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• W2890897291 abstract "9578 Background: Time to treatment failure (TTF) has been suggested as a practical clinical endpoint for studies of oncologic agents using real-world evidence (RWE). However, TTF is rarely studied as an endpoint in the clinical trial setting; thus, little is known about its association with commonly used endpoints such as progression-free survival (PFS) or overall survival (OS). Methods: All studies submitted to CDER as part of a marketing application between 2010 and 2016 for treatment of patients with advanced melanoma were considered. 11 phase 3, randomized, and active-controlled trials were included in this analysis; 3 studies had 3 arms, resulting in a total of 25 randomized arms. Therapeutic agents were categorized as chemotherapy (CT), single agent PD-1 inhibitors (PD1), all immunotherapy (IT), and targeted therapy (TT). Patient-level association between TTF and PFS or OS was determined using correlation coefficients (corr) for each trial and for each therapeutic category. Additionally, to determine associations of trial-level comparative efficacy measures, pair-wise analyses were performed of hazard ratios (HR) for TTF, PFS, and OS using a weighted linear regression model. Results: 6021 patients from 11 clinical trials were included in the analysis. Patient-level corr for each trial ranged from 0.62 to 0.93 for TTF and PFS and from 0.53 to 0.82 for TTF and OS. Corr between TTF and PFS, and TTF and OS by therapeutic category are listed in the Table below. Trial-level associations between TTF HR & PFS HR and TTF HR & OS HR in all patients were poor. However, in TT these associations were much stronger (TTF & PFS: R2 = 0.56 and TTF & OS: R2 = 0.80). Conclusions: Though these analyses indicate a clear association of TTF & PFS for all categories, the association of TTF & OS may only exist for a few therapeutic categories. Extension of this work to other disease types and therapeutic categories would benefit the discussion of clinical endpoints for RWE. Therapeutic Category N mTTF mPFS mOS Corr of TTF & PFS Corr of TTF & OS All patients 6021 5.1 5.1 18.7 0.80 0.60 CT 786 2.3 2.1 11.2 0.65 0.35 PD1 1354 8.4 6.2 28.2 0.86 0.67 IT 2937 3.2 3.5 18.7 0.79 0.58 TT 2298 7.5 7.4 19.8 0.79 0.72" @default.
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• W2890897291 date "2018-05-20" @default.
• W2890897291 modified "2023-10-18" @default.
• W2890897291 title "Time to treatment failure (TTF) as a potential clinical endpoint in real-world evidence (RWE) studies of melanoma." @default.
• W2890897291 doi "https://doi.org/10.1200/jco.2018.36.15_suppl.9578" @default.
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