Practical aspects of modern antineoplastic therapy in locally advanced and metastatic biliary tract cancer
https://doi.org/10.18027/2224-5057-2019-9-3-71-81
Abstract
Although gallbladder and biliary tract cancer is a rather rare group of diseases, it is among the pressing issues of modern oncology. Adequate surgery is the only curative method that can give a chance for recovery for a small proportion of patients at early stages of the disease. The scope of opportunities of drug therapy in biliary tract cancer is limited by the low effectiveness of the few currently available cytostatics. The addition of chemotherapy has little effect on the long-term outcome of surgery and other local interventions. Apparently, future treatments for these patients should be developed based on studies of targeted therapy and its combination with standard cytotoxic therapy, as well as possible targeting of anticancer immune response, which necessitates a search for immunotherapy efficacy predictors. The objective of this article is to consider the practical potential of drug therapy for biliary tract cancer and to review the studies that looked into molecular genetic targets and effective combinations of existing drugs, analyzing possible practical applications of the study results.
About the Authors
V. V. Breder
N.N. Blokhin National Medical Research Center of Oncology
Russian Federation
Competing Interests: not
Russian Federation
Valeriy V. Breder - MD, PhD, DSc, Leading Researcher of the Oncology Drug Therapy Department (Chemotherapy Department No. 17).
Moscow
Competing Interests: not
S. Yu. Kruteleva
N.N. Blokhin National Medical Research Center of Oncology
Russian Federation
Competing Interests: not
Russian Federation
Svetlana Yu. Kruteleva - Research Fellow of the Oncology Drug Therapy Department (Chemotherapy Department No. 17).
MoscowCompeting Interests: not
M. A. Kazantseva
N.N. Blokhin National Medical Research Center of Oncology
Russian Federation
Competing Interests: not
Russian Federation
Mariya A. Kazantseva - MD, PhD, Junior Researcher of the Oncology Drug Therapy Department (Chemotherapy Department No. 17).
Moscow
Competing Interests: not
K. K. Laktionov
N.N. Blokhin National Medical Research Center of Oncology
Russian Federation
Competing Interests: not
Russian Federation
Konstantin K. Laktionov - MD, PhD, DSc, Head of the Oncology Drug Therapy Department (Chemotherapy Department No. 17).
MoscowCompeting Interests: not
References
1. Goetze T. O. Gallbladder carcinoma: Prognostic factors and therapeutic options. World J Gastroenterol. 2015;21 (43):12211 —12217.
2. Harrington J.A., Carter L.L., Basu B., Cook N. Drug development and clinical trial design in pancreatico-biliary malignancies. Curr Probl Cancer. 2018 2018;42 (1):73-94.
3. Valle J. W, Lamarca A., Goyal L., Barriuso J., Zhu A. X. New horizons for precision medicine in biliary tract cancers. 2017;7 (9):943 - 962
4. Okuda K., Nakanuma Y., Miyazaki M., Cholangiocarcinoma: recent progress. Part 1: epidemiology and etiology. J. Gastroenterol. Hepatol. 2002;17 (10):1049-1055
5. Злокачественные новообразования в России в 2017 году (заболеваемость и смертность) под редакцией А.Д. Каприна, В. В. Старинского, Г. В. Петровой, Москва 2018, стр. 13 -17
6. Squadroni M., Tondulli L., Gatta G., Mosconi S., Beretta G., Labianca R. Cholangiocarcinoma. Crit Rev Oncol Hematol. 2017;116:11-31
7. Kim S. J, Akita M., Sung Y. N, Fujikura K., Lee J. H. etal. MDM2 Amplification in intrahepatic cholangiocarcinomas: its relationship with large-duct type morphology and uncommon KRAS mutations. Am J Surg Pathol. 2018;42 (4):512 - 521.
8. Horgan A. M., Amir E., Walter T., Knox J.J. Adjuvant therapy in the treatment of biliary tract cancer: a systematic review and meta-analysis. J Clin Oncol. 2012;30 (16):1934-40.
9. Takada T., Amano H., Yasuda H., Nimura Y., Matsushiro T., Kato H., et al. Is postoperative adjuvant chemotherapy useful for gallbladder carcinoma? A phase III multicenter prospective randomized controlled trial in patients with resected pancreaticobiliary carcinoma. Cancer. 2002;95 (8):1685 —1695
10. Ebata T., Hirano S., Konishi M., et al. Randomized clinical trial of adjuvant gemcitabine chemotherapy versus observation in resected bile duct cancer. Br J Surg. 2018;105 (3):192 -202.
