CHEMOTHERAPY FOR UNRESECTABLE BILIARY CANCER: REVIEW

УДК 616.367-006.6:615.28

Authors

DOI:

https://doi.org/10.31684/25418475-2024-1-121

Keywords:

malignant tumors of the biliary ducts, chemotherapy

Abstract

Malignant tumors of the biliary ducts (BDC, biliary duct cancer) are rare cancers arising from the epithelium of the extrahepatic biliary tract, including intrahepatic and extrahepatic cholangiocarcinomas, as well as malignant tumors of the gallbladder and ampullae of the big duodenal papilla (BDP). The global and Russian incidence of these diseases is <1% of all cancer cases. Despite their rarity, BDC has one of the lowest five-year survival rates, second only to pancreatic head tumors. The lack of early symptoms leads to late diagnosis, with 80% of patients presenting with unresectable BDC or advanced disease, significantly impacting life expectancy and quality of life. Unresectable cholangiocarcinoma is primarily treated with chemotherapy, including systemic, targeted, and local invasive methods. However, obstructive jaundice and hepatorenal failure limit the use of aggressive chemotherapy in most patients, hindering the implementation of effective systemic protocols. While targeted chemotherapy shows promise due to the abundance of molecular targets in bile duct malignancies, its impact on complications is limited. Local chemotherapy directly affects tumor size, invasion, and bile duct lumen, but its clinical effectiveness and impact on overall survival remain inconclusive. The search for new local and systemic approaches to cholangiocarcinoma is promising, aiming to improve overall survival and address obstructive jaundice.

Downloads

Download data is not yet available.

Author information

Alexander E. Tseimakh,
Altai State Medical University, Barnaul, Russia

Cand. Sci. (Med.), Associate Professor of the Department of Faculty Surgery named after Professor I.I. Neimark, Altai State Medical University, Barnaul.
E-mail: alevtsei@rambler.ru.
https://orcid.org/0000-0002-1199-3699.
Scopus Author ID: 57216871819, Web of Science Researcher ID: ACB-4622-2022.

Alexander N. Mishchenko,
City Hospital No. 5, Barnaul, Russia

Head of the Department of X-ray Surgical Methods of Diagnosis and Treatment, City Hospital No. 5, Barnaul.
E-mail: mi-ross@mail.ru.
https://orcid.org/0000-0001-5632-845X.

Yakov N. Shoikhet,
Altai State Medical University, Barnaul, Russia

Dr. Sci. (Med.), Professor, Corresponding Member of the Russian Academy of Sciences, Professor of the Department of Faculty Surgery named after Professor I.I. Neimark, Altai State Medical University, Barnaul.
E-mail: starok100@mail.ru.
https://orcid.org/0000-0002-5253-4325.
Scopus Author ID: 55913368500, Web of Science Researcher ID: L-7465-2015.

Nvard K. Bedyan,
Altai Regional Oncologic Dispensary, Barnaul, Russia

Oncologist, Department of Radiosurgical Methods of Treatment, Altai Regional Oncologic Dispensary, Barnaul.
E-mail: nvard_b@mail.ru.
https://orcid.org/0000-0002-5015-6228.

