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In Reply

Dana-Farber Cancer Institute, Brigham & Women's Hospital, Harvard Medical School, Boston, MA

Drs Dang, Norton, and Hudis raise important questions about how much pilot or feasibility data should be required before widespread adoption of a new regimen or variant, especially in an evolving field like adjuvant trastuzumab-based therapy. Relevant considerations include the generalizability of the patient population and the assurances as to efficacy and safety. When appraising exploratory studies, point estimates of risk are probably less clinically significant than confidence intervals, given the small numbers of events and inherent patient selection factors. As we noted, trastuzumab effects may be so potent as to render the choice of specific chemotherapy regimens less material, and cardiac safety may be less of an issue if patients with higher ejection fractions, especially after anthracycline therapy, are treated. Nonetheless, the proven survival advantage and extensive safety experience reported among patients with HER-2–positive breast cancer receiving trastuzumab/chemotherapy in the published phase III trials informs our current preference for those treatment plans.

AUTHORS’ DISCLOSURES OF POTENTIAL CONFLICTS OF INTEREST

The author(s) indicated no potential conflicts of interest.

Related Correspondence

• Dose-Dense Chemotherapy With Trastuzumab Is an Appropriate Option
  Chau Dang, Larry Norton, and Clifford Hudis
  JCO 2008 26: 3655-3656 [Full Text]

This Article Full Text (PDF) Purchase Article View Shopping Cart Alert me when this article is cited Alert me if a correction is posted Services Email this article to a colleague Similar articles in this journal Alert me to new issues of the journal Save to my personal folders Download to citation manager Rights & Permissions Google Scholar Articles by Burstein, H. J. Articles by Mayer, E. L. PubMed Articles by Burstein, H. J. Articles by Mayer, E. L. Related Articles Related Correspondence