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"Berclaz, Gilles"
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Tomosynthesis-guided vacuum-assisted breast biopsy: A feasibility study
Purpose
Evaluation of feasibility and clinical performance of a tomosynthesis-guided vacuum-assisted breast biopsy (TVAB) system compared to Stereotaxy (SVAB).
Materials and methods
All biopsies were performed on consecutive patients: 148 TVAB biopsies and 86 biopsies on different patients using SVAB. Evaluation criteria for each biopsy were technical feasibility, histopathology, procedure time, and complications.
Results
All 148 TVAB biopsies were technically successful, and gained the targeted groups of microcalcifications (100 %). In 1 of 86 SVAB procedures, it was not possible to gain the targeted microcalcifications (1 %), in 3 of 86 the needle had to be adjusted (4 %). All TVAB biopsies were performed without clinically relevant complications. Distortions were biopsied exclusively by TVAB, mean size 0.9 cm,
p
< 0.0001. Of the 24 distortions, 13 were cancer, 11 Radial Scars/ CSL. The mean procedure time for TVAB was 15.4 minutes (range 7–28 min), for SVAB 23 minutes (range 11–46 min),
p
< 0.0001.
Conclusions
TVAB is able to biopsy small architectural distortions with high accuracy. TVAB is easily feasible and appears to have the same degree of clinical performance for diagnosing microcalcifications. The increased number of biopsied distortions by TVAB is presumably due to increased use of tomosynthesis and its diagnostic potential.
Key points
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TVAB is easily feasible
.
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TVAB is able to target architectural distortions with high accuracy
.
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TVAB diagnoses microcalcifications with the same clinical performance as SVAB
.
Journal Article
Accuracy of frozen section of sentinel lymph nodes: a prospective analysis of 659 breast cancer patients of the Swiss multicenter study
Objective To assess the accuracy of sentinel lymph node (SLN) frozen section in a prospective multicenter study of early-stage breast cancer patients. Summary background data The decision to perform an immediate completion axillary node dissection (ALND) is based on results of SLN frozen section. However, SLN frozen sections are not routinely performed in all centers. Moreover, the accuracy of SLN frozen section remains a matter of great debate. Methods Prospective multicenter trial analyzing 659 early stage breast cancer patients (pT1 and pT2 <= 3 cm, cN0) enrolled between January 2000 and December 2003. SLN were intraoperatively examined by frozen section. Final histopathology consisted in performing step sectioning as well as staining with H&E and immunohistochemistry. Results SLN were identified in 98.3% (648/659) of all patients. The accuracy of frozen section was 90.1% (584/648), the sensitivity for SLN macro-metastases 98% (142/145), and the specificity 100%. A total of 47 patients with SLN micro-metastases (n = 36) or isolated tumor cells (n = 11) underwent a delayed completion ALND. In 96% (45/47) of these patients the ALND specimens were free of macro-metastases. Conclusions SLN frozen section provides highly accurate information regarding identification of SLN macro-metastases, a delayed completion ALND can be avoided in 98% of these patients. More importantly, in the present investigation the vast majority (96%) of patients with SLN micro-metastases or isolated tumor cells undergoing delayed completion ALND did not benefit from the second operation as ALND specimens were free of macro-metastases. We strongly recommend the routine use of SLN frozen section in early stage breast cancer patients.
Journal Article
Axillary dissection versus no axillary dissection in patients with breast cancer and sentinel-node micrometastases (IBCSG 23-01): 10-year follow-up of a randomised, controlled phase 3 trial
We previously reported the 5-year results of the phase 3 IBCSG 23-01 trial comparing disease-free survival in patients with breast cancer with one or more micrometastatic (≤2 mm) sentinel nodes randomly assigned to either axillary dissection or no axillary dissection. The results showed no difference in disease-free survival between the groups and showed non-inferiority of no axillary dissection relative to axillary dissection. The current analysis presents the results of the study after a median follow-up of 9·7 years (IQR 7·8–12·7).
