Stage IV Gastric Cancer with Peritoneal Metastasis: Direct Chemotherapy Administration Enables Surgery in 40% of Patients
Phase 2 Results at Seoul National University Bundang Hospital
One-Year Survival Rate of 86.4%, Phase 3 Trial Underway
According to the results of a clinical trial, directly administering anticancer drugs into the abdominal cavity of patients with stage IV gastric cancer with peritoneal metastasis, combined with intravenous chemotherapy, led to improvements in four out of ten patients to the point where surgery became possible. The overall one-year survival rate was 86.4%, with a median overall survival of 20.2 months.
The research team led by Professor Kang Sohyun of the Department of Surgery and Professor Kim Jinwon of the Division of Hematology and Oncology at Seoul National University Bundang Hospital announced on the 29th that they had published the results of the phase 2 'IPLUS' clinical trial—conducted in patients with peritoneal metastasis from gastric cancer and combining intraperitoneal paclitaxel infusion with FOLFOX-based intravenous chemotherapy—in the international academic journal "Gastric Cancer."
Conceptual diagram showing intraperitoneal paclitaxel infusion therapy. Seoul National University Bundang Hospital
View original imagePeritoneal metastasis from gastric cancer is extremely difficult to treat surgically, as cancer cells are widely spread over the peritoneal surface. Moreover, due to the barrier between the blood and the peritoneum, anticancer drugs administered intravenously struggle to sufficiently reach peritoneal lesions. Consequently, conventional systemic chemotherapy alone results in a median survival of just 9 to 11 months, and cases proceeding to conversion surgery are rare.
The research team adopted a treatment approach involving the insertion of a port under the abdominal skin, connected to the peritoneal cavity, to directly infuse paclitaxel, while simultaneously administering FOLFOX-based intravenous chemotherapy.
A clinical trial conducted from 2021 to 2022 in 22 patients with peritoneal metastasis from gastric cancer found a one-year overall survival rate of 86.4% and a progression-free survival rate of 63.6%. The median overall survival was confirmed to be 20.2 months.
Notably, nine patients (40.9%) showed disappearance of peritoneal metastases and improved to the point where conversion surgery became possible. These patients underwent complete resection through gastrectomy and lymph node dissection, and the median overall survival among those who received conversion surgery was 32.9 months.
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Based on these results, the research team is currently conducting a multicenter phase 3 clinical trial involving 321 patients at six hospitals nationwide. The researchers explained that if efficacy is confirmed in phase 3, this approach may become a new standard treatment strategy for peritoneal metastasis of gastric cancer.
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