• N. Engl. J. Med. · Dec 2024

    Axillary Surgery in Breast Cancer - Primary Results of the INSEMA Trial.

    • Toralf Reimer, Angrit Stachs, Kristina Veselinovic, Thorsten Kühn, Jörg Heil, Silke Polata, Frederik Marmé, Thomas Müller, Guido Hildebrandt, David Krug, Beyhan Ataseven, Roland Reitsamer, Sylvia Ruth, Carsten Denkert, Inga Bekes, Dirk-Michael Zahm, Marc Thill, Michael Golatta, Johannes Holtschmidt, Michael Knauer, Valentina Nekljudova, Sibylle Loibl, and Bernd Gerber.
    • From the Department of Obstetrics and Gynecology, University of Rostock, Rostock, Germany (T.R., A.S., B.G.); University Hospital Ulm, Ulm, Germany (K.V., I.B.); Hospital Esslingen, Esslingen, Germany (T.K.); University Hospital Heidelberg, Heidelberg, Germany (J. Heil, M.G.); the Breast Unit, Sankt Elisabeth Hospital, Heidelberg, Germany (J. Heil, M.G.); Evang. Waldkrankenhaus Spandau, Berlin (S.P.); the Faculty of Medicine Mannheim, Department of Obstetrics and Gynecology, University of Heidelberg, Mannheim, Germany (F.M.); the Department of Obstetrics and Gynecology, Hanau City Hospital, Hanau, Germany (T.M.); the Department of Radiation Oncology, University Hospital Rostock, Rostock, Germany (G.H.); the Department of Radiotherapy and Radiation Oncology, University Hospital Hamburg-Eppendorf (UKE), Hamburg, Germany (D.K.); the Department of Radiation Oncology, University Medical Center Schleswig-Holstein, Kiel, Germany (D.K.); Medical School and University Medical Center OWL, Department of Gynecology and Obstetrics, Bielefeld University, Klinikum Lippe, Detmold, Germany (B.A.); Salzburg Regional Hospital, Salzburg, Austria (R.R.); Johanniter-Hospital Genthin-Stendal, Genthin, Germany (S.R.); the Institute of Pathology, Philipps-University Marburg and University Hospital Marburg (UKGM), Marburg, Germany (C.D.); Breast Center St. Gallen, Kantonsspital, St. Gallen, Switzerland (I.B.); SRH Wald-Klinikum Gera, Gera, Germany (D.-M.Z.); the Department of Gynecology and Gynecologic Oncology, Agaplesion Markus Hospital, Frankfurt am Main, Germany (M.T.); the German Breast Group, Neu-Isenburg, Germany (J. Holtschmidt, V.N., S.L.); and the Tumor and Breast Center Eastern Switzerland, St. Gallen, Switzerland (M.K.).
    • N. Engl. J. Med. 2024 Dec 12.

    BackgroundWhether surgical axillary staging as part of breast-conserving therapy can be omitted without compromising survival has remained unclear.MethodsIn this prospective, randomized, noninferiority trial, we investigated the omission of axillary surgery as compared with sentinel-lymph-node biopsy in patients with clinically node-negative invasive breast cancer staged as T1 or T2 (tumor size, ≤5 cm) who were scheduled to undergo breast-conserving surgery. We report here the per-protocol analysis of invasive disease-free survival (the primary efficacy outcome). To show the noninferiority of the omission of axillary surgery, the 5-year invasive disease-free survival rate had to be at least 85%, and the upper limit of the confidence interval for the hazard ratio for invasive disease or death had to be below 1.271.ResultsA total of 5502 eligible patients (90% with clinical T1 cancer and 79% with pathological T1 cancer) underwent randomization in a 1:4 ratio. The per-protocol population included 4858 patients; 962 were assigned to undergo treatment without axillary surgery (the surgery-omission group), and 3896 to undergo sentinel-lymph-node biopsy (the surgery group). The median follow-up was 73.6 months. The estimated 5-year invasive disease-free survival rate was 91.9% (95% confidence interval [CI], 89.9 to 93.5) among patients in the surgery-omission group and 91.7% (95% CI, 90.8 to 92.6) among patients in the surgery group, with a hazard ratio of 0.91 (95% CI, 0.73 to 1.14), which was below the prespecified noninferiority margin. The analysis of the first primary-outcome events (occurrence or recurrence of invasive disease or death from any cause), which occurred in a total of 525 patients (10.8%), showed apparent differences between the surgery-omission group and the surgery group in the incidence of axillary recurrence (1.0% vs. 0.3%) and death (1.4% vs. 2.4%). The safety analysis indicates that patients in the surgery-omission group had a lower incidence of lymphedema, greater arm mobility, and less pain with movement of the arm or shoulder than patients who underwent sentinel-lymph-node biopsy.ConclusionsIn this trial involving patients with clinically node-negative, T1 or T2 invasive breast cancer (90% with clinical T1 cancer and 79% with pathological T1 cancer), omission of surgical axillary staging was noninferior to sentinel-lymph-node biopsy after a median follow-up of 6 years. (Funded by the German Cancer Aid; INSEMA ClinicalTrials.gov number, NCT02466737.).Copyright © 2024 Massachusetts Medical Society.

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