Heather Han, MD, an oncologist at Moffitt Cancer Center in Tampa, Florida, talks about a new treatment for advanced breast cancer.
Interview conducted by Ivanhoe Broadcast News in May 2017.
The significance of the Ribociclib, can you tell us how this came to be?
Dr. Han: Until a few years ago, a patient with hormone receptor positive or negative for advanced cancer patient had limited therapy options. This is one of new therapy in addition to recently approved medication called Palbociclib.
Why is it significant for patient with advanced breast cancer patient?
Dr. Han: For patient living with metastatic breast cancer, they have to receive different types of treatment to control their disease, potentially to prolong their life and have improved quality of life. Among those many options of therapy, this is a new addition that shows significant improvement of their disease control when it was added to traditional approved therapy called Letrozole which is an anti-estrogen therapy. This treatment trial was conducted by including over six hundred female patients, who have advanced breast cancer with hormonal receptor positive or HER2 negative breast cancer. Patients were randomized to receive either Letrozole alone with the placebo or Ribociclib added to Letrozole. This trial was reported last year in the conference and also published showing significant efficacy when patients received the combination treatment, it was able to reduce the risk of progression or death by forty four percent, which is really significant. Therefore, this trial confirmed that combination strategy of Ribociclib added to Letrozole is more effective than patients taking Letrozole alone which is anti-estrogen therapy.
So for patients is this a big deal?
Dr. Han: Right, because this trial actually comes from another medication called Palbociclib that was approved about two years ago. It’s the same class of medication to the Ribociclib. Palbociclib was approved by the FDA because it showed significant improvements of survival progression for patient with advanced breast cancer, hormone receptor positive or negative breast cancer. It almost doubled the progression-free survivor by taking these two medications compared to Letrozole alone. So both these medication and their results support that this is really indeed a new standard of front line therapy for patients with advanced breast cancer who has hormonal receptor positive breast cancer.
Does it take a long time for new drugs to be approved?
Dr. Han: This medication has been in clinical trial for several years, but had these amazing results in the interim analysis. This trial has been ongoing since 2013 but they actually stopped this clinical trial prematurely because the interim analysis showed that combination treatment is going to be superior without continuing therapy as planned. Subsequently, it’s been on the clinical trial for several years, but FDA was able to approve it quickly when it showed dramatic improvement of the patients’ progression free survival.
So this could really affect the patient’s survival rate?
Dr. Han: Potentially yes. We don’t yet have, given the short term follow up and drug being approved quickly, long-term mature survivor data because the patients continue to be followed. So we will see this data in the near future. But as of now, we do have the data that it does reduce the risk of progression or death by forty four percent, because the main primary end point of clinical trial was progression free survival. They have a plan to look for overall survival as well as a secondary end point.
How does the drug work?
Dr. Han: This drug Ribociclib works by stopping signals that cancer cells use to grow and divide. Ribociclib uses this class of medication called CDK46 inhibitor that’s signals that cancer cells use to grow and divide. So when this medication was combined with Letrozole it’s effectively able to control breast cancer if it’s hormonal receptor positive kind, subtypes.
So it concentrates on the signal?
Dr. Han: Essentially the signal, essentially you need the cell cycle progression. The cancer cells have to divide and grow by using the enzymes, and this medication will block the signals the cancer cells use to grow. So it’s the class of medication called cell cyclin inhibitor.
It kind of stops it in its tracks? How is it given to the patient and for how long?
Dr. Han: Yes. It’s actually given orally so the patient will take pills, twice a day. They take every day for three weeks then they take a week break. As long as the medication is working well and the patient is tolerating it well, without any major toxicity, the patient will be continued on this medication. In combination with Letrozole or any other Aromatase inhibitor, which is a hormonal blocker, is commonly used to treat patients with hormonal receptor positive breast cancer.
So they can take it indefinitely?
Dr. Han: Yes.
Are there side effects?
Dr. Han: Common side effects of this particular medication or this class of medication have been a decrease in the white blood cells, particularly called Neutrophil. More than half of patients experienced something called Neutropenia, which is lowering Neutrophils, a part of white blood cells. However, it didn’t result in major increase of Neutropenia fever or major danger of infection. Commonly some patients may have to reduce their dose of medication. It can also cause sometimes abnormal liver function, some patients may experience increased rate of nausea, diarrhea or fatigue. Also that it can increase or change the some of the EKG’s, that’s the heart monitoring. Fairly rarely, tiny, in very rare instances. But FDA did ask when patients take this medication to have EKGs to be monitored for the first few weeks to make sure that it doesn’t change something called acute PC interver.
For your patients, will this affect them in their treatment plan?
Dr. Han: With this new class of medication added to what we were doing, we’re significantly able to make patients response better and also prevent disease progressing faster. Therefore, this is you know, day to day it’s a very exciting time for—for patients and oncologists because this is indeed we see day to day how this is impacting patient’s daily life, for how much a patient is doing better without any significant side effect. So that’s been a key.
Who are the candidates?
Dr. Han: Any patient with hormonal receptor positive, Her2 negative or advanced breast cancer patient. It’s actually approved for front line therapy, which means that the patient was either recently diagnosed, or newly diagnosed for advanced breast cancer. Also, that a tumor has hormonal receptor expression and Her2 negative. Essentially then, it’s post-menopausal women. Post-menopausal women with advanced breast cancer, hormonal receptor positive, Her2 negative all would be viable to be seen with this medication.
When you found out this was approved what did you think?
Dr. Han: It’s very exciting; we anticipate this would be approved. I was fortunate enough to be able to use this medication on clinical trial study for my patients at Moffitt. Because we had clinical trials using the same medication for patients with hormonal receptor positive advanced breast cancer patients. I had already seen dramatic improvement in helping patients and impacting their daily life. So I already expected it because I already witnessed the many, many patients benefiting from this combination treatment. Thus, I’m obviously very excited that this drug finally actually got approved. I’m able to be there to help patients to do better than existing prior therapy.
END OF INTERVIEW
This information is intended for additional research purposes only. It is not to be used as a prescription or advice from Ivanhoe Broadcast News, Inc. or any medical professional interviewed. Ivanhoe Broadcast News, Inc. assumes no responsibility for the depth or accuracy of physician statements. Procedures or medicines apply to different people and medical factors; always consult your physician on medical matters.
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