Plain language summary of the TOPAZ-1 study: durvalumab and chemotherapy for advanced biliary tract cancer
This is a summary describing the results of a Phase III study called TOPAZ-1. The study looked at treatment with durvalumab (a type of immunotherapy) and chemotherapy to treat participants with advanced biliary tract cancer (BTC). Advanced BTC is usually diagnosed at late stages of disease, when it...
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| Published in | Future Oncology Vol. 19; no. 34; pp. 2277 - 2289 |
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| Main Authors | , , , , , , , , , , , , , , , , , , , , , , , , , , , , |
| Format | Journal Article |
| Language | English |
| Published |
England
Future Medicine Ltd
01.11.2023
Informa UK Limited |
| Subjects | |
| Online Access | Get full text |
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| Abstract | This is a summary describing the results of a Phase III study called TOPAZ-1. The study looked at treatment with durvalumab (a type of immunotherapy) and chemotherapy to treat participants with advanced biliary tract cancer (BTC). Advanced BTC is usually diagnosed at late stages of disease, when it cannot be cured by surgery. This study included participants with advanced BTC who had not received previous treatment, or had their cancer come back at least 6 months after receiving treatment or surgery that aimed to cure their disease. Participants received treatment with durvalumab and chemotherapy or placebo and chemotherapy. The aim of this study was to find out if treatment with durvalumab and chemotherapy could increase the length of time that participants with advanced BTC lived, compared with placebo and chemotherapy.
Participants who took durvalumab and chemotherapy had a 20% lower chance of experiencing death at any point in the study compared with participants who received placebo and chemotherapy. The side effects experienced by participants were similar across treatment groups, and less than 12% of participants in either treatment group had to stop treatment due to treatment-related side effects.
Overall, these results support durvalumab and chemotherapy as a new treatment option for people with advanced BTCs. Based on the results of this study, durvalumab is now approved for the treatment of adults with advanced BTCs in combination with chemotherapy by government organizations in Europe, the United States and several other countries. |
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| AbstractList | This is a summary describing the results of a Phase III study called TOPAZ-1. The study looked at treatment with durvalumab (a type of immunotherapy) and chemotherapy to treat participants with advanced biliary tract cancer (BTC). Advanced BTC is usually diagnosed at late stages of disease, when it cannot be cured by surgery. This study included participants with advanced BTC who had not received previous treatment, or had their cancer come back at least 6 months after receiving treatment or surgery that aimed to cure their disease. Participants received treatment with durvalumab and chemotherapy or placebo and chemotherapy. The aim of this study was to find out if treatment with durvalumab and chemotherapy could increase the length of time that participants with advanced BTC lived, compared with placebo and chemotherapy.
Participants who took durvalumab and chemotherapy had a 20% lower chance of experiencing death at any point in the study compared with participants who received placebo and chemotherapy. The side effects experienced by participants were similar across treatment groups, and less than 12% of participants in either treatment group had to stop treatment due to treatment-related side effects.
Overall, these results support durvalumab and chemotherapy as a new treatment option for people with advanced BTCs. Based on the results of this study, durvalumab is now approved for the treatment of adults with advanced BTCs in combination with chemotherapy by government organizations in Europe, the United States and several other countries. This is a summary describing the results of a Phase III study called TOPAZ-1. The study looked at treatment with durvalumab (a type of immunotherapy) and chemotherapy to treat participants with advanced biliary tract cancer (BTC). Advanced BTC is usually diagnosed at late stages of disease, when it cannot be cured by surgery. This study included participants with advanced BTC who had not received previous treatment, or had their cancer come back at least 6 months after receiving treatment or surgery that aimed to cure their disease. Participants received treatment with durvalumab and chemotherapy or placebo and chemotherapy. The aim of this study was to find out if treatment with durvalumab and chemotherapy could increase the length of time that participants with advanced BTC lived, compared with placebo and chemotherapy.WHAT IS THIS SUMMARY ABOUT?This is a summary describing the results of a Phase III study called TOPAZ-1. The study looked at treatment with durvalumab (a type of immunotherapy) and chemotherapy to treat participants with advanced biliary tract cancer (BTC). Advanced BTC is usually diagnosed at late stages of disease, when it cannot be cured by surgery. This study included participants with advanced BTC who had not received previous treatment, or had their cancer come back at least 6 months after receiving treatment or surgery that aimed to cure their disease. Participants received treatment with durvalumab and chemotherapy or placebo and chemotherapy. The aim of this study was to find out if treatment with durvalumab and chemotherapy could increase the length of time that participants with advanced BTC lived, compared with placebo and chemotherapy.Participants who took durvalumab and chemotherapy had a 20% lower chance of experiencing death at any point in the study compared with participants who received placebo and chemotherapy. The side effects experienced by participants were similar across treatment groups, and less than 12% of participants in either treatment