Journal of Cancer Therapy, 2013, 4, 49-55
http://dx.doi.org/10.4236/jct.2013.47A008 Published Online August 2013 (http://www.scirp.org/journal/jct)
49
Sentinel-Node-Driven Personalized Radiation
Techniques Ranging from Partial Breast Irradiation to
Regional Nodal Radiation after Breast-Conserving
Surgery*
Kazuhiko Sato1#, Yoshio Mizuno1, Hiromi Fuchikami1, Masahiro Kato2, Takahiro Shimo2,
Jun Kubota2, Naoko Takeda1,3, Yuko Inoue3, Hiroshi Seto4, Tomohiko Okawa5
1Department of Breast Oncology, Tokyo-West Tokushukai Hospital, Tokyo, Japan; 2Department of Radiation Oncology, Tokyo-
West Tokushukai Hospital, Tokyo, Japan; 3Inoue Ladies Clinic, Tokyo, Japan; 4Seto Hospital, Saitama, Japan; 5Health Evaluation
Center, Utsunomiya Memorial Hospital, Tochigi, Japan.
Email: #kazsato.boc@gmail.com
Received June 11th, 2013; revised July 10th, 2013; accepted July 17th, 2013
Copyright © 2013 Kazuhiko Sato et al. This is an open access article distributed under the Creative Commons Attribution
License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly
cited.
ABSTRACT
Background: Breast-conserving surgery (BCS) followed by whole breast irradiation (WBI) has become the standard of
care for treating patients with early-stage breast cancer. Recently, various radiation techniques followed by BCS have
been reported. We have been investigating “personalized radiotherapy after BCS” ranging from accelerated partial
breast irradiation (APBI) to WBI with regional nodal irradiation (RNI) based on the axillary node status. In this study,
we compared different cohorts that received personalized radiotherapy. Method: Of 317 consecutive patients who un-
derwent BCS followed by radiotherapy since November 2007, 187 who received APBI and 122 who received WBI
were analyzed. Results: The local-only recurrence rate was 1.1% in the APBI group and 3.3% in the WBI group, and
the regional-only recurrence rate was 1.1% for APBI and 0.8% for WBI. Conclusions: The clinical efficacy of APBI
for local control after BCS was comparable to that of WBI ± RNI. Although this study was based on a small number of
patients with a short follow-up period, the feasibility of breast-conserving therapy using multicatheter brachytherapy to
achieve acceptable clinical outcomes was demonstrated.
Keywords: Breast Cancer; Personalized Radiotherapy; Sentinel Node; Partial Breast Irradiation; Regional Nodal
Radition
1. Introduction
Breast-conserving surgery (BCS) followed by whole
breast irradiation (WBI) is reportedly as effective as mas-
tectomy and has now become the standard of care for
treating patients with early-stage breast cancer [1,2]. Al-
though the Oxford meta-analysis demonstrated not only a
significant reduction of local recurrence but also an over-
all survival benefit with adjuvant breast radiation therapy
after BCS [3,4], 15% - 30% of patients who undergo
BCS refuse WBI [5-10]. The latter may be caused by po-
tential factors, including severe and long-term adverse
events, such as rib fracture, lung injury, and late cardio-
vascular toxicity, and by long-term daily visits to radia-
tion institutions for at least 5 - 6 weeks. However, no
subset of patients who should forego radiation therapy
after BCS has been identified [11-13] and local recur-
rence after BCS with WBI is most likely to occur in the
vicinity of the lumpectomy site [14-17]. Considering the
above, the efficacy and feasibility of accelerated partial
breast irradiation (APBI) as an alternative to WBI have
been evaluated in many Phases II and III studies [18-22].
In general, these rapid advances in APBI radiation
therapy have been introduced for patients for whom the
absence of positive nodes has been confirmed by senti-
nel-node (SN) biopsy (SNB), and the addition of regional
nodal radiation (RNI) to WBI is recommended for pa-
*This study was not funded by any public or private grant. All authors
declare no conflict of interest.
#Corresponding author.
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Sentinel-Node-Driven Personalized Radiation Techniques Ranging from Partial Breast Irradiation to
Regional Nodal Radiation after Breast-Conserving Surgery
50
tients with 4 positive nodes confirmed by axillary
lymph node dissection (ALND). Although the National
Cancer Institute of Canada Clinical Trials Group (NCIC
CTG) MA.20 trial provided evidence that selected pa-
tients with 1 - 3 positive nodes benefit from RNI [23],
the number of positive nodes from ALND could still
provide important information with regard to several dif-
ferent approaches of radiotherapy. Recently, the Ameri-
can College of Surgeons Oncology Group trial (ACOSOG)
Z0011 [24] and the European Organisation for Research
and Treatment of Cancer (EORTC) 10981-22023 After
Mapping of the Axilla: Radiotherapy or Surgery (AMA-
ROS) trial [25] have shown that both ALND and radio-
therapy without ALND provide excellent regional con-
trol for SN-positive patients. However, there are several
issues such as indications for SNB in which ALND may
be omitted and the optimal radiation technique for axilla
and systemic treatment after surgery.
