BOA discussion Chan SL on 11 July 09.ppt

ESPAC-03 (v2) A multicentre, international, open label, randomised controlled phase III trial of adjuvant 5-fluorouracil/folinic acid (5-FU/FA) versus gemcitabine (GEM) in patients with resected pancreatic ductal adenocarcinoma Primary Endpoint: Median overall survival Neuroendocrine tumors Classification Foregut (bronchus, stomach, proximal duodenum and pancreas) Midgut (distal duodenum to mid-transverse colon) Hindgut (descending colon to rectum) Variable clinical course in metastatic disease Indolent vs. Aggressive Extent of metastasis Age Octreotide LAR 30mg Significantly Increases Time to Tumor Progression (TTP) * So the UK-ABC-02 trial a randomiized phase III trial comparing gemcitabine/cisplatin versus gemcitabine alone in advanced biliary tract cancer. * This is the study schema: control arm receiving gemcitabine 1000mg/m2 D1, 8 and 15 every 4 weeks while the experiemental arm receiving gemictabine + cisplatin 25mg/m2 D1, 8 every 3 weeks for 8 cycles till PD. * So this are the main results, in summary, there is overall survival benefits in patients receiving gemcitabine/cisplatin with Hazard ratio 0.7 and p value of 0.002. * So the PROMID study is looking at the comparison of octreotide LAR with placebo in midgut tumors * This is the study design, the accrued no. is 90 and randomizing into 1 to 1 ratio into 2 arms namely octreotide LAR vs. placebo and the endpoint is TTP. * First, let us look at the adjuvant therapy in pancreatic cancer. At the present moment, surgical resection is still the only treatment that can offer cure to patients with Ca pancreas. However, only a small proportion of patients get cure as evidenced by around 5 yr survival rate as low as 10%. As most of you and investigators might be aware, adjuvant therapy is important to potentially improve the outcome of such a deadly disease. Despite the fact that there were many controversies on the modality of adjuvant treatment in resected CA pancreas, from the literatures,