Comparison of palbociclib in combination with letrozole or fulvestrant with endocrine therapies for advanced/metastatic breast cancer: network meta-analysis

Chirila, Costel; Mitra, Debanjali; Colosia, Ann; Ling, Caroline; Odom, Dawn; Iyer, Shrividya; Kaye, James A.

doi:10.1080/03007995.2017.1325730

Cited by 20 publications

(15 citation statements)

References 18 publications

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“…An SLR was conducted to identify randomized controlled trials (RCTs) published from January 2000 to January 2016. All references used in two previous NMAs by Generali et al [ 7 ] and Chirila et al [ 8 ] formed the starting point for the current systematic review. These represent the most recent NMAs conducted for chemotherapy agents and for endocrine therapies.…”

Section: Methodsmentioning

confidence: 99%

“…The NMA by Generali et al [ 7 ] compared everolimus + exemestane with various chemotherapy agents, and the literature search spanned from 2000 to May 2014. The NMA by Chirila et al [ 8 ] compared palbociclib with other endocrine-based therapies, and the literature search was conducted in January 2015 with no date restrictions. An updated literature search was performed by searching MEDLINE, EMBASE, Cochrane CENTRAL, and PubMed from May 2014 (search date of Generali) to January 2016 to identify RCTs that were published since the aforementioned two reviews.…”

Section: Methodsmentioning

confidence: 99%

“…An updated literature search was performed by searching MEDLINE, EMBASE, Cochrane CENTRAL, and PubMed from May 2014 (search date of Generali) to January 2016 to identify RCTs that were published since the aforementioned two reviews. A predefined search strategy (Online Appendix A) was used, based on the previous searches by Generali et al [ 7 ] and Chirila et al [ 8 ]. The search was designed to identify all RCTs of chemotherapy agents, chemotherapy agents + biological therapies, and endocrine therapies used to treat postmenopausal women with HR+/HER2− ABC/MBC who had not received any prior systemic anticancer treatment for advanced disease (first line) or whose disease had progressed after prior endocrine therapy or chemotherapy (second line).…”

Section: Methodsmentioning

confidence: 99%

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Systematic review and network meta-analysis comparing palbociclib with chemotherapy agents for the treatment of postmenopausal women with HR-positive and HER2-negative advanced/metastatic breast cancer

Wilson¹,

Varu²,

Mitra

et al. 2017

Breast Cancer Res Treat

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PurposeTo compare palbociclib + letrozole and palbociclib + fulvestrant with chemotherapy agents in postmenopausal women with hormone receptor-positive (HR+)/human epidermal growth factor receptor 2-negative (HER2−) advanced/metastatic breast cancer (ABC/MBC) who had no prior systemic treatment for advanced disease (first line) or whose disease progressed after prior endocrine therapy or chemotherapy (second line).MethodsA systematic search identified randomized controlled trials (RCTs) published from January 2000 to January 2016 that compared endocrine-based therapies, chemotherapy agents, and/or chemotherapy agents + biological therapies in the first- and second-line treatment of postmenopausal women with HR+/HER2− ABC/MBC. The main outcome of interest was progression-free survival (PFS)/time to progression (TTP). Bayesian network meta-analyses (NMAs) and pairwise meta-analyses were conducted. Heterogeneity and inconsistency were assessed.ResultsSixty RCTs met eligibility criteria and were stratified by line of therapy. In the first line, palbociclib + letrozole showed statistically significant improvements in PFS/TTP versus capecitabine [intermittent: HR 0.28 (95% CrI 0.11–0.72)] and mitoxantrone [HR 0.28 (0.13–0.61)], and trended toward improvements versus paclitaxel [HR 0.59 (0.19–1.96)], docetaxel [HR 0.51 (0.14–2.03)] and other monotherapy or combination agents (HRs ranging from 0.24 to 0.99). In the second line, palbociclib + fulvestrant showed statistically significant improvements in PFS/TTP versus capecitabine [intermittent: HR 0.28 (0.13–0.65)], mitoxantrone [HR 0.26 (0.12–0.53)], and pegylated liposomal doxorubicin [HR 0.19 (0.07–0.50)], and trended toward improvements versus paclitaxel [HR 0.48 (0.16–1.44)], docetaxel [HR 0.71 (0.24–2.13)] and other monotherapy or combination agents (HRs ranging from 0.23–0.89). NMA findings aligned with direct evidence and were robust to sensitivity analyses.ConclusionsPalbociclib + letrozole and palbociclib + fulvestrant demonstrate trends in incremental efficacy compared with chemotherapy agents for the first- and second-line treatment of HR +/HER2− ABC/MBC.Electronic supplementary materialThe online version of this article (doi:10.1007/s10549-017-4404-4) contains supplementary material, which is available to authorized users.

