|Year : 2016 | Volume
| Issue : 7 | Page : 138-142
Evaluation of the safety and efficacy of percutaneous radiofrequency ablation for treating multiple breast fibroadenoma
Ping Li, Tang Xiao-yin, Dan Cui, Jia-chang Chi, Zhi Wang, Tao Wang, Xing-xing Qi, Bo Zhai
Department of Interventional Oncology, Renji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai 200127, China
|Date of Web Publication||21-Feb-2017|
Department of Interventional Oncology, Renji Hospital, School of Medicine, Shanghai Jiao Tong University, 160# Pujian Road, Shanghai 200127
Source of Support: None, Conflict of Interest: None
Background: This study was conducted to evaluate the safety and efficacy of ultrasound (US)-guided percutaneous radiofrequency ablation (RFA) for multiple breast fibroadenoma as an alternative to surgical resection.
Patients and Methods: Sixty-five patients with multiple breast fibroadenoma accepted general anesthesia and US-guided percutaneous RFA in our hospital from September 2014 to January 2016. Contrast-enhanced US (CEUS) was used immediately after operation to determine whether the tumor was ablated completely. The complete ablation rate (CAR) and the change of focal volume were evaluated by CEUS at the 1st month and the 3rd month after operation.
Results: All the patients were diagnosed by needle biopsy. Among all the patients, 256 nodules were found. Forty-six nodules (17.96%) were located <5 mm from epidermis; 26 nodules (10.15%) were located below areola. Complete ablation was achieved for 251 nodules (98.04%) after the 1st month of operation. The volume reduce rate was 39.06% and 75.99% at the 1st and the 3rd month after operation, respectively, of which 45 nodules were completely absorbed (17.58%). There was a statistically significant difference of the volume reduction rate (VRR) after operation (P < 0.01) compared with preoperative breast nodules volume. There were no complications such as skin burn, hemorrhage, and hematoma, nipple discharge in the process during and after RFA.
Conclusion: Given advantages of high CAR, mild injury, rapid recovery, and cosmetic outcome desired by the patients, RFA has the potential to become the preferred method in the treatment of breast fibroadenoma.
Keywords: Breast fibroadenoma, efficacy, radiofrequency ablation, safety
|How to cite this article:|
Li P, Xiao-yin T, Cui D, Chi Jc, Wang Z, Wang T, Qi Xx, Zhai B. Evaluation of the safety and efficacy of percutaneous radiofrequency ablation for treating multiple breast fibroadenoma. J Can Res Ther 2016;12, Suppl S3:138-42
|How to cite this URL:|
Li P, Xiao-yin T, Cui D, Chi Jc, Wang Z, Wang T, Qi Xx, Zhai B. Evaluation of the safety and efficacy of percutaneous radiofrequency ablation for treating multiple breast fibroadenoma. J Can Res Ther [serial online] 2016 [cited 2021 Mar 6];12:138-42. Available from: https://www.cancerjournal.net/text.asp?2016/12/7/138/200612
| > Introduction|| |
Breast fibroadenoma is one of the most common benign breast tumors, which is hard, and has good mobility. Although the pathological results are very essential, general high-frequency ultrasound (US) imaging examination can confirm the diagnosis. Studies suggest that nonproliferative benign breast lesions or nonabnormal proliferative lesions will not develop into breast cancer, but those abnormal proliferative lesions have a high risk of developing into breast cancer; therefore, close observation and early intervention must be done for benign breast tumors with large volume or rapid volume increase in a short period, especially those with a family history of breast malignant lesions.
In the recent years, the rapid development of US technology provides a new idea for treating breast fibroadenoma. High-frequency US can accurately measure the size, shape, location, depth, internal echo, and blood flow of breast nodules, and it can be used to identify the breast nodules, guiding needle biopsy, and treatment. Contrast-enhanced US (CEUS) and elastography technology have further improved the accuracy of identifying benign and malignant breast nodules as well as the precision of guided therapy.,,,,, Meanwhile, needle biopsy of breast nodules has provided important basis for pathological diagnosis and treatment guidelines.
