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 III trial comparing intensive induction chemoradiotherapy (60 Gy, infusional 5-FU and intermittent cisplatin) followed by maintenance gemcitabine with gemcitabine alone for locally advanced unresectable pancreatic cancer. Definitive results of the 2000-01 FFCD/SFRO study.
BACKGROUND The role of chemoradiation with systemic chemotherapy compared with chemotherapy alone in locally advanced pancreatic cancer ( LAPC ) is uncertain . PATIENTS AND METHODS One hundred and nineteen patients with LAPC , World Health Organization performance status of zero to two were r and omly assigned to either the induction CHRT group ( 60 Gy , 2 Gy/fraction ; concomitant 5-fluorouracil infusion , 300 mg/m(2)/day , days 1 - 5 for 6 weeks ; cisplatin , 20 mg/m(2)/day , days 1 - 5 during weeks 1 and 5 ) or the induction gemcitabine group ( GEM : 1000 mg/m(2 ) weekly for 7 weeks ) . Maintenance gemcitabine ( 1000 mg/m(2 ) weekly , 3/4 weeks ) was given in both arms until disease progression or toxicity . RESULTS Overall survival was shorter in the CHRT than in GEM arm [ median survival 8.6 ( 99 % confidence interval 7.1 - 11.4 ) and 13 months ( 8.7 - 18.1 ) , P = 0.03 ] . One-year survival was , respectively , 32 % and 53 % . These results were confirmed in a per- protocol analysis for patients who received 75 % or more of the planned dose of radiotherapy . More overall grade s 3 - 4 toxic effects were recorded in the CHRT arm , both during induction ( 36 versus 22 % ) and maintenance ( 32 versus 18 % ) . CONCLUSION This intensive induction schedule of CHRT was more toxic and less effective than gemcitabine alone
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 .