In this multicentre, randomised, controlled, open-label, non-inferiority, phase 3 trial, participants were recruited from 27 hospitals and cancer centres in nine countries. Eligible women could be of any age with clinical, mammographic, ultrasonographic, or pathological diagnosis of breast cancer with largest lesion diameter of 5 cm or smaller, and one or more metastatic sentinel nodes, all of which were 2 mm or smaller and with no extracapsular extension. Patients were randomly assigned (1:1) before surgery (mastectomy or breast-conserving surgery) to no axillary dissection or axillary dissection using permuted blocks generated by a web-based congruence algorithm, with stratification by centre and menopausal status. The protocol-specified primary endpoint was disease-free survival, analysed in the intention-to-treat population (as randomly assigned). Safety was assessed in all randomly assigned patients who received their allocated treatment (as treated). We did a one-sided test for non-inferiority of no axillary dissection by comparing the observed hazard ratios (HRs) for disease-free survival with a margin of 1·25. This 10-year follow-up analysis was not prespecified in the trial's protocol and thus was not adjusted for multiple, sequential testing. This trial is registered with ClinicalTrials.gov, number NCT00072293.
Between April 1, 2001, and Feb 8, 2010, 6681 patients were screened and 934 randomly assigned to no axillary dissection (n=469) or axillary dissection (n=465). Three patients were ineligible and were excluded from the trial after randomisation. Disease-free survival at 10 years was 76·8% (95% CI 72·5–81·0) in the no axillary dissection group, compared with 74·9% (70·5–79·3) in the axillary dissection group (HR 0·85, 95% CI 0·65–1·11; log-rank p=0·24; p=0·0024 for non-inferiority). Long-term surgical complications included lymphoedema of any grade in 16 (4%) of 453 patients in the no axillary dissection group and 60 (13%) of 447 in the axillary dissection group, sensory neuropathy of any grade in 57 (13%) in the no axillary dissection group versus 85 (19%) in the axillary dissection group, and motor neuropathy of any grade (14 [3%] in the no axillary dissection group vs 40 [9%] in the axillary dissection group). One serious adverse event (postoperative infection and inflamed axilla requiring hospital admission) was attributed to axillary dissection; the event resolved without sequelae.
The findings of the IBCSG 23-01 trial after a median follow-up of 9·7 years (IQR 7·8–12·7) corroborate those obtained at 5 years and are consistent with those of the 10-year follow-up analysis of the Z0011 trial. Together, these findings support the current practice of not doing an axillary dissection when the tumour burden in the sentinel nodes is minimal or moderate in patients with early breast cancer.
International Breast Cancer Study Group.
Journal Article
Association of the Presence of Bone Marrow Micrometastases with the Sentinel Lymph Node Status in 410 Early Stage Breast Cancer Patients: Results of the Swiss Multicenter Study
The sentinel lymph node (SLN) status has proven to accurately reflect the remaining axillary lymph nodes and represents the most important prognostic factor. It is unknown whether an association exists between the SLN status and the presence of bone marrow (BM) micrometastases. The objective of the present investigation was to evaluate whether or not such an association exists.
In the present investigation 410 patients with early stage breast cancer (pT1 and pT2
Journal Article
Trends in use of neoadjuvant systemic therapy in patients with clinically node-positive breast cancer in Europe: prospective TAXIS study (OPBC-03, SAKK 23/16, IBCSG 57-18, ABCSG-53, GBG 101)
PurposeThe aim of this study was to evaluate clinical practice heterogeneity in use of neoadjuvant systemic therapy (NST) for patients with clinically node-positive breast cancer in Europe.MethodsThe study was preplanned in the international multicenter phase-III OPBC-03/TAXIS trial (ClinicalTrials.gov Identifier: NCT03513614) to include the first 500 randomized patients with confirmed nodal disease at the time of surgery. The TAXIS study’s pragmatic design allowed both the neoadjuvant and adjuvant setting according to the preferences of the local investigators who were encouraged to register eligible patients consecutively.ResultsA total of 500 patients were included at 44 breast centers in six European countries from August 2018 to June 2022, 165 (33%) of whom underwent NST. Median age was 57 years (interquartile range [IQR], 48–69). Most patients were postmenopausal (68.4%) with grade 2 and 3 hormonal receptor-positive and human epidermal growth factor receptor 2-negative breast cancer with a median tumor size of 28 mm (IQR 20–40). The use of NST varied significantly across the countries (p < 0.001). Austria (55.2%) and Switzerland (35.8%) had the highest percentage of patients undergoing NST and Hungary (18.2%) the lowest. The administration of NST increased significantly over the years (OR 1.42; p < 0.001) and more than doubled from 20 to 46.7% between 2018 and 2022.ConclusionSubstantial heterogeneity in the use of NST with HR+/HER2-breast cancer exists in Europe. While stringent guidelines are available for its use in triple-negative and HER2+ breast cancer, there is a need for the development of and adherence to well-defined recommendations for HR+/HER2-breast cancer.
