Fleissig A, Fallowfield LJ, Langridge CI, Johnson L, Newcombe RG, Dixon JM, Kissin M, Mansel REPost-operative arm morbidity and quality of life. Results of the ALMANAC randomised trial comparing sentinel node biopsy with standard axillary treatment in the management of patients with early breast cancer. Breast Cancer Res Treat 95(3): 279-293

Cancer Research UK Psychosocial Oncology Group, Brighton & Sussex Medical School, Falmer, UK.
Breast Cancer Research and Treatment (Impact Factor: 4.2). 03/2006; 95(3):279-93. DOI: 10.1007/s10549-005-9025-7
Source: PubMed

ABSTRACT This study is the first large prospective RCT of sentinel node biopsy (SNB) compared with standard axillary treatment (level I-III axillary lymph node dissection or four node sampling), which includes comprehensive and repeated quality of life (QOL) assessments over 18 months. Patients (n = 829) completed the Functional Assessment of Cancer Therapy - Breast (FACT-B+4) and the Spielberger State/Trait Anxiety Inventory (STAI) at baseline (pre-surgery) and at 1, 3, 6, 12, and 18 months post-surgery. There were significant differences between treatment groups favouring the SNB group throughout the 18 months assessment. Patients in the standard treatment group showed a greater decline in Trial Outcome Index (TOI) scores (physical well-being, functional well-being and breast cancer concerns subscales in FACT-B+4) and recovered more slowly than patients in the SNB group (p < 0.01). The change in total FACT-B+4 scores (measuring global QOL) closely resembled the TOI results. 18 months post-surgery approximately twice as many patients in the standard group compared with the SNB group reported substantial arm swelling (14% versus 7%) (p = 0.002) or numbness (19% versus 8.7%) (p < 0.001). Despite the uncertainty about undergoing a relatively new procedure and the possible need for further surgery, there was no evidence of increased anxiety amongst patients randomised to SNB (p > 0.05). For 6 months post-surgery younger patients reported less favourable QOL scores (p < 0.001) and greater levels of anxiety (p < 0.01). In view of the benefits regarding arm functioning and quality of life, the data from this randomised study support the use of SNB in patients with clinically node negative breast cancer.

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    • "Results have shown no significant difference in overall survival and disease-free survival between the two groups [4] [5]. A recent meta-analysis has shown that there is significantly less post-operative morbidity in the SNLB group, including post-operative wound infection, seroma, lymphoedema and limb paraesthesia [5] [6] [7] [8] [9] [10] [11] [12] [13] [14]. SLNB has been shown to be accurate for axillary staging and patients with negative SLNs can safely avoid an ALND with its associated higher morbidity [15] [16]. "
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    ABSTRACT: The management of the axilla in the presence of positive sentinel lymph node (SLN) remains controversial. Many centres forgo completion axillary lymph node dissection (cALND) in the presence of micrometastatic disease. The American College of Surgeons Oncology Group (ACOSOG) Z0011 trialists argue for extending this to macrometastasis. The aim of this study was to correlate tumour burden in SLNs with that in the residual lymph node basin to determine the likelihood of residual disease in patients with micro- and macrometastasis in the SLN. Patients who underwent cALND following a positive SLN were analysed for histopathological features of the primary tumour and burden of axillary disease. Of 155 patients, 115 (74%) had macrometastases and 40 (26%) micrometastases in the SLNs. Residual axillary disease was detected in 55/155 (35%) patients with macrometastases and 4/40 (10%) with micrometastases. Generally, with increasing size of metastasis in the SLN there was an increasing risk of further disease in residual lymph nodes. Logistic regression analysis showed increased odds ratios for further disease for all groups when compared with the <2mm (micrometastasis) SLN group. Patients may be advised to forgo cALND where the SLN contains isolated tumour cells or micrometastasis. Recommendations for proceeding to cALND can be based on the size of metastasis in the SLN, which relates to the risk of further disease in the residual axillary lymph nodes and subsequent regional recurrence.
    European journal of cancer (Oxford, England: 1990) 12/2013; 50(4). DOI:10.1016/j.ejca.2013.11.024 · 4.82 Impact Factor
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    • "In case of macrometastatic SLN (> 2 mm), a complete axillary lymphadenectomy is needed. Despite the evolution of this surgical procedure in the locoregional staging of breast cancer, SLN biopsy remains invasive and has disadvantages [3] such as exposure to ionizing radiation, high costs in terms of time, hospitalization and medical staff. Moreover, in a number of cases (less than 5% for experienced teams) it does not lead to the detection of SLN. "
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    ABSTRACT: Preoperative ultrasound-guided fine-needle aspiration cytology (UG-FNAC) of axillary lymph nodes in breast cancer emerged after the onset of the surgical sentinel node (SN) procedure. Today it is established as one of the preoperative routine procedures in patients with a cytological or histological confirmation or strong suspicion of breast carcinoma, the interest being that a positive UG-FNAC allows to avoid SLN biopsy or two-stage surgical procedure. Our article reviews the recent data in the literature regarding the diagnostic accuracy of lymph node FNAC in breast cancer staging, and presents the experience of the Breast Diagnostic Centre of Oslo University Hospital Ullevaal, Norway, in this context. Nowadays, UG-FNAC is indicated whenever the breast radiologist finds a suspicious or otherwise abnormal axillary lymph node, regardless of the size of the primary tumour. UG-FNAC is a cost effective and safe method. A diagnosis of metastatic malignancy has a very high accuracy and false-positives are virtually non-existent. False-negatives do occur, especially in lymph nodes with partial involvement as micrometastases and isolated tumor cells (ITC), and recent recommendations advocate that in these particular situations the axillary dissection is not necessary.
    Annales de Pathologie 12/2012; 32(6):410-4. DOI:10.1016/j.annpat.2012.09.201 · 0.29 Impact Factor
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    • "The majority of older patients tolerate surgery and anesthesia with very low morbidity and almost nonexistent mortality [Wyld and Reed, 2007]. Older patients do not appear to be at increased risk of complications following axillary surgery, and quality of life after both sentinel node biopsy and axillary clearance was shown to be higher in older women than in younger women [Fleissig et al. 2006]. According to an overview of the Early Breast Cancer Trialists' Collaborators Group, age did not affect the proportional reduction in local recurrence for irradiation after breast-conserving surgery. "
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    ABSTRACT: Breast cancer is the most frequent malignant tumor in women worldwide and as breast cancer incidence increases with increasing age, over 40% of new cases are diagnosed in women older than 65 years of age. However, older patients are not treated to the same extent as younger patients and increasing age at diagnosis predicts deviation from guidelines for all treatment modalities. Evidence-based medicine in older patients is lacking as they are usually excluded from clinical trials often because of existing comorbidities and limited life expectancy. Accordingly, there is a higher competing risk of death from other causes than breast cancer compared with younger patients and this may have led to the false interpretation that prognosis of breast cancer in older patients is relatively good. However, every treatment modality should be evaluated during treatment decision making. Multimodal therapy should not be routinely withheld as data show that disease-specific mortality increases with age, probably due to undertreatment. Prognostic markers, fitness and comorbidities rather than chronological age should determine optimal, individualized therapy. It is recommended that treatment decisions should be discussed in a multidisciplinary setting, ideally in combination with any form of geriatric assessment, to improve breast cancer outcome in the older population.
    rapeutic Advances in Medical Oncology, The 11/2012; 4(6):321-7. DOI:10.1177/1758834012455684
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