External Validation of the SERC Trial Population: Comparison with the Multicenter French Cohort, the Swedish and SENOMIC Trial Populations for Breast Cancer Patients with Sentinel Node Micro-Metastasis

Houvenaeghel, Gilles; Hajj, Houssein El; Barrou, Julien; Cohen, Monique; Raro, Pédro; Troyer, Jérémy De; Gimbergues, Pierre; Lara, C. Tunon de; Ceccato, Vivien; Vaini-Cowen, Véronique; Faure-Virelizier, Christelle; Marchal, Frédéric; Gauthier, Tristan; Jouve, Eva; Théret, Pierrick; Régis, Claudia; Desmons, F; Tallet, Agnès; Boher, Jean‐Marie

doi:10.3390/cancers12102924

Cited by 9 publications

(8 citation statements)

References 24 publications

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“…Due to insufficient evidence to support the omission of ALND in case of SN micro-metastasis after a mastectomy, SERC trial evaluated macro-metastatic as well as micro-metastasis and ITCs with a planned stratification based on metastasis size 27 . Moreover, we have recently confirmed the external validity of SERC trial population in comparison with others populations studies for BC patients with SN micrometastasis 28 .…”

Section: Discussionsupporting

confidence: 73%

“…27 Centre Hospitalier Auxerre, 2 bd de Verdun, BP 69, 89011 Auxerre, France. 28 Centre Francois Baclesse, Avenue du Général Harris, 14076 Caen Cedex 5, France. 29 and one or two involved sentinel nodes (SNs) by micro-or macrometastases without extracapsular extension with whole breast radiotherapy and systemic adjuvant treatment (endocrine therapy and or chemotherapy) 9 .…”

Section: Introductionmentioning

confidence: 99%

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Sentinel node involvement with or without completion axillary lymph node dissection: treatment and pathologic results of randomized SERC trial

Houvenaeghel

Cohen²,

Raro³

et al. 2021

npj Breast Cancer

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Based on results of clinical trials, completion ALND (cALND) is frequently not performed for patients with breast conservation therapy and one or two involved sentinel nodes (SN) by micro- or macro-metastases. However, there were limitations despite a conclusion of non-inferiority for cALND omission. No trial had included patients with SN macro-metastases and total mastectomy or with >2 SN macro-metastases. The aim of the study was too analyze treatment delivered and pathologic results of patients included in SERC trial. SERC trial is a multicenter randomized non-inferiority phase-3 trial comparing no cALND with cALND in cT0-1-2, cN0 patients with SN ITC (isolated tumor cells) or micro-metastases or macro-metastases, mastectomy or breast conservative surgery. We randomized 1855 patients, 929 to receive cALND and 926 SLNB alone. No significant differences in patient’s and tumor characteristics, type of surgery, and adjuvant chemotherapy (AC) were observed between the two arms. Rates of involved SN nodes by ITC, micro-metastases, and macro-metastases were 5.91%, 28.12%, and 65.97%, respectively, without significant difference between two arms for all criteria. In multivariate analysis, two factors were associated with higher positive non-SN rate: no AC versus AC administered after ALND (OR = 3.32, p < 0.0001) and >2 involved SN versus ≤2 (OR = 3.45, p = 0.0258). Crude rates of positive NSN were 17.62% (74/420) and 26.45% (73/276) for patient’s eligible and non-eligible to ACOSOG-Z0011 trial. No significant differences in patient’s and tumor characteristics and treatment delivered were observed between the two arms. Higher positive-NSN rate was observed for patients with AC performed after ALND (17.65% for SN micro-metastases, 35.22% for SN macro-metastases) in comparison with AC administered before ALND.

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Section: Discussionsupporting

confidence: 73%

Section: Introductionmentioning

confidence: 99%

Sentinel node involvement with or without completion axillary lymph node dissection: treatment and pathologic results of randomized SERC trial

Houvenaeghel

Cohen²,

Raro³

et al. 2021

npj Breast Cancer

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“…Macro-metastasis in SLN is associated with worse disease-free survival [ 16 ], and current guidelines recommend further axillary surgery or radiotherapy when there are macro-metastases in the SLN [ 17 ]. With the increasing use of SLNB, identification rates of micrometastases in sentinel nodes have increased, but the prognostic significance and clinical management remain controversial [ 18 , 19 ].…”

Section: Discussionmentioning

confidence: 99%

Impact of Post-Mastectomy Radiation Therapy for Sentinel Lymph Node Micrometastases in Early-Stage Breast Cancer Patients

