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European Journal of Surgical Oncology xxx (2018) 1e7

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European Journal of Surgical Oncology

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Neoadjuvant systemic treatment for breast cancer in Italy: The Italian

Society of Surgical Oncology (SICO) Breast Oncoteam survey
E. Vicini a, *, A. Invento b, M. Cuoghi c, A. Bafile d, C. Battaglia e, N. Biglia f, M. Busani g,
R. Bussone h, E. Cianchetti i, F. Caruso j, M.C. Cucchi c, M. Dessena k, F. Di Filippo l, N. Fabi l,
S. Folli m, D. Friedman n, G. Macellari o, P. Mainente p, R. Murgo q, A. Neri r, G.P. Pollini b,
D. Palli s, F. Ricci t, G. Scalco u, M. Taffurelli v, M. Trunfio w, V. Galimberti a, the Italian
Society of Surgical Oncology (SICO) Breast Oncoteam
Division of Breast Surgery, European Institute of Oncology, Milan, Italy
U.O.C. Breast Unit AOUI Borgo Trento, Verona, Italy
U.O.S.D. Chirurgia Senologica Breast Unit Bellaria USL Bologna, Italy
Division of Breast Surgery, Ospedale San Salvatore Coppito, L'Aquila, Italy
Unit of Senology Ospedale Civile di Sanremo, Italy
f  di Torino, Osp. Mauriziano Umberto I, Torino, Italy
SSD di Chirurgia Senologica, Az. Osp. " C. Poma ", Mantova, Italy
Chirurgia Senologica-Breast Unit, Ospedale Cottolengo, Torino, Italy
Chirurgia generale a indirizzo Senologico, Ospedale Gaetano Bernabeo, Ortona, CH, Italy
Breast Centre Humanitas, Catania, Italy
S.C. Chirurgia Sperimentale, Ospedale Oncologico, Azienda Ospedaliera Brotzu, Cagliari, Italy
Regina Elena National Cancer Institute, Roma, Italy
AUSL Romagna, Ospedale GB Morgagni S.C. di Senologia, Forlì, FC, Italy
U.O. Chirurgia Senologica, Ospedale Policlinico San Martino, Genova, Italy
Breast Centre Ospedale S. Giuseppe, Milano, Italy
UOS Senologia c/o S.C. di Chirurgia Generale, Ospedale "Alto Vicentino" - ULSS 7 PEDEMONTANA e Santorso, Vicenza, Italy
UOC di Chirurgia Senologica, Ospedale IRCCS Casa Sollievo della Sofferenza, San Giovanni Rotondo, FG, Italy
Centro Senologico AOU Senese, Policlinico Le Scotte, Siena, Italy
U.O.S.D. di Chirurgia Senologia-Breast Unit Ospedale "Guglielmo da Saliceto", Piacenza, Italy
Breast Unit "S. M. Goretti" Hospital, ASL-Latina/Sapienza University of Rome, Polo Pontino, Latina, Italy
U.O.S. di Senologia Chirurgica, U.O.C. di Chirurgia Generale, Ospedale San Bortolo, Vicenza, Italy
Dipartimento di Medicina e Chirurgia (DIMEC), Universita  di Bologna, Policlinico di Sant’Orsola, Bologna, Italy
Dipartimento di Senologia Chirurgica, Azienda Ospedaliera A. Cardarelli, Napoli, Italy

a r t i c l e i n f o a b s t r a c t

Article history: The Italian Society of Surgical Oncology (SICO) Breast Oncoteam developed a survey to explore the state
Accepted 20 March 2018 of the art of neoadjuvant treatment for breast cancer in Italy, specifically focusing on cases treated during
Available online xxx the two-year period 2014e2015.
A questionnaire was sent to Italian Breast Units with a minimum of 150 new breast cancer cases
Keywords: treated/year according to the Senonetwork directory and to the SICO Breast Oncoteam Breast Unit
Breast cancer
A total of 23/107 Breast Units submitted the survey, reporting a total amount of 20156 cases of breast
Breast surgery
carcinoma (17241 invasive, 2915 in situ) treated in the biennium, corresponding approximately to 20% of
Pathological complete response newly diagnosed breast cancers in Italy.
In the United States, medical treatment before surgery for breast cancer is indicated in about 22.7% of
newly diagnosed cases according to the National Cancer Database, while a German study reported
approximately 20% of cases treated with neoadjuvant therapy. In our survey, a total of 1673/17241 cases
(9.7%) were treated with neoadjuvant therapy, ranging from 2.9% to 23.6% according to different centres,

