Review Article


Intraperitoneal gemcitabine chemotherapy as an adjuvant treatment for patients with resected pancreatic cancer: Phase II and pharmacologic studies

Paul H. Sugarbaker, O. Anthony Stuart, Lana Bijelic

Abstract

Background: Currently, the surgical management of pancreas cancer is recognized around the world as/> inadequate. Despite a potentially curative R0 resection long-term survival is rare. There is a strong rationale for the use of intraperitoneal chemotherapy in the operating room and long term to reduce local-regional progressive disease.
Methods: Gemcitabine monotherapy was administered by an intraperitoneal route in the operating room with hyperthermia. Then, through an intraperitoneal port placed at the time of pancreatectomy a longterm/> treatment postoperatively was performed. The peritoneal fluid, plasma and urine concentrations of gemcitabine were measured by high pressure liquid chromatography.
Results: The adverse events associated with hyperthermic intraoperative gemcitabine and long-term/> intraperitoneal gemcitabine through an intraperitoneal port was well tolerated. Pharmacologic studies showed that the exposure of peritoneal surfaces to intraperitoneal gemcitabine is approximately 200-500 times the exposure that occurs within the plasma.
Conclusions: This standardized treatment with intraoperative and long-term gemcitabine chemotherapy/> was well tolerated. The pharmacologic studies showed marked local-regional chemotherapy concentrations. These results may facilitate further improvements in pancreas cancer treatment and may lead the way to an evolution of more successful treatment strategies of this dread disease. These early phase II and/> pharmacologic data on a protocol in progress in patients with resected pancreatic cancer show promising results.