Statistics reveal that fibroadenomas are one of the most prevalent breast conditions, affecting approximately 10% of women at some point in their lives. Yet, available treatment options for these non-cancerous breast tumors have traditionally been limited and often involve invasive surgery, leading to a need for more effective and less invasive treatment options.
In this article, we will explore the prevalence of fibroadenomas, current fibroadenoma management, the unmet need, and recent advances in minimally invasive approaches.
What are Fibroadenomas?
Fibroadenomas (FAs) are benign breast masses that arise from the glandular and connective tissues of the breast. The exact cause is unknown, but hormonal factors and fluctuations during reproductive years may play a role. They are characterized as firm, non-tender, clearly demarcated masses usually 2 to 3 cm in size, though they may range from < 1 cm to greater than 10 cm. The size of these benign masses may enlarge slowly over time without associated pain or nipple and skin changes. Should there be any symptoms, they usually persist for approximately 5 months.
Patients with fibroadenomas typically present with various symptoms, including the presence of palpable lumps or swelling in the breast. Patients may also experience pain or discomfort, which can cause anxiety and concern. Fibroadenomas can also lead to cosmetic concerns and physical deformities that may affect a patient’s body image and quality of life. Physicians can typically detect fibroadenomas through mammograms, ultrasound or physical examinations.
Fibroadenoma Management Options Available Today
Management of breast fibroadenomas today involves different treatment options, with the most common including observation, surgery, and thermal ablation such as cryoablation. Based on the patient’s history, wishes, and needs, physicians should carefully consider which treatment approach is best suited to each patient.
Observation of Fibroadenomas
Particularly dependent on the size and symptomatic experience of the lesion, physicians may adopt a cautious monitoring approach, observing the progression of the fibroadenoma over time. A biopsy may be performed to ascertain that the lesion is indeed a fibroadenoma and is benign in nature.
However, should the fibroadenoma enlarge and start causing discomfort to the patient, various treatment options should be considered, ensuring patient comfort and health is prioritized. For fibroadenoma management by observation, physicians should consider that minimally invasive cryoablation is ideally suited for treating smaller lesions so early referral is important, while for masses over 4 cm in size, surgery is the only treatment option.
Surgical Removal of Breast Fibroadenoma
Surgery has traditionally been the most common treatment approach for fibroadenomas, involving excisional biopsy or lumpectomy to remove the fibroadenoma. Although surgery is effective, it requires hospitalization, general anesthesia, and results in scarring and an extended recovery time. Additionally, fear may drive some women to opt for surgery, even for smaller fibroadenomas.
Studies have reported recurrence rates ranging from less than 1% to around 10% after surgical excision of fibroadenomas. Factors associated with an increased risk of recurrence include larger tumor size, incomplete removal of the fibroadenoma, multiple fibroadenomas, and the presence of atypical features within the fibroadenoma.
One study of 90 cases of fibroadenoma that showed phyllodal features (unilateral firm, enlarging painless breast masses that stretch the overlying skin with striking distension of superficial veins) .and positive surgical margins, revealed a low recurrence rate of 3%. Recurrence of 15% over 22 months was more likely to occur for masses >2 cm at initial diagnosis.
Regular patient follow-up examinations and mammograms following surgery is recommended to monitor for any signs of recurrence or new growths.
Recent advances now provide patients with the option of a minimally invasive procedure.
Cryoablation of Breast Fibroadenoma
Cryoablation, a safe and effective minimally invasive procedure, has gained recognition as a promising treatment option for fibroadenomas.
Cryoablation is a simple, ultrasound-guided technique that utilizes freezing temperatures to ablate the fibroadenoma. Unlike more invasive treatments that may require a hospital setting, cryoablation opens the door to perform these procedures in the convenience of an office-based setting or outpatient clinic.
The procedure is known for its excellent patient experience, as it leaves the breast tissue intact without any removal. Moreover, it yields cosmetically superior results, as there is no cavity for hematoma formation or volume loss, and no sutures are required.
Cryoablation is also fast with treatments usually lasting under an hour and with minimal pain from the analgesic cooling effect of the cryoablation. If the patient has multiple fibroadenoma lesions, they can generally be treated in the same session. Patients can also return immediately to their daily life and the procedure eliminates the need for hospital admission and associated costs.
Supported by more than a decade of clinical experience, IceCure’s ProSense Cryoablation System provides an easily integrated and revenue-generating option for clinical practice, with small disposable probes and minimal office waste.
Ultrasound-guided cryoablation has been extensively investigated and found to be similar in efficacy and safety to open surgical excision for benign breast tumors, including fibroadenomas.
The American Society of Breast Surgeons (ASBrS) has issued a consensus guideline on cryoablation for the treatment of fibroadenomas. In order to proceed with a fibroadenoma cryoablation procedure, the lesion must be ultrasound visible and a diagnosis should be confirmed with a biopsy before treatment. The fibroadenoma should be less than 4 cm.
Clinical evidence to date shows that cryoablation can achieve a reduction of approximately 90% in benign lesion volume and up to 99% in tumors up to 4.2 cm after 12 months, with 80% of the lesions becoming non-palpable within the same period. Fibroadenomas measuring less than 2 cm have ben show to have the best response to treatment with cryoablation.
A case report using the ProSense Cryoablation System demonstrated significant results, with a fibroadenoma almost vanishing at the 6-month follow-up.
It is important to note that after cryoablation, some patients may still feel the presence of the treated lesion or experience an increase in its size temporarily.
The Future of Fibroadenoma Treatment
It is crucial to recognize that one size treatment does not fit all. Different management approaches should be considered based on each patient’s individual factors, including patient history, age, preferences, size of the fibroadenoma, complexity, and growth rate.
For some patients, surgery may be preferable based on the size of fibroadenoma and growth rate.
Clinical evidence supports cryoablation as an optimal treatment approach for fibroadenomas, offering a convenient minimally invasive in-office procedure with immediate recovery. By preserving breast tissue, providing rapid and durable ablation, and yielding cosmetically superior results, cryoablation addresses the unmet need for a non-invasive approach in managing fibroadenomas.