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3 result(s) for "Duez, Nicole J"
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Radiotherapy or surgery of the axilla after a positive sentinel node in breast cancer (EORTC 10981-22023 AMAROS): a randomised, multicentre, open-label, phase 3 non-inferiority trial
If treatment of the axilla is indicated in patients with breast cancer who have a positive sentinel node, axillary lymph node dissection is the present standard. Although axillary lymph node dissection provides excellent regional control, it is associated with harmful side-effects. We aimed to assess whether axillary radiotherapy provides comparable regional control with fewer side-effects. Patients with T1–2 primary breast cancer and no palpable lymphadenopathy were enrolled in the randomised, multicentre, open-label, phase 3 non-inferiority EORTC 10981-22023 AMAROS trial. Patients were randomly assigned (1:1) by a computer-generated allocation schedule to receive either axillary lymph node dissection or axillary radiotherapy in case of a positive sentinel node, stratified by institution. The primary endpoint was non-inferiority of 5-year axillary recurrence, considered to be not more than 4% for the axillary radiotherapy group compared with an expected 2% in the axillary lymph node dissection group. Analyses were by intention to treat and per protocol. The AMAROS trial is registered with ClinicalTrials.gov, number NCT00014612. Between Feb 19, 2001, and April 29, 2010, 4823 patients were enrolled at 34 centres from nine European countries, of whom 4806 were eligible for randomisation. 2402 patients were randomly assigned to receive axillary lymph node dissection and 2404 to receive axillary radiotherapy. Of the 1425 patients with a positive sentinel node, 744 had been randomly assigned to axillary lymph node dissection and 681 to axillary radiotherapy; these patients constituted the intention-to-treat population. Median follow-up was 6·1 years (IQR 4·1–8·0) for the patients with positive sentinel lymph nodes. In the axillary lymph node dissection group, 220 (33%) of 672 patients who underwent axillary lymph node dissection had additional positive nodes. Axillary recurrence occurred in four of 744 patients in the axillary lymph node dissection group and seven of 681 in the axillary radiotherapy group. 5-year axillary recurrence was 0·43% (95% CI 0·00–0·92) after axillary lymph node dissection versus 1·19% (0·31–2·08) after axillary radiotherapy. The planned non-inferiority test was underpowered because of the low number of events. The one-sided 95% CI for the underpowered non-inferiority test on the hazard ratio was 0·00–5·27, with a non-inferiority margin of 2. Lymphoedema in the ipsilateral arm was noted significantly more often after axillary lymph node dissection than after axillary radiotherapy at 1 year, 3 years, and 5 years. Axillary lymph node dissection and axillary radiotherapy after a positive sentinel node provide excellent and comparable axillary control for patients with T1–2 primary breast cancer and no palpable lymphadenopathy. Axillary radiotherapy results in significantly less morbidity. EORTC Charitable Trust.
Sentinel Node Identification Rate and Nodal Involvement in the EORTC 10981-22023 AMAROS Trial
Background The randomized EORTC 10981-22023 AMAROS trial investigates whether breast cancer patients with a tumor-positive sentinel node biopsy (SNB) are best treated with an axillary lymph node dissection (ALND) or axillary radiotherapy (ART). The aim of the current substudy was to evaluate the identification rate and the nodal involvement. Methods The first 2,000 patients participating in the AMAROS trial were evaluated. Associations between the identification rate and technical, patient-, and tumor-related factors were evaluated. The outcome of the SNB procedure and potential further nodal involvement was assessed. Results In 65 patients, the sentinel node could not be identified. As a result, the sentinel node identification rate was 97% (1,888 of 1,953). Variables affecting the success rate were age, pathological tumor size, histology, year of accrual, and method of detection. The SNB results of 65% of the patients ( n  = 1,220) were negative and the patients underwent no further axillary treatment. The SNB results were positive in 34% of the patients ( n  = 647), including macrometastases ( n  = 409, 63%), micrometastases ( n  = 161, 25%), and isolated tumor cells ( n  = 77, 12%). Further nodal involvement in patients with macrometastases, micrometastases, and isolated tumor cells undergoing an ALND was 41, 18, and 18%, respectively. Conclusions With a 97% detection rate in this prospective international multicenter study, the SNB procedure is highly effective, especially when the combined method is used. Further nodal involvement in patients with micrometastases and isolated tumor cells in the sentinel node was similar—both were 18%.
WHO global research priorities for traditional, complementary, and integrative (TCI) medicine: an international consensus and comparisons with LLMs
Traditional, complementary, and integrative (TCI) medicine is an essential component of health systems worldwide, especially in low- and middle-income countries. Despite its widespread use, existing research on the safety, efficacy, and integration of TCI medicine within conventional healthcare systems is fragmented. This fragmentation highlights the urgent need for a clearly defined global research agenda to guide future studies, secure funding, and inform governance in this field. The Traditional, Complementary, and Integrative Medicine Unit at the World Health Organization Headquarters in Geneva, Switzerland coordinated an international research priority-setting exercise using the Child Health and Nutrition Research Initiative (CHNRI) method between June and December 2023. We invited a purposive sample of 120 experts from established academic networks to participate; 53 experts (44.16% response rate) contributed, and 34 of them scored 157 unique research ideas according to five CHNRI criteria: feasibility, effectiveness, deliverability, equity, and potential for disease burden reduction. Additionally, we performed a comparative analysis by generating research priorities using large language models (LLMs), including ChatGPT-4o, Claude 3.5, and Grok 3, and these outputs were compared with the expert-derived priorities. Top-ranked research priorities focused on chronic disease management (e.g. diabetes, dyslipidemia), geriatric safety (e.g. herb-drug interactions), mental health (e.g. resilience and mood disorders), and integration of TCI into health systems. Priorities varied by income setting. Comparison with LLM-generated lists showed thematic overlap in efficacy and safety but divergence in focus, with LLMs emphasising research capacity, policy, and systems-level priorities. We established a global, expert-informed research agenda to guide the future direction of TCI medicine and ensure alignment with public health needs. The comparison with LLMs highlights the complementary potential of artificial intelligence in research governance and agenda-setting.