Biweekly cisplatin (C) and gemcitabine (G) in patients (pts) with advanced biliary tract cancer (ABTC): A retrospective analysis.

Authors

null

Daniel H. Ahn

The Ohio State University Comprehensive Cancer Center, Arthur G. James Cancer Hospital, Richard J. Solove Research Institute, Columbus, OH

Daniel H. Ahn , Josh Reardon , Chul Ahn , Manojkumar Bupathi , Kristen Keon Ciombor , Christina Sing-Ying Wu , Tanios S. Bekaii-Saab

Organizations

The Ohio State University Comprehensive Cancer Center, Arthur G. James Cancer Hospital, Richard J. Solove Research Institute, Columbus, OH, The University of Texas Southwestern Medical Center, Dallas, TX, The Ohio State University, James Cancer Center, Columubs, OH, The Ohio State University Comprehensive Cancer Center, Arthur G. James Cancer Hospital, Columbus, OH, Mayo Clinic Cancer Center, Phoenix, AZ

Research Funding

Other

Background: Based on the ABC 02 trial, standard therapy for ABTC is CG for up to 8 cycles. However, a recent abstract (Doherty et al, ASCO 2016) confirmed that a cohort of pts does benefit from continued therapy. The weekly administration of G and C can add significant toxicities that may prohibit prolonged treatment (trmt). Previous studies have shown that a biweekly schedule (Ko AH et al JCO 2012) of fixed dose rate (FDR) G helps optimize the prescribed regimen with an improved toxicity profile and added convenience to pts while maintaining efficacy. Methods: Pts with ABTC treated with FDR G (1000mg/m2 at 10mg/m2/min) with C 20mg/m2(GC) on days 1 and 15 of every 28-day cycle were included for analysis. Pts received trmt until time of progression. Data was collected including demographics, clinico-pathologic features, toxicities and survival. Kaplan-Meier curves were used to calculate the median overall survival (OS) and progression free survival (PFS). Results: The study included 109 evaluable pts with ABTC who received CG. Pts had disease that was locally advanced (16.5%) or metastatic (83.5%). Median age was 60 years (28-86). Sites of tumor included gallbladder (21.1%), ampullary (3.6%) and bile duct (75.2%). Median number of cycles was 6 (1-27). Median PFS was 8.34 (6.74, 9.23) months and median OS was 10.32 (9.10, 11.43) months. Most common grade 3 or 4 adverse events included neutropenia (11%), fatigue (10%), thrombocytopenia (TCP) (6.4%), anemia (2.8%), and abnormal liver function tests (2.8%). Fifty-two percent of pts received second line therapy. Conclusions: Biweekly CG in ABTC is associated with a more favorable toxicity profile while maintaining efficacy similar to that observed in prior clinical trials. Minimal toxicities were observed despite a prolonged course for many. Further prospective exploration should consider evaluating the role of biweekly gemcitabine and cisplatin regimen in ABTC especially as a potentially more favorable platform to combine with novel agents.

Grade 3/4 toxicities* (%)

Biweekly GC (n = 109)ABC 02 (n = 198)
Neutropenia1125.3
TCP6.48.6
Anemia2.87.6
Abnormal liver function2.816.7
Fatigue1018.7

*Acknowledging limitations of cross-study comparison.

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Abstract Details

Meeting

2017 Gastrointestinal Cancers Symposium

Session Type

Poster Session

Session Title

Poster Session B: Cancers of the Pancreas, Small Bowel and Hepatobiliary Tract

Track

Cancers of the Pancreas, Small Bowel, and Hepatobiliary Tract

Sub Track

Multidisciplinary Treatment

Citation

J Clin Oncol 35, 2017 (suppl 4S; abstract 434)

DOI

10.1200/JCO.2017.35.4_suppl.434

Abstract #

434

Poster Bd #

K18

Abstract Disclosures