A retrospective analysis of clinical characteristics, treatment and outcome of patients with locally advanced or metastatic gall bladder cancer treated at Tata Memorial Centre, Mumbai from January 2012 to Oct 2013.

Gallbladder cancer (GBC) is a growing healthproblem in various parts of northern India. When diagnosed more than70- 90%gallbladder cancers are advanced and are beyond surgical resection, which isthe only curative option presently. With median survival of less than one year,GBC is one of most aggressive cancers. Currently Gemcitabine combined withplatinum is considered as the first line therapy in unresectable and metastaticgallbladder cancer based on recent reports of survival benefit.  Chemotherapy trials in the past have combineddifferent biliary tract cancers including cholangiocarcinomas, hence studiesdealing only with GBC are very few. We have the unique experience of treatingpatients with advanced GBC with standardized gemcitabine-platinum basedregimen. This retrospective review will focus on looking at response rates andsurvival within this group of patients over a time period of Jan 2012 to Oct2013. 

Primary Objective

-To study the clinical characteristics of patients with advanced gallbladder carcinoma

-To determine the response rate with Gemcitabine-Platinum chemotherapy,toxicity, Progression free survival and overall survival of patients with advanced gallbladder carcinoma

Secondary Objective

-Prognostic factors related to outcome of patient if any

Study methodology:

All previously untreated patientswith advanced gallbladder carcinoma, if suitable are treated with Gemcitabine-Platinum(cisplatin or oxaliplatin) combination.The subjects included in the study willbe analyzed with respect to their demographic parameters, presenting clinicalfeatures, baseline haematological, biochemical,radiological and pathological features,treatment toxicity and outcomes.

Case records and prospectively entered data of allpatients from Jan. 2012 to Oct 2013  whohave received treatment including palliative chemotherapy in accordance withthe inclusion and exclusion criteria would be screened for clinicalcharacteristics, sex, ECOG PS, Pathology (adenocarcinoma versus others), extentof disease involvement, the outcome of interest (Overall survival[OS],Progression free survival[PFS], Response rate[RR] and toxicity). OS wouldbe defined from the date of diagnosis till date of death due to any cause. Allpatients who were considered for chemotherapy and given the option ofchemotherapy would be included in the analysis. For overall survival KaplanMeier estimator curves would be generated. Clinical factors and laboratoryfactors individual would be tested with log-rank test. Those factors whichprognosticated for OS would be then tested in a Cox proportional Hazard methodfor multivariate analysis. For response rates Fischers exact t test or Chisquare or Mann Whitney would be used as appropriate. Those factors which show asignificant association would be then tested with logistic regression analysis.Interaction test would be used to identify which factors predict response tochemotherapy.