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Jack Cuzick, Endpoints for the Evaluation of Breast Cancer Treatments, JNCI: Journal of the National Cancer Institute, Volume 106, Issue 12, December 2014, dju323, https://doi.org/10.1093/jnci/dju323
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In this issue of the Journal, Moossdorff et al. ( 1 ), report on a systematic approach for reaching a consensus about the definition of endpoints for breast cancer patients. The goals were very focussed and limited, but still this is an important contribution to the standardization of reporting of study outcomes. It was based on a multiround process, consisting of two rounds of questionnaires followed by a face-to-face meeting involving 24 experts in the field. Being based on opinion rather than data, there is no certainty that the correct answers were obtained. However, this is less important for this question, where standardization is the key outcome, than for treatment or biomarker questions, which must be evidence- and not opinion-based.
The focus was primarily on reproducible objective categories rather than biologic entities. Thus, the categories considered for classification of a recurrence were local, regional, contralateral, and distant. One of the most interesting areas was in the classification of local recurrence. No attempt was made to separate true recurrence from a new ipsilateral primary cancer, and recurrent ductal carcinoma in situ (DCIS) was not treated separately from recurrent invasive disease. While the simplicity and reproducibility of this approach is commendable, there are situations in which it is probably not adequate. One of these is the management of DCIS, where ‘recurrent’ DCIS alone is often considered to reflect incomplete excision of the primary tumor, whereas recurrent invasive disease is a strong indicator of a progressive lesion. This distinction seems important to retain in this situation, as the biology is quite different. Additionally, one recent trial of intraoperative radiotherapy ( 2 ) attempted to distinguish within quadrant recurrence as a treatment failure and a local recurrence in other quadrants as new disease. For such localized treatments, including surgical ones, this may be valuable to distinguish, but it may be very hard to standardize more generally.
