Five-Year Outcomes From the Randomized, Phase III Trials CheckMate 017 and 057: Nivolumab Versus Docetaxel in Previously Treated Non–Small-Cell Lung Cancer
| العنوان: | Five-Year Outcomes From the Randomized, Phase III Trials CheckMate 017 and 057: Nivolumab Versus Docetaxel in Previously Treated Non–Small-Cell Lung Cancer |
|---|---|
| المؤلفون: | Markus Wohlleber, Hossein Borghaei, Scott N. Gettinger, Everett E. Vokes, Wilfried Enst Erich Eberhardt, David M. Waterhouse, Enriqueta Felip, Charles Butts, Marco Angelo Burgio, Laura Q.M. Chow, David R. Spigel, Osvaldo Arén Frontera, Miriam Alonso Garcia, Joanna Wojcik-Tomaszewska, Manuel Domine, Scott J. Antonia, Fabrice Barlesi, Rita Chiari, Adam Pluzanski, S. Marimuthu, Grzegorz Czyzewicz, Ang Li, Lucio Crinò, David E. Gerber, Julie R. Brahmer, Neal Ready, Oscar Arrieta, Marina Chiara Garassino, Bruno Coudert, Javier de Castro Carpeño |
| المساهمون: | Institut Català de la Salut, [Borghaei H] Fox Chase Cancer Center, Philadelphia, PA. [Gettinger S] Yale Comprehensive Cancer Center, New Haven, CT. [Vokes EE] Univeristy of Chicago Medicine and Biologic Sciences Division, Chicago, IL. [Chow LQM] University of Washington, Seattle Cancer Care Alliance, Seattle, WA. [Burgio MA] Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, Italy. [de Castro Carpeno J] Hospital De Madrid, Norte Sanchinarro, Madrid, Spain. [Felip E] Vall d’Hebron Hospital Universitari, Barcelona, Spain. Vall d’Hebron Institute of Oncology (VHIO), Barcelona, Spain, Vall d'Hebron Barcelona Hospital Campus |
| المصدر: | Scientia J Clin Oncol |
| بيانات النشر: | American Society of Clinical Oncology, 2021. |
| سنة النشر: | 2021 |
| مصطلحات موضوعية: | Oncology, Male, Cancer Research, Phase iii trials, Lung Neoplasms, Time Factors, Checkmate, Medizin, Immunoteràpia, Docetaxel, Other subheadings::Other subheadings::/drug therapy [Other subheadings], 0302 clinical medicine, Carcinoma, Non-Small-Cell Lung, 030212 general & internal medicine, Immune Checkpoint Inhibitors, Randomized Controlled Trials as Topic, Aged, 80 and over, terapéutica::terapia biológica::inmunomodulación::inmunoterapia [TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS], Middle Aged, Neoplasms::Neoplasms by Site::Thoracic Neoplasms::Respiratory Tract Neoplasms::Lung Neoplasms::Bronchial Neoplasms::Carcinoma, Bronchogenic::Carcinoma, Non-Small-Cell Lung [DISEASES], Progression-Free Survival, Tubulin Modulators, Nivolumab, 030220 oncology & carcinogenesis, Disease Progression, Female, Non small cell, Immunotherapy, medicine.drug, Adult, medicine.medical_specialty, Otros calificadores::Otros calificadores::/farmacoterapia [Otros calificadores], 03 medical and health sciences, Young Adult, Internal medicine, medicine, Humans, Lung cancer, Aged, Errata, business.industry, Therapeutics::Biological Therapy::Immunomodulation::Immunotherapy [ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT], diagnóstico::pronóstico::resultado del tratamiento [TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS], neoplasias::neoplasias por localización::neoplasias torácicas::neoplasias del tracto respiratorio::neoplasias pulmonares::neoplasias de los bronquios::carcinoma broncogénico::carcinoma de pulmón de células no pequeñas [ENFERMEDADES], medicine.disease, Diagnosis::Prognosis::Treatment Outcome [ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT], Clinical Trials, Phase III as Topic, Avaluació de resultats (Assistència sanitària), Previously treated, business, Pulmons - Càncer - Tractament |
| الوصف: | PURPOSE Immunotherapy has revolutionized the treatment of advanced non–small-cell lung cancer (NSCLC). In two phase III trials (CheckMate 017 and CheckMate 057), nivolumab showed an improvement in overall survival (OS) and favorable safety versus docetaxel in patients with previously treated, advanced squamous and nonsquamous NSCLC, respectively. We report 5-year pooled efficacy and safety from these trials. METHODS Patients (N = 854; CheckMate 017/057 pooled) with advanced NSCLC, ECOG PS ≤ 1, and progression during or after first-line platinum-based chemotherapy were randomly assigned 1:1 to nivolumab (3 mg/kg once every 2 weeks) or docetaxel (75 mg/m2 once every 3 weeks) until progression or unacceptable toxicity. The primary end point for both trials was OS; secondary end points included progression-free survival (PFS) and safety. Exploratory landmark analyses were investigated. RESULTS After the minimum follow-up of 64.2 and 64.5 months for CheckMate 017 and 057, respectively, 50 nivolumab-treated patients and nine docetaxel-treated patients were alive. Five-year pooled OS rates were 13.4% versus 2.6%, respectively; 5-year PFS rates were 8.0% versus 0%, respectively. Nivolumab-treated patients without disease progression at 2 and 3 years had an 82.0% and 93.0% chance of survival, respectively, and a 59.6% and 78.3% chance of remaining progression-free at 5 years, respectively. Treatment-related adverse events (TRAEs) were reported in 8 of 31 (25.8%) nivolumab-treated patients between 3–5 years of follow-up, seven of whom experienced new events; one (3.2%) TRAE was grade 3, and there were no grade 4 TRAEs. CONCLUSION At 5 years, nivolumab continued to demonstrate a survival benefit versus docetaxel, exhibiting a five-fold increase in OS rate, with no new safety signals. These data represent the first report of 5-year outcomes from randomized phase III trials of a programmed death-1 inhibitor in previously treated, advanced NSCLC. |
| وصف الملف: | application/pdf |
| اللغة: | English |
| URL الوصول: | https://explore.openaire.eu/search/publication?articleId=doi_dedup___::d89b8198e8ce6230aa2c1dd4a7f7a11b https://hdl.handle.net/11351/7634 |
| Rights: | OPEN |
| رقم الانضمام: | edsair.doi.dedup.....d89b8198e8ce6230aa2c1dd4a7f7a11b |
| قاعدة البيانات: | OpenAIRE |
| الوصف غير متاح. |