دورية أكاديمية
Exploratory analyses of treatment subgroup interaction by PD-L1 status and according to PD-L1 expression in the JAVELIN Bladder 100 trial.
العنوان: | Exploratory analyses of treatment subgroup interaction by PD-L1 status and according to PD-L1 expression in the JAVELIN Bladder 100 trial. |
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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).) |
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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 |
تدمد: | 1699-3055 |
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DOI: | 10.1007/s12094-023-03358-4 |