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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.

Background The targeted axillary dissection (TAD) procedure is used in clinically positive lymph node (cN+) breast cancer to assess whether pathological complete response (pCR) is achieved after neoadjuvant systemic therapy (NST) to decide on de-escalation of axillary lymph node dissection (ALND). In this study, we review the implementation of the TAD procedure in a large regional breast cancer center. Methods All TAD procedures between 2016 and 2022 were reviewed. The TAD procedure consists of marking pre-NST the largest suspected metastatic lymph node(s) using a radioactive I-125 seed. During surgery, the marked node was excised together with a sentinel node procedure. Axillary therapy (ALND, axillary radiotherapy, or nothing) recommendations were based on the amount of suspected positive axillary lymph nodes (ALNs < 4 or ≥ 4) pre-NST and if pCR was achieved after NST. Results A total of 312 TAD procedures were successfully performed in 309 patients. In 134 (43%) cases, pCR of the TAD lymph nodes were achieved. Per treatment protocol, 43 cases (14%) did not receive any axillary treatment, 218 cases (70%) received adjuvant axillary radiotherapy, and 51 cases (16%) underwent an ALND. During a median follow-up of 2.8 years, 46 patients (14%) developed recurrence, of which 11 patients (3.5%) had axillary recurrence. Conclusions Introduction of the TAD procedure has resulted in a reduction of 84% of previously indicated ALNDs. Moreover, 18% of cases did not receive adjuvant axillary radiotherapy. These data show that implementation of de-escalation axillary treatment with the TAD procedure appeared to be successful.

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.

Landmark trials have shown that axillary lymph node dissection (ALND) can be safely omitted in early breast cancer patients with 1-2 positive nodes. Despite lack of prospective data, the National Comprehensive Cancer Network (NCCN) guidelines recommend that patients with 1-2 suspicious or biopsy-proven positive lymph nodes having primary surgery can undergo sentinel lymph node biopsy (SLNB). In the era of de-escalation of axillary surgery, breast cancer management in patients with clinically node-positive (cN +) axilla is driven by tumour biology and response to neoadjuvant chemotherapy (NACT). In this review, we discuss the management of the axilla in early breast cancer patients with low-volume biopsy-proven nodal disease and summarise the evidence supporting omission of ALND in these patients undergoing primary surgery.

Background/Aim: Studies have suggested that benefits of definitive radiotherapy might be limited to specific patients in clinically lymph node positive (cN1) prostate cancer (PC). However, the beneficial subgroup remains to be elucidated. This study aimed to analyze survival outcomes and prognostic factors after definitive radiotherapy and androgen deprivation therapy (definitive RT+ADT) in these patients and to define subgroups of patients who would benefit from definitive RT+ADT the most. Patients and Methods: A total of 60 patients with cN1 PC treated with definitive RT+ADT in a single tertiary hospital were accrued. Their clinicopathological variables were analyzed and a new subgroup was identified based on statistically significant variables. Results: At a median follow-up of 31 months, ADT duration ≥24 months (p=0.043, HR=0.26) and positive biopsy core ≥75% (p=0.044, HR=5.29) showed significant relationships with distant metastasis-free survival. Overall survival showed significant relationships with ADT duration ≥24 months (p=0.002, HR=0.06) and number of lymph node (LN) metastases ≥4 (p=0.019, HR=7.17). For prognostic subgroup analysis, patients were divided into three risk groups: low-risk group (LN metastases <4 and ADT ≥24 months), high-risk group (LN metastases ≥4 and ADT <24 months), and intermediate-risk group (all remaining cases). Three-year actuarial overall survival rates for the low-, intermediate-, and high-risk groups were 100%, 93.3%, and 45.7%. Conclusion: ADT duration and number of LN metastases were important prognostic factors in patients with cN1 PC receiving definitive RT+ADT, with low-risk cN1 PC patients showing better outcomes than others.

Objective: To retrospectively analyze outcomes of patients who received definitive pelvic irradiation for clinically pelvic node-positive (cT1-4N1M0) prostate cancer (PCa). Materials and methods: Clinical records of 148 patients with cT1-4N1M0 PCa treated with definitive pelvic radiotherapy (RT) between 2011 and 2015 were retrospectively collected from 25 institutions by the Japanese Radiation Oncology Study Group. The median age, initial prostate-specific antigen (PSA) level, and biologically effective dose (BED) to the prostate with α/β of 1.5 Gy were 69 (interquartile range [IQR], 65–74.3) years, 41.5 (IQR, 20.3–89) ng/ml, and 177.3 (IQR, 163.3–182) Gy, respectively. All patients underwent neoadjuvant androgen-deprivation therapy (ADT) for a median duration of 10 months. Most patients (141; 95.2%) received concurrent ADT during the irradiation period. The median duration of adjuvant ADT was 16 (IQR, 5–27.8) months. The Phoenix definition was used to assess biochemical failure. Results: The median follow-up period was 53.5 months (IQR, 41–69.3). The 5-year overall survival (OS) probability was 86.8%. The 5-year biochemical failure-free survival and clinical progression-free survival rates were 69.6% and 76.3%, respectively. Multivariate analysis indicated the BED to the prostate to be a significant prognostic factor for OS. Regarding late adverse events, the estimated cumulative incidences of late Grade 2 or higher gastrointestinal and genitourinary toxicities at 5 years were 8.2% and 5.8%, respectively. Conclusion: Long-term ADT combined with definitive pelvic external beam RT for cT1-4N1M0 PCa leaded to favorable outcomes. Future prospective studies should validate the suggested survival benefit of local dose escalation to the prostate in this cohort.

