Gunter von Minckwitz, MD, PhD, president of the German Breast Group in Neu-Isenburg, Germany, discusses the safety profile of the phase III APHINITY trial for patients with HER2-positive breast cancer. 

There has been a safety analysis of the APHINITY trial that focused on the impact on the cardiac toxicity, which was shown to be very low, explains von Minckwitz.    

The most significant grade 3 side effect that was experienced was diarrhea, states von Minckwitz. This was confined to the chemotherapy period of the trial.  

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Gunter von Minckwitz, MD, PhD, president of the German Breast Group in Neu-Isenburg, Germany, discusses the safety profile of the phase III APHINITY trial for patients with HER2-positive breast cancer.

Dr. von Minckwitz on the Safety Profile of the APHINITY Trial for HER2+ Breast Cancer

Gunter von Minckwitz, MD, PhD, president of the German Breast Group in Neu-Isenburg, Germany, discusses the phase III results of the APHINITY trial, which explored the addition of pertuzumab (Perjeta) to standard postoperative trastuzumab (Herceptin) therapy for patients with HER2-positive early breast cancer.

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Dr. von Minckwitz on Phase III Results of the APHINITY Trial for Breast Cancer

Gunter von Minckwitz, MD, PhD, Chairman, German Breast Group, Professor of Gynecology, University of Frankfurt, Germany, discusses the rationale behind the phase III PENELOPE trial.

It has been known for a while that patients who do not reach pathologic complete response (pCR) after neoadjuvant chemotherapy have a worse prognosis compared with those who do achieve pCR.

The NATAN study had investigated the use of a bisphosphonate in this setting, though improvement in event-free survival could not be achieved. This further proved the need for new treatment options.

Upon the announcement of progression-free survival benefit in a phase II study of palbociclib plus letrozole, von Minckwitz says oncologists believed the combination should be moved to an early disease setting. A conclusion was then reached to identify patients who have not achieved pCR to be candidates for a “post-neoadjuvant” study investigating palbociclib.

Dr. von Minckwitz on the Rationale of PENELOPE

Gunter von Minckwitz, MD, PhD, Chairman, German Breast Group, Professor of Gynecology, University of Frankfurt, Germany, discusses the current unsolved medical situation regarding patients with breast cancer who do not respond to treatment.

In most breast cancer subtypes, standard treatment strategy is understood: patients with hormone receptor-positive disease receive endocrine treatment and HER2-positive patients receive the remainder of their treatment. Patients with triple-negative disease have nothing, von Minckwitz says.

According to data, adding chemotherapy in triple-negative patients before surgery demonstrates no benefit, forcing a need for new options. There are two new studies upcoming: looking at T-DM1 in HER2-positive disease for non-responding patients and looking for a CDK inhibitor in hormone receptor-positive, HER2-negative disease without pathologic complete response and a high risk for relapse.

Gunter von Minckwitz, MD, PhD, discusses the current unsolved medical situation regarding patients with breast cancer who do not respond to treatment.

Dr. von Minckwitz on Breast Cancer Responses

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 pathologic complete response (pCR) and outcomes.

Gunter von Minckwitz, MD, PhD

Articles

Dr. von Minckwitz on the Safety Profile of the APHINITY Trial for HER2+ Breast Cancer

Dr. von Minckwitz on Phase III Results of the APHINITY Trial for Breast Cancer

Dr. von Minckwitz on the Rationale of PENELOPE

Dr. von Minckwitz on Breast Cancer Responses

Dr. von Minckwitz on pCR and Outcomes in Breast Cancer