11. Edeline J., Benabdelghani M., Bertaut A., Watelet J., Hammel P. et al Gemcitabine and Oxaliplatin Chemotherapy or Surveillance in Resected Biliary Tract Cancer (PRODIGE 12-ACCORD 18-UNICANCER GI): A Randomized Phase III Study. Clin Oncol 37:658-667
12. Primrose J. N., Fox R. P., Palmer D. H., Malik H. Z., Prasad R., Mirza D. et al Capecitabine compared with observation in resected biliary tract cancer (BILCAP): a randomised, controlled, multicentre, phase 3 study. Lancet Oncol 2019, 20 (5):663 - 673.
13. Kim T. H., Han S. S., Park S.J., Lee W. J., Woo S. M., Moon S.H., etal. Role of adjuvant chemoradiotherapy for resected extrahepatic biliary tract cancer. Int J Radiat Oncol Biol Phys. 2011;81 (5): 853-9.
14. Ben-Josef E., Guthrie K.A., El-Khoueiry A.B.., Corless C.L.., Zalupski M.M.., Lowy A.M., et al. A Phase II Intergroup Trial of Adjuvant Capecitabine and Gemcitabine Followed by Radiotherapy and Concurrent Capecitabine in Extrahepatic Cholangiocarcinoma and Gallbladder Carcinoma. Clin Oncol. 2015;33 (24):2617 -22.
15. Kim J. H. Won H.J., Shin Y. M., Kim K. A., Kim P. N. Radiofrequency ablation for the treatment of primary intrahepatic cholangiocarcinoma. AJR Am J Roentgenol. 2011;196 (2):W205-9.
16. Kuhlmann J. B., Euringer W., Spangenberg H. C., Breidert M., Blum H. E., Harder J., etal. Treatment of unresectable cholangiocarcinoma: conventional transarterial chemoembolization compared with drug eluting bead-transarterial chemoembolization and systemic chemotherapy. Eur J Gastroenterol Hepatol. 2012;24 (4):437-43.
17. Hyder O., Marsh J.W., Salem R., Petre E.N., Kalva S., Liapi E. etal. Intra-arterial therapy for advanced intrahepatic cholangiocarcinoma: a multi-institutional analysis. Ann Surg Oncol. 2013;20 (12):3779 — 86.
18. Al-Adra D.P., Gill R.S., Axford S.J., Shi X., Kneteman N., Liau S.S. Treatment of unresectable intrahepatic cholangiocarcinoma with yttrium-90 radioembolization: a systematic review and pooled analysis. Eur J Surg Oncol. 2015;41 (1):120-7.
19. Konstantinidis I. T., Groot Koerkamp B., Do R. K.., Gonen M., Fong Y., Allen P. J., D»Angelica M. I. Mar Unresectable intrahepatic cholangiocarcinoma: Systemic plus hepatic arterial infusion chemotherapy is associated with longer survival in comparison with systemic chemotherapy alone. Cancer 2016;122 (5):758-65.
20. Долгушин Б.И., Сергеева О.Н., Францев Д.Ю., Кукушкин А.В., Панов В.О., Виршке Э.Р., и др. Внутрипротоковая фотодинамическая терапия при воротной холангиокарциноме у неоперабельных больных. Анналы хирургической гепатологии, № 3, стр. 106, 2016 г.
21. Gonzalez-Carmona M. A., Bolch M., Jansen C., Vogt A., Sampels M., Mohr R. U. etal. Combined photodynamic therapy with systemic chemotherapy for unresectable cholangiocarcinoma. Aliment Pharmacol Ther. 2019 Feb;49 (4):437 -447.
22. Pereira S.P., Jitlal M., Duggan M., Lawrie E., Beare S., O»Donoghue P., Wasan H. S. PHOTOSTENT-02: porfimer sodium photodynamic therapy plus stenting versus stenting alone in patients with locally advanced or metastatic biliary tract cancer. ESMO Open. 2018;3 (5):000379.
23. Valle J., Wasan H., Palmer D.H., et al. Cisplatin plus gemcitabine versus gemcitabine for biliary tract cancer. N Engl J Med. 2010;362 (14):1273-1281
24. Morizane C., Okusaka T., Mizusawa J. Randomized phase III study of gemcitabine plus S-1 combination therapy versus gemcitabine plus cisplatin combination therapy in advanced biliary tract cancer: a Japan Clinical Oncology Group study (JCOG1113, FUGA-BT). J Clin Oncol. 2018;36 (4):205-205.
