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 .
Phase II trial of cetuximab, gemcitabine, and oxaliplatin followed by chemoradiation with cetuximab for locally advanced (T4) pancreatic adenocarcinoma: correlation of Smad4(Dpc4) immunostaining with pattern of disease progression.
PURPOSE This phase II trial was design ed to assess the efficacy and safety of cetuximab , gemcitabine , and oxaliplatin followed by cetuximab , capecitabine , and radiation therapy in locally advanced pancreatic cancer ( LAPC ) . PATIENTS AND METHODS Treatment-naive eligible patients ( n = 69 ) received intravenous gemcitabine ( 1,000 mg/m(2 ) ) and oxaliplatin ( 100 mg/m(2 ) ) every 2 weeks for four doses , followed by radiation ( 50.4 Gy to the gross tumor only ) with concurrent capecitabine ( 825 mg/m(2 ) twice daily on radiation treatment days ) . Cetuximab ( 500 mg/m(2 ) ) was started on day 1 of chemotherapy and was continued every 2 weeks during chemotherapy and chemoradiotherapy . Diagnostic cytology specimens were immunostained for Smad4(Dpc4 ) expression . RESULTS Median overall survival time was 19.2 months ( 95 % CI , 14.2 to 24.2 months ) , and 1-year , 2-year , and 4-year actuarial overall survival rates were 66.0 % , 25.02 % , and 11.3 % , respectively . Acneiform rash correlated with improved survival ( P = .001 ) , but initial CA19 - 9 , borderline resectable initial stage , and surgical resection ( n = 7 ) did not . The 1-year and 2-year radiographic local progression rates were 22.8 % and 61.0 % , respectively . The worst acute toxic effects were GI toxicity ( 32 % and 10 % for grade s 2 and 3 , respectively ) ; fatigue ( 26 % and 6 % for grade s 2 and 3 , respectively ) ; sensory neuropathy ( 9 % and 1 % for grade s 2 and 3 , respectively ) ; and acneiform rash ( 54 % and 3 % for grade s 2 and 3 , respectively ) . Smad4(Dpc4 ) expression correlated with a local rather than a distant dominant pattern of disease progression ( P = .016 ) . CONCLUSION This regimen appears effective and has acceptable toxicity . The primary end point ( 1-year overall survival rate > 45 % ) was met , with encouraging survival duration . Smad4(Dpc4 ) immunostaining correlated with the pattern of disease progression . Prospect i ve validation of Smad4(Dpc4 ) expression in cytology specimens as a predictive biomarker is warranted and may lead to personalized treatment strategies for patients with localized pancreatic cancer
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 .