Insights for Clinical Management from the Real-life Data of the Centralized West of Scotland Biliary Cancer Clinic

Overview

Journal BMC Cancer

Publisher Biomed Central

Specialty Oncology

Date 2024 May 16

PMID 38755562

Authors

Valentina Zanuso

Tamsin Nash

Raffaella Casolino

Gregory Armstrong

Ona Pallise

Jen Milne

Chiara Braconi

Affiliations

Soon will be listed here.

Abstract

Background: With the increasing of novel therapeutics for the treatment of Biliary Tract Cancers (BTC), and the need to assess their socio-economic impacts for national licence approvals, it is as important as ever to have real-life data in national populations.

Methods And Results: We performed an audit of the first 2 year-activity (Sep 2019-Sep 2021) of the centralized West-of-Scotland-BTC clinic. 122 patients accessed the service, including 68% with cholangiocarcinoma (CCA), 27% with gallbladder cancer (GBC), and 5% with ampulla of Vater carcinoma with biliary phenotype (AVC). Median age at diagnosis was 66 (28-84), with 30% of newly diagnosed patients being younger than 60 years-old. Thirty-five cases (29%) underwent surgery, followed by adjuvant-chemotherapy in 66%. 60% had recurrent disease (80% with distant relapse). Sixty-four patients (58%) started first-line Systemic-AntiCancer-Treatment (SACT). Of these, 37% received second line SACT, the majority of which had iCCA and GBC. Thirty-% of those who progressed received third line SACT.

Conclusions: About 30% of BTC were eligible for curative surgery. Fifty-eight and twenty% of the overall cohort of advanced BTC patients received first and second line SACT. Our data suggest that reflex genomic profiling may not be cost-effective until molecularly driven strategies are limited to second line setting.

References

Abou-Alfa G, Macarulla T, Javle M, Kelley R, Lubner S, Adeva J . Ivosidenib in IDH1-mutant, chemotherapy-refractory cholangiocarcinoma (ClarIDHy): a multicentre, randomised, double-blind, placebo-controlled, phase 3 study. Lancet Oncol. 2020; 21(6):796-807. PMC: 7523268. DOI: 10.1016/S1470-2045(20)30157-1. View

Javle M, Lowery M, Shroff R, Weiss K, Springfeld C, Borad M . Phase II Study of BGJ398 in Patients With FGFR-Altered Advanced Cholangiocarcinoma. J Clin Oncol. 2017; 36(3):276-282. PMC: 6075847. DOI: 10.1200/JCO.2017.75.5009. View

Banales J, Marin J, Lamarca A, Rodrigues P, Khan S, Roberts L . Cholangiocarcinoma 2020: the next horizon in mechanisms and management. Nat Rev Gastroenterol Hepatol. 2020; 17(9):557-588. PMC: 7447603. DOI: 10.1038/s41575-020-0310-z. View

Marin J, Prete M, Lamarca A, Tavolari S, Landa-Magdalena A, Brandi G . Current and novel therapeutic opportunities for systemic therapy in biliary cancer. Br J Cancer. 2020; 123(7):1047-1059. PMC: 7525457. DOI: 10.1038/s41416-020-0987-3. View

Zhu A, Macarulla T, Javle M, Kelley R, Lubner S, Adeva J . Final Overall Survival Efficacy Results of Ivosidenib for Patients With Advanced Cholangiocarcinoma With IDH1 Mutation: The Phase 3 Randomized Clinical ClarIDHy Trial. JAMA Oncol. 2021; 7(11):1669-1677. PMC: 8461552. DOI: 10.1001/jamaoncol.2021.3836. View

Abou-Alfa G, Sahai V, Hollebecque A, Vaccaro G, Melisi D, Al-Rajabi R . Pemigatinib for previously treated, locally advanced or metastatic cholangiocarcinoma: a multicentre, open-label, phase 2 study. Lancet Oncol. 2020; 21(5):671-684. PMC: 8461541. DOI: 10.1016/S1470-2045(20)30109-1. View

