Abstract

379 Background: Gemcitabine/platinum (Gem-P) is currently the standard of care for patients with advanced biliary tract cancers based on the ABC02 study. Pts usually present in locally advanced (LA) stage in India and as surgery remains the only curative option- neoadjuvant (NA) strategy needs to be explored. Methods: This is retrospective analysis of the prospectively maintained database of 38 patients with LA GB cancer treated at TMC between Feb 2009 to May 2013. Aim of the study was to assess resectability rate in patients with LA GB cancer (defined as GB mass invading liver > 2cm without porta hepatis / vascular invasion, GB mass adherent to duodenum and hepatic flexure, coeliac/gastrohepatic adenopathy/portocaval and peripancreatic nodes). Pts received cisplatin 25 mg/m2 and gemcitabine 1000 mg/m2 on D1 and D8 of 21d cycle, for gem-oxaliplatin, pts received gemcitabine 1000mg/m2 D1 and oxaliplatin 100mg/m2 D2 every 14 days. Response was assessed after 3-4 cycles. Results: Of the 38 pts (median age 54 y,30-71; 11M, 29F, median CA19.9 19 (<2-74605), 33patients were treated with Gem-P (25 oxaliplatin, 8 cisplatin; 1cetuximab-Gem-P) based therapy and 5 pts received chemoradiotherapy (CTRT) with wkly gemcitabine 300mg/m2. Site of disease was liver in 22 pts, nodal in 12, adjacent organ in 9 & other in 3 pts. Median number of chemotherapy cycles given were 4 (1-12). Response rate to NA therapy was 5 (13%) complete response (CR), 17(45%) partial response (PR), 9 stable disease (SD), 5 (13%) progressive disease and not assessed in 2 patients (1 pt died post CTRT and 1 was inoperable at surgery). Overall clinical benefit rate (CR+PR+SD) was 82%. Of the 24 pts who underwent surgery, 21 (87%) had curative resection and 3 were inoperable. Of 9 pts with SD, 6 received 2nd –line NA therapy as they were not downstaged enough to undergo surgery– 4 CTRT, 1 gemcitabine-cape, 1 cape-Ox. Perioperative morbidity (biliary leak) was higher post CTRT. Overall, 7 pts have relapsed. Conclusions: This is the first report of the use of neoadjuvant chemotherapy in patients with LA GB cancer. We conclude that preoperative chemotherapy is feasible with acceptable toxicity and perioperative morbidity.

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