Cryoablation (Cry-o-a-blay-shun) or tumor freezing is a minimally invasive procedure that utilizes a needle-like cryoprobe and extremely cold temperatures to kill cancers along with a surrounding margin of normal breast tissue, similar to what would be achieved with lumpectomy. Unlike breast cancer surgery, cryoablation is performed in the office under local anesthesia. The procedure minimizes breast appearance and quality of life and permits rapid resumption of work and daily activities.
In April 2024, the 5-year follow-up results of the ICE3 Trial were presented at the annual meeting of the American Society of Breast Surgeons in Orlando, Florida. The ICE3 Trial is a multicenter, single-arm, non-randomized clinical trial that evaluated the role of cryoablation as an alternative to surgery. The trial enrolled 194 women ranging in age from 55-94 (mean 75) years with clinical stage I, ≤1.5 cm, histologic grade 1 or 2, estrogen receptor-positive, progesterone receptor-positive, HER2/neu negative invasive ductal carcinoma diagnosed by needle biopsy. The use of anti-estrogen therapy, radiation therapy, and sentinel node biopsy were not mandated by the trial. As a result, nearly 80% of ICE3 trial participants utilized endocrine therapy, but only 14% received adjuvant radiation therapy, and only 8% of participants underwent a sentinel node biopsy. At five years of follow-up, there were only seven recurrences of cancer in the same breast, yielding a local recurrence-free survival rate of 96.7%, which is comparable to lumpectomy clinical trials in women over 60 years of age where radiation therapy was omitted—the previously published. The 5-year results will be published this upcoming summer.
My Cryoablation Journey
I began my journey with cryoablation in 2002 when I heard about the procedure while attending the annual meeting of the American Society of Breast Surgeons. At the time, cryoablation was a new treatment available only for women with benign breast tumors called fibroadenomas. Concurrently, I was preparing to begin my career as a breast surgeon, and I immediately recognized the potential for cryoablation to provide a minimally invasive alternative to lumpectomy or mastectomy for women who were reluctant to undergo breast cancer surgery, many of whom I had already encountered in my young career. Envisioning this opportunity, one year later, I began performing cryoablation of benign breast tumors to develop my cryoablation skills, preparing for the day that I could use cryoablation to treat breast cancer. My learning process also included the establishment of a special clinic at Los Angeles County U.S.C. Medical Center, where I taught breast surgery trainees how to perform cryoablation and other core biopsy procedures.
My journey to treating breast cancer continued in 2009, when I traveled to Kamogawa, Japan to visit with pioneering breast surgeon Dr. Eisuke Fukuma, to learn about his breast cancer cryoablation experience, which had begun several years earlier. During that trip I taught his team about intraoperative radiotherapy, my area of expertise.
Later that same year, I joined the American College of Surgeons Oncology Group’s Z1072 clinical trial in which women with invasive breast cancers ≤2 cm underwent cryoablation followed by removal of the cryoablation site with lumpectomy or mastectomy. The results of the trial were published in 2016, showing cryoablation to be highly effective at completely ablating stage I invasive breast cancers.
Following completion of the Z1072 trial, I launched and led an investigator-initiated, multi-center, clinical trial called the FROST (Freezing without Resection Of Small Tumors) Trial in which women with stage I (≤2 cm) invasive breast cancer underwent cryoablation without subsequent lumpectomy or mastectomy. Like the ICE3 trial, early results of the FROST trial showed cryoablation to be an excellent alternative to surgery for stage 1 invasive breast cancer. The FROST trial is closed to enrollment. We are currently in the process of obtaining updated information about FROST trial participants prior to publishing long-term results this upcoming summer.
While enrolling patients in the FROST Trial, I had the opportunity to offer cryoablation to a number of women outside of the FROST trial who did not actually qualify for the FROST Trial but for various reasons were unwilling to undergo traditional surgery. This helped to broaden my experience to treating larger, higher-stage breast cancers. As the COVID pandemic spread in 2020, I recognized a new opportunity for cryoablation. At the time, many overwhelmed hospitals were unable to accommodate routine breast cancer operations, causing countless breast cancer patients to wait additional weeks or months before undergoing surgery. This situation prompted me to publish Breast Cancer Care During A Pandemic: an Opportune Time for Cryoablation? to inform the medical community and patients how cryoablation could be used to effectively manage breast cancer either as a complete substitute for surgery or as a stopgap measure until surgery (e.g., mastectomy and/or reconstruction) could be conveniently scheduled.
