Primary results of STRONG: An open-label, multicenter, phase 3b study of fixed-dose durvalumab monotherapy in previously treated patients with urinary tract carcinoma

被引：10

作者：

Sonpavde, Guru P. ^{[1
]}

Sternberg, Cora N. ^{[2
,3
]}

Loriot, Yohann ^{[4
]}

Marabelle, Aurelien ^{[4
]}

Lee, Jae Lyun ^{[5
]}

Flechon, Aude ^{[6
]}

Roubaud, Guilhem ^{[7
]}

Pouessel, Damien ^{[8
]}

Zagonel, Vittorina ^{[9
]}

Calabro, Fabio ^{[10
]}

Banna, Giuseppe L. ^{[11
]}

Shin, Sang Joon ^{[12
]}

Vera-Badillo, Francisco E. ^{[13
]}

Powles, Thomas ^{[14
]}

Hellmis, Eva ^{[15
]}

Miranda, Paulo A. P. ^{[16
]}

Lima, Ana Rita ^{[16
]}

Emeribe, Ugochi ^{[17
]}

Oh, Sun Min ^{[16
]}

Hotte, Sebastien J. ^{[18
]}

机构：

[1] Dana Farber Canc Inst, Med Oncol, 450 Brookline Ave, Boston, MA 02215 USA

[2] Weill Cornell Med, Englander Inst Precis Med, Div Hematol & Oncol, Hematol Oncol,Sandra & Edward Meyer Canc Ctr, 413 E 69th St,Belfer Res Bldg, New York, NY 10021 USA

[3] Presbyterian Hosp, 1305 York Ave, New York, NY 10021 USA

[4] Univ Paris Saclay, Dept Canc Med, Gustave Roussy, Villejuif, France

[5] Univ Ulsan, Asan Med Ctr, Dept Oncol & Internal Med, Coll Med, 88 Olymp Ro 43 Gil, Seoul 05505, South Korea

[6] Ctr Leon Berard, Dept Med Oncol, 28 Rue Laennec, F-69008 Lyon, France

[7] Inst Bergonie, Med Oncol, 229 Cours Argonne, F-33000 Bordeaux, France

[8] IUCT Oncopole, Med Oncol Dept, Inst Claudius Regaud, 1 Ave Irene Joliot Curie, F-31059 Toulouse 9, France

[9] Veneto Inst Oncol, Oncol Dept, IRCCS, IOV,Oncol Unit 1, Padua, Italy

[10] San Camillo Forlanini Hosp, Med Oncol, 75 Circonvallazione Gianicolense, I-00152 Rome, RM, Italy

[11] Osped Cannizzaro, Dept Oncol, I-95126 Catania, Province Of Cat, Italy

[12] Yonsei Univ Hlth Syst, Dept Internal Med, 50-1 Yonsei Ro, Seoul 03722, South Korea

[13] Queens Univ, Dept Oncol, 25 King St W, Kingston, ON K7L 5P9, Canada

[14] Queen Mary Univ London, Ctr Expt Canc Med, Barts Canc Inst, Mile End Rd, London E1 4NS, England

[15] Inst Urologicum Duisburg, Kometenpl 29-33, D-47179 Duisburg, Germany

[16] AstraZeneca, Oncol Business Unit OBU, Global Med Affairs, 1 MedImmune Way, Gaithersburg, MD 20878 USA

[17] AstraZeneca, Stat Sci Immunooncol, 1 MedImmune Way, Gaithersburg, MD 20878 USA

[18] Juravinski Canc Ctr JCC, Dept Oncol, Hamilton Hlth Sci 699 Concess St, Hamilton, ON, Canada

来源：

EUROPEAN JOURNAL OF CANCER | 2022年 / 163卷

关键词：

Adverse events of special interest; Durvalumab; Fixed dose; Immune checkpoint inhibitor; Immune-mediated adverse events; Immune-related adverse events; Overall survival; PD-L1; Urinary tract carcinoma; Urothelial carcinoma; TREMELIMUMAB; CHEMOTHERAPY;

D O I：

10.1016/j.ejca.2021.12.012

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

Background: Prior durvalumab (anti-PD-L1 agent) studies in platinum-refractory metastatic urothelial carcinoma evaluated a dose of 10 mg/kg administered every two weeks. The nonrandomised phase 3b STRONG study (NCT03084471) evaluated the safety and efficacy of fixed-dose durvalumab at a more convenient dosing schedule in a previously treated patient population, more similar to a real-world clinical setting.Patients and methods: 867 patients with urothelial or nonurothelial urinary tract carcinoma (UTC) who progressed on or after platinum or nonplatinum chemotherapy were treated with durvalumab 1500 mg every four weeks; 87% had an Eastern Cooperative Oncology Group performance status (ECOG PS) of 0-1, and 13% had an ECOG PS of 2. The primary endpoint was the incidence of adverse events of special interest (AESIs), including immune mediated AEs (imAEs). Secondary and exploratory end-points included overall survival (OS), objective response rate (ORR) and disease control rate (at six and 12 months) (DCR).Results: AESIs of any grade were reported in 51% of patients (8% grade > 3). The incidence of imAEs was 11% (2% grade > 3). The median OS was 7.0 months (95% confidence interval [CI]: 6.4-8.2) and ORR was 18% (95% CI: 14.8-20.6), with complete responses in 5% of patients and a DCR at six months of 19% (95% CI: 16.1-22.1). Conclusion: Fixed-dose durvalumab monotherapy every four weeks has an acceptable safety profile and yields durable clinical activity in previously chemotherapy-treated patients with UTC. Safety and efficacy are consistent with previous durvalumab studies and other antiPD-1/PD-L1 agents in this setting.Clinicaltrials.gov identifier: NCT03084471 https://clinicaltrials.gov/ct2/show/NCT03084471. 2021 The Author(s). Published by Elsevier Ltd. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).

引用

页码：55 / 65

页数：11

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