Abstract 3695: Efficacy of gemcitabine combined with hyperthermia therapy in the treatment of unresectable pancreatic cancer: Phase II study

Abstract

Abstract [Background] Pancreatic cancer is an aggressive malignant tumor. Gemcitabine is the standard first line therapy for pancreatic cancer. Several gemcitabine based chemotherapy combinations were studied for the treatment of pancreatic cancer, but these combination therapies showed no major success over single agent gemcitabine in the treatment of pancreatic cancer. Hyperthermia has been shown to increase the cytotoxic effects of some anticancer agents by facilitating drug penetration into tissue, and Gemcitabine has recently been shown to be a potent hyperthermic sensitizer in preclinical studies. We conducted a phase II study to determine the availability of combination therapy with gemcitabine and hyperthermia in the treatment of unresectable pancreatic cancer. [Methods] Patients who participated in the study had advanced pancreatic cancer and their performance status score ware 0-2. The primary end point was one-year survival rate. And the secondary end points were safety and response rate. We set the expectation one-year survival rate to 30% Gemcitabine (1000mg/m2) was given weekly for 3 weeks (day 1,8,15) in four-week cycles, and hyperthermia (40min/once) weekly. This schedule was repeated until disease progression. [Result] From November 2008 to November 2009,18 patients were enrolled in this study. Median patient age was 64 years old(range 47-78), male/female:10/8 All patient died until September 2011, and the one year survival rate is 33.3%, exceeded the expected rate. Disease control rates (CR+PR+SD) were 61.1% (PR/SD/PD=2/9/7) Median survival times were 6 months. Adverse events (Grade3/4) were neutropenia (16.7%), anemia (16.7%), anorexia (5.6%), gastrointestinal bleeding (5.6%). [Conclusion] Combination therapy with gemcitabine and hyperthermia is both a safe and effective treatment in patients with advanced unresectable pancreatic cancer. To clarify the effects of sequential combination of hyperthermia and Gemcitabine as compared with Gemcitabine monotherapy, further studies should be performed, particularly prospective randomized trials. Citation Format: {Authors}. {Abstract title} [abstract]. In: Proceedings of the 103rd Annual Meeting of the American Association for Cancer Research; 2012 Mar 31-Apr 4; Chicago, IL. Philadelphia (PA): AACR; Cancer Res 2012;72(8 Suppl):Abstract nr 3695. doi:1538-7445.AM2012-3695