Overall survival (OS) results of the phase III MONALEESA-3 trial of postmenopausal patients (pts) with hormone receptor-positive (HR+), human epidermal growth factor 2-negative (HER2−) advanced breast cancer (ABC) treated with fulvestrant (FUL) ± ribociclib (RIB)

Slamon, Dennis J.; Neven, Patrick; Chia, Stephen; Fasching, PA; Laurentiis, Michelino De; Im, Sungbin; Petráková, Katarína; Bianchi, Giulia; Esteva, FJ; Martin, M.; Nusch, Arndt; Sonke, Gabe S.; Cruz-Merino, Luis de la; Beck, J. Thaddeus; Pivot, Xavier; Sondhi, Manu; Wang, Y.; Chakravartty, Arunava; Rodriguez-Lorenc, Karen; Jérusalem, Guy

doi:10.1093/annonc/mdz394.007

Cited by 48 publications

(59 citation statements)

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“…In the second-line setting, the median PFS was 14.6 months in the combination arm, versus 9.1 months in the placebo arm. 31 Moreover, MONALEESA-3 demonstrated a statistically significant OS benefit with ribociclib plus fulvestrant vs placebo plus fulvestrant, with a 28% reduction in the relative risk of death (HR: 0.724; 95% CI, 0.568-0.924; P = 0.00455). OS benefit was consistent across patient subgroups.…”

Section: Discussionmentioning

confidence: 96%

“…OS benefit was consistent across patient subgroups. 31 Interestingly, the remarkable results of the phase III FALCON trial for endocrine therapy-naïve HR+ MBC patients, comparing upfront anastrozole with upfront fulvestrant, showed a PFS advantage of fulvestrant (16.6 vs 13.8 months, HR 0.80, P = 0.049), with the most benefit seen in patients without visceral disease (22.3 vs 13.8 months, HR 0.59). 3 Therefore, the FALCON and MONALEESA-3 trial results are encouraging and fulvestrant plus a CDK 4/6 inhibitor may represent a reasonable option for patients with de novo HR+/HER2-MBC.…”

Section: Discussionmentioning

confidence: 99%

“…27 In the MONARCH-2 study, patients receiving abemaciclib plus fulvestrant and with primary resistance to endocrine therapy showed a better OS in the overall survival subgroup analysis. 31 The separation curves between the abemaciclib arm and the placebo arm occurred early, in the first year of treatment. In the PALOMA-3 study with palbociclib and fulvestrant, the OS data are different 27 The mechanism potentially responsible for the effects on OS in populations with visceral disease and with disease primarily resistant to endocrine therapy is unknown.…”

Section: Discussionmentioning

confidence: 99%

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<p>Fulvestrant in Combination with CDK4/6 Inhibitors for HER2- Metastatic Breast Cancers: Current Perspectives</p>

Iorfida¹,

Mazza²,

Munzone³

2020

BCTT

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The development of CDK 4/6 inhibitors has dramatically changed the therapeutic management of hormone receptor-positive (HR+) and HER2 negative metastatic breast cancer (MBC). In combination with fulvestrant, palbociclib, ribociclib and abemaciclib have each been approved for HR+/HER2-MBC following the results of randomized Phase III studies (PALOMA-3, MONALEESA-3, MONARCH-2) and shown a significant advantage in PFS. Data from clinical trials support the combination with aromatase inhibitors in the first line setting and with fulvestrant in the second line. Each agent is well tolerated, and most of the toxicities observed with this class of drugs are generally easily manageable and free from particular complications. The latest evidence from MONARCH-2 and MONALEESA-3 trials shows benefits in terms of overall survival (OS), suggesting an option of using fulvestrant in combination with CDK 4/6 inhibitors in the first line setting. Additional research is needed to determine optimal treatment sequencing, understand the mechanisms of resistance, and develop novel therapeutic strategies to overcome clinical resistance and further improve the outcomes of patients with HR+/HER-MBC. Key questions in the field include the further impact on progression-free survival, overall survival, and the role of continuing CDK 4/6 blockade beyond progression. The purpose of this review is to describe the clinical relevance of fulvestrant in combination with CDK 4/6 inhibitors in HR+/HER2-MBC patients, as well as to discuss the current controversies and evolving research areas.

