Lymph Node Radiotherapy Instead of Extended Axillary Surgery - the New Standard?
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ABSTRACT:
SUBMITTER: Niehoff P
PROVIDER: S-EPMC6062724 | biostudies-literature | 2018 Jul
REPOSITORIES: biostudies-literature
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Lymph Node Radiotherapy Instead of Extended Axillary Surgery - the New Standard?
Niehoff Peter P Hey-Koch Silla S
Breast care (Basel, Switzerland) 20180606 3
Breast cancer treatment has undergone major changes in the last 20 years. Specifically, the role of axillary lymph node dissection has changed from radical axillary dissection with excision of a high number of lymph nodes to sentinel lymph node biopsy (SLNB). This paradigm shift is associated with a controversial debate regarding the significance of axillary staging, the need for surgery, and the role of radiotherapy. Looking ahead, lymph node staging and axillary treatment might shift from SLNB ...[more]
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Project description:Clinical trials evaluating the benefit of pelvic radiotherapy (PRT) in the radiotherapeutic management of patients with higher-risk prostate cancer have limited the superior field border to the S1/S2 or L5/S1 interspace. However, imaging and surgical series have demonstrated a high frequency of prostatic lymph node (LN) drainage beyond these landmarks.To determine the patterns of radiographically defined abdominopelvic LN failures and their potential implications for PRT field design.During 1992-2008, 2694 patients with localized prostate cancer were treated with prostate/seminal vesicle-only radiotherapy without PRT. Some 156 patients had their first failure within the abdominopelvic LNs, of whom 60 had isolated failures within the pelvic LNs.A radiologist reviewed all imaging and mapped each LN failure to a template consisting of 34 abdominopelvic LN stations.The median follow-up was 8.9 yr. Of patients who experienced first recurrence in the pelvic LNs (n=60), the common iliac station was involved in 55% (n=33) of patients, including 10% (n=6) who had isolated common iliac failures. Use of a PRT field superior border of L5/S1 would fully cover only 42% of the first recurrences among these patients. Extending the field to cover the common iliac stations would increase coverage to 93% of recurrences. The presence of T3/T4 disease and omission of androgen-deprivation therapy both independently conferred an approximate fivefold increase in the likelihood of having a common iliac LN failure. Use of imaging as a surrogate for LN involvement is the primary study limitation.Pelvic LN failures frequently occur superior to the commonly used L5/S1 landmark for PRT coverage, and use of ADT may be protective of more superior LN failures. The current RTOG 0924 trial is evaluating the benefit of PRT with extended superior coverage to L4/5 when possible, which, according to our data, should significantly improve the coverage of potential sites of failure.We looked at lymph node recurrence patterns after external beam radiotherapy of the prostate in men who did not have their lymph nodes treated. We found that there was a high incidence of pelvic lymph node recurrences above the internal and external iliac lymph node regions. Therefore, the current field recommendation for pelvic lymph nodes that stops at the superior border of the internal and external iliac vessels provides inadequate coverage of common sites of cancer recurrence, namely the common iliac lymph nodes.
