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Advanced biliary tract cancer: clinical outcomes with ABC-02 regimen and analysis of prognostic factors in a tertiary care center in the United States

  
@article{JGO10559,
	author = {Rishi Agarwal and Arun Sendilnathan and Nabeela Iffat Siddiqi and Shuchi Gulati and Abhimanyu Ghose and Changchun Xie and Olugbenga Olanrele Olowokure},
	title = {Advanced biliary tract cancer: clinical outcomes with ABC-02 regimen and analysis of prognostic factors in a tertiary care center in the United States},
	journal = {Journal of Gastrointestinal Oncology},
	volume = {7},
	number = {6},
	year = {2016},
	keywords = {},
	abstract = {Background: Gemcitabine plus cisplatin (GC) is currently the standard regimen for advanced biliary tract cancers (BTC) based on the outcomes in ABC-02 trial. Multiple factors can affect outcomes in these patients. This retrospective review evaluates the University of Cincinnati experience with GC in advanced intrahepatic (IHC)/extrahepatic cholangiocarcinoma (EHC) and gall bladder carcinoma (GBC). 
Methods: In this study approved by University of Cincinnati IRB, retrospective analysis of advanced BTC patients seen between 01/2008 and 01/2015 was done. Kaplan Meyer method was used to calculate progression free survival (PFS), and overall survival (OS). Cox model was used to test the association between baseline variables and OS/PFS, adjusting for gender and age at diagnosis. Patients were identified using ICD code for BT tumors, 26 patients met inclusion criteria: histologically proven advanced BTC that received GC as their initial chemotherapy. GC was given as per ABC-02 protocol with appropriate modifications until disease progression or unacceptable toxicities. 
Results: Median age at diagnosis was 62 years (range, 31–81 years). Eighteen (69%) were IHC, 5 EHC, 3 GBC, 61% male, 73% whites. Performance status (PS): 0–1: 69%, PS 2: 31%. Baseline CA19-9 data was available for 21 patients, (range 1 to 69,543), and abnormal CA19-9 was seen in 14 patients (54%). PFS was 4.5 months (95% CI: 3.1–8.9 months) and OS was 10.5 months (95 % CI: 7.9–18.8 months). OS at 6 and 12 months was 69% (18/26) and 42% (11/26). Thirty-eight percent (10/26) received 2nd line chemotherapy, of these 9/10 received 5FU based chemotherapy. Eleven percent (3/26) received 3rd line chemotherapy. Increase in baseline carcinoembryonic antigen (CEA), alanine aminotransferase, alkaline phosphatase (ALP) and total bilirubin was associated with increased risk of death while increase in baseline CEA and ALP was associated with increased risk of progression (P valve 3, and stage IVb), the median survival was 2.9 months (95% CI: 2.6–9.3 months), which was significantly worse compared to rest of the population [median 18 months (95% CI: 5.4–19.5 months), P3, and stage IVb) did poorly and may need careful selection prior to initiating chemotherapy.},
	issn = {2219-679X},	url = {https://jgo.amegroups.org/article/view/10559}
}