Table 1.
Patient characteristics.
| Number of the patients | All patients, n (%) | First line, n (%) | Second line, n (%) | ≥Third line, n (%) | P-value |
|---|---|---|---|---|---|
| Number | 308 (100) | 139 (45.1) | 118 (38.3) | 51 (16.6) | |
| Age median (min-max) | 53 (22-79) | 52 (18-82) | 57 (18-80) | 55 (19-80) | |
| Age groups | .39 | ||||
| <50 | 124 (44.6) | 60 (43.2) | 44 (37.3) | 20 (39.2) | |
| 50-70 | 154 (42) | 66 (47.5) | 5 (50) | 29 (56.9) | |
| >70 | 30 (13.4) | 13 (9.4) | 15 (12.7) | 2 (3.9) | |
| Gender | .24 | ||||
| Female | 151 (49) | 61 (43.9) | 64 (54.2) | 26 (51) | |
| Male | 157 (51) | 78 (56.1) | 54 (45.8) | 2 (49) | |
| PS (ECOG) | .53 | ||||
| 0 | 155 (50.3) | 76 (54.7) | 58 (49.2) | 21 (41.2) | |
| 1 | 118 (38.3) | 50 (36.0) | 45 (38.1) | 23 (45.1) | |
| 2 | 35 (11.4) | 13 (9.4) | 15 (12.7) | 7 (13.7) | |
| Comorbidities* | .53 | ||||
| Yes | 137 (44.5) | 64 (46.0) | 48 (40.7) | 25 (40) | |
| No | 171 (55.5) | 75 (54.0) | 70 (59.3) | 26 (51) | |
| Site (primary) | .39 | ||||
| Pancreas | 145 (47.1) | 75 (54.0) | 48 (40.7) | 22 (43.1) | |
| Gastrointestinal system | 90 (29.2) | 34 (24.5) | 39 (33.1) | 17 (33.3) | |
| Lung | 57 (18.5) | 22 (15.8) | 26 (22) | 9 (17.6) | |
| Unknown | 16 (5.2) | 8 (5.8) | 5 (4.2) | 3 (5.9) | |
| Histologic grade | .01 | ||||
| Grade 1 | 62 (20.1) | 19 (13.7) | 33 (28.0) | 10 (19.6) | |
| Grade 2 | 193 (62.7) | 104 (74.8) | 65 (55.1) | 24 (47.1) | |
| Grade 3 | 40 (13) | 14 (10.1) | 11 (9.3) | 15 (29.4) | |
| Unknown (Ki-67 1-20%) | 13 (4.2) | 2 (1.4) | 9 (7.6) | 2 (3.9) | |
| Metastatic sites | .34 | ||||
| Liver | 101 (32.8) | 37 (26.6) | 45 (38.1) | 19 (37.3) | |
| Extra-liver | 54 (17.5) | 26 (18.7) | 20 (16.9) | 8 (15.7) | |
| Liver and extra-liver | 153 (49.7) | 76 (45.1) | 53 (44.9) | 24 (47.1) | |
| Ki-67 (%) | .27 | ||||
| <3 | 63 (20.5) | 27 (19.4) | 33 (23.7) | 8 (15.7) | |
| 3-20 | 196 (63.6) | 91 (65.5) | 76 (64.4) | 29 (56.9) | |
| 21-55 | 37 (12) | 16 (11.5) | 10 (8.5) | 11 (21.6) | |
| Unknown (grades 1/2) | 12 (3.9) | 5 (3.6) | 4 (3.4) | 3 (5.9) | |
| No. of cycles | |||||
| Median (min-max) | 6 (1-64) | 6 (1-64) | 6 (1-39) | 6 (2-21) | |
| Mean ± SD | 8.21 ± 7.49 | 8.79 ± 8.13 | 8.12 ± 7.64 | 6.00 ± 4.82 | |
| Prior surgery (curative) | .28 | ||||
| Yes | 78 (25.3) | 41 (29.5) | 27 (27.9) | 10 (19.6) | |
| No | 230 (74.7) | 98 (70.5) | 91 (77.1) | 41 (80.4) | |
| Previous treatment at metastatic stage, n (%) | |||||
| Somatostatin analog | 106 (34.5) | — | 73 (61.9) | 33 (64.7) | |
| PRRT | 27 (8.8) | — | 10 (8.5) | 17 (33.3) | |
| Cytotoxic chemotherapy | 61 (19.8) | — | 31 (26.3 | 30 (58.8) | |
| Everolimus | 28 (9.1) | — | 6 (5.1) | 22 (43.1) | |
| Sunitinib | 9 (2.9) | — | 1 (0.8) | 8 (15.7) | |
| Locoregional therapy | 30 (9.7) | — | 21 (17.8) | 9 (17.6) | |
| Grade 3-4 adverse effects | .29 | ||||
| Yes | 69 (22.4) | 32 (23) | 22 (18.6) | 15 (29.4) | |
| No | 239 (77.6) | 107 (77) | 96 (81.4) | 36 (70.6) | |
| Drug holiday | .19 | ||||
| Yes | 5 (16.9) | 21 (15.1) | 18 (15.3) | 13 (25.5) | |
| No | 256 (83.1) | 118 (84.9) | 100 (84.7) | 38 (74.5) | |
| Dose reduction | .001 | ||||
| Yes | 65 (21.1) | 25 (18) | 19 (16.1) | 21 (41.2) | |
| No | 243 (78.9) | 114 (82) | 99 (83.9) | 30 (58.8) | |
| Treatment interruption | .37 | ||||
| Yes | 23 (9.1) | 8 (5.8) | 9 (7.6) | 6 (11.8) | |
| No | 285 (92.5) | 131 (94.2) | 109 (92.4) | 45 (88.2) |
Bold values indicate statistically significant (P<0.05).
*Hypertension, diabetes, coronary heart disease, chronic kidney disease, cerebrovascular disease, chronic obstructive pulmonary disease, thyroiditis.