Omitting sentinel lymph node biopsy improves arm symptoms

Patients with early-stage breast cancer have better quality of life outcomes when forgoing a sentinel lymph node biopsy (SLNB) and axillary lymph node dissection (ALND), results from the INSEMA trial showed. Patients had improved arm symptoms and functioning with omitting SLNB versus ALND.

Despite increasing evidence disfavouring ALND for loco-regional control, it remains part of guidelines for breast cancer treatment. In an attempt to re-evaluate standard local therapy, the INSEMA trial (NCT02466737) was designed to assess non-inferiority of avoiding SLNB or completion ALND (cALND) in early-stage, clinically node-negative breast cancer patients. First, 5,154 patients were randomised 1:4 to no SLNB and SLNB. Patients with pN1a(sn) metastasis in the SLNB arm were 1:1 randomised to either SLNB alone (no further surgery) or cALND. Primary outcome data are expected to be complete in 2024. Patient-reported outcomes were assessed at baseline as well as at 1, 3, 6, 12, and 18 months after final axillary surgery. Prof. Bernd Gerber (University of Rostock, Germany) presented the results [1].

Of 4,124 patients undergoing a SLNB, 485 patients were randomised between SLNB alone and cALND. Overall, recruited patients presented with low-risk breast cancer. All quality-of-life baseline parameters were well-balanced between arms. There were significant and persistent differences for the breast symptoms and arm symptoms scores favouring the no SLNB group in all post-baseline assessments. However, these differences were clinically meaningful only for the BRAS score. In particular, lower pain and arm or shoulder scores, swelling in arm or hand, and arm mobility favoured no SLNB over SLNB in the first randomisation (P<0.001). In addition, in patients who underwent a second randomisation, there were significant and clinically meaningful differences for the BRAS scores, which were better in the SLNB group compared with the cALND group.

“This first randomised trial investigating the omission of SLNB in clinically node-negative patients shows that omitting SLNB improves arm symptoms with no relevant differences in other quality of life scales. In addition, in patients who underwent SLNB, omitting cALND improved arm symptoms,” concluded Prof. Gerber.

1. Gerber B, et al. Patient-reported outcomes (PROs) for the intergroup sentinel mamma study (INSEMA, GBG75, ABCSG43): Persistent impact of axillary surgery on arm and breast symptoms in early breast cancer. GS4-03, SABCS 2021 Virtual Meeting, 7–10 December.

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Posted on 31 January, 2022