e16605 Background: Treatment of pancreatobiliary cancer patients with severe liver dysfunction including hyperbilirubinemia secondary to liver metastasis or biliary obstruction is challenging. A significant number of patients at presentation are in advanced/ locally advanced stage thus severely limiting chemotherapy options. FOLFOX (5 FU, Leucovorin, Oxaliplatin) represents a feasible option considering the pharmacokinetics. Clinical data on the dosage and tolerability of chemotherapy is limited and no recommendations are available to treat such patients in upfront setting with persistent hyperbilirubinemia. This observational study was done to find out safety and efficacy of FOLFOX based chemotherapy in these patients. Methods: Patients with advanced pancreatobiliary cancers with hyperbilirubinemia were treated with mFOLFOX6 based chemotherapy. Patients were treated till progression or 6 months or death (whichever occurred ealy) and assessed for toxicity and survival. Results: Only 13 out of 40 patients were able to complete all 12 cycle of chemotherapy. 12 patients were able to receive 2nd line chemotherapy of physician choice and 2 patients were able to received 3rd line chemotherapy. Total bilirubin of patients at start of chemotherapy ranged from 3 to 39.4 mg/dl with a mean value of 9.17±6.67 mg/dl and a median value of 7.5 mg/dl. Median progression free survival (PFS) of mFOLFOX6 was 5.97 months whereas median overall survival (OS) was 8.2 months. 6 patients were able to receive only one cycle of chemotherapy. 2 patients were able to receive only 2 cycles of chemotherapy. 26 patients completed 6 cycles of chemotherapy. Objective response rate was 45% after 6 cycles of chemotherapy. Of these 26 patients response assessment revealed progressive disease in 7 patients. 2 patient had complete metabolic response of which one of them had locally advanced disease. On laparotomy of this patient there were an extensive peritoneal disease curative surgery was not feasible. One patient successfully underwent Whipple’s procedure after 6 cycles of chemotherapy followed by adjuvant radiotherapy. Conclusions: FOLFOX based chemotherapy is a feasible option and a hope for patients of advanced pancreatobiliary cancers presenting with hyperbilirubinemia with a tolerable toxicity profile and providing comparable PFS and OS to other chemotherapy drugs/ regimens used in non hyperbilirubinemic patients.
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