Neratinib Not Superior to Trastuzumab in ERBB2-Breast CA

FRIDAY, April 15, 2016 (HealthDay News) — Neratinib-paclitaxel is no better than trastuzumab-paclitaxel for progression-free survival in recurrent and/or metastatic ERBB2-positive breast cancer, although it may delay the onset and reduce the frequency of central nervous system progression, according to a study published online April 14 in JAMA Oncology.

Ahmad Awada, M.D., Ph.D., from the Université Libre de Bruxelles in Belgium, and colleagues conducted a randomized open-label trial at 188 centers in 34 countries involving 479 women with previously untreated recurrent and/or metastatic ERBB2-positive breast cancer. Participants were randomized to neratinib-paclitaxel or trastuzumab-paclitaxel (242 and 237, respectively). Randomization was stratified by prior trastuzumab and lapatinib exposure, hormone-receptor status, and region.

The researchers found that the median progression-free survival was 12.9 months with both neratinib-paclitaxel and trastuzumab-paclitaxel (hazard ratio, 1.02; 95 percent confidence interval, 0.81 to 1.27). The incidence of central nervous system recurrences was lower with neratinib-paclitaxel (relative risk, 0.48; 95 percent confidence interval, 0.29 to 0.79), and time to central nervous system metastases delayed (hazard ratio, 0.45; 95 percent confidence interval, 0.26 to 0.78). Common grade 3 to 4 adverse events included diarrhea, neutropenia, and leukopenia; there was no grade 4 diarrhea.

“In spite of similar overall efficacy, neratinib-paclitaxel may delay the onset and reduce the frequency of central nervous system progression, a finding that requires a larger study to confirm,” the authors write.

Several authors disclosed financial ties to biopharmaceutical companies, including Wyeth, Pfizer, and Puma Biotechnology (manufacturer of neratinib), all of which funded the study.

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