Frequently Asked Questions
1. WHAT ARE THE POSSIBLE BENEFITS OF UNDERGOING THIS PROCEDURE?
The main benefit of undergoing cryoablation is that your cancer might be adequately treated without the need for breast surgery. Cryoablation avoids potentially negative cosmetic effects of breast cancer surgery by eliminating the need for tissue removal or a large breast incision. Cryoablation is performed under local anesthesia which allows you to avoid general anesthesia.
2. WHAT ARE THE POSSIBLE RISKS AND DISCOMFORTS?
Expect mild pain: Injection of local anesthesia causes temporary pain followed by numbness. The cryoablation procedure itself might also cause temporary pain near the back of the breast, followed immediately by numbness since the freezing process is pain-relieving. Local anesthetic injected during the procedure usually wears off after 4-6 hours. Acetomenophen (e.g., Tylenol) is usually sufficient to control breast pain after the procedure. Only rarely do patients need narcotic pain medications after cryoablation.
Expect Swelling of the Breast Right After the Procedure: Saline may be injected under the skin to protect it from freezing. Depending on the amount of saline injected, you may have considerable swelling that temporarily increases the size of your breast. Your body will absorb the saline and your breast will return to near-normal size after a few of days.
Expect Bruising of the Breast After the Procedure: Bruising of the breast is normal after cryoablation and usually develops in the first few days after the procedure. Bruising gradually disappears over a week. The bruising may sometimes spread to the flank or upper abdomen.
Expect Drainage of Fluid from the Skin Puncture Wound: The small skin puncture wound through which the cryoablation probe is inserted commonly drains watery and bloody fluid after the procedure during the first 24 hours. You may be given extra gauze pads to place inside your bra to absorb the fluid. Change the gauze as often as needed to keep your clothes dry. If the drainage washes off the cloth tape (Steri-strip) that is applied to the incision at the end of the procedure, simply apply antibiotic ointment to the incision daily until the incision heals.
Expect Some Persistent Swelling: The body’s initial response to any injury is swelling at the site of injury. The same is true for cryoablation. Swelling will make the tumor area feel much larger than it did before the procedure. For example, cryoablation of a 2 cm breast cancer will produce a lump about the size of a large egg or small lemon, which gradually disappears over 2-3 years as your body absorbs the cryoablated tissue. You should NOT expected the cryoablated area to become sunken as it heals. The original shape of the breast is usually maintained.
Expect Some Skin Redness: Redness of the skin is normal. It is similar to a mild sunburn that heals after a few days. Effort will be made to protect the skin from a cold/freeze injury. However, in some instances, a mild frost-bite injury will cause blistering, loss of skin pigmentation at the frost-bite site, and/or skin ulceration. When blistering or ulceration occurs, the wound typically heals closed with topical wound care (antibiotic ointment and bandages). Eventually, the skin color will gradually return to normal or near-normal color. Infection after cryoablation is rare, but possible, and will need to be treated appropriately.
3. IS THERE A RISK OF RECURRENCE IN THE BREAST AFTER CRYOABLATION?
The success of cryoablation depends on the ability of the cancer to be completely and accurately targeted. If mammograms, ultrasound, or MRI underestimates the size and location of your cancer, then parts of the cancer may remain untreated or undertreated and therefore not killed by cryoablation. In some cases, the doctor will arrange to have an ultrasound-visible marker inserted into the center of the cancerous area to make the area a clearer target for ultrasound-guided cryoablation, which is the preferred cryoablation approach.
To increase the chance of complete cancer kill, the doctor will aim to cryoablate the cancerous area as well as a rim of normal tissue surrounding the cancerous area in case the cancer is actually larger than it appears on mammogram, ultrasound, or MRI. However, complete cancer kill cannot be guaranteed by cryoablation since invisible parts of the cancer may extend beyond the cryoablation area. If the cancerous area is not completely killed, the untreated areas might grow and spread beyond the breast. To reduce the risk of the cancer spreading, it is recommended that the treated breast be monitored regularly for signs of remaining or recurring cancer so that it can be detected, biopsied and treated appropriately. Similar to patients treated with surgery, appropriate anti-cancer medications and radiation therapy after cryoablation can also reduce the risk of recurrence in the breast and beyond.
