Place of durvalumab in the treatment of biliary tract cancer: A review
Biliary tract cancer (BTC) is a group of rare and aggressive types of malignancies that arise from the epithelium of the intra- and extrahepatic bile ducts (cholangiocarcinoma) and gallbladder. The prognosis of unresectable BTC is poor, and less than 5% of patients are alive at 5 years after diagnos...
| Main Authors: | , , , , , |
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| Format: | Article |
| Language: | Russian |
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IP Habib O.N.
2023-02-01
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| Series: | Современная онкология |
| Subjects: | |
| Online Access: | https://modernonco.orscience.ru/1815-1434/article/viewFile/114991/pdf |
| _version_ | 1811155617650311168 |
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| author | Valeriy V. Breder Evgenii V. Ledin Viacheslav A. Chubenko Rashida V. Orlova Vladislav V. Petkau Ilya A. Pokataev |
| author_facet | Valeriy V. Breder Evgenii V. Ledin Viacheslav A. Chubenko Rashida V. Orlova Vladislav V. Petkau Ilya A. Pokataev |
| author_sort | Valeriy V. Breder |
| collection | DOAJ |
| description | Biliary tract cancer (BTC) is a group of rare and aggressive types of malignancies that arise from the epithelium of the intra- and extrahepatic bile ducts (cholangiocarcinoma) and gallbladder. The prognosis of unresectable BTC is poor, and less than 5% of patients are alive at 5 years after diagnosis. Radical surgical resection remains the only potentially curative treatment for early stage BTC, and antitumor chemotherapy extends survival rates in patients with unresectable or metastatic BTC. With the emerging of monoclonal antibodies targeting immune checkpoints, the possibility of such therapy in first- and subsequent-line treatment of advanced BTC has been actively studied. The positive high-level results from the TOPAZ-1 Phase III trial showed durvalumab, in combination with standard-of-care chemotherapy (gemcitabine plus cisplatin), statistically improved overall survival versus chemotherapy alone and showed improvements versus chemotherapy alone in prespecified secondary endpoints including progression-free survival and objective response rate. Durvalumab plus chemotherapy was well tolerated, had a similar safety profile versus the comparator arm and did not increase the discontinuation rate due to adverse events compared to chemotherapy alone. The U.S. Food and Drug Administration approved the combination of durvalumab and chemotherapy (gemcitabine plus cisplatin) as the first immunotherapy regimen for patients with locally advanced or metastatic BTC. In July 2022, durvalumab plus chemotherapy (gemcitabine plus cisplatin) was added to the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) as a preferred regimen category 1 in first-line therapy for Unresectable or metastatic BTC based on the data from TOPAZ-1. In addition, the durvalumab plus gemcitabine and cisplatin was recently added to the practical recommendations of the Russian Society of Clinical Oncology (RUSSCO) for the treatment of hepatobiliary cancers as an alternative to standard first-line treatment of BTC. |
| first_indexed | 2024-04-10T04:37:28Z |
| format | Article |
| id | doaj.art-71087bfdb09b419b9c49705ded01adb7 |
| institution | Directory Open Access Journal |
| issn | 1815-1434 1815-1442 |
| language | Russian |
| last_indexed | 2024-04-10T04:37:28Z |
| publishDate | 2023-02-01 |
| publisher | IP Habib O.N. |
| record_format | Article |
| series | Современная онкология |
| spelling | doaj.art-71087bfdb09b419b9c49705ded01adb72023-03-09T13:58:56ZrusIP Habib O.N.Современная онкология1815-14341815-14422023-02-0124440741210.26442/18151434.2022.4.20200679442Place of durvalumab in the treatment of biliary tract cancer: A reviewValeriy V. Breder0https://orcid.org/0000-0002-6244-4294Evgenii V. Ledin1Viacheslav A. Chubenko2https://orcid.org/0000-0001-6644-6687Rashida V. Orlova3Vladislav V. Petkau4https://orcid.org/0000-0002-0342-4007Ilya A. Pokataev5https://orcid.org/0000-0001-9864-3837Blokhin National Medical Research Center of OncologyClinical Hospital №2 "Medsi Group of Companies"Saint Petersburg Clinical Scientific and Practical Center for Specialised Types of Medical Care (oncological)City Clinical Oncology DispensarySverdlovsk Regional Oncological DispensaryCity Clinical Oncological HospitalBiliary tract cancer (BTC) is a group of rare and aggressive types of malignancies that arise from the epithelium of the intra- and extrahepatic bile ducts (cholangiocarcinoma) and gallbladder. The prognosis of unresectable BTC is poor, and less than 5% of patients are alive at 5 years after diagnosis. Radical surgical resection remains the only potentially curative treatment for early stage BTC, and antitumor chemotherapy extends survival rates in patients with unresectable or metastatic BTC. With the emerging of monoclonal antibodies targeting immune checkpoints, the possibility of such therapy in first- and subsequent-line treatment of advanced BTC has been actively studied. The positive high-level results from the TOPAZ-1 Phase III trial showed durvalumab, in combination with standard-of-care chemotherapy (gemcitabine plus cisplatin), statistically improved overall survival versus chemotherapy alone and showed improvements versus chemotherapy alone in prespecified secondary endpoints including progression-free survival and objective response rate. Durvalumab plus chemotherapy was well tolerated, had a similar safety profile versus the comparator arm and did not increase the discontinuation rate due to adverse events compared to chemotherapy alone. The U.S. Food and Drug Administration approved the combination of durvalumab and chemotherapy (gemcitabine plus cisplatin) as the first immunotherapy regimen for patients with locally advanced or metastatic BTC. In July 2022, durvalumab plus chemotherapy (gemcitabine plus cisplatin) was added to the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) as a preferred regimen category 1 in first-line therapy for Unresectable or metastatic BTC based on the data from TOPAZ-1. In addition, the durvalumab plus gemcitabine and cisplatin was recently added to the practical recommendations of the Russian Society of Clinical Oncology (RUSSCO) for the treatment of hepatobiliary cancers as an alternative to standard first-line treatment of BTC.https://modernonco.orscience.ru/1815-1434/article/viewFile/114991/pdfbiliary tract cancercholangiocarcinomagallbladder cancerdurvalumabimmunotherapytopaz-1 |
| spellingShingle | Valeriy V. Breder Evgenii V. Ledin Viacheslav A. Chubenko Rashida V. Orlova Vladislav V. Petkau Ilya A. Pokataev Place of durvalumab in the treatment of biliary tract cancer: A review Современная онкология biliary tract cancer cholangiocarcinoma gallbladder cancer durvalumab immunotherapy topaz-1 |
| title | Place of durvalumab in the treatment of biliary tract cancer: A review |
| title_full | Place of durvalumab in the treatment of biliary tract cancer: A review |
| title_fullStr | Place of durvalumab in the treatment of biliary tract cancer: A review |
| title_full_unstemmed | Place of durvalumab in the treatment of biliary tract cancer: A review |
| title_short | Place of durvalumab in the treatment of biliary tract cancer: A review |
| title_sort | place of durvalumab in the treatment of biliary tract cancer a review |
| topic | biliary tract cancer cholangiocarcinoma gallbladder cancer durvalumab immunotherapy topaz-1 |
| url | https://modernonco.orscience.ru/1815-1434/article/viewFile/114991/pdf |
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