Dr. von Minckwitz on pCR and Outcomes in Breast Cancer

Gunter von Minckwitz, MD, PhD
Published: Friday, Mar 15, 2013

Gunter von Minckwitz, MD, PhD, Chairman, German Breast Group, Professor of Gynecology, University of Frankfurt, Germany, discusses the correlation between pathologic complete response (pCR) and outcomes.

Von Minckwitz notes that he was disappointed to see no surrogacy between pCR and outcome in the FDA analysis as improved pCR usually elicits improved outcomes. The analysis looked at trials using chemotherapy and asked chemotherapy-related questions, of which pCR is not a good surrogate. When the FDA drafted guidelines to use pCR as a marker they were considering targeted therapies, not chemotherapy.

Trastuzumab and lapatinib are good examples of targeted therapies that correlate well with the outcome of patients. Von Minckwitz thinks the standard should continue in that direction and use pCR as a benchmark for response.

Gunter von Minckwitz, MD, PhD, Chairman, German Breast Group, Professor of Gynecology, University of Frankfurt, Germany, discusses the correlation between pathologic complete response (pCR) and outcomes.

Von Minckwitz notes that he was disappointed to see no surrogacy between pCR and outcome in the FDA analysis as improved pCR usually elicits improved outcomes. The analysis looked at trials using chemotherapy and asked chemotherapy-related questions, of which pCR is not a good surrogate. When the FDA drafted guidelines to use pCR as a marker they were considering targeted therapies, not chemotherapy.

Trastuzumab and lapatinib are good examples of targeted therapies that correlate well with the outcome of patients. Von Minckwitz thinks the standard should continue in that direction and use pCR as a benchmark for response.


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