Sentinel-lymph-node biopsy in patients with breast cancer before and after neoadjuvant chemotherapy (SENTINA): a prospective, multicentre cohort study
TL;DR: Sentinel-lymph-node biopsy is a reliable diagnostic method before neoadjuvant chemotherapy and after systemic treatment or early sentinel-allymph- node biopsy, the procedure has a lower detection rate and a higher false-negative rate compared with sentinel
Abstract: Summary Background The optimum timing of sentinel-lymph-node biopsy for breast cancer patients treated with neoadjuvant chemotherapy is uncertain. The SENTINA (SENTinel NeoAdjuvant) study was designed to evaluate a specific algorithm for timing of a standardised sentinel-lymph-node biopsy procedure in patients who undergo neoadjuvant chemotherapy. Methods SENTINA is a four-arm, prospective, multicentre cohort study undertaken at 103 institutions in Germany and Austria. Women with breast cancer who were scheduled for neoadjuvant chemotherapy were enrolled into the study. Patients with clinically node-negative disease (cN0) underwent sentinel-lymph-node biopsy before neoadjuvant chemotherapy (arm A). If the sentinel node was positive (pN1), a second sentinel-lymph-node biopsy procedure was done after neoadjuvant chemotherapy (arm B). Women with clinically node-positive disease (cN+) received neoadjuvant chemotherapy. Those who converted to clinically node-negative disease after chemotherapy (ycN0; arm C) were treated with sentinel-lymph-node biopsy and axillary dissection. Only patients whose clinical nodal status remained positive (ycN1) underwent axillary dissection without sentinel-lymph-node biopsy (arm D). The primary endpoint was accuracy (false-negative rate) of sentinel-lymph-node biopsy after neoadjuvant chemotherapy for patients who converted from cN1 to ycN0 disease during neoadjuvant chemotherapy (arm C). Secondary endpoints included comparison of the detection rate of sentinel-lymph-node biopsy before and after neoadjuvant chemotherapy, and also the false-negative rate and detection rate of sentinel-lymph-node biopsy after removal of the sentinel lymph node. Analyses were done according to treatment received (per protocol). Findings Of 1737 patients who received treatment, 1022 women underwent sentinel-lymph-node biopsy before neoadjuvant chemotherapy (arms A and B), with a detection rate of 99·1% (95% CI 98·3–99·6; 1013 of 1022). In patients who converted after neoadjuvant chemotherapy from cN+ to ycN0 (arm C), the detection rate was 80·1% (95% CI 76·6–83·2; 474 of 592) and false-negative rate was 14·2% (95% CI 9·9–19·4; 32 of 226). The false-negative rate was 24·3% (17 of 70) for women who had one node removed and 18·5% (10 of 54) for those who had two sentinel nodes removed (arm C). In patients who had a second sentinel-lymph-node biopsy procedure after neoadjuvant chemotherapy (arm B), the detection rate was 60·8% (95% CI 55·6–65·9; 219 of 360) and the false-negative rate was 51·6% (95% CI 38·7–64·2; 33 of 64). Interpretation Sentinel-lymph-node biopsy is a reliable diagnostic method before neoadjuvant chemotherapy. After systemic treatment or early sentinel-lymph-node biopsy, the procedure has a lower detection rate and a higher false-negative rate compared with sentinel-lymph-node biopsy done before neoadjuvant chemotherapy. These limitations should be considered if biopsy is planned after neoadjuvant chemotherapy. Funding Brustkrebs Deutschland, German Society for Senology, German Breast Group.
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TL;DR: This work presents the results of a meta-analysis conducted at the 2016 European Oncology and Radiotherapy Guidelines Working Group (ESMO) workshop on breast cancer diagnosis and prognosis of women with atypical central giant cell granuloma (CGM) who have previously had surgery.
2,274 citations
University of Alabama at Birmingham1, University of South Florida2, Vanderbilt University3, City of Hope National Medical Center4, Fox Chase Cancer Center5, University Of Tennessee System6, Brigham and Women's Hospital7, Seattle Cancer Care Alliance8, Case Western Reserve University9, Roswell Park Cancer Institute10, Northwestern University11, Harvard University12, University of Nebraska Medical Center13, University of Utah14, Memorial Sloan Kettering Cancer Center15
TL;DR: This manuscript focuses on the NCCN Guidelines Panel recommendations for the workup, primary treatment, risk reduction strategies, and surveillance specific to DCIS.
Abstract: Ductal carcinoma in situ (DCIS) of the breast represents a heterogeneous group of neoplastic lesions in the breast ducts. The goal for management of DCIS is to prevent the development of invasive breast cancer. This manuscript focuses on the NCCN Guidelines Panel recommendations for the workup, primary treatment, risk reduction strategies, and surveillance specific to DCIS.
