Table 5.
Summary of clinical trials performed investigating β RIT in PDAC.
| Study | Target | RIC | Study Type | Sample (n) | Patient Group | Median Overall Survival (Months) | Tumour Responses | Disease Control Rate | Adverse Events * (Grade ≥ 3) |
|---|---|---|---|---|---|---|---|---|---|
| Sultana et al. [77] | CEA | 131I-KAb201 | Single RIT comparing IV and IA administration | 18 | Locally advanced or metastatic PDAC, with at least one tumour site in head of pancreas. KPS ≥ 70, life expectancy < 3 months. Prior treatment allowed but not necessary for inclusion. | 5.2 No survival difference between IV and IA administrations |
1/18 (5.6%) partial responses 1/18 (5.6%) stable disease 16/18 (88.9%) progression |
11.2% | In total, 31 therapy related adverse events were observed. Haemotological toxicity, 18 events; sepsis and vomiting, two events each; alanine aminotransferase, anaemia, anorexia, aspartate aminotransferase, blood alkaline phosphatase, febrile neutropenia, haematemesis, neutrophilia and thrombosis, one event each. |
| Picozzi et al. [78] | MUC1/MUC5ac | 90Y-hPAM4 | Combination with gemcitabine | 58 | Metastatic PDAC, ≥ 2 prior chemotherapy regimens with measurable disease by CT. No CNS metastases of single masses ≥10cm. KPS ≥ 70. Adequate haematologic parameters. | 2.7 (overall survival for all patients) 7.9 (multiple cycles of combined therapy) 3.4 (multiple cycles of RIT only) |
2/29 (6.9%) partial responses (combined therapy group) 10/29 (34.5%) stable disease (combined therapy group) 12/29 (41.4%) stable disease (RIT only group) |
41.4% | Thrombocytopenia, 19% of patients (11/58); anaemia, leukopenia and neutropenia, 7% each (4/58), unspecified, 2% (1/58). |
| Ocean et al. [79] | MUC1 | 90Y-hPAM4 | Fractionated RIT combined with gemcitabine | 38 | Untreated adults with locally advanced or metastatic PDAC. KPS ≥ 70. Life expectancy > 3 months, no CNS tumours or single tumour mass > 10cm. Adequate haematologic parameters. | 7.7 | 6/38 (15.8%) partial response 16/38 (42.1%) stable disease 16/38 (42.1%) disease progression |
57.9% | No significant therapy related adverse events occurred. |
| Gulec et al. [80] | MUC1 | 90Y-hPAM4 | Single RIT | 20 | Stage III or IV PDAC. If stage III, must have progressed after therapy. Stage IV patients must have had no more than one prior chemotherapy regimen. No CNS tumours or single mass > 10cm. KPS ≥ 70 or ECOG ≤1. Adequate haematological parameters. | 4.3 | At 4 weeks: 3/20 (15.0%) partial response 4/20 (20.0%) stable disease |
At 4 weeks: 35.0% Follow up: 0% |
Eight therapy related adverse events occurred consisting of seven cytopenia events and a single vomiting event. |
| ClinicalTrials.gov [81] | MUC1 | 90Y-hPAM4 | RIT with gemcitabine | Data not available | Metastatic PDAC, completed at least one prior treatment cycle, progressed following gemcitabine regimen, KPS ≥ 70. No CNS tumours or single mass > 10 cm. | No significant improvements in survival in combined therapy group compared to gemcitabine only group | Data not available | Data not available | Data not available. |
* Includes only adverse events considered possibly treatment related. RIC: radioimmunoconjugate, IV: intravenous, IA: intraarterial, KPS: Karnofsky Performance Status, CNS: central nervous system, ECOG: Eastern Cooperative Oncology Group.