- Background:
- Sentinel node (SN) biopsy (SNB) with immunohistochemistry (IHC) of histologically negative SN:
- Identifies metastases not seen by standard histology
- The impact of IHC-detected BM metastasis:
- Has been reported in several large single-institution studies
- 5,539 patients were entered into this prospective multicenter observational study:
- To determine the clinical significance of SN and BM mets
- Sentinel node (SN) biopsy (SNB) with immunohistochemistry (IHC) of histologically negative SN:
- Methods:
- Patients underwent lumpectomy and SNB with bilateral iliac crest BM aspiration
- BM and histologically negative SN were evaluated:
- With IHC in a central laboratory (results not clinically reported)
- Overall survival (OS), disease-free survival, and locoregional recurrence were determined
- Results with OS (the primary endpoint) are shown here
- Results:
- SN were successfully identified:
- In 5,184 of 5,485 pts:
- 94.5%
- In 5,184 of 5,485 pts:
- Histologic SN mets were found:
- In 1,239 pts:
- 23.9%
- In 1,239 pts:
- IHC detected:
- An additional 350 pts (10.5%) with SN metastasis
- BM metastasis were identified by IHC:
- In 105 of 3491 examined (3.0%)
- 5-yr overall survival is shown in the Table
- BM IHC positivity:
- Significantly predicted:
- Decreased OS (p=0.015)
- Significantly predicted:
- A multivariable analysis that included:
- SN and BM status, ER, PR, grade, size, and age:
- Showed that neither IHC detected metastasis in SN (p=0.66) or BM (p=0.08):
- Were independent predictors of OS:
- Although BM status showed a strong trend
- Were independent predictors of OS:
- Showed that neither IHC detected metastasis in SN (p=0.66) or BM (p=0.08):
- SN and BM status, ER, PR, grade, size, and age:
- SN were successfully identified:
- Conclusions:
- The detection of BM metastasis by IHC in patients with clinical T1 to T2, N0, M0 breast cancer:
- Identifies those patients at significantly increased risk for death
- The impact of BM metastasis on outcome:
- Supports and confirms prior studies
- In this study:
- SN IHC-detected metastasis:
- Appear to have no significant impact on OS
- The routine examination of SN by IHC:
- Is not supported in this patient population by this study
- SN IHC-detected metastasis:
- The detection of BM metastasis by IHC in patients with clinical T1 to T2, N0, M0 breast cancer:

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