1,545 citations
TL;DR: The 14th St Gallen International Breast Cancer Conference (2015) reviewed new evidence on locoregional and systemic therapies for early breast cancer and summarizes treatment-oriented classification of subgroups and treatment recommendations.
1,457 citations
Cites background from "Sentinel-lymph-node biopsy in patie..."
...Sentinel node biopsy is feasible and accurate after neoadjuvant chemotherapy and allows precise assessment of pCR[92-95]....
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TL;DR: This guideline update reflects changes in practice since the 2005 guideline and recommends women without sentinel lymph node (SLN) metastases should not receive axillary lymph node dissection (ALND).
Abstract: Purpose To provide evidence-based recommendations to practicing oncologists, surgeons, and radiation therapy clinicians to update the 2005 clinical practice guideline on the use of sentinel node biopsy (SNB) for patients with early-stage breast cancer. Methods The American Society of Clinical Oncology convened an Update Committee of experts in medical oncology, pathology, radiation oncology, surgical oncology, guideline implementation, and advocacy. A systematic review of the literature was conducted from February 2004 to January 2013 in Medline. Guideline recommendations were based on the review of the evidence by Update Committee. Results This guideline update reflects changes in practice since the 2005 guideline. Nine randomized clinical trials (RCTs) met systematic review criteria for clinical questions 1 and 2; 13 cohort studies informed clinical question 3. Recommendations Women without sentinel lymph node (SLN) metastases should not receive axillary lymph node dissection (ALND). Women with one to t...
806 citations
Harvard University1, Medical University of Vienna2, Institut Jules Bordet3, University of St. Gallen4, Kantonsspital St. Gallen5, Institut Gustave Roussy6, Memorial Sloan Kettering Cancer Center7, Karolinska Institutet8, University of Bordeaux9, University of North Carolina at Chapel Hill10, Queen Mary University of London11, Charité12, Marmara University13, Mount Sinai Hospital, Toronto14, Ludwig Maximilian University of Munich15, University of Michigan16, National Taiwan University17, University of Ulm18, National Institutes of Health19, Gdańsk Medical University20, Sahlgrenska University Hospital21, Baylor College of Medicine22, University of Toronto23, Netherlands Cancer Institute24, Paracelsus Private Medical University of Salzburg25, Fudan University26, The Royal Marsden NHS Foundation Trust27, Kyoto University28, Institute of Cancer Research29, University of Milan30, McMaster University31
TL;DR: The 15th St. Gallen International Breast Cancer Conference 2017 in Vienna, Austria reviewed substantial new evidence on loco-regional and systemic therapies for early breast cancer, and recommended bisphosphonate use in postmenopausal women to prevent breast cancer recurrence.
777 citations
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01 Jan 1987
TL;DR: Head and Neck Tumours.- Lip and Oral Cavity.- Pharynx.- Larynx.' Maxillary Sinus.- Salivary Glands.- Thyroid Gland.- Digestive System Tumour .
Abstract: Head and Neck Tumours.- Lip and Oral Cavity.- Pharynx.- Larynx.- Maxillary Sinus.- Salivary Glands.- Thyroid Gland.- Digestive System Tumours.- Oesophagus.- Stomach.- Colon and Rectum.- Anal Canal.- Liver.- Gall Bladder.- Extrahepatic Bile Ducts.- Ampulla of Vater.- Pancreas.- Lung Tumours.- Tumours of Bone and Soft Tissues.- Bone.- Soft Tissue.- Skin Tumours.- Carcinoma of Skin.- Melanoma of Skin.- Breast Tumours.- Gynaecological Tumours.- Cervix Uteri.- Corpus Uteri.- Ovary.- Vagina.- Vulva.- Urological Tumours.- Prostate.- Testis.- Penis.- Urinary Bladder.- Kidney.- Renal Pelvis and Ureter.- Urethra.- Ophthalmic Tumours.- Carcinoma of Eyelid.- Malignant Melanoma of Eyelid.- Carcinoma of Conjunctiva.- Malignant Melanoma of Conjunctiva.- Malignant Melanoma of Uvea.- Retinoblastoma.- Sarcoma of Orbit.- Carcinoma of Lacrimal Gland.- Brain Tumours.- Hodgkin's Disease.- Non-Hodgkin's Lymphoma.- Paediatric Tumours.- Nephroblastoma (Wilms' Tumour).- Neuroblastoma.- Soft Tissue Sarcomas - Paediatric.
15,624 citations
TL;DR: A review of the available evidence demonstrates that, when performed by experienced clinicians, SNB appears to be a safe and acceptably accurate method for identifying early-stage breast cancer without involvement of the axillary lymph nodes.
Abstract: Purpose To develop a guideline for the use of sentinel node biopsy (SNB) in early stage breast cancer.