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Project description:BACKGROUND:Complete lymph node removal through conventional axillary dissection (ALND) has been standard treatment for breast cancer patients for almost a century. In the 1990s, however, and in parallel with the advent of the sentinel lymph node (SLN) procedure, ALND came under increasing scrutiny due to its association with significant patient morbidity. Several studies have since provided evidence to suggest omission of ALND, often in favor of axillary radiation, in selected clinically node-negative, SLN-positive patients, thus supporting the current trend in clinical practice. Clinically node-positive patients, by contrast, continue to undergo ALND in many cases, if only for the lack of studies re-assessing the indication for ALND in these patients. Hence, there is a need for a clinical trial to evaluate the optimal treatment for clinically node-positive breast cancer patients in terms of surgery and radiotherapy. The TAXIS trial is designed to fill this gap by examining in particular the value of tailored axillary surgery (TAS), a new technique for selectively removing positive lymph nodes. METHODS:In this international, multicenter, phase-III, non-inferiority, randomized controlled trial (RCT), including 34 study sites from four different countries, we plan to randomize 1500 patients to either receive TAS followed by ALND and regional nodal irradiation excluding the dissected axilla, or receive TAS followed by regional nodal irradiation including the full axilla. All patients undergo adjuvant whole-breast irradiation after breast-conserving surgery and chest-wall irradiation after mastectomy. The main objective of the trial is to test the hypothesis that treatment with TAS and axillary radiotherapy is non-inferior to ALND in terms of disease-free survival of clinically node-positive breast cancer patients in the era of effective systemic therapy and extended regional nodal irradiation. The trial was activated on 31 July 2018 and the first patient was randomized on 7 August 2018. DISCUSSION:Designed to test the hypothesis that TAS is non-inferior to ALND in terms of curing patients and preventing recurrences, yet is significantly superior in reducing patient morbidity, this trial may establish a new worldwide treatment standard in breast cancer surgery. If found to be non-inferior to standard treatment, TAS may significantly contribute to reduce morbidity in breast cancer patients by avoiding surgical overtreatment. TRIAL REGISTRATION:ClinicalTrials.gov, ID: NCT03513614. Registered on 1 May 2018. www.kofam.ch , ID: NCT03513614 . Registered on 17 June 2018. EudraCT No.: 2018-000372-14.
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Project description:BackgroundBreast magnetic resonance (MR) imaging does not usually assess axillary lymph nodes -using dedicated axillary sequence. The additional utility of dedicated axillary sequence is poorly understood. We evaluated the diagnostic performance of dedicated axillary imaging sequence for evaluation of axillary lymph node.MethodsIn this retrospective study from January 2018 to March 2018, 750 consecutive women underwent breast MR imaging. 263 patients were excluded, due to neoadjuvant chemotherapy (n = 235), incomplete histopathological information (n = 14) and follow-up loss (n = 14), 487 women were included. Two radiologists scored lymph node on confidence level scale from 0 (definitely benign) to 4 (definitely malignant), -using standard MR and dedicated axillary imaging sequences. Diagnostic performance parameters were compared and calculated correlation coefficient of quantitative features (largest dimension, cortical thickness, and the ratio of cortical thickness to largest dimension of lymph node).Results68 (14.0%) were node-positive and 419 (86.0%) were node-negative. The sensitivity, specificity, positive, negative predictive values and accuracy were respectively, 66.2, 93.3, 61.6, 94.4, and 89.5% for dedicated axillary sequence and 64.7, 94.0, 63.8, 94.3, 89.9% for standard MR sequence The dedicated axillary and standard sequences s did not exhibit significant differences in detection of positive lymph nodes (AUC, 0.794 for standard and 0.798 for dedicated axillary sequence, P = 0.825). The cortical thickness appeared to be the most discriminative quantitative measurement using both axillary (AUC, 0.846) and standard sequences (AUC, 0.823), with high correlation coefficient (0.947).ConclusionEvaluation of axillary nodal status using standard breast MR imaging is comparable to dedicated axillary MR imaging.
| S-EPMC7195753 | biostudies-literature
Project description:Purpose: Mediastinal and hilar lymph node metastasis is one of the recurrence patterns after definitive treatment of lung cancer. Salvage radiotherapy (RT) can be a treatment option for lymph node metastasis. However, the usefulness of additional RT remains unclear after surgery or RT for the primary lung tumor. We retrospectively evaluated the efficacy and safety of hypofractionated carbon-ion RT for isolated lymph node metastasis. Methods and Materials: Between April 2013 and August 2016, 15 consecutive patients with isolated lymph node metastasis underwent carbon-ion RT. The pretreatment evaluations confirmed the isolated lymph node metastasis and the absence of local recurrence or distant metastasis, which was oligometastatic disease. The median age was 72 (range, 51-83) years, with 11 male patients. The first treatments for primary lung tumors were carbon-ion RT for 8 patients and surgery for 7 patients. There were 9 adenocarcinomas, 4 squamous cell carcinomas, 1 adenosquamous cell carcinoma, and 1 mucoepidermoid carcinoma. Most patients (93%) were irradiated with 52.8 Gy relative biological effectiveness in 12 fractions for 3 weeks. There were no patients treated with concurrent or adjuvant therapy such as chemotherapy, molecular-targeted therapy, or immunotherapy. Adverse events were evaluated according to the Common Terminology Criteria for Adverse Events (version 4.0). Results: The median follow-up for surviving patients was 28 months. One patient experienced local lymph node recurrence, and the 2-year local control rate was 92% for all patients. Distant metastasis was observed in 7 patients, and 2-year progression-free survival rate was 47%. During follow-up, there were 4 deaths from lung cancer, and the 2-year overall survival rate was 75%. There were 2 patients with acute grade 2 esophagitis and 2 with late grade 2 cough, which were improved by conservative therapy. There were no other grade 2 or higher adverse events. Conclusions: Hypofractionated carbon-ion RT showed excellent local control and overall survival without severe toxicities in lung cancer patients with isolated lymph node metastasis after surgery or carbon-ion RT for primary lung tumors. A multi-institutional prospective study is required to establish the efficacy and safety of carbon-ion RT.