References

  • Surya H., Abdullah M., Nelwan E.J., et al. Current Updates on Diagnosis and Management of Cholangiocarcinoma: from Surgery to Targeted Therapy. Acta Med Indones. 2023; 55(3): 361-370.
  • Peirce V., Paskow M., Qin L., et al. A Systematised Literature Review of Real-World Treatment Patterns and Outcomes in Unresectable Advanced or Metastatic Biliary Tract Cancer. Target Oncol. 2023; 18(6): 837-852. https://doi.org/10.1007/s11523-023-01000-5
  • Status of oncological care for the population of Russia in 2020 / ed. A.D. Kaprin, V.V. Starinskogo, G.V. Petrova – M .: MSIOI named after. P.A. Herzen, branch of the FSBI "NMICR" of the Russian Ministry of Health, 2021. – 239 p. (In Russ.)
  • Russian Oncology Association. Biliary cancer. Clinical guidelines. 2020. 51 p. Accessed March 23, 2023. https://oncology-association.ru/wp-content/uploads/2020/09/biliarnyj_rak.pdf (In Russ.)
  • Vogel A., Bridgewater J., Edeline J., Kelley R.K., Klumpen H.J., Malka D., et al. Biliary tract cancer: ESMO clinical practice guideline for diagnosis, treatment and follow-up. Ann Oncol. 2023; 34(2): 127-40. https://doi.org/10.1016/j.annonc.2022.10.506
  • Trifylli E.M., Kriebardis A.G., Koustas E., et al. The Arising Role of Extracellular Vesicles in Cholangiocarcinoma: A Rundown of the Current Knowledge Regarding Diagnostic and Therapeutic Approaches. Int J Mol Sci. 2023; 24(21): 15563. https://doi.org/10.3390/ijms242115563
  • Zhao D.Y., Lim K.H. Current biologics for treatment of biliary tract cancers. J Gastrointest Oncol. 2017; 8(3): 430-40. https://doi.org/10.21037/jgo.2017.05.04
  • Baria K., De Toni E.N., Yu B., Jiang Z., Kabadi S.M., Malvezzi M. Worldwide incidence and mortality of biliary tract cancer. Gastro Hep Adv. 2022; 1(4): 618-26. https://doi.org/10.1016/j.gastha.2022.04.007
  • Zamani Z., Fatima S. Biliary tract cancer. Treasure Island: Stat Pearls; 2021.
  • Chоlеstаtic Jаundicе / R. Shаh, S. Jоhn // In: StаtPеаrls Intеrnеt. Trеаsurе Islаnd (FL): StаtPеаrls Publishing. 2022. – PMID: 29489239.
  • Nakachi K., Gotohda N., Hatano E., Nara S., Takahashi S., Kawamoto Y., Ueno M. Adjuvant and neoadjuvant chemotherapy for biliary tract cancer: a review of randomized controlled trials. Jpn J Clin Oncol. 2023 Nov 5; 53(11): 1019-1026. https://doi.org/10.1093/jjco/hyad103. PMID: 37599063
  • Oh D.Y., He A.R., Qin S., Chen L.T., Okusaka T., Vogel A., et al. Plain language summary of the TOPAZ-1 study: durvalumab and chemotherapy for advanced biliary tract cancer. Future Oncol. 2023 Nov; 19(34): 2277-2289. https://doi.org/10.2217/fon-2023-0468. Epub 2023 Sep 25. PMID: 37746835.
  • Shin D.W. Treatment of Ampullary Adenocarcinoma. Korean J Gastroenterol. 2023 Oct 25; 82(4): 159-170. Korean. https://doi.org/10.4166/kjg.2023.110. PMID: 37876255
  • Fung S., Syed Y.Y. Durvalumab: A Review in Advanced Biliary Tract Cancer. Target Oncol. 2023 Nov 9. https://doi.org/10.1007/s11523-023-01007-y.
  • Oh D-Y., Ruth He A., Qin S., Chen L-T., Okusaka T., Vogel A., et al. Durvalumab plus gemcitabine and cisplatin in advanced biliary tract cancer. NEJM Evid. 2022; 1(8): EVIDoa2200015. https://doi.org/10.1056/EVIDoa2200015
  • Bekaii-Saab T.S., Valle J.W., Van Cutsem E., Rimassa L., Furuse J., Ioka T., et al. FIGHT-302: first-line pemigatinib vs gemcitabine plus cisplatin for advanced cholangiocarcinoma with FGFR2 rearrangements. Future Oncol. 2020; 16(30): 2385-2399. https://doi.org/10.2217/fon-2020-0429
  • Hyung J., Kim B., Yoo C., Kim K.P., Jeong J.H., Chang H.M., et al. Clinical benefit of maintenance therapy for advanced biliary tract cancer patients showing no progression after first-line gemcitabine plus cisplatin. Cancer Res Treat. 2019; 51(3): 901-909. https://doi.org/10.4143/crt.2018.326
  • Shin D.W., Kim M.J., Lee J.C., Kim J., Woo S.M., Lee W.J., et al. Gemcitabine plus cisplatin chemotherapy prolongs the survival in advanced hilar cholangiocarcinoma: a large multicenter study. Am J Clin Oncol. 2020; 43(6): 422-427. https://doi.org/10.1097/COC.0000000000000682
