Table 2:
Comparison of PIPAC-Ox regimens and their dose-finding studies.
| PIPOX study | NUH study | Turin study | |
|---|---|---|---|
| RP2D | 90 mg/m2 | 120 mg/m2 | 135 mg/m2 |
| Study design | 3 + 3 | 3 + 3 | Continual reassessment method |
| DLT defined | Any grade III or IV toxicity or unexpected post-operative complication. | Any grade 3 toxicity | Not defined |
| Predefined dose levels | 90, 145, 200, 255, 300 | 45, 60, 90, 120 | 100, 135, 155 |
| No of included patients | 10 | 17 | 6 |
| Repeated PIPAC | 10 | 8 | No |
| sCT | Yes | No | No |
| Grade 3 toxicity | Nausea, neutropenia, anemia, hypersensitivity to Pt, hemorrhage, obstruction | Acute pancreatitis in the first dose level | No |
| Response at P2RD | PRGS3 | PRGS1 | NR |
| Origin of PM | Gastric, CRC + App | Gastric, CRC + App, HPB | Gastric, CRC + App, HPB |
| Criticism | Hypersensitivity considered as a DLT while it is not dose-dependent | DLT not attained | DLT not clearly defined |
| Neutropenia usually excluded from other studies or used as a combined parameter. | Last level not doubled (n=3) | Very limited number of included patients | |
| Last dose level not doubled (inclusions stopped because of insurance issues) |
App, appendiceal cancer; CRC, colorectal cancer; CRM, continual reassessment method; DLT, dose limiting toxicity; HPB, hepato-pancreato-biliary malignancies; NR, not reported; P2RD, phase 2 recommended dose; PRGS, peritoneal regression grading score; sCT, systemic chemotherapy.