The mood is bright in the office of Olga Ivanov, MD, FACS, Medical Director of the Comprehensive Breast Health Center. As a board certified and fellowship-trained breast surgeon, she is a highly respected, forward thinking leader in breast cancer treatment and has played an integral role in advancing breast cancer treatment nationwide. Specifically, she has played a critical role in bringing a breast cancer trial to Florida Hospital Celebration Health that over the years has not only improved the quality of life for many of her patients, but has helped them move on from their cancer diagnosis and get back to a normal life.
Clinical Trial Comes to Florida Hospital Celebration Health
The cutting-edge treatment approach called Intraoperative Radiation Therapy (IORT) came to Florida Hospital Celebration Health as a clinical trial in 2012. At the time IORT was a relatively new cancer treatment technique in the United States; although European countries had been using it for the past decade. Dr. Ivanov was among the first breast surgeons in the country to explore clinical trials surrounding the usage and effectiveness of IORT in patients diagnosed with early stage breast cancer. It was while practicing at Little Company of Mary Hospital in Chicago that Dr. Ivanov and her former Radiation Oncologist colleague, Adam Dickler, MD, completed a clinical study with data gathered from 75 patients over a four-year period. The results of this clinical trial, under Dr. Ivanov’s direction, were published in Annals of Surgical Oncology.
In 2012, the goal of the national trial was to enroll 1,000 eligible patients at sites nationwide and monitor them for 10 years post-surgery. Now, four years later Florida Hospital Celebration Health has treated more than 70 women with IORT as part of this trial and monitors them regularly. None of these 70 women, who have taken part in this trial at Florida Hospital, have experienced recurrence. Nationwide, 827 patients have been treated on this IORT trial, with only one experiencing recurrence.
For Dr. Ivanov the results are encouraging “I am excited and optimistic. So far the study has probably exceeded what we would have expected, we would have expected a higher rate of recurrence.”
Intraoperative Radiation Therapy (IORT)
Dr. Ivanov has had thousands of women sit down in her office with her, fearful and uncertain as they embark on a journey no woman wants to take.
“I have these women come in all set for a double mastectomy and they may not qualify. We are trying to provide the most effective way to treat patients without over-treatment,” says Dr. Ivanov.
Intraoperative Radiation Therapy is an option for women over the age of 50, with early stage lymph node negative disease (stage 0, I and IIA) and no genetic predisposition. According to Dr. Ivanov, nearly seventy percent of patients diagnosed with early stage breast cancer select a lumpectomy, a breast conserving surgery, combined with up to six weeks of radiation therapy. The 30 treatments are stressful on the physical and emotional health of the patient and their loved ones, and nearly one-third of patients don’t fulfill their full radiation treatment plan. Dr. Ivanov offers them a possible alternative to six weeks of traditional radiation therapy – IORT, an innovative treatment plan that delivers optimum lifesaving results.
Patients opting for IORT undergo a lumpectomy followed by radiation treatment while still in surgery. The surgeon removes the area around the lump followed by one dose of radiation directly into the remaining tissue. Based on clinical trial outcomes, this one dose controls tumor recurrence as effectively as the six weeks of radiation treatment. In addition, patients experience considerably less downtime and less severe side effects.
Dr. Ivanov describes it like this, “Do you want six weeks in pain, with expanders and possibly follow up surgeries, or do you want an outpatient procedure, with general anesthesia and approximately an hour and a half in the operating room? With IORT you can be back to normal the next day.”
Dr. Ivanov says that patients who come to see her often requesting bilateral mastectomies do so because of the fear of follow up radiation from lumpectomies. IORT provides them an option where they can avoid a mastectomy and the six weeks of radiation.
“Their reaction goes from one extreme to the other. Once I educate them that a double mastectomy is not indicated for them and there is an alternative to six weeks of driving somewhere to radiation, they make the switch and ask to be signed up,” adds Dr. Ivanov.
The IORT trial at Florida Hospital Celebration Health is using a type of device called Xoft® Axxent® Electronic Brachytherapy (eBx®) System®. A study recently released at the national American Society for Radiation Oncology (ASTRO) annual conference in Boston, Massachusetts found that IORT with the Xoft® System is safe, has low morbidity, good cosmetic results and a low rate of low-grade adverse events.
The Patient Experience with IORT
Patients who are considered possible candidates for IORT will first learn about all care options. If eligible, the potential IORT patient will then undergo genetic counseling, and if appropriate genetic testing, prior to surgery.
