Evidence map›Paper›PMID 42081886›Full record

ArticleTechnology in cancer research & treatment

RNI Precision Trial Protocol: Optimization of Regional Node Irradiation for Sentinel Lymph Node-positive Breast Cancer Omitting Axillary Dissection Based on Clinical and Genomic Risk Assessment: A Prospective Clinical Trial.

Wei-Xiang Qi, Lu Cao, Siyue Zheng, Shuyan Li, Feifei Xu, Cheng Xu, Rong Cai, Gang Cai, Jiayi Chen

Abstract readClinical Trial Protocol
In one paragraph

Article in Technology in cancer research & treatment. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors.

Wei-Xiang QiDepartment of Radiation Oncology, Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China.ORCID 0000-0001-5484-3343
Lu CaoDepartment of Radiation Oncology, Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China.
Siyue ZhengDepartment of Radiation Oncology, Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China.
Shuyan LiDepartment of Radiation Oncology, Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China.
Feifei XuDepartment of Radiation Oncology, Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China.
Cheng XuDepartment of Radiation Oncology, Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China.
Rong CaiDepartment of Radiation Oncology, Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China.
Gang CaiDepartment of Radiation Oncology, Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China.
Jiayi ChenDepartment of Radiation Oncology, Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China.ORCID 0000-0001-6417-290X

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BackgroundSentinel lymph node biopsy (SLNB) has been the standard treatment procedure for clinically node-negative (cN0) breast cancer (BC). Three randomized trials (Z0011, AMAROS and SENOMAC) have shown that patients with low-burden sentinel lymph node metastasis can be safely omitted axillary lymph node dissection who receive adjuvant radiotherapy. However, these published studies have been insufficient to accurately assess the recurrence risk in this patient population, leading to variability in adjuvant radiotherapy volume across different studies.ObjectiveThis study evaluates whether an integrated axillary management strategy combining SLNB with individualized regional nodal irradiation (RNI) based on recurrence risk reduces 2-year lymphedema compared to ALND followed by comprehensive RNI.Materials and MethodsThis trial is a single institute, open-labeled, non-randomized cohort trial. Participants are stratified into two cohorts based on the extent of axillary surgery after enrollment. For SLNB cohort, patients are divided into three groups according to clinical and genomic risk assessment. Clinically high-risk patients are defined as having at least two factors (tumor size≥2cm, percent of positive SLNs>30%, LVI positive and SLN macro-metastases), who have a predicted risk of n-SLN involvement greater than 30%. Clinically high-risk n-SLN involvement patients are further detected by using RecurIndex test. For pathological node positive (pN+) after ALND cohort, patients are treated with WBI/chest wall irradiation combined with comprehensive RNI excluding the dissected axillary region; A total of 205 patients will be enrolled, with 68 patients in SLNB cohort and 137 patients in ALND cohort with a 1:2 ratio assignment. The RNI precision trial uses a clinical-genomic model to accurately stratify the recurrence risk and provides the individualized RNI volume for early-stage BC with low-burden sentinel lymph node metastasis, and we anticipate that our study will provide high-quality data to potentially support individualized RNI in this patient population.

Indexed as

Breast NeoplasmsSentinel Lymph NodeAxillaFemaleGenomicsHumansLymphatic MetastasisLymph Node ExcisionNeoplasm Recurrence, LocalNeoplasm StagingPrecision MedicineProspective StudiesRadiotherapy, AdjuvantRisk AssessmentSentinel Lymph Node Biopsybreast cancerclinical-genomic modellymphoedemaomitting axillary dissectionregional node irradiationsentinel lymph node

Identifiers

PMID42081886
PMCPMC13157548

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.