دورية أكاديمية

Exploratory analyses of treatment subgroup interaction by PD-L1 status and according to PD-L1 expression in the JAVELIN Bladder 100 trial.

التفاصيل البيبلوغرافية
العنوان: Exploratory analyses of treatment subgroup interaction by PD-L1 status and according to PD-L1 expression in the JAVELIN Bladder 100 trial.
المؤلفون: Climent MÁ; Valencian Institute of Oncology, Valencia, Spain., Álvarez C; Hospital Universitario Central de Asturias, Oviedo, Spain., Morales R; Vall d'Hebron University Hospital, Barcelona, Spain., Maroto P; Hospital Universitari de La Santa Creu I Sant Pau, Barcelona, Spain., Rodríguez-Vida A; Hospital del Mar-CIBERONC, IMIM Research Institute, Barcelona, Spain., Méndez-Vidal MJ; Maimonides Institute for Biomedical Research of Cordoba (IMIBIC), Reina Sofia University Hospital (HURS), Cordoba, Spain., Del Muro XG; Catalan Institute of Oncology, Barcelona, Spain., Puente J; Hospital Universitario Clínico San Carlos, Madrid, Spain., Láinez N; University Hospital of Navarra, Pamplona, Spain., Vázquez S; Hospital Universitario Lucus Augusti, Lugo, Spain., Castellano D; Hospital 12 de Octubre, Madrid, Spain., Lang CG; Merck S.L.U., an Affiliate of Merck KGaA, Madrid, Spain., Wang J; Pfizer, Cambridge, MA, USA., di Pietro A; Pfizer Srl, Milan, Italy., Davis C; Pfizer Translational Oncology, La Jolla, CA, USA., Sanz-Castillo B; Pfizer Oncology, Madrid, Spain., Bolós MV; Pfizer Oncology, Madrid, Spain., Valderrama BP; Virgen del Rocío University Hospital, Seville, Spain. bpvalderrama@gmail.com.
المصدر: Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico [Clin Transl Oncol] 2024 Jun; Vol. 26 (6), pp. 1532-1538. Date of Electronic Publication: 2023 Dec 15.
نوع المنشور: Journal Article; Randomized Controlled Trial; Clinical Trial, Phase III
اللغة: English
بيانات الدورية: Publisher: Country of Publication: Italy NLM ID: 101247119 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1699-3055 (Electronic) Linking ISSN: 1699048X NLM ISO Abbreviation: Clin Transl Oncol Subsets: MEDLINE
أسماء مطبوعة: Publication: <2010- >: Milan : Springer Italia
Original Publication: Barcelona, Spain : Doyma, c2005-
مواضيع طبية MeSH: B7-H1 Antigen*/metabolism , Antibodies, Monoclonal, Humanized*/therapeutic use , Urinary Bladder Neoplasms*/drug therapy , Urinary Bladder Neoplasms*/metabolism , Urinary Bladder Neoplasms*/pathology , Urinary Bladder Neoplasms*/mortality , Carcinoma, Transitional Cell*/drug therapy , Carcinoma, Transitional Cell*/metabolism , Carcinoma, Transitional Cell*/pathology, Humans ; Progression-Free Survival ; Female ; Male ; Antineoplastic Agents, Immunological/therapeutic use ; Aged ; Middle Aged ; Maintenance Chemotherapy ; Survival Rate
مستخلص: Purpose: Post hoc analysis of the JAVELIN Bladder 100 trial of avelumab maintenance in locally advanced/metastatic urothelial carcinoma (la/mUC) to determine the interaction by programmed death ligand 1 (PD-L1) status for overall survival (OS), and additional analyses of survival per a different PD-L1 expression cutoff of ≥ 1% in tumor cells or immune cells (TC/IC).
Methods: JAVELIN Bladder 100 data were used for the analysis of the interaction by PD-L1 status (per cutoff used in the trial) for OS and, additionally, OS and progression-free survival (PFS) analyses per a different ≥ 1% TC/IC PD-L1 expression cutoff (Ventana SP263 assay).
Results: No significant interaction between treatment and PD-L1 status was observed for OS. Clinically meaningful and robust survival data were observed in favor of avelumab using the different ≥ 1% TC/IC PD-L1 expression cutoff.
Conclusions: These results demonstrate the benefit of avelumab maintenance in la/mUC regardless of PD-L1 expression, consistent with approved labels.
(© 2023. The Author(s).)
References: J Clin Oncol. 2023 Jul 1;41(19):3486-3492. (PMID: 37071838)
Nat Med. 2021 Dec;27(12):2200-2211. (PMID: 34893775)
Lancet. 2018 Feb 24;391(10122):748-757. (PMID: 29268948)
Eur J Cancer. 2019 Jan;106:234-243. (PMID: 30528808)
J Immunother Cancer. 2019 Oct 26;7(1):278. (PMID: 31655605)
Crit Rev Oncol Hematol. 2022 Jun;174:103683. (PMID: 35439541)
Lancet Oncol. 2017 Feb;18(2):212-220. (PMID: 28081914)
Ann Oncol. 2022 Mar;33(3):244-258. (PMID: 34861372)
N Engl J Med. 2017 Mar 16;376(11):1015-1026. (PMID: 28212060)
Lancet Oncol. 2021 Jul;22(7):931-945. (PMID: 34051178)
N Engl J Med. 2020 Sep 24;383(13):1218-1230. (PMID: 32945632)
معلومات مُعتمدة: 10.13039/100009945 Merck KGaA
فهرسة مساهمة: Keywords: Advanced urothelial carcinoma; Avelumab; Interaction test; Maintenance treatment; PD-L1
المشرفين على المادة: 0 (avelumab)
0 (CD274 protein, human)
تواريخ الأحداث: Date Created: 20231215 Date Completed: 20240521 Latest Revision: 20240524
رمز التحديث: 20240524
مُعرف محوري في PubMed: PMC11108865
DOI: 10.1007/s12094-023-03358-4
PMID: 38102374
قاعدة البيانات: MEDLINE
الوصف
تدمد:1699-3055
DOI:10.1007/s12094-023-03358-4