LymphedemaV1, Main, Exploration, bibRecord, 004B49

Sentinel Lymph Node Dissection With and Without Axillary Dissection in Women With Invasive Breast Cancer and Sentinel Node Metastasis: A Randomized Clinical Trial

Identifieur interne : 004B49 ( Main/Exploration ); précédent : 004B48; suivant : 004B50

Sentinel Lymph Node Dissection With and Without Axillary Dissection in Women With Invasive Breast Cancer and Sentinel Node Metastasis: A Randomized Clinical Trial

Auteurs : Armando E. Giuliano [États-Unis] ; Kelly K. Hunt [États-Unis] ; Karla. V. Ballman [États-Unis] ; Peter D. Beitsch [États-Unis] ; Pat W. Whitworth [États-Unis] ; Peter W. Blumencranz [États-Unis] ; A. Marilyn Leitch [États-Unis] ; Sukamal Saha [États-Unis] ; Linda M. Mccall [États-Unis] ; Monica Morrow [États-Unis]

Source :

JAMA [ 0098-7484 ] ; 2011.

RBID : PMC:5389857

Abstract

Context

Sentinel lymph node dissection (SLND) accurately identifies nodal metastasis of early breast cancer.

Objective

To determine the impact of complete axillary lymph node dissection (ALND) on survival of patients with sentinel lymph node (SLN) metastasis of breast cancer.

Design and Setting

The 115 sites participating in the American College of Surgeons Oncology Group Z0011 trial enrolled patients from May 1999 to December 2004. In this phase III noninferiority trial, patients with SLN metastasis were randomized to ALND or no further axillary treatment. Targeted enrollment was 1900 women, with final analysis after 500 deaths, but the trial closed early because mortality rate was lower than expected.

Patients

Women with clinical T1–T2 invasive breast cancer, no palpable adenopathy, and 1–2 SLNs containing metastases identified by frozen section, touch preparation, or hematoxylin and eosin staining on permanent section.

Interventions

All patients underwent lumpectomy and tangential whole-breast irradiation. Those randomized to ALND underwent dissection of ≥10 nodes. Systemic therapy was at the discretion of the treating physician.

Main Outcome Measures

Overall survival (OS) was the primary endpoint, with a noninferiority margin of a one-sided hazard ratio of 1.3 or less favoring ALND. Disease-free survival (DFS) was a secondary endpoint.

Results

Clinical and tumor characteristics were similar between 445 patients randomized to ALND and 446 randomized to SLND alone. However, the median number of nodes removed was 17 with ALND and 2 with SLND alone. At a median follow-up of 6.3 years (last follow-up date 03/04/2010), 5-year OS was 91.8% (95% CI: 89.1 to 94.5) with ALND and 92.5% (95% CI: 90.0 to 95.1) with SLND alone; 5-year DFS was 82.2% (95% CI: 78.3 to 86.3) with ALND and 83.9% (95% CI: 80.2 to 87.9) with SLND alone. Hazard ratio for treatment-related OS was 0.79 (90% CI: 0.56 to 1.11) without adjustment and 0.87 (90% CI: 0.62 to 1.23) after adjusting for age and adjuvant therapy.

Conclusions

Among patients with limited SLN metastatic breast cancer treated with breast conservation and systemic therapy, the use of SLND compared with ALND did not result in inferior survival.

Url:

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5389857

DOI: 10.1001/jama.2011.90
PubMed: 21304082
PubMed Central: 5389857

Affiliations:

