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1.  IBCSG 23-01 randomised controlled trial comparing axillary dissection versus no axillary dissection in patients with sentinel node micrometastases 
The lancet oncology  2013;14(4):297-305.
For breast cancer patients with a metastatic sentinel node (SN), axillary dissection (AD) has been standard treatment. However, for patients with minimal SN involvement, AD may be overtreatment. IBCSG Trial 23-01 was designed to determine whether no AD is non-inferior to AD in patients with one or more micrometastatic (≤2 mm) SNs and tumour ≤5 cm.
In this multicentre trial patients were randomised to AD or no AD. Eligibility was limited to patients with clinically-palpable axillary lymph node(s) and a primary tumour ≤ 5 cm who, after sentinel node biopsy, had one or more micrometastatic (≤ 2 mm) sentinel lymphs nodes with no extracapsular extension. The primary endpoint was disease-free survival (DFS). Non-inferiority was defined as a hazard ratio of <1·25 for no AD vs. AD. The analysis was intention to treat. Patients were randomly allocated in a 1:1 ratio to AD or no AD with stratification by centre and menopausal status. There was no attempt to blind the treatment assignment. The trial is registered with, NCT00072293. Per protocol, disease and survival information continues to be collected yearly.
From 2001 to 2010, 934 patients were randomised; 931 were evaluable (464 in the AD group and 467 in the no AD group). After a median follow-up of 5·0 (IQR 3.6–7.3) years, there were 124 DFS events, including breast-cancer-related events in 95 patients (local, 18; contralateral breast, 12; regional, 6; and distant, 59), and other events in 29 (second malignancy, 26; death without prior cancer event, 3). Five-year DFS was 87·8% (95% CI 84·4%–91·2%) in the no AD group and 84·4% (95% CI 80·7%–88·1%) in the AD group (log-rank p=0·16) (HR no AD vs. AD=0·78, 95% CI 0·55–1·11, non-inferiority p=0·0042). Patients with reported long-term surgical events (grade 3–4) included 1 sensory neuropathy (grade 3), 3 lymphedema (2 grade 3 and 1 grade 4), and 3 motor neuropathy (grade 3), all in the AD group, and 1 grade 3 motor neuropathy in the no AD group. One serious adverse event was reported, a post-operative infection in the axilla in the AD group.
AD in patients with early breast cancer represented in this study (most had tumours < 3 cm (92%; 856/931), received breast conserving surgery (91%; 845/931) and adjuvant systemic therapy (96%; 892/931)) should be avoided when the SN is minimally involved, thus eliminating complications of axillary surgery with no adverse effect on survival.
Supported in part: local participating centres, IBCSG central funds, CA075362 from the U.S. National Cancer Institute, and Swiss Cancer League/Cancer Research- Switzerland/Oncosuisse (ICPOCS 01688-03-2005). No pharmaceutical company funds were used.
PMCID: PMC3935346  PMID: 23491275
breast cancer; sentinel node; axillary node; micrometastasis; sentinel node biopsy; axillary dissection; lymph node
2.  Sentinel Lymph Node Biopsy in Early Breast Cancer: The Experience of the European Institute of Oncology in Special Clinical Scenarios 
Breast Care  2011;6(3):208-214.
While axillary nodal status is still one of the most important prognostic factors in breast cancer, sentinel lymph node biopsy (SLNB) has evolved as a main procedure to strongly reduce postsurgical morbidity improving early and long-term quality of life.
Material and Methods
Between 1996 and 2010, we performed 18,884 SLNBs for breast cancer, successfully confirming the validity of this technique and its positive impact on patients' quality of life, even though decision-making processes for adjuvant treatment strongly depend on biological features.
This paper summarizes published data mainly collected in our institute considering special clinical scenarios such as ductal intraepithelial neoplasia, intramammary sentinel nodes, multicentric breast cancer, prior breast surgery, previous breast aesthetic surgery, second axillary SLNB, pregnant patients, primary chemotherapy, and male patients.
