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ImmunoPeCa trial: Long-term outcome following intraperitoneal MOC31PE immunotoxin treatment in colorectal peritoneal
Ida S Frøysnes1, Yvonne Andersson2, Stein G Larsen3
1Department of Tumor Biology, Norwegian Radium Hospital, Oslo University Hospital, Oslo, Norway; Faculty of Medicine, University of Oslo, Oslo, Norway.
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.
Insights
The ImmunoPeCa trial showed promising long-term survival for intraperitoneal MOC31PE immunotoxin in treating peritoneal metastasis from colorectal cancer (PM-CRC). Further studies are warranted to confirm clinical efficacy.
Area of Science:
- Oncology
- Immunotherapy
- Surgical Oncology
Background:
- Peritoneal metastasis from colorectal cancer (PM-CRC) presents a significant therapeutic challenge.
- Intraperitoneal MOC31PE immunotoxin is investigated as a novel treatment strategy for PM-CRC.
- The ImmunoPeCa trial reports long-term outcomes of this therapeutic approach.
Purpose of the Study:
- To evaluate the safety and toxicity of intraperitoneal MOC31PE immunotoxin in patients with PM-CRC undergoing CRS-HIPEC.
- To assess the long-term overall survival (OS) and disease-free survival (DFS) as secondary endpoints.
- To explore the potential of MOC31PE as a targeted therapy for peritoneal carcinomatosis.
Main Methods:
- A dose-finding trial design was employed.
- Twenty-one patients with PM-CRC received intraperitoneal MOC31PE at four dose levels post-CRS-HIPEC with mitomycin C.
- Safety, toxicity, OS, and DFS were evaluated, with an expansion cohort included.
Main Results:
- With a median follow-up of 31 months, the 3-year OS was 78% and 3-year DFS was 33%.
- Median OS was not reached.
- Excluding patients with favorable characteristics showed a median DFS of 13 months and 3-year OS of 72%.
Conclusions:
- The promising long-term outcomes suggest MOC31PE immunotoxin warrants further clinical investigation.
- Low systemic absorption and high peritoneal drug concentration support its potential efficacy.
- Further studies are recommended to confirm the clinical benefit of MOC31PE in PM-CRC treatment.
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