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Comment & Response
December 6, 2018

Trastuzumab Therapy for 9 Weeks vs 1 Year for Human Epidermal Growth Factor 2-Positive Breast Cancer—Reply

Author Affiliations
  • 1National Health and Medical Research Council Clinical Trials Centre, University of Sydney, Sydney, New South Wales, Australia
  • 24Pharma Ltd, Turku, Finland
  • 3Department of Oncology, Helsinki University Hospital, Helsinki University, Helsinki, Finland
JAMA Oncol. Published online December 6, 2018. doi:10.1001/jamaoncol.2018.5739

In Reply We thank McCaw and colleagues for their comments and for providing additional interpretation of the results from the SOLD trial.1 The event rate in the SOLD study was lower than expected because 60% of the patients had node-negative cancer. In studies with low event rates, common methods of analysis all have limitations, and one is guided by both pragmatic considerations and clinical interpretations. We increased the noninferiority (NI) margin to 1.385, corresponding to the observed disease-free survival (DFS) rate of 88.7%, to maintain the study power despite the lower-than-expected event rate.1

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