Extract

Demicheli et al. are quite correct that the vast majority of patients in our series were not enrolled in a clinical trial and that the time period under consideration, from 1945 through mid-1987, was long. Consequently, ascertainment of the timing of recurrences was probably not as reliable as in their series of patients, all of whom were enrolled in clinical trials in Milan between 1964 and 1980. In fact, we noted that in our cohort, 146 of the 647 patients who died of breast cancer did so without a previously detected recurrence. (Presumably such cases were rare or nonexistent in the Milan dataset.) We were, therefore, left with little choice but to define failure as the combined event “first recurrence or death from breast cancer,” and we agree that this combination could have obscured a second peak.

We are likewise impressed by the similar patterns seen in the hazard rates for all-cause mortality between the two studies displayed in Fig. 1. In this case, there is no ambiguity in the timing of events, and both series provide evidence for a second peak in the hazard curve. Clearly, the two series are far more consistent with one another than they are contradictory.

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