Myelopreservation with the CDK4/6 inhibitor trilaciclib in patients with small-cell lung cancer receiving first-line chemotherapy: a phase Ib/randomized phase II trial

Annals of Oncology - Tập 30 - Trang 1613-1621 - 2019
J.M. Weiss1, T. Csoszi2, M. Maglakelidze3, R.J. Hoyer4, J.T. Beck5, M. Domine Gomez6, A. Lowczak7, R. Aljumaily8, C.M. Rocha Lima9, R.V. Boccia10, W. Hanna11, P. Nikolinakos12, V.K. Chiu13, T.K. Owonikoko14, S.R. Schuster15, M.A. Hussein16, D.A. Richards17, P. Sawrycki18, I. Bulat19, J.T. Hamm20
1Division of Hematology and Oncology, Lineberger Comprehensive Cancer Center at the University of North Carolina, Chapel Hill, USA
2Oncology, Hetenyi Geza Korhaz, Onkologiai Kozpont, Szolnok, Hungary
3Department of Oncology, Research Institute of Clinical Medicine, Tbilisi, Georgia, USA
4Department of Oncology, Memorial Hospital, University of Colorado Health, Colorado Springs, USA
5Department of Medical Oncology and Hematology, Highlands Oncology Group, Fayetteville, USA
6Department of Oncology, University Hospital Fundacion Jimenez Diaz, IIS-FJD, Madrid, Spain
7Department of Pulmonology, Faculty of Health and Science, University of Warmia and Mazury in Olsztyn, Poland
8Stephenson Cancer Center, University of Oklahoma, Oklahoma City, USA
9Gibbs Cancer Center and Research Institute, Spartanburg, USA
10Center for Cancer and Blood Disorders, Bethesda, USA
11Hematology/Oncology, University of Tennessee Medical Center, Knoxville, USA
12University Cancer & Blood Center, LLC, Athens, Greece
13Department of Hematology/Oncology, University of New Mexico Comprehensive Cancer Center, Albuquerque, USA
14Department of Hematology and Medical Oncology, Winship Cancer Institute, Emory University, Atlanta, USA
15University of Colorado, Fort Collins, USA
16Department of Oncology, Florida Cancer Specialists, Leesburg, USA
17Department of Oncology, US Oncology Research, Tyler, USA
18Department of Cancer Chemotherapy, Provincial Hospital, Toruń, Poland
19ARENSIA Oncology Unit, Institute of Oncology, Chisinau, Moldova
20Department of Medical Oncology, Norton Health Care, Louisville, USA

Tài liệu tham khảo

Bisi, 2016, Preclinical characterization of G1T28: a novel CDK4/6 inhibitor for reduction of chemotherapy-induced myelosuppression, Mol Cancer Ther, 15, 783, 10.1158/1535-7163.MCT-15-0775 He, 2017, Transient CDK4/6 inhibition protects hematopoietic stem cells from chemotherapy-induced exhaustion, Sci Transl Med, 9, eaal3986, 10.1126/scitranslmed.aal3986 Johnson, 2010, Mitigation of hematologic radiation toxicity in mice through pharmacological quiescence induced by CDK4/6 inhibition, J Clin Invest, 120, 2528, 10.1172/JCI41402 Roberts, 2012, Multiple roles of cyclin-dependent kinase 4/6 inhibitors in cancer therapy, J Natl Cancer Inst, 104, 476, 10.1093/jnci/djs002 Deng, 2018, CDK4/6 inhibition augments antitumor immunity by enhancing T-cell activation, Cancer Discov, 8, 216, 10.1158/2159-8290.CD-17-0915 Lai, 2018, Abstract 1752: transient exposure of trilaciclib, a CDK4/6 inhibitor, modulates gene expression in tumor immune infiltrates to promote a pro-inflammatory tumor microenvironment, Cancer Res, 78, 1752, 10.1158/1538-7445.AM2018-1752 Sorrentino, 2017, Abstract 5628: trilaciclib (G1T28), a CDK4/6 inhibitor, enhances the efficacy of combination chemotherapy and immune checkpoint inhibitor treatment in preclinical models, Cancer Res, 77, 5628, 10.1158/1538-7445.AM2017-5628 George, 2015, Comprehensive genomic profiles of small cell lung cancer, Nature, 524, 47, 10.1038/nature14664 Brown, 2014, 1 Kim, 2013 Arbuck, 1986, Etoposide pharmacokinetics in patients with normal and abnormal organ function, J Clin Oncol, 4, 1690, 10.1200/JCO.1986.4.11.1690 Elferink, 1987, Pharmacokinetics of carboplatin after i.v. administration, Cancer Treat Rep, 71, 1231 Kaul, 1995, Pharmacokinetics and bioequivalence of etoposide following intravenous administration of etoposide phosphate and etoposide in patients with solid tumors, J Clin Oncol, 13, 2835, 10.1200/JCO.1995.13.11.2835 van der Vijgh, 1991, Clinical pharmacokinetics of carboplatin, Clin Pharmacokinet, 21, 242, 10.2165/00003088-199121040-00002 Weiss, 2019, Positive effects of trilaciclib on patient myelosuppression-related symptoms and functioning: results from three phase 2 randomized, double-blind, placebo-controlled small cell lung cancer trials, Support Care Cancer, 27, S274 O'Shaughnessy, 2019, Trilaciclib (T), a CDK4/6 inhibitor, dosed with gemcitabine (G), carboplatin (C) in metastatic triple negative breast cancer (mTNBC) patients: preliminary phase 2 results, Cancer Res, 79, 10.1158/1538-7445.SABCS18-PD1-01