  • Cheon J., Lee C.K., Sang Y.B., Choi H.J., Kim M.H., Ji J.H., et al. Real-world efficacy and safety of nab-paclitaxel plus gemcitabine-cisplatin in patients with advanced biliary tract cancers: a multicenter retrospective analysis. Ther Adv Med Oncol. 2021; 13. https://doi.org/10.1177/17588359211035983
  • Salati M., Caputo F., Cunningham D., Marcheselli L., Spallanzani A., Rimini M., et al. The A.L.A.N. score identifies prognostic classes in advanced biliary cancer patients receiving first-line chemotherapy. Eur J Cancer. 2019; 117: 84-90. https://doi.org/10.1016/j.ejca.2019.05.030
  • Kelley R.K., Ueno M., Yoo C., Finn R.S., Furuse J., Ren Z., et al. Pembrolizumab in combination with gemcitabine and cisplatin compared with gemcitabine and cisplatin alone for patients with advanced biliary tract cancer (KEYNOTE-966): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2023; 401(10391): 1853-1865. https://doi.org/10.1016/S0140-6736(23)00727-4
  • Zhang Z., Wang X., Li H., Sun H., Chen J., Lin H. Case Report: Camrelizumab combined with gemcitabine and oxaliplatin in the treatment of advanced intrahepatic cholangiocarcinoma: a case report and literature review. Front Immunol. 2023 Aug 21; 14: 1230261. https://doi.org/10.3389/fimmu.2023.1230261. PMID: 37671157; PMCID: PMC10475830.
  • US Food and Drug Administration. FDA D.I.S.C.O. Burst Edition: FDA approval of Imfinzi (durvalumab) for adult patients with locally advanced or metastatic biliary tract cancer. 2022. Available from: https://www.fda.gov/drugs/resources-information-approved-drugs/fda-disco-burst-edition-fda-approval-imfinzi-durvalumab-adult-patients-locally-advanced-or#:~:text=On%20September%202%2C%202022%2C%20FDA,or%20metastatic%20biliary%20tract%20cancer. Accessed 21 Apr 2023.
  • Jiang Y., Zeng Z., Zeng J., Liu C., Qiu J., Li Y., et al. Efficacy and safety of first-line chemotherapies for patients with advanced biliary tract carcinoma: a systematic review and network meta-analysis. Front Oncol. 2021; 11: 736113. https://doi.org/10.3389/fonc.2021.736113
  • Wiazzane N., Chauffert B., Ghiringhelli F. Retrospective analysis of survival benefits of chemotherapy for metastatic or non-resectable intrahepatic cholangiocarcinoma. Clin Res Hepatol Gastroenterol. 2013; 37(6): 614-618. https://doi.org/10.1016/j.clinre.2013.03.003
  • You M.S., Ryu J.K., Choi Y.H., Choi J.H., Huh G., Paik W.J.H., et al. Therapeutic outcomes and prognostic factors in unresectable gallbladder cancer treated with gemcitabine plus cisplatin. BMC Cancer. 2019; 19(1): 10. https://doi.org/10.1186/s12885-018-5211-y
  • Ulusakarya A., Karaboué A., Ciacio O., Pittau G., Haydar M., Biondani P., et al. A retrospective study of patient-tailored FOLFIRINOX as a first-line chemotherapy for patients with advanced biliary tract cancer. BMC Cancer. 2020; 20(1): 515. https://doi.org/10.1186/s12885-020-07004-y
  • Zheng-Lin B., Graham R.P., Bekaii-Saab T.S. Targeting ERBB2/HER2 genetic alterations: an expanding therapeutic opportunity in gastrointestinal cancers. Chin Clin Oncol. 2023 Oct; 12(5): 55. https://doi.org/10.21037/cco-23-72. PMID: 37964543.
  • Xing P., Wang S., Cao Y., Liu B., Zheng F., Guo W., Huang J., Zhao Z., Yang Z., Lin X., Sang L., Liu Z. Treatment strategies and drug resistance mechanisms in adenocarcinoma of different organs. Drug Resist Updat. 2023 Aug 22; 71: 101002. https://doi.org/10.1016/j.drup.2023.101002. Epub ahead of print. PMID: 37678078.
  • Jansen H., Pape U.F., Utku N. A review of systemic therapy in biliary tract carcinoma. J Gastrointest Oncol. 2020; 11(4): 770-789. https://doi.org/10.21037/jgo-20-203
