دورية أكاديمية
أعرض في EDS

Treating relapsed/refractory mature T- and NK-cell neoplasms with tislelizumab: a multicenter open-label phase 2 study.

التفاصيل البيبلوغرافية
العنوان: Treating relapsed/refractory mature T- and NK-cell neoplasms with tislelizumab: a multicenter open-label phase 2 study.
المؤلفون: Bachy E; Hematology Department, Lyon Sud Hospital and Claude Bernard Lyon 1 University, Lyon, France., Savage KJ; Division of Medical Oncology, University of British Columbia, BC Cancer, Vancouver, Canada., Huang H; Sun Yat-Sen University Cancer Center, Guangzhou, China., Kwong YL; Queen Mary Hospital, Hong Kong SAR, China., Gritti G; ASST Papa Giovanni XXIII, Bergamo, Italy., Zhang Q; Harbin Medical University Cancer Hospital, Harbin, China., Liberati AM; Azienda Ospedaliera Santa Maria Terni, Terni, Italy., Cao J; Fudan University Shanghai Cancer Center, Shanghai, China., Yang H; The Cancer Hospital of the University of Chinese Academy of Sciences (Zhejiang Cancer Hospital), Hangzhou, China., Hao S; Xin Hua Hospital, Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, China., Hu J; Fujian Medical University Union Hospital, Fujian Institute of Hematology, Fuzhou, China., Zhou K; Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital, Zhengzhou, China., Petrini M; Azienda Ospedaliero Universitaria Pisana, Stabilimento di Santa Chiara, Pisa, Italy., Russo F; Ospedale Maggiore, Ematologia e Centro Trapianti Midollo Osseo (CTMO), AOU Parma, Parma, Italy., Zhang H; Tianjin Medical University Cancer Institute & Hospital, Tianjin, China., Sang W; The Affiliated Hospital of Xuzhou Medical University, Xuzhou, China., Ji J; West China Hospital, Sichuan University, Chengdu, China., Ferreri AJM; Lymphoma Unit, IRCCS San Raffaele Scientific Institute, Milano, Italy., Damaj GL; Institut d'Hematologie de Basse Normandie, Caen, France., Liu H; Beijing Hospital, Beijing, China., Zhang W; Peking Union Medical College Hospital, Beijing, China., Ke X; Peking University Third Hospital, Beijing, China., Ghiggi C; Ospedale Policlinico San Martino, Genoa, Italy., Huang S; BeiGene (Shanghai) Co Ltd, Shanghai, China., Li X; BeiGene (Shanghai) Co Ltd, Shanghai, China., Yao H; BeiGene (Shanghai) Co Ltd, Shanghai, China., Paik J; BeiGene USA, Inc, San Mateo, CA., Novotny W; BeiGene USA, Inc, San Mateo, CA., Zhou W; BeiGene (Shanghai) Co Ltd, Shanghai, China., Zhu H; BeiGene (Shanghai) Co Ltd, Shanghai, China., Zinzani PL; IRCCS Azienda Ospedaliero-Universitaria di Bologna, Istituto di Ematologia 'Seràgnoli,' Bologna, Italy.; Dipartimento di Medicina Specialistica, Diagnostica e Sperimentale, Università di Bologna, Bologna, Italy.
المصدر: Blood advances [Blood Adv] 2023 Aug 22; Vol. 7 (16), pp. 4435-4447.
نوع المنشور: Multicenter Study; Clinical Trial, Phase II; Journal Article; Research Support, Non-U.S. Gov't
اللغة: English
بيانات الدورية: Publisher: American Society of Hematology Country of Publication: United States NLM ID: 101698425 Publication Model: Print Cited Medium: Internet ISSN: 2473-9537 (Electronic) Linking ISSN: 24739529 NLM ISO Abbreviation: Blood Adv Subsets: MEDLINE
أسماء مطبوعة: Original Publication: Washington, DC : American Society of Hematology, [2016]-
مواضيع طبية MeSH: Mycosis Fungoides*/drug therapy , Lymphoma, T-Cell, Cutaneous*/drug therapy , Skin Neoplasms*/drug therapy, Humans ; Killer Cells, Natural/pathology
مستخلص: Patients with relapsed/refractory (R/R) mature T- and natural killer (NK)-cell neoplasms lack effective treatments after failure of standard therapies. This phase 2 study evaluated the efficacy and safety of the programmed cell death protein 1 inhibitor tislelizumab in these patients. Seventy-seven patients were treated with 200 mg tislelizumab every 3 weeks. Twenty-two patients with extranodal NK-/T-cell lymphomas were enrolled in cohort 1; 44 patients with peripheral T-cell lymphoma (PTCL) were enrolled in cohort 2 (21 patients had PTCL not otherwise specified, 11 patients had angioimmunoblastic T-cell lymphoma, and 12 patients had anaplastic large-cell lymphoma). Cohort 3 comprised 11 patients with cutaneous T-cell lymphoma, of which 8 patients had mycosis fungoides (MF) and 3 had Sézary syndrome. Of the 77 patients, 76.6% had advanced-stage disease, 51.9% had refractory disease, and 49.4% received ≥3 prior systemic regimens. Promising efficacy was observed in cohort 3 (median follow-up [FU], 16.6 months; overall response rate [ORR], 45.5%; complete response [CR], 9.1%; median duration of response [DOR], 11.3 months; median progression-free survival, 16.8 months; median overall survival, not reached). Modest efficacy was observed in cohort 1 (median FU, 8.4 months; ORR, 31.8%; CR, 18.2%; median DOR, not reached) and cohort 2 (median FU, 9.3 months; ORR, 20.5%; CR, 9.1%; median DOR, 8.2 months). Most treatment-related adverse events were grade 1 or 2, and the safety profile was consistent with the known safety profile of tislelizumab. In conclusion, tislelizumab was well tolerated, achieving modest efficacy in R/R mature T- and NK-cell neoplasms, with some long-lasting remissions. This trial was registered at www.clinicaltrials.gov as #NCT03493451.
(© 2023 by The American Society of Hematology. Licensed under Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International (CC BY-NC-ND 4.0), permitting only noncommercial, nonderivative use with attribution. All other rights reserved.)
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سلسلة جزيئية: ClinicalTrials.gov NCT03493451
المشرفين على المادة: 0KVO411B3N (tislelizumab)
تواريخ الأحداث: Date Created: 20230605 Date Completed: 20230824 Latest Revision: 20230824
رمز التحديث: 20240628
مُعرف محوري في PubMed: PMC10440460
DOI: 10.1182/bloodadvances.2022009575
PMID: 37276067
قاعدة البيانات: MEDLINE
الوصف
تدمد:2473-9537
DOI:10.1182/bloodadvances.2022009575