MONARCHplus: A phase III trial of abemaciclib plus nonsteroidal aromatase inhibitor (NSAI) or fulvestrant (F) for women with HR+/HER2- advanced breast cancer (ABC)

Jiang, Ze; Zhang, Q.; Sun, Tao; Yin, Yuan; Li, H.; Costa, Rafaela Lira Mendes; Yan, Max; Tong, Zhongsheng; Liu, Y.; Zhang, Y.; Cheng, Yu Ching; Ouyang, Quchang; Chen, X.; Liao, Naishun; Wu, Xinhong; Wang, X.; Han, Rong Xun; Lu, You Min

doi:10.1093/annonc/mdz394.014

Cited by 13 publications

(17 citation statements)

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“…33,35 Our meta-analysis showed an increase in PFS among patients with HR-positive, ERBB2-negative metastatic breast cancer associated with the use of CDK4/6 inhibitors plus ET compared with ET alone. 16,17,22,23,25,26,28,30,31 Our findings are consistent with the conclusions of previous meta-analyses. [36][37][38] In addition, our results supplement and update PFS data from previous studies.…”

Section: Discussionsupporting

confidence: 93%

“…After application of the exclusion criteria, we determined that 9 studies were eligible for this meta-analysis (eFigure 1 in the Supplement): 1 phase 2 trial and 8 phase 3 trials reported on the efficacy and safety of treatment with CDK inhibitors plus ET vs ET alone. 16,17,22,23,25,26,28,30,31 Thus, 9 articles, including a total of 5043 participants with HR-positive metastatic breast cancer, were included in the analysis.…”

Section: Characteristics Of the Included Studiesmentioning

confidence: 99%

“…The main characteristics and relevant outcomes of the included studies are provided in Table 1 and in the eTable in the Supplement. 16,17,22,23,25,26,28,30,31 There was more than 1 treatment group, and the control group is last.…”

Section: Characteristics Of the Included Studiesmentioning

confidence: 99%

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Association of Cyclin-Dependent Kinases 4 and 6 Inhibitors With Survival in Patients With Hormone Receptor–Positive Metastatic Breast Cancer

Huo

Zhao

et al. 2020

JAMA Netw Open

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IMPORTANCE One of the most recent treatment regimens used for hormone receptor (HR)positive, ERBB2 (formerly HER2)-negative metastatic breast cancer is treatment with the cyclindependent kinases 4 and 6 (CDK4/6) inhibitors and endocrine therapy (ET). OBJECTIVE To assess overall survival (OS), progression-free survival (PFS), objective response rate, and adverse events, especially grades 3 and 4 adverse events, among patients with HR-positive, ERBB2-negative metastatic breast cancer who were treated with CDK4/6 inhibitors plus ET vs ET alone. DATA SOURCES A systematic search of PubMed, Embase, the main oncology conference of the European Society of Medical Oncology, and the American Society of Clinical Oncology and the San Antonio Breast Cancer Symposium databases for randomized clinical trials of CDK4/6 inhibitors plus ET vs ET for HR-positive, ERBB2-negative metastatic breast cancer. Searches were performed up to March 30, 2020. STUDY SELECTION A total of 472 records were assessed in PubMed and Embase by 2 authors, including studies, international meeting reports, and reviews. Inclusion criteria were Englishlanguage phase 2 or 3 randomized clinical trials of HR-positive, ERBB2-negative metastatic breast cancer, with patients randomly assigned to receive CDK4/6 inhibitors plus ET or ET alone, and having OS or PFS outcomes. The exclusion criteria were phase 1 trials, retrospective studies, or studies without survival outcomes. Excluding the references, 16 articles were relevant. After excluding studies based on exclusion criteria, 9 studies were considered eligible for this meta-analysis. DATA EXTRACTION AND SYNTHESIS Two researchers independently extracted data and assessed potential bias. Data assessment followed the Preferred Reporting Items for Systematic Reviews and Meta-analyses reporting guideline. The results were pooled using a fixed-effect model. MAIN OUTCOMES AND MEASURES Study heterogeneity was assessed using the I 2 statistic. Hazard ratios (HRs) and 95% CIs were used to evaluate PFS, OS, and subgroup analyses. Overall response and 95% CIs were used to evaluate the objective response rate and grade 3 or 4 adverse events. The primary outcome was OS. RESULTS In total, 9 studies that included a total of 5043 patients with metastatic breast cancer were assessed in this meta-analysis.

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Section: Discussionsupporting

confidence: 93%

Section: Characteristics Of the Included Studiesmentioning

confidence: 99%

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Association of Cyclin-Dependent Kinases 4 and 6 Inhibitors With Survival in Patients With Hormone Receptor–Positive Metastatic Breast Cancer

Huo

Zhao

et al. 2020

JAMA Netw Open

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“…After screening the titles and abstracts, 124 remaining records were considered to be eligible for a full text review. Ultimately, 35 articles were selected which met all the inclusion criteria, giving a total of 12,285 patients involved in this network meta-analysis, as shown in [ 7 8 12 13 14 15 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 ]. The search process based on the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) technique is shown in in Figure 1 [ 48 ].…”

Section: Resultsmentioning

confidence: 99%

Comparison of Endocrine Therapies in Hormone Receptor-Positive and Human Epidermal Growth Factor Receptor 2-Negative Locally Advanced or Metastatic Breast Cancer: A Network Meta-Analysis