Journal Article
Impact of a Surgical Sealing Patch on Lymphatic Drainage After Axillary Dissection for Breast Cancer: The SAKK 23/13 Multicenter Randomized Phase III Trial
BackgroundSeveral studies and a meta-analysis showed that fibrin sealant patches reduced lymphatic drainage after various lymphadenectomy procedures. Our goal was to investigate the impact of these patches on drainage after axillary dissection for breast cancer.MethodsIn a phase III superiority trial, we randomized patients undergoing breast-conserving surgery at 14 Swiss sites to receive versus not receive three large TachoSil® patches in the dissected axilla. Axillary drains were inserted in all patients. Patients and investigators assessing outcomes were blinded to group assignment. The primary endpoint was total volume of drainage.ResultsBetween March 2015 and December 2016, 142 patients were randomized (72 with TachoSil® and 70 without). Mean total volume of drainage in the control group was 703 ml [95% confidence interval (CI) 512–895 ml]. Application of TachoSil® did not significantly reduce the total volume of axillary drainage [mean difference (MD) −110 ml, 95% CI −316 to 94, p = 0.30]. A total of eight secondary endpoints related to drainage, morbidity, and quality of life were not improved by use of TachoSil®. The mean total cost per patient did not differ significantly between the groups [34,253 Swiss Francs (95% CI 32,625–35,880) with TachoSil® and 33,365 Swiss Francs (95% CI 31,771–34,961) without, p = 0.584]. In the TachoSil® group, length of stay was longer (MD 1 day, 95% CI 0.3–1.7, p = 0.009), and improvement of pain was faster, although the latter difference was not significant [2 days (95% CI 1–4) vs. 5.5 days (95% CI 2–11); p = 0.2].ConclusionsTachoSil® reduced drainage after axillary dissection for breast cancer neither significantly nor relevantly.
Journal Article
Bone Marrow Micrometastases Do Not Impact Disease-Free and Overall Survival in Early Stage Sentinel Lymph Node–Negative Breast Cancer Patients
Background
The presence of lymph node metastases is the most important prognostic factor in early stage breast cancer. Whether bone marrow micrometastases (BMM) impact the prognosis in sentinel lymph node (SLN)–negative breast cancer patients remains a matter of debate. Therefore, the objective of this study was to assess the impact of BMM on 5-year disease-free and overall survival among those patients.
Methods
We analyzed 410 patients with early stage breast cancer (pT1 and pT2 ≤ 3 cm, cN0) who were prospectively enrolled into the Swiss Multicenter Sentinel Lymph Node Study in Breast Cancer between January 2000 and December 2003. All patients underwent bone marrow aspiration followed by SLN biopsy. All SLN were stained with hematoxylin and eosin and immunohistochemistry (Lu-5, CK-22). Cancer cells in the bone marrow were identified after staining with monoclonal antibodies A45-B/B3 against CK-8, -18, and -19.
Results
Negative SLN were found in 67.6 % (277 of 410) of the enrolled patients. Of those, BMM status was negative in 75.8 % (210 of 277) and positive in 24.2 % (67 of 277) patients. Median follow-up was 61 (range 11–96) months. Five-year disease-free survival was 93.6 % (95 % confidence interval [CI] 89.1–96.0) in BMM-negative and 92.2 % (95 % CI 82.5–96.2) in BMM-positive patients (
p
= 0.50). Five-year overall survival was 92.7 % (95 % CI 87.9–95.8) for the BMM-negative and 92.5 % (95 % CI 83.4–96.2) for the BMM-positive group (
p
= 0.85).
