Durvalumab plus Gemcitabine and Cisplatin in Advanced Biliary Tract Cancer

Do-Youn Oh; Aiwu Ruth He; Shukui Qin; Li-Tzong Chen; Takuji Okusaka; Arndt Vogel; Jin Won Kim; Thatthan Suksombooncharoen; Myung Ah Lee; Masayuki Kitano; Howard Burris; Mohamed Bouattour; Suebpong Tanasanvimon; Mairéad G McNamara; Renata Zaucha; Antonio Avallone; Benjamin Tan; Juan Cundom; Choong-Kun Lee; Hidenori Takahashi; Masafumi Ikeda; Jen-Shi Chen; Julie Wang; Mallory Makowsky; Nana Rokutanda; Philip He; John F Kurland; Gordon Cohen; Juan W Valle

doi:10.1056/EVIDoa2200015

Durvalumab plus Gemcitabine and Cisplatin in Advanced Biliary Tract Cancer

NEJM Evid. 2022 Aug;1(8):EVIDoa2200015. doi: 10.1056/EVIDoa2200015. Epub 2022 Jun 1.

Authors

Do-Youn Oh¹, Aiwu Ruth He², Shukui Qin³, Li-Tzong Chen^{4

5

6}, Takuji Okusaka⁷, Arndt Vogel⁸, Jin Won Kim⁹, Thatthan Suksombooncharoen¹⁰, Myung Ah Lee¹¹, Masayuki Kitano¹², Howard Burris¹³, Mohamed Bouattour¹⁴, Suebpong Tanasanvimon¹⁵, Mairéad G McNamara¹⁶, Renata Zaucha¹⁷, Antonio Avallone¹⁸, Benjamin Tan¹⁹, Juan Cundom²⁰, Choong-Kun Lee²¹, Hidenori Takahashi²², Masafumi Ikeda²³, Jen-Shi Chen²⁴, Julie Wang²⁵, Mallory Makowsky²⁵, Nana Rokutanda²⁵, Philip He²⁵, John F Kurland²⁵, Gordon Cohen²⁵, Juan W Valle¹⁶

Affiliations

¹ Division of Medical Oncology, Department of Internal Medicine, Seoul National University Hospital, Cancer Research Institute, Seoul National University College of Medicine, Seoul, South Korea.
² Division of Hematology and Oncology, Georgetown Lombardi Comprehensive Cancer Center, Georgetown University, Washington, DC.
³ Cancer Center of Nanjing, Jinling Hospital, Nanjing, China.
⁴ Kaohsiung Medical University Hospital, Kaohsiung Medical University, Kaohsiung, Taiwan.
⁵ National Institute of Cancer Research, Tainan, Taiwan.
⁶ National Cheng Kung University Hospital, National Cheng Kung University, Tainan, Taiwan.
⁷ Department of Hepatobiliary and Pancreatic Oncology, National Cancer Center Hospital, Tokyo, Japan.
⁸ Gastroenterology, Hepatology and Endocrinology, Hannover Medical School, Hannover, Germany.
⁹ Division of Medical Oncology, Department of Internal Medicine, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam, South Korea.
¹⁰ Department of Internal Medicine, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand.
¹¹ Division of Medical Oncology, Department of Internal Medicine, Seoul St. Mary's Hospital, College of Medicine, The Catholic University, Seoul, South Korea.
¹² Second Department of Internal Medicine, Wakayama Medical University, Wakayama, Japan.
¹³ Sarah Cannon Research Institute, Tennessee Oncology, Nashville, TN.
¹⁴ Department of Liver Cancer Unit, Assistance Publique-Hôpitaux de Paris Hôpital Beaujon, Paris, France.
¹⁵ Department of Internal Medicine, Faculty of Medicine, Chulalongkorn University, King Chulalongkorn Memorial Hospital, Bangkok, Thailand.
¹⁶ Division of Cancer Sciences, The University of Manchester/The Christie NHS Foundation Trust, Manchester, UK.
¹⁷ Department of Oncology and Radiotherapy, Medical University of Gdańsk, Gdańsk, Poland.
¹⁸ Istituto Nazionale Tumori-IRCCS Fondazione G. Pascale, Naples, Italy.
¹⁹ Department of Medicine, Washington University School of Medicine, St. Louis, MO.
²⁰ Instituto de Investigaciones Metabólicas, Buenos Aires, Argentina.
²¹ Division of Medical Oncology, Department of Internal Medicine, Yonsei Cancer Center, Yonsei University College of Medicine, Seoul, South Korea.
²² Department of Gastroenterological Surgery, Osaka International Cancer Institute, Osaka, Japan.
²³ Department of Hepatobiliary and Pancreatic Oncology, National Cancer Center Hospital East, Kashiwa, Japan.
²⁴ Department of Hematology-Oncology, Linkou Chang-Gung Memorial Hospital and Chang-Gung University, Taoyuan City, Taiwan.
²⁵ AstraZeneca, Gaithersburg, MD.

PMID: 38319896
DOI: 10.1056/EVIDoa2200015

Abstract

Durvalumab Combination for Biliary Tract CancerThis trial randomly assigned patients with previously untreated locally advanced or metastatic biliary tract cancer to receive durvalumab or placebo in combination with gemcitabine plus cisplatin. Median overall survival (95% Cl) was 12.8 (11.1-14.0) months in the durvalumab group. Rates of grade 3 or 4 adverse events were similar between groups.