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As always, I both enjoyed and learned something interesting from Dr. Don Berry, one of the great biostatisticians of our era. I find, reading his analysis of ALTTO and NeoALTTO, much that I agree with. I am certainly no statistician, and must bow to his statistical analysis of ALTTO and NeoALTTO. And yet at the same time I think it misses the point. So I will beg to differ.
An article in the June 6 issue of The Cancer Letter described plenary presentations at ASCO 2014. One presentation was the adjuvant breast cancer clinical trial ALTTO in HER2-positive disease, which “was chosen [for the plenary session] because it addressed the reliability of pathological complete response as a surrogate for patient benefit.” The article and much ASCO and post-ASCO rhetoric in the breast cancer community focused on the conclusion that ALTTO failed to show a statistically significant benefit in disease-free survival (DFS) for combination lapatinib/trastuzumab in comparison with trastuzumab, both on a backbone of chemotherapy. This was despite a statistically significant benefit in pathological complete response (pCR) in NeoALTTO, the neoadjuvant version of ALTTO.
