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 .
Erlotinib 150 mg daily plus chemotherapy in advanced pancreatic cancer: an interim safety analysis of a multicenter, randomized, cross-over phase III trial of the ‘Arbeitsgemeinschaft Internistische Onkologie’
To date , only limited toxicity data are available for the combination of erlotinib with either capecitabine or gemcitabine as front-line therapy for advanced pancreatic cancer . Within a r and omized phase III trial , 281 treatment-naive patients were r and omly assigned between capecitabine ( 2000 mg/m2/day , for 14 days , once every 3 weeks ) plus erlotinib ( 150 mg/day , arm A ) and gemcitabine ( 1000 mg/m2 as a 30-min infusion ) plus erlotinib ( 150 mg/day , arm B ) . In case of treatment failure , patients were crossed over to a second-line treatment with the comparator cytostatic drug without erlotinib . The primary study endpoint was the time to treatment failure of second-line therapy ( TTF2 ) . This interim analysis of toxicity contains safety data from the first 127 r and omized patients . During first-line therapy , patients received a median number of three treatment cycles ( range 0–13 ) in both the arms . Regarding chemotherapy , a treatment delay was observed in 12 % of the cycles in arm A and in 22 % of the cycles in arm B. Dose reductions of the cytostatic drug were performed in 18 and 27 % of treatment cycles , respectively . Erlotinib dose reductions were performed in 6 and 11 % of all cycles . Grade 3/4 hematological toxicity was < 10 % in both the arms ; major grade 3/4 toxicities in arms A and B were diarrhea ( 9 vs. 7 % ) , skin rash ( 4 vs. 12 % ) , and h and –foot syndrome ( 7 vs. 0 % ) . No treatment-related death was observed . In conclusion , this interim safety analysis suggests that treatment with erlotinib 150 mg/day is feasible in combination with capecitabine or gemcitabine
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 .