A Randomized Trial Comparing Axillary Dissection to No Axillary Dissection in Older Patients With T1N0 Breast Cancer
Identifieur interne : 001227 ( Pmc/Curation ); précédent : 001226; suivant : 001228A Randomized Trial Comparing Axillary Dissection to No Axillary Dissection in Older Patients With T1N0 Breast Cancer
Auteurs : Gabriele Martelli ; Patrizia Boracchi ; Michaela De Palo ; Silvana Pilotti ; Saro Oriana ; Roberto Zucali ; Maria Grazia Daidone ; Giuseppe De PaloSource :
- Annals of Surgery [ 0003-4932 ] ; 2005.
Abstract
Axillary dissection, an invasive procedure that may adversely affect quality of life, used to obtain prognostic information in breast cancer, is being supplanted by sentinel node biopsy. In older women with early breast cancer and no palpable axillary nodes, it may be safe to give no axillary treatment. We addressed this issue in a randomized trial comparing axillary dissection with no axillary dissection in older patients with T1N0 breast cancer.
From 1996 to 2000, 219 women, 65 to 80 years of age, with early breast cancer and clinically negative axillary nodes were randomized to conservative breast surgery with or without axillary dissection. Tamoxifen was prescribed to all patients for 5 years. The primary endpoints were axillary events in the no axillary dissection arm, comparison of overall mortality (by log rank test), breast cancer mortality, and breast events (by Gray test).
Considering a follow-up of 60 months, there were no significant differences in overall or breast cancer mortality, or crude cumulative incidence of breast events, between the 2 groups. Only 2 patients in the no axillary dissection arm (8 and 40 months after surgery) developed overt axillary involvement during follow-up.
Older patients with T1N0 breast cancer can be treated by conservative breast surgery and no axillary dissection without adversely affecting breast cancer mortality or overall survival. The very low cumulative incidence of axillary events suggests that even sentinel node biopsy is unnecessary in these patients. Axillary dissection should be reserved for the small proportion of patients who later develop overt axillary disease.
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DOI: 10.1097/01.sla.0000167759.15670.14
PubMed: 15973094
PubMed Central: 1357697
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<author><name sortKey="Martelli, Gabriele" sort="Martelli, Gabriele" uniqKey="Martelli G" first="Gabriele" last="Martelli">Gabriele Martelli</name>
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<author><name sortKey="Boracchi, Patrizia" sort="Boracchi, Patrizia" uniqKey="Boracchi P" first="Patrizia" last="Boracchi">Patrizia Boracchi</name>
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<author><name sortKey="De Palo, Michaela" sort="De Palo, Michaela" uniqKey="De Palo M" first="Michaela" last="De Palo">Michaela De Palo</name>
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<author><name sortKey="Daidone, Maria Grazia" sort="Daidone, Maria Grazia" uniqKey="Daidone M" first="Maria Grazia" last="Daidone">Maria Grazia Daidone</name>
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<author><name sortKey="Boracchi, Patrizia" sort="Boracchi, Patrizia" uniqKey="Boracchi P" first="Patrizia" last="Boracchi">Patrizia Boracchi</name>
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<author><name sortKey="De Palo, Michaela" sort="De Palo, Michaela" uniqKey="De Palo M" first="Michaela" last="De Palo">Michaela De Palo</name>
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<author><name sortKey="Daidone, Maria Grazia" sort="Daidone, Maria Grazia" uniqKey="Daidone M" first="Maria Grazia" last="Daidone">Maria Grazia Daidone</name>
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<series><title level="j">Annals of Surgery</title>
<idno type="ISSN">0003-4932</idno>
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<imprint><date when="2005">2005</date>
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<front><div type="abstract" xml:lang="en"><sec><title>Summary Background Data:</title>
<p>Axillary dissection, an invasive procedure that may adversely affect quality of life, used to obtain prognostic information in breast cancer, is being supplanted by sentinel node biopsy. In older women with early breast cancer and no palpable axillary nodes, it may be safe to give no axillary treatment. We addressed this issue in a randomized trial comparing axillary dissection with no axillary dissection in older patients with T1N0 breast cancer.</p>
</sec>
<sec><title>Methods:</title>
<p>From 1996 to 2000, 219 women, 65 to 80 years of age, with early breast cancer and clinically negative axillary nodes were randomized to conservative breast surgery with or without axillary dissection. Tamoxifen was prescribed to all patients for 5 years. The primary endpoints were axillary events in the no axillary dissection arm, comparison of overall mortality (by log rank test), breast cancer mortality, and breast events (by Gray test).</p>
</sec>
<sec><title>Results:</title>
<p>Considering a follow-up of 60 months, there were no significant differences in overall or breast cancer mortality, or crude cumulative incidence of breast events, between the 2 groups. Only 2 patients in the no axillary dissection arm (8 and 40 months after surgery) developed overt axillary involvement during follow-up.</p>
