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Treatment Patterns and Survival in Locally Advanced or Metastatic Biliary Tract Cancer Using SEER Medicare Data

Open AccessPublished:January 20, 2023DOI:https://doi.org/10.1016/j.gastha.2023.01.009
Treatment Patterns and Survival in Locally Advanced or Metastatic Biliary Tract Cancer Using SEER Medicare Data
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      Background & Aims

      Biliary tract cancer (BTC) is a rare, lethal, heterogeneous group of cancers often diagnosed at an advanced stage. While gemcitabine plus cisplatin is the standard of care (SoC) for first-line treatment of locally advanced or metastatic BTC, no globally accepted SoC currently exists for second-line treatment of BTC following chemotherapy. However, the treatment landscape is evolving with approvals for therapies targeting actionable mutations. This study aimed to characterize treatment patterns and survival in patients with locally advanced or metastatic BTC.

      Methods

      Patients with advanced or metastatic BTC in the Surveillance, Epidemiology, and End Results Medicare database between 2010 and 2015 (N=2,063) were included; patients with non-primary BTC were excluded. Patient and clinical characteristics, line and type of therapy, and overall survival (OS) of patients were analyzed.

      Results

      Only 45.5% (n=938) of patients initiated systemic therapy within 90 days of diagnosis. The most common event following diagnosis was initiation of first-line therapy, and the most common event following first-line treatment was death. Median survival ranged from 5.0 months for patients receiving second-line fluoropyrimidine , to 9.7 months for patients receiving second-line gemcitabine. Duration of therapy ranged from 0.7 months for patients receiving second-line fluoropyrimidine, to 3.7 months for patients receiving first-line gemcitabine plus cisplatin therapy.

      Conclusions

      OS from diagnosis was poor and influenced by age, sex, stage, mobility limitations, comorbidity burden, poverty, and previous cancer. Treatment patterns varied for patients who progressed following first-line therapy, as there was no consensus second-line treatment for locally advanced or metastatic BTC without clinically targetable mutations.

      Keywords

      Abbreviations:

      BTC (biliary tract cancer), FDA (US Food and Drug Administration), FOLFOX (leucovorin, fluorouracil, and oxaliplatin), ORR (objective response rate), NCI (National Cancer Institute), SEER (Survival, Epidemiology, and End Results Program)

      Article info

      Publication history

      Accepted: January 12, 2023
      Received in revised form: January 4, 2023
      Received: July 19, 2022

      Publication stage

      In Press Accepted Manuscript

      Footnotes

      Funding: This manuscript was funded by Merck (CrossRef Funder ID: 10.13039/100009945) and was previously part of an alliance between Merck and GlaxoSmithKline.

      Conflicts of Interest: These authors disclose the following: M. Danese reports research funding from Amgen; Merck; Seattle Genetics; and Bristol Myers Squibb. F. Audhuy reports employment at EMD Serono Research & Development Institute, Inc., Billerica, MA, USA, an affiliate of Merck KGaA. J. Duryea reports research funding from Amgen; Merck; Seattle Genetics; and Bristol Myers Squibb. S. Bobiak reports employment at EMD Serono Research & Development Institute, Inc., Billerica, MA, USA, an affiliate of Merck KGaA, and stock/ownership interest at Bristol Myers Squibb. The remaining authors disclose no conflicts.

      Writing assistance: Medical writing support was provided by Spencer Hughes, PhD, of ClinicalThinking, which was funded by Merck (CrossRef Funder ID: 10.13039/100009945), and was previously part of an alliance between Merck and GlaxoSmithKline, in accordance with Good Publication Practice (GPP3) guidelines (http://www.ismpp.org/gpp3).

      Author contributions: M.D.- conceptualization: supporting, data curation: lead, analysis: lead, writing - original draft: lead, writing - reviewing and editing: lead. K.M. - conceptualization: equal, data curation: supporting, formal analysis: equal, methodology: supporting, investigation: supporting, writing - original draft: supporting, writing - reviewing and editing: equal. R.A-W.- conceptualization: equal, data curation: supporting, formal analysis: equal, methodology: equal, investigation: supporting, writing - original draft: equal, writing - reviewing and editing: equal. J.D. - conceptualization: supporting, data curation: supporting, writing - original draft: supporting, writing - reviewing and editing: supporting. S.B.- conceptualization: lead, methodology: supporting, writing - original draft: supporting, writing - reviewing and editing: supporting

      Data Transparency Statement: Any requests for data by qualified scientific and medical researchers for legitimate research purposes will be subject to Merck’s Data Sharing Policy. All requests should be submitted in writing to Merck’s data sharing portal (https://www.merckgroup.com/en/research/our-approach-to-research-and-development/healthcare/clinical-trials/commitment-responsible-data-sharing.html). When Merck has a co-research, co-development, or co-marketing or co-promotion agreement, or when the product has been out-licensed, the responsibility for disclosure might be dependent on the agreement between parties. Under these circumstances, Merck will endeavor to gain agreement to share data in response to requests.

      Ethical Statement: The corresponding author, on behalf of all authors, jointly and severally, certifies that their institution has approved the protocol for any investigation involving humans or animals and that all experimentation was conducted in conformity with ethical and humane principles of research.

      Reporting Guidelines: STROBE

      Identification

      DOI: https://doi.org/10.1016/j.gastha.2023.01.009

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      © 2023 Published by Elsevier, Inc on behalf of the AGA Institute

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