Abstract
PurposeIncreasing evidence suggests that completion axillary lymph node dissection (ALND) may be omitted in breast cancer patients with limited axillary nodal metastases. However, the representativeness of trial participants for the original clinical practice population, and thus, the generalizability of published trials have been questioned. We propose the use of background data from national registers as a means to assess whether trial participants mirror their target population and to strengthen the generalizability and implementation of trial outcomes.MethodsThe Swedish prospective SENOMIC trial, omitting a completion ALND in breast cancer patients with sentinel lymph node micrometastases, reached full target accrual in 2017. To assess the generalizability of trial results for the target population, a comparative analysis of trial participants versus cases reported to the Swedish National Breast Cancer Register (NKBC) was performed.ResultsComparing 548 trial participants and 1070 NKBC cases, there were no significant differences in age, tumor characteristics, breast surgery, or adjuvant treatment. Only the mean number of sentinel lymph nodes with micrometastasis per individual was lower in trial participants than in register cases (1.06 vs. 1.09, p = 0.037).ConclusionsPatients included in the SENOMIC trial are acceptably representative of the Swedish breast cancer target population. There were some minor divergences between trial participants and the NKBC population, but taking these into consideration, upcoming trial outcomes should be generalizable to breast cancer patients with micrometastases in their sentinel lymph node biopsy.
Highlights
Sentinel lymph node biopsy (SLN biopsy) is the standard axillary staging procedure in breast cancer and in SLNnegative patients, completion axillary lymph node dissection (ALND) is omitted without compromising oncological safety [1–4]
Between January 2014 and March 2017, 566 patients were included in the SENOMIC trial and 1162 new eligible breast cancer cases reported to the Swedish National Breast Cancer Register (NKBC)
There were 23 sites participating in the SENOMIC trial and 39 sites reporting to NKBC
Summary
Sentinel lymph node biopsy (SLN biopsy) is the standard axillary staging procedure in breast cancer and in SLNnegative patients, completion axillary lymph node dissection (ALND) is omitted without compromising oncological safety [1–4]. The randomized ACOSOG Z0011 and IBCSG 23-01 trials found no survival benefit in SLN-positive patients who had completion ALND compared with those who had SLN biopsy only [10–12]. This had a major impact on clinical practice: In many countries, completion ALND is today omitted in patients with. The generalizability of results has been questioned [13–16] Both ACOSOG Z0011 and IBCSG 23-01 closed early due to slow accrual and low event rates, and the majority of included patients had favorable prognostic tumor characteristics [17, 18].
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