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. 2023 Feb;12(4):4195-4205.
doi: 10.1002/cam4.5282. Epub 2022 Oct 20.

Real-world outcomes among patients with advanced or metastatic biliary tract cancers initiating second-line treatment

David P Cosgrove  1 , Emily S Reese  2 , Nicole M Fulcher  3 , Sarah S Bobiak  2 , Francois-Xavier Lamy  4 , Arthur Allignol  4 , Marley Boyd  3 , Seyed H Mahmoudpour  4
Affiliations

Real-world outcomes among patients with advanced or metastatic biliary tract cancers initiating second-line treatment

David P Cosgrove et al. Cancer Med. 2023 Feb.

Abstract

Background: Limited data are available regarding second-line (2 L) treatment for advanced or metastatic biliary tract cancers (BTC) in the US real-world setting. This study explores the rapidly evolving and growing treatment landscape in the 2 L setting for advanced or metastatic BTC with a large cohort of patients treated in a community oncology setting.

Methods: Adult patients with BTC initiating 2 L treatment after a platinum-containing first-line between 1/1/10- and 6/30/19 were identified from the US Oncology Network electronic healthcare record database and followed through 12/31/19. Baseline patient and treatment characteristics were analyzed descriptively, including overall response rate (ORR) in the real-world clinical setting. Kaplan-Meier methods were used to measure duration of response, progression-free survival (PFS), and overall survival (OS).

Results: The overall population (N = 160) included 74 patients (46.3%) with intrahepatic cholangiocarcinoma, 41 (25.6%) with extrahepatic cholangiocarcinoma, and 45 (28.1%) with gallbladder cancer. Thirty unique 2 L regimens were recorded for the study population, with folinic acid, fluorouracil and oxaliplatin (FOLFOX, 34.4%) and capecitabine monotherapy (20.0%) being the most common. ORR was 7.5% (95% CI, 3.9%-12.7%). From 2 L initiation, median PFS was 2.8 months (95% CI, 2.4-3.3 months), and median OS was 5.2 months (95% CI, 4.2-6.7 months).

Conclusion: Results from this study provide real-world evidence that although patients treated in the community oncology setting receive a wide variety of 2 L treatments, the regimens are consistent with those recommended by guidelines. Although responses are observed with 2 L treatment, duration is brief and associated with poor OS in patients with advanced or metastatic disease.

Keywords: bile duct cancer; biliary cancer; chemotherapy; cholangiocarcinoma; gallbladder cancer; second line.

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Conflict of interest statement

David P. Cosgrove reports employment at Compass Oncology, consulting fees from Daiichi Sankyo/Lilly and Merck KGaA, honoraria from Pfizer, and travel meeting support from US Oncology. Emily S. Reese reports employment with EMD Serono. Nicole M. Fulcher reports employment with Ontada. Sarah S. Bobiak reports employment with EMD Serono. Francois‐Xavier Lamy reports employment with Merck KGaA at the time of the study. Arthur Allignol reports employment with Merck KGaA at the time of the study. Marley Boyd reports employment with Ontada at the time of the study. S. Hamidreza Mahmoudpour reports employment with Merck KGaA.

Figures

FIGURE 1
FIGURE 1
(A) Kaplan–Meier curve and estimates of progression‐free survival from initiation of second‐line treatment and (B) Kaplan–Meier curve and estimates of overall survival from initiation of second‐line treatment.
See this image and copyright information in PMC

References

    1. Siegel RL, Miller KD, Fuchs HE, Jemal A. Cancer statistics, 2022. CA Cancer J Clin. 2022;72(1):7‐33. - PubMed
    1. Valle JW, Kelley RK, Nervi B, Oh DY, Zhu AX. Biliary tract cancer. Lancet. 2021;397(10272):428‐444. - PubMed
    1. Oneda E, Abu Hilal M, Zaniboni A. Biliary tract cancer: current medical treatment strategies. Cancers (Basel). 2020;12(5):1237. - PMC - PubMed
    1. Van Dyke AL, Shiels MS, Jones GS, et al. Biliary tract cancer incidence and trends in the United States by demographic group, 1999–2013. Cancer. 2019;125(9):1489‐1498. - PMC - PubMed
    1. Valle J, Wasan H, Palmer DH, et al. Cisplatin plus gemcitabine versus gemcitabine for biliary tract cancer. N Engl J Med. 2010;362(14):1273‐1281. - PubMed

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