التفاصيل البيبلوغرافية
| العنوان: |
Programmed Death-Ligand 1 Expression and Response to the Anti–Programmed Death 1 Antibody Pembrolizumab in Melanoma |
| المؤلفون: |
Daud, Adil I, Wolchok, Jedd D, Robert, Caroline, Hwu, Wen-Jen, Weber, Jeffrey S, Ribas, Antoni, Hodi, F Stephen, Joshua, Anthony M, Kefford, Richard, Hersey, Peter, Joseph, Richard, Gangadhar, Tara C, Dronca, Roxana, Patnaik, Amita, Zarour, Hassane, Roach, Charlotte, Toland, Grant, Lunceford, Jared K, Li, Xiaoyun Nicole, Emancipator, Kenneth, Dolled-Filhart, Marisa, Kang, S Peter, Ebbinghaus, Scot, Hamid, Omid |
| المصدر: |
Journal of Clinical Oncology, vol 34, iss 34 |
| بيانات النشر: |
eScholarship, University of California |
| سنة النشر: |
2016 |
| المجموعة: |
University of California: eScholarship |
| مصطلحات موضوعية: |
Cancer, Brain Disorders, Clinical Research, Clinical Trials and Supportive Activities, Adolescent, Adult, Aged, 80 and over, Antibodies, Monoclonal, Humanized, Antineoplastic Agents, B7-H1 Antigen, Biomarkers, Tumor, Drug Administration Schedule, Female, Humans, Immunohistochemistry, Male, Melanoma, Middle Aged, Neoplasm Staging, Programmed Cell Death 1 Receptor, Survival Rate, Treatment Outcome, Clinical Sciences, Oncology and Carcinogenesis, Oncology & Carcinogenesis |
| الوقت: |
4102 - 4109 |
| الوصف: |
Purpose Expression of programmed death-ligand 1 (PD-L1) is a potential predictive marker for response and outcome after treatment with anti-programmed death 1 (PD-1). This study explored the relationship between anti-PD-1 activity and PD-L1 expression in patients with advanced melanoma who were treated with pembrolizumab in the phase Ib KEYNOTE-001 study (clinical trial information: NCT01295827). Patients and Methods Six hundred fifty-five patients received pembrolizumab10 mg/kg once every 2 weeks or once every 3 weeks, or 2 mg/kg once every 3 weeks. Tumor response was assessed every 12 weeks per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by independent central review. Primary outcome was objective response rate. Secondary outcomes included progression-free survival (PFS) and overall survival (OS). Membranous PD-L1 expression in tumor and tumor-associated immune cells was assessed by a clinical trial immunohistochemistry assay (22C3 antibody) and scored on a unique melanoma (MEL) scale of 0 to 5 by one of three pathologists who were blinded to clinical outcome; a score ≥ 2 (membranous staining in ≥ 1% of cells) was considered positive. Results Of 451 patients with evaluable PD-L1 expression, 344 (76%) had PD-L1-positive tumors. Demographic and staging variables were equally distributed among PD-L1-positive and -negative patients. An association between higher MEL score and higher response rate and longer PFS (hazard ratio, 0.76; 95% CI, 0.71 to 0.82) and OS (hazard ratio, 0.76; 95% CI, 0.69 to 0.83) was observed ( P < .001 for each). Objective response rate was 8%, 12%, 22%, 43%, 57%, and 53% for MEL 0, 1, 2, 3, 4, and 5, respectively. Conclusion PD-L1 expression in pretreatment tumor biopsy samples was correlated with response rate, PFS, and OS; however, patients with PD-L1-negative tumors may also achieve durable responses. |
| نوع الوثيقة: |
article in journal/newspaper |
| وصف الملف: |
application/pdf |
| اللغة: |
unknown |
| العلاقة: |
qt4qt4v9j2; https://escholarship.org/uc/item/4qt4v9j2Test |
| الإتاحة: |
https://escholarship.org/uc/item/4qt4v9j2Test |
| حقوق: |
public |
| رقم الانضمام: |
edsbas.9F574298 |
| قاعدة البيانات: |
BASE |
