BACKGROUND: Even after curative resection of pancreatic cancer, there is a high probability of systemic recurrence. This indicates that subclinical metastases are already present at the time of operation. The purpose of this study was to assess the feasibility and outcomes of patients who received a novel multimodality therapy combining pancreatic resection and intraoperative radiation therapy (IORT) with pre- and postoperative chemotherapy for pancreatic cancer. METHODS: For eligible patients with pancreatic cancer, 5-FU was administered at a dose of 125 mg/m(2)/day on days 1-5 every week as a continuous pancreatic and hepatic arterial infusion, and gemcitabine was infused intravenously at a dose of 800 mg/m(2) per day once per week for 2 weeks for preoperative chemotherapy. Pancreatic resection combined with IORT was performed 1 week after preoperative chemotherapy. Postoperative chemotherapy was performed in the same way as preoperative chemotherapy. We performed an intention-to-treat analysis for all enrolled patients. RESULTS: This study enrolled 44 patients. The most common toxicities were hematological and gastrointestinal events. Grade 3/4 hematological toxicities were observed during preoperative chemotherapy, although there were no grade 3/4 nonhematological events. Postoperative chemotherapy-related toxicities were more critical and frequent than preoperative ones. There were no pre- or postoperative chemotherapy-associated deaths. Median overall survival was 36.5 months with 30.5% overall 5-year survival. CONCLUSIONS: This multimodality therapy is feasible and promises to contribute to survival. It should be evaluated in a phase III setting.
BACKGROUND: Even after curative resection of pancreatic cancer, there is a high probability of systemic recurrence. This indicates that subclinical metastases are already present at the time of operation. The purpose of this study was to assess the feasibility and outcomes of patients who received a novel multimodality therapy combining pancreatic resection and intraoperative radiation therapy (IORT) with pre- and postoperative chemotherapy for pancreatic cancer. METHODS: For eligible patients with pancreatic cancer, 5-FU was administered at a dose of 125 mg/m(2)/day on days 1-5 every week as a continuous pancreatic and hepatic arterial infusion, and gemcitabine was infused intravenously at a dose of 800 mg/m(2) per day once per week for 2 weeks for preoperative chemotherapy. Pancreatic resection combined with IORT was performed 1 week after preoperative chemotherapy. Postoperative chemotherapy was performed in the same way as preoperative chemotherapy. We performed an intention-to-treat analysis for all enrolled patients. RESULTS: This study enrolled 44 patients. The most common toxicities were hematological and gastrointestinal events. Grade 3/4 hematological toxicities were observed during preoperative chemotherapy, although there were no grade 3/4 nonhematological events. Postoperative chemotherapy-related toxicities were more critical and frequent than preoperative ones. There were no pre- or postoperative chemotherapy-associated deaths. Median overall survival was 36.5 months with 30.5% overall 5-year survival. CONCLUSIONS: This multimodality therapy is feasible and promises to contribute to survival. It should be evaluated in a phase III setting.
Authors: Susanne Roth; Christoph Springfeld; Markus K Diener; Christine Tjaden; Phillip Knebel; Ulla Klaiber; Christoph W Michalski; Markus Mieth; Dirk Jäger; Markus W Büchler; Thilo Hackert Journal: BMJ Open Date: 2019-08-20 Impact factor: 2.692