| S-EPMC6692658 | biostudies-literature
Project description:BackgroundThis systematic review and meta-analysis aimed to study the evidence on the efficacy and safety of omitting axillary lymph node dissection (ALND) for patients with clinically node-negative but sentinel lymph node (SLN)-positive breast cancer using all the available evidence.MethodsThe Embase, Medline, and Cochrane Library databases were searched through February 25, 2023. Original trials that compared only the sentinel lymph node biopsy (SLNB) with ALND as the control group for patients with clinically node-negative but SLN-positive breast cancer were included. The primary outcomes were axillary recurrence rate, total recurrence rate, disease-free survival (DFS), and overall survival (OS). Meta-analyses were performed to compare the odds ratio (OR) in rates and the hazard ratios (HR) in time-to-event outcomes between both interventions. Based on different study designs, tools in the revised Cochrane risk of bias tool were used for randomized trials and the risk of bias in nonrandomized studies of interventions to assess the risk of bias for each included article. Funnel plots and Egger's test were used for the publication's bias assessment.ResultsIn total, 30 reports from 26 studies were included in the systematic review (9 reports of RCTs, 21 reports of retrospective cohort studies). According to our analysis, omitting ALND in patients with clinically node-negative but SLN-positive breast cancer had a similar axillary recurrence rate (OR = 0.95, 95% confidence interval (CI): 0.76-1.20), DFS (HR = 1.02, 95% CI: 0.89-1.16), and OS (HR = 0.97, 95% CI: 0.92-1.03), but caused a significantly lower incidence of adverse events and benefited in locoregional recurrence rate (OR = 0.76, 95% CI: 0.59-0.97) compared with ALND.ConclusionFor patients with clinically node-negative but SLN-positive breast cancer (no matter the number of the positive SLN), this review showed that SLNB alone had a similar axillary recurrence rate, DFS, and OS, but caused a significantly lower incidence of adverse events and showed a benefit for the locoregional recurrence compared with ALND. An OS benefit was found in the Macro subset that used SLNB alone versus complete ALND. Therefore, omitting ALND is feasible in this setting.Trial registrationCRD 42023397963.
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Project description:IntroductionBreast cancer surgery currently focuses on de-escalating treatment without compromising patient survival. Axillary radiotherapy (ART) now replaces axillary lymph node dissection (ALND) in patients with limited sentinel lymph node (SLN) involvement during the primary surgery, and this has significantly reduced the incidence of lymphedema without worsening the prognosis. However, patients treated with neoadjuvant systemic treatment (NST) cannot benefit from this option despite the low incidence of residual disease in the armpit in most cases. Data regarding the use of radiotherapy instead of ALND in this population are lacking. This study will assess whether ART is non-inferior to ALND in terms of recurrence and overall survival in patients with positive SLN after NST, including whether it reduces surgery-related adverse effects.Methods and analysesThis multicenter, randomized, open-label, phase 3 trial will enroll 1660 patients with breast cancer and positive SLNs following NST in approximately 50 Spanish centers over 3 years. Patients will be stratified by NST regimen and nodal involvement (isolated tumoral cells or micrometastasis versus macrometastasis) and randomly assigned 1:1 to ART without ALND (study arm) or ALND alone (control arm). Level 3 and supraclavicular radiotherapy will be added in both arms. The primary outcome is the 5-year axillary recurrence determined by clinical and radiological examination. The secondary outcomes include lymphedema or arm dysfunction, quality of life based (EORTC QLQ-C30 and QLQ-BR23 questionnaires), disease-free survival, and overall survival.DiscussionThis study aims to provide data to confirm the efficacy and safety of ART over ALND in patients with a positive SLN after NST, together with the impact on morbidity.Ethics and disseminationThe Research Ethics Committee of Bellvitge University Hospital approved this trial (Protocol Record PR148/21, version 3, 1/2/2022) and all patients must provide written informed consent. The involvement of around 50 centers across Spain will facilitate the dissemination of our results.Trial registrationClinicalTrials.gov, identifier number NCT04889924.