  • Benson A.B., D'Angelica M.I., Abrams T., Abbott D.E., Ahmet A., Anaya D.A., et al. Biliary tract cancers, version 1.2023, NCCN clinical practice guidelines in oncology. 2023. Available from: https://www.nccn.org/guidelines/guidelines-detail?category=1&id=1517. Accessed 21 Apr 2023.
  • Ghidini M., Pizzo C., Botticelli A., Hahne J.C., Passalacqua R., Tomasello G., et al. Biliary tract cancer: current challenges and future prospects. Cancer Manag Res. 2019; 11: 379-388. https://doi.org/10.2147/CMAR.S157156
  • National Comprehensive Cancer Network. NCCN clinical practice guidelines in oncology (NCCN Guidelines®). 2022. Available from: https://www.nccn.org/professionals/physician_gls/pdf/hepatobiliary.pdf. Accessed 6 Dec 2022.
  • Alberta Health Services. Cholangiocarcinoma and gallbladder cancer. 2019. Available from: https://www.albertahealthservices.ca/assets/info/hp/cancer/if-hp-cancer-guide-gi010-biliary.pdf. Accessed 12 Jan 2023.
  • Gotfrit J., Goodwin R., Asmis T., Hyde A.J., Alcindor T., Aubin F., et al. Eastern Canadian Gastrointestinal Cancer Consensus Conference 2019. Curr Oncol. 2021; 28(3): 1988-2006. https://doi.org/10.3390/curroncol28030185
  • Abou-Alfa G.K., Macarulla T., Javle M.M., et al. 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. https://doi.org/10.1016/S1470-2045(20)30157-1
  • Zhu A.X., Macarulla T., Javle M.M., et al. 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): 1669-77. https://doi.org/10.1001/jamaoncol.2021.3836
  • Javle M., Borad M.J., Azad N.S., et al. 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): 1290-300. https://doi.org/10.1016/S1470-2045(21)00336-3
  • Javle M., Roychowdhury S., Kelley R.K., et al. Infigratinib (BGJ398) in previously treated patients with advanced or metastatic cholangiocarcinoma with FGFR2 fusions or rearrangements: mature results from a multicentre, open-label, single-arm, phase 2 study. Lancet Gastroenterol Hepatol. 2021; 6(10): 803-15. https://doi.org/10.1016/S2468-1253(21)00196-5
  • Borad M.J., Bridgewater J.A., Morizane C., Shroff R.T., Oh D-Y., Moehler M.H., et al. A phase III study of futibatinib (TAS-120) versus gemcitabine-cisplatin (gem-cis) chemotherapy as first-line (1L) treatment for patients (pts) with advanced (adv) cholangiocarcinoma (CCA) harboring fibroblast growth factor receptor 2 (FGFR2) gene rearrangements (FOENIX-CCA3). J Clin Oncol. 2020; 38(4_Suppl.): TPS600.
  • Abou-Alfa G.K., Sahai V., Hollebecque A, et al. Pemigatinib for previously treated, locally advanced or metastatic cholangiocarcinoma: a multicentre, open-label, phase 2 study. Lancet Oncol. 2020; 21(5): 671-84. https://doi.org/10.1016/S1470-2045(20)30109-1
  • Chawla S.P., Wong S., Quon D., et al. Three year results of Blessed: Expanded access for DeltaRex-G for an intermediate size population with advanced pancreatic cancer and sarcoma (NCT04091295) and individual patient use of DeltaRex-G for solid malignancies (IND# 19130). Front. Mol. Med. 2022; 2: 1092286. https://doi.org/10.3389/fmmed.2022.1092286
  • Liu S., Chawla S.P., Bruckner H., et al. Long Term Survival Following DeltaRex-G/DeltaVax Tumor-Targeted Gene Therapy for Advanced Chemotherapy Resistant Malignancies: An Academic Milestone. Clin Oncol. 2021; 6: 1807.
  • Wang J., Xue Y., Liu R., Wen Z., Ma Z., Yang X., Yu L., Yang B., Xie H. DEB-TACE with irinotecan versus C-TACE for unresectable intrahepatic cholangiocarcinoma: a prospective clinical study. Front Bioeng Biotechnol. 2023; 10: 1112500. https://doi.org/10.3389/fbioe.2022.1112500
  • Yuan P., Song J., Wang F., Zhu G., Chen B. Corrections to: Combination of TACE and Lenvatinib as a promising option for downstaging to surgery of initially unresectable intrahepatic cholangiocarcinoma. Invest New Drugs. 2023; 41(1): 182. https://doi.org/10.1007/s10637-022-01323-6
  • He M., Jiang N., Yin X., Xu A., Mu K. Conventional and drug-eluting beads transarterial chemoembolization in patients with unresectable intrahepatic cholangiocarcinoma: a systematic review and pooled analysis. J Cancer Res Clin Oncol. 202; 149(1): 531-540. https://doi.org/10.1007/s00432-022-04485-1