4. DOES CRYOABLATION ELIMINATE THE NEED FOR ANTI-CANCER MEDICATION AND/OR RADIATION?
Cryoablation is intended to eliminate the need for surgery but it does not eliminate the need for standard treatments that are essential components of comprehensive cancer care that, when combined with cryoablation, aim to reduce the risk of cancer recurrence to a low level. Depending on your age and cancer characteristics, you might be advised to receive treatments like radiation, anti-estrogen (endocrine) therapy, chemotherapy, lymph node surgery, and/or anti-HER2/neu immunotherapy. Anti-cancer medication are given to treat cancer cells that may have already metastasized to distant parts of the body even if there is no detectable cancer cells remaining within the body. Radiation is usually given after lumpectomy to treat invisible tumor cells that might be present outside the tumor. Even patients treated with lumpectomy or mastectomy might be advised to receive one or more of these treatments to reduce the risk of cancer recurrence in the breast area and/or elsewhere within the body. Your doctor should let you know which of these treatments are appropriate for your cancer and discuss the benefits and risks or each. You should also be advised to consult with other cancer specialists that play a role in administering these treatments.
It’s important to understand that no combination of treatments can completely eliminate the risk of breast cancer recurrence, but radiation, anti-estrogen (endocrine) therapy, chemotherapy, anti-HER2/neu immunotherapy, and/or lymph node surgery have been clearly shown to dramatically reduce the risk of breast cancer recurrence within the breast and elsewhere within the body. Depending on your cancer characteristics and estimated risk of recurrence, you might be required to commit to certain other treatments (e.g., anti-estrogen therapy) before you are offered cryoablation. At the end of the day, it is up to you to follow through with additional recommended treatments after cryoablation to minimize your risk of breast cancer recurrence within the breast and elsewhere within the body.
Cryoablation of breast cancer is still considered an experimental treatment. As a result, some consulting doctors may not feel comfortable treating you with radiation or other standard treatments. If needed, the doctor performing cryoablation might be able to help you identify consulting doctors to assist with your cancer treatment and follow-up. It might also be necessary to seek these treatments from a consulting doctor outside of your home community.
5. SHOULD YOU HAVE CRYOABLATION PERFORMED BY A BREAST SURGEON OR RADIOLOGIST?
An important consideration for women considering cryoablation is whether or not, if given the option, you should choose to have cryoablation performed by a breast surgeon or radiologist. The bottom line is that treating a patient with breast cancer is more than just 1 one-hour office procedure. Although radiologists undoubtedly possess the technical skills to perform cryoablation, the advantage of seeking treatment from a breast surgeon is that breast surgeons are better suited to helping women weigh the pros and cons of cryoablation compared to other treatments. Breast surgeons are generally more committed to providing ongoing follow-up care, coordination of care with your local healthcare providers, and supervision or facilitation of ongoing follow-up.
6. WHAT TRADITIONAL CANCER TREATMENTS SHOULD I CONSIDER?
Breast Surgery: Lumpectomy or mastectomy surgery are the current standard treatments for breast cancer. Unlike cryoablation, lumpectomy and mastectomy permit complete removal of the cancerous area and assessment of the surgical margins to confirm that the area has been removed completely. Additional breast surgery might be recommended if cancer removal is judged to be incomplete.
Preliminary results of several cryoablation studies indicate that cryoablation may be an effective alternative to surgery for estrogen or progesterone-sensitive breast cancers measuring 2 cm or smaller, and without evidence of lymph node spread. There are no conclusive studies showing the effectiveness of cryoablation in the treatment of breast cancers greater than 2 cm, breast cancers with lymph node involvement, breast cancers that have previously been treated with chemotherapy or anti-estrogen therapy, recurrent breast cancers, multiple cancers in the same breast, non-hormone dependent breast cancer (like triple negative breast cancer), non-invasive breast cancer (ductal carcinoma in situ or DCIS), or invasive lobular breast cancers. On a case-by-case basis, your doctor might agree to perform cryoablation for these less acceptable circumstances if you are clearly unwilling to undergo surgery. However, since cryoablation has not been well-studied in these less common circumstances, it is not possible to predict how effective cryoablation would be under these circumstances.
