Phase 2 trial results of pressurized intraperitoneal aerosol chemotherapy (PIPAC) offer promising treatment option of unresectable peritoneal metastases.
The multicenter, single-arm, phase 2 CRC-PIPAC-II study included 20 patients undergoing a combined total of 52 bi-directional treatment cycles. PIPIAC is an innovative treatment strategy involving the application of chemotherapy via a specialized burn nebulizer, allowing for an evenly distributed mist within the abdominal cavity. According to Vincent van de Vlaskker, MD, the PIPAC approach demonstrated robust feasibility, with 75% of patients having successfully completed the treatment. “The dropout rate was low, with only one patient discontinuing due to toxicity,” Dr. van de Vlasakker said. “This suggests that our approach is not only feasible but also safe.”
In terms of efficacy, the trial reported encouraging results. The median progression-free survival was 10 months, while the median overall survival was 17.5 months. “These numbers are promising, especially when compared with the typical overall survival of 12 months observed with systemic therapy alone,” Dr. van de Vlasakker noted.
The trial’s results were not without complications. The impact on the patient’s quality of life was mixed. Adverse events included abdominal pain, peripheral neuropathy, nausea, vomiting, and fatigue. However, an improvement in emotional functioning was also observed.
“Despite the safety of the treatment, it is crucial not to overlook its significant impact on patients’ lives,” he said.
The overall conclusion from this trial was that the PIPAC technique represents an innovative leap in intra-peritoneal therapies, demonstrating that a localized high-dose treatment strategy could improve outcomes for patients with advanced peritoneal metastases. However, the complexity and mixed impact on quality of life suggests that this approach should be reserved for carefully selected patients, while more research is needed to further refine and assess this technique.
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