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56]

Original Article

Evaluation of the safety and efficacy of

percutaneous radiofrequency ablation for
treating multiple breast fibroadenoma
ABSTRACT Ping Li,
Background: This study was conducted to evaluate the safety and efficacy of ultrasound (US)‑guided percutaneous radiofrequency Xiao‑yin Tang,
ablation (RFA) for multiple breast fibroadenoma as an alternative to surgical resection. Dan Cui,
Jia‑chang Chi,
Patients and Methods: Sixty‑five patients with multiple breast fibroadenoma accepted general anesthesia and US‑guided
Zhi Wang,
percutaneous RFA in our hospital from September 2014 to January 2016. Contrast‑enhanced US (CEUS) was used immediately
Tao Wang,
after operation to determine whether the tumor was ablated completely. The complete ablation rate (CAR) and the change of focal
Xing‑xing Qi,
volume were evaluated by CEUS at the 1st month and the 3rd month after operation.
Bo Zhai
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 Department of
Interventional
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
Oncology,
3rd month after operation, respectively, of which 45 nodules were completely absorbed (17.58%). There was a statistically significant Renji Hospital,
difference of the volume reduction rate (VRR) after operation (P < 0.01) compared with preoperative breast nodules volume. There School of Medicine,
were no complications such as skin burn, hemorrhage, and hematoma, nipple discharge in the process during and after RFA. Shanghai Jiao Tong
University, Shanghai
Conclusion: Given advantages of high CAR, mild injury, rapid recovery, and cosmetic outcome desired by the patients, RFA has 200127, China
the potential to become the preferred method in the treatment of breast fibroadenoma.
For correspondence:
Prof. Bo Zhai,
KEY WORDS: Breast fibroadenoma, efficacy, radiofrequency ablation, safety Department of
Interventional
Oncology,
Renji Hospital,
INTRODUCTION echo, and blood flow of breast nodules, and it can School of Medicine,
be used to identify the breast nodules, guiding Shanghai Jiao
Breast fibroadenoma is one of the most common needle biopsy, and treatment.[3] Contrast‑enhanced Tong University,
160# Pujian Road,
benign breast tumors, which is hard, and has good US (CEUS) and elastography technology have
Shanghai 200127, China.
mobility. Although the pathological results are very further improved the accuracy of identifying E‑mail: zhaiboshi@
essential, general high‑frequency ultrasound (US) benign and malignant breast nodules as well as the sina.com
imaging examination can confirm the diagnosis. precision of guided therapy.[4‑9] Meanwhile, needle
Studies suggest that nonproliferative benign breast biopsy of breast nodules has provided important
lesions or nonabnormal proliferative lesions will basis for pathological diagnosis and treatment
not develop into breast cancer, but those abnormal guidelines.[10]
proliferative lesions have a high risk of developing
into breast cancer;[1] therefore, close observation Up to now, surgical resection is still the preferred
and early intervention must be done for benign treatment of breast fibroadenoma. Although
breast tumors with large volume or rapid volume surgical resection is effective, the permanent
increase in a short period, especially those with a retention of surgical scar often causes serious Access this article online
family history of breast malignant lesions.[2] psychological shadow for female patients. In Website: www.cancerjournal.net
DOI: 10.4103/jcrt.JCRT_966_16
This is an open access article distributed under the terms of the Creative Commons
In the recent years, the rapid development of US PMID: ***
Attribution‑NonCommercial‑ShareAlike 3.0 License, which allows others to remix,
technology provides a new idea for treating breast tweak, and build upon the work non‑commercially, as long as the author is credited Quick Response Code:

fibroadenoma. High‑frequency US can accurately and the new creations are licensed under the identical terms.
measure the size, shape, location, depth, internal For reprints contact: reprints@medknow.com

Cite this article as: Li P, Xiao-yin T, Cui D, Chi JC, Wang Z, Wang T, et al. Evaluation of the safety and efficacy of percutaneous
radiofrequency ablation for treating multiple breast fibroadenoma. J Can Res Ther 2016;12:C138-42.

C138 © 2017 Journal of Cancer Research and Therapeutics | Published by Wolters Kluwer - Medknow
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Li, et al.: Percutaneous RFA for multiple breast fibroadenoma
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.[11‑13]
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.[14‑18] Some scholars have already successfully
cured breast cancer by applying RFA[19‑21] 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.
Inclusion criteria
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.
Journal of Cancer Research and Therapeutics - Volume 12 - Special Issue 2 - 2016
Preoperative preparation and operation process of
radiofrequency ablation
1. 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 (mm3) were calculated using volume
formula
2. 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)
3. 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
Time setting
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.
Follow‑up indicators
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)
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Li, et al.: Percutaneous RFA for multiple breast fibroadenoma
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%
Statistical analysis
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
General condition
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%.
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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 mm3 (the maximum diameter
of nodules was 5–34 mm) before ablation. That size was
359.96 ± 857.76 mm3 (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].
Complication
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
a b
c
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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Li, et al.: Percutaneous RFA for multiple breast fibroadenoma
Table 1: Preoperative and postoperative (1 and 3 months) nodule condition and volume reduction rate
Before operation
Mean Volume 638.63+1117.32mm3
(Range) 5‑34mm
VRR
Mean Volume is displayed as mean value±standard deviation VRR=Volume reduction rate
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[22] but slowly
being applied for benign breast tumor resection.[23] 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.[24] 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%,[25] 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
Journal of Cancer Research and Therapeutics - Volume 12 - Special Issue 2 - 2016
1 month after RFA 3 months after RFA P
359.96+857.76mm3 126.06+249.08mm3 0.00
0‑19.5 0‑15
39.06% 75.99%
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.[26] 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.[13] did a 6‑month follow‑up after
Mammotome and found the tumor residual rate reached
3.4%. Thurley et al.[27] 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.[28]
reported the CAR for treating breast cancers at an early stage
using RFA was 87.8%; Teh and Tan[29] 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
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Li, et al.: Percutaneous RFA for multiple breast fibroadenoma
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
Nil.
Conflicts of interest
There are no conflicts of interest.
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