Lymph node surgery and CDK4/6 inhibitors in early breast cancer: a pooled analysis from five randomised trials
Background - Omitting sentinel lymph node biopsy (SLNB) and completion axillary lymph node dissection (cALND) in early-stage breast cancer reduces morbidity without compromising overall survival or recurrence rates. However, reduced axillary surgery restricts staging information, impacting eligibili...
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| Main Authors: | , , , , , , , , , |
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| Format: | Article (Journal) |
| Language: | English |
| Published: |
May 2026
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| In: |
The lancet. Oncology
Year: 2026, Volume: 27, Issue: 5, Pages: 604-613 |
| ISSN: | 1474-5488 |
| DOI: | 10.1016/S1470-2045(26)00064-1 |
| Online Access: | Verlag, lizenzpflichtig, Volltext: https://doi.org/10.1016/S1470-2045(26)00064-1 Verlag, lizenzpflichtig, Volltext: https://www.sciencedirect.com/science/article/pii/S1470204526000641 
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| Author Notes: | André Pfob, Thi Hao Pham, Jana de Boniface, Oreste Davide Gentilini, Sibylle Loibl, Andreas Schneeweiss, Maarten Postma, Antoinette DI van Asselt, Toralf Reimer, Jörg Heil |
| Summary: | Background - Omitting sentinel lymph node biopsy (SLNB) and completion axillary lymph node dissection (cALND) in early-stage breast cancer reduces morbidity without compromising overall survival or recurrence rates. However, reduced axillary surgery restricts staging information, impacting eligibility for CDK4/6 inhibitors. We evaluated the impact of omitting SLNB or cALND on CDK4/6 inhibitor eligibility and the associated benefits and harms. - Methods - We used data from the SOUND, INSEMA, SENOMAC, monarchE, and NATALEE randomised trials. These five trials evaluated the safety of de-escalated lymph node surgery and adjuvant CDK4/6 inhibitors in patients with early breast cancer. The primary outcome was the number needed to diagnose and treat with CDK4/6 inhibitor—ie, number of axillary surgeries leading to adjuvant CDK4/6 inhibitor use, preventing one invasive disease-free survival event, distant disease-free survival event, or overall survival event at 5 years. - Findings - Between Jan 31, 2015, and Dec 31, 2021, 19 541 patients were randomly assigned and analysed within five trials, of whom 19 475 (99·7%) were women and 66 (0·3%) were men; median follow-up was 57·2 months (IQR 44·1-81·6). For SLNB and ribociclib, the number needed to diagnose and treat for one prevented event was 123 for invasive disease-free survival, 129 for distant disease-free survival, and 345 for overall survival. For cALND and abemaciclib, the number needed to diagnose and treat for one prevented event was 106 invasive disease-free survival, 119 for distant disease-free survival, and 807 for overall survival. - Interpretation - Performing SLNB or cALND solely to determine eligibility for CDK4/6 inhibition requires very high number needed to diagnose and treat, adds substantial morbidity, and is costly, with only marginal overall survival benefit. - Funding - None. |
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| Item Description: | Online verfügbar: 27. April 2026 Gesehen am 14.08.2026 |
| Physical Description: | Online Resource |
| ISSN: | 1474-5488 |
| DOI: | 10.1016/S1470-2045(26)00064-1 |