Abbreviations: NAT, NeoAdjuvant systemic Treatment; SICO, Italian Society of Surgical Oncology; DTMP, Diagnostic Therapeutic and Healthcare Management Protocol;
QoL, Quality of Life; Fig, Figure.
* Corresponding author.
E-mail address: (E. Vicini).
0748-7983/© 2018 Elsevier Ltd, BASO ~ The Association for Cancer Surgery, and the European Society of Surgical Oncology. All rights reserved.

Please cite this article in press as: Vicini E, et al., Neoadjuvant systemic treatment for breast cancer in Italy: The Italian Society of Surgical
Oncology (SICO) Breast Oncoteam survey, European Journal of Surgical Oncology (2018),
2 E. Vicini et al. / European Journal of Surgical Oncology xxx (2018) 1e7

showing heterogeneity in neoadjuvant treatment indications, even in multidisciplinary breast units.

Better resources should be engaged to achieve a standardised quality indicator for neoadjuvant treat-
ment, and this indicator could be included among the European Society of Breast Cancer Specialists
(EUSOMA) quality indicators. In the near future, we plan to develop a second survey to better test im-
provements in the employment of neoadjuvant therapy after the expiry of the 2016 European Parliament
deadline and after the 2017 St. Gallen Conference recommendations.
© 2018 Elsevier Ltd, BASO ~ The Association for Cancer Surgery, and the European Society of Surgical
Oncology. All rights reserved.

