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Posted by on Apr 4, 2021 in Breast cancer | 0 comments

In a nutshell

This study reported the final effectiveness and safety outcomes of neratinib treatment in patients with early-stage HER2+/HR+ breast cancer. The data showed that neratinib significantly improved invasive disease-free survival in these patients who initiated treatment within 1 year of trastuzumab-based therapy.

Some background

BC is classified into different subtypes depending on the presence or absence of certain receptors (proteins found on the surface of the cancer cells). Hormone receptor (HR)-positive and HER2 positive is a subtype of BC that tests positive for both the hormone receptor and the HER2 protein. This type of cancer accounts for 15-20% of all BCs. Patients with this subtype of BC commonly receive targeted therapy such as trastuzumab (Herceptin).

Since the approval of the drug trastuzumab, the survival of patients with HER2+ early-stage BCs has improved dramatically. Trastuzumab locks onto HER2 and inhibits its actions. Neratinib (Nerlynx) is a targeted therapy that is also designed to inhibit HER2. It has been approved for use after the patient has already been treated with trastuzumab. However, the long-term effectiveness and safety of neratinib in patients with early-stage HER2+/HR+ BC already treated with trastuzumab is not known.

Methods & findings

This study involved 2840 women with stage 1-3 HER2-positive BC that had received trastuzumab therapy and chemotherapy. Patients were randomly assigned to receive either neratinib (240 mg/day) or a placebo for 12 months. Patients were followed up for an average of 8 years.

1631 women of the population had HR-positive BC. 82% (1334) of these patients had started study treatment within 1 year of prior trastuzumab (group 1) and 18% (297) of the patients had started study treatment after 1 year of trastuzumab (group 2).

In group 1, 90.8% of those treated with neratinib and 85.7% of those treated with placebo were free of invasive disease after 5 years. In group 2, 93.0% of those treated with neratinib and 91.7% in those treated with a placebo were free of invasive BC. The benefits of neratinib were more pronounced for distant recurrences such as brain metastasis (cancer spread to the brain).

The estimated 8-year overall survival (OS) rates for group 1 were 91.5% in the neratinib group and 89.4% in the placebo group. The most common side effect reported in patients treated with neratinib was diarrhea.

The bottom line

This study concluded that neratinib significantly improved invasive disease-free survival in patients with HER2+/HR+ early-stage BC who initiated treatment within 1 year of prior trastuzumab.

The fine print

This study was supported by Puma Biotechnology, the manufacturer of neratinib.

Published By :

Clinical Breast Cancer

Date :

Feb 01, 2021

Original Title :

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

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