Hainsworth J, Meric-Bernstam F, Swanton C, Hurwitz H, Spigel D, Sweeney C . Targeted Therapy for Advanced Solid Tumors on the Basis of Molecular Profiles: Results From MyPathway, an Open-Label, Phase IIa Multiple Basket Study. J Clin Oncol. 2018; 36(6):536-542. DOI: 10.1200/JCO.2017.75.3780. View

Meric-Bernstam F, Bahleda R, Hierro C, Sanson M, Bridgewater J, Arkenau H . Futibatinib, an Irreversible FGFR1-4 Inhibitor, in Patients with Advanced Solid Tumors Harboring / Aberrations: A Phase I Dose-Expansion Study. Cancer Discov. 2021; 12(2):402-415. PMC: 9762334. DOI: 10.1158/2159-8290.CD-21-0697. View

Subbiah V, Lassen U, Elez E, Italiano A, Curigliano G, Javle M . Dabrafenib plus trametinib in patients with BRAF-mutated biliary tract cancer (ROAR): a phase 2, open-label, single-arm, multicentre basket trial. Lancet Oncol. 2020; 21(9):1234-1243. DOI: 10.1016/S1470-2045(20)30321-1. View

10.

Valle J, Wasan H, Palmer D, Cunningham D, Anthoney A, Maraveyas A . Cisplatin plus gemcitabine versus gemcitabine for biliary tract cancer. N Engl J Med. 2010; 362(14):1273-81. DOI: 10.1056/NEJMoa0908721. View

11.

Vogel A, Bridgewater J, Edeline J, Kelley R, Klumpen H, Malka D . Biliary tract cancer: ESMO Clinical Practice Guideline for diagnosis, treatment and follow-up. Ann Oncol. 2022; 34(2):127-140. DOI: 10.1016/j.annonc.2022.10.506. View

12.

Primrose J, Fox R, Palmer D, Malik H, Prasad R, Mirza D . Capecitabine compared with observation in resected biliary tract cancer (BILCAP): a randomised, controlled, multicentre, phase 3 study. Lancet Oncol. 2019; 20(5):663-673. DOI: 10.1016/S1470-2045(18)30915-X. View

13.

Oh D, He A, Qin S, Chen L, Okusaka T, Vogel A . Durvalumab plus Gemcitabine and Cisplatin in Advanced Biliary Tract Cancer. NEJM Evid. 2024; 1(8):EVIDoa2200015. DOI: 10.1056/EVIDoa2200015. View

14.

Javle M, Borad M, Azad N, Kurzrock R, Abou-Alfa G, George B . Pertuzumab and trastuzumab for HER2-positive, metastatic biliary tract cancer (MyPathway): a multicentre, open-label, phase 2a, multiple basket study. Lancet Oncol. 2021; 22(9):1290-1300. DOI: 10.1016/S1470-2045(21)00336-3. View

15.

Zalin-Miller A, Jose S, Knott C, Paley L, Tataru D, Morement H . Regional variation in routes to diagnosis of cholangiocarcinoma in England from 2006 to 2017. World J Gastroenterol. 2023; 29(24):3825-3842. PMC: 10324535. DOI: 10.3748/wjg.v29.i24.3825. View

16.

Nooijen L, Banales J, de Boer M, Braconi C, Folseraas T, Forner A . Impact of Positive Lymph Nodes and Resection Margin Status on the Overall Survival of Patients with Resected Perihilar Cholangiocarcinoma: The ENSCCA Registry. Cancers (Basel). 2022; 14(10). PMC: 9140174. DOI: 10.3390/cancers14102389. View

17.

Izquierdo-Sanchez L, Lamarca A, La Casta A, Buettner S, Utpatel K, Klumpen H . Cholangiocarcinoma landscape in Europe: Diagnostic, prognostic and therapeutic insights from the ENSCCA Registry. J Hepatol. 2022; 76(5):1109-1121. DOI: 10.1016/j.jhep.2021.12.010. View

18.

Horgan A, Amir E, Walter T, Knox J . Adjuvant therapy in the treatment of biliary tract cancer: a systematic review and meta-analysis. J Clin Oncol. 2012; 30(16):1934-40. DOI: 10.1200/JCO.2011.40.5381. View