Patients who undergo BCS generally receive WBI at
our institution; however, we have introduced the concept
of “personalized radiation therapy after BCS” to deliver
radiation therapy based on the results of SNB and ALND
that ranges from APBI to WBI with RNI. We initiated a
prospective observational study on APBI with multi-
catheter brachytherapy after BCS. Data regarding the
long-term efficacy of our technique indicated a few in-
stances of local recurrence and a low rate of adverse
events [26,27]. Therefore, APBI, rather than WBI, is
primarily performed in node-negative patients. On the
other hand, an additional RNI is administered to patients
with 4 positive nodes.
In this study, we optimized our personalized radiation
therapy ranging from APBI to WBI with RNI for breast-
conserving treatment. First, the ability to select patients
with 4 positive nodes as candidates for RNI using
ALND was evaluated to assess the potential of persona-
lized radiotherapy in SN-positive patients without ALND.
Second, we compared different cohorts that received per-
sonalized radiation therapy on the basis of SNB and ALND.
2. Patients and Methods
2.1. Management of the Axilla and Personalized
Radiotherapy after BCS
Before breast surgery, several imaging studies, including
ultrasound (US), magnetic resonance imaging (MRI),
and positron emission tomography/computed tomogram-
phy (CT), were performed to evaluate axillary nodes for
metastasis [28]. When axillary nodes were suspected as
metastatic on the basis of any axillary imaging, US-
guided fine needle aspiration (FNA) was performed to
look for suspicious lymph nodes or axillary ultrasound
was performed to identify the largest visible node. When
axillary FNA revealed any evidence for metastases,
ALND was performed without SNB. Therefore, SNB
was performed in the absence of evidence for positive
axillary nodes. When SNs were revealed to be positive
for metastasis by frozen section analysis, ALND was per-
formed.
Multicatheter brachytherapy is considered to be an al-
ternative to WBI in patients with negative SNs. Patients
with 4 positive nodes were administered WBI with RNI
administered to Level III/supraclavicular nodes. Other
key APBI criteria were patient age of 40 years and max-
imum tumor diameter of 3.0 cm. This APBI registry
study was approved by the institutional review board of
our hospital. In WBI, patients received a total dose of 50
Gy in fractions of 2 Gy to the entire breast. Patients with
risks, such as positive margins and young age, received a
10-Gy boost to the tumor bed. Combined RNI with WBI
after BCS was performed in patients with 4 positive
nodes (Figure 1).
2.2. APBI with Multicatheter Brachytherapy
The technique details of multicatheter brachytherapy as
APBI have been previously reported [27,29]. The pro-
cedure involves insertion of applicators and delivery
doses simulated by preoperative CT. Applicators for in-
troduction of iridium wires were inserted according to
preoperative CT-based simulation (Figure 2). The lum-
pectomy cavity was identified on postoperative CT scans
with the help of hemoclips. The planned target volume
was defined as the estimated tumor volume plus a 20-mm
margin. Dose distribution analysis using dose-volume
histograms was performed on the basis of postoperative
CT. APBI was initiated on the day of primary surgery at
a dose of 32 Gy in 8 fractions over 5 - 6 days. Fractions
delivered twice daily were separated by an interval of at
least 6 h.
2.3. Assessment of Outcomes
The prospective follow-up policy was designed so that
Figure 1. Management of axilla and personalized radio-
therapy after breast-conserving surgery.
Copyright © 2013 SciRes. JCT
Sentinel-Node-Driven Personalized Radiation Techniques Ranging from Partial Breast Irradiation to
Regional Nodal Radiation after Breast-Conserving Surgery
Copyright © 2013 SciRes. JCT
51
Figure 2. Implantation of multicatheters and optimization of treatment regimens.
all patients had a predefined schedule, including clinical
examination every 3 - 4 months and annual mammo-
graphy. Contrast-enhanced breast MRI was also per-
formed every 12 months for the first 5 years of follow-up.
For analysis, ipsilateral breast tumor recurrence (IBTR)
was classified by clinical location in relation to the initial
lumpectomy cavity. Tumor-bed recurrence (true recur-
rence) was defined as recurrence of the treated cancer
within or immediately adjacent to the primary tumor site.