To make an informed decision about cryoablation, your doctor should give you an estimate of your risk of recurrence after lumpectomy, mastectomy, or cryoablation, as best as they can be determined.
Lymph Node Surgery: Cryoablation of the cancer within the breast is unlikely to slow or prevent growth of cancer cells that have already spread to the nearby underarm lymph nodes. Therefore, sentinel node biopsy (removal of just a few normal appearing nodes) and axillary lymph node dissection (removal of cancerous lymph nodes) are the standard surgical procedures performed to detect and/or remove cancer-containing lymph nodes in the nearby underarm area. One exception to this rule is that most women age 70 and older with estrogen and/or progesterone-sensitive breast cancers can avoid lymph node surgery if they are willing to take anti-estrogen therapy. Another exception is that women of any age with pure ductal carcinoma in situ (DCIS) do not require lymph node surgery. However, all other women should discuss the pros and cons of lymph node surgery. Some low risk tumors might night require lymph node surgery.
Information obtained from lymph node surgery can help guide your overall cancer treatment. Lymph node surgery is performed in the hospital under general anesthesia or local anesthesia with sedation. Your doctor should discuss with you the appropriate timing of the lymph node procedure, either before or after the cryoablation procedure. If you refuse lymph node surgery, your doctor will likely recommend regular imaging studies (e.g., ultrasound) to screen for evidence of lymph node recurrence so that the problem may be managed quickly. Failure to undergo recommended lymph node surgery can lead to uncontrolled cancer growth in the lymph node.
Radiation: In general, radiation reduces the relative risk of cancer recurrence within the breast by 60% beyond what is usually achieved by surgery or cryoablation. The actual magnitude of benefit of radiation depends on your personal estimated risk of recurrence. For example, if your estimated 10-year risk of recurrence is 10%, radiation will generally reduce your risk to 4%, which a 60% lower relative-risk of recurrence. In some cases, your doctor will recommend a commercial test to estimate your personal risk of recurrence; the test might not be covered by insurance.
To make an informed decision about radiation, your doctor should give you an estimate of your risk of recurrence both with and without radiation.
Anti-estrogen (endocrine) therapy: In general, anti-estrogen (endocrine) therapy reduces the risk of recurrence of estrogen and/or progesterone receptor positive cancers by 50% on top of what is usually achieved by surgery, cryoablation, and radiation. Anti-estrogen (endocrine) therapy also reduces the risk of cancer recurrence in the lymph nodes, opposite breast and other parts of the body. The actual benefit of anti-estrogen therapy to you depends on your personal estimated risk of recurrence. For example, if your estimated 10-year risk of recurrence is 12%, radiation will generally reduce your risk to 6%, which a 50% lower relative-risk of recurrence. In some cases, your doctor will recommend a commercial test to estimate your personal risk of recurrence. In some cases, the test might not be covered by insurance.
To make an informed decision about lymph node surgery, your doctor should give you an estimate of your risk of recurrence both with and without anti-estrogen (endocrine) therapy.
Chemotherapy: Chemotherapy has the potential to reduce the risk of cancer recurrence within the overall body, lymph nodes and breast on top ofthat which is achieved by surgery, cryoablation, radiation, and anti-estrogen therapy. The actual benefit of chemotherapy depends on your personal estimated risk of recurrence. In most cases, your cryoablation doctor or your medical oncologist will recommend a commercial test to estimate your personal 5- or 10-year risk of cancer recurrence.
Anti-HER2 immunotherapy: In general, anti-HER2 immunotherapy medications like Herceptin and Perjeta reduce the risk of cancer recurrence and are highly effective against breast cancers that make excessive HER2 proteins. The actual benefit of anti-HER2 immunotherapy to you depends on your personal estimated risk of recurrence. Anti-HER2 immunotherapy is most effective when combined with chemotherapy. Patients who refuse chemotherapy may sometimes be offered anti-HER2 immunotherapy without chemotherapy.
Other strategies: In addition to the standard treatments discussed above, your doctor should discuss with you lifestyle modifications and other strategies that might further reduce your risk of cancer recurrence. Some women choose to avoid standard treatments and instead pursue complimentary or alternative therapy. Please understand that the effectiveness of many complimentary or alternative treatments remains unproven.
