Trilaciclib prior to gemcitabine plus carboplatin for metastatic triple-negative breast cancer: phase III PRESERVE 2

被引:16
作者
Goel, Shom [1 ]
Tan, Antoinette R. [2 ]
Rugo, Hope S. [3 ]
Aftimos, Philippe [4 ]
Andric, Zoran [5 ]
Beelen, Andrew [6 ]
Zhang, Jingshan [6 ]
Yi, John S. [6 ]
Malik, Rajesh [6 ]
O'Shaughnessy, Joyce [7 ]
机构
[1] Peter MacCallum Canc Ctr, Melbourne, Vic 3000, Australia
[2] Atrium Hlth, Levine Canc Inst, Charlotte, NC 28204 USA
[3] Univ Calif San Francisco, Comprehens Canc Ctr, San Francisco, CA 94158 USA
[4] Univ Libre Bruxelles, Inst Jules Bordet, B-1070 Brussels, Belgium
[5] Clin Hosp Ctr Bezanijska Kosa, Belgrade 11080, Serbia
[6] G1 Therapeut, Res Triangle Pk, NC 27709 USA
[7] Baylor Univ, Med Ctr, Texas Oncol, US Oncol, Dallas, TX 75246 USA
关键词
carboplatin; CDK4/6; inhibitor; gemcitabine; immunotherapy; metastatic; overall survival; patient-reported outcome; phase III; trilaciclib; triple-negative breast cancer; DOUBLE-BLIND; SURVIVAL; CHEMOTHERAPY; WOMEN; FULVESTRANT;
D O I
10.2217/fon-2022-0773
中图分类号
R73 [肿瘤学];
学科分类号
100214 ;
摘要
Triple-negative breast cancer (TNBC) is an aggressive malignancy for which cytotoxic chemotherapy remains the backbone of treatment. Trilaciclib is an intravenous cyclin-dependent kinase 4/6 inhibitor that induces transient cell cycle arrest of hematopoietic stern and progenitor cells and immune cells during chemotherapy exposure, protecting them from chemotherapy-induced damage and enhancing immune activity. Administration of trilaciclib prior to gemcitabine plus carboplatin (GCb) significantly improved overall survival (OS) compared with GCb alone in an open-label phase II trial in patients with metastatic TNBC, potentially through protection and direct activation of immune function. The randomized, doubleblind, placebo-controlled, phase III PRESERVE 2 trial will evaluate the efficacy and safety of trilaciclib administered prior to GCb in patients with locally advanced unresectable or metastatic TNBC.
引用
收藏
页码:3701 / 3711
页数:11
相关论文
共 38 条
[1]   Sacituzumab Govitecan in Metastatic Triple-Negative Breast Cancer [J].
Bardia, A. ;
Hurvitz, S. A. ;
Tolaney, S. M. ;
Loirat, D. ;
Punie, K. ;
Oliveira, M. ;
Brufsky, A. ;
Sardesai, S. D. ;
Kalinsky, K. ;
Zelnak, A. B. ;
Weaver, R. ;
Traina, T. ;
Dalenc, F. ;
Aftimos, P. ;
Lynce, F. ;
Diab, S. ;
Cortes, J. ;
O'Shaughnessy, J. ;
Dieras, V ;
Ferrario, C. ;
Schmid, P. ;
Carey, L. A. ;
Gianni, L. ;
Piccart, M. J. ;
Loibl, S. ;
Goldenberg, D. M. ;
Hong, Q. ;
Olivo, M. S. ;
Itri, L. M. ;
Rugo, H. S. .
NEW ENGLAND JOURNAL OF MEDICINE, 2021, 384 (16) :1529-1541
[2]   Biology and Etiology of Young-Onset Breast Cancers among Premenopausal African American Women: Results from the AMBER Consortium [J].
Chollet-Hinton, Lynn ;
Olshan, Andrew F. ;
Nichols, Hazel B. ;
Anders, Carey K. ;
Lund, Jennifer L. ;
Allott, Emma H. ;
Bethea, Traci N. ;
Hong, Chi -Chen ;
Cohen, Stephanie M. ;
Khoury, Thaer ;
Zirpoli, Gary R. ;
Borges, Virginia F. ;
Rosenbergs, Lynn A. ;
Bandera, Elisa V. ;
Ambrosone, Christine B. ;
Palmers, Julie R. ;
Troester, Melissa A. .
CANCER EPIDEMIOLOGY BIOMARKERS & PREVENTION, 2017, 26 (12) :1722-1729
[3]   KEYNOTE-355: Final results from a randomized, double-blind phase III study of first-line pembrolizumab plus chemotherapy vs placebo plus chemotherapy for metastatic TNBC [J].