Patients will also meet with a member of the radiation oncology team at Florida Hospital for consultation. According to Dr. Ivanov, ninety-nine percent of the time patients who meet the criteria for IORT are able to move forward. While in surgery, however, surgeons check for additional disease in the lymph nodes. Lymph nodes are biopsied immediately. If clear, IORT is administered instantly. In all cases patients are discharged the same day and, most of the time, will not require additional radiation. Approximately one percent of the time patients may need additional radiation and may need to be back in for additional surgery.
“Ninety-nine percent of the time, once patients are wheeled out of the OR, they are done. Their margins are clean, their lymph nodes are clear and they are done with radiation. They may still need chemotherapy if they have a high risk cancer and they may need hormonal therapy, but they won’t have to undergo six weeks of radiation,” adds Dr. Ivanov.
In addition to avoiding six weeks of treatment, Dr. Ivanov points out that the physical toll on patients after undergoing IORT is far less than traditional radiation.
“The majority of my patients don’t have to use prescription pain medication, just extra strength acetaminophen. It truly is a cost effective treatment and just as effective in terms of outcomes. What can be more satisfying for a patient than taking over-the-counter medication and going on with their life the next day?” says Dr. Ivanov.
To date, IORT is now covered by the vast majority of insurances, making it even more accessible for patients. The majority of patients undergoing IORT at Florida Hospital are from Florida, with patients traveling to Central Florida for IORT from as far away as California, Michigan and Illinois.
For Dr. Ivanov the success that Florida Hospital Celebration Health has seen with IORT treatment is due to a unique group of dedicated radiation oncologists on board.
They are exceptional,” adds Dr. Ivanov. “They have embraced this vision. This group is very much on par with the new protocols, more localized, efficient, effective and shorter care. They are the main drivers and are passionate about that. They want to deliver effective treatment to control cancer and they won’t compromise. They are committed to this program and IORT and have contributed greatly to our overall success.”
Presently Florida Hospital has three radiation oncologists specifically trained and dedicated to the IORT technique. In addition, each patient is paired with a nurse navigator who helps them with their logistics for treatment. Every patient undergoes a formal class that explains what to expect from their treatment plan and gets a tour of the hospital, which takes the fear and apprehension away.
After performing IORT for the past four years at Florida Hospital Celebration Health, Dr. Ivanov uses a simple analogy to explain it to colleagues and patients.
“Imagine you have a splinter in your right foot. Would you amputate both feet? Instead of amputation, we take out the splinter and provide one powerful dose of radiation.”
Dr. Ivanov believes that educating patients and physicians about the proven benefits of cancer treatment is key. “Bilateral mastectomy is not going to prolong your survival. But, for sure it is going to be extensive and a longer recovery. Or, you can go to sleep, get a lumpectomy, receive IORT, wake up and you are likely done with treatment.”
Dr. Ivanov reminds that the success of any kind of treatment, however, depends on early diagnosis and finding the cancer early.
“If we find it early we can give these treatments in one day. Obviously though we are not naive, sometimes cancer is aggressive, even if found early. But, we are much better at figuring out though genomic testing if this simplified treatment is an option,” says Dr. Ivanov.
Whether it’s using cutting edge treatment such as IORT or other advanced cancer care options, Dr. Ivanov believes that the Comprehensive Breast Health Center is cutting-edge in its ability to refine breast cancer treatment and treat the whole patient.
“Breast cancer is such an assortment of diseases, not every breast cancer is created equal. What we are getting good at is defining that category, we are getting better at defining that population. It’s about getting down to the biology of the cancer, drilling down to the cancer cell itself and determining whether to treat it as a systemic disease or a local disease.”
Moving forward, Dr. Ivanov hopes that primary care physicians and oncologists will move their conversations with their patients towards IORT. Currently, The National Institute for Health and Care Excellence (NICE) in the United Kingdom, the UK version of the Centers for Medicare and Medicaid Services (CMS), recommends that IORT is encouraged for women who meet the criteria. Dr. Ivanov would like the United States to adopt similar practices. She is hopeful that with the IORT trials at Florida Hospital and around the nation, and the overwhelming positive outcomes that it is showing, that the National Comprehensive Care Network (NCCN) guidelines will join the UK and other European countries in exploring IORT as a preferential treatment for breast cancer patients.
During the month of October, all Florida Hospital locations will offer $35 screening mammograms for those women who do not receive full insurance coverage as a preventative service. The hope is that more women will get screened and breast cancer will be diagnosed early when it has a better chance for a cure.
By Katie Dagenais