546 A Randomized Trial Comparing Sentinel Lymph Node Biopsy Vs. No Axillary Surgical Staging in Patients with Small Breast Cancer and a Negative Preoperative Axillary Assessment

Gentilini, Oreste Davide; Agresti, Roberto; Busani, M.; Farfaglia, Roberto; Panizza, Pietro; Regolo, L.; Rovera, F.; Sangalli, Claudia; Tinterri, Corrado; Vischi, S.

doi:10.1016/s0959-8049(12)70611-1

European Journal of Cancer

2012

DOI: 10.1016/s0959-8049(12)70611-1

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546 A Randomized Trial Comparing Sentinel Lymph Node Biopsy Vs. No Axillary Surgical Staging in Patients with Small Breast Cancer and a Negative Preoperative Axillary Assessment

Oreste Davide Gentilini¹,

Roberto Agresti²,

M. Busani³

et al.

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Cited by 21 publications

(38 citation statements)

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“…The SOUND trial opened in 2012 and closed in 2017 with 1463 women enrolled (94% of the planned sample size). 7 The median (IQR) age was 60 (52-68) years, substantially younger than the group for whom omission of sentinel node biopsy has been agreed on based on expert opinion (Choosing Wisely). Overall, the tumors diagnosed in this study population had very favorable features; the median (IQR) tumor size was 1.1 (0.8-1.5) cm, and almost 90% were hormone receptor positive and ERBB2 (formerly HER2) negative.…”

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confidence: 96%

“…The SOUND (Sentinel Node vs Observation After Axillary Ultra-Sound) randomized clinical trial, the results of which are reported by Gentilini et al 7 in this issue of JAMA Oncology, brings welcome clarity to these issues with prospective, unbiased data. It was conducted at 24 European sites (the majority in Italy) and 1 Chilean site.…”

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confidence: 99%

“…What questions should we now consider in applying the SOUND results 7 to clinical practice, where the 2 main anxiet-ies regarding the omission of sentinel node biopsy relate to local control and lack of pathological nodal staging, which may deprive some patients of beneficial adjuvant therapy? The SOUND trial addresses the first concern nicely with prospective data on over 1400 women: the nodal positivity rate in the sentinel node biopsy group was 13.7%, while the axillary recurrence rate in the omission group was 0.7%.…”

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confidence: 99%

“…As the authors acknowledge, 7 clinical application of these data requires multidisciplinary consultation, and there are situations where pathological nodal staging will clarify recommendations regarding intensity of adjuvant systemic therapy or decisions by the patient. Similar decisions apply to the scope of radiotherapy (or to its omission) for which SOUND provides no data, since essentially all participants received breast radiotherapy.…”

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confidence: 99%

“…The SOUND trial opened in 2012 and closed in 2017 with 1463 women enrolled (94% of the planned sample size) . The median (IQR) age was 60 (52-68) years, substantially younger than the group for whom omission of sentinel node biopsy has been agreed on based on expert opinion (Choosing Wisely).…”

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Sentinel Node Biopsy for Early Breast Cancer—A SOUND for De-escalation

Khan

2023

JAMA Oncol

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confidence: 99%

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Sentinel Node Biopsy for Early Breast Cancer—A SOUND for De-escalation

Khan

2023

JAMA Oncol

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The SOUND Randomized Clinical Trial Results

