Plain language summary of the TOPAZ-1 study: durvalumab and chemotherapy for advanced biliary tract cancer

被引：6

作者：

Oh, Do-Youn ^{[1
]}

He, Aiwu Ruth ^{[2
]}

Qin, Shukui ^{[3
]}

Chen, Li-Tzong ^{[4
,5
,6
]}

Okusaka, Takuji ^{[7
]}

Vogel, Arndt ^{[8
]}

Kim, Jin Won ^{[9
]}

Suksombooncharoen, Thatthan ^{[10
]}

Lee, Myung Ah ^{[11
]}

Kitano, Masayuki ^{[12
]}

Burris, Howard ^{[13
]}

Bouattour, Mohamed ^{[14
]}

Tanasanvimon, Suebpong ^{[15
]}

McNamara, Mairead G. ^{[16
]}

Zaucha, Renata ^{[17
]}

Avallone, Antonio ^{[18
]}

Tan, Benjamin ^{[19
]}

Cundom, Juan ^{[20
]}

Lee, Choong-kun ^{[21
]}

Takahashi, Hidenori ^{[22
]}

Ikeda, Masafumi ^{[23
]}

Chen, Jen-Shi ^{[24
,25
]}

Wang, Julie ^{[26
]}

Makowsky, Mallory ^{[26
]}

Rokutanda, Nana ^{[26
]}

Zotkiewicz, Magdalena ^{[27
]}

Kurland, John F. ^{[26
]}

Cohen, Gordon ^{[26
]}

Valle, Juan W. ^{[16
]}

机构：

[1] Seoul Natl Univ, Seoul Natl Univ Hosp, Coll Med, Canc Res Inst,Dept Internal Med,Div Med Oncol, Seoul, South Korea

[2] Georgetown Univ, Georgetown Lombardi Comprehens Canc Ctr, Div Hematol & Oncol, Washington, DC USA

[3] Jinling Hosp, Canc Ctr Nanjing, Nanjing, Peoples R China

[4] Kaohsiung Med Univ, Kaohsiung Med Univ Hosp, Kaohsiung, Taiwan

[5] Natl Inst Canc Res, Tainan, Taiwan

[6] Natl Cheng Kung Univ, Natl Cheng Kung Univ Hosp, Tainan, Taiwan

[7] Natl Canc Ctr, Dept Hepatobiliary & Pancreat Oncol, Tokyo, Japan

[8] Hannover Med Sch, Gastroenterol Hepatol & Endocrinol, Hannover, Germany

[9] Seoul Natl Univ, Bundang Hosp, Coll Med, Dept Internal Med,Div Med Oncol, Seongnam, South Korea

[10] Chiang Mai Univ, Fac Med, Dept Internal Med, Chiang Mai, Thailand

[11] Catholic Univ, Seoul St Marys Hosp, Coll Med, Dept Internal Med,Div Med Oncol, Seoul, South Korea

[12] Wakayama Med Univ, Dept Internal Med 2, Wakayama, Japan

[13] Tennessee Oncol, Sarah Cannon Res Inst, Nashville, TN USA

[14] Hop Beaujon, AP HP, Dept Liver Canc Unit, Paris, France

[15] Chulalongkorn Univ, King Chulalongkorn Mem Hosp, Fac Med, Dept Internal Med, Bangkok, Thailand

[16] Univ Manchester, Christie NHS Fdn Trust, Div Canc Sci, Manchester, England

[17] Med Univ Gdansk, Dept Oncol & Radiotherapy, Gdansk, Poland

[18] Ist Nazl Tumori IRCCS Fdn G Pascale, Naples, Italy

[19] Washington Univ, Sch Med, Dept Med, St Louis, MO USA

[20] Inst Invest Metab, Buenos Aires, Argentina

[21] Yonsei Univ, Yonsei Canc Ctr, Coll Med, Dept Internal Med,Div Med Oncol, Seoul, South Korea

[22] Osaka Int Canc Inst, Dept Gastroenterol Surg, Osaka, Japan

[23] Natl Canc Ctr Hosp East, Dept Hepatobiliary & Pancreat Oncol, Kashiwa, Japan

[24] Linkou Chang Gung Mem Hosp, Dept Hematol Oncol, Taoyuan, Taiwan

[25] Chang Gung Univ, Taoyuan, Taiwan

[26] AstraZeneca, Gaithersburg, MD USA

[27] AstraZeneca, Warsaw, Poland

来源：

FUTURE ONCOLOGY | 2023年 / 19卷 / 34期

关键词：

bile duct cancer; biliary tract cancer; chemotherapy; cholangiocarcinoma; cisplatin; durvalumab; gemcitabine; immunotherapy; lay summary; plain language summary;

D O I：

10.2217/fon-2023-0468

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

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.

