APHINITY
In early HER2-positive breast cancer treated with adjuvant chemotherapy and trastuzumab, does adding pertuzumab improve invasive disease-free survival?
Absolute Effect
At 10 years, the descriptive IDFS difference was 3.4 percentage points. The benefit was larger in node-positive disease; the long-term analysis reported an adjusted HR of 0.79 (95% CI 0.68–0.92).
Key efficacy: The original primary analysis showed an iDFS HR of 0.81 (95% CI 0.66–1.00), P=.045. Long-term benefit persisted, while OS remained statistically non-significant at the prespecified 8-year analysis.
Safety/burden: Pertuzumab increases treatment-related toxicity, particularly diarrhea; cardiac events were uncommon. A single clinically central fixed-time NNH is not assigned here.
Subgroups & limitations
The clearest absolute benefit has consistently been observed in node-positive patients. The trial predates some contemporary HER2-directed strategies, and subsequent therapies can dilute OS differences.
Primary sources
von Minckwitz G, et al. N Engl J Med. 2017;377:122–131. Loibl S, et al. J Clin Oncol. 2024;42:1543–1552.