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

ABSTRACT: 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.

SUBMITTER: Houvenaeghel G

PROVIDER: S-EPMC8501060 | biostudies-literature | 2021 Oct

REPOSITORIES: biostudies-literature

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

Houvenaeghel Gilles G Cohen Monique M Raro Pédro P De Troyer Jérémy J Gimbergues Pierre P Tunon de Lara Christine C Ceccato Vivien V Vaini-Cowen Véronique V Faure-Virelizier Christelle C Marchal Frédéric F Gauthier Tristan T Jouve Eva E Theret Pierrick P Regis Claudia C Gabelle Philippe P Pernaut Julia J Del Piano Francesco F D'Halluin Gauthier G Lantheaume Stéphane S Darai Emile E Beedassy Bassoodéo B Dhainaut-Speyer Caroline C Martin Xavier X Girard Sophie S Villet Richard R Monrigal Emilie E Hoyek Théophile T Le Brun Jean-François JF Colombo Pierre-Emmanuel PE Tallet Agnès A Boher Jean-Marie JM

NPJ breast cancer 20211008 1

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 patien ...[more]

PMID: 34625562

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Project description:The aim of this study was to asses quality of life (QoL) after axillary or inguinal sentinel lymph node biopsy (SLNB) with or without completion lymph node dissection (CLND) in patients with cutaneous melanoma by comparing patients to a norm group of the general population and by comparing QoL between four patient groups depending on surgical procedure and location, i.e., patients receiving an axillary or groin SLNB, or an axillary or groin CLND.Between 1995 and 2003, a total of 242 axillary and inguinal SLNBs were performed. Of the 127 patients eligible for the study, 116 patients participated (91%). QoL was measured by the 30-item European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30), the McGill Pain Questionnaire and the Groningen Activity Restriction Scale.Median age at diagnosis was 50 (range, 18-77) years; median Breslow thickness 2.0 (range, 1-13) mm; median follow-up 56 (range, 4-94) months. SLNB only was performed in 89 patients (77%): 48 in the groin and 41 in the axilla. CLND was performed in 27 patients (23%): 13 in the axilla and 14 in the groin. More postoperative complications (13 vs. 5; P < 0.001) and lymphedema (10 vs. 8; P < 0.001) occurred in the CLND group than in the SLNB group. The total group of patients reported better physical (P < 0.001), role (P < 0.001), emotional (P < 0.001), and social functioning (P = 0.049), global QoL (P < 0.001), and less fatigue (P < 0.001) and pain (P < 0.001) than a German norm group. Analysis of variance revealed significant differences in role functioning (P = 0.02) and tendencies toward physical problems (P = 0.051) and fatigue (P = 0.051) between the four groups. Post hoc Bonferroni tests showed that the axillary CLND group had more problems than the axillary and inguinal SLNB groups. Kruskal-Wallis tests showed that the axillary CLND group reported most pain.QoL in melanoma survivors after axillary or inguinal SLNB with or without CLND was better than that in a norm group. Patients who underwent CLND in the axilla after SLNB reported most problems.

Project description:BackgroundThree randomized trials have concluded at non inferiority of omission of complementary axillary lymph node dissection (cALND) for patients with involved sentinel node (SN). However, we can outline strong limitations of these trials to validate this attitude with a high scientific level. We designed the SERC randomized trial ( ClinicalTrials.gov , number NCT01717131) to compare outcomes in patients with SN involvement treated with ALND or no further axillary treatment. The aim of this study was to analyze results of the first 1000 patients included.MethodsSERC trial is a multicenter non-inferiority phase 3 trial. Multivariate logistic regression analysis was used to identify independent factors associated with adjuvant chemotherapy administration and non-sentinel node (NSN) involvement.ResultsOf the 963 patients included in the analysis set, 478 were randomized to receive cALND and 485 SLNB alone. All patient demographics and tumor characteristics were balanced between the two arms. SN ITC was present in 6.3% patients (57/903), micro metastases in 33.0% (298), macro metastases in 60.7% (548) and 289 (34.2%) were non eligible to Z0011 trial criteria. Whole breast or chest wall irradiation was delivered in 95.9% (896/934) of patients, adjuvant chemotherapy in 69.5% (644/926), endocrine therapy in 89.6% (673/751) and the proportions were similar in the two arms. The overall rate of positive NSN was 19% (84/442) for patients with cALND. Crude rates of positive NSN according to SN status were 4.5% for ITC (1/22), 9.5% for micro metastases (13/137), 23.9% for macro metastases (61/255) and were respectively 29.36% (64/218), 9.33% (7/75) and 7.94% (10/126) when chemotherapy was administered after cALND, before cALND and for patients without chemotherapy.ConclusionThe main objective of SERC trial is to demonstrate non inferiority of cALND omission. A strong interaction between timing of cALND and chemotherapy with positive NSN rate was observed.Trial registrationThis study is registered with ClinicalTrials.gov , number NCT01717131 October 19, 2012.

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

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

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