引用

页码：2277 / 2289

页数：13

共 50 条

[21] Three-year survival, safety and extended long-term survivor (eLTS) analysis from the phase III TOPAZ-1 study of durvalumab (D) plus chemotherapy in advanced biliary tract cancer (aBTC)
Oh, D-Y.
He, A. R.
Qin, S.
Chen, L-T.
Okusaka, T.
Vogel, A.
Kim, J. W.
Suksombooncharoen, T.
Lee, M. A.
Kitano, M.
Burris, H. A.
Bouattour, M.
Tanasanvimon, S.
Zaucha, R. E.
Avallone, A.
Cundom, J. E.
Kuzko, A.
Wang, J.
Xynos, I.
Valle, J. W.
ANNALS OF ONCOLOGY, 2024, 35 : S1457 - S1458
[22] Impact of mutation status on efficacy outcomes in TOPAZ-1: A phase III study of durvalumab (D) or placebo (PBO) plus gemcitabine and cisplatin ( plus GC) in advanced biliary tract cancer (BTC)
Valle, J. W.
Qin, S.
Antonuzzo, L.
Tougeron, D.
Lee, C-K.
Tan, B. J.
Ikeda, M.
Guthrie, V.
McCoon, P.
Lee, Y. S.
Rokutanda, N.
Zotkiewicz, M.
Cohen, G.
Oh, D-Y.
ANNALS OF ONCOLOGY, 2022, 33 : S1457 - S1457
[23] Impact of mutation status on efficacy outcomes in TOPAZ-1: A Phase 3 study of Durvalumab (D) or Placebo (PBO) plus Gemcitabine and Cisplatin ( plus GC) in advanced Biliary Tract Cancer (BTC)
Vogel, A.
Valle, J.
Qin, S.
Antonuzo, L.
Tougeron, D.
Lee, C. -K.
Tan, B.
Ikeda, M.
Guthrie, V.
McCoon, P.
Lee, Y.
Rokutanda, N.
Watras, M.
Cohen, G.
Oh, D. -Y.
ONCOLOGY RESEARCH AND TREATMENT, 2023, 46 : 63 - 64
[24] Impact of mutation status on efficacy outcomes in TOPAZ-1: A Phase 3 study of durvalumab (D) or placebo (PBO) plus gemcitabine and cisplatin ( plus GC) in advanced biliary tract cancer (BTC)
Vogel, Arndt
Valle, Juan
Qin, Shukui
Antonuzzo, Lorenzo
Tougeron, David
Lee, Choongkun
Tan, Benjamin
Ikeda, Masafumi
Guthrie, Violeta
Mccoon, Patricia
Lee, Young
Rokutanda, Nana
Zotkiewicz, Magdalena
Cohen, Gordon
Oh, Do-Youn
ONCOLOGY RESEARCH AND TREATMENT, 2024, 47 : 68 - 68
[25] A phase 3 randomized, double-blind, placebo-controlled study of durvalumab in combination with gemcitabine plus cisplatin (GemCis) in patients (pts) with advanced biliary tract cancer (BTC): TOPAZ-1
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 A., III
Bouattour, Mohamed
Tanasanvimon, Suebpong
Zaucha, Renata
Avallone, Antonio
Cundom, Juan
Rokutanda, Nana
Xiong, Julia
Cohen, Gordon
Valle, Juan W.
JOURNAL OF CLINICAL ONCOLOGY, 2022, 40 (04)
[26] Durvalumab: A Review in Advanced Biliary Tract Cancer
Fung, Simon
Syed, Yahiya Y.
TARGETED ONCOLOGY, 2023, 18 (06) : 965 - 972
[27] Three-year survival, safety and extended long-term survivor (eLTS) analysis from the phase III TOPAZ-1 study of durvalumab (D) plus chemotherapy in biliary tract cancer (BTC)
Oh, D-Y.
He, A. R.
Qin, S.
Chen, L-T.
Okusaka, T.
Vogel, A.
Kim, J. W.
Suksombooncharoen, T.
Lee, M. A.
Kitano, M.
Burris, H. A.
Bouattour, M.
Tanasanvimon, S.
Zaucha, R. E.
Avallone, A.
Cundom, J. E.
Kuzko, A.
Wang, J.
Xynos, I.
Valle, J. W.
ANNALS OF ONCOLOGY, 2024, 35 : S117 - S117
[28] Durvalumab: A Review in Advanced Biliary Tract Cancer
Simon Fung
Yahiya Y. Syed
Targeted Oncology, 2023, 18 : 965 - 972
[29] A phase III, randomized, double-blind, placebo-controlled, international study of durvalumab in combination with gemcitabine plus cisplatin for patients with advanced biliary tract cancers: TOPAZ-1
Oh, D-Y.
Chen, L-T.
He, A. R.
Okusaka, T.
Qin, S.
Chin, S.
Rokutanda, N.
Uchinda, H.
Vogel, A.
Valle, J. W.
Kim, H.
ANNALS OF ONCOLOGY, 2019, 30 : 319 - 319
[30] Updated overall survival (OS) from the phase III TOPAZ-1 study of durvalumab (D) or placebo (PBO) plus gemcitabine and cisplatin ( plus GC) in patients (pts) with advanced biliary tract cancer (BTC)
Oh, D. Y.
He, A. R.
Qin, S.
Chen, L. T.
Okusaka, T.
Vogel, A.
Kim, J. W.
Suksombooncharoen, T.
Lee, M. A.
Kitano, M.
Burris, H. A.
Bouattour, M.
Tanasanvimon, S.
Zaucha, R. E.
Avallone, A.
Cundom, J. E.
Rokutanda, N.
Watras, M.
Cohen, G.
Valle, J. W.
ANNALS OF ONCOLOGY, 2022, 33 (07) : S565 - S566

← 1 2 3 4 5 →