Recent advances in systemic treatment for breast cancer have been underpinned by recognising and exploiting subtype-specific vulnerabilities to achieve higher rates of pathologic complete response (pCR) after neo-adjuvant systemic therapy (NAST). This down-staging of disease has permitted safe surgical de-escalation in patients who respond well. Triple-negative (TNBC) or HER2-positive breast cancer is most likely to achieve complete radiological response (rCR) and pCR after NAST. Hence, for selected patients, particularly those who are clinically node-negative (cN0) at diagnosis, the probability of disease in the sentinel node after NAST could be low enough to justify omitting axillary surgery. The aim of this pooled analysis was to determine the rate of sentinel node positivity (ypN+) in patients with TNBC or HER2-positive breast cancer who were initially cN0, achieving rCR and/or pCR in the breast after NAST. MedLine was searched using appropriate search terms. Five studies (N = 3834) were included in the pooled analysis, yielding a pooled ypN+ rate of 2.16% (95% CI: 1.70–2.63). This is significantly lower than the acceptable false negative rate of sentinel lymph node biopsy (SLNB) and supports consideration of omission of SLNB in this subset of patients.

The purpose of this review is to present the current knowledge about the diagnostic and treatment options for bladder cancer (BCa) patients with clinically positive lymph nodes (cN+). This review shows compaction of CT and MRI performance in preoperative prediction of lymph node invasion (LNI) in BCa patients, along with other diagnostic methods. Most scientific societies do not distinguish cN+ patients in their guidelines; recommendations concern muscle-invasive bladder cancer (MIBC) and differ between associations. The curative treatment that provides the best long-term survival in cN+ patients is a multimodal approach, with a combination of neoadjuvant chemotherapy (NAC) and radical cystectomy (RC) with extended pelvic lymph node dissection (ePLND). The role of adjuvant chemotherapy (AC) remains uncertain; however, emerging evidence indicates comparable outcomes to NAC. Therefore, in cN+ patients who have not received NAC, AC should be implemented. The response to ChT is a crucial prognostic factor for cN+ patients. Recent studies demonstrated the growing importance of immunotherapy, especially in ChT-ineligible patients. Moreover, immunotherapy can be suitable as adjuvant therapy in selected cases. In cN+ patients, the extended template of PLND should be utilized, with the total resected node count being less important than the template. This review is intended to draw special attention to cN+ BCa patients, as the oncological outcomes are significantly worse for this group.

The advent of taxane-based chemotherapy has revolutionized breast cancer care. This advance has helped improve the response to downstaging tumors that might otherwise be inoperable. It has also helped in rendering clinically (cN+) positive lymph nodes (LNs) pathologically negative (ypN0). The standard of care for cN+ patients included post-mastectomy radiotherapy (PMRT), regardless of the response to neoadjuvant chemotherapy. However, PMRT in patients with 1–3 positive LNs still lacks definitive guidelines. Numerous retrospective results have been inconclusive about the benefit of PMRT on survival in patients with 1–3 positive LNs. This pooled analysis attempts to reach a consensus. The PubMed database was searched through October 2023. The search yielded 27 papers, of which 11 satisfied the inclusion criteria. The locoregional recurrence-free survival (LRRFS), disease-free survival (DFS), and overall survival (OS) for each study were tabulated when given, and two groups were created, the PMRT and NO PMRT, respectively. The results were then pooled for analysis. The total number of patients was 8340, 4136 in the PMRT group, and 4204 in the NO PMRT group, respectively. The LRRFS, DFS, and OS were 96.9%, 82.1%, and 87.3% for the PMRT group and 93.2%, 79.6%, and 84.8% for the NO PMRT group, respectively. There was no statistical significance in LRRFS, DFS, or OS between the two groups (p = 0.61, p = 0.61, and p = 0.38, respectively). PMRT does not seem to confer survival benefits in patients with pN1 rendered ypN0 for stages T1-3. This pooled analysis’s findings should be confirmed prospectively with a longer period of follow-up.