FRINK Linked Data Fragments server

Matches in SemOpenAlex for { <https://semopenalex.org/work/W2977694751> ?p ?o ?g. }

• W2977694751 endingPage "v394" @default.
• W2977694751 startingPage "v393" @default.
• W2977694751 abstract "Abstract Background Conventional measures such as median progression-free survival may suboptimally characterize the full impact of immuno-oncology (I-O) agents vs other systemic anticancer therapies. Patients discontinuing I-O agents may experience periods of disease control without needing subsequent systemic anticancer therapy (Rx) but may still experience toxicity (TOX). Treatment-free survival (TFS) ± TOX can simultaneously characterize disease control and TOX for this off-treatment period. Methods Data were analyzed from all 1082 patients initiating Rx on the randomized phase 3 CheckMate 214 trial of nivolumab + ipilimumab (NIVO+IPI) vs sunitinib (SUN) for treatment-naive predominantly clear cell advanced renal cell carcinoma. TFS is defined as the area between Kaplan–Meier (KM) curves for 2 conventional time-to-event endpoints defined from randomization: time to protocol Rx cessation and time to subsequent Rx or death. TFS was subdivided as TFS with and without TOX by defining a third endpoint: time to cessation of Rx and TOX. TOX was defined as grade ≥3 Rx-related adverse events. Area under each KM curve was estimated by the 36-month restricted mean time to event. Results At 36 months, 60% of NIVO+IPI and 51% of SUN patients were alive, 15% NIVO+IPI and 9% SUN remained on original Rx, and 34% NIVO+IPI and 19% SUN patients were surviving free of subsequent Rx. The 36-month restricted mean TFS was 6.7 and 2.9 months for all NIVO+IPI and SUN patients, respectively (6.4 vs 2.8 months TFS without TOX). The table shows time by TFS subdivision and IMDC risk. Table . 971P IMDC risk group All Favorable Intermediate/Poor N = 547 N = 535 N = 124 N = 119 N = 423 N = 416 Restricted mean time NIVO+IPI SUN Difference NIVO+IPI SUN Difference NIVO+IPI SUN Difference OS, months 28.0 25.6 32.0 32.9 26.9 23.5 Time on protocol Rx, months 13.4 12.7 13.5 20.1 13.4 10.6 TFS, months (95% CI) 6.7 2.9 3.8 (2.4–5.3) 9.8 2.7 7.2 (4.4–10.0) 5.8 3.0 2.8 (1.7–4.0) TFS with TOX 0.4 0.1 0.2 (0.05–0.4) 0.5 0.1 0.4 (0.2–0.6) 0.3 0.2 –0.1 (–0.03–0.3) TFS without TOX 6.4 2.8 3.6 (2.3–5.0) 9.4 2.6 6.8 (4.1–9.5) 5.5 2.8 2.7 (1.6–3.8) Survival after subsequent Rx initiation, months 7.9 10.0 8.7 10.2 7.7 10.0 IMDC, International Metastatic Renal Cell Carcinoma Database Consortium; OS, overall survival. Conclusions NIVO+IPI provides longer survival and delayed time to subsequent Rx vs SUN. More importantly, NIVO+IPI provides longer TFS without TOX, during which patients do not require Rx and are free from TOX. Given the durability of I-O responses relative to SUN after Rx cessation, it will be of interest to measure TFS over time. Clinical trial identification NCT02231749. Editorial acknowledgement Nicolette Belletier, PhD, and Lawrence Hargett of Parexel. Legal entity responsible for the study Bristol-Myers Squibb. Funding Bristol-Myers Squibb and ONO Pharmaceutical Company Limited. Disclosure M.M. Regan: Advisory / Consultancy, Research grant / Funding (institution): Merck; Advisory / Consultancy, Research grant / Funding (institution): IPSEN; Research grant / Funding (institution), Travel / Accommodation / Expenses: BMS; Research grant / Funding (institution): Veridex; Research grant / Funding (institution): OncoGenex; Research grant / Funding (institution): Pfizer; Research grant / Funding (institution): Novartis; Research grant / Funding (institution): Ferring; Research grant / Funding (institution): Celgene; Research grant / Funding (institution): AstraZeneca; Research grant / Funding (institution): Pierre Fabre; Research grant / Funding (institution): Bayer; Research grant / Funding (institution): Roche; Research grant / Funding (institution): Astellas Pharma; Research grant / Funding (institution): Janssen; Research grant / Funding (institution): Millennium Pharmaceuticals; Research grant / Funding (institution): Sanofi; Research grant / Funding (institution): Sotio; Research grant / Funding (institution): Dendreon; Research grant / Funding (institution): Medivation. M.B. Atkins: Honoraria (self), Advisory / Consultancy: BMS; Advisory / Consultancy: Genentech; Advisory / Consultancy: Pfizer; Advisory / Consultancy: Novartis; Advisory / Consultancy: X4 Pharma; Advisory / Consultancy: Merck; Advisory / Consultancy: Exelixis; Advisory / Consultancy: Acceleron; Advisory / Consultancy: Eisai; Advisory / Consultancy: Glactone Pharma; Advisory / Consultancy: Agenus; Advisory / Consultancy: Array BioPharma; Advisory / Consultancy: Boehringer Ingelheim; Advisory / Consultancy: Aduro Biotech; Advisory / Consultancy: Newlink Genetics/Pharmatech; Advisory / Consultancy: Arrowhead Pharmaceuticals; Advisory / Consultancy: Werewolf Pharma; Advisory / Consultancy: Oncolys BioPharma; Advisory / Consultancy: Surface; Advisory / Consultancy: Iovance