Final Efficacy Results of Neratinib in HER2-positive Hormone Receptor-positive Early-stage Breast Cancer From the Phase III ExteNET Trial

Chan, Arlene; Moy, Beverly; Mansi, Janine; Ejlertsen, Bent; Holmes, Frankie A.; Chia, Stephen; Iwata, Hiroji; Gnant, Michael; Loibl, Sibylle; Barrios, Carlos H.; Somali, İşıl; Smichkoska, Snezhana; Martínez, Noelia; Alonso, Mirta Garcia; Link, John S.; Mayer, Ingrid A.; Cold, Søren; Morales, Serafín; Senecal, Francis M.; Inoue, Kentaro; Ruíz‐Borrego, Manuel; Hui, Rina; Denduluri, Neelima; Patt, Debra A.; Rugo, Hope S.; Johnston, Stephen; Bryce, Richard; Zhang, Bo; Xu, Feng; Wong, Alvin; Martín, Miguel

doi:10.1016/j.clbc.2020.09.014

Cited by 171 publications

(158 citation statements)

References 28 publications

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“…In the randomized phase III trial, ExteNET, demonstrated that 1 year of adjuvant neratinib after chemotherapy plus trastuzumab contributes to significant better PFS in operable breast cancer (hazard ratio, 0.73; 95% CI 0.57–0.92, p = 0.0083) [ 107 ]. The cumulative incidence of CNS recurrences was fewer in the neratinib group (0.7% with neratinib, 2.1% with placebo, respectively) in the HR-positive patients who initiated the study treatment within 1 year of prior trastuzumab [ 108 ].…”

Section: Systemic Therapy For Bcbmmentioning

confidence: 99%

Breast Cancer Brain Metastasis—Overview of Disease State, Treatment Options and Future Perspectives

Watase

Shiino

Shimoi³

et al. 2021

Cancers

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Breast cancer is the second most common origin of brain metastasis after lung cancer. Brain metastasis in breast cancer is commonly found in patients with advanced course disease and has a poor prognosis because the blood–brain barrier is thought to be a major obstacle to the delivery of many drugs in the central nervous system. Therefore, local treatments including surgery, stereotactic radiation therapy, and whole-brain radiation therapy are currently considered the gold standard treatments. Meanwhile, new targeted therapies based on subtype have recently been developed. Some drugs can exceed the blood–brain barrier and enter the central nervous system. New technology for early detection and personalized medicine for metastasis are warranted. In this review, we summarize the historical overview of treatment with a focus on local treatment, the latest drug treatment strategies, and future perspectives using novel therapeutic agents for breast cancer patients with brain metastasis, including ongoing clinical trials.

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Section: Systemic Therapy For Bcbmmentioning

confidence: 99%

Breast Cancer Brain Metastasis—Overview of Disease State, Treatment Options and Future Perspectives

Watase

Shiino

Shimoi³

et al. 2021

Cancers

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“…Since neratinib proved to be particularly effective in hormone receptor positive (HR+) cancers and when therapy was initiated within one year following trastuzumab (HR+ population/treatment initiated ≤ 1 year), approval in the US and Europe was granted with the corresponding restrictions. Further subgroup analyses after 8 years of follow-up were presented at the SABCS in December 2020 and recently published [80]. In the HR+/therapy start ≤ 1 year population, the 5-year iDFS rate was 90.8 vs. 85.7 % in the neratinib arm (delta 5.1 %, HR = 0.58; 95 % CI: 0.41-0.82).…”

Section: Palbociclib In Patients Without Pcr After Neoadjuvant Chemotherapy and High Risk Of Relapsementioning

confidence: 99%

“…Als besonders wirksam erwies sich Neratinib bei hormonrezeptorpositiven (HR+) Karzino-men und bei Therapiestart binnen eines Jahres nach Trastuzumab (Population HR+/Therapiestart ≤ 1 Jahr), sodass die Zulassung in den USA und Europa mit entsprechenden Einschränkungen folgte. Auf dem SABCS wurden im Dezember 2020 weitere Subgruppenanalysen nach 8 Jahren Nachbeobachtung vorgestellt und kürzlich publiziert [80]. In der Population HR+/Therapiestart ≤ 1 Jahr lag die 5-Jahres-iDFS-Rate im Neratinib-Arm bei 90,8 vs. 85,7 % (delta 5,1 %, HR = 0,58; 95 %-KI: 0,41-0,82).…”

