Table 1.
Characteristics of patients in ASPEN study
| Overall (n = 500) |
Active surveillance (n = 406) |
Surgical resection (n = 94) |
P§ | |
|---|---|---|---|---|
| Sex | 0.529 | |||
| F | 238 (47.6) | 196 (48.3) | 42 (45) | |
| M | 262 (52.4) | 210 (51.7) | 52 (55) | |
| Age (years), median (i.q.r.) | 64 (54–71) | 65 (56–71) | 59 (51–68) | <0.001¶ |
| BMI (kg/m2) | 0.052 | |||
| ≤ 25 | 175 (35.0) | 134 (33.0) | 41 (44) | |
| > 25 | 325 (65.0) | 272 (67.0) | 53 (56) | |
| Diabetes | 0.268 | |||
| No | 417 (83.4) | 335 (82.5) | 82 (87) | |
| Yes | 83 (16.6) | 71 (17.5) | 12 (13) | |
| ECOG PS score | 0.305 | |||
| 0 | 436 (87.2) | 349 (86.0) | 87 (93) | |
| 1 | 52 (10.4) | 45 (11.1) | 7 (7) | |
| ≥ 2 | 12 (2.4) | 12 (2.9) | 0 (0) | |
| Year of diagnosis | 0.059 | |||
| 2017–2018 | 271 (54.2) | 212 (52.2) | 59 (63) | |
| 2019–2020 | 229 (45.8) | 194 (47.8) | 35 (37) | |
| Site of lesion | 0.323 | |||
| Head | 121 (24.2) | 101 (24.9) | 20 (21) | |
| Uncinate process | 55 (11.0) | 48 (11.8) | 7 (8) | |
| Body | 167 (33.4) | 136 (33.5) | 31 (33) | |
| Tail | 157 (31.4) | 121 (29.8) | 36 (38) | |
| Radiological tumour size (mm), mean(s.d.)* | 13.2 (4.1) | 12.9 (3.9) | 14.8 (4.5) | <0.010# |
| rN status | 1.000 | |||
| rN0 | 499 (99.8) | 406 (100) | 93 (99) | |
| rN1 | 1 (0.02) | 0 (0) | 1 (1) | |
| rM status | 0.671 | |||
| rM0 | 496 (99.2) | 406 (100) | 90 (96) | |
| rM1 | 4 (0.08) | 0 (0) | 4 (4) | |
| MPD diameter (mm), mean(s.d.) | 2.9 (3.4) | 2.5 (3.1) | 4.3 (4.0) | 0.001# |
| CgA (ng/ml), median (i.q.r.) | 61 (30–36) | 60 (25–106) | 63 (44–123) | 0.259¶ |
| [18F]FDG PET | 0.454 | |||
| Not performed | 427 (85.4) | 344 (84.7) | 83 (88) | |
| Negative | 55 (11.0) | 48 (11.8) | 7 (8) | |
| Positive | 18 (3.6) | 14 (3.4) | 4 (4) | |
| FNA(B) | 0.001 | |||
| Not performed | 170 (34.0) | 124 (30.5) | 46 (49) | |
| Negative | 45 (9.0) | 34 (8.4) | 11 (12) | |
| Positive | 285 (57.0) | 248 (61.1) | 37 (39) | |
| Tumour grade† | <0.001 | |||
| PanNET-G1 | 195 (68.4) | 179 (72.2) | 16 (43) | |
| PanNET-G2 | 22 (7.7) | 12 (4.8) | 10 (27) | |
| Not evaluable | 68 (23.9) | 57 (23.0) | 11 (30) | |
| Surgical centre | 0.006 | |||
| No | 178 (35.6) | 156 (38.4) | 22 (23) | |
| Yes | 322 (64.4) | 250 (61.6) | 72 (77) | |
| HADS score‡ | 0.295 | |||
| ≤ 5 | 167 (33.4) | 142 (35.0) | 25 (27) | |
| 6–12 | 172 (34.4) | 137 (33.7) | 35 (37) | |
| > 12 | 161 (32.2) | 127 (31.3) | 34 (36) | |
| HADS—anxiety score‡ | 0.108 | |||
| ≤ 3 | 148 (29.6) | 126 (31.0) | 22 (23) | |
| 4–6 | 178 (35.6) | 136 (33.5) | 42 (45) | |
| > 6 | 174 (34.8) | 144 (35.5) | 30 (32) | |
| HADS—depression score‡ | ||||
| ≤ 2 | 114 (22.8) | 95 (23.4) | 19 (20) | 0.563 |
| 3–4 | 207 (41.4) | 170 (41.9) | 37 (39) | |
| > 4 | 179 (35.8) | 141 (34.7) | 38 (41) |
Values are n (%) unless otherwise indicated. *Maximum size on radiological imaging or endoscopic ultrasonography. †Evaluated for patients with positive fine-needle aspiration (biopsy) (FNA(B) specimen. ‡Categorized by tertiles of Hospital Anxiety and Depression Scale (HADS) distribution. ECOG PS, Eastern Cooperative Oncology Group performance status; MPD, main pancreatic duct; CgA, chromogranin A; FDG, fluorodeoxyglucose. §Pearson χ2 test, except ¶Wilcoxon Mann–Whitney test and #t test.