Carlos H. Barrios, MD
Invited discussant of the NALA trial, Carlos H. Barrios, MD, of the Centro de Pesquisa em Oncologia and Latin American Cooperative Oncology Group in Porto Alegre, Brazil, said the results suggest that neratinib plus capecitabine “may represent an alternative for third-line treatment of HER2-positive metastatic breast cancer.” The reasons are the significant 24% reduction in the risk of disease progression or death and the 2.2-month absolute difference, he noted.
Dr. Barrios said the strengths of the study (and the regimen) are that it was randomized against an appropriate third-line regimen, showed modest benefits in progression-free survival, points to activity in central nervous system disease, and does not compromise quality of life compared with capecitabine/lapatinib. However, he noted, NALA was an open-label trial in which 40% of patients had received trastuzumab alone as an anti-HER2 therapy. “Although compared with previous studies there was improved control of diarrhea in the NALA trial, this still remains a problem for 25% of patients with this combination,” Dr. Barrios pointed out.
Jame Abraham, MD
Jame Abraham, MD, Director of the Breast Medical Oncology Program at the Cleveland Clinic and Professor of Medicine at Lerner College of Medicine, commented in an interview: “NALA is a positive trial for neratinib and capecitabine, and this is exciting news for clinicians. There were big differences in progression-free survival rates at 6, 12, and 18 months. If neratinib obtains [U.S. Food and Drug Administration] approval for metastatic disease, neratinib/capecitabine could be established as the new third-line standard.” ■
DISCLOSURE: Dr. Barrios owns stock in Biomarker and MedSIR; has received honoraria from Boehringer Ingelheim, Eisai, GlaxoSmithKline, Novartis, Pfizer, Roche/Genentech, and Sanofi; has consulted or advised for AstraZeneca, Boehringer Ingelheim, Eisai, GlaxoSmithKline, Libbs, MSD Oncology, Novartis, Pfizer, Roche/Genentech, and United Medical; has received travel expenses from AstraZeneca, Bristol-Myers Squibb Brazil, MSD Oncology, Novartis, Pfizer, and Roche/Genentech; and has received research funding from AB Science, AbbVie, Abraxis BioScience, Amgen, Asana Biosciences, Astellas Pharma, AstraZeneca, Atlantis Clinica, BioMarin, Boehringer Ingelheim, Bristol-Myers Squibb, Celgene, Covance, Daiichi Sankyo, Exelixis, GlaxoSmithKline, Halozyme, ImClone Systems, INC Research/inVentiv Health, Janssen, LEO Pharma, Lilly, Medivation, Merck, Merrimack, Millennium, Mylan, Novartis, Pfizer, Roche/Genentech, Sanofi, and Taiho Pharmaceutical. Dr. Abraham reported no conflicts of interest.
In the global phase III NALA trial, treatment of metastatic HER2-positive breast cancer with neratinib plus capecitabine significantly improved progression-free survival, delayed the time to intervention for central nervous system disease, and showed a trend toward improved overall survival vs...