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Section: Discussionmentioning

confidence: 96%

Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

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<p>Fulvestrant in Combination with CDK4/6 Inhibitors for HER2- Metastatic Breast Cancers: Current Perspectives</p>

Iorfida¹,

Mazza²,

Munzone³

2020

BCTT

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“…These results give greater coherence to the use of CDK4/6 inhibitors in combination with HT in the first-or second-line treatment of luminal MBC. Finally, data were presented at ASCO 2019 on the impact on OS of ribociclib combined with HT in premenopausal patients who, for the first time, showed an increase in OS with the combination of HT and CDK4/6 inhibitors [96], and later in ESMO 2019 the benefit in OS has been presented in other two trials, one for the combination of ribociclib with fulvestrant in first and second line in postmenopausal women (MONALEESA3) [97] and the other for abemaciclib in combination with fulvestrant in second line [98].…”

Section: Discussionmentioning

confidence: 99%

Review of concepts in therapeutic decision-making in HER2-negative luminal metastatic breast cancer

et al. 2020

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Purpose Hormone receptor (HR)-positive, Human epidermal growth factor receptor 2 (HER2)-negative metastatic breast cancer (MBC) requires a therapeutic approach that takes into account multiple factors, with treatment being based on antiestrogen hormone therapy (HT). As consensus documents are valuable tools that assist in the decision-making process for establishing clinical strategies and optimize the delivery of health services, this consensus document has been created with the aim of developing recommendations on cretiera for hormone sensitivity and resistance in HER2-negative luminal MBC and facilitating clinical decision-making. Methods This consensus document was generated using a modification of the RAND/UCLA methodology, which included the definition of the project and identification of issues of interest, a non-exhaustive systematic review of the literature, an analysis and synthesis of the scientific evidence, preparation of recommendations, and external evaluation with a panel of 64 medical oncologists specializing in breast cancer. Results A Spanish panel of experts reached consensus on 32 of the 32 recommendations/conclusions presented in the first round and were accepted with an approval rate of 100% about definition of metastatic disease not susceptible to local curative treatment, definition of hormone sensitivity and hormone resistance in metastatic luminal disease and therapeutic decision-making. Conclusion We have developed a consensus document with recommendations on the treatment of patients with HER2negative luminal MBC that will help to improve therapeutic benefits.

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“…Results of progression-free survival (PFS), which was defined as primary study endpoint, had already been published and combination therapy yielded a prolongation of median PFS from 12.8 to 20.5 months (HR 0.593; 95% CI 0.480-0.732; p = 0.001) [4]. At the 2019 ESMO Meeting, OS data were presented indicating a significant OS benefit in favour of the ribociclib group as well (median OS 40 months vs. not reached; HR 0.724; 95% CI 0.568-0.924; p = 0.00455); this effect was similar in first-and second-line patients (the latter group included patients with early relapse after adjuvant endocrine therapy) [5]. In MONARCH-2, patients progressing on adjuvant endocrine therapy or within one year since the end of prior adjuvant endocrine treatment as well as second-line patients were randomized to fulvestrant with abemaciclib or placebo.…”

Section: Monaleesa-3 and Monacrh2: Overall Survival Updatementioning

confidence: 99%

ESMO 2019: breast cancer

Bartsch

2020

memo

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This articles reviews results of relevant breast cancer trials presented at the 2019 ESMO Meeting. In triple-negative disease, addition of pembrolizumab to standard neoadjuvant chemotherapy yielded a pathologic complete response (pCR) rate of 64.8%, the highest pCR rate reported to date in this setting; in addition, a trend towards improved eventfree survival was observed in the immunotherapy group. In pretreated patients with metastatic triplenegative breast cancer, single-agent pembrolizumab was not superior to conventional chemotherapy. In metastatic hormone-receptor positive disease, an update of the MONARCH2 and MonaLEEsa-3 studies indicated an overall-survival benefit in favour of the respective CDK4/6 inhibitor groups emphasizing the clinical importance of this class of drugs.

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Overall survival (OS) results of the phase III MONALEESA-3 trial of postmenopausal patients (pts) with hormone receptor-positive (HR+), human epidermal growth factor 2-negative (HER2−) advanced breast cancer (ABC) treated with fulvestrant (FUL) ± ribociclib (RIB)

Cited by 48 publications

References 0 publications

<p>Fulvestrant in Combination with CDK4/6 Inhibitors for HER2- Metastatic Breast Cancers: Current Perspectives</p>

<p>Fulvestrant in Combination with CDK4/6 Inhibitors for HER2- Metastatic Breast Cancers: Current Perspectives</p>

Review of concepts in therapeutic decision-making in HER2-negative luminal metastatic breast cancer

ESMO 2019: breast cancer

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