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• W2953577079 abstract "// Ling Wang 1 , 3 , Hung Lam 2 , Yaping Shou 1 , 4 and Aaron Galaznik 1 , 5 1 Millennium Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, Cambridge, MA, USA 2 MMS Holdings Inc., Canton, MI, USA 3 Currently employed at Pfizer, Inc. 4 Currently employed at Trillium Therapeutics Inc. 5 Currently employed at SHYFT Analytics, a Medidata Company Correspondence to: Aaron Galaznik, email: aaron.galaznik.wg04@wharton.upenn.edu Keywords: diffuse large B-cell lymphoma; meta-analyses; outcomes; overall response rate; durable response rate Received: August 24, 2018     Accepted: April 14, 2019     Published: May 14, 2019 ABSTRACT Relapsed/refractory diffuse large B-cell lymphoma (DLBCL) is highly heterogeneous and current trials are investigating new approaches to improve outcomes. Limited data on response endpoints can confound estimation of a treatment effect when designing studies of novel agents in this setting, which can hinder study sample size calculations, especially if a net estimate is required for a &#x2018;physician&#x2019;s choice&#x2019; comparator arm. Here we estimate complete response rate (CRR), overall response rate (ORR), and extrapolate durable response rates (DRR; CR/partial response lasting &#x2265;16 weeks) for such a comparator arm from published ORRs in DLBCL. CRR, ORR, and DRR (if reported) were obtained from published clinical trials for approved single-agent therapies in patients with relapsed/refractory aggressive non-Hodgkin lymphoma after &#x2265;2 prior therapies. Meta-analyses were performed to estimate CRR, ORR, and DRR based on ORR data reported from these studies. Published data from studies of eight monotherapies were included. Meta-analyses using fixed and random effects models showed a pooled estimate for a CRR of 12% (95% confidence interval [CI]: 9&#x2212;15) and 11% (95% CI: 8&#x2212;15), respectively, an ORR of 30% (95% CI: 25&#x2212;35) and 30% (95% CI: 24&#x2212;36), respectively, and a DRR of 14% (95% CI: 11&#x2212;18; same for fixed and random effects models). Bayesian meta-analysis estimated a pooled DRR of 14% (95% credible interval: 11&#x2212;19). CRR estimates for a physician&#x2019;s choice comparator arm in patients with relapsed/refractory DLBCL were 11&#x2212;12%; DRR estimates were 14% regardless of methodology. Lack of consistency in reported data and choice of endpoints can be addressed using meta-analytic approaches." @default.
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• W2953577079 date "2019-05-14" @default.
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• W2953577079 title "Meta-analytical methods for estimating outcomes from overall response rate in patients with relapsed/refractory diffuse large B-cell lymphoma" @default.
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• W2953577079 doi "https://doi.org/10.18632/oncotarget.26904" @default.
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