25. Kim S.T., Kang J.H., Lee J., Lee H.W., Oh S.Y., etal. Capecitabine Plus Oxaliplatin Versus Gemcitabine Plus Oxaliplatin as First-Line Therapy for Advanced Biliary Tract Cancers: A Multicenter, Open-Label, Randomized, Phase Three, Non-Inferiority Trial. Annals of Oncology, mdz058, 20 February 2019
26. Brieau B., Dahan L., De Rycke Y., et al. Second-line chemotherapy for advanced biliary tract cancer after failure of the gemcitabine-platinum combination: A large multicenter study by the Association des GastroEnterologues Oncologues: Chemotherapy for Advanced Biliary Tract Cancer. Cancer 2015 Sep 15;121 (18):3290-7.
27. Lamarca A., Hubner R.A., David Ryder W., et al. Secondline chemotherapy in advanced biliary cancer: a systematic review. Ann Oncol 2014; 25:2328-38.
28. Fornaro L., Vivaldi C., Cereda S., et al. Second-line chemotherapy in advanced biliary cancer progressed to first-line platinum-gemcitabine combination: a multicenter survey and pooled analysis with published data. J Exp Clin Cancer Res 2015;34:156
29. Lamarca A., Palmer H. P., Wasan H. S., et al. A randomized phase III, multi-centre, open-label study of active symptom control (ASC) alone or ASC with oxaliplatin/ 5-FU chemotherapy for patients with locally advanced/ metastatic biliary tract cancer previously-treated with CisGem chemotherapy, 2019 ASCO Annual Meeting.
30. C. Neuzillet, A. C. Gardini, B. Brieau»d et al. Prediction of Survival With Second-Line Therapy in Biliary Tract Cancer Eur.J. Cancer; Mar 12, 2019 ESMO 2018 Congress
31. Simile M. M., Bagella P., Vidili G., Spanu A., Manetti R., et al. Targeted Therapies in Cholangiocarcinoma: Emerging Evidence from Clinical Trials Medicina 2019;55 (2):42.
32. Sia D.; Tovar V.; Moeini A.; Llovet J.M. Intrahepatic cholangiocarcinoma: Pathogenesis and rationale for molecular therapies. Oncogene 2013 10;32 (41):4861-70.
33. Yoshikawa D.; Ojima H.; Iwasaki M.; Hiraoka N.; Kosuge T.; Kasai S.; Hirohashi S.; Shibata T. Clinicopathological and prognostic significance of EGFR, VEGF, and HER2 expression in cholangiocarcinoma. Br.J. Cancer 2008;98:418-425.
34. Walter D.; Hartmann S.; Waidmann O. Update on cholangiocarcinoma: Potential impact of genomic studies on clinical management. Z. Gastroenterol. 2017;55:575-581.
35. Перегудова М. В., Зарецкий А. Р. Бредер В. В., Романова К. А., Мороз Е.А., Лактионов К. К. Эффективность тар-гетной терапии у пациентки с BRAF- позитивной метастатической холангиокарциномой. Экспериментальная клиническая гастроэнтерология. 2017; 144 (8): 87-90.
36. Roa I., de Toro G., Schalper K., de Aretxabala X., Churi C., Javle M. Overexpression of the HER2 /neu Gene: A New Therapeutic Possibility for Patients With Advanced Gallbladder Cancer. Gastrointest Cancer Res. 2014 Mar;7 (2):42 - 8.
37. Heeke A.L., Pishvaian M.J., Lynce F., Xiu J., Brody J.R., Chen W. J., et al. Prevalence of Homologous Recombination-Related Gene Mutations Across Multiple Cancer Types. JCO Precis Oncol. 2018.
38. Lee, J.; Park, S.; Chang, H. M.; Kim, J. S.; Choi, H. J.; Lee, M. A.; et al. Gemcitabine and oxaliplatin with or without erlotinib in advanced biliary-tract cancer: A multicentre, open-label, randomised, phase 3 study. Lancet Oncol. 2012 Feb;13 (2):e49
39. Ferraro D., Goldstein D., O»Connell R.L., et al. TACTIC: a multicentre, open-label, single-arm phase II trial of panitumumab, cisplatin, and gemcitabine in biliary tract cancer. Cancer Chemother Pharmacol. 2016;78 (2):361 — 367
40. Vogel A., Kasper S., Bitzer M., et al. PICCA study: panitumumab in combination with cisplatin / gemcitabine chemotherapy in KRAS wildtype patients with biliary cancer-a randomised biomarker-driven clinical phase II AIO study. Eur J Cancer. 2018 Mar;92:11-19.
