Table 1.
Demographics, Clinicopathologic, and Treatment Characteristics of Included Patients
| Variable | All Patients (n = 957) | No Recurrence (n = 204) | Recurrence (n = 753) | P Value |
|---|---|---|---|---|
|
| ||||
| Female, n (%) | 456 (47.6%) | 88 (43.1%) | 368 (48.9%) | 0.146 |
| Race/ethnicity, n (%) | 0.367 | |||
| Caucasian | 821 (85.8%) | 179 (87.7%) | 642 (85.3%) | |
| Other | 136 (14.2%) | 25 (12.3%) | 111 (14.7%) | |
| Age, mean years (SD) | 65.8 (10.5) | 68.2 (10.4) | 65.2 (10.5) | <0.001 |
| Charlson age-comorbidity index, n (%) | ||||
| <4 points | 657 (68.7%) | 152 (74.5%) | 505 (67.1%) | |
| ≥4 points | 300 (31.3%) | 52 (25.5%) | 248 (32.9%) | 0.042 |
| Preoperative CA 19–9 (U/mL)* | ||||
| Median (IQR) | 130 (50–398) | 72 (28–269) | 148 (56–455) | 0.006 |
| Postoperative CA 19–9 (U/mL)† | ||||
| Median (IQR) | 38 (19–113) | 28 (16–45) | 43 (22–138) | <0.001 |
| Operation procedure, n (%) | 0.100 | |||
| PPPD | 415 (43.4%) | 92 (45.1%) | 323 (42.9%) | |
| Classic PD | 383 (40.0%) | 83 (40.7%) | 300 (39.8%) | |
| Total pancreatectomy | 34 (3.6%) | 11 (5.4%) | 23 (3.1%) | |
| Distal pancreatectomy | 125 (13.1%) | 18 (8.8%) | 107 (14.2%) | |
| Complications, n (%) | 0.123 | |||
| Clavien-Dindo grade ≤II | 803 (83.9%) | 164 (80.4%) | 639 (84.9%) | |
| Clavien-Dindo grade ≥III | 154 (16.1%) | 40 (19.6%) | 114 (15.1%) | |
| Resection margin, n (%) | <0.001 | |||
| R0 (>1.0 mm) | 658 (68.8%) | 167 (81.9%) | 491 (65.2%) | |
| R1 (≤1.0 mm) | 299 (31.2%) | 37 (18.1%) | 262 (34.8%) | |
| Tumour differentiation, n (%) | <0.001 | |||
| Well-moderate | 591 (61.8%) | 148 (72.5%) | 443 (58.8%) | |
| Poor | 366 (38.2%) | 56 (27.5%) | 310 (41.2%) | |
| Tumour size, mean cm (SD) | 3.2 (1.5) | 3.0 (1.7) | 3.2 (1.4) | 0.010 |
| T-stage, n (%) | 0.028 | |||
| 1–2 | 283 (29.6%) | 73 (35.8%) | 210 (27.9%) | |
| 3–4 | 674 (70.4%) | 131 (64.2%) | 543 (72.1%) | |
| Positive lymph nodes, n (%) | 719 (75.1%) | 130 (63.7%) | 589 (78.2%) | <0.001 |
| Positive lymph node ratio, n (%) | <0.001 | |||
| ≤0.2 | 646 (67.5%) | 174 (85.3%) | 472 (62.7%) | |
| >0.2 | 311 (32.5%) | 30 (14.7%) | 281 (37.3%) | |
| Micr. perineural invasion, n (%) | 859 (89.8%) | 163 (79.9%) | 696 (92.4%) | <0.001 |
| Micr. lymphovascular invasion, n (%) | 544 (56.8%) | 81 (39.7%) | 463 (61.5%) | <0.001 |
| AJCC stage 7th edition, n (%) | 0.001 | |||
| ≤2A | 671 (28.3%) | 76 (37.3%) | 195 (25.9%) | |
| ≥2B | 686 (71.7%) | 128 (62.7%) | 558 (74.1%) | |
| Adjuvant therapy, n (%) | 0.002 | |||
| No adjuvant | 307 (32.1%) | 55 (27.0%) | 252 (33.5%) | |
| Chemotherapy | 207 (21.6%) | 62 (30.4%) | 145 (19.3%) | |
| Chemoradiotherapy | 443 (46.3%) | 87 (42.6%) | 356 (47.3%) | |
| Recurrence site, n (%) | NA | |||
| Local only | 190 (19.9%) | 0 (0%) | 190 (25.2%) | |
| Metastatic | 563 (58.8%) | 0 (0%) | 563 (74.8%) | |
| Survival (median months, 95% CI) | ||||
| Recurrence-free survival | 15.2 (14.0–16.4) | NA | 11.7 (10.8–12.6) | NA |
| Post-recurrence survival | NA | NA | 7.5 (6.8–8.2) | NA |
| Overall survival | 24.8 (23.3–26.3) | 93.0 (61.0–125.1) | 21.1 (19.2–22.9) | <0.001 |
Three hundred ninety-eight patients had preoperative CA 19–9 levels available for analysis. Excluded from analysis were 65 Lewis antigen negative patients and 494 patients with missing preoperative values.
Five hundred thirty-two patients had postoperative CA 19–9 levels available for analysis. Excluded from analysis were 65 Lewis antigen negative patients and 360 patients with missing postoperative values.
SD indicates standard deviation; CA, carbohydrate antigen; IQR, interquartile range; PPPD, pylorus-preserving pancreatoduodenectomy; PD, pancreatoduodenectomy; AJCC, American Joint Committee on Cancer; Micr, microscopic; CI, confidence interval; NA, not applicable.