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Fabio Bagante, Eliza W. Beal, Katiuscha Merath, Griffin Olsen, Ozgür Akgül, Jay Idrees, Qinyu Chen, Mary Dillhoff, Jordan Cloyd, Carl Schmidt, Timothy M. Pawlik*
Surgery, The Ohio State Wexner Medical Center, Columbus, OH

Background: Compliance with national guidelines is an important component of evidence-based medicine. The National Comprehensive Cancer Network (NCCN) guidelines recommend chemotherapy for patients with inoperable bile duct cancers (BDC), as well as adjuvant chemotherapy following resection of BDC in the setting of nodal metastasis (N1)/positive surgical margins (R1). We sought to define compliance with NCCN BDC chemotherapy guidelines, identify factors associated with compliance, as well as assess the impact of compliance on clinical outcomes.
Methods: A total of 176,536 patients with BDC admitted to a hospital participating in the National Cancer Database between 2004 and 2015 were identified. Overall compliance with the NCCN chemotherapy guidelines was defined and factors associated with compliance were analyzed. Differences in long-term outcomes among patients stratified by compliance with NCCN guidelines were assessed.
Results: Among the 176,536 patients, 131,597 (74.5%) had inoperable BDC (unresectable: n=20,364, 11.5% vs. metastatic: n=111,233, 63.0%). Among the 44,939 (25.5%) who underwent curative-intent resection, 18,582 (41.3%) had N1 disease and 3,926 (9.7%) had R1 disease. Overall, according to the NCCN guidelines, 152,245 (86.2%) patients were eligible for chemotherapy (inoperable BDC: n=131,597, 74.5%; resected N1 and/or R1 disease: n=20,648, 11.7%). Among these 152,245 eligible patients, only 64,615 (42.4%) received chemotherapy (inoperable BDC: n=51,832, 80.1%; resected N1 and/or R1 disease: n=12,832, 19.9%). Factors associated with a lower compliance with NCCN guidelines included patient age (> 65 years: OR 1.02), race (Black: OR 1.14, Hispanic: OR 1.21, Asian: OR 1.24) and insurance status (non-private: OR 1.45)(all p<0.001). A small subset of patients was either recommended chemotherapy but refused (n=9,269, 10.6%) or had medical factors that contraindicated chemotherapy (n=8,275, 9.4%). On multivariable analysis, after adjustment for clinical and tumor-specific factors, compliance with NCCN guidelines was associated with a survival benefit among inoperable (HR 0.72) and resected (HR 0.79) patients (both p<0.001). Specifically, non-compliance versus compliance with NCCN guidelines was associated with a shorter median survival among both inoperable (4 months vs. 10 months) and resected (35 months vs. 46 months) patients (both p<0.001).
Conclusion: Less than one-half of patients with BDC received systemic chemotherapy in compliance with NCCN guidelines. While a subset of patients had contraindications or refused chemotherapy, other factors such as insurance status and race were associated with guideline compliance. Compliance with chemotherapy guidelines may impact long-term outcomes, especially in light of the new BILCAP trial data.

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