Reply to Z.R. McCaw et al

Abstract

We appreciate the comments from McCaw et al 1 regarding the statistical analysis of end points in our study. 2 The primary end point of the study was response rate, but we agree that the estimate of absolute value by median improvement in progression-free survival using Kaplan-Meier can be misleading and may underestimate the true value of new treatment approaches.Using a time-based (t-year) approach to estimate benefit in mean event-free (survival) time to summarize the survival curve is interesting and may provide clinically meaningful results. The t-year mean survival time is the area under the Kaplan-Meier curve. The higher the curve, the larger the area under the curve. The group difference between two treatments can then be quantified by the difference or ratio of two mean survival times. It is interesting that the results using this new summary measure have similar statistical conclusions as those via the hazard ratio estimates in terms of P values. We agree that with such a time scale summary, the quantification of the treatment effect could be easier to interpret and could potentially help with a more accurate estimate of clinical impact for both providers and patients.

ASCO update—best of the best

“…These data will broaden the population of patients with metastatic BC who are candidates for a HER-directed therapy dramatically by about 50%! Other ADCs, like sacituzumab govitecan (SG) also showed superior OS in pretreated triple-negative BC compared to physician’s choice [ 3 ] and disitamab vedotin showed excellent response rates again not only in HER2/IHC3+ and HER2/IHC2+ positive patients but also in HER2 low (i.e., HER2/IHC2+ FISH negative) patients with locally advanced or metastatic urothelial carcinoma [ 4 ].…”