DIAGNOSED WITH BREAST CANCER: WHAT ARE MY CHOICES?

After breast imaging and confirmation of cancer type by biopsy, surgical removal of the breast cancer tumor (e.g., “lumpectomy”) is the conventional treatment. It is often followed by adjuvant therapies. However, for a select group of patients, surgery may not be the only option.

Cryoablation for early-stage, low risk breast cancer when combined with endocrine therapy offers the choice of a minimally-invasive treatment. The procedure can be performed in your doctor’s office under local anesthesia with minimal scarring. Cryoablation is possible for the treatment of breast cancer in patients ≥70 years of age with biologically low-risk* tumors ≤1.5 cm in size and treated with adjuvant endocrine therapy, including patients not suitable for surgery of breast cancer treatment.  The procedure uses extreme cold to destroy the tumor by freezing. Cryoablation has been used for decades in clinical practice for the safe and effective ablation of benign and cancerous tumors.

* Biologically low-risk breast cancer is defined as unifocal tumor, size ≤1.5cm, ER+, PR+, HER2-, Ki-67<15% and/or genomic testing indicative of low-risk breast cancer, infiltrating ductal carcinoma (excluding lobular carcinoma, extensive intraductal component, or evidence of lymphovascular invasion), and clinically negative lymph node (N0).

 

WHAT ARE THE BENEFITS OF CRYOABLATION?

• • Maintain breast shape: No tissue is removed and there is minimal scarring. Most patients and physicians reported satisfaction or high satisfaction with cosmetic results*. No breast reconstruction needed.

• • Short, office-based procedure: Average cryoablation procedure time is approximately 30 – 45 minutes with no hospital waiting or overnight stay

• • Recovery to normal activity within median 1 day recovery time (range 0-8 days)

• • Minimal pain and discomfort: Cold numbs the area

• • Local anesthesia: numbing agents are injected only into the area being treat. During treatment, the ice formed can also have a numbing effect on the treatment area.

*99.1 % of patients and 97% of physicians responding to a survey stated they were ‘satisfied’ or ‘very satisfied’ with the breast cosmetic outcomes at 5 years follow up.

 

WHAT ARE THE POTENTAL RISKS OF CRYOABLATION?

Breast Cancer Treatment Risks

• • Incomplete destruction of the cancer which could lead to disease progression
    
    • • Unlike surgical removal of the tumor (e.g., lumpectomy) where there is a specimen for pathology to confirm whether the tumor was completely removed, cryoablation relies on imaging to determine if the tumor was destroyed. However, the exact boundaries may not be visible on imaging which can result in incomplete destruction of the tumor.

• • Tumor recurrence

• • Death due to breast cancer

• • Theoretical risk of tumor seeding (when malignant cells are deposited along the needle or cryoprobe) upon cryoprobe removal, which could result in cancer spread.

Procedure Related Risks:

• • Scarring

• • Bleeding

• • Damage to nearby tissue (skin burn)

• • Post-procedural pain

• • Tenderness

• • Edema (swelling)

• • Bruising

• • Hematoma (bleeding into tissues).

 

WHAT MAKES ME A CANDIDATE FOR BREAST CANCER CRYOABLATION?

The ProSense Cryoablation System is indicated for the local treatment of patients with early stage, low risk breast cancer with adjuvant endocrine therapy (also known as hormonal therapy) and who meet the following criteria:

• • Patient age: 70 years-of-age and above, including patients who are not suitable for surgical alternatives of breast cancer treatment. Cryoablation is not suitable for younger patients or those with more aggressive types of breast cancer who may be at a greater risk of recurrence.

• • Stage and size of breast cancer tumor:  unifocal tumor less than 1.5 cm

• • Type of breast cancer: ER+, PR+, HER2-. Ki-67<15% and/or genomic testing indicative of low-risk breast cancer, infiltrating ductal carcinoma (excluding lobular carcinoma, extensive intraductal component, or evidence of lymphovascular invasion)

• • Clinically negative lymph node (N0)

• • Willingness to adhere to endocrine therapy (also known as hormonal therapy)

• • Breast size sufficient for safe cryoablation

Your doctor will evaluate your unique condition and discuss with you if ProSense™ Cryoablation is right for you. To evaluate the benefits and risks of other treatment options, please discuss them with your physician.

 

WHAT HAPPENS AFTER MY CRYOABLATION PROCEDURE?

Patients who have undergone cryoablation for breast tumors have reported mild-to-moderate pain, edema (swelling), and bruising.

Other adverse events can include the risk of incomplete ablation (not fully treating the tumor area). Skin burns to nearby tissue can also occur. Skin burns can be mitigated by injected saline. There is a risk of tumor seeding (when malignant cells are deposited along the needle or cryoprobe tract) upon cryoprobe removal. This could result in cancer spread, although this was not studied in the ICE3 trial.

You will have a palpable mass (area that can be felt) while your body naturally reabsorbs the destroyed cells. The size of the mass typically reduces over time, depending on the initial size of the mass and other factors. The mass may not completely resolve. Share with your breast imaging specialists that you have had cryoablation when you have follow up imaging (e.g., mammography, ultrasound, MRI).

 

Endocrine therapy (hormonal therapy) and cryoablation

Endocrine therapy (also known as hormonal therapy) will be included in your treatment plan. The ProSense Cryotherapy treatment should be used with endocrine therapy. This is because the safety and effectiveness of ProSense Cryotherapy without endocrine therapy is not established.  Discuss with your doctor why endocrine therapy is a necessary part of your treatment and how it should be taken. Your doctor will discuss with you if there are any other therapies necessary as part of your cancer treatment plan. There is a risk of cancer recurrence and death. Risks of cancer recurrence and death associated with the ProSense cryotherapy treatment beyond 5 years are unknown.

Breast imaging following cryoablation

Breast imaging following treatment of breast cancer is expected. Follow-up breast imaging is important after cryoablation to look for evidence of tumor recurrence. The procedure is monitored in real-time by ultrasound. However, ultrasound might not detect the tumor’s exact boundaries. Without removal of the tumor there is no specimen to check that the tumor is completely destroyed. Periodic imaging tests (like mammogram, ultrasound or MRI) are important after treatment. These tests are performed to check whether there is evidence of tumor recurrence. Tumor recurrence could happen if there is residual tumor following cryoablation.

 

PROSENSE™ CRYOABLATION: STEP-BY-STEP

During the minimally-invasive ProSense™ cryoablation procedure, your doctor will inject local anesthesia. They will use ultrasound (sonographic) imaging to guide a small cryoprobe (thin hollow needle) into the breast tumor.

Once the cryoprobe is placed, it undergoes a freeze-thaw-freeze cycle. Extremely cold temperatures (lower than -170C°) destroy the breast tumor by creating an ice ball around the targeted tissue. The tissue destroyed by the ice ball is naturally reabsorbed by the body over time. Adjacent tissue is left unharmed.

The procedure is monitored in real-time by ultrasound to ensure the ice ball is growing sufficiently around the tumor, including a margin (area of tissue surrounding the tumor, similar to surgery), and to avoid damage to the skin or muscle.

1. Your doctor may use hydro-dissection (a saline injection) to protect the skin or muscle during a procedure depending on the location of the tumor. The cryoprobe is inserted into the tumor at a small incision site.
2. The tumor is enveloped by an ice ball. The extreme cold kills the tumor tissue.
3. The cryoprobe is removed and a Steri-Strip is applied, requiring no stitches.