Biotherapeutics. T. Powles: Honoraria (self), Research grant / Funding (institution): AstraZeneca; Honoraria (self), Research grant / Funding (institution): Roche; Honoraria (self), Research grant / Funding (institution): Novartis; Honoraria (self): Merck; Honoraria (self): BMS; Honoraria (self): Pfizer; Honoraria (self): IPSEN; Honoraria (self): Novartis; Honoraria (self): Exelixis. S. Yang: Shareholder / Stockholder / Stock options, Full / Part-time employment: BMS. J.L. Johansen: Shareholder / Stockholder / Stock options, Full / Part-time employment: BMS. S. Rao: Shareholder / Stockholder / Stock options, Full / Part-time employment: BMS. K.M. Gooden: Shareholder / Stockholder / Stock options, Full / Part-time employment: BMS. D.F. McDermott: Advisory / Consultancy, Research grant / Funding (institution): BMS; Advisory / Consultancy, Research grant / Funding (institution): Merck; Advisory / Consultancy, Research grant / Funding (institution): Genentech/Roche; Advisory / Consultancy: Pfizer; Advisory / Consultancy: Exelixis; Advisory / Consultancy, Research grant / Funding (institution): Novartis; Advisory / Consultancy: X4 Pharma; Advisory / Consultancy: Array Biophrama; Advisory / Consultancy, Research grant / Funding (institution): Peloton Therapeutics; Advisory / Consultancy: EMD Serono; Advisory / Consultancy: Jounce Therapeutics; Advisory / Consultancy, Research grant / Funding (institution): Alkermes; Advisory / Consultancy: Lilly; Full / Part-time employment: BIDMC; Research grant / Funding (institution): Promethus Laboratories. All other authors have declared no conflicts of interest." @default.
• W2977694751 created "2019-10-10" @default.
• W2977694751 creator A5007052233 @default.
• W2977694751 creator A5016079502 @default.
• W2977694751 creator A5020560113 @default.
• W2977694751 creator A5025216921 @default.
• W2977694751 creator A5030070924 @default.
• W2977694751 creator A5030303670 @default.
• W2977694751 creator A5033518868 @default.
• W2977694751 creator A5059753491 @default.
• W2977694751 creator A5060579574 @default.
• W2977694751 creator A5062269075 @default.
• W2977694751 date "2019-10-01" @default.
• W2977694751 modified "2023-09-23" @default.
• W2977694751 title "Treatment-free survival, with and without toxicity, as a novel outcome applied to immuno-oncology agents in advanced renal cell carcinoma" @default.
• W2977694751 doi "https://doi.org/10.1093/annonc/mdz249.067" @default.
• W2977694751 hasPublicationYear "2019" @default.
• W2977694751 type Work @default.
• W2977694751 sameAs 2977694751 @default.
• W2977694751 citedByCount "3" @default.
• W2977694751 countsByYear W29776947512021 @default.
• W2977694751 countsByYear W29776947512022 @default.
• W2977694751 countsByYear W29776947512023 @default.
• W2977694751 crossrefType "journal-article" @default.
• W2977694751 hasAuthorship W2977694751A5007052233 @default.
• W2977694751 hasAuthorship W2977694751A5016079502 @default.
• W2977694751 hasAuthorship W2977694751A5020560113 @default.
• W2977694751 hasAuthorship W2977694751A5025216921 @default.
• W2977694751 hasAuthorship W2977694751A5030070924 @default.
• W2977694751 hasAuthorship W2977694751A5030303670 @default.
• W2977694751 hasAuthorship W2977694751A5033518868 @default.
• W2977694751 hasAuthorship W2977694751A5059753491 @default.
• W2977694751 hasAuthorship W2977694751A5060579574 @default.
• W2977694751 hasAuthorship W2977694751A5062269075 @default.
• W2977694751 hasBestOaLocation W29776947511 @default.
• W2977694751 hasConcept C126322002 @default.
• W2977694751 hasConcept C143998085 @default.
• W2977694751 hasConcept C2777472916 @default.
• W2977694751 hasConcept C2777546739 @default.
• W2977694751 hasConcept C29730261 @default.
• W2977694751 hasConcept C71924100 @default.
• W2977694751 hasConceptScore W2977694751C126322002 @default.
• W2977694751 hasConceptScore W2977694751C143998085 @default.
• W2977694751 hasConceptScore W2977694751C2777472916 @default.
• W2977694751 hasConceptScore W2977694751C2777546739 @default.
• W2977694751 hasConceptScore W2977694751C29730261 @default.
• W2977694751 hasConceptScore W2977694751C71924100 @default.
• W2977694751 hasLocation W29776947511 @default.
• W2977694751 hasOpenAccess W2977694751 @default.
• W2977694751 hasPrimaryLocation W29776947511 @default.
• W2977694751 hasRelatedWork W2005149537 @default.
• W2977694751 hasRelatedWork W2006667932 @default.
• W2977694751 hasRelatedWork W2014435840 @default.
• W2977694751 hasRelatedWork W2045758635 @default.
• W2977694751 hasRelatedWork W2332510130 @default.
• W2977694751 hasRelatedWork W2360810719 @default.
• W2977694751 hasRelatedWork W2530207419 @default.
• W2977694751 hasRelatedWork W2790557737 @default.
• W2977694751 hasRelatedWork W2948170385 @default.
• W2977694751 hasRelatedWork W4230673599 @default.
• W2977694751 hasVolume "30" @default.
• W2977694751 isParatext "false" @default.
• W2977694751 isRetracted "false" @default.
• W2977694751 magId "2977694751" @default.
• W2977694751 workType "article" @default.