Results from a phase 2 clinical trial showed that combination neratinib and paclitaxel treatment better managed central nervous system progression versus trastuzumab and paclitaxel in patients with ERBB2-positive metastatic breast cancer.
Investigators, led by Ahmad Awada, MD, PhD, Université Libre de Bruxelles, (Belgium), evaluated the treatment regimens in a total of 479 women with ERBB2-positive breast cancer and asymptomatic central nervous system lesions. Participants were randomly assigned to receive neratinib with paclitaxel (n = 242) or trastuzumab plus paclitaxel (n = 237).
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Progression-free survival (PFS) was the primary outcome of trial, but investigators also looked at time to symptomatic or progressive central nervous system lesions as well as safety data. Their results were published in JAMA Oncology.
PFS survival for both treatment arms was 12.9 months, indicating no significant difference between the two regimens. However, the neratinib-paclitaxel arm was associated with delayed onset and reduced frequency of central nervous system metastases.
The frequency of grade 3 to 4 adverse events was similar between the two groups, with the most common events being neutropenia (31 patients [12.9%] with neratinib-paclitaxel vs 34 patients [14.5%] with trastuzumab-paclitaxel) and leukopenia (19 patients [7.9%] vs 25 patients [10.7%]). The only exception was diarrhea, which was far more common in the neratinib-paclitaxel group (73 patients [30.4%]) than in those treated with trastuzumab and paclitaxel (9 patients [3.8%]).
Investigators concluded that, although neratinib plus paclitaxel was not superior to trastuzumab and paclitaxel in terms of PFS, it did result in better management of central nervous system recurrence and progression, which could be a starting point for future research.
In a editorial piece that accompanied the article’s publication, Mark D Pegram, MD, Stanford School of Medicine, CA, 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.”