Introduction SICO Breast Oncoteam Breast Unit network. The authors certify that
ethical approval was not required for the study.
Initially developed as a treatment option for locally advanced Descriptive analysis was carried out as appropriate.
breast tumours, the concept of neoadjuvant systemic treatment
(NAT) has, over the years, been translated into the setting of early Results
breast cancer [1,2].
NAT can be employed to downstage a tumour and therefore to A total of 23/107 (21,4%) Breast Units completed and submitted
achieve loco-regional disease control allowing breast surgery in the survey to the SICO Breast Oncoteam, reporting a total of 20156
initially unresectable neoplasms [3]. cases of breast carcinoma (17241 invasive carcinoma, 2915 in situ)
The rationale of primary systemic treatment for operable breast treated in the 2014e2015 biennium. A total of 1673 of 17241 cases
cancers is the opportunity to test in vivo chemosensitivity, instead (9.7%) were treated with NAT, ranging from 2.9% to 23.6% according
of administering adjuvant treatment after tumour removal [4]. In to different centres.
fact, recent meta-analyses have shown how pathologic complete Unfortunately, it was not possible to report T and N status before
response (pCR) after NAT can occur in around 20% of cases and how NAT, due to the lack of information from many centres. Breast
it is associated with a better prognosis [5,6]. pathological response was complete (ypT0 and ypTis in the defin-
Primary systemic treatment can convert a surgical indication for itive histological examination) in 538 from 1673 cases (32,1%), 410/
mastectomy into a conservative option (breast conservative sur- 1673 (24,5%) ypT0 and 128/1673 (7,6%) ypTis respectively (Fig. 1).
gery, nipple/skin sparing mastectomies with immediate recon- In 859 cases, pathological nodal status after NAT was negative,
struction) [7,8] and can downstage axillary node-positive disease to ypN0 and ypN0sn, with a total of 21 (91.3%) centres performing
node-negative [9,10]. sentinel node biopsy in clinically node-negative patients pre-NAC
In order to select those patients most likely to respond to NAT and 14 (60.8%) centres performing sentinel node biopsy in pa-
and thus avoid unnecessary aggressive treatments, molecular bio- tients with nodal involvement pre-NAC who showed a complete
markers are required. radiological response. A total of 17 (73.9%) centres reported a
The wide range of responses to NAT is related to histotype sentinel node detection rate >90% post NAT, 2 centres <90%. In 15
(ductal/lobular/other types), to molecular subtypes of breast cancer (65.2%) centres, the tracer employed is 99Tc only, 4 centres employ
(Luminal A, Luminal B, HER2-enriched, and triple negative) and to the double tracer technique with 99Tc and blue dye, one centre uses
the proliferation index. Triple negative and even more HER2- indocyanine green, while 3 (13%) centres did not respond to the
enriched subtypes, particularly in the absence of hormone recep- question.
tor expression, show a higher rate of pCR, while luminal B/HER2- In all centres, a Diagnostic, Therapeutic and Healthcare Man-
negative subtypes demonstrates a lower rate of pCR [5,11]. Only a agement Protocol (DTMP) is active and the final planning decision
minority of patients affected by Luminal A subtypes and lobular is discussed during multidisciplinary meetings. The major indica-
histotype achieve pCR [11,12]. tion reported for NAT is biological subtype (86.4%), as shown in
Pre-surgical systemic treatment can include chemotherapy Fig. 2 and, in relation to the biological subtypes, all the 23 Breast
regimens (in the majority of cases), associated with anti-HER2 Units indicate NAT for HER2þ tumours, 21 (91.3%) for triple-
targeted agents in HER2-overexpressed tumours, or endocrine negative tumours, 15 (65.2%) for luminal B cancers, while only 5
therapy that could represent an option in clinical trials for hor- (21.7%) multidisciplinary groups indicate NAT for luminal A cancers
monal sensitive cancers [13]. (Fig. 3). In 14 centres, HER2 status is considered crucial for preop-
The aim of the present survey is to estimate the current erative treatment indication in all cases, while in the remaining 9
employment of NAT for breast cancer treatment in Italy and the centres it is considered only for selected cases. Among the 1673
current modalities. reported cases treated with NAT, 527 (31.5%) were HER2 positive
cases. In 17 breast units, neoadjuvant endocrine therapy is
Materials and methods Regarding diagnostic procedures, although there may be some
concerns regarding the actual need for staging in asymptomatic
In July 2016, the Italian Society of Surgical Oncology (SICO) patients according to the recent guidelines [15], we enquired about
Breast Oncoteam developed a questionnaire involving various as- the procedures employed. We found that 54.5% of centres perform
pects of NAT and specifically referred to cases treated during the a CT total body and a skeletal scintigraphy; the other centres re-
two-year period 2014e2015. The questionnaire was divided into 7 ported that they conduct positron emission tomography only
sections: general information, clinical records, indications, diag- (17.4%), positron emission tomography and skeletal scintigraphy
nosis, surgical treatment, radiation therapy, and final consider- (13%), positron emission tomography or CT total body (8.7%), or CT
ations (Table 1). It was sent by e-mail to all the Italian Breast Units total body only (4.3%).
which handle a minimum of 150 new breast cancer cases treated Also regarding breast diagnostic procedures, in 17 breast
per year, according to the Senonetwork directory [14] and to the units, pre- and post-NAT Breast MRI is performed for every

Please cite this article in press as: Vicini E, et al., Neoadjuvant systemic treatment for breast cancer in Italy: The Italian Society of Surgical
Oncology (SICO) Breast Oncoteam survey, European Journal of Surgical Oncology (2018),
E. Vicini et al. / European Journal of Surgical Oncology xxx (2018) 1e7 3