group had to stop treatment due to treatment-related side effects.WHAT WERE THE RESULTS OF THE STUDY?Participants who took durvalumab and chemotherapy had a 20% lower chance of experiencing death at any point in the study compared with participants who received placebo and chemotherapy. The side effects experienced by participants were similar across treatment groups, and less than 12% of participants in either treatment group had to stop treatment due to treatment-related side effects.Overall, these results support durvalumab and chemotherapy as a new treatment option for people with advanced BTCs. Based on the results of this study, durvalumab is now approved for the treatment of adults with advanced BTCs in combination with chemotherapy by government organizations in Europe, the United States and several other countries.WHAT DO THE RESULTS OF THE STUDY MEAN?Overall, these results support durvalumab and chemotherapy as a new treatment option for people with advanced BTCs. Based on the results of this study, durvalumab is now approved for the treatment of adults with advanced BTCs in combination with chemotherapy by government organizations in Europe, the United States and several other countries. |
| Author | Nana, Rokutanda Shukui, Qin Magdalena, Żotkiewicz Mallory, Makowsky Aiwu Ruth, He Takuji, Okusaka Mairead G, McNamara Li-Tzong, Chen Arndt, Vogel Jin Won, Kim Myung Ah, Lee Suebpong, Tanasanvimon Masafumi, Ikeda Do-Youn, Oh Mohamed, Bouattour John F, Kurland Masayuki, Kitano Benjamin, Tan Antonio, Avallone Juan W, Valle Jen-Shi, Chen Howard, Burris Julie, Wang Thatthan, Suksombooncharoen Hidenori, Takahashi Choong-Kun, Lee Gordon, Cohen Juan, Cundom Renata, Zaucha |
| AuthorAffiliation | 17Department of Medicine, Washington University School of Medicine, St. Louis, MO, USA 18Instituto de Investigaciones Metabolicas, Buenos Aires, Argentina 19Division of Medical Oncology, Department of Internal Medicine, Yonsei Cancer Center, Yonsei University College of Medicine, Seoul, South Korea 20Department of Gastroenterological Surgery, Osaka International Cancer Institute, Osaka, Japan 3Cancer Center of Nanjing, Jinling Hospital, Nanjing, China 6Gastroenterology, Hepatology & Endocrinology, Hannover Medical School, Hannover, Germany 8Department of Internal Medicine, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand 7Division of Medical Oncology, Department of Internal Medicine, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam, South Korea 16Istituto Nazionale Tumori-IRCCS Fondazione G. Pascale, Naples, Italy 22Department of Hematology-Oncology, Linkou Chang-Gung MemorialHospital & Chang-Gung University, Tao-yuan City, Taiw |
| AuthorAffiliation_xml | – name: 16Istituto Nazionale Tumori-IRCCS Fondazione G. Pascale, Naples, Italy – name: 9Division of Medical Oncology, Department of Internal Medicine, Seoul St. Mary's Hospital, College of Medicine, The Catholic University, Seoul, South Korea – name: 14Division of Cancer Sciences, The University of Manchester/The Christie NHS Foundation Trust, Manchester, UK – name: 17Department of Medicine, Washington University School of Medicine, St. Louis, MO, USA – name: 1Division of Medical Oncology, Department of Internal Medicine, Seoul National University Hospital, Cancer Research Institute, Seoul National University College of Medicine, Seoul, South Korea – name: 2Division of Hematology & Oncology, Georgetown Lombardi Comprehensive Cancer Center, Georgetown University, Washington, DC, USA – name: 3Cancer Center of Nanjing, Jinling Hospital, Nanjing, China – name: 11Sarah Cannon Research Institute, Tennessee Oncology, Nashville, TN, USA – name: 4Kaohsiung Medical University Hospital, Kaohsiung Medical University, Kaohsiung, & National Institute of Cancer Research, Tainan, & National Cheng Kung University Hospital, National Cheng Kung University, Tainan, Taiwan – name: 7Division of Medical Oncology, Department of Internal Medicine, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam, South Korea – name: 8Department of Internal Medicine, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand – name: 22Department of Hematology-Oncology, Linkou Chang-Gung MemorialHospital & Chang-Gung University, Tao-yuan City, Taiwan – name: 23AstraZeneca, Gaithersburg, MD, USA – name: 5Department of Hepatobiliary & Pancreatic Oncology, National Cancer Center Hospital, Tokyo, Japan – name: 20Department of Gastroenterological Surgery, Osaka International Cancer Institute, Osaka, Japan – name: 19Division of Medical Oncology, Department of Internal Medicine, Yonsei Cancer Center, Yonsei University College of Medicine, Seoul, South Korea – name: 10Second Department of Internal Medicine, Wakayama Medical University, Wakayama, Japan – name: 13Department of Internal Medicine, Faculty of Medicine, Chulalongkorn University, King Chulalongkorn Memorial Hospital, Bangkok, Thailand – name: 18Instituto de Investigaciones Metabolicas, Buenos Aires, Argentina – name: 12Department of Liver Cancer Unit, AP-HP Hopital Beaujon, Paris, France – name: 15Department of Oncology & Radiotherapy, Medical University of Gdańsk, Gdańsk, Poland – name: 21Department of Hepatobiliary & Pancreatic Oncology, National Cancer Center Hospital East, Kashiwa, Japan – name: 24AstraZeneca, Warsaw, Poland – name: 6Gastroenterology, Hepatology & Endocrinology, Hannover Medical School, Hannover, Germany |
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| SubjectTerms | Adult Antineoplastic Combined Chemotherapy Protocols Antineoplastic Combined Chemotherapy Protocols - adverse effects bile duct cancer Bile Duct Neoplasms Bile Duct Neoplasms - drug therapy biliary tract cancer Biliary Tract Neoplasms Biliary Tract Neoplasms - drug therapy chemotherapy cholangiocarcinoma Cisplatin Deoxycytidine durvalumab Gemcitabine Humans ICTS (Institute of Clinical and Translational Sciences) immunotherapy lay summary Medicine and Health Sciences plain language summary |
| Title | Plain language summary of the TOPAZ-1 study: durvalumab and chemotherapy for advanced biliary tract cancer |
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