41. Malka D., Cervera P., Foulon S., et al. Gemcitabine and oxaliplatin with or without cetuximab in advanced biliary-tract cancer (BINGO): a randomised, open-label, non-comparative phase 2 trial. Lancet Oncol. 2014;15 (8)
42. Iyer R. V., Pokuri V. K., Groman A., et al. A multicenter Phase II study of gemcitabine, capecitabine, and bevacizumab for locally advanced or metastatic biliary tract cancer. Am J Clin Oncol. 2018;41 (7): 649-655.
43. Larsen F. O., Markussen A., Diness L.V., Nielsen D. Efficacy and safety of capecitabine, irinotecan, gemcitabine, and bevacizumab as second-line treatment in advanced biliary tract cancer: a Phase II cancer: A Phase II Study. Oncology. 2018 Aug;23 (8):919 - 927
44. Lubner, S. J.; Mahoney, M. R.; Kolesar, J. L.; Loconte, N. K.; Kim, G. P.; Pitot, H. C.; et al. Report of a multicenter phase II trial testing a combination of biweekly bevacizumab and daily erlotinib in patients with unresectable biliary cancer: A phase II Consortium study. J. Clin. Oncol. 2010;28:3491-3497
45. Moehler M., Maderer A., Schimanski C., et al. Gemcitabine plus sorafenib versus gemcitabine alone in advanced biliary tract cancer: a double-blind placebo-controlled multicentre phase II AIO study with biomarker and serum programme. Eur J Cancer. 2014;50 (18):3125-3135.
46. Neuzillet C, Seitz JF, Fartoux L, et al. Sunitinib as second-line treatment in patients with advanced intrahepatic cholangiocarcinoma (SUN-CK phase II trial): safety, efficacy, and updated translational results. J Clin Oncol. 2015;33 (3 Suppl): 343-343.
47. Santoro A., Gebbia V., Pressiani T., et al. A randomized, multicenter, phase II study of vandetanib monotherapy versus vandetanib in combination with gemcitabine versus gemcitabine plus placebo in subjects with advanced biliary tract cancer: the VanGogh study. Ann Oncol. 2015;26 (3):542-547.
48. Fontugne J., Augustin J., Pujals A., et al. PD-L1 expression in perihilar and intrahepatic cholangiocarcinoma. Oncotarget. 2017;8 (15):24644-24651.
49. Bang Y.J., Doi T., Braud F. D., et al. 525 Safety and efficacy of pembrolizumab (MK-3475) in patients (pts) with advanced biliary tract cancer: Interim results of KEYNOTE-028. Eur J Cancer. 2015 51 (3):S112
50. Sahai V., Griffith K.A., Beg M. S., Zalupski M. A multi-center randomized phase II study of nivolumab in combination with gemcitabine / cisplatin or ipilimumab as first line therapy for patients with advanced unresectable biliary tract cancer. J Clin Oncol. 2018;36 (15 Suppl).
51. Abou-Alfa GK, Macarulla Mercade T, Javle M, et al. ClarlDHy: A global, phase 3, randomized, double-blind study of ivosidenib (IVO) vs placebo in patients with advanced cholangiocarcinoma (CC) with an isocitrate dehydrogenase 1 (IDH1) mutation.
52. Silkin S., Startsev S., Krasnova M. et al. Complete Clinical Response of БкАк-Mutated Cholangiocarcinoma to Vemurafenib, Panitumumab, and Irinotecan. J Gastrointest Cancer. -2015. — Dec 19.
53. Marabelle A, Le D. T., Ascierto P. A., et al. Efficacy of Pembrolizumab in Patients With Noncolorectal High Microsatellite Instability / Mismatch Repair-Deficient Cancer: Results From the Phase II KEYNOTE-158 Study Clin Oncol. 2019 Nov 4.
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For citations:
Breder V.V., Kruteleva S.Yu., Kazantseva M.A., Laktionov K.K. Practical aspects of modern antineoplastic therapy in locally advanced and metastatic biliary tract cancer. Malignant tumours. 2019;9(3):71-81. (In Russ.) https://doi.org/10.18027/2224-5057-2019-9-3-71-81
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