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Metastatic ERBB2-positive breast cancer has a particular involvement, where cancer cells are spread to the liver in most patients, and in 50% of the cases there's involvement of the central nervous system which results in a poorer prognosis. Secondary outcomes were also examined, which included what the time of development of progressive or symptomatic central nervous system (CNS) lesions and safety was.
A randomized, controlled study was performed at the Jules Bordet Institute in Brussels, Belgium, in order to examine what the progression-free survival was in women who were diagnosed with metastatic or recurrent breast cancer which was associated with a positive finding of the ERBB2 gene.
The NEfERT-T trial was performed with data collected from 479 women in 34 countries from 2009-2014. These patients were eligible for the study if they had been diagnosed with previously untreated recurrent and/or metastatic ERBB2-positive cancer, and who had CNS lesions which were asymptomatic. The group was divided into 242 patients who received the drugs neratinib and paclitaxel, and 237 who received trastuzumab together with paclitaxel.
Side-effects were noted with neratinib combined with paclitaxel, which included gastrointestinal issues such as diarrhoea, vomiting and nausea.
There were some limitations to this study, namely that metastases to the CNS weren't screened for but were rather identified on the presentation of patients' symptoms. This then meant that it was likely that CNS issues were underestimated. Other limitations were that patient numbers to be included in the study were reduced and this affected the efficacy of the research, and that patients with symptomatic or progressive CNS diseases were excluded.
The sought after results showed that both the mentioned drug combinations resulted in a median progression-free survival of nearly 13 months.
The secondary findings though showed that the combination of neratinib and paclitaxel reduced the occurrence of central nervous system issues, and delayed the time to the development of central nervous system metastases.
The significance of the study
In a related article, it was stated that the results which were presented in the NEfERT-T trial were interesting enough to warrant further prospective investigation, together with antidiarrhoeal prophylaxis as well as be combined with an extensive companion biomarker campaign, in order to further classify and characterize patients who are at the highest risk for developing metastasis in ERBB2-positive breast cancer.
These findings, as well as further research, has and will continue to help improve the advances in treatment of breast cancer. The survival rates for breast cancer have increased and the numbers in deaths has been steadily decreasing. Not only has the reason for this been due to the strides made in early detection of this disease due to timely screening, but also due to a better understanding of it as well as having a new personalized approach to its treatment.