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  3. Research Domains
  5. Biomedical And Clinical Sciences
  7. Oncology And Carcinogenesis
  9. Predictive And Prognostic Markers
  11. Completion Axillary Lymph Node Dissection For The Identification Of Pn2-3 Status As An Indication For Adjuvant Cdk4/6 Inhibitor Treatment: A Post-hoc Analysis Of The Randomised, Phase 3 Senomac Trial.
  1. Home
  3. Research Domains
  5. Biomedical And Clinical Sciences
  7. Oncology And Carcinogenesis
  9. Predictive And Prognostic Markers
  11. Completion Axillary Lymph Node Dissection For The Identification Of Pn2-3 Status As An Indication For Adjuvant Cdk4/6 Inhibitor Treatment: A Post-hoc Analysis Of The Randomised, Phase 3 Senomac Trial.

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Completion axillary lymph node dissection for the identification of pN2-3 status as an indication for adjuvant CDK4/6 inhibitor treatment: a post-hoc analysis of the randomised, phase 3 SENOMAC trial.

Jana de Boniface1, Matilda Appelgren1, Robert Szulkin2

  • 1Department of Molecular Medicine and Surgery, Karolinska Institutet, Stockholm, Sweden; Department of Surgery, Breast Center, Capio St Göran's Hospital, Stockholm, Sweden.

The Lancet. Oncology
|August 9, 2024

View abstract on PubMed

Summary
This summary is machine-generated.

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Completion axillary lymph node dissection (cALND) for early breast cancer patients may identify need for adjuvant abemaciclib but causes significant arm morbidity. Omitting cALND in select patients avoids arm problems without compromising survival outcomes.

Area of Science:

  • Oncology
  • Surgical Oncology
  • Clinical Trials

Background:

  • Adjuvant CDK4/6 inhibitors improve survival in luminal breast cancer.
  • Completion axillary lymph node dissection (cALND) is used to identify patients needing adjuvant abemaciclib based on nodal metastases.
  • cALND can cause significant arm morbidity.

Purpose of the Study:

  • To pragmatically assess the individual patient-level benefit and harm of cALND in luminal breast cancer.
  • To evaluate the risk of arm morbidity associated with cALND versus sentinel lymph node biopsy alone.
  • To determine if the potential benefit of identifying patients for adjuvant abemaciclib outweighs the harm of cALND.

Main Methods:

  • Post-hoc analysis of patients from the SENOMAC trial with specific tumor characteristics (T1-2, grade 1-2, luminal, HER2-negative).
  • Comparison of severe/very severe arm function impairment (Lymph-ICF Questionnaire) 1 year after cALND versus sentinel lymph node biopsy only.
  • Calculation of the number of patients needing cALND to prevent one invasive disease-free survival event.

    • Main Results:

    • Severe or very severe impairment of physical arm function was reported in 13% of patients after cALND versus 4% after sentinel lymph node biopsy only (p<0.0001).
    • To avoid one invasive disease-free survival event, 104 patients would need cALND, resulting in 9 cases of severe arm impairment.
    • The SENOMAC trial is a randomized phase 3 trial (NCT02240472).

    Conclusions:

    • cALND carries a substantial risk of severe arm morbidity.
    • Discouraging cALND for the sole purpose of identifying eligibility for adjuvant abemaciclib is recommended.
    • Omitting cALND in select early breast cancer patients may be a safer strategy.