Luo

Yang

et al. 2021

Med Sci Monit

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Background The association of radiotherapy with breast cancer survival in patients who underwent a mastectomy and had micrometastases in the sentinel lymph node is unclear. Material/Methods The survival benefit of radiotherapy was examined in patients with T0/1-T2N1mi breast cancer undergoing mastectomy plus sentinel lymph node biopsy (SLNB). Kaplan-Meier curves were employed for survival analysis and competing risk analysis, and a propensity score matching (PSM) cohort was enrolled to investigate whether such patients benefit from radiotherapy. Results We identified 2864 patients in the SEER database from 2004 to 2015. All eligible patients were divided into the radiotherapy and the no-radiotherapy cohorts. With the median follow-up of 53 months, 5-year breast cancer-specific survival (BCSS) was 94.4% vs 95.2% ( P =0.135), and 5-year overall survival (OS) was 91.2% vs 90.1% ( P =0.466) in the radiotherapy cohorts and no-radiotherapy cohorts, respectively. The results of the competing risk analysis showed a comparable 5-year cumulative incidence of breast cancer-specific death (BCSD) in the radiotherapy and no-radiotherapy groups (5.5% vs 4.7%, P =0.107) but a higher 5-year cumulative incidence of other causes of death (OCD) in the no-radiotherapy cohort (3.3% vs 5.3%, P =0.011). No significant difference was observed for BCSS or OS in the PSM cohort. Conclusions Radiotherapy has no benefit for patients with T0/1-T2 breast cancer undergoing mastectomy with N1mi disease on SLNB. This analysis provides evidence that radiotherapy may safely be omitted in this group of patients.

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“…An analysis of studies using the National Cancer Data Base (NCDB) and a prospective, randomized clinical trial (AATRM 048/13/2000) also came to the same conclusion that SLNB with complete ALND did not appear to be associated with a signi cant improvement in survival in SLN micrometastases [19]. Recently, the SERC (Sentinelle Envahi et Randomisation du Curage) and the SENOMIC (Sentinelle node Micrometastasis) trials were designed with the intention of con rming the safety of the ALND omission in the populations of patients who were under-represented in previously published trials [20,21]. However, the above cited trials were not designed to speci cally evaluate patients presenting SN micro-metastasis speci cally.…”

Section: Introductionmentioning

confidence: 96%

The Prognostic Significance of Further Axillary Dissection for Sentinel Lymph Node Micrometastases in Female Breast Cancer: A Competing Risk Analysis using the SEER Database

Zhou

Jiang

et al. 2022

Preprint

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On the basis of the Surveillance, Epidemiology, and End Results (SEER) database, the aim of this study is to identify whether complete axillary lymph node dissection (ALND) is actually required and has an impact on breast cancer-specific survival (BCSS) and overall survival (OS) in breast cancer patients with micrometastases. We identified 13,848 women whose nodal status was micrometastases (pTxN1miM0) were classified into two groups: the sentinel lymph node biopsy (SLNB) only group and SLNB with complete ALND group. After the PSM, we found that the SLNB with complete ALND showed no significant difference in OS (HR = 1.04, 95% CI: 0.84–1.28, P = 0.73) or BCSS (HR = 1.03, 95% CI: 0.79–1.35, P = 0.82) compared to the SLNB only group. There was no statistically significant difference in the cumulative incidence of BCSD (Grey’s test, P = 0.819) or OCSD (Grey’s test, P = 0.788) for between the two groups either. Our results suggest that in early breast cancer patients with micrometastasis, complete ALND does not seem to be required and that SLNB suffices to control locoregional and distant disease, with no significant adverse effects on survival compared to complete ALND.

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External Validation of the SERC Trial Population: Comparison with the Multicenter French Cohort, the Swedish and SENOMIC Trial Populations for Breast Cancer Patients with Sentinel Node Micro-Metastasis

Cited by 9 publications

References 24 publications

Sentinel node involvement with or without completion axillary lymph node dissection: treatment and pathologic results of randomized SERC trial

Sentinel node involvement with or without completion axillary lymph node dissection: treatment and pathologic results of randomized SERC trial

Impact of Post-Mastectomy Radiation Therapy for Sentinel Lymph Node Micrometastases in Early-Stage Breast Cancer Patients

The Prognostic Significance of Further Axillary Dissection for Sentinel Lymph Node Micrometastases in Female Breast Cancer: A Competing Risk Analysis using the SEER Database

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