Neratinib plus paclitaxel did not improve outcomes in metastatic ERBB2-positive breast cancer.
Metastatic ERBB2-positive breast cancer has been known to spread, potentially causing liver metastases, as about half of patients experience central nervous system involvement.
Researchers conducted a randomized clinical trial to examine the effect of a new treatment, neratinib plus paclitaxel, on progression-free survival in patients with recurrent or metastatic ERBB2-positive breast cancer. Researchers also examined secondary outcomes, such as central nervous system lesions and safety.
The study, published in JAMA Onocolgy, was conducted from 2009 to 2014 including 479 women with metastatic ERBB2-positve breast cancer who had asymptomatic central nervous system lesions.
Patients were randomized into 2 groups, with 242 patients administered neratinib plus paclitaxel and 237 patients administered trastuzumab plus paclitaxel.
Researchers found that median progression-free survival was 12.9 months in both groups.
The results also showed central nervous system recurrences were lower and the time to central nervous system metastases was delayed in the group receiving neratinib plus paclitaxel.
Researchers also found a higher instance of diarrhea and gastrointestinal effect in the group administered neratinib plus paclitaxel.
One limit of the study was that screening for central nervous system metastases was not included. These were identified based on the presentation of symptoms, which means that the number of women with nervous system metastases was likely underestimated, according to the study.
"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 study authors concluded.