Academic Journal
Updated Analysis From KEYNOTE-189: Pembrolizumab or Placebo Plus Pemetrexed and Platinum for Previously Untreated Metastatic Nonsquamous Non-Small-Cell Lung Cancer
| العنوان: | Updated Analysis From KEYNOTE-189: Pembrolizumab or Placebo Plus Pemetrexed and Platinum for Previously Untreated Metastatic Nonsquamous Non-Small-Cell Lung Cancer |
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| المؤلفون: | Gadgeel S., Rodriguez-Abreu D., Speranza G., Esteban E., Felip E., Domine M., Hui R., Hochmair M. J., Clingan P., Powell S. F., Cheng S. Y. -S., Bischoff H. G., Peled N., Grossi F., Jennens R. R., Reck M., Garon E. B., Novello S., Rubio-Viqueira B., Boyer M., Kurata T., Gray J. E., Yang J., Bas T., Pietanza M. C., Garassino M. C. |
| المساهمون: | Gadgeel S., Rodriguez-Abreu D., Speranza G., Esteban E., Felip E., Domine M., Hui R., Hochmair M.J., Clingan P., Powell S.F., Cheng S.Y.-S., Bischoff H.G., Peled N., Grossi F., Jennens R.R., Reck M., Garon E.B., Novello S., Rubio-Viqueira B., Boyer M., Kurata T., Gray J.E., Yang J., Bas T., Pietanza M.C., Garassino M.C. |
| سنة النشر: | 2020 |
| المجموعة: | Università degli studi di Torino: AperTo (Archivio Istituzionale ad Accesso Aperto) |
| الوصف: | PURPOSE: In KEYNOTE-189, first-line pembrolizumab plus pemetrexed-platinum significantly improved overall survival (OS) and progression-free survival (PFS) compared with placebo plus pemetrexed-platinum in patients with metastatic nonsquamous non‒small-cell lung cancer (NSCLC), irrespective of tumor programmed death-ligand 1 (PD-L1) expression. We report an updated analysis from KEYNOTE-189 (ClinicalTrials.gov: NCT02578680). METHODS: Patients were randomly assigned (2:1) to receive pemetrexed and platinum plus pembrolizumab (n = 410) or placebo (n = 206) every 3 weeks for 4 cycles, then pemetrexed maintenance plus pembrolizumab or placebo for up to a total of 35 cycles. Eligible patients with disease progression in the placebo-combination group could cross over to pembrolizumab monotherapy. Response was assessed per RECIST (version 1.1) by central review. No alpha was assigned to this updated analysis. RESULTS: As of September 21, 2018 (median follow-up, 23.1 months), the updated median (95% CI) OS was 22.0 (19.5 to 25.2) months in the pembrolizumab-combination group versus 10.7 (8.7 to 13.6) months in the placebo-combination group (hazard ratio [HR], 0.56; 95% CI, 0.45 to 0.70]). Median (95% CI) PFS was 9.0 (8.1 to 9.9) months and 4.9 (4.7 to 5.5) months, respectively (HR, 0.48; 95% CI, 0.40 to 0.58). Median (95% CI) time from randomization to objective tumor progression on next-line treatment or death from any cause, whichever occurred first (progression-free-survival-2; PFS-2) was 17.0 (15.1 to 19.4) months and 9.0 (7.6 to 10.4) months, respectively (HR, 0.49; 95% CI, 0.40 to 0.59). OS and PFS benefits with pembrolizumab were observed regardless of PD-L1 expression or presence of liver/brain metastases. Incidence of grade 3-5 adverse events was similar in the pembrolizumab-combination (71.9%) and placebo-combination (66.8%) groups. CONCLUSION: First-line pembrolizumab plus pemetrexed-platinum continued to demonstrate substantially improved OS and PFS in metastatic nonsquamous NSCLC, regardless of PD-L1 ... |
| نوع الوثيقة: | article in journal/newspaper |
| اللغة: | English |
| Relation: | info:eu-repo/semantics/altIdentifier/pmid/32150489; info:eu-repo/semantics/altIdentifier/wos/WOS:000537768800002; volume:38; issue:14; firstpage:1505; lastpage:1517; numberofpages:13; journal:JOURNAL OF CLINICAL ONCOLOGY; http://hdl.handle.net/2318/1753225; info:eu-repo/semantics/altIdentifier/scopus/2-s2.0-85083573113 |
| DOI: | 10.1200/JCO.19.03136 |
| الاتاحة: | http://hdl.handle.net/2318/1753225 https://doi.org/10.1200/JCO.19.03136 |
| Rights: | info:eu-repo/semantics/openAccess |
| رقم الانضمام: | edsbas.E2E2ED7 |
| قاعدة البيانات: | BASE |
| DOI: | 10.1200/JCO.19.03136 |
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