Gallbladder and Biliary Tract Malignancies – Experience of a Center

Introduction: Gallbladder and biliary tract carcinomas (GBC) represent a rare group of tumors with a poor prognosis and devastating impact on patients. Complete surgical resection remains the mainstay of treatment. Due to the high incidence of relapse and frequent advanced disease at the diagnosis, other therapies have been explored, including radiotherapy, chemotherapy and chemoradiation. There isn't a standard chemotherapeutic treatment, but gemcitabine-based regimens have shown potential benefit. The aim of our study is to describe the main characteristics and outcomes of the patients with GBC treated with chemotherapy in our hospital.Methods: Retrospective analysis of histologically confirmed gallbladder, cholangiocarcinoma and ampulla of Vater carcinoma cases submitted to chemotherapy between January 2005 and March 2013. Survival analysis was done by Kaplan-Meier method and log-rank test.Results: Of the 63 patients analyzed, the majority were male (63.5%) and the median age at diagnosis was 60 years old [26; 77]. Extra-hepatic cholangiocarcinoma was the most frequent (34.9%), followed by gallbladder carcinoma (25,4%), intra-hepatic cholangiocarcinoma (20.6%) and ampulla of Vater carcinoma (19%). The majority of patients (46%) had locally advanced disease and 34.9% had metastasis at diagnosis, being hepatic metastization the most frequent location (25.4%). Thirty five patients were submitted to surgery and chemotherapy, 18 only did chemotherapy, 8 did surgery followed by chemoradiation and 2 did chemoradiation only. The most frequent toxicity due to chemotherapy was thrombocytopenia (48%). The median follow-up was 10 months, with a clinical benefit and mortality rates of 41.3% and 46%, respectively. There was a loss of follow-up of 28.6% and the 5 year overall-survival was 31% (median: 31 months; IC 95%, 20.74-41.26). Adjuvant chemotherapy was given to 31 patients (gemcitabine: 29; gemcitabine + cisplatin: 2), with a recurrence rate of 58.1%, a 1 year recurrence-free survival of 57.5% (median: 18 months; IC 95%, 6.96-20.04) and 5 year overall-survival of 46.1%. In the palliative setting, 32 patients received chemotherapy (gemcitabine: 18; gemcitabine + cisplatin: 13; capecitabine: 1), with a 6 months progression-free survival of 58.7% (median: 8 months; IC 95%, 6.93-9.07) and a 1 year overall-survival of 63.3% (median: 18 months; IC 95%, 15.25-20.75). There was no statistically significant advantage of gemcitabine-platinum combination compared to gemcitabine alone regarding progression-free survival (p = 0.57, p < 0.05) and overall-survival (p = 0.52, p < 0.05).Conclusion: In general, our survival results are similar with those reported in the actual literature. With respect to gemcitabine-platinum combination and survival, our results were different from the current data. The retrospective nature of the analysis, which included a small number of patients, with no differentiation between bile ducts and gallbladder cancer are a possible explanation for this result. There is a lack of prospective data in this subject and future randomized trials should help to clarify the role of complementary therapy in these types of tumors. Introduction: Gallbladder and biliary tract carcinomas (GBC) represent a rare group of tumors with a poor prognosis and devastating impact on patients. Complete surgical resection remains the mainstay of treatment. Due to the high incidence of relapse and frequent advanced disease at the diagnosis, other therapies have been explored, including radiotherapy, chemotherapy and chemoradiation. There isn't a standard chemotherapeutic treatment, but gemcitabine-based regimens have shown potential benefit. The aim of our study is to describe the main characteristics and outcomes of the patients with GBC treated with chemotherapy in our hospital. Methods: Retrospective analysis of histologically confirmed gallbladder, cholangiocarcinoma and ampulla of Vater carcinoma cases submitted to chemotherapy between January 2005 and March 2013. Survival analysis was done by Kaplan-Meier method and log-rank test. Results: Of the 63 patients analyzed, the majority were male (63.5%) and the median age at diagnosis was 60 years old [26; 77]. Extra-hepatic cholangiocarcinoma was the most frequent (34.9%), followed by gallbladder carcinoma (25,4%), intra-hepatic cholangiocarcinoma (20.6%) and ampulla of Vater carcinoma (19%). The majority of patients (46%) had locally advanced disease and 34.9% had metastasis at diagnosis, being hepatic metastization the most frequent location (25.4%). Thirty five patients were submitted to surgery and chemotherapy, 18 only did chemotherapy, 8 did surgery followed by chemoradiation and 2 did chemoradiation only. The most frequent toxicity due to chemotherapy was thrombocytopenia (48%). The median follow-up was 10 months, with a clinical benefit and mortality rates of 41.3% and 46%, respectively. There was a loss of follow-up of 28.6% and the 5 year overall-survival was 31% (median: 31 months; IC 95%, 20.74-41.26). Adjuvant chemotherapy was given to 31 patients (gemcitabine: 29; gemcitabine + cisplatin: 2), with a recurrence rate of 58.1%, a 1 year recurrence-free survival of 57.5% (median: 18 months; IC 95%, 6.96-20.04) and 5 year overall-survival of 46.1%. In the palliative setting, 32 patients received chemotherapy (gemcitabine: 18; gemcitabine + cisplatin: 13; capecitabine: 1), with a 6 months progression-free survival of 58.7% (median: 8 months; IC 95%, 6.93-9.07) and a 1 year overall-survival of 63.3% (median: 18 months; IC 95%, 15.25-20.75). There was no statistically significant advantage of gemcitabine-platinum combination compared to gemcitabine alone regarding progression-free survival (p = 0.57, p < 0.05) and overall-survival (p = 0.52, p < 0.05). Conclusion: In general, our survival results are similar with those reported in the actual literature. With respect to gemcitabine-platinum combination and survival, our results were different from the current data. The retrospective nature of the analysis, which included a small number of patients, with no differentiation between bile ducts and gallbladder cancer are a possible explanation for this result. There is a lack of prospective data in this subject and future randomized trials should help to clarify the role of complementary therapy in these types of tumors.