Beduk Esen,

Yildirim

2024

JAMA Oncol

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carcinoma. The noninferiority margin of 1.08 is clearly clinically justifiable. It is based on the data from the 2 sorafenib trials in first-line hepatocellular carcinoma (HCC), namely the SHARP trial. 2 Using the 95% CI lower limit method on log hazard ratio (HR) as described in Rothmann et al, 3 the noninferiority margin corresponding to 60% retention of the sorafenib effect vs placebo was calculated as 1.08. Given the consistent survival improvement of sorafenib vs placebo demonstrated in the SHARP and Asia-Pacific trials, and the fact that, at the time the BGB-A317-301 study was designed, no other monotherapy treatment was able to show superiority compared with sorafenib since its approval in 2007, a margin of 1.08 derived from 2 wellconducted phase 3 pivotal trials was statistically persuasive. Notably, the same margin was used in other noninferiority monotherapy HCC trials, namely the REFLECT (lenvatinib) and HIMALAYA (durvalumab) trials. 4,5 HRs are a well-established parameter to quantify overall survival difference, widely used in pivotal clinical trials, and accepted by regulatory agencies worldwide. The acceptability of using HRs to characterize overall survival between the arms in BGB-A317-301 was confirmed by regulatory agencies during scientific consultations before initiation of the trial. The duration of response, as per its definition, is based on responders only and is also a well-accepted clinical end point in oncology trials.Noninferiority active control study design is an established scientific concept accepted by health authorities worldwide. In addition, as indicated in the RATIONALE-301 documentation, 6 a test sequence starting with noninferiority and followed with a superiority test was prespecified in this study. While superiority is desirable, the demonstration of noninferiority in efficacy with improvement in safety and quality of life reflects a meaningful clinical benefit provided by the investigational treatment. Those were both achieved with tislelizumab monotherapy.

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Electronic Health Record–Based Nudge Intervention and Axillary Surgery in Older Women With Breast Cancer

Carleton,

Radomski,

et al. 2024

JAMA Surg

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ImportanceChoosing Wisely recommendations advocate against routine use of axillary staging in older women with early-stage, clinically node-negative (cN0), hormone receptor–positive (HR+), and HER2-negative breast cancer. However, rates of sentinel lymph node biopsy (SLNB) in this population remain persistently high.ObjectiveTo evaluate whether an electronic health record (EHR)–based nudge intervention targeting surgeons in their first outpatient visit with patients meeting Choosing Wisely criteria decreases rates of SLNB.Design, Setting, and ParticipantsThis nonrandomized controlled trial was a hybrid type 1 effectiveness-implementation study with subsequent postintervention semistructured interviews and lasted from October 2021 to October 2023. Data came from EHRs at 8 outpatient clinics within an integrated health care system; participants included 7 breast surgical oncologists. Data were collected for female patients meeting Choosing Wisely criteria for omission of SLNB (aged ≥70 years with cT1 and cT2, cN0, HR+/HER2− breast cancer). The study included a 12-month preintervention control period; baseline surveys assessing perceived acceptability, appropriateness, and feasibility of the designed intervention; and a 12-month intervention period.InterventionA column nudge was embedded into the surgeon’s schedule in the EHR identifying patients meeting Choosing Wisely criteria for potential SLNB omission.Main Outcomes and MeasuresThe primary outcome was rate of SLNB following nudge deployment into the EHR.ResultsSimilar baseline demographic and tumor characteristics were observed before (control period, n = 194) and after (intervention period, n = 193) nudge deployment. Patients in both the control and intervention period had a median (IQR) age of 75 (72-79) years. Compared with the control period, unadjusted rates of SLNB decreased by 23.1 percentage points (46.9% SLNB rate prenudge to 23.8% after; 95% CI, −32.9 to −13.8) in the intervention period. An interrupted time series model showed a reduction in the rate of SLNB following nudge deployment (adjusted odds ratio, 0.26; 95% CI, 0.07 to 0.90; P = .03). The participating surgeons scored the intervention highly on acceptability, appropriateness, and feasibility. Dominant themes from semistructured interviews indicated that the intervention helped remind the surgeons of potential Choosing Wisely applicability without the need for additional clicks or actions on the day of the patient visit, which facilitated use.Conclusions and RelevanceThis study showed that a nudge intervention in the EHR significantly decreased low-value axillary surgery in older women with early-stage, cN0, HR+/HER2− breast cancer. This user-friendly and easily implementable EHR-based intervention could be a beneficial approach for decreasing low-value care in other practice settings or patient populations.Trial RegistrationClinicalTrials.gov Identifier: NCT06006910

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546 A Randomized Trial Comparing Sentinel Lymph Node Biopsy Vs. No Axillary Surgical Staging in Patients with Small Breast Cancer and a Negative Preoperative Axillary Assessment

Cited by 21 publications

References 0 publications

Sentinel Node Biopsy for Early Breast Cancer—A SOUND for De-escalation

Sentinel Node Biopsy for Early Breast Cancer—A SOUND for De-escalation

The SOUND Randomized Clinical Trial Results

Electronic Health Record–Based Nudge Intervention and Axillary Surgery in Older Women With Breast Cancer

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