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

Cardiff University, Cardiff, Wales, United Kingdom
Breast Cancer Research and Treatment (Impact Factor: 3.94). 03/2006; 95(3):279-93. DOI: 10.1007/s10549-005-9025-7
Source: PubMed


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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    • "In case of pre-operatively negative lymph nodes, the standard procedure is sentinel node biopsy (SNB), performed using 99m Tc with or without blue, which accurately predicts the status of the other axillary lymph nodes with an identification rate of 96–97% (Krag et al. 1993, 2007; Giuliano et al. 1994; Albertini et al. 1996; Veronesi et al. 1997, 2003; Harlow et al. 2005; Mansel et al. 2006; Sakorafas & Safioleas 2010; D'Angelo-Donovan et al. 2012). SNB provides the same prognostic information as axillary dissection, but reduces the morbidity: lymphedema, seroma, infections, reduced shoulder mobility and pain (Schrenk et al. 2000; Swenson et al. 2002; Fleissig et al. 2006). "
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    ABSTRACT: The European Union has determined that from 2016 breast cancer patients should be treated in Specialist Breast Units that achieve the minimum standards for the mandatory quality indicators as defined by Eusoma. The existing standard for axillary lymph node staging in breast cancer is sentinel node biopsy (SNB), performed using Technetium-sulphur colloid ((99m) Tc) alone or with blue dye. The major limits of radioisotope consist in the problems linked to radioactivity, in the shortage of tracer and nuclear medicine units. Among existing alternative tracers, SentiMag(®) , which uses superparamagnetic iron oxide particles, can represent a valid option for SNB. We conducted a paired, prospective, multicentre study to evaluate the non-inferiority of SentiMag(®) vs. (99m) Tc. The primary end point was the detection rate (DR) per patient. The study sample consists of 193 women affected by breast carcinoma with negative axillary assessment. The concordance rate per patients between (99m) Tc and SentiMag(®) was 97.9%. The DR per patient was 99.0% for (99m) Tc and 97.9% for SentiMag(®) . SentiMag(®) appears to be non-inferior to the radiotracer and safe. While (99m) Tc remains the standard, SentiMag(®) DR appears adequate after a minimum learning curve. In health care settings where nuclear medicine units are not available, SentiMag/Sienna+(®) allows effective treatment of breast cancer patients.
    Full-text · Article · Sep 2015 · European Journal of Cancer Care
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    • "The disease status of axillary lymph nodes is the most significant prognostic factor for patients with early-stage breast cancer (BC), and determining this status is essential in the decision-making process of administering adjuvant systemic therapy12. The sentinel lymph node (SLN) is defined as the first lymph node that receives lymph drainage from a tumor area; negative findings after an SNL biopsy in clinically node-negative BC patients can prevent unnecessary dissection of the axillary lymph node, which can preclude any morbidity that is associated with this procedure3. Conventional hematoxylin and eosin (H&E)-based histopathological studies are limited to the accurate measurement of the total metastatic volume in a lymph node4. "
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    ABSTRACT: The one-step nucleic acid amplification (OSNA) assay is a molecular procedure that can identify deposits of breast cancer (BC) cells in the sentinel lymph node (SLN). We examined the consistency of the OSNA assay with a classic hematoxylin-eosin (H&E)-based immunohistochemistry (IHC) study and evaluated how OSNA-based axillary staging might impact the therapeutic management of BC patients. SLN biopsy results were considered to be positive in 60 patients (40%) in the OSNA group (N = 148) and in 43 (28%) patients in the IHC cohort (N = 153, p = 0.023). There was no difference in the macrometastasis (22% for OSNA, 15% for H&E, p = 0.139) or micrometastasis (19% for OSNA, 13% for H&E, p = 0.166) rates, but we found statistically significant differences in the number of isolated tumor cells (1% for OSNA, 11% for H&E, p < 0.001). There were no differences in the administration rate of adjuvant systemic therapy between the OSNA (66% in the SLN(+) patients) and the H&E (74% in the SLN(+) patients) groups (p = 0.159). The OSNA assay allows for the detection of SLN metastases more precisely than conventional pathologic methods but does not alter the therapeutic management of SLN(+) BC patients.
    Full-text · Article · Jul 2014 · Scientific Reports
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    • "Specifically, this treatment is applicable in patients with tumors that are considered N1 or N2 according to the TNM staging system [2]. ALND was replaced in clinical practice by sentinel lymph node biopsy (SLNB) in patients that lack axillary lymph node involvement (N0) and some N1 patients [3], due to its reduced morbidity [4-7]. However, despite widespread mammography use for disease screening and early diagnosis, approximately one-third of patients in the U.S. suffer from tumors that have spread to the regional lymph nodes at diagnosis according to the Surveillance, Epidemiology and End Results (SEER) database [8]. "
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    ABSTRACT: Conventional axillary lymph node dissection (ALND) has recently become less radical. The treatment morbidity effects of reduced ALND aggressiveness are unknown. This article investigates the prevalence of the main complications of ALND: lymphedema, range-of-motion restriction, and arm paresthesia and pain. This cross-sectional study included 200 women with invasive breast cancer who underwent breast-conserving surgery (82.5%, n = 165) or mastectomy (17.5%, n = 35) with ALND from 2007 to 2011. Arm perimetry was used to assess lymphedema, defined as a difference >2 cm in the upper arm circumference between the nonsurgical and surgical arms. Range-of-motion restriction was assessed by evaluating the degree of arm abduction. Paresthesia was measured in the inner and proximal arm regions. Arm pain was assessed by directly questioning the patients and defined as either present or absent. The average (+/-SD) time between ALND and morbidity evaluation was 35 +/- 18 months (range, 7-60 months). The average dissected lymph node number per patient was 14 +/- 4 (range, 6-30 lymph nodes). Only 3.5% (n = 7) of the patients presented with lymphedema. Single-incision approaches to breast tumor and ALND (P = 0.04) and the presence of a postoperative seroma (P = 0.02) were associated with lymphedema in univariate analysis. Paresthesia was the most frequent side effect observed (53% of patients, n = 106).This complication was associated with increased age (P < 0.0001) and a larger dissected lymph node number (P = 0.01) in univariate and multivariate analysis. Additionally, 24% (n = 48) of patients had noticeable limited arm abduction. Among the patients, 27.5% (n = 55) experienced sporadic arm pain corresponding to the surgically treated armpit. In multivariate analysis, the pain risk was 1.9-fold higher in patients who underwent ALND corresponding to their dominant arm (95% CI, 1.0-3.7, P = 0.04). Conventional ALND in breast cancer patients can result in unwanted complications. However, the current lymphedema prevalence is lower than that of the other analyzed side effects.
    Full-text · Article · Mar 2014 · World Journal of Surgical Oncology
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