Journal
EJSO
Volume 47, Issue 1, Pages 134-138Publisher
ELSEVIER SCI LTD
DOI: 10.1016/j.ejso.2019.04.014
Keywords
Peritoneal metastasis; Colorectal cancer; Immunotoxin; MOC31PE; Phase I/II trial; CRS-HIPEC
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The ImmunoPeCa trial investigated intraperitoneal MOC31PE immunotoxin as a novel therapeutic approach for peritoneal metastasis from colorectal cancer. The long-term outcomes showed promising results with high survival rates and potential benefits for certain patients with favorable characteristics. Further investigations into the clinical efficacy are supported by the study's findings.
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. (C) 2019 Elsevier Ltd, BASO - The Association for Cancer Surgery, and the European Society of Surgical Oncology. All rights reserved.
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