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Plain language summary of the TOPAZ-1 study: durvalumab and chemotherapy for advanced biliary tract cancer.
Oh, Do-Youn; He, Aiwu Ruth; Qin, Shukui; Chen, Li-Tzong; Okusaka, Takuji; Vogel, Arndt; Kim, Jin Won; Suksombooncharoen, Thatthan; Lee, Myung Ah; Kitano, Masayuki; Burris, Howard; Bouattour, Mohamed; Tanasanvimon, Suebpong; McNamara, Mairead G; Zaucha, Renata; Avallone, Antonio; Tan, Benjamin; Cundom, Juan; Lee, Choong-Kun; Takahashi, Hidenori; Ikeda, Masafumi; Chen, Jen-Shi; Wang, Julie; Makowsky, Mallory; Rokutanda, Nana; Zotkiewicz, Magdalena; Kurland, John F; Cohen, Gordon; Valle, Juan W.
Affiliation
  • Oh DY; Division of Medical Oncology, Department of Internal Medicine, Seoul National University Hospital, Cancer Research Institute, Seoul National University College of Medicine, Seoul, South Korea.
  • He AR; Division of Hematology & Oncology, Georgetown Lombardi Comprehensive Cancer Center, Georgetown University, Washington, DC, USA.
  • Qin S; Cancer Center of Nanjing, Jinling Hospital, Nanjing, China.
  • Chen LT; Kaohsiung Medical University Hospital, Kaohsiung Medical University, Kaohsiung, & National Institute of Cancer Research, Tainan, & National Cheng Kung University Hospital, National Cheng Kung University, Tainan, Taiwan.
  • Okusaka T; Department of Hepatobiliary & Pancreatic Oncology, National Cancer Center Hospital, Tokyo, Japan.
  • Vogel A; Gastroenterology, Hepatology & Endocrinology, Hannover Medical School, Hannover, Germany.
  • Kim JW; Division of Medical Oncology, Department of Internal Medicine, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam, South Korea.
  • Suksombooncharoen T; Department of Internal Medicine, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand.
  • Lee MA; Division of Medical Oncology, Department of Internal Medicine, Seoul St. Mary's Hospital, College of Medicine, The Catholic University, Seoul, South Korea.
  • Kitano M; Second Department of Internal Medicine, Wakayama Medical University, Wakayama, Japan.
  • Burris H; Sarah Cannon Research Institute, Tennessee Oncology, Nashville, TN, USA.
  • Bouattour M; Department of Liver Cancer Unit, AP-HP Hopital Beaujon, Paris, France.
  • Tanasanvimon S; Department of Internal Medicine, Faculty of Medicine, Chulalongkorn University, King Chulalongkorn Memorial Hospital, Bangkok, Thailand.
  • McNamara MG; Division of Cancer Sciences, The University of Manchester/The Christie NHS Foundation Trust, Manchester, UK.
  • Zaucha R; Department of Oncology & Radiotherapy, Medical University of Gdansk, Gdansk, Poland.
  • Avallone A; Istituto Nazionale Tumori-IRCCS Fondazione G. Pascale, Naples, Italy.
  • Tan B; Department of Medicine, Washington University School of Medicine, St. Louis, MO, USA.
  • Cundom J; Instituto de Investigaciones Metabolicas, Buenos Aires, Argentina.
  • Lee CK; Division of Medical Oncology, Department of Internal Medicine, Yonsei Cancer Center, Yonsei University College of Medicine, Seoul, South Korea.
  • Takahashi H; Department of Gastroenterological Surgery, Osaka International Cancer Institute, Osaka, Japan.
  • Ikeda M; Department of Hepatobiliary & Pancreatic Oncology, National Cancer Center Hospital East, Kashiwa, Japan.
  • Chen JS; Department of Hematology-Oncology, Linkou Chang-Gung MemorialHospital & Chang-Gung University, Tao-yuan City, Taiwan.
  • Wang J; AstraZeneca, Gaithersburg, MD, USA.
  • Makowsky M; AstraZeneca, Gaithersburg, MD, USA.
  • Rokutanda N; AstraZeneca, Gaithersburg, MD, USA.
  • Zotkiewicz M; AstraZeneca, Warsaw, Poland.
  • Kurland JF; AstraZeneca, Gaithersburg, MD, USA.
  • Cohen G; AstraZeneca, Gaithersburg, MD, USA.
  • Valle JW; Division of Cancer Sciences, The University of Manchester/The Christie NHS Foundation Trust, Manchester, UK.
Future Oncol ; 19(34): 2277-2289, 2023 Nov.
Article in En | MEDLINE | ID: mdl-37746835
ABSTRACT
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. 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. 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.
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Full text: 1 Database: MEDLINE Main subject: Bile Duct Neoplasms / Biliary Tract Neoplasms Type of study: Clinical_trials Limits: Adult / Humans Language: En Journal: Future Oncol Year: 2023 Type: Article Affiliation country: South Korea
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Full text: 1 Database: MEDLINE Main subject: Bile Duct Neoplasms / Biliary Tract Neoplasms Type of study: Clinical_trials Limits: Adult / Humans Language: En Journal: Future Oncol Year: 2023 Type: Article Affiliation country: South Korea