It was during the pandemic that I developed a clinical trial to evaluate the use of ultrasound-guided cryoablation as an alternative to surgery for the treatment of ductal carcinoma in situ (DCIS), which up to then had been excluded from cryoablation clinical trials due to the difficulty of detecting DCIS by ultrasound. I was determined to change that. With help from a patient-initiated crowdfunding campaign, a matching grant from Doterra, and research support from the CORI Foundation and the Helen Rey Breast Cancer Foundation, I launched the DCIS Cryoablation Trial. Since DCIS is not usually visible by ultrasound, the DCIS Cryoablation Trial involves the insertion of an ultrasound-visible biopsy site marker at the site of DCIS, which can then be targeted for ultrasound-guided cryoablation of the surrounding DCIS.
I recently had the opportunity to present preliminary results of the DCIS Cryoablation Trial at the International Oncoplastic Breast Surgery Symposium in Mikazuki, Japan. Preliminary results show cryoablation to be 100% effective in ablating DCIS ≤2cm, which is great news for the 55,000 women diagnosed with DCIS in the U.S. each year.
The DCIS Cryoablation Trial is still open to enrollment of women with a core-needle biopsy diagnosis of DCIS measuring ≤2 cm based on its appearance on mammography, ultrasound, and breast MRI if performed. The study is open to women across the U.S. and requires only one in-person visit to Los Angeles. If you know of someone recently diagnosed with DCIS, please let her know about the trial. Limited spots are available. Cryoablation administered as part of the DCIS Cryoablation Trial is free of charge.
Patients made the DCIS Cryoablation Trial possible through their crowdfunding effort, but enrollment in the trial is limited by funding. If you’d like more women to have access to the trial, please consider making a tax-deductible donation to https://helenreybreastcancerfoundation.com. As for me, I will continue to donate my time to perform cryoablation procedures for clinical trial participants.
The Next Frontier
With cryoablation growing in popularity nationwide, many patients find that their doctors know relatively little about cryoablation, making it harder for patients to seek appropriate follow-up care. To address this follow-up care. To addres this concern, I published “Breast Cancer Cryoablation in the Multidisciplinary Setting: Practical Guidelines for Patients and Physicians” in June 2023. . The purpose of the guideline was to educate patients, primary care physicians, and oncologists about cryoablation and to establish practice standards for new cryoablation providers.
Building upon our experience with Stage 0 and I breast cancer, my next goal is to demonstrate the ability of cryoablation to effectively manage stage II, III, and IV breast cancer among persons who refuse recommended surgery or are at high risk for surgery or anesthesia complications. For such patients, I’ve innovated techniques using multiple overlapping cryoablation treatments to manage larger, more complex cancers, ideally combined with radiation, anti-estrogen therapy, or chemotherapy, as appropriate. I will publish some of these techniques and patient outcomes in the summer of 2024.
Coverage
Although significant progress is being made in demonstrating the effectiveness of treating breast cancer with cryoablation, the insurance coverage landscape is progressing slowly.
At present, there is no established reimbursement value for breast cancer cryoablation. Consequently, there is no guarantee that insurers will reimburse doctors adequately to cover the equipment cost, expertise, and time of performing cryoablation. Consequently, in my practice, patients must pay in advance for the procedure and are provided documentation to seek reimbursement from their insurers.
CareCredit is also accepted. Medicare patients must complete an Advanced Beneficiary Notice of Non-coverage (ABN) form. That said, cryoablation remains free of charge for DCIS Cryoablation Trial participants.
We also offer free case previews for patients who simply want to find out if they qualify for cryoablation. You can also email info@cryoablation.com.
Dennis R. Holmes, M.D., F.A.C.S., is an internationally renowned breast cancer surgeon, surgeon educator, and cancer researcher specializing in managing breast cancer. Dr. Holmes is the medical director of the Sam and Grace Carvajal Comprehensive Breast Center at Adventist Health Glendale in Los Angeles, CA. He is also Co-Founder and CEO of XpediteMD, Inc., a digital health technology company working to improve the efficiency, quality, and value of cancer care. Dr. Holmes is a board-certified Fellow of the American College of Surgeons. He has also served as department head of several academic breast cancer programs and program director of two breast surgery fellowship programs. He has also played a pivotal role in several breast cancer treatment innovations, including intraoperative radiotherapy, oncoplastic surgery, and cryoablation.
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