In women with ERBB2-positive metastatic breast cancer, the combination treatment of neratinib-paclitaxel may help to delay and reduce metastases in the central nervous system compared to trastuzumab-paclitaxel. The study, “Neratinib Plus Paclitaxel vs Trastuzumab Plus Paclitaxel in Previously Untreated Metastatic ERBB2-Positive Breast Cancer The NEfERT-T Randomized Clinical Trial,” published in JAMA Oncology, was led by Dr. Ahmad Awada of the Jules Bordet Institute, Brussels.
Researchers conducted a controlled efficacy study, taking place between 2009 through 2014 at 188 centers in 34 counties, involving a total of 479 women, eligible if they had asymptomatic central nervous system lesions. The enrolled study cohort was randomized into two different treatment groups: 242 who received neratinib with paclitaxel, and 237 who received trastuzumab plus paclitaxel.
The Phase 2 trial (named NEfERT-T) aimed to primarily assess progression-free survival in women with recurrent or metastatic ERBB2-positive breast cancer. Other secondary outcome measures of interest included time to symptomatic or progressive central nervous system lesions, and safety.
Primary findings showed that neratinib plus paclitaxel was not superior to trastuzumab plus paclitaxel as first-line treatment for ERBB2-positive metastatic breast cancer in terms of progression-free survival, but the combination was associated with delayed onset and reduced frequency of central nervous system metastases.
The only adverse study events of interest were diarrhea and gastrointestinal effects, such as nausea and vomiting, which were consistent with the safety profile previously documented for this treatment combination.
According to a journal press release, the reduction in central nervous system metastases will require a larger confirmatory study for validation. “Neratinib in combination with paclitaxel was not superior in terms of PFS [progression-free survival] compared with trastuzumab-paclitaxel in the first-line treatment of women with ERBB2-positive metastatic breast cancer but showed similar efficacy and may delay the onset and reduce the frequency of CNS [central nervous system] metastases,” the authors wrote.
In a separate editorial, Dr. Mark D. Pegram of the Stanford School of Medicine, wrote: “The results presented herein by Awada et al are of sufficient interest to merit further investigation, preferably prospectively (with antidiarrheal prophylaxis), and in principle coupled with an extensive companion biomarker campaign designed to further characterize and classify those patients at highest risk for development of metastasis.”
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