | 191 (44) | 180 (42) | 371 (43) |
| Body | 132 (31) | 136 (32) | 268 (31) |
| Tail | 105 (24) | 110 (26) | 215 (25) |
| Unknown | 3 (1) | 4 (1) | 7 (1) |
| Site of metastatic disease — no. (%) | |||
| Liver | 365 (85) | 360 (84) | 725 (84) |
| Lung | 153 (35) | 184 (43) | 337 (39) |
| Peritoneum | 19 (4) | 10 (2) | 29 (3) |
| No. of metastatic sites — no. (%) | |||
| 1 | 33 (8) | 21 (5) | 54 (6) |
| 2 | 202 (47) | 206 (48) | 408 (47) |
| 3 | 136 (32) | 140 (33) | 276 (32) |
| >3 | 60 (14) | 63 (15) | 123 (14) |
| Level of carbohydrate antigen 19-9 — no./total no. (%) | |||
| Normal§ | 60/379 (16) | 56/371 (15) | 116/750 (15) |
| ULN to <59× ULN | 122/379 (32) | 120/371 (32) | 242/750 (32) |
| ≥59× ULN | 197/379 (52) | 195/371 (53) | 392/750 (52) |
| Carbohydrate antigen 19-9 — U/ml¶ | |||
| Median | 2293.7 | 2759.2 | 2469.7 |
| Range | 1.9–6,159,233.0 | 0.3–12,207,654.2 | 0.3–12,207,654.2 |
| Previous therapy — no. (%) | |||
| Radiation therapy | 19 (4) | 11 (3) | 30 (3) |
| Chemotherapy | 23 (5) | 12 (3) | 35 (4) |
| Whipple procedure | 32 (7) | 30 (7) | 62 (7) |
| Biliary stent | 80 (19) | 68 (16) | 148 (17) |
There were no significant between-group differences at baseline. The term nab-paclitaxel denotes 130-nm albumin-bound paclitaxel, and ULN upper limit of the normal range.
Race or ethnic group was self-reported.
Karnofsky performance-status scores range from 0 to 100, with higher scores indicating better performance status. Two patients in the nab-paclitaxel–gemcitabine group had a score of 70 or more at the screening visit but a score of 60 at the baseline visit on day 1 of cycle 1.
The normal range was 0 to 35 U per milliliter. Approximately 10 to 15% of patients with pancreatic cancer do not have Lewis antigens and thus do not have the ability to secrete carbohydrate antigen 19-9.
Data were missing for 52 patients in the nab-paclitaxel–gemcitabine group and for 59 in the gemcitabine group.