Table 1.
Baseline characteristics of the study population
| N = 30 | |
|---|---|
| Age, years | |
| Median (range) | 55 (27-75) |
| Sex, n (%) | |
| Male | 19 (63.3) |
| ECOG PS, n (%) | |
| 0 | 3 (10.0) |
| 1 | 27 (90.0) |
| Primary tumor location, n (%) | |
| Pancreas | 13 (43.3) |
| Stomach | 1 (3.3) |
| Small bowel | 4 (13.3) |
| Biliary tract | 4 (13.3) |
| Rectum | 3 (10.0) |
| Unknown primary with liver metastases | 5 (16.7) |
| Carcinoid symptomsb, n (%) | |
| Absent | 24 (80.0) |
| Presentb | 6 (20.0) |
| Histology by WHO 2019 classification, n (%) | |
| W/D NET G3 | 23 (76.7) |
| P/D NEC, large-cell | 2 (6.7) |
| P/D NEC, small-cell | 5 (16.7) |
| Ki-67 index, n (%) | |
| >20, <30 | 10 (33.3) |
| ≥30, <55 | 20 (66.6) |
| Ki-67 index, centrally reviewed, n (%) | |
| >20, <30 | 11 (36.7) |
| ≥30, <55 | 14 (46.7) |
| ≥55 | 5 (16.7) |
| Krenning score by 68Ga-DOTATOC PET/CT, n (%) | |
| 0-1 | 0 (0.0) |
| 2 | 2 (6.7) |
| 3-4 | 13 (43.3) |
| Unknown | 15 (50.0) |
| Disease status at enrollment, n (%) | |
| Locally advanced, inoperable | 1 (3.3) |
| Initially metastatic | 18 (60.0) |
| Recurrent after curative local treatment | 11 (36.7) |
| Number of metastatic sites, n (%) | |
| 0 | 1 (3.3) |
| 1 | 13 (43.3) |
| ≥2 | 16 (53.3) |
| Sites of metastasis, n (%) | |
| Liver | 27 (90.0) |
| Distant lymph node | 11 (36.7) |
| Peritoneum | 3 (10.0) |
| Lung | 4 (13.3) |
| Previous treatment, n (%) | |
| Surgery | 11 (36.7) |
| Radiotherapy | 1 (3.3) |
| Somatostatin analog | 5 (16.7) |
| PRRT | 0 (0.0) |
| Cytotoxic chemotherapy | 18 (60.0) |
| Previous chemotherapy regimen, n (%) | |
| Etoposide and cisplatin | 14 (46.7) |
| Cyclophosphamide, doxorubicin, and vincristine | 4 (13.3) |
| Other cytotoxic chemotherapy | 6 (20.0) |
| Everolimus | 1 (3.3) |
| Previous lines of palliative systemic treatmenta, n (%) | |
| 0 | 11 (36.7) |
| 1 | 12 (40.0) |
| ≥2 | 7 (23.3) |
| MGMT protein expression by IHC, n (%) | N = 26 |
| Loss of expression (≤50) | 14 (53.8) |
| Expressed (>50) | 12 (46.2) |
| MGMT MS-PCR, n (%) | N = 25 |
| Methylated | 24 (96.0) |
| Not methylated | 1 (4.0) |
CT, computed tomography; ECOG PS, European Cooperative Oncology Group performance status; IHC, immunohistochemistry; MGMT, O6-methyl-guanine methyltransferase; MS-PCR, methylation-specific polymerase chain reaction; P/D, poorly differentiated; PET, positron emission tomography; PRRT, peptide receptor radionuclide therapy; W/D, well differentiated; WHO, World Health Organization.
a
Includes somatostatin analogs, chemotherapy, and PRRT.
b
Includes one patient with Zollinger-Ellison syndrome and five patients with diarrhea.