| S-EPMC10446877 | biostudies-literature
Project description:Long-term follow-up data from multicenter phase III non-inferiority trials confirmed the safety of omission of axillary dissection in selected patients with clinically node-negative, sentinel node-positive breast cancer. Several ongoing trials investigate extended eligibility of the Z0011 protocol in the adjuvant setting. De-escalation of axillary surgery in patients with clinically node-positive breast cancer is currently limited to the neoadjuvant setting, where the sentinel procedure is used to determine nodal pathological complete response. Targeted axillary dissection lowers the false-negative rate of the sentinel procedure, which, however, is consistently associated with a very low risk of axillary recurrence in several recent single-center series. Axillary dissection remains standard care in patients with residual disease after neoadjuvant chemotherapy while the results of Alliance A011202 are pending. The TAXIS trial investigates the role of tailored axillary surgery in patients with clinically node-positive breast cancer, a novel concept designed to selectively remove positive nodes in the adjuvant and neoadjuvant setting.
| S-EPMC9097794 | biostudies-literature
Project description:ImportanceSentinel lymph node biopsy (SLNB) is the standard of care for axillary node staging of patients with early breast cancer (BC), but its necessity can be questioned since surgery for examination of axillary nodes is not performed with curative intent.ObjectiveTo determine whether the omission of axillary surgery is noninferior to SLNB in patients with small BC and a negative result on preoperative axillary lymph node ultrasonography.Design, setting, and participantsThe SOUND (Sentinel Node vs Observation After Axillary Ultra-Sound) trial was a prospective noninferiority phase 3 randomized clinical trial conducted in Italy, Switzerland, Spain, and Chile. A total of 1463 women of any age with BC up to 2 cm and a negative preoperative axillary ultrasonography result were enrolled and randomized between February 6, 2012, and June 30, 2017. Of those, 1405 were included in the intention-to-treat analysis. Data were analyzed from October 10, 2022, to January 13, 2023.InterventionEligible patients were randomized on a 1:1 ratio to receive SLNB (SLNB group) or no axillary surgery (no axillary surgery group).Main outcomes and measuresThe primary end point of the study was distant disease-free survival (DDFS) at 5 years, analyzed as intention to treat. Secondary end points were the cumulative incidence of distant recurrences, the cumulative incidence of axillary recurrences, DFS, overall survival (OS), and the adjuvant treatment recommendations.ResultsAmong 1405 women (median [IQR] age, 60 [52-68] years) included in the intention-to-treat analysis, 708 were randomized to the SLNB group, and 697 were randomized to the no axillary surgery group. Overall, the median (IQR) tumor size was 1.1 (0.8-1.5) cm, and 1234 patients (87.8%) had estrogen receptor-positive ERBB2 (formerly HER2 or HER2/neu), nonoverexpressing BC. In the SLNB group, 97 patients (13.7%) had positive axillary nodes. The median (IQR) follow-up for disease assessment was 5.7 (5.0-6.8) years in the SLNB group and 5.7 (5.0-6.6) years in the no axillary surgery group. Five-year distant DDFS was 97.7% in the SLNB group and 98.0% in the no axillary surgery group (log-rank P = .67; hazard ratio, 0.84; 90% CI, 0.45-1.54; noninferiority P = .02). A total of 12 (1.7%) locoregional relapses, 13 (1.8%) distant metastases, and 21 (3.0%) deaths were observed in the SLNB group, and 11 (1.6%) locoregional relapses, 14 (2.0%) distant metastases, and 18 (2.6%) deaths were observed in the no axillary surgery group.Conclusions and relevanceIn this randomized clinical trial, omission of axillary surgery was noninferior to SLNB in patients with small BC and a negative result on ultrasonography of the axillary lymph nodes. These results suggest that patients with these features can be safely spared any axillary surgery whenever the lack of pathological information does not affect the postoperative treatment plan.Trial registrationClinicalTrials.gov Identifier: NCT02167490.
