Under pressure: A phase I pilot trial evaluating pressurised intraperitoneal aerosol chemotherapy with oxaliplatin in resectable high-risk gastric cancer.
Josipa Petric, Emma L Bradshaw, Harsh A Kanhere et al.
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In 30 seconds
This prospective, single-centre, non-randomised, open-label phase I pilot trial assessed the safety and feasibility of adding pressurised intraperitoneal aerosol chemotherapy with oxaliplatin (PIPAC-O+) to perioperative FLOT in patients with high-risk, resectable gastric adenocarcinoma. Ten patients received PIPAC-O+ after neoadjuvant FLOT and before gastrectomy. No PIPAC-O+-related morbidity or mortality was reported, and treatment was not delayed or interrupted. Quality of life was maintained. The findings support feasibility in this small pilot population but do not establish comparative efficacy.
Key findings
- Ten patients were enrolled; all received neoadjuvant FLOT, and 90% completed adjuvant FLOT.
- No PIPAC-O+-related morbidity or mortality occurred, and the intervention did not delay or interrupt treatment.
- One patient reported transient bloating, fatigue, and cold sensitivity; another reported nausea. No other CTCAE-grade events were reported.
- Quality of life was maintained.
Why it matters
Peritoneal recurrence is a substantial concern after treatment of gastric cancer, and this pilot examined an intraperitoneal approach alongside curative-intent perioperative therapy. The absence of reported treatment-related morbidity or mortality and lack of treatment interruption provide preliminary safety and feasibility information. These results are useful for framing further evaluation, but the small, non-randomised study cannot determine whether PIPAC-O+ improves cancer outcomes.
What to keep in mind
This was a single-centre, non-randomised pilot trial involving only ten patients; it cannot establish comparative efficacy.