Initial systemic chemotherapy ( 6 months ) with a combination regimen is recommended for most patients ( for some patients radiation therapy may be offered up front ) with Eastern Cooperative Oncology Group performance status 0 or 1 and a favorable comorbidity profile .
There is no clear evidence to support one regimen over another .
PURPOSE To provide evidence -based recommendations to oncologists and others for treatment of patients with locally advanced , unresectable pancreatic cancer .
Randomized phase III multi-institutional study of TNFerade biologic with fluorouracil and radiotherapy for locally advanced pancreatic cancer: final results.
PURPOSE TNFerade biologic is a novel means of delivering tumor necrosis factor alpha to tumor cells by gene transfer . We herein report final results of the largest r and omized phase III trial performed to date among patients with locally advanced pancreatic cancer ( LAPC ) and the first to test gene transfer against this malignancy . PATIENTS AND METHODS In all , 304 patients were r and omly assigned 2:1 to st and ard of care plus TNFerade ( SOC + TNFerade ) versus st and ard of care alone ( SOC ) . SOC consisted of 50.4 Gy in 28 fractions with concurrent fluorouracil ( 200 mg/m(2 ) per day continuous infusion ) . TNFerade was injected intratumorally before the first fraction of radiotherapy each week at a dose of 4 × 10(11 ) particle units by using either a percutaneous transabdominal or an endoscopic ultrasound approach . Four weeks after chemoradiotherapy , patients began gemcitabine ( 1,000 mg/m(2 ) intravenously ) with or without erlotinib ( 100 to 150 mg per day orally ) until progression or toxicity . RESULTS The analysis included 187 patients r and omly assigned to  SOC + TNFerade  and  90 to SOC  by using a modified intention-to-treat approach . Median follow-up was 9.1 months ( range , 0.1 to 50.5 months ) . Median survival was 10.0 months for patients in both the SOC + TNFerade and SOC arms ( hazard ratio [ HR ] , 0.90 ; 95 % CI , 0.66 to 1.22 ; P = .26 ) . Median progression-free survival ( PFS ) was 6.8 months for SOC + TNFerade versus 7.0 months for SOC ( HR , 0.96 ; 95 % CI , 0.69 to 1.32 ; P = .51 ) . Among patients treated on the SOC + TNFerade arm , multivariate analysis showed that TNFerade injection by an endoscopic ultrasound-guided transgastric/transduodenal approach rather than a percutaneous transabdominal approach was a risk factor for inferior PFS ( HR , 2.08 ; 95 % CI , 1.06 to 4.06 ; P = .032 ) . The patients in the SOC + TNFerade arm experienced more grade 1 to 2 fever and chills than those in the SOC arm ( P < .001 ) but both arms had similar rates of grade 3 to 4 toxicities ( all P > .05 ) . CONCLUSION SOC + TNFerade  is safe but not effective for prolonging survival in patients with LAPC
Initial systemic chemotherapy ( 6 months ) with a combination regimen is recommended for most patients ( for some patients radiation therapy may be offered up front ) with Eastern Cooperative Oncology Group performance status 0 or 1 and a favorable comorbidity profile .
There is no clear evidence to support one regimen over another .
PURPOSE To provide evidence -based recommendations to oncologists and others for treatment of patients with locally advanced , unresectable pancreatic cancer .