Cortes, J. ;
Cescon, D. W. ;
Rugo, H. S. ;
Im, S-A. ;
Yusof, M. Md ;
Gallardo, C. ;
Lipatov, O. ;
Barrios, C. H. ;
Perez-Garcia, J. ;
Iwata, H. ;
Masuda, N. ;
Otero, M. Torregroza ;
Gokmen, E. ;
Loi, S. ;
Guo, Z. ;
Zhou, X. ;
Karantza, V. ;
Pan, W. ;
Schmid, P. .
ANNALS OF ONCOLOGY, 2021, 32 :S1289-S1290
[4]  
Cortes J, 2020, LANCET, V396, P1817, DOI 10.1016/S0140-6736(20)32531-9
[5]  
Cristofanilli M., 2022, CLIN CANCER RES, V28, P3433
[6]   Trilaciclib prior to chemotherapy and atezolizumab in patients with newly diagnosed extensive-stage small cell lung cancer: A multicentre, randomised, double-blind, placebo-controlled Phase II trial [J].
Daniel, Davey ;
Kuchava, Vladimer ;
Bondarenko, Igor ;
Ivashchuk, Oleksandr ;
Reddy, Sreekanth ;
Jaal, Jana ;
Kudaba, Iveta ;
Hart, Lowell ;
Matitashvili, Amiran ;
Pritchett, Yili ;
Morris, Shannon R. ;
Sorrentino, Jessica A. ;
Antal, Joyce M. ;
Goldschmidt, Jerome .
INTERNATIONAL JOURNAL OF CANCER, 2021, 148 (10) :2557-2570
[7]   Survival with metastatic breast cancer based on initial presentation, de novo versus relapsed [J].
den Brok, Wendie D. ;
Speers, Caroline H. ;
Gondara, Lovedeep ;
Baxter, Emily ;
Tyldesley, Scott K. ;
Lohrisch, Caroline A. .
BREAST CANCER RESEARCH AND TREATMENT, 2017, 161 (03) :549-556
[8]   CDK4/6 Inhibition Augments Antitumor Immunity by Enhancing T-cell Activation [J].
Deng, Jiehui ;
Wang, Eric S. ;
Jenkins, Russell W. ;
Li, Shuai ;
Dries, Ruben ;
Yates, Kathleen ;
Chhabra, Sandeep ;
Huang, Wei ;
Liu, Hongye ;
Aref, Amir R. ;
Ivanova, Elena ;
Paweletz, Cloud P. ;
Bowden, Michaela ;
Zhou, Chensheng W. ;
Herter-Sprie, Grit S. ;
Sorrentino, Jessica A. ;
Bisi, John E. ;
Lizotte, Patrick H. ;
Merlino, Ashley A. ;
Quinn, Max M. ;
Bufe, Lauren E. ;
Yang, Annan ;
Zhang, Yanxi ;
Zhang, Hua ;
Gao, Peng ;
Chen, Ting ;
Cavanaugh, Megan E. ;
Rode, Amanda J. ;
Haines, Eric ;
Roberts, Patrick J. ;
Strum, Jay C. ;
Richards, William G. ;
Lorch, Jochen H. ;
Parangi, Sareh ;
Gunda, Viswanath ;
Boland, Genevieve M. ;
Bueno, Raphael ;
Palakurthi, Sangeetha ;
Freeman, Gordon J. ;
Ritz, Jerome ;
Haining, W. Nicholas ;
Sharpless, Norman E. ;
Arthanari, Haribabu ;
Shapiro, Geoffrey I. ;
Barbie, David A. ;
Gray, Nathanael S. ;
Wong, Kwok-Kin .
CANCER DISCOVERY, 2018, 8 (02) :216-233
[9]   First-line atezolizumab plus nab-paclitaxel for unresectable, locally advanced, or metastatic triple-negative breast cancer: IMpassion130 final overall survival analysis [J].
Emens, L. A. ;
Adams, S. ;
Barrios, C. H. ;
Dieras, V ;
Iwata, H. ;
Loi, S. ;
Rugo, H. S. ;
Schneeweiss, A. ;
Winer, E. P. ;
Patel, S. ;
Henschel, V ;
Swat, A. ;
Kaul, M. ;
Molinero, L. ;
Patel, S. ;
Chui, S. Y. ;
Schmid, P. .
ANNALS OF ONCOLOGY, 2021, 32 (08) :983-993
[10]   Atezolizumab and nab-Paclitaxel in Advanced Triple-Negative Breast Cancer: Biomarker Evaluation of the IMpassion130 Study [J].
Emens, Leisha A. ;
Molinero, Luciana ;
Loi, Sherene ;
Rugo, Hope S. ;
Schneeweiss, Andreas ;
Dieras, Veronique ;
Iwata, Hiroji ;
Barrios, Carlos H. ;
Nechaeva, Marina ;
Anh Nguyen-Duc ;
Chui, Stephen Y. ;
Husain, Amreen ;
Winer, Eric P. ;
Adams, Sylvia ;
Schmid, Peter .
JNCI-JOURNAL OF THE NATIONAL CANCER INSTITUTE, 2021, 113 (08) :1005-1016