Yunfu Deng1, Guangzhi Ma2, Wen Li1, Ting Wang3, Yaqin Zhao1, Qiang Wu4. 1. Cancer Center, Sichuan University, Chengdu, China. 2. Department of Thoracic Surgery, Sichuan University, Chengdu, China. 3. Lung Cancer Center, West China Hospital, Sichuan University, Chengdu, China. 4. Lung Cancer Center, West China Hospital, Sichuan University, Chengdu, China. Electronic address: wuqiang818@126.com.
Abstract
BACKGROUND: This meta-analysis of randomized controlled trials aimed to comprehensively assess the efficacy and toxicity of cyclin-dependent kinase (CDK) 4/6 inhibitors in advanced breast cancer (ABC) with hormone-receptor positive (HR+) and human epidermal growth factor receptor 2 negative (HER2-) disease. METHODS: We performed a systematical search using Cochrane Library, PubMed, Embase, and Web of Science up to March 2018. Only phase 2 and 3 randomized clinical trials assessing the efficacy and toxicity of the combination regimen of CDK4/6 inhibitors plus hormone therapy compared with hormone therapy alone were eligible for this meta-analysis. The pooled analyses of relative risk (RR) and hazard ratio were carried out by Stata software. RESULTS: A total of 7 randomized controlled trials including 3854 patients with HR+/HER2- ABC were included in this meta-analysis. The pooled hazard ratio for progression-free survival was 0.54 (95% confidence interval, 0.49-0.59; P < .001), and the pooled RR for the objective response rate in all intent-to-treat patients was 1.51 (95% confidence interval, 1.26-1.81; P < .001). The pooled RRs for all grade adverse events (AEs) and grade 3/4 AEs were 1.07 (95% confidence interval, 1.03-1.11; P < .001) and 2.81 (95% confidence interval, 2.54-3.11; P < .001), respectively. However, to investigate the influence of CDK4/6 inhibitors on overall survival, sufficient follow-up is still needed. CONCLUSION: CDK4/6 inhibitors plus hormone therapy can significantly prolong the progression-free survival of patients with HR+/HER2- ABC and improve the objective response rate compared to conventional hormone therapy alone. The combined regimen results in a higher risk of AEs, especially grade 3/4 AEs.
BACKGROUND: This meta-analysis of randomized controlled trials aimed to comprehensively assess the efficacy and toxicity of cyclin-dependent kinase (CDK) 4/6 inhibitors in advanced breast cancer (ABC) with hormone-receptor positive (HR+) and humanepidermal growth factor receptor 2 negative (HER2-) disease. METHODS: We performed a systematical search using Cochrane Library, PubMed, Embase, and Web of Science up to March 2018. Only phase 2 and 3 randomized clinical trials assessing the efficacy and toxicity of the combination regimen of CDK4/6 inhibitors plus hormone therapy compared with hormone therapy alone were eligible for this meta-analysis. The pooled analyses of relative risk (RR) and hazard ratio were carried out by Stata software. RESULTS: A total of 7 randomized controlled trials including 3854 patients with HR+/HER2- ABC were included in this meta-analysis. The pooled hazard ratio for progression-free survival was 0.54 (95% confidence interval, 0.49-0.59; P < .001), and the pooled RR for the objective response rate in all intent-to-treat patients was 1.51 (95% confidence interval, 1.26-1.81; P < .001). The pooled RRs for all grade adverse events (AEs) and grade 3/4 AEs were 1.07 (95% confidence interval, 1.03-1.11; P < .001) and 2.81 (95% confidence interval, 2.54-3.11; P < .001), respectively. However, to investigate the influence of CDK4/6 inhibitors on overall survival, sufficient follow-up is still needed. CONCLUSION:CDK4/6 inhibitors plus hormone therapy can significantly prolong the progression-free survival of patients with HR+/HER2- ABC and improve the objective response rate compared to conventional hormone therapy alone. The combined regimen results in a higher risk of AEs, especially grade 3/4 AEs.
Authors: Anna E Vilgelm; Nabil Saleh; Rebecca Shattuck-Brandt; Kelsie Riemenschneider; Lauren Slesur; Sheau-Chiann Chen; C Andrew Johnson; Jinming Yang; Ashlyn Blevins; Chi Yan; Douglas B Johnson; Rami N Al-Rohil; Ensar Halilovic; Rondi M Kauffmann; Mark Kelley; Gregory D Ayers; Ann Richmond Journal: Sci Transl Med Date: 2019-08-14 Impact factor: 17.956
Authors: Harold J Burstein; Mark R Somerfield; Debra L Barton; Ali Dorris; Lesley J Fallowfield; Dharamvir Jain; Stephen R D Johnston; Larissa A Korde; Jennifer K Litton; Erin R Macrae; Lindsay L Peterson; Praveen Vikas; Rachel L Yung; Hope S Rugo Journal: J Clin Oncol Date: 2021-07-29 Impact factor: 44.544
Authors: Michela Piezzo; Paolo Chiodini; Maria Riemma; Stefania Cocco; Roberta Caputo; Daniela Cianniello; Germira Di Gioia; Vincenzo Di Lauro; Francesca Di Rella; Giuseppina Fusco; Giovanni Iodice; Francesco Nuzzo; Carmen Pacilio; Matilde Pensabene; Michelino De Laurentiis Journal: Int J Mol Sci Date: 2020-09-03 Impact factor: 5.923