In general, we believe that SLNB represents the standard procedure for axillary staging in virtually all clinical situations, even in those which were previously considered a contraindication for this procedure. At the moment, the only contraindication to SLNB is the presence of documented axillary metastases.
PMCID: PMC3132968  PMID: 21779226
Sentinel node; Breast cancer; Axillary dissection; Axillary staging
3.  Breast cancer: from “maximum tolerable” to “minimum effective” treatment 
Frontiers in Oncology  2012;2:125.
Randomized trials have played a fundamental role in identifying better treatments for most type of diseases, especially in the oncological field. In breast cancer, the shift from “maximum tolerable” to “minimum effective” treatment has been evident since the 1970s and has been based on the results of international randomized trials. The progress of breast surgery represents an excellent model of the evolution of science and the aim of this article is to review the main randomized studies that changed everyday practice in breast surgery.
PMCID: PMC3465814  PMID: 23061042
breast cancer; randomized trials; maximum tolerable treatment; minimum effective treatment; conservative treatment
4.  Nonpalpable Breast Carcinomas: Long-Term Evaluation of 1,258 Cases 
The Oncologist  2010;15(12):1248-1252.
A steady improvement in imaging diagnostics has been observed together with a rising adherence to regular clinical breast examinations. As a result, the detection of small clinically occult (nonpalpable) lesions has progressively increased. Nonpalpable carcinomas show very favorable prognostic features and high survival rates, showing the important role of modern imaging techniques.
In recent decades, a steady improvement in imaging diagnostics has been observed together with a rising adherence to regular clinical breast examinations. As a result, the detection of small clinically occult (nonpalpable) lesions has progressively increased. At present in our institution some 20% of the cases are treated when nonpalpable. The aim of the present study is to analyze the characteristics and prognosis of such tumors treated in a single institution.
The analysis focused on 1,258 women who presented at the European Institute of Oncology with a primary clinically occult carcinoma between 2000 and 2006. All patients underwent radioguided occult lesion localization (ROLL), axillary dissection when appropriate, whole breast radiotherapy, or partial breast intraoperative irradiation and received tailored adjuvant systemic treatment.
Median age was 56 years. Imaging showed a breast nodule in half of the cases and a breast nodule accompanied by microcalcifications in 9%. Microcalcifications alone were present in 17.1% of the cases, whereas suspicious opacity, distortion, or thickening represented the remaining 24.6%. Most tumors were characterized by low proliferative rates (68.9%), positive estrogen receptors (92.3%), and non-overexpressed Her2/neu (91.3%). After a median follow-up of 60 months, we observed 19 local events (1.5%), 12 regional events (1%), and 20 distant metastases (1.6%). Five-year overall survival was 98.6%.
Clinically occult (nonpalpable) carcinomas show very favorable prognostic features and high survival rates, showing the important role of modern imaging techniques.
PMCID: PMC3227928  PMID: 21147866
Nonpalpable breast cancer; Radioguided occult lesion localization; Diagnostics by imaging; Early detection
5.  A new option for early breast cancer patients previously irradiated for Hodgkin's disease: intraoperative radiotherapy with electrons (ELIOT) 
Breast Cancer Research  2005;7(5):R828-R832.
Patients who have undergone mantle radiotherapy for Hodgkin's disease (HD) are at increased risk of developing breast cancer. In such patients, breast conserving surgery (BCS) followed by breast irradiation is generally considered contraindicated owing to the high cumulative radiation dose. Mastectomy is therefore recommended as the first option treatment in these women.
Six patients affected by early breast cancer previously treated with mantle radiation for HD underwent BCS associated with full-dose intraoperative radiotherapy with electrons (ELIOT).
A total dose of 21 Gy (prescribed at 90% isodose) in five cases and 17 Gy (at 100% isodose) in one case were delivered directly to the mammary gland without acute complications and with good cosmetic results. After an average of 30.8 months of follow up, no late sequelae were observed and the patients are free of disease.
In patients previously irradiated for HD, ELIOT can avoid repeat irradiation of the whole breast, permit BCS and decrease the number of avoidable mastectomies.
PMCID: PMC1242162  PMID: 16168129

Results 1-5 (5)