| S-EPMC10514873 | biostudies-literature
Project description:BackgroundSome studies suggested that the patients included in the Z0011 trial may represent patients with ultrasound-negative axillary nodes and axillary invasion diagnosed by sentinel node (SN) biopsy. Nevertheless, the National Comprehensive Cancer Network (NCCN) guidelines recommend SN mapping if 1 or 2 suspicious lymph nodes are identified on axillary ultrasound (AU). The aim of this preliminary phase of the Multimodal Targeted Axillary Surgery (MUTAS) trial was to establish the accuracy of SN mapping in patients with axillary involvement undergoing upfront surgery.MethodsBetween September 2019 and March 2022, we recruited patients with biopsy-proven metastatic axillary nodes and upfront surgery from a single center. We performed SN mapping in these patients before the surgical intervention, which included axillary lymph node dissection. The biopsy-proven metastatic node, SNs and the remaining axillary nodes were excised separately. SN status was considered representative of the status of the remaining axillary nodes. We calculated the sensitivity, specificity, negative predictive value and positive predictive value of the SN, overall and in patients with palpable nodes, in those with non-palpable nodes and an AU leading to diagnosis of axillary involvement, in those with 1 or 2 suspicious nodes on AU, and in patients with a single suspicious node on AU. We evaluated clinical, imaging and pathology features as predictors of the status of the remaining axillary nodes, false-negatives, and false-positives.ResultsWe included 25 patients in this phase. The false-negative rate of SN mapping was 28% overall, 21.42% for patients with palpable nodes, 36.36% for patients with non-palpable nodes and an AU diagnosis of axillary involvement, 28.75% for those with 1 or 2 suspicious nodes on AU, and 15.38% in patients with a single suspicious node on AU. The negative predictive value was highest in patients with a single suspicious node on AU (75%). The only significant predictive factor was that FN showed a higher Ki67 index score.ConclusionsIn this study, SN mapping was not reliable in patients with biopsy-proven metastatic axillary nodes and upfront surgery for any of the subgroups studied. Further research should elucidate the best staging pathways in these patients to avoid premature de-escalation.
| S-EPMC10005988 | biostudies-literature
Project description:BackgroundNear infrared fluorescence imaging with Indocyanine Green (ICG) is now used for the imaging of lymph nodes and lymphatic vessels. In this work, we investigated the impact of its pre-operative and peri-operative administration on our ability to detect axillary lymphatic loss after breast cancer surgery.MethodsOne subcutaneous injection of ICG was administered in the ipsilateral hand of 109 women who were scheduled to have either a mastectomy with total axillary lymph node dissection (CALND) or a lumpectomy with selective lymphadenectomy (SLN) the day before (n = 53) or the same day of surgery (n = 56). The lymph leakages were assessed by means of the application of a compress in the operated armpit and by the presence or absence of fluorescence on it, as well as in the post-operative axillary drains.ResultsThe compress was fluorescent in 28% of SLN patients and 71% of CALND patients. The liquids in the axillary drains were also fluorescent in 71% of patients with CALND. No statistical significance was observed between the ICG injection groups. The association between compressive fluorescent and the presence of fluorescence in the axillary drains is significant in the pre-operative subgroup and in the whole group.ConclusionOur research demonstrates that lymphatic leaks aid in the development of seromas and calls into question the effectiveness of the ligatures and/or cauterizations used during surgery. A prospective, multicentric, randomized trial should be conducted to verify the efficacy of this approach.
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