  • Ning Z., Xie L., Yan X., Hua Y., Shi W., Lin J., Xu L., Meng Z. Transarterial chemoembolization plus lenvatinib with or without a PD-1 inhibitor for advanced and metastatic intrahepatic cholangiocarcinoma: a retrospective real-world study. Br J Radiol. 2023; 96(1150): 20230079. https://doi.org/10.1259/bjr.20230079
  • Zhang H., Han C., Zheng X., Zhao W., Liu Y., Ye X. Significant response to transarterial chemoembolization combined with PD-1 inhibitor and apatinib for advanced intrahepatic cholangiocarcinoma: A case report and literature review. J Cancer Res Ther. 2023; 19(4): 1055-1060. https://doi.org/10.4103/jcrt.jcrt_1697_22. PMID: 37675736.
  • Young S., Torkian P., Flanagan S., D'Souza D., Sanghvi T., Golzarian J. Intrahepatic cholangiocarcinoma: a dose threshold evaluation in those undergoing transarterial radioembolization. J Gastrointest Oncol. 2023; 14(5): 2202-2211. https://doi.org/10.21037/jgo-23-210
  • White J., Carolan-Rees G., Dale M., Patrick H.E., See T.C., Bell J.K., et al. Yttrium-90 transarterial radioembolization for chemotherapy-refractory intrahepatic cholangiocarcinoma: a prospective, observational Study. J Vasc Interv Radiol. 2019; 30(8): 1185-1192. https://doi.org/10.1016/j.jvir.2019.03.018
  • Schaarschmidt B.M., Kloeckner R., Dertnig T., Demircioglu A., Müller L., Auer T.A., Santos D.P.D., Steinle V., Miederer M., Gebauer B., Radunz S., Kasper S., Weber M., Theysohn J. Real-Life Experience in the Treatment of Intrahepatic Cholangiocarcinoma by 90Y Radioembolization: A Multicenter Retrospective Study. J Nucl Med. 2023; 64(4): 529-535. https://doi.org/10.2967/jnumed.122.264598
  • Owen M., Makary M.S., Beal E.W. Locoregional Therapy for Intrahepatic Cholangiocarcinoma. Cancers (Basel). 2023; 15(8): 2384. https://doi.org/10.3390/cancers15082384
  • Auer T.A., Collettini F., Segger L., Pelzer U., Mohr R., Krenzien F., Gebauer B., Geisel D., Hosse C., Schöning W., Fehrenbach U. Interventional Treatment Strategies in Intrahepatic Cholangiocarcinoma and Perspectives for Combined Hepatocellular-Cholangiocarcinoma. Cancers (Basel). 2023; 15(9): 2655. https://doi.org/10.3390/cancers15092655
  • Page M.J., McKenzie J.E., Bossuyt P.M., Boutron I., Hoffmann T.C., Mulrow C.D., et al. The PRISMA 2020 statement: an updated guideline for reporting systematic reviews. J Clin Epidemiol. 2021; 134: 178-189. https://doi.org/10.1016/j.jclinepi.2021.03.001
  • Müller L., Mähringer-Kunz A., Jungmann F., Tanyildizi Y., Bartsch F., Czauderna C., et al. Risk stratification in advanced biliary tract cancer: validation of the A.L.A.N. score. J Oncol. 2020. https://doi.org/10.1155/2020/6180613
  • Beaulieu C., Lui A., Yusuf D., Abdelaziz Z., Randolph B., Batuyong E., et al. A population-based retrospective study of biliary tract cancers in Alberta, Canada. Curr Oncol. 2021; 28(1): 417-427. https://doi.org/10.3390/curroncol28010044
  • Koch C., Franzke C., Bechstein W.O., Schnitzbauer A.A., Filmann N., Vogl T., et al. Poor prognosis of advanced cholangiocarcinoma: real-world data from a tertiary referral center. Digestion. 2020; 101(4): 458-465. https://doi.org/10.1159/000500894.
  • Gonzalez-Carmona M.A., Bolch M., Jansen C., Vogt A., Sampels M., Mohr R.U., et al. Combined photodynamic therapy with systemic chemotherapy for unresectable cholangiocarcinoma. Aliment Pharmacol Ther. 2019; 49(4): 437-447. https://doi.org/10.1111/apt.15050.
  • Published

    2024-03-25

    How to Cite

    Tseimakh A. E., Mishchenko A. N., Shoikhet Y. N., Bedyan N. K. CHEMOTHERAPY FOR UNRESECTABLE BILIARY CANCER: REVIEW: УДК 616.367-006.6:615.28 // Bulletin of Medical Science, 2024. Vol. 33, № 1. P. 121–127 DOI: 10.31684/25418475-2024-1-121. URL: https://newbmn.asmu.ru/bmn/article/view/672.

    Most read articles by the same author(s)