P-155 - Prognostic model in locally advanced and metastatic gall bladder cancer

Abstract

Introduction: Gallbladder cancer (GBC) is a major cause of cancer mortality in parts of the world where it is common including India. GBC is commonly diagnosed in advanced stages. There are no prognostic models to predict outcome in patients with advanced localized and metastatic disease. We present a pilot study to develop a prognostic model in advanced stage disease to predict outcome Methods:: This is a prospective study of metastatic and unresectable gall bladder carcinoma patients presented at Sri Aurobindo Institute of Medical Sciences, Indore, India from February 2015 to February 2017. A total of 30 patients were evaluated with initial clinical characteristics and laboratory parameters like hepatic encephalopathy, jaundice, Ca 19-9 levels, ascites and Total Leukocyte count. A prognostic risk scoring system which was formulated based on these parameters is as followsHepatic Encephalopathy – 1 point if there is any clinical evidence of encephalopathySerum Total Bilirubin - 1.5 mg/dl to 5 mg/dl - 0.5 points, > 5 mg/dl – 1 pointCa 19-9 – 1 point is given if the serum level is more than 100 IU/mlAscites – 1 point is given if there is any clinical evidence of ascitesTotal Leukocyte count – 1 point is given if the count is more than 11000/cmm Maximum possible score was 5 points and minimum possible score was 0 points. Based on this scoring system patients were categorized in two groupsLow risk group (LR)– 0 to 3 pointsHigh risk group (HR)– 3.5 and above points Chemotherapy with Gemcitabine 1400mg/m2 D1 and D8, combined with oxaliplatin 130mg/m2; D1 every 21 days was given. Interim Response was assessed after 3-4 cycles and after completion of 6 cycles. Results: 18 patients (60%) were in the low risk group and 12 patients (40%) in high risk group. All the patients received gemcitabine-oxaliplatin chemotherapy. One patient (3.3%) had a complete response, 9 patients (30%) had a partial response; 2 patients (6.6%) had stable disease, and 18 patients (60%) had progressive disease as their best response with first line chemotherapy. The estimated median PFS was 4 months and median OS was 5.5 months for the entire cohort. Separating low risk and high risk groups, PFS was significantly longer in Low risk (6.2 months) than in the high risk (2.1 months) (p <.001); and OS was significantly longer in the low risk (9.1 months) while it was 3.1 months in the high risk (p <.001) Conclusion: This risk scoring system could provide prognostic information at diagnosis in gall bladder cancer and needs to be further validated in a larger study.