Stage migration after introduction of sentinel lymph node dissection in breast cancer treatment in Denmark: A nationwide study

Tvedskov, Tove Filtenborg; Jensen, Maj‐Britt; Balslev, Eva; Ejlertsen, Bent; Kroman, Niels

doi:10.1016/j.ejca.2010.11.022

Cited by 34 publications

(19 citation statements)

References 29 publications

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“…This is consistent with our retrospective study and others demonstrating that patients with a false negative AUS typically have minimal disease in the axilla [38, 39]. Of note, micrometastatic disease in the axilla (disease < 2.0 mm) has almost no impact on prognosis and medical decision making [40-45]. Numerous studies have demonstrated that additional sections, immunohistochemistry (IHC), or molecular analysis of “negative” SLN will identify “occult” micrometastatic disease in a significant proportion of cases, and occult disease has minimal impact on clinical outcome.…”

Section: Discussionsupporting

confidence: 91%

Successful Completion of the Pilot Phase of a Randomized Controlled Trial Comparing Sentinel Lymph Node Biopsy to No Further Axillary Staging in Patients with Clinical T1-T2 N0 Breast Cancer and Normal Axillary Ultrasound

Cyr

Tucker

Ademuyiwa

et al. 2016

Journal of the American College of Surgeons

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Background Axillary surgery is not considered therapeutic in patients with clinical T1-T2 N0 breast cancer. The importance of axillary staging is eroding in an era where tumor biology, as defined by biomarker and gene expression profile, is increasingly important in medical decision making. We hypothesize that axillary ultrasound (AUS) is a noninvasive alternative to sentinel lymph node biopsy (SLNB), and AUS could replace SLNB without compromising patient care. Study Design Patients with clinical T1-T2 N0 breast cancer and normal AUS were eligible for enrollment. Subjects were randomized to no further axillary staging (Arm 1) versus SLNB (Arm 2). Descriptive statistics were used to describe the results of the pilot phase of the randomized controlled trial. Results 68 subjects were enrolled in the pilot phase of the trial (34 subjects in Arm 1, no further staging; 32 subjects in Arm 2, SLNB, and 2 subjects voluntarily withdrew from the trial). The median age was 61 years (range 40-80) in Arm 1 and 59 years (range 31-81) in Arm 2, and there were no significant clinical or pathologic differences between the arms. Median follow-up was 17 months (range 1-32). The negative predictive value (NPV) of AUS for identification of clinically significant axillary disease (> 2.0 mm) was 96.9%. No axillary recurrences have been observed in either arm. Conclusions Successful completion of the pilot phase of the randomized controlled trial confirms the feasibility of the study design, and provides prospective evidence supporting the ability of AUS to exclude clinically significant disease in the axilla. The results provide strong support for a phase 2 randomized controlled trial.

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Section: Discussionsupporting

confidence: 91%

Successful Completion of the Pilot Phase of a Randomized Controlled Trial Comparing Sentinel Lymph Node Biopsy to No Further Axillary Staging in Patients with Clinical T1-T2 N0 Breast Cancer and Normal Axillary Ultrasound

Cyr

Tucker

Ademuyiwa

et al. 2016

Journal of the American College of Surgeons

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“…Thus, although the effect of untreated micrometastases in Z0010 patients is unknown, it is not relevant to current practice. This conclusion is supported by a population-based study of 24,051 patients in Denmark, 19 which reported that micrometastasis was the sole indication for administration of chemotherapy in only 2.1% of patients. Decisions regarding adjuvant systemic therapy most often reflect consideration of biologic or molecular factors associated with the primary tumor.…”

Section: Discussionmentioning

confidence: 75%

Association of Occult Metastases in Sentinel Lymph Nodes and Bone Marrow With Survival Among Women With Early-Stage Invasive Breast Cancer