Up to now, surgical resection is still the preferred treatment of breast fibroadenoma. Although surgical resection is effective, the permanent retention of surgical scar often causes serious psychological shadow for female patients. In recent years, minimally invasive treatment for breast nodules, such as Mammotome, has become another option for patients with benign breast tumors; furthermore, it also caters for postoperative breast shape, function, and cosmetic outcomes desired by female patients at some degree, but its high incidence of postoperative breast internal bleeding, hematoma, mammary duct injury (lesions around the areola), skin damage (lesions close to surface), and residual nodules has limited the universal application of Mammotome.,,
Even more exciting is that thermal ablation treatment has become another potential treatment for tumors after surgical resection in recent years, with radiofrequency ablation (RFA), microwave ablation, and laser ablation as its representatives. When US, computed tomography, or other imaging-guided ablation electrode is placed inside the tumor through percutaneous puncture, the thermal effect causes coagulation necrosis of the tumor, thereby achieving the results similar to surgical resection.,,,, Some scholars have already successfully cured breast cancer by applying RFA ,, although its long-term effects have not yet been verified.
Since September 2014, our department has treated 37 cases of breast fibroadenoma patients through US-guided percutaneous RFA. In this study, the clinical data of these patients were collected and used to evaluate the safety, efficacy, and feasibility of US-guided percutaneous RFA for treating breast fibroadenoma.
| > Patients and Methods|| |
General condition of the patients
From September 2014 to January 2016, 65 patients with breast fibroadenoma accepted CEUS-guided percutaneous RFA at our hospital. Patients aged 18–66 years (35.44 ± 13.50 years). The patients signed the consent for accepting RFA for treating breast fibroadenoma and anesthesia before operation, providing detail explanations of the risk of anesthesia and surgical complications. The protocol was approved by the Ethics Committee of the hospital.
All the patients met the following conditions: (1) Breast Imaging Reporting and Data System grading was within 3–4a through high-frequency US examination; (2) all the patients went through core needle biopsy, and the pathological results indicated breast fibroadenoma; (3) the follow-up time for all the patients was above 3 months to evaluate the volume change of the ablated lesion; (4) preference was given to patients with multiple breast fibroadenomas; (5) all the patients aged over 18 years old; (6) the maximum diameter of the breast nodule was smaller than 3 cm and was followed by breast surgery specialist for >1 year, and the nodule had no significant change; (7) no pregnancy; (8) no dysfunction nor severe concomitant diseases of important organs, such as heart, brain, and liver.
Preoperative preparation and operation process of radiofrequency ablation
- All the patients went through high-frequency US examination before operation, to evaluate the location, depth, size, shape, internal echo distribution, calcification, and internal blood flow of the breast fibroadenoma. The diameters (left to right diameter, top to bottom diameter, and front to back diameter) of each nodule were measured, and the volumes (mm 3) were calculated using volume formula
- Two US system (Esaote, Italy), L522 and L523 probes, 7–10 MHz center frequency, with CEUS function, were used. US contrast agent was SonoView (Sine Pharma, Italy). RFA treatment system was Medsphere RF Generator S-500 (Medsphere, Shanghai, China)
- All the operations were carried out in standard surgical operating room under general anesthesia. The patients took supine position, with their arms extended outside and fixed. RFA electrode was placed at the distal end of the tumor capsule under US guidance. The power was set to 10–15W, with the center temperature up to 65–95°C. The impedance of the tissues in the ablation zone slowly increased with the increase of the ablation degree, and the RFA analyzer automatically stopped working once the impedance reached the highest, indicating complete ablation of the tissue. US monitoring was applied during the operation. If the gasification range did not cover the tumor completely, the location of the probe would be adjusted with one more ablation until the gasification covers the whole tumor. No perfusion showed at the tumor area by CEUS indicated treatment complete. As for multiple tumors, they were ablated in the same way one after another. For tumors that were located <5 mm from epidermis, 5–10 ml of 0.9% saline was injected between the skin and the nodule under US guidance, forming an isolation zone to avoid local skin burns or scalding. Local cold packs were applied for 6 h after the operation to lower the temperature of the operation zone. Appropriate supporting treatments, such as hemostasis by compression, were given to the patients.
Review and follow-up
follow-up was made at 1 and 3 months after operation. Two-dimensional high-frequency US and CEUS imaging were conducted to evaluate if complete ablation was achieved for the breast tumors as well as the nodule volume change after the operation.
Lesion volume (V)
the diameters (left to right diameter A, top to bottom diameter B, and front to back diameter C) of the tumors were measured under high-frequency US; Formula 1 was used to evaluate the volume (V). V1, V2, and V3 were used to represent the volume of the nodules before operation, 1 month (30 ± 5 days) after operation, and 3 months (90 ± 5 days) after operation, respectively.
