ImmunoPeCa trial: Long-term outcome following intraperitoneal MOC31PE immunotoxin treatment in colorectal peritoneal metastasis
| Autor: | Stein Gunnar Larsen, Janne-Merete T. Oien, Øystein Fodstad, Svein Dueland, Lars Julsrud, Kjersti Flatmark, Ida S. Frøysnes, Yvonne Andersson, Ben Davidson |
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| Rok vydání: | 2021 |
| Předmět: |
Adult
Male 0301 basic medicine medicine.medical_specialty Peritoneal metastasis Immunoconjugates Colorectal cancer Mitomycin Hyperthermic Intraperitoneal Chemotherapy Gastroenterology MOC31PE immunotoxin 03 medical and health sciences 0302 clinical medicine Immunotoxin Internal medicine medicine Clinical endpoint Humans Peritoneal Neoplasms Aged Antibiotics Antineoplastic Norway business.industry Peritoneal fluid Cytoreduction Surgical Procedures General Medicine Middle Aged medicine.disease Combined Modality Therapy 030104 developmental biology Oncology 030220 oncology & carcinogenesis Toxicity Cohort Female Surgery Colorectal Neoplasms business |
| Zdroj: | European Journal of Surgical Oncology. 47:134-138 |
| ISSN: | 0748-7983 |
| DOI: | 10.1016/j.ejso.2019.04.014 |
| Popis: | Background The ImmunoPeCa trial investigated the use of intraperitoneal MOC31PE immunotoxin as a novel therapeutic principle for the treatment of peritoneal metastasis from colorectal cancer (PM-CRC). We here report long-term outcome from the trial. Methods This was a dose-finding trial aiming to evaluate safety and toxicity (primary endpoint) upon a single dose of intraperitoneal MOC31PE in patients with PM-CRC undergoing CRS-HIPEC with mitomycin C. Overall survival (OS) and disease-free survival (DFS) were secondary endpoints. Twenty-one patients received the study drug at four dose levels on the first postoperative day, including six patients constituting an expansion cohort. Results With a 34-month follow-up, the median OS was not reached and the estimated 3-year OS was 78%. Median DFS for all patients was 21 months and the 3-year DFS was 33%, with a median follow-up of 31 months. When excluding patients with potential favorable characteristics from the analysis (n = 4), the median DFS was 13 months and the 3-year OS 72%. Conclusions The promising long-term outcome combined with low systemic absorbance, high drug concentration and cytotoxic activity in peritoneal fluid support further investigations of clinical efficacy. |
| Databáze: | OpenAIRE |
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