1,736 citations
TL;DR: Preoperative therapy reduced the size of most breast tumors and decreased the incidence of positive nodes in women with primary breast cancer and should be considered for the initial management of breast tumors judged too large for lumpectomy.
Abstract: PURPOSETo determine whether preoperative doxorubicin and cyclophosphamide (AC) permits more lumpectomies to be performed and decreases the incidence of positive nodes in women with primary breast cancer.PATIENTS AND METHODSWomen (n = 1,523) were randomized to National Surgical Adjuvant Breast and Bowel Project (NSABP) B-18; 759 eligible patients received postoperative AC and 747, preoperative AC. The clinical size of breast and axillary tumors was determined before each of four cycles of AC and before surgery. Tumor response to preoperative therapy was clinically complete (cCR), partial (cPR), stable (cSD), or progressive disease (cPD). Tissue from patients with a cCR was evaluated for a pathologic complete response (pCR).RESULTSBreast tumor size was reduced in 80% of patients after preoperative therapy; 36% had a cCR. Tumor size and clinical nodal status were independent predictors of cCR. Twenty-six percent of women with a cCR had a pCR. Clinical nodal response occurred in 89% of node-positive patients:...
1,677 citations
TL;DR: Overall survival, disease-free survival, and regional control were statistically equivalent between groups, and outcome analyses were done in patients who were assessed as having pathologically negative sentinel nodes and for whom follow-up data were available.
Abstract: Summary Background Sentinel-lymph-node (SLN) surgery was designed to minimise the side-effects of lymph-node surgery but still offer outcomes equivalent to axillary-lymph-node dissection (ALND). The aims of National Surgical Adjuvant Breast and Bowel Project (NSABP) trial B-32 were to establish whether SLN resection in patients with breast cancer achieves the same survival and regional control as ALND, but with fewer side-effects. Methods NSABP B-32 was a randomised controlled phase 3 trial done at 80 centres in Canada and the USA between May 1, 1999, and Feb 29, 2004. Women with invasive breast cancer were randomly assigned to either SLN resection plus ALND (group 1) or to SLN resection alone with ALND only if the SLNs were positive (group 2). Random assignment was done at the NSABP Biostatistical Center (Pittsburgh, PA, USA) with a biased coin minimisation approach in an allocation ratio of 1:1. Stratification variables were age at entry (≤49 years, ≥50 years), clinical tumour size (≤2·0 cm, 2·1–4·0 cm, ≥4·1 cm), and surgical plan (lumpectomy, mastectomy). SLN resection was done with a blue dye and radioactive tracer. Outcome analyses were done in patients who were assessed as having pathologically negative sentinel nodes and for whom follow-up data were available. The primary endpoint was overall survival. Analyses were done on an intention-to-treat basis. All deaths, irrespective of cause, were included. The mean time on study for the SLN-negative patients with follow-up information was 95·6 months (range 70·1–126·7). This study is registered with ClinicalTrials.gov, number NCT00003830. Findings 5611 women were randomly assigned to the treatment groups, 3989 had pathologically negative SLN. 309 deaths were reported in the 3986 SLN-negative patients with follow-up information: 140 of 1975 patients in group 1 and 169 of 2011 in group 2. Log-rank comparison of overall survival in groups 1 and 2 yielded an unadjusted hazard ratio (HR) of 1·20 (95% CI 0·96–1·50; p=0·12). 8-year Kaplan-Meier estimates for overall survival were 91·8% (95% CI 90·4–93·3) in group 1 and 90·3% (88·8–91·8) in group 2. Treatment comparisons for disease-free survival yielded an unadjusted HR of 1·05 (95% CI 0·90–1·22; p=0·54). 8-year Kaplan-Meier estimates for disease-free survival were 82·4% (80·5–84·4) in group 1 and 81·5% (79·6–83·4) in group 2. There were eight regional-node recurrences as first events in group 1 and 14 in group 2 (p=0·22). Patients are continuing follow-up for longer-term assessment of survival and regional control. The most common adverse events were allergic reactions, mostly related to the administration of the blue dye. Interpretation Overall survival, disease-free survival, and regional control were statistically equivalent between groups. When the SLN is negative, SLN surgery alone with no further ALND is an appropriate, safe, and effective therapy for breast cancer patients with clinically negative lymph nodes. Funding US Public Health Service, National Cancer Institute, and Department of Health and Human Services.
1,440 citations
TL;DR: Despite the potential for residual axillary disease after SLND, SLND without ALND can offer excellent regional control and may be reasonable management for selected patients with early-stage breast cancer treated with breast-conserving therapy and adjuvant systemic therapy.
Abstract: Background and Objective:Sentinel lymph node dissection (SLND) has eliminated the need for axillary dissection (ALND) in patients whose sentinel node (SN) is tumor-free. However, completion ALND for patients with tumor-involved SNs remains the standard to achieve locoregional control. Few studies ha
1,128 citations