Formula 1: V =4/3 × π× (1/2A) × (1/2B) × (1/2C)
Complete ablation rate
one month (30 ± 5 days) after the operation, evaluation of whether the tumor achieved complete ablation was done according to the tumor ablation evaluation standards, and the complete ablation rate (CAR) was calculated using Formula 2.
Formula 2: CAR = Number of complete ablated tumors/Total number of the tumors × 100%.
Tumor ablation evaluation criteria
- Complete ablation: No enhancement showed by the US imaging at all stages of the lesion, showed as “black hole”
- Partial ablation: US imaging still showed the lesion has partial enhancement
- No change: US imaging showed homogeneous or inhomogeneous enhancement, without significant change compared to its preoperative state.
Volume reduction rate
the volume reduction rate (VRR) was evaluated using the measurements of the lesion volume at 1 month and 3 months after operation, applying Formula 3. VRR1 was the VRR after 1 month, and VRR2 was the VVR after 3 months.
Formula 3: VRR1= (V2 − V1)/V1 × 100%
VRR2= (V3 − V1)/V1 × 100%
Windows SPSS software (version 19.0; Chicago, IL, USA) was used to perform t-test analysis for the volumes of the breast nodules before and after ablation, with P < 0.01 as statistical significant. All the data were displayed as mean ± standard deviation.
| > Results|| |
Sixty-five cases of multiple nodules with a total of 256 nodules. The maximum mean diameter of nodules was 11.68 ± 6.26 mm. There were 46 nodules with distance to the epidermis <5 mm, accounting for 17.96%. Furthermore, there were 26 nodules located beneath the areola, accounting for 10.15%.
Complete ablation rate
One month after ablation, the CEUS showed: among the total 256 nodules, 5 nodules' edges had a little contrast agent filled indicating presence of residual, and the remaining 251 nodules had no perfusion, suggesting complete necrosis. The CAR was 98.04%.
Size change of breast nodules
The VRR at 1 month and 3 months after RFA was 39.06% and 75.99%, respectively [Table 1]. The average size of breast nodules was 638.63 ± 1117.32 mm 3 (the maximum diameter of nodules was 5–34 mm) before ablation. That size was 359.96 ± 857.76 mm 3 (the maximum diameter of ablation lesion was 0–19.5 mm) 1 month after ablation. Three months after ablation, the size was 126.06 ± 249.08 mm 3 (the maximum diameter of ablation lesion was 0–15 mm). The size change of the tumors was significant (P = 0.00) [Figure 1].
|Table 1: Preoperative and postoperative (1 and 3 months) nodule condition and volume reduction rate|
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|Figure 1: Comparison of ultrasound imaging of the breast nodule before and after radiofrequency ablation patient, female, 25 year old. Breast nodule was found 2 years ago. (a) Preoperative imaging of breast nodule was hypoechoic, with lobular outer shape, homogeneous internal echo, size about 15 mm × 6 mm. (b) Ultrasound imaging of the ablated lesion at 1 month after operation: the original breast nodule outer shape shrunk, size about 9 mm × 6 mm, with low internal echo. (c) Three months after operation, the volume of the ablated lesion continue to shrink, size about 5.8 mm × 4 mm, change of internal echo to high echo, displayed "black hole-like" appearance|
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There was no significant skin burn after RFA. Three cases had mild skin hyperemia but disappeared after 1 week. In addition, there were no complications, such as breast internal bleeding, breast hematoma, and infection, after RFA. There was no nipple discharge or bleeding after RFA for nodules around the areola.
| > Discussion|| |
Up to now, there is still considerable controversy about the timing and method of treatment for benign tumors such as breast fibroadenoma. Surgical resection was the only treatment method for breast fibroadenoma in the past. It has been questioned by both doctors and patients, whether it is worthwhile to undergo giant invasive surgical resection to remove small and benign tumors that do not endanger the lives of patients. The most common advice is to observe and follow-up and only conduct surgical resection under certain conditions, such as large tumor size and inability to rule out malignancy. This concept has reduced accidental injuries for patients with breast fibroadenoma by casual invasive treatments, but it ignored the huge psychological pressure caused by the word “tumor.” In addition, the larger fibroadenoma, the more severe injury, would be caused by surgical resection, especially for the irreversible damage of the breast shape and lifetime effect of the life quality of patients. Therefore, it is the voice from patients with breast fibroadenoma to adapt treatment methods which has good therapeutic efficacy and is minimally invasive that does not affect the shape of the breast.
