دورية أكاديمية

Five-Year Outcomes with Pembrolizumab Versus Chemotherapy as First-Line Therapy in Patients with Non-Small-Cell Lung Cancer and Programmed Death Ligand-1 Tumor Proportion Score ? 1% in the KEYNOTE-042 Study

التفاصيل البيبلوغرافية
العنوان: Five-Year Outcomes with Pembrolizumab Versus Chemotherapy as First-Line Therapy in Patients with Non-Small-Cell Lung Cancer and Programmed Death Ligand-1 Tumor Proportion Score ? 1% in the KEYNOTE-042 Study
المؤلفون: De Castro G., Cho, Byoung Chul, Kudaba I., Wu Y.-L., Lopes G., Kowalski D.M., Turna H.Z.
بيانات النشر: Lippincott Williams and Wilkins
سنة النشر: 2023
مصطلحات موضوعية: anaplastic lymphoma kinase, carboplatin, epidermal growth factor, paclitaxel, pembrolizumab, pemetrexed, programmed death 1 ligand 1, antineoplastic agent, CD274 protein, human, epidermal growth factor receptor, protein tyrosine kinase, adult, advanced cancer, adverse drug reaction, aged, alopecia, anemia, area under the curve, Article, brain metastasis, cancer chemotherapy, cancer combination chemotherapy, cancer patient, cancer radiotherapy, clinical outcome, comparative study, constipation, current smoker, death
الوصف: Clinical trials frequently include multiple end points that mature at different times. The initial report, typically based on the primary end point, may be published when key planned co-primary or secondary analyses are not yet available. Clinical Trial Updates provide an opportunity to disseminate additional results from studies, published in JCO or elsewhere, for which the primary end point has already been reported.We report 5-year results from the phase III KEYNOTE-042 study (ClinicalTrials.gov identifier: NCT02220894). Eligible patients with locally advanced/metastatic non-small-cell lung cancer (NSCLC) without EGFR/ALK alterations and with programmed death ligand-1 (PD-L1) tumor proportion score (TPS) ? 1% received pembrolizumab 200 mg once every 3 weeks for 35 cycles or chemotherapy (carboplatin + paclitaxel or pemetrexed) for 4-6 cycles with optional maintenance pemetrexed. Primary end points were overall survival (OS) in PD-L1 TPS ? 50%, ? 20%, and ? 1% groups. Patients who completed 35 cycles of pembrolizumab with ? stable disease could begin second-course pembrolizumab upon progression. One thousand two hundred seventy-four patients were randomly assigned (pembrolizumab, n = 637; chemotherapy, n = 637). Median follow-up time was 61.1 (range, 50.0-76.3) months. OS outcomes favored pembrolizumab (v chemotherapy) regardless of PD-L1 TPS (hazard ratio [95% CI] for TPS ? 50%, 0.68 [0.57 to 0.81]; TPS ? 20%, 0.75 [0.64 to 0.87]; TPS ? 1%, 0.79 [0.70 to 0.89]), with estimated 5-year OS rates with pembrolizumab of 21.9%, 19.4%, and 16.6%, respectively. No new toxicities were identified. Objective response rate was 84.3% among 102 patients who completed 35 cycles of pembrolizumab and 15.2% among 33 patients who received second-course pembrolizumab. First-line pembrolizumab monotherapy continued to show durable clinical benefit versus chemotherapy after 5 years of follow-up in PD-L1-positive, locally advanced/metastatic NSCLC without EGFR/ALK alterations and remains a standard of care. © American Society of ...
نوع الوثيقة: article in journal/newspaper
وصف الملف: application/pdf
اللغة: English
ردمك: 978-0-01-037306-6
0-01-037306-3
تدمد: 0732183X
36306479
العلاقة: Journal of Clinical Oncology; Makale - Uluslararası Hakemli Dergi - Kurum Öğretim Elemanı; https://doi.org/10.1200/JCO.21.02885Test; https://hdl.handle.net/20.500.12831/12965Test; 41; 11; 1986; 1991; WOS:001037306300010; 2-s2.0-85152165284
DOI: 10.1200/JCO.21.02885
الإتاحة: https://doi.org/10.1200/JCO.21.02885Test
https://doi.org/20.500.12831/12965Test
https://hdl.handle.net/20.500.12831/12965Test
حقوق: info:eu-repo/semantics/openAccess
رقم الانضمام: edsbas.B6138C1B
قاعدة البيانات: BASE
الوصف
ردمك:9780010373066
0010373063
تدمد:0732183X
36306479
DOI:10.1200/JCO.21.02885