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ClinicalTrials & Tribulations
At its most recent meeting, the FDA Oncologic Drugs Advisory Committee focused on perioperative clinical trials, which the agency defined as neoadjuvant phase followed by surgery and continuing with adjuvant treatment using the same experimental agent (The Cancer Letter, July 26, 2024).
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.