Giuliano¹,

Hawes²,

Ballman³

et al. 2011

JAMA

245

119

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Context Immunochemical staining of sentinel lymph nodes (SLNs) and bone marrow identifies breast cancer metastases not seen with routine pathologic or clinical examination. Objective To determine the association between survival and metastases detected by immunochemical staining of SLNs and bone marrow from patients with early-stage breast cancer. Design, Setting, and Patients From May 1999 to May 2003, 126 sites in the American College of Surgeons Oncology Group Z0010 trial enrolled women with clinical T1–T2, N0, M0 invasive breast carcinoma in a prospective observational study. Interventions All patients underwent breast-conserving surgery and SLN dissection; bone marrow aspiration at the time of operation was initially optional and subsequently mandatory (March 2001). SLN specimens (hematoxylin-eosin negative) and bone marrow specimens were sent to a central laboratory for immunochemical staining; treating clinicians were blinded to results. Main Outcome Measures Overall survival (primary end point) and disease-free survival (a secondary end point). Results Of 5119 (98.3%) SLN specimens, 3904 (76.3%) were tumor-negative by hematoxylin-eosin staining. Of 3326 SLN specimens examined by immunohistochemistry, 349 (10.5%) were tumor-positive. Of 3413 bone marrow specimens examined by immunocytochemistry, 104 (3.0%) were positive. At a median follow-up of 6.3 years (through April 2010), 435 patients had died and 376 had disease recurrence. Immunohistochemical evidence of SLN metastases was not significantly associated with overall survival (5-year rates: 95.7% (95% CI, 95.0%–96.5%) for immunohistochemical positive and 95.1% (95% CI, 92.7%–97.5% for immunohistochemical negative disease, P=0.64), unadjusted hazard ratio [HR], 0.90; 95% confidence interval [CI], 0.59–1.39; P=.64). Bone marrow metastases were associated with decreased overall survival (5-year rates: 95.0% (95% CI, 94.3%–95.8%) and 90.1% (95% CI, 84.5%–96.1%), respectively (P=.01) (unadjusted HR, 1.94; 95% CI, 1.02–3.67; P=.04), but neither immunohistochemical evidence of tumor in SLNs (adjusted HR, 0.88; 95% CI, 0.45–1.71; P=.70) nor immunocytochemical evidence of tumor in bone marrow (adjusted HR, 1.83; 95% CI, 0.79–4.26; P=.15) was statistically significant on multivariable analysis. Conclusion Among women receiving breast-conserving therapy and SLN dissection, immunochemical evidence of SLN metastasis was not associated with decreased overall survival over a median of 6.3 years whereas, occult bone marrow metastasis, although rare, was associated with decreased survival. Trial Registration ClinicalTrials.gov number, NCT00003854

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“…It is possible that more extensive sampling might have identified treatment changes in some of these cases just as the use of serial sectioning of the SN identifies more tumor than bisecting the node and making a slide from each face. 10,11 …”

Section: Discussionmentioning

confidence: 99%

How Often Is Treatment Effect Identified in Axillary Nodes with a Pathologic Complete Response After Neoadjuvant Chemotherapy?

et al. 2016

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Background False-negative rates (FNR) of sentinel node biopsy (SNB) after neoadjuvant chemotherapy (NAC) in node-positive (N+) breast cancer patients are < 10% when ≥ 3 negative SNs are obtained. Marking positive nodes has been suggested to reduce FNR. Identification of treatment effect in the nodes post-NAC is an alternative to decrease FNR. We evaluated the frequency of treatment effect in N+ patients after a pathologic complete response (pCR) with NAC. Methods Biopsy-proven N+ patients receiving NAC were identified. Patients with nodal pCR after ALND or SNB with dual mapping and ≥ 3 SNs removed were evaluated for treatment effect; ALND and SNB patients were compared. Results From 01/09–12/15, 528 N+ patients received NAC. Of these, 204 had a nodal pCR; 135 had an ALND and 69 had SNB. Median age was 49yrs, 15% were hormone receptor positive (HR+)/HER2-, 27% triple negative, and 58% HER2+. The median number of nodes removed in ALND patients was 17 versus 4 in SNB patients. Treatment effect in nodes was identified in 192 (94%) patients, and was more common in ALND versus SNB patients (97% versus 88%, p=0.02). HR+ patients and patients without a breast pCR were less likely to have treatment effect in the nodes (p=0.05). Other characteristics did not differ. Conclusions Following NAC, SNs with treatment effect were retrieved in 88% of patients without marking nodes, suggesting that nodal clipping may not be necessary to achieve an acceptable FNR. Longer follow-up is needed to determine regional recurrence rates in the SN-only cohort.

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Stage migration after introduction of sentinel lymph node dissection in breast cancer treatment in Denmark: A nationwide study

Cited by 34 publications

References 29 publications

Successful Completion of the Pilot Phase of a Randomized Controlled Trial Comparing Sentinel Lymph Node Biopsy to No Further Axillary Staging in Patients with Clinical T1-T2 N0 Breast Cancer and Normal Axillary Ultrasound

Successful Completion of the Pilot Phase of a Randomized Controlled Trial Comparing Sentinel Lymph Node Biopsy to No Further Axillary Staging in Patients with Clinical T1-T2 N0 Breast Cancer and Normal Axillary Ultrasound

Association of Occult Metastases in Sentinel Lymph Nodes and Bone Marrow With Survival Among Women With Early-Stage Invasive Breast Cancer

How Often Is Treatment Effect Identified in Axillary Nodes with a Pathologic Complete Response After Neoadjuvant Chemotherapy?

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