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VIDEO: Physician questions dichotomy between statistical significance, clinical impact
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SAN ANTONIO — Andrew D. Seidman, MD, medical oncologist at Memorial Sloan Kettering Cancer Center, spoke with HemOnc Today about results of the PERTAIN trial, presented at San Antonio Breast Cancer Symposium.
The randomized, open-label, multicenter phase 2 trial evaluated the addition of pertuzumab (Perjeta, Genentech) to trastuzumab (Herceptin, Genentech) and an aromatase inhibitor as first-line therapy for women with HER-2–positive and hormone receptor–positive metastatic or locally advanced breast cancer.
The trial met its primary endpoint, extending PFS by approximately 3 months.
“This result makes me think about the dichotomy between a statistically significant P-value and a trial that may actually impact practice,” said Seidman, a HemOnc Today Editorial Board member. “The notion of incremental gain in PFS that is perhaps modest but statistically significant must be filtered by a metric that captures toxicity [and] that perhaps captures logistical inconvenience to patients. Something we’re not really addressing is cost in our own analysis, but certainly that is a variable that we need to think about.” – by Kristie L. Kahl
Reference:
Arpino G, et al. Abstract S3-04. Presented at: San Antonio Breast Cancer Symposium; Dec. 7-9, 2016; San Antonio.
Disclosure: Seidman reports speaking and consultant roles with Roche/Genentech.