@article{fbba5ac55f884364a235179ae474c729,
title = "ENGINE: A Phase III randomized placebo controlled study of enzastaurin/R-CHOP as frontline therapy in high-risk diffuse large B-cell lymphoma patients with the genomic biomarker DGM1",
abstract = "While combination of rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone (R-CHOP) cures most patients with diffuse large B-cell lymphoma (DLBCL), those with high-risk international prognostic index disease have inferior survival. Enzastaurin as a potent inhibitor of PKC-β and PI3K/AKT pathway suppressor has been tested in many clinical trials including two key studies in DLBCL: Phase III maintenance study (Preventing Relapse in Lymphoma Using Daily Enzastaurin [PRELUDE]) and a first-line Phase II study (S028). DNA extracted from PRELUDE patients' blood samples was retrospectively genotyped identifying a novel genetic biomarker, DGM1 that showed high correlation with response to enzastaurin. A similar finding observed in the S028 study suggested that addition of enzastaurin to R-CHOP may significantly improve outcomes as frontline therapy for high-risk DGM1 positive DLBCL patients. ENGINE is a global, multicenter, placebo-controlled and randomized study to compare the effect of R-CHOP/enzastaurin as frontline treatment in high-risk DLBCL patients. The primary end point for this study is overall survival in patients who are DGM1 positive. Clinical Trial Registration Identifier: NCT0326302.",
keywords = "DGM1, Enzastaurin, Lymphoma, Personalized chemotherapy",
author = "Nowakowski, {Grzegorz S.} and Jun Zhu and Qingyuan Zhang and Joshua Brody and Xiuhua Sun and Joseph Maly and Yuqin Song and Syed Rizvi and Yongping Song and Frederick Lansigan and Hongmei Jing and Junning Cao and Lue, {Jennifer K.} and Wen Luo and Lei Zhang and Ling Li and Isabel Han and Joan Sun and Manoj Jivani and Young Liu and Thomas Heineman and Smith, {Stephen D.}",
note = "Funding Information: The other coauthors are ENGINE study investigators: GS Nowakowski is a physician from Mayo Clinic, Rochester, MN, USA; J Zhu and Y Song are physicians from Peking University Cancer Hospital & Institute, Beijing, China; Q Zhang is a physician from Harbin Medical University Cancer Hospital, Harbin, China; J Brody is a physician from Icahn School of Medicine at Mount Sinai, NY, USA; X Sun is a physician from The Second Hospital of Dalian Medical University, Dalian, China; J Maly is a physician from Norton Cancer Institute, Louisville, KY, USA; S Rizvi is a physician from University of Texas Southwestern Medical Center, Dallas, TX, USA; Y Song is a physician from Affliliated Cancer Hospital of Zhengzhou University, Zhengzhou, China; F Lansigan is a physician from Dartmouth-Hitchcock Medical Center, Lebanon, NH, USA; H Jing is a physician from Peking University Third Hospital, Beijing, China; J Cao is a physician from Fudan University Shanghai Cancer Center, Shanghai, China; JK Lue is a physician from Columbia University Medical Center, NY, USA and SD Smith is a physician from University of Washington/Fred Hutchinson Cancer Center, Seattle, WA, USA. The coauthors acknowledge that Contract Research Organization support was executed by Covance. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed. No writing assistance was utilized in the production of this manuscript.",
year = "2020",
month = may,
doi = "10.2217/fon-2020-0176",
language = "English (US)",
volume = "16",
pages = "991--999",
journal = "Future Oncology",
issn = "1479-6694",
publisher = "Future Medicine Ltd.",
number = "15",
}