Failure elsewhere was defined as IBTR several centime-
ters from the primary site and was generally considered
to be a new primary cancer.
The chi-square test was used to analyze associations
among categorical variables with treatment groups. Stu-
dent’s unpaired t-test was used to analyze differences
between 2 sample means of continuous variables. A p
value of <0.05 was considered to indicate statistical sig-
nificance. Statview 5.0 (SAS Institute Inc. Cary, NC,
USA) was used to perform statistical analyses.
3. Results
3.1. Personalized Radiotherapy in SN-Positive
Patients without ALND
Between August 2008 and April 2013, SNB using blue
dye and radioisotopes was performed in 371 patients, and
Sentinel-Node-Driven Personalized Radiation Techniques Ranging from Partial Breast Irradiation to
Regional Nodal Radiation after Breast-Conserving Surgery
52
ALND was performed without SNB in 55 patients with
positive axillary FNA findings. Among the 371 patients
who underwent SNB, ALND was performed in 52
because of positive SNs. For the patients with 4 positive
nodes, RNI was combined with WBI for 12 (23.1%)
patients who underwent SNB followed by ALND and for
32 (58.2%) patients who underwent ALND and were
axillary FNA positive, respectively (Table 1). Therefore,
among the ALND patients, those with positive axillary
FNA findings had a significantly higher rate of require-
ment for RNI with WBI than those who underwent SNB
(p < 0.001).
3.2. SN-Driven Personalized Radiation Therapy
after BCS
A total of 317 consecutive patients who underwent BCS
followed by radiotherapy since November 2007 were
analyzed. Patients who received neoadjuvant chemo-
therapy were not enrolled in this study. A prospective
multicatheter brachytherapy study on these patients was
initiated in October 2008. A consort diagram is shown in
Figure 3. Table 2 lists the clinical, pathological, and
treatment-related characteristics of the 2 groups. The
mean age of the interstitial APBI patients (56.0 years)
was significantly higher than that of the WBI patients;
however, the difference was not significant (51.3 years, p <
0.05). APBI patients were more likely to have negative
margins than WBI patients (86.1% vs. 77.9%, respec-
tively; n.s.) and less likely to be node negative (86.6% vs.
Table 1. Potential of personalized radiotherapy in sentinel
node-positive patients without axillary lymph node dissec-
tion (August 2008-April 2013).
371 SNB followed
by ALND
ALND with axillary
FNA-positive status
Patients (n) 52 55
Positive nodes (mean) 2.4 (1 - 15) 8.7 (1 - 31)
Patients with 4 positive
nodes (n) 12 32
Patients who required
RNI (%) 23.1% 58.2%
Figure 3. Consort diagram of radiotherapy after breast-con-
serving surgery.
Table 2. Patient demographics and tumor characteristics.
APBI
(2008.10-2013.4)
WBI (+RNI)
(2007.11-2013.4) p-value
Age (mean) 56.0 (30 - 92 y/o) 51.3 (31 - 84 y/o)p < 0.05
<50 68 (36.4%) 58 (47.5%)
50 - 59 46 (24.6%) 38 (31.2%)
60 73 (39%) 26 (21.3%)
Follow-up
time (mean) 30.1 months 36.5 months p < 0.05
Pathological
diameter of invasive
tumor (mean)
12.1 mm
(0 - 38 mm)
12.3 mm
(0 - 27 mm) n.s.
Tis 18 (9.6%) 19 (15.6%)
T1 156 (83.4%) 93 (76.2%)
T2 13 (7.0%) 10 (8.2%)
Margin negative161 (86.1%) 95 (77.9%) n.s.
Grades II-III 31 (16.6%) 24 (19.7%) n.s.
ER positive 167 (89.3%) 105 (86.0%) n.s.
HER2 overexpressed17 (9.1%) 17 (13.9%) n.s.
Node negative 162 (86.6%) 93 (76.2%) p < 0.05
Adjuvant
chemotherapy 52 (27.8%) 42 (34.4%) n.s.
76.2%, respectively; n.s.). Further, patients in the APBI
cohort received adjuvant chemotherapy less frequently
than those in the WBI cohort (27.8% vs. 34.4%, respec-
tively; n.s.).
3.3. Recurrence and Survival Rates
The treatment outcomes for the 2 cohort groups are
shown in Table 3. With our follow-up period, locoer-
gional and distant recurrence were similar between the 2
groups. The local-only recurrence rate (IBTR) was 1.1%
in the APBI group and 3.3% in the WBI group. The re-
gional-only recurrence rate was 1.1% in the APBI cohort
and 0.8% in the WBI group. The characteristics of the
patients who experienced disease recurrence are also
described in Table 3. There were 4 patients with distant
recurrence only in the WBI cohort, and 1 death from
other causes among the 2 arms.