Conclusions
This is one of the first prospective studies to examine 5-year disease-free and overall survivals in SLN-negative patients in correlation to their BMM status. Although BMM are identified in one of four SLN-negative patients, they do not impact disease-free and overall survival.
Journal Article
Can the Addition of Regional Radiotherapy Counterbalance Important Risk Factors in Breast Cancer Patients with Extracapsular Invasion of Axillary Lymph- Node Metastases?
To evaluate if locoregional radiotherapy (RT) versus local irradiation only can alter the pattern of failure in breast cancer patients with extranodal invasion.
From 08/1988 to 06/1998, 81 patients with extranodal invasion were treated with adjuvant RT (median total dose: 50.4 Gy), 46/81 only locally, 35/81 loco regionally due to presumed adverse parameters. The mean number of resected (positive) lymph nodes was 17 (seven). 78 patients received adjuvant systemic treatment(s).
Patients treated with locoregional RT had significantly more often lymphatic vessel invasion (LVI; 63% vs. 28%; p = 0.003), T3/T4 tumors (43% vs. 17%; p = 0.014), and four or more positive lymph nodes (91% vs. 46%; p < 0.001) than patients irradiated only locally. Disease progression occurred in 24/81 patients (locoregional RT: 26% vs. local RT: 33%). The above risk factors were highly significant of worse outcome. Despite their overrepresentation in the locoregional RT group, no difference was found between both groups in regard to disease-free survival (DFS; p = 0.83) and overall survival (OS; p = 0.56), suggesting that regional RT was able to counterbalance the increased risk. There was even a trend toward a better 3-year DFS, 61% in locoregional RT and 37% in local RT, in the subgroup of patients with four or more positive lymph nodes. In a Cox regression model, higher T-stage, four or more positive lymph nodes, and LVI remained significant. For DFS and distant metastasis-free survival (DMFS), the absence of estrogen receptors and the omission of regional RT were also significant.
Our data suggest that the addition of regional RT might be beneficial in selected subgroups of patients with extranodal invasion and other poor prognostic factors.
Journal Article
Sites of Failure in Breast Cancer Patients with Extracapsular Invasion of Axillary Lymph Node Metastases
Extracapsular spread (ECS) is frequent, but the specific sites of relapse are seldom given in the literature. In this study it was evaluated, if ECS might be an indicator for axillary irradiation.
After a retrospective review of pathology reports, the information about ECS was available in 254 lymph node-positive patients: ECS was absent in 34% (ECS-negative; n = 87) and present in 66% (ECS-positive; n = 167). All patients were irradiated locally, 78 patients got periclavicular and 74 axillary irradiation (median total dose: 50.4 Gy). 240/254 patients (94.5%) received systemic treatment/s. Mean follow-up was 46 months.
The regional relapse rate was 4.6% without ECS versus 9.6% with ECS. The 5-year axillary relapse-free survival was 100% in ECS-negative and 90% in ECS-positive patients (p = 0.01), whereas corresponding values for periclavicular relapse-free survival (with ECS: 91% +/- 4%; without ECS: 94% +/- 3%; p = 0.77) and local relapse-free survival (with ECS: 86% +/- 4%; without ECS: 91% +/- 3%; p = 0.69) were not significantly different. chi(2)-tests revealed a high correlation of ECS with T-stage, number of positive lymph nodes and progesterone receptor status, comparisons with estrogen receptor, grade, or age were not significant. In multivariate analysis number of positive lymph nodes was solely significant for regional failure. Dividing the patients into those with one to three and those with four or more positive lymph nodes, ECS lost its significance for axillary failure.
ECS was accompanied by an enhanced axillary failure rate in univariate analysis, which was no longer true after adjusting for the number of positive lymph nodes.
Journal Article