dc.contributor | Vall d'Hebron Barcelona Hospital Campus |
dc.contributor.author | Borghaei, Hossein |
dc.contributor.author | Gettinger, Scott |
dc.contributor.author | Vokes, Everett |
dc.contributor.author | Chow, Laura |
dc.contributor.author | Burgio, Marco Angelo |
dc.contributor.author | de Castro Carpeno, Javier |
dc.contributor.author | Felip Font, Enriqueta |
dc.date.accessioned | 2022-06-07T12:46:24Z |
dc.date.available | 2022-06-07T12:46:24Z |
dc.date.issued | 2021-03-01 |
dc.identifier.citation | Borghaei H, Gettinger S, Vokes EE, Chow LQM, Burgio MA, de Castro Carpeno J, et al. Five-Year Outcomes From the Randomized, Phase III Trials CheckMate 017 and 057: Nivolumab Versus Docetaxel in Previously Treated Non-Small-Cell Lung Cancer. J Clin Oncol. 2021 Mar 1;39(7):723–33. |
dc.identifier.issn | 1527-7755 |
dc.identifier.uri | https://hdl.handle.net/11351/7634 |
dc.description | Nivolumab; Docetaxel; Lung cancer |
dc.description.abstract | 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. |
dc.language.iso | eng |
dc.publisher | American Society of Clinical Oncology |
dc.relation.ispartofseries | Journal of Clinical Oncology;39(7) |
dc.rights | Attribution-NonCommercial-NoDerivatives 4.0 International |
dc.rights.uri | http://creativecommons.org/licenses/by-nc-nd/4.0/ |
dc.source | Scientia |
dc.subject | Avaluació de resultats (Assistència sanitària) |
dc.subject | Pulmons - Càncer - Tractament |
dc.subject | Immunoteràpia |
dc.subject.mesh | Carcinoma, Non-Small-Cell Lung |
dc.subject.mesh | /drug therapy |
dc.subject.mesh | Immunotherapy |
dc.subject.mesh | Treatment Outcome |
dc.title | Five-Year Outcomes From the Randomized, Phase III Trials CheckMate 017 and 057: Nivolumab Versus Docetaxel in Previously Treated Non–Small-Cell Lung Cancer |
dc.type | info:eu-repo/semantics/article |
dc.identifier.doi | 10.1200/JCO.20.01605 |
dc.subject.decs | carcinoma de pulmón de células no pequeñas |
dc.subject.decs | /farmacoterapia |
dc.subject.decs | inmunoterapia |
dc.subject.decs | resultado del tratamiento |
dc.relation.publishversion | https://doi.org/10.1200/JCO.20.01605 |
dc.type.version | info:eu-repo/semantics/publishedVersion |
dc.audience | Professionals |
dc.contributor.organismes | Institut Català de la Salut |
dc.contributor.authoraffiliation | [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 |
dc.identifier.pmid | 33449799 |
dc.identifier.wos | 000635371200005 |
dc.rights.accessrights | info:eu-repo/semantics/openAccess |