Le document en format XML

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<author><name sortKey="Mccall, Linda M" sort="Mccall, Linda M" uniqKey="Mccall L" first="Linda M." last="Mccall">Linda M. Mccall</name>
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<author><name sortKey="Morrow, Monica" sort="Morrow, Monica" uniqKey="Morrow M" first="Monica" last="Morrow">Monica Morrow</name>
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<sourceDesc><biblStruct><analytic><title xml:lang="en" level="a" type="main">Sentinel Lymph Node Dissection With and Without Axillary Dissection in Women With Invasive Breast Cancer and Sentinel Node Metastasis: A Randomized Clinical Trial</title>
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<country xml:lang="fr">États-Unis</country>
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<country xml:lang="fr">États-Unis</country>
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<series><title level="j">JAMA</title>
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<front><div type="abstract" xml:lang="en"><sec id="S1"><title>Context</title>
<p id="P1">Sentinel lymph node dissection (SLND) accurately identifies nodal metastasis of early breast cancer.</p>
</sec>
<sec id="S2"><title>Objective</title>
<p id="P2">To determine the impact of complete axillary lymph node dissection (ALND) on survival of patients with sentinel lymph node (SLN) metastasis of breast cancer.</p>
</sec>
<sec id="S3"><title>Design and Setting</title>
<p id="P3">The 115 sites participating in the American College of Surgeons Oncology Group Z0011 trial enrolled patients from May 1999 to December 2004. In this phase III noninferiority trial, patients with SLN metastasis were randomized to ALND or no further axillary treatment. Targeted enrollment was 1900 women, with final analysis after 500 deaths, but the trial closed early because mortality rate was lower than expected.</p>
</sec>
<sec id="S4"><title>Patients</title>
<p id="P4">Women with clinical T1–T2 invasive breast cancer, no palpable adenopathy, and 1–2 SLNs containing metastases identified by frozen section, touch preparation, or hematoxylin and eosin staining on permanent section.</p>
</sec>
<sec id="S5"><title>Interventions</title>
<p id="P5">All patients underwent lumpectomy and tangential whole-breast irradiation. Those randomized to ALND underwent dissection of ≥10 nodes. Systemic therapy was at the discretion of the treating physician.</p>
</sec>
<sec id="S6"><title>Main Outcome Measures</title>
<p id="P6">Overall survival (OS) was the primary endpoint, with a noninferiority margin of a one-sided hazard ratio of 1.3 or less favoring ALND. Disease-free survival (DFS) was a secondary endpoint.</p>
</sec>
<sec id="S7"><title>Results</title>
<p id="P7">Clinical and tumor characteristics were similar between 445 patients randomized to ALND and 446 randomized to SLND alone. However, the median number of nodes removed was 17 with ALND and 2 with SLND alone. At a median follow-up of 6.3 years (last follow-up date 03/04/2010), 5-year OS was 91.8% (95% CI: 89.1 to 94.5) with ALND and 92.5% (95% CI: 90.0 to 95.1) with SLND alone; 5-year DFS was 82.2% (95% CI: 78.3 to 86.3) with ALND and 83.9% (95% CI: 80.2 to 87.9) with SLND alone. Hazard ratio for treatment-related OS was 0.79 (90% CI: 0.56 to 1.11) without adjustment and 0.87 (90% CI: 0.62 to 1.23) after adjusting for age and adjuvant therapy.</p>
</sec>
<sec id="S8"><title>Conclusions</title>
<p id="P8">Among patients with limited SLN metastatic breast cancer treated with breast conservation and systemic therapy, the use of SLND compared with ALND did not result in inferior survival.</p>
</sec>
</div>
</front>
</TEI>
<affiliations><list><country><li>États-Unis</li>
</country>
<region><li>Californie</li>
<li>Caroline du Nord</li>
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<li>Michigan</li>
<li>Minnesota</li>
<li>Tennessee</li>
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<li>État de New York</li>
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<tree><country name="États-Unis"><region name="Californie"><name sortKey="Giuliano, Armando E" sort="Giuliano, Armando E" uniqKey="Giuliano A" first="Armando E." last="Giuliano">Armando E. Giuliano</name>
</region>
<name sortKey="Ballman, Karla V" sort="Ballman, Karla V" uniqKey="Ballman K" first="Karla. V." last="Ballman">Karla. V. Ballman</name>
<name sortKey="Beitsch, Peter D" sort="Beitsch, Peter D" uniqKey="Beitsch P" first="Peter D." last="Beitsch">Peter D. Beitsch</name>
<name sortKey="Blumencranz, Peter W" sort="Blumencranz, Peter W" uniqKey="Blumencranz P" first="Peter W." last="Blumencranz">Peter W. Blumencranz</name>
<name sortKey="Hunt, Kelly K" sort="Hunt, Kelly K" uniqKey="Hunt K" first="Kelly K." last="Hunt">Kelly K. Hunt</name>
<name sortKey="Leitch, A Marilyn" sort="Leitch, A Marilyn" uniqKey="Leitch A" first="A. Marilyn" last="Leitch">A. Marilyn Leitch</name>
<name sortKey="Mccall, Linda M" sort="Mccall, Linda M" uniqKey="Mccall L" first="Linda M." last="Mccall">Linda M. Mccall</name>
<name sortKey="Morrow, Monica" sort="Morrow, Monica" uniqKey="Morrow M" first="Monica" last="Morrow">Monica Morrow</name>
<name sortKey="Saha, Sukamal" sort="Saha, Sukamal" uniqKey="Saha S" first="Sukamal" last="Saha">Sukamal Saha</name>
<name sortKey="Whitworth, Pat W" sort="Whitworth, Pat W" uniqKey="Whitworth P" first="Pat W." last="Whitworth">Pat W. Whitworth</name>
</country>
</tree>
</affiliations>
</record>

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Sentinel Lymph Node Dissection With and Without Axillary Dissection in Women With Invasive Breast Cancer and Sentinel Node Metastasis: A Randomized Clinical Trial

Sentinel Lymph Node Dissection With and Without Axillary Dissection in Women With Invasive Breast Cancer and Sentinel Node Metastasis: A Randomized Clinical Trial

Source :

Abstract

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