Abstract

Background: Gallbladder cancer (GBC) is a major cause of cancer mortality in parts of the world where it is common including India. Gemcitabine with cisplatin is currently the standard of care for pateints with advanced biliary tract cancers. The aim of the study is to Determine The Clinical Characteristics, Treatment And Outcome of Patients With Locally Advanced Or Metastatic Gall Bladder Cancer.
Materials and Methods: This is a prospective study of metastatic and unresectable gall bladder carcinoma patients presented in Sri Aurobindo Institute of Medical Sciences from Feb 15 to Dec16.Total 30 patients were evaluated with initial clinical characteristic like jaundice, leukemoid reaction, hepaticencephalopathy, Metastatic sites, Ascites, Tumor Markers. Chemotherapy, Gemcitabine 1000mg/m2 D1 and D8 combined with Oxaliplatin 100mg/m2 D1 Every 21 days were given. Interim Response was assessed after 3-4 cycles and after completion of treatment .Patients progressing on initial chemotherapy were offered 2nd line chemotherapy or best supportive care according to performance status.
Results: Median age was 60 years. There were 17(57%) women and 13(43%) men diagnosed with advanced GBC. Out of 30 patients 7(23%) had encephalopathy and 23(76%) had ascites. The median CA19.9 was 23 U/mL, median CEA 3.01 ng/mL, median billirubin 11.72 mg/dl, median leucocyte count 14700, median AFP 2.1ng/ml .Site of metastases was nodal in 17(56%), Liver (10(33.3), peritoneal in 3(10%) and bilateral ovarian in 1(3.3%) patient. Extrabdominal 1(3.3%). Total 30 patients received Gemcitabine with oxaliplatin chemotherapy. The median number of cycles administered was 4 (Range 1-6). 30 Patients were evaluated for response ,out of which 1 (3.3% ) had CR, 9(30%) had PR, 2(6.6%) had SD, and 18 (60%) had progressive disease as their best response with first line chemotherapy. The grade 3 & 4 toxicities reported on treatment included, thrombocytopenia in 4 (13%) patients, neutropenia in 2 (6%),Liver Toxicity occurred in 3 (10%) patients, platinum induced peripheral neuropathy interfering with daily activities was documented in 3 (10%) and diarrhea requiring hospital treatment occurred in 4 (13 %).
Conclusion: This is the prospective study to show tolerance and efficacy of Gem-Ox in patients with advanced GB cancer. The clinical benefit rate is low at 40 % suggesting that the biology of advanced GB cancers patients is likely to be aggressive and needs to be studied in large prospectively designed studies with newer chemotherapy or targeted therapies.