Section: Neratinib Nach (Neo-)adjuvanter Therapie Des Her2-positiven Mammakarzinomsunclassified

Update Breast Cancer 2021 Part 1 – Prevention and Early Stages

Stickeler

Aktas

Behrens

et al. 2021

Geburtshilfe Frauenheilkd

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This review summarises not only the latest evidence on prevention, but also the current research on the treatment of early-stage breast cancer patients. Recent years have seen a growing body of evidence on the risk of high- and moderate-penetrance breast cancer susceptibility genes. A large international consortium has now been able to further refine the answer to the question of the significance of the so-called panel genes. Moreover, the data on treatment selection regarding endocrine efficacy and the decision for or against chemotherapy have also been advanced markedly. There is also new data on adjuvant CDK4/6 (cyclin-dependent kinase 4/6) inhibitors, which are standard in first-line treatment in patients with metastatic HER2-negative, hormone receptor-positive (HR+) breast cancer. For other therapies such as immune checkpoint inhibitors, which have successfully improved the rate of pathologic complete response (pCR) in neoadjuvant treatment settings for patients with triple-negative breast cancer (TNBC), there is a growing understanding of the quality of life and side effects. This is especially important in situations where patients could possibly be cured without such a regimen.

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“…tumours who started treatment B 1 year of completing trastuzumab (HR?/ B 1-year population) (Fig. 3; [29]). Among patients with HR?…”

Section: Use Of Neratinib In the Extended Adjuvant Settingmentioning

confidence: 99%

“…2 ExteNET study design [27]. CNS central nervous system; DCIS ductal carcinoma in situ; DFS disease-free survival; EQ-5D EuroQoL 5-dimension; ER oestrogen receptor; FACT-B Functional Assessment of Cancer Therapy-Prostate; HER2?, human epidermal growth factor receptor 2-positive; iDFS invasive disease-free survival; IHC immunohistochemistry; OS overall survival; PR progesterone receptor Subsequent analysis of CNS recurrence data in a HR?/ B 1-year population and in a subgroup of patients of clinical interest in the ExteNET study has also suggested that neratinib may reduce the risk of brain metastases [29]. Although the between-group differences did not reach statistical significance in these patient subgroups, the cumulative incidence of CNS recurrence was numerically lower in the neratinib arm at 5 years (0.7% vs. 2.1% with placebo).…”

Section: Use Of Neratinib In the Extended Adjuvant Settingmentioning

confidence: 99%

How to Optimise Extended Adjuvant Treatment with Neratinib for Patients with Early HER2+ Breast Cancer

et al. 2021

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Over the last 20 years, treatment of patients with human epidermal growth factor receptor 2-positive (HER2?) early breast cancer has considerably improved. The development and addition of (neo)adjuvant trastuzumab to chemotherapy in patients with early HER2? breast cancer (EHBC) has been shown to provide improvements in both disease-free survival (DFS) and overall survival, with some patients having a good prognosis being candidates for chemotherapy de-escalation strategies. However, despite such promising clinical outcomes, a significant proportion of patients still recur calling for the development of new preventive approaches. To this aim, the use of (neo)adjuvant trastuzumab for longer than one year or followed by lapatinib were tested without additional clinical improvement. Based on more recent advances, therapeutic strategies for patients with HER2? tumours are now incorporating the use of newer (neo)adjuvant treatments, such as pertuzumab and trastuzumab emtansine, which have shown to further improve the invasive DFS (iDFS) benefit gained with trastuzumab. In this context, the tyrosine kinase inhibitor neratinib is approved in Europe for the extended adjuvant treatment of adult patients with early-stage hormone receptorpositive HER2? breast cancer who completed adjuvant trastuzumab-based therapy less than one year ago. Clinical data have demonstrated that neratinib significantly improves iDFS when used for the total recommended duration of 12 months. This review paper provides an overview of the treatment of patients with EHBC, with a focus on the post-trastuzumab use of neratinib.

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Final Efficacy Results of Neratinib in HER2-positive Hormone Receptor-positive Early-stage Breast Cancer From the Phase III ExteNET Trial

Cited by 171 publications

References 28 publications

Breast Cancer Brain Metastasis—Overview of Disease State, Treatment Options and Future Perspectives

Breast Cancer Brain Metastasis—Overview of Disease State, Treatment Options and Future Perspectives

Update Breast Cancer 2021 Part 1 – Prevention and Early Stages

How to Optimise Extended Adjuvant Treatment with Neratinib for Patients with Early HER2+ Breast Cancer

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