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Section: Methodsmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

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Systematic review and network meta-analysis comparing palbociclib with chemotherapy agents for the treatment of postmenopausal women with HR-positive and HER2-negative advanced/metastatic breast cancer

Wilson¹,

Varu²,

Mitra

et al. 2017

Breast Cancer Res Treat

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“…6,7 Surprisingly, no grade 3/4 lymphopenia were documented in the phase III PALOMA clinical trial. 2,[7][8][9] In our presentation, the patient experienced a severe and fatal immunodeficiency characterized by an extended grade 3 lymphopenia, according to the Common Terminology Criteria for Adverse Events v5.0, which was concomitant to the palbociclib and exemestane administration. This has led to the reactivation of viral infections: herpes simplex virus, varicella-zoster virus, Aleution disease virus, and Epstein-Barr virus, and to the occurrence of pneumocystis pneumonia.…”

Section: Discussionmentioning

confidence: 87%

Severe Cellular Immunodeficiency Triggered by the CDK4/6 Inhibitor Palbociclib

Guillaume

Médioni

Lillo‐Lelouet

et al. 2020

Clinical Breast Cancer

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“…Ribociclib plus fulvestrant may also shortly enter the treatment landscape following positive results from the MONALEESA-3 trial [73]. In a systematic meta-analysis that used statistical analyses to rank the efficacy of therapy options for patients with MBC whose disease had progressed on a prior endocrine therapy (maximum efficacy score of 100), everolimus plus exemestane had an efficacy score of 95.0, palbociclib plus fulvestrant had an efficacy score of 93.9, and various endocrine monotherapies had efficacy scores below 70.0 [74]. These and the results of NCT02291913, where patients initiated everolimus but remained on the same endocrine therapy after disease progression [39], support the use of everolimus combination therapy as one option after disease progression on endocrine monotherapy.…”

Section: The Role Of Everolimus Within the Mbc Treatment Algorithmmentioning

confidence: 99%

Everolimus-based combination therapies for HR+, HER2− metastatic breast cancer

O’Shaughnessy

Beck

Royce

2018

Cancer Treatment Reviews

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Metastatic breast cancer (MBC) is the leading cause of cancer-related morbidity and mortality among women worldwide. Endocrine therapy is the standard of care for the most common subtype of MBC, hormone-receptor positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) disease. Advances in treating this type of MBC have focused on improving the efficacy of endocrine therapy by adding agents that target specific molecular pathways of breast cancer cell growth and survival. The combination of the aromatase inhibitor exemestane and the mammalian target of rapamycin inhibitor, everolimus, more than doubled median progression-free survival compared with exemestane alone (7.8 vs 3.2 months, respectively; hazard ratio 0.45 [95% confidence interval 0.38-0.54]; log rank P < 0.0001) in the BOLERO-2 study in postmenopausal women with HR+, HER2- locally advanced or metastatic breast cancer that had recurred or progressed on prior non-steroidal aromatase inhibitor therapy. In addition, everolimus plus exemestane was associated with a manageable safety profile. The results of BOLERO-2 led to regulatory approval of everolimus plus exemestane. Additional everolimus-based combinations have been or are under investigation in the HR+, HER2- MBC setting, including combinations with letrozole, fulvestrant, ribociclib, tamoxifen, and chemotherapy. This review summarizes key data on everolimus-based combinations focusing on efficacy, safety, biomarkers, quality of life, and health economic outcomes. These data are discussed in the context of the changing MBC treatment algorithm to provide insights into the clinical relevance of everolimus-based combinations.

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Comparison of palbociclib in combination with letrozole or fulvestrant with endocrine therapies for advanced/metastatic breast cancer: network meta-analysis

Cited by 20 publications

References 18 publications

Systematic review and network meta-analysis comparing palbociclib with chemotherapy agents for the treatment of postmenopausal women with HR-positive and HER2-negative advanced/metastatic breast cancer

Systematic review and network meta-analysis comparing palbociclib with chemotherapy agents for the treatment of postmenopausal women with HR-positive and HER2-negative advanced/metastatic breast cancer

Severe Cellular Immunodeficiency Triggered by the CDK4/6 Inhibitor Palbociclib

Everolimus-based combination therapies for HR+, HER2− metastatic breast cancer

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