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Clinical Trial
. 2018 Nov 21;18(1):1153.
doi: 10.1186/s12885-018-5053-7.

Overview of the pathological results and treatment characteristics in the first 1000 patients randomized in the SERC trial: axillary dissection versus no axillary dissection in patients with involved sentinel node

Gilles Houvenaeghel  1   2 , Monique Cohen  3   4 , Pédro Raro  5 , Jérémy De Troyer  6 , Christine Tunon de Lara  7 , Pierre Gimbergues  8 , Tristan Gauthier  9 , Christelle Faure-Virelizier  10 , Véronique Vaini-Cowen  11 , Stéphane Lantheaume  12 , Claudia Regis  13 , Emile Darai  14 , Vivien Ceccato  15 , Gauthier D'Halluin  16 , Francesco Del Piano  17 , Richard Villet  18 , Eva Jouve  19 , Bassoodéo Beedassy  20 , Pierrick Theret  21 , Philippe Gabelle  22 , Cécile Zinzindohoue  23 , Pierre Opinel  24 , Catherine Marsollier-Ferrer  25 , Caroline Dhainaut-Speyer  26 , Pierre-Emmanuel Colombo  27 , Eric Lambaudie  3   4 , Agnès Tallet  3   28 , Jean-Marie Boher  3   29 ; Others investigators (SERC trial group)
Collaborators, Affiliations
Clinical Trial

Overview of the pathological results and treatment characteristics in the first 1000 patients randomized in the SERC trial: axillary dissection versus no axillary dissection in patients with involved sentinel node

Gilles Houvenaeghel et al. BMC Cancer. .

Abstract

Background: Three 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.

Methods: SERC 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.

Results: Of 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.

Conclusion: The 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 registration: This study is registered with ClinicalTrials.gov , number NCT01717131 October 19, 2012.

Keywords: Axillary lymph node dissection; Breast cancer; Randomized trial; Sentinel lymph node biopsy.

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Conflict of interest statement

Ethics approval and consent to participate

All relevant ethical approvals from our institutional review board ethics committee (IPC - Comité d’Orientation Stratégique) have been obtained prior to study commencement.

Written informed consent was obtained from all patients prior to study entry.

Consent for publication

Not applicable.

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Observed vs. expected cumulative accrual numbers during (20/07/2012–09/12/2015)
Fig. 2
Fig. 2
Number of patients accrued by participating center during the accrual period of first 1000 randomized patients: The majority of patients (528) were recruited from 4 different institutions and 20 centers accrued less than 10 patients
See this image and copyright information in PMC

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