Evidence map›Paper›PMID 41760969›Full record

Trial reportAnnals of surgical oncology2026

Omission of Axillary Surgery in Patients with Negative Axillary Evaluation Integrated with LymphPET: A Prospective Clinical Study.

Fei-Lin Qu, Jing-Yi Cheng, Shu-Hao Jiang, Qun Zhang, Guang-Yu Liu, A-Yong Cao, Jiong Wu, Ke-Da Yu, Gen-Hong Di, Jun-Jie Li and 1 more

Registry-linked trialAbstract readClinical Trial, Phase II
PubMed Publisher
In one paragraph

Trial report in Annals of surgical oncology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04072653 (Sentinel Node Biopsy Vs Observation After Axillary PET Examination), which is not on this map. Not yet cited in PubMed.

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0cells of the map it votes in
0citing 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.

NCT04072653 narecruitingnot on this map

Sentinel Node Biopsy Vs Observation After Axillary PET Examination

TypeinterventionalSponsorFudan UniversityRan2019 to 2027Enrolled1,528ConditionsBreast CancerArmsSLNB is spared
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

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

11 authors.

Fei-Lin Qu *Department of Breast Surgery, Fudan University Shanghai Cancer Center, Shanghai, China.
Jing-Yi Cheng *Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, China.
Shu-Hao JiangDepartment of Breast Surgery, Fudan University Shanghai Cancer Center, Shanghai, China.
Qun ZhangDepartment of Breast Surgery, Fudan University Shanghai Cancer Center, Shanghai, China.
Guang-Yu LiuDepartment of Breast Surgery, Fudan University Shanghai Cancer Center, Shanghai, China.
A-Yong CaoDepartment of Breast Surgery, Fudan University Shanghai Cancer Center, Shanghai, China.
Jiong WuDepartment of Breast Surgery, Fudan University Shanghai Cancer Center, Shanghai, China.
Ke-Da YuDepartment of Breast Surgery, Fudan University Shanghai Cancer Center, Shanghai, China.
Gen-Hong DiDepartment of Breast Surgery, Fudan University Shanghai Cancer Center, Shanghai, China.
Jun-Jie LiDepartment of Breast Surgery, Fudan University Shanghai Cancer Center, Shanghai, China. lijunjie_ronaldo@hotmail.com.
Zhi-Ming ShaoDepartment of Breast Surgery, Fudan University Shanghai Cancer Center, Shanghai, China. zhimin_shao@yeah.net.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundSentinel lymph node biopsy (SLNB) is the standard surgical approach for axillary node staging in patients with early-stage breast cancer (EBC). However, there is an increasing trend in investigating the omission of SLNB, as molecular tumor biology has become a primary determinant of systemic therapy, overshadowing the importance of nodal status. PATIENTS AND

methodsThe SOAPET trial constitutes a prospective phase II study structured into two phases. In the first stage, we demonstrated that LymphPET could be utilized to screen patients to potentially forego SLNB, achieving a negative predictive value of 91%. In the second stage, SLNB was omitted for patients with a negative preoperative axillary evaluation (PAE) integrated with LymphPET. Primary endpoints were the 3-year distant disease-free survival (DDFS) and locoregional recurrence-free survival (LRRFS).

resultsA total of 304 patients were enrolled with a median age of 52.5 years (IQR 44-62 years). Of these patients, 240 (78.9%) presented with clinical T1 tumors. Among all the cases, 218 (71.7%) were classified as luminal-like breast cancer. The median follow-up was 43.5 months. The 3-year DDFS and LRRFS rates were 100% and 99.7% (95% CI 99.0-100.0), respectively. In the entire cohort, two cases (0.7%) of ipsilateral axillary node relapse, one (0.3%) ipsilateral in-breast recurrence, and one (0.3%) distant metastasis were reported.

conclusionsThe second phase of the study corroborates the oncologic safety of omitting SLNB on the basis of PAE incorporating LymphPET. For patients with clinically node-negative EBC with high-risk characteristics, SLNB might be safely spared with the added diagnostic benefit provided by LymphPET.

trial registrationClinicalTrials.Gov ID NCT04072653.

Indexed as

Breast NeoplasmsLymph Node ExcisionNeoplasm Recurrence, LocalSentinel Lymph Node BiopsyAdultAxillaFemaleFollow-Up StudiesHumansLymphatic MetastasisMiddle AgedNeoplasm StagingPrognosisProspective StudiesSurvival RateEarly-stage breast cancerLymphPETPreoperative axillary evaluationSentinel lymph node biopsy

Identifiers

PMID41760969

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