Table 1

General Information Date of completion Centre Principal Investigator

Clinical Records How many new breast cancer cases were How many cases were treated with How do you routinely stage patients before
treated at your Centre? How many DCIS? NAT? NAT? (choose at least 1 option)
N … new breast cancers treated N … PET þ skeletal scintigraphy
N … comprehensive of DCIS CT total body
CT total body þ skeletal scintigraphy
Skeletal Scintigraphy
Divide the number of cases treated with How many HER2 positive cases were
NAT by pathological response (ypT) treated with NAT?
Complete response ypT0 þ ypTis N … N …
ypT2 N …
ypT3 N …
ypT4 N …
Indications Is a Diagnostic, Therapeutic and Healthcare Do you discuss NAT indication during Which factors do you consider as determinant
Management Protocol (DTMP) active in multidisciplinary meetings? to indicate NAT? (choose at least 1 option)
your Centre? y/n Tumour dimension (>2.5 cm)
y/n Conversion mastectomy/conservative
Nodal involvement
Tumour biology
Outcome benefit (PFS)
Outcome benefit (OS)
You indicate NAT for: (choose at least 1 Is HER2 status crucial for you to Do you employ neoadjuvant endocrine
option) prescribe NAT? therapy?
HER 2 positive Yes, for all patients y/n
Triple negative Only for selected cases
Luminal A No, we consider other factors
Luminal B
Diagnosis Do you perform pre- and post-NAT Breast Do you perform pre and post NAT Do you perform pre and post NAT
MRI? (choose only 1 option) Breast UltraSound? (choose only 1 Mammogram? (choose only 1 option)
For all cases option) y/n
Never y/n
For multifocal or multicentric disease
How do you perform biopsies? (choose only Is biopsy site marked? If marked, how?
1 option) y/n Clip
Tru-Cut Tattoo
Incisional biopsy Picture of skin clinical mapping
Do you routinely perform axillary Do you perform FNAC/biopsy of any Do you perform clinical/radiological monitoring
UltraSound? suspicious axillary node? during NAT?
y/n y/n y/n
If yes, do you mark it with a clip?
Surgery Is surgery performed within 30 days after In node-negative patients do you In node-positive patients converted to node
the completion of NAT? perform sentinel node biopsy before or negative on imaging after NAT do you perform
y/n after NAT? sentinel node biopsy?
Before y/n
What is your sentinel node detection rate What tracer do you use for sentinel What type of breast surgery after NAT?
after NAT? node biopsy after NAT? (choose only 1 Conservative N …
>90% option) Demolitive N …
<90 99Tc
Blue dye
99Tc þ Blue dye
Indocyanine green
In the case of conservative surgery do you In the case of mastectomy, do you If radiation therapy is planned, do you perform
excise an area corresponding to the initial perform nipple-sparing technique after reconstruction?
tumour size? NAT? y/n
y/n y/n If yes, what type of reconstruction?
In what percentage of cases? … % Expander
Expander þ lipofilling
Adjuvant Therapy You base radiation therapy indication on: After surgery, do you prescribe In what percentage of cases?
Pre-NAT status additional chemotherapy? …%
Post-NAT status y/n Please specify indications …
Final Considerations In your opinion, what are the major
limitations to NAT?
Quality of Life (QoL) impact
Treatment delay
Progression risk
Organisation difficulties
Patient compliance

patient, while the remaining 7 centres employ MRI only when with suspected node cytology/histology in 21 centres. In 2 cen-
there is a suspicion of multifocal/multicentric disease. Pre- and tres a clip is placed in the suspected node before NAT and in 20
post-NAT mammogram and breast US are performed in 18 and 20 centres a clinical/radiological monitoring is conducted during
centres respectively; routine axillary US is reported in 21 centres, NAT. Marking before NAT is reported in 22/23 centres, using a clip

Please cite this article in press as: Vicini E, et al., Neoadjuvant systemic treatment for breast cancer in Italy: The Italian Society of Surgical
Oncology (SICO) Breast Oncoteam survey, European Journal of Surgical Oncology (2018),
4 E. Vicini et al. / European Journal of Surgical Oncology xxx (2018) 1e7

Fig. 1. Breast pathological response to NAT.

in 11 centres, a tattoo in 9 centres, a picture of skin clinical Timing for surgery in all centres was adequate according to the
mapping in 2 cases. Three centres employ clip or tattoo. A total of current literature [16,17], within 30 days after the completion of
21 centres perform core biopsy, while in the remaining 2 centres NAT. Among the whole group of patients treated with NAT, 40.4%
an incisional biopsy is performed. received conservative surgery, while 59.6% underwent a

Fig. 2. NAT indications in the 23 reported centers.