In addition, there is a common belief that cryoablation stimulates the immune system to build natural immunity against the cancer. This phenomenon has been demonstrated in animal studies but remains unproven in humans. Therefore, until we understand better the immune effects in humans, it is recommended that you follow through with standard cancers treatments to reduce the risk of recurrence.
Clinical trials: Dr.Holmes is a strong supporter of clinical trial participation. However after undergoing cryoablation,
you might be disqualified from participating in clinical trials that require participants to undergo surgery. If you are considering participation in a clinical trial, make sure that cryoablation does not disqualify your from participant in the clinical trial.
7. HOW IS THE BREAST MONITORED AFTER CRYOABLATION?
To monitor the healing of your breast and to look for signs of cancer recurrence, it is recommended that you receive follow-up imaging studies (e.g., mammograms, ultrasound and breast MRI) at regular intervals after cryoablation. Your cryoablation doctor should help you figure out the right screening regimen after cryoablation based on your age, cancer characteristics, and estimated risk of recurrence. In addition, you should consider undergoing a needle biopsy of the cancerous area sometime after cryoablation to confirm that the cancer has been completely killed by cryoablation. Failure to perform one or more of the breast imaging and/or needle biopsy procedures could lead to a delay in the detection of a cancer recurrence.
Since cryoablation is a relatively new procedure for treating breast cancer, most radiologists do not have extensive experience interpreting mammograms, ultrasounds, and contrast-MRI of patients treated with cryoablation. This lack of experience could contribute to a delay in detection of cancer recurrences or result in additional and perhaps unnecessary biopsies being recommended to evaluate unclear imaging findings. Despite these challenges, it is recommended that you undergo regular breast imaging with mammograms, ultrasound, and/ or MRI to reduce the chance of missing a cancer recurrence.
It should also be noted that some radiologists are uncomfortable interpreting mammograms, ultrasound, and contrast-MRI images after cryoablation. As a result, it might be necessary for you to shop around for a radiologist willing to interpret your imaging studies.
8. WHEN IS SURGERY REQUIRED AFTER CRYOABLATION?
Lymph node surgery is commonly recommended before or after cryoablation to check for cancer in the lymph nodes.
In addition, your doctor will recommend surgery after cryoablation if any of the following occur:
-- A needle biopsy of a suspicious area shows that your cancer was not completely killed or has recurred.
--Your cryoablation procedure cannot be completed. Reasons why the procedure might not be completed include technical difficulties or your anxiety or discomfort.
--You develop a breast cancer in a different area of the same breast.
--Needle biopsy of a suspicious lymph node shows that cancer has developed or recurred in the lymph nodes.
9. WHAT ARE ADDITIONAL SIDE EFFECTS AND RISKS OF CRYOABLATION?
Side effects may be mild or very serious. Many side effects go away soon after you recover from cryoablation. In some cases, side effects can be serious, long-lasting, or may never go away.
--Temporary pain with injection of anesthetic agent (e.g., Lidocaine, Marcaine)
--Brief period of pain during the cryoablation procedure
--Mild bleeding or drainage of bloody fluid from cryoprobe insertion site
--Swelling of the breast after cryoablation
--Bruising of the breast after cryoablation
--Tenderness of the breast at the cryoablation site
--Shoulder stiffness lasting a short time after cryoablation
--Skin blisters caused by bandages
--Skin redness caused by freezing
Uncommon Risks (seen in less than 5% of procedures):
--Freezing and damage to skin
--Significant bleeding from cryoprobe insertion site
--Allergic reaction to anesthetic agent (e.g., Lidocaine, Marcaine)
--Skin blister or ulcer caused by freezing
Rare Risk (seen in less than 1% of procedures):
--Puncture of lung (rare)
10. WHAT OTHER OPTIONS ARE THERE?
If you choose not to undergo cryoablation:
---You may choose to receive standard surgery (lumpectomy or mastectomy and lymph node surgery), radiotherapy, and drug therapy in some combination.
--You may choose to seek alternative therapy for your breast cancer.
--You may choose to have no treatment for your breast cancer.