Clinical Edge

Summaries of Must-Read Clinical Literature, Guidelines, and FDA Actions

Three-Year Data Help Forge Path to T-DM1-Based Deescalation in HER2+ BC

Key clinical point: T-DM1 + pertuzumab reduced grade 3+ toxicity, but led to lower EFS and pCR rates vs standard chemotherapy + dual HER2 blockade.

Major finding: Overall EFS and grade 3+ AE rates with T-DM1+P vs. TCH+P: 94.2% vs. 85.3% and 31.8% vs. 67.6%.

Study details: The phase 3 KRISTINE study of 444 patients.

Disclosures: F. Hoffmann-La Roche and Genentech funded the study. Dr. Hurvitz reported research funding to her institution from Ambryx, Amgen, Bayer, Biomarin, Boehringer Ingelheim, Cascadian Therapeutics, Daiichi Sankyo, Dignitana, Genentech/Roche, GlaxoSmithKline, Lilly, Macrogenics, Medivation, Merrimack, Novartis, OBI Pharma, Pfizer, Puma Biotechnology, Sanofi, and Seattle Genetics, and travel/accommodations/expenses from Lilly, Novartis, and OBI Pharma.


Hurvitz S et al. ASCO 2019: Abstract 500.