Clinical application of Mammotome (vacuum peeling) technology has maximally meet the demands from patients with breast fibroadenoma. This technology was originally used to identify the nature of the breast cancer  but slowly being applied for benign breast tumor resection. Comparing to traditional surgical resection, Mammotome only needs one or several 3–5 mm small incision, which leaves much less scarring after surgery. However, comparing to the skin and shape damage caused by the 19-gauge puncture electrode of RFA, Mammotome is much inferior. From our clinical data, there was no obvious scar on the skin of the breast of all the patients, and there was no significant change of the breast shape; thus, RFA has some undoubtable significant advantages on the perspectives of keeping the shape and skin integrity of the breast as well as for the esthetic effects.
Compared with surgical resection, Mammotome has lower the incidence of complications at some degree, but it still cannot meet the patient's expectations due to its inherent defects, such as high incidence of surgical field bleeding, hematoma, damage of the surrounding tissues, and tumor residuals. Especially for treating lesions located deep under the areola, Mammotome can easily damage the mammary duct, potentially effect the future breastfeeding of unmarried women. Some scholars reported that the ratio of the skin burns and surrounding chest muscle tissue burns caused by RFA for treating breast cancers was higher than 30%, but our data indicated that even for the 26 nodules that were located <5 mm to the skin, there was no case of skin burn, achieved by establishing ablation-isolation zone through water injection and postoperative local cold packs. Second, the diameter of the RFA probe was only 19-gauge, with pointed head, and this maximally reduced the damage to the tissues (including lobular and ductal tissues) along the puncture routes. Third, different from the temperature control modes of most scholars, this study adopted power control mode, with low power, short ablation time, and multiple ablation points, so as to achieve more accurate and controllable ablation range. Of all the cases in this study, 26 nodules were located deep under the areola, but no breast discharge, bleeding, or other complications occurred in these cases.
From the aspect of therapeutic efficacy, the CAR of RFA is not inferior to traditional surgical resection nor Mammotome. For removing breast fibroadenoma with surgical resection, some scholars like Cochrane et al. suggested that the best cosmetic effect and patient satisfaction could be achieved by surgical resection only when <10% of breast volume was removed; otherwise, it would cause huge psychological pressure due to varicose veins on the breast surface, causing venous congestion, gland deformation, pressure necrosis, and ulcers, as well as breast deformation. The tumor residual rate of Mammotome has hampered the development of this technology. Wang et al. did a 6-month follow-up after Mammotome and found the tumor residual rate reached 3.4%. Thurley et al. verified the finding that although Mammotome had gained high satisfaction from the patients due to its small surgical wound that did not affect the outer appearance of breast, the recurrence rate of fibroadenoma was as high as 30%. This is due to the inability to clarify the edge of the nodules during the Mammotome. RFA has achieved some results for treating breast fibroadenoma. Ohtani et al. reported the CAR for treating breast cancers at an early stage using RFA was 87.8%; Teh and Tan  applied RFA to treat two cases of breast fibroadenoma and achieved complete ablation in the review 6 weeks after the operation. In our study, immediate CEUS imaging review after ablation was conducted, and the CAR reached 98.04%.
Unlike effectiveness evaluation of ablation for abdominal tumor and intrathoracic tumor, the effectiveness evaluation of RFA for superficial tumors such as breast fibroadenoma should depend on both the CAR of tumor and VRR of ablated lesion. Otherwise, the patients would have adverse psychological reaction. To avoid those adverse effects, two main jobs were done in this study. First, low ablation power, short ablation time, and multipoint ablation were adopted just to reach basic temperature for cell coagulation necrosis, rather than achieving temperature higher than 65–95°C in the ablation zone, so as to avoid rapid tissue necrosis and formation of large-scale hard crust which would affect the shrinkage and absorption of ablated lesion. Second, this study made the first initiative to apply VRR into the effectiveness evaluation of tumor ablation and had calculated size change of the ablated lesion in different stages before and after ablation. The combination of VRR and CAR might be the best quantitative indicators for evaluating the thoroughness of RFA for tumor.
| > Conclusion|| |
Comparing to surgery resection, percutaneous RFA has its incomparable significant advantages in treating breast fibroadenoma, especially for multiple fibroadenoma. Not only does it has proven effectiveness and high absorption rate of ablated lesions but also mild damage to surrounding tissues which can maximally meet the esthetic demands of patients. Therefore, RFA can become the preferred treatment for benign breast tumor.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
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