LBA4 Updated overall survival (OS) results from the first-line (1L) population in the phase III MONALEESA-3 trial of postmenopausal patients (PTS) with HR+/HER2− advanced breast cancer (ABC) treated with ribociclib (RIB) + fulvestrant (FUL)

Neven, P.; Fasching, Peter A.; Chia, S.; Jérusalem, Guy; Laurentiis, Michelino De; Im, Sun; Petráková, Katarína; Bianchi, G.; Jiménez, M. Martín; Nusch, A.; Sonke, Gabe S.; Merino, Luis de la Cruz; Beck, J. Thaddeus; Zarate, J.P.; Wang, Y.; Chakravartty, Arunava; Wang, C.; Slamon, Dennis J.

doi:10.1016/j.annonc.2022.03.280

Cited by 14 publications

(15 citation statements)

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“…The median overall survival in this population was 51.8 months for fulvestrant monotherapy and 67.6 months for ribociclib-fulvestrant therapy. In the hormone-resistant group (MONALEESA-3 second-line population), the difference was not so clear (HR = 0.80; 95% CI: 0.61 – 1.05) with median overall survival times of 33.7 and 39.7 months 19 .…”

Section: Data From the Large Randomized Cdk4/6 Inhibitor Studies Are ...mentioning

confidence: 98%

“…Patients with a treatment-free interval of less than 12 months (even if they had been treated in the first line of therapy) and patients with endocrine preliminary therapy were treated as patients of the second-line therapy. In the patients sensitive to hormone therapy (MONALEESA-3 first-line population), a very clear difference between the treatment arms could be seen with a hazard ratio of 0.67 (95% CI: 00.50 – 0.90) 19 . The median overall survival in this population was 51.8 months for fulvestrant monotherapy and 67.6 months for ribociclib-fulvestrant therapy.…”

Section: Data From the Large Randomized Cdk4/6 Inhibitor Studies Are ...mentioning

confidence: 99%

“…Therapielinie bezeichnet. Bei den für eine Hormontherapie sensiblen Patientinnen (MONALEESA-3 Erstlinienpopulation) konnte ein sehr deutlicher Unterschied zwischen den Therapiearmen gesehen werden mit einer Hazard Ratio von 0,67 (95%-KI: 0,50 – 0,90) 19 . Das mediane Gesamtüberleben betrug in dieser Population 51,8 Monate für die Fulvestrant-Monotherapie und 67,6 Monate für die Ribociclib-Fulvestrant-Therapie.…”

Section: Subgruppenanalyse Der Monaleesa-3-studie Berichtet Medianes ...unclassified

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Update Breast Cancer 2022 Part 4 – Advanced-Stage Breast Cancer

Aktas

Fehm

Welslau

et al. 2022

Geburtshilfe Frauenheilkd

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For the treatment of patients with advanced HER2-negative hormone receptor-positive breast cancer, several substances have been introduced into practice in recent years. In addition, other drugs are under development. A number of studies have been published over the past year which have shown either an advantage for progression-free survival or for overall survival. This review summarizes the latest results, which have been published at current congresses or in specialist journals, and classifies them in the clinical treatment context. In particular, the importance of therapy with CDK4/6 inhibitors – trastuzumab deruxtecan, sacituzumab govitecan and capivasertib – is discussed. For trastuzumab deruxtecan, an overall survival benefit in HER2-negative breast cancer with low HER2 expression (HER2-low expression) was reported in the Destiny-Breast-04 study. Similarly, there was an overall survival benefit in the FAKTION study with capivasertib. The lack of overall survival benefit for palbociclib in the first line of therapy raises the question of clinical classification.

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Section: Data From the Large Randomized Cdk4/6 Inhibitor Studies Are ...mentioning

confidence: 98%

Section: Data From the Large Randomized Cdk4/6 Inhibitor Studies Are ...mentioning

confidence: 99%

Section: Subgruppenanalyse Der Monaleesa-3-studie Berichtet Medianes ...unclassified

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Update Breast Cancer 2022 Part 4 – Advanced-Stage Breast Cancer

Aktas

Fehm

Welslau

et al. 2022

Geburtshilfe Frauenheilkd

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“…Эффективность ингибиторов CDK4/6 в комбинации с ЭТ изучалась и во 2-й линии терапии (табл. 2) [16][17][18][35][36][37][38][39].…”

Section: -я линия терапииunclassified

“…На сегодняшний день в истории клинических исследований III фазы, изучающих 1-ю линию ЭТ, данный исследовательский анализ показал самую продолжительную медиану ОВ -67,6 мес с улучшением на 15,8 мес по сравнению с плацебо и относительным снижением риска смерти на 33% в группе рибоциклиба и фулвестранта. Эти впечатляющие результаты в популяции 1-й линии терапии еще больше поддерживают использование комбинации рибоциклиба с ЭТ у пациентов с HR-положительным, ERBB2-отрицательным метастатическим РМЖ [37].…”

Section: -я линия терапииunclassified

Current treatment aspects of hormone-dependent ERBB2-negative metastatic breast cancer: overall survival outcomes

Snegovoy

Кононенко²

2022

J. Mod. Onco.

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This review provides an overall survival analysis in patients with hormone-dependent ERBB2-negative metastatic breast cancer (mBC) treated with CDK4/6 inhibitors combined with endocrine therapy (ET). The results of MONALEESA-2, 3, 7, PALOMA-2, 3, and MONARCH-2, 3 studies are provided. The emergence of a new class of drugs, CDK4/6 inhibitors, opened the way to revise the treatment algorithm for patients with HR+/HER2- mBC. Currently, in treatment lines 1 and 2, the combination of CDK4/6 inhibitors with ET is preferable. The proven overall survival advantage in treatment lines 1 and 2, and data from an exploratory analysis subgroup, demonstrate the efficacy of ribociclib in combination with ET. The results of the studies confirm the benefits of combination therapy in routine practice to treat HR+/HER2- mBC regardless of the patient's age, menopausal status, ET variant, and disease prevalence.

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