Real-world Data on First-line Systemic Therapy for Hormone Receptor-positive HER2-negative Metastatic Breast Cancer: A Trend Shift in the Era of CDK 4/6 Inhibitors

Werutsky, Gustavo; Reinert, Tomás; Rosa, Mahira Lopes; Barrios, Carlos H.

doi:10.1016/j.clbc.2021.04.003

Cited by 7 publications

(3 citation statements)

References 28 publications

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“…Overall, our study results were satisfactory. Both in terms of the effectiveness and tolerability of palbociclib in real-world clinical practice and corresponded with those of the RCTs [9,14–16] and other clinical retrospective experiences in the Americas and Europe [13,17–20,25] …”

Section: Discussionsupporting

confidence: 73%

“…Both in terms of the effectiveness and tolerability of palbociclib in realworld clinical practice and corresponded with those of the RCTs [9,[14][15][16] and other clinical retrospective experiences in the Americas and Europe. [13,[17][18][19][20]25] In addition, our study demonstrated that the statuses of Ki67 <30% and PR ≥20% in metastatic tumors might be potential predictive biomarkers of palbociclib sensitivity in patients with HR+/HER2À MBC. Currently, no robust predictive or prognostic biomarkers that guide clinical medication have been explored in the randomized trials of palbociclib, other than ER expression in a large-pooled America FDA group analysis.…”

Section: Discussionmentioning

confidence: 55%

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Real-world effectiveness and sensitivity of palbociclib plus endocrine therapy in HR+/HER2– patients with metastatic breast cancer

Zhang²,

Yang

et al. 2021

Medicine

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Palbociclib has shown satisfactory outcomes when combined with endocrine therapy (ET) in hormone receptor–positive and human epidermal growth factor receptor 2–negative (HR+/HER2–) metastatic breast cancer (MBC). However, data in Asia are currently scarce.This retrospective study aimed to evaluate the real-world effectiveness, sensitivity, and toxicity of palbociclib plus ET in HR+/HER2– MBC in North China. We recruited patients with HR+/HER2– MBC from August 2018 to July 2020 across 7 hospitals in North China. The primary endpoint was to evaluate progression-free survival (PFS) after initial progress on palbociclib therapy. The secondary endpoints included determining predictive biomarkers of palbociclib sensitivity and toxicity of palbociclib.A total of 54 patients were analyzed in this cohort with an estimated median follow-up time of 14.3 months. Patients who received palbociclib as a first-line treatment showed significantly prolonged PFS compared with those who received palbociclib as a second-line or beyond treatment (21.8 months vs 15.9 months vs 6.8 months) (P < .001). Besides, patients with Ki67 <30% (P = .024) and PR ≥20% (P = .041) in metastatic tumors had significantly longer PFS. The Cox proportional-hazards regression analyses proved that different lines (P = .001 in multivariate analysis), Ki67 <30% (P = .035 in multivariate analysis), and PR ≥20% (P = .045 in univariate analysis) in metastatic tumors affected PFS significantly. The most common adverse events were hematologic, with 31.48% of patients having neutropenia.Palbociclib plus ET significantly prolonged PFS for patients with HR+/HER2– MBC who received first-line therapy, with manageable toxicity. The values of Ki67 and PR in metastatic tumors may be potential predictive biomarkers of palbociclib sensitivity.

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Section: Discussionsupporting

confidence: 73%

Section: Discussionmentioning

confidence: 55%

Real-world effectiveness and sensitivity of palbociclib plus endocrine therapy in HR+/HER2– patients with metastatic breast cancer

Zhang²,

Yang

et al. 2021

Medicine

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“…In itself, this is a more accessible and less expensive treatment than chemotherapy, a fact that is particularly important bearing in mind the progressive increase in the costs of cancer treatment 9 . In addition, endocrine therapy is associated with lower rates of adverse events and better quality of life, with no negative effect on progression-free survival or overall survival 37,38 . Therefore, the underutilization of endocrine therapy found in this study may reflect an inappropriate approach to treatment according to current recommendations and even according to the standard clinical practice within the time period studied 8,15,37 .…”

Section: Discussionmentioning

confidence: 99%

Real-world data on metastatic breast cancer in Goiânia, Brazil: a 17-year analysis (1995–2011)

Soares

Freitas‐Junior

Nunes³

et al. 2022

Mastology

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Introduction: Most of the data on metastatic breast cancer (MBC) originate from hospital-based studies or controlled trials involving specific populations and controlled treatments. In this respect, few population-based studies have analyzed the profile of MBC in low- and middle-income countries. Objective: To describe the epidemiological profile of women with de novo MBC using data from a population-based cancer registry (PBCR). Methods: An ecological study conducted in a PBCR in Goiânia, Brazil, for the 1995–2011 period. Women with MBC at diagnosis were included and the standardized incidence rate and annual percent change (APC) over the period were calculated. The women’s clinical and demographic characteristics and data on diagnosis and treatment were analyzed. Results: Overall, 5,289 cases of breast cancer were registered in the Goiânia PBCR, 277 (5.2%) at metastatic stage. The adjusted incidence was 8.9/100,000 in 1995 and 6.04/100,000 in 2011 (APC: 1.1; p=0.6). Most of the patients (70.3%) were receiving care within the public healthcare system and the mean age at diagnosis was 54.7±14.5 years. Additional data for a subpopulation of 156 patients were identified at the city’s two main treatment centers. According to immunohistochemistry, 53 women (67.1%) had hormone receptor-positive cancer. Of these, 14.0% (6/43) received endocrine therapy as first-line systemic treatment and 48.5% (17/35) as second-line treatment. A comparison of clinical data between the 1995–2003 and 2004–2011 periods revealed no significant differences in age, histological grade, locoregional staging, the presence of symptoms at diagnosis, or in treatment. Conclusion: This study population of women with MBC consisted predominantly of locally advanced tumors and the luminal-like subtype. The incidence rate of MBC in Goiânia did not change over the 17-year period. Most cases received chemotherapy as first-line systemic treatment irrespective of the tumor phenotype.

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Systemic treatment for hormone receptor-positive/HER2-negative advanced/metastatic breast cancer: A review of European real-world evidence studies

Vieira

Piperis²,

Sagkriotis

et al. 2022

Critical Reviews in Oncology/Hematology

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Real-world Data on First-line Systemic Therapy for Hormone Receptor-positive HER2-negative Metastatic Breast Cancer: A Trend Shift in the Era of CDK 4/6 Inhibitors

Cited by 7 publications

References 28 publications

Real-world effectiveness and sensitivity of palbociclib plus endocrine therapy in HR+/HER2– patients with metastatic breast cancer

Real-world effectiveness and sensitivity of palbociclib plus endocrine therapy in HR+/HER2– patients with metastatic breast cancer

Real-world data on metastatic breast cancer in Goiânia, Brazil: a 17-year analysis (1995–2011)

Systemic treatment for hormone receptor-positive/HER2-negative advanced/metastatic breast cancer: A review of European real-world evidence studies

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