Stefan Gluck, MD: Avastin Improves PFS in HER2-Positive Breast Cancer in AVEREL Study
Dr. Stefan Gluck discusses the Avastin (bevacizumab) and how it has been shown to improve progression-free survival in HER2-Positive Breast Cancer in the AVEREL Study presented at the 34th Annual CTRC-AACR San Antonio Breast Cancer Symposium.
Dr. Gluck is a Professor of Medicine, University of Miami, Associate Division Chief for Clinical Affaris, Division of Hematology/Oncology Sylvester Comprehensive Cancer Center, University of Miami Health Systems and the Clinical Director, Braman Family Breast Cancer Institute.
The Group Room at the 34th Annual CTRC-AACR San Antonio Breast Cancer Symposium was made possible by support from:
VIDEO TRANSCRIPT:
Selma Schimmel, Founder & CEO, Vital Options International:
Hello and welcome to the Group Room where we’re at the 34th Annual CTRC-AACR San Antonio Breast Cancer Symposium. I’m very glad to be back with you, Professor-Doctor Stefan Gluck. You are the Associate Division Chief in Clinical Affairs in the Division of Hematology/Oncology at the Sylvester Comprehensive Cancer Center, the University of Miami Health Systems where you’re also the Clinical Director of the Braemon Family Breast Cancer Institute, and Professor of Medicine at the University of Miami, and you love your work in the area of breast cancer.
Stefan Gluck, MD, Assoc, Division Chief, Sylvester Comprehensive Cancer Center, Univ. of Miami:
Absolutely. It’s my professional life. I do anything and everything for my patients, and for those who might be patients in the future.
Selma Schimmel:
Let’s talk about the addition of Avastin to conventional therapy improving progression-free survival in the Her2-Positive breast cancer patient.
Stefan Gluck, MD:
So why am I chuckling and you know of course, Avastin was initially approved on a very, very – extremely, actually – well designed study run by ECOG, Eastern Corporate of Oncology Group, which is not pharmaceutical. And it was not meant to be a study to approve a drug; it was meant to do research, what we do best. We’re not here to approve drugs we’re here to research, which leads to improvement of outcomes. Turns out the study was testing A-chemotherapy versus the same chemotherapy plus Avastin. And the study showed in Her2-Negative – there’s a difference here – disease a huge, and until then unseen progression-free survival benefit of almost half a year. Now at that time survival was not different. There was a small blip, insignificant a few patients more alive at one year with Avastin than without Avastin. But it was not significant and it was not good enough for the FDA to say ‘let’s approve the drug’.
So they did a very interesting trick, and rightly so – let’s do accelerated approval and the drug was approved under the condition confirming studies, complementary studies – two or three of them – so in the last five years or four years after it was approved there was a whole area of studies in Her2-Negative disease that show qualitatively the same, improving progression-free survival but not showing any improvement over survival. And we get out data that it may have some unexpected toxicity over time, which leads to grade 5 toxicity – that’s the term for death on a study.
And to make a long story short, even if you calculate all these studies together, the goal was the same, the outcome was the same – progression-free survival is better by some time one study is better than the other but overall survival is not. So the FDA just a month ago – or less than a month ago – revoked the approval for Avastin in breast cancer. So it’s still approved for the other indications, they are for other indications.
European agency did a different approach. They looked in each study individually and identified always the partner of Avastin the drug, and showed that Taxol with Avastin is beneficial, and Capecitabine with Avastin is also beneficial, and the risk-benefit ratio is in favor of keeping Avastin. So they approved the drug for these two combinations only. So you can’t combine it with any other. And it probably is correct.
Anyway, this is completely new. This is in Her2-Positive disease now, and there was some preliminary data, preclinical data that veg receptor and Her2 receptor crossed and they inference each other in aggressivity of cancer. So phase one and phase two studies have shown that it’s safe and it’s beneficial. So the phase three now being shown in San Antonio this year shows almost again the same stuff – same progression-free survival improved by half a year, 4 ½ to 5 months without, at the moment, survival benefit. So is it good enough for the FDA, is it good enough for us to use it? Well it may have been good enough two, four, three years ago but now we have so many other new compounds that you discussed for Her2 targeting that it may not be necessary – I’m not saying not good, but not necessary – to have such a drug adding to our Her2-Positive disease.
Selma Schimmel:
Thank you, Doctor Gluck, Associate Division Chief for Clinical Affairs at the Sylvester Comprehensive Cancer Center, University of Miami, Professor at the University of Miami School of Medicine, and Clinical Director of the Braemon Family Breast Cancer Institute. Thank you always for making time. I love your passion.
Stefan Gluck, MD:
Thank you, Selma. It is a pleasure to be here.
END OF VIDEO