Surprising Results From the PALLAS Trial

Kathy D. Miller, MD


July 01, 2020

This transcript has been edited for clarity.

Hi. It's Dr Kathy Miller from Indiana University.

I want to make sure you saw a press release on the results of the PALLAS trial, which caught many of us by surprise shortly after ASCO had wrapped up the virtual meeting.

PALLAS was the first of several ongoing adjuvant trials designed to investigate the incorporation of a cyclin-dependent kinase inhibitor — in this case, palbociclib — into the adjuvant hormone therapy of our patients with ER-positive disease. This trial, based on strong science and incredibly positive results in the metastatic trial, did not meet its primary endpoint; it did not improve distant recurrence-free survival or overall survival when incorporated into the adjuvant therapy. That is certainly not the result we had hoped for, and it's not the result many of us were expecting.

We have only the press release to guide us at this point. There will be much to learn from delving into the details of this trial and from the correlative samples that were collected as part of it.

More than anything else, this trial reminds us of the absolute necessity of putting our ideas to the test and doing appropriately powered, appropriately controlled, and well-conducted randomized trials. When we think we've gotten too smart that we know what the results will be and it's not ethical to randomize patients in a trial, we should be cautious because sometimes we're not nearly as smart as we think we are. We will look forward to learning much more from this trial.

Kathy D. Miller, MD, is associate director of clinical research and co-director of the breast cancer program at the Melvin and Bren Simon Cancer Center at Indiana University. Her career has combined both laboratory and clinical research in breast cancer.

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