4. Discussion
Breast cancer is the most frequently occurring cancer in
Japan [30]. After the introduction of a mammography
program to screen for breast cancer, the ratio of patients
who underwent BCS increased, and this procedure be-
came the most common treatment for breast cancer after
2003 [31,32]. Breast-conserving therapy consisting of
BCS with radiotherapy has become the standard of care
for early-stage breast cancer because of equivalent local
control and survival for both BCT and mastectomy.
Copyright © 2013 SciRes. JCT
Sentinel-Node-Driven Personalized Radiation Techniques Ranging from Partial Breast Irradiation to
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53
Table 3. Locoregional control and distant recurrence.
APBI (n = 187) WBI (+RNI) (n = 122)
Locoregional Recurrence
Local only (IBTR) 2 (1.1%) 4 (3.3%)
Tumor bed recurrence 1 3
Failure elsewhere 1 1
Regional only 2 (1.1%) 1 (0.8%)
Local + regional 4 (2.1%) 5 (4.1%)
Distant Recurrence
First or concurrent 0 4 (3.3%)
After locoregional 0 0
Moreover, according to a recent report, BCT was associ-
ated with improvement in overall survival and disease-
specific survival regardless of age or hormone receptor
status [33]. Although EBCTCG data demonstrated that
omission of radiotherapy was one of the most relevant
factors associated with local recurrence and the rela-
tionship between effects on local control and breast can-
cer mortality showed that 1 death from breast cancer
could be avoided for every 4 local recurrences prevented
[3,4], 20% of patients who underwent BCS in Japan did
not receive WBI [34] because they had complete patho-
logically negative margins, occasional severe adverse
events because of WBI, and long-term daily visits to ra-
diation institutes.
Therefore, we previously initiated a prospective ob-
servational study of APBI with multicatheter brachy-
therapy as an alternative to WBI after BCS. Data regard-
ing the long-term efficacy of our technique in Japanese
breast cancer patients indicated a few instances of local
recurrence and a low rate of adverse events [25,26].
In this study, we optimized our personalized radiation
therapy ranging from APBI to WBI with RNI for breast-
conserving treatment. The results demonstrated that
clinical efficacy of APBI for local control after BCS was
comparable to that of WBI ± RNI at approximately 2.5
years of follow-up. The limitations of this study were
that it was not randomized, was based on only a small
number of participants, and covered only a short follow-
up period. However, to the best of our knowledge, this is
one of the largest observational studies from Asia to
demonstrate the feasibility of BCT using multicatheter
brachytherapy and with acceptable clinical outcomes.
In terms of “personalized radiotherapy after BCS”,
many other factors other than axillary node status need to
be considered because the risk of recurrence has been
reported to be associated with not only the number of
positive nodes but also various other factors (e.g., tumor
subtype was recently claimed to be a factor relevant to
local recurrence). The recent publication of the results of
the American College of Surgeons Oncology Group trial
Z0011 demonstrated equivalent survival and local con-
trol in patients with 1 - 2 positive SNs who were ran-
domly assigned to SNB alone or SNB followed by
ALND [23]. The EORTC AMAROS trial has also shown
that both ALND and axillary radiotherapy without ALND
provided excellent regional control for SN positive pa-
tients [24]. The number of positive nodes was still im-
portant for the personalization of radiotherapy through
several different approaches, from APBI to WBI with
RNI. However, the number of positive nodes present
cannot be determined if ALND is omitted.
When multi-image analyses and axillary FNA for sus-
picious lymph nodes have been introduced to select can-
didates for SNB, about 80% of SN-positive patients did
not require RNI. On the other hand, if axillary FNA re-
vealed metastatic lymph nodes, approximately 60% need-
ed RNI because they had 4 positive nodes. Therefore, to
extend “personalized radiotherapy after BCS”, we may
adopt the following strategy: APBI (or WBI in selected
patients) for SN-negative patients, WBI and ALND (or
APBI and ALND in selected patients) for SN-positive
patients, and WBI and ALND with or without RNI for
axillary FNA-positive patients. Additional research infor-
mation from several institutions is required, and random-
ized clinical trials to confirm the validity of the above
strategy are warranted.
5. Acknowledgements
The authors would like to thank Enago (www.enago.jp)
for the English language review. This study was pre-
sented in part at the 2013 the Japanese Breast Cancer
Society Annual Meeting.
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