Liu

Sun

et al. 2020

J Breast Cancer

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We aimed to explore what kind of endocrine treatments are optimal for hormone receptor-positive and human epidermal growth factor receptor 2-negative locally advanced or metastatic breast cancer in some specific clinical situations. We searched randomized controlled trials in Embase, Medline, the Cochrane library, and PubMed from inception to April 1, 2020 and performed a network meta-analysis based on a Bayesian fixed-effects model. Progression-free survival (PFS) with hazard ratios and corresponding 95% confidence interval was defined as the primary endpoint, while overall survival (OS), objective response rate (ORR), clinical benefit rate and serious adverse events were used as secondary endpoints. A total of 35 studies involving 12,285 patients and 24 treatment options were included. In general, most co-treatment options prolonged PFS compared to single-agent therapy, of which aromatase inhibitor (AI) plus everolimus and fulvestrant plus palbociclib were probably the most effective agents, and the latter had the best safety record. However, despite the superior efficacy of fulvestrant plus capecitabine for PFS and OS, palpable toxic effects have been demonstrated for this treatment, so its application must be scrupulously considered. The results of subgroup analysis indicated that fulvestrant combined with palbociclib improved prognosis for phosphatidylinositol 3-kinase (PI3K)-mutated patients, PI3K-unmutated patients, patients with endocrine therapy resistance, and visceral metastatic patients, while no obvious improvement was detected in OS. Moreover, the efficacy of fulvestrant plus cyclin-dependent kinase 4/6 (CDK4/6) inhibitors was slightly better than that of AI plus CDK4/6 inhibitors, while AI plus everolimus was more efficacious than fulvestrant combined with everolimus in terms of PFS, OS, and ORR. In conclusion, our results provide moderate evidence that fulvestrant plus palbociclib and AI plus everolimus were the most effective treatments, while the efficacy and safety of fulvestrant plus palbociclib was obviously superior in some specific clinical situations.

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“…Among the 9 enrolled studies, 3 were palbociclib trials [12][13][14], 3 were riboliclib trials [15][16][17] and 3 were abemaciclib trials [18,19]. As for menopausal status, 6 trials included treatment of postmenopausal women [12,13,15,16,19,20], 1 trial treated pre-or perimenopausal women [17] and 2 trials treated women with both menopausal status [14,18]. As for combination schemes, 5 trials applied first-line ET strategy in our studies [12,13,15,17,19], and 4 trials included firstline and subsequent-line ET strategies simultaneously [14,16,18,20].…”

Section: Characteristics Of the Eligible Studiesmentioning

confidence: 99%

Combination cyclin-dependent kinase 4/6 inhibitors and endocrine therapy versus endocrine monotherapy for hormonal receptor-positive, human epidermal growth factor receptor 2-negative advanced breast cancer: A systematic review and meta-analysis

Zheng

Wang

et al. 2020

PLoS ONE

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This meta-analysis aimed to assess the efficacy and safety of cyclin-dependent kinase (CDK) 4/6 inhibitors plus endocrine therapy (ET) in hormonal receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer (ABC). Methods We searched PubMed, Embase, Cochrane, ClinicalTrials.gov., ASCO, ESMO and AACR databases from inception to October 10, 2019 for randomized controlled trials (RCTs) that compared CDK 4/6 inhibitors plus ET to single-agent ET with no treatment-line restriction. The main outcomes analyzed were progression-free survival (PFS), overall survival (OS), objective response rate (ORR), clinical benefit rate (CBR), and adverse events (AEs). Results Of 938 identified studies, 9 RCTs with 5043 women were eligible and included. Compared with ET alone, CDK 4/6 inhibitors and ET combination improved in PFS (hazard ratio (HR) 0.54, 95% confidence interval (CI) 0.50-0.59, p< 0.00001) and OS (HR 0.77, 95% CI 0.69-0.85, p< 0.00001), regardless of ET strategies (HR 0.54, 95% CI 0.50-0.59 in PFS; HR 0.77, 95% CI 0.69-0.85 in OS), treatment line of advanced disease (HR 0.52, 95% CI 0.46-0.59 in PFS; HR 0.75, 95% CI 0.66-0.85 in OS) and menopausal status (HR 0.54, 95% CI 0.50-0.58 in PFS; HR 0.76, 95% CI 0.68-0.84 in OS). Higher risk of grade 3/4 AEs

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MONARCHplus: A phase III trial of abemaciclib plus nonsteroidal aromatase inhibitor (NSAI) or fulvestrant (F) for women with HR+/HER2- advanced breast cancer (ABC)

Cited by 13 publications

References 0 publications

Association of Cyclin-Dependent Kinases 4 and 6 Inhibitors With Survival in Patients With Hormone Receptor–Positive Metastatic Breast Cancer

Association of Cyclin-Dependent Kinases 4 and 6 Inhibitors With Survival in Patients With Hormone Receptor–Positive Metastatic Breast Cancer

Comparison of Endocrine Therapies in Hormone Receptor-Positive and Human Epidermal Growth Factor Receptor 2-Negative Locally Advanced or Metastatic Breast Cancer: A Network Meta-Analysis

Combination cyclin-dependent kinase 4/6 inhibitors and endocrine therapy versus endocrine monotherapy for hormonal receptor-positive, human epidermal growth factor receptor 2-negative advanced breast cancer: A systematic review and meta-analysis

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