Overall Survival with Ribociclib plus Endocrine Therapy in Breast Cancer

Im, Seock‐Ah; Lu, Yen‐Shen; Bardia, Aditya; Harbeck, Nadia; Colleoni, Marco; Franke, Fábio; Chow, Louis W.C.; Sohn, Joohyuk; Lee, Keun-Seok; Campos-Gomez, Saúl; Vázquez, Rafael; Jung, Kyung-Hae; Chakravartty, Arunava; Hughes, G.; Gounaris, Ioannis; Rodriguez-Lorenc, Karen; Taran, Tetiana; Hurvitz, Sara A.; Tripathy, Debu

doi:10.1056/nejmoa1903765

Cited by 762 publications

(695 citation statements)

References 29 publications

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“…31 At 3.5 years, an improvement in OS was reported with ribociclib (70% vs 46%; HR, 0.71; 95% CI, 0.54-0.95). 32 Grade 3 and 4 adverse events reported in greater than 10% of patients in either group included neutropenia (61% vs 4%), hot flashes (34% in each arm), and leukopenia (14% vs 1%). 31 Based on the previously cited data, the NCCN panel has included AI in combination with CDK 4/6 inhibitors as a category 1 first-line option for postmenopausal women and premenopausal women with ovarian ablation/suppression with HR-positive, HER2-negative recurrent/stage IV breast cancer.…”

Section: Systemic Therapy For Stage IV or Recurrent Metastatic Hr-posmentioning

confidence: 92%

Breast Cancer, Version 3.2020, NCCN Clinical Practice Guidelines in Oncology

Gradishar

Anderson

Abraham

et al. 2020

Journal of the National Comprehensive Cancer Network

1,036

602

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Several new systemic therapy options have become available for patients with metastatic breast cancer, which have led to improvements in survival. In addition to patient and clinical factors, the treatment selection primarily depends on the tumor biology (hormone-receptor status and HER2-status). The NCCN Guidelines specific to the workup and treatment of patients with recurrent/stage IV breast cancer are discussed in this article.

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Section: Systemic Therapy For Stage IV or Recurrent Metastatic Hr-posmentioning

confidence: 92%

Breast Cancer, Version 3.2020, NCCN Clinical Practice Guidelines in Oncology

Gradishar

Anderson

Abraham

et al. 2020

Journal of the National Comprehensive Cancer Network

1,036

602

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“…Specifically, the current standard of care is a combination of the hormone therapy with cyclin-dependent kinase 4/6 (CDK4/6) inhibitors, even though, until very recently, clinical trials had failed to see a significant increase in overall survival with this combination (3). In any case, and while antiestrogen therapy is certainly effective, around one fifth of the patients relapse into a metastatic stage for which there is no cure.…”

Section: Introductionmentioning

confidence: 99%

Estrogen deprivation triggers an immunosuppressive phenotype in breast cancer cells

Hühn

Martí‐Rodrigo

Mourón³

et al. 2019

Preprint

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Estrogen receptor (ER)-positive breast tumors are routinely treated with estrogen-depriving therapies. Despite their effectiveness, patients often progress into a more aggressive form of the disease. Through a chemical screen oriented to identify chemicals capable of inducing the expression of the immune-checkpoint ligand PD-L1, we found antiestrogens as hits. Subsequent validations confirmed that estrogen deprivation or ERa depletion induces PD-L1 expression in ER-positive breast cancer cells, both in vitro and in vivo. Likewise, PD-L1 expression is increased in metastasis arising from breast cancer patients receiving adjuvant hormonal therapy for their local disease. Transcriptome analyses indicate that estrogen deprivation triggers a broad immunosuppressive program, not restricted to PD-L1. Accordingly, estrogen deprived MCF7 cells are resistant to T-cell mediated cell killing, in a manner that can be reverted by estradiol. Our study reveals that while antiestrogen therapies effectively limit tumor growth in ER-positive breast cancers, they also trigger a transcriptional program that favors immune evasion.

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“…The Study of Efficacy and Safety in Premenopausal Women with HR-positive, HER2-negative Advanced Breast Cancer (MONALEESA-7) phase 3 randomized controlled trial of first-line endocrine therapy with ribociclib or a placebo in pre/perimenopausal women with HRpositive/HER2-negative MBC did show a statistically significant OS benefit at 42 months with the addition of ribociclib (hazard ratio, 0.71; P = .00973); however, 60% of this study population had not received prior adjuvant endocrine therapy. 22 In the S0226 study looking at first-line anastrozole with or without fulvestrant in postmenopausal women with HR-positive/HER2negative MBC, an OS benefit was seen in the combination arm (hazard ratio, 0.81; P = .05). 23 However, this study also had a large proportion of patients who had not been treated in the adjuvant setting (59.7% of the study population had not received prior adjuvant tamoxifen, and 66.6% had not received prior adjuvant chemotherapy).…”

Section: Discussionmentioning

confidence: 99%

The impact of new systemic therapies on survival and time on hormonal treatment in hormone receptor–positive, human epidermal growth factor receptor 2–negative metastatic breast cancer: A population‐based study in British Columbia from 2003 to 2013

Le¹,

Speers

Thompson

et al. 2019

Cancer

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Background The purpose of this study was to determine whether new systemic therapy regimens have resulted in improved survival and increased time on first‐ and second‐line hormonal treatment for patients with hormone receptor (HR)–positive metastatic breast cancer (MBC) over time. Methods Patients diagnosed with HR‐positive, human epidermal growth factor receptor 2 (HER2)–negative MBC were identified across 3 time cohorts (2003‐2005, 2007‐2009, and 2011‐2013). Data were prospectively collected. Cases with previous, synchronous, or subsequent contralateral breast cancer were excluded. The types of first‐ and second‐line therapies, the times on first‐ and second‐line hormonal treatment, and the median survival times were compared across the cohorts. Results Within the time period analyzed, 9 new adjuvant systemic therapies (with or without neoadjuvant therapy) and 2 metastatic systemic therapies were approved at BC Cancer for the treatment of HR‐positive, HER2‐negative MBC. In the 3 time cohorts, 3953 patients diagnosed with MBC were identified. Among the 2432 patients (62%) who had HR‐positive/HER2‐negative disease, 2197 (90%) received at least 1 line of systemic therapy after the diagnosis of MBC, and 80% of these patients (1752 of 2197) received first‐ and/or second‐line hormonal treatment. The median duration on hormonal treatment was 9.0 months for the first line and 6.1 months for the second line. The durations were similar across the time cohorts (range for the first line, 8.9‐9.0 months; range for the second line, 6.0‐6.1 months). The median survival for the entire study population was 2.0 years (95% confidence interval, 1.8‐2.1 years), and there was no significant difference between the cohorts (range, 1.9‐2.0 years). Conclusions Even though more adjuvant and metastatic systemic therapies have been approved since 2003, population‐level gains in survival and the time on hormonal treatment for patients with HR‐positive, HER2‐negative MBC have not been made over the course of a decade.

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Overall Survival with Ribociclib plus Endocrine Therapy in Breast Cancer

Cited by 762 publications

References 29 publications

Breast Cancer, Version 3.2020, NCCN Clinical Practice Guidelines in Oncology

Breast Cancer, Version 3.2020, NCCN Clinical Practice Guidelines in Oncology

Estrogen deprivation triggers an immunosuppressive phenotype in breast cancer cells

The impact of new systemic therapies on survival and time on hormonal treatment in hormone receptor–positive, human epidermal growth factor receptor 2–negative metastatic breast cancer: A population‐based study in British Columbia from 2003 to 2013

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