BACKGROUND/AIMS: This prospective phase II study on a combination of intraarterial (i.a.) and systemic chemotherapy was performed to test whether regional chemotherapy may overcome the chemoresistance of pancreatic cancer. METHODOLOGY: One treatment cycle consisted of an i.a. infusion through an angiographic catheter into the celiac artery of 8.5mg/m2 mitomycin C (MMC) and 500 mg/m2 gemcitabine on days 1 and 22, and intravenous infusions of 500 mg/m2 gemcitabine on days 8 and 15. Study-endpoints were overall survival and tumor response as measured by computed tomography (CT). Treatment was continued until disease progression or complete remission on CT. RESULTS: Thirty-seven treatment cycles were performed in 17 patients. The most frequent side effects were hematological with 18 episodes of grade III/IV toxicities. According to radiographic and tumor marker criteria, four (24%) and seven patients (41%), respectively, demonstrated an objective response. The median actual progression-free and overall survivals were 4.6 and 9.1 months, respectively. Patients without distant metastases had a longer median survival (15 months) than those with distant metastases (7.1 months, p = 0.037). CONCLUSIONS: This combination treatment was well tolerated and resulted in tumor response rates, median overall- and progression-free survival times superior to systemic gemcitabine chemotherapy, and comparable to the more toxic FOLFIRINOX regimen.
BACKGROUND/AIMS: This prospective phase II study on a combination of intraarterial (i.a.) and systemic chemotherapy was performed to test whether regional chemotherapy may overcome the chemoresistance of pancreatic cancer. METHODOLOGY: One treatment cycle consisted of an i.a. infusion through an angiographic catheter into the celiac artery of 8.5mg/m2 mitomycin C (MMC) and 500 mg/m2 gemcitabine on days 1 and 22, and intravenous infusions of 500 mg/m2 gemcitabine on days 8 and 15. Study-endpoints were overall survival and tumor response as measured by computed tomography (CT). Treatment was continued until disease progression or complete remission on CT. RESULTS: Thirty-seven treatment cycles were performed in 17 patients. The most frequent side effects were hematological with 18 episodes of grade III/IV toxicities. According to radiographic and tumor marker criteria, four (24%) and seven patients (41%), respectively, demonstrated an objective response. The median actual progression-free and overall survivals were 4.6 and 9.1 months, respectively. Patients without distant metastases had a longer median survival (15 months) than those with distant metastases (7.1 months, p = 0.037). CONCLUSIONS: This combination treatment was well tolerated and resulted in tumor response rates, median overall- and progression-free survival times superior to systemic gemcitabine chemotherapy, and comparable to the more toxic FOLFIRINOX regimen.