Second-line chemotherapy with gemcitabine and oxaliplatin in combination with loco-regional hyperthermia (EHY-2000) in patients with refractory metastatic pancreatic cancer – preliminary results of a prospective trial

There is no standard treatment for second-line in patients with metastatic pancreatic cancer. The treatment with local hyperthermia (41–42°C) in order to enhance the activity gemcitabine-oxaliplatin on liver metastasis and primary advanced tumor was added as standard treatment. The primary objective was the response rate while the secondary objective were the safety of chemotherapy associated with hyperthermia and overall survival. There were 26 patients included, diagnosed with metastatic pancreatic cancer with progressive disease after gemcitabine treatment. The patients were enrolled in the period January 2005 – May 2011. The patients received gemcitabine 1000 mg/msq IV and oxaliplatin 100 mg/msq IV day 1(GEMOX) combined with locoregional hyperthermia days1, 3 and 5 all repeated at 14 days. From 26 patients included, 19 patients had an evaluable response at the treatment. The toxicity of chemotherapy for these patients was related with chemotherapy (neutropeniagrade III – 24%; anemia grade III – 8%, thrombopenia grade III– 6%; neurologic toxicity grade III – 22%. Toxicity related to hyperthermia was:discomfort because of bolus pressure (2%), pain related with position (12%), power related pain (2%). Rate of response was stable disease 53%, partial response 18% and progression disease 29%. Progression-free-survival was 3.9 months. Overall survival was 8.9 months.