Please cite this article in press as: Vicini E, et al., Neoadjuvant systemic treatment for breast cancer in Italy: The Italian Society of Surgical
Oncology (SICO) Breast Oncoteam survey, European Journal of Surgical Oncology (2018),
E. Vicini et al. / European Journal of Surgical Oncology xxx (2018) 1e7 5

Fig. 3. Indications for NAT according to molecular subtypes in different centres.

mastectomy. According to the 2017 St. Gallen conference, regarding Resolution on Breast Cancer [23,24]. Recent data shows how im-
conservative surgery, the tendency to excise an area corresponding provements in survival have been achieved, with a slight difference
to the initial tumour size should decrease in the future in the remaining between the north and south of Italy [25].
absence of microcalcifications or scattered residual disease [18]; We decided to focus our survey to the specific topic of neo-
there were found to be 7 centres that still excise an area corre- adjuvant chemotherapy because the whole process requires orga-
sponding to the initial tumour size. Nipple-sparing mastectomy nisation, support, excellent communication skills, specialised
after NAT is offered in 21 breast units, in line with the 2017 St. services and qualified professionals. It could offer a good surrogate
Gallen Conference statements and the diffusion of the technique endpoint to effectively sample the quality of a multidisciplinary
[18,19]. team, despite the limitations due to the arbitrary nature of inter-
As the role played by post-mastectomy radiation therapy and preting a multiple-choice questionnaire. Moreover, controversies
regional nodal irradiation after NAT is still a matter of controversy
in the medical literature, with several trials ongoing [20], the
centres were asked about indications for radiation therapy. In 15
centres radiation therapy was reported to be based on pre-NAC
We asked about issues pertaining to reconstruction, considering
that radiation therapy represents a risk factor for complications
which can affect the quality of results in both the immediate and
the delayed setting: 20 centres perform immediate reconstruction
if radiation therapy is planned after surgery, 12 of them with an
expander, 8 with an expander plus lipofilling. The authors agree
that immediate reconstruction could be considered an available
option consistent with a personalised approach based on the pa-
tient's medical history and expectations [21].
Additional chemotherapy after surgery in patients with an
incomplete response and who are at a high risk of recurrence, in the
absence of hormone receptor expression, could be considered
(Capecitabine is a possible option) [22] and eleven (47.8%) centres
prescribe it.
The answers to the final question “what are the major limita-
tions to NAC?” are reported in Fig. 4.


During the past decade, Italy has devoted considerable and

sustained effort to establishing certified multidisciplinary breast
units nationwide, in accordance with the European Parliament Fig. 4. Clinicians’ opinion regarding limitations to primary systemic treatment.

Please cite this article in press as: Vicini E, et al., Neoadjuvant systemic treatment for breast cancer in Italy: The Italian Society of Surgical
Oncology (SICO) Breast Oncoteam survey, European Journal of Surgical Oncology (2018),
6 E. Vicini et al. / European Journal of Surgical Oncology xxx (2018) 1e7

regarding the issue of neoadjuvant treatment are still present in the Conflict of interest statement
guidelines [15,26]. It is currently a matter of discussion and debate
at key international conferences, particularly during the 2017 St. We wish to confirm that there are no known conflicts of interest
Gallen International Conference (tumour biology, breast and axil- associated with this publication and there has been no significant
lary surgery, radiation therapy, additional chemotherapy in pa- financial support for this work that could have influenced its
tients with partial pathological response) [18,22,27]. Our survey outcome.
provided data regarding approximately 20% of the total breast
cancers treated in Italy in the 2014e2015 biennium.
In the United States, medical treatment before surgery for breast Acknowledgments
cancer is indicated in about 23% of newly diagnosed cases accord-
ing to the National Cancer Database (2010e2011) [28]. A German The authors thank Maria Carla Massa for data processing and
study reported approximately 20% of cases treated with NAT in the William Russell-Edu and Maria Grazia Villardita for constructive
years 2009e2011 from a cohort of 39570 patients [29], while in our criticism of the manuscript.
survey, primary systemic treatment is employed in 9.7% of cases
(range 2.9%e23.6% according to different centres), showing het- References
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Please cite this article in press as: Vicini E, et al., Neoadjuvant systemic treatment for breast cancer in Italy: The Italian Society of Surgical
Oncology (SICO) Breast Oncoteam survey, European Journal of Surgical Oncology (2018),

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