</sec>
<sec><title>Conclusions:</title>
<p>Older patients with T1N0 breast cancer can be treated by conservative breast surgery and no axillary dissection without adversely affecting breast cancer mortality or overall survival. The very low cumulative incidence of axillary events suggests that even sentinel node biopsy is unnecessary in these patients. Axillary dissection should be reserved for the small proportion of patients who later develop overt axillary disease.</p>
</sec>
</div>
</front>
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<pmc article-type="other"><pmc-comment>The publisher of this article does not allow downloading of the full text in XML form.</pmc-comment>
<front><journal-meta><journal-id journal-id-type="nlm-ta">Ann Surg</journal-id>
<journal-id journal-id-type="publisher-id">Annals of Surgery</journal-id>
<journal-title>Annals of Surgery</journal-title>
<issn pub-type="ppub">0003-4932</issn>
<issn pub-type="epub">1528-1140</issn>
</journal-meta>
<article-meta><article-id pub-id-type="pmid">15973094</article-id>
<article-id pub-id-type="pmc">1357697</article-id>
<article-id pub-id-type="publisher-id">0000658-200507000-00001</article-id>
<article-id pub-id-type="doi">10.1097/01.sla.0000167759.15670.14</article-id>
<article-categories><subj-group subj-group-type="heading"><subject>Feature</subject>
</subj-group>
</article-categories>
<title-group><article-title>A Randomized Trial Comparing Axillary Dissection to No Axillary Dissection in Older Patients With T1N0 Breast Cancer</article-title>
<subtitle>Results After 5 Years of Follow-up</subtitle>
</title-group>
<contrib-group><contrib contrib-type="author"><name><surname>Martelli</surname>
<given-names>Gabriele</given-names>
</name>
<degrees>MD</degrees>
<xref ref-type="aff" rid="N0x8b41838.0x913a558">*</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Boracchi</surname>
<given-names>Patrizia</given-names>
</name>
<degrees>PhD</degrees>
<xref ref-type="aff" rid="N0x8b41838.0x913a558">†</xref>
</contrib>
<contrib contrib-type="author"><name><surname>De Palo</surname>
<given-names>Michaela</given-names>
</name>
<degrees>PhD</degrees>
<xref ref-type="aff" rid="N0x8b41838.0x913a558">†</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Pilotti</surname>
<given-names>Silvana</given-names>
</name>
<degrees>MD</degrees>
<xref ref-type="aff" rid="N0x8b41838.0x913a558">‡</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Oriana</surname>
<given-names>Saro</given-names>
</name>
<degrees>MD</degrees>
<xref ref-type="aff" rid="N0x8b41838.0x913a558">§</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Zucali</surname>
<given-names>Roberto</given-names>
</name>
<degrees>MD</degrees>
<xref ref-type="aff" rid="N0x8b41838.0x913a558">∥</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Daidone</surname>
<given-names>Maria Grazia</given-names>
</name>
<degrees>PhD</degrees>
<xref ref-type="aff" rid="N0x8b41838.0x913a558">¶</xref>
</contrib>
<contrib contrib-type="author"><name><surname>De Palo</surname>
<given-names>Giuseppe</given-names>
</name>
<degrees>MD</degrees>
<xref ref-type="aff" rid="N0x8b41838.0x913a558">*</xref>
</contrib>
</contrib-group>
<aff id="N0x8b41838.0x913a558">From the *Unit of Diagnostic Oncology and Out-Patient Clinic, †Unit of Medical Statistics and Biometry, ‡Unit of Pathology, §Unit of Surgical Oncology, ∥Unit of Radiotherapy, and ¶Unit of Biomolecular Determinants in Prognosis and Therapy, Istituto Nazionale Tumori, Milan, Italy.<break></break>
</aff>
<pub-date pub-type="ppub"><month>7</month>
<year>2005</year>
</pub-date>
<volume>242</volume>
<issue>1</issue>
<fpage>1</fpage>
<lpage>6</lpage>
<copyright-statement>© 2005 Lippincott Williams & Wilkins, Inc.</copyright-statement>
<abstract><sec><title>Summary Background Data:</title>
<p>Axillary dissection, an invasive procedure that may adversely affect quality of life, used to obtain prognostic information in breast cancer, is being supplanted by sentinel node biopsy. In older women with early breast cancer and no palpable axillary nodes, it may be safe to give no axillary treatment. We addressed this issue in a randomized trial comparing axillary dissection with no axillary dissection in older patients with T1N0 breast cancer.</p>
</sec>
<sec><title>Methods:</title>
<p>From 1996 to 2000, 219 women, 65 to 80 years of age, with early breast cancer and clinically negative axillary nodes were randomized to conservative breast surgery with or without axillary dissection. Tamoxifen was prescribed to all patients for 5 years. The primary endpoints were axillary events in the no axillary dissection arm, comparison of overall mortality (by log rank test), breast cancer mortality, and breast events (by Gray test).</p>
</sec>
<sec><title>Results:</title>
<p>Considering a follow-up of 60 months, there were no significant differences in overall or breast cancer mortality, or crude cumulative incidence of breast events, between the 2 groups. Only 2 patients in the no axillary dissection arm (8 and 40 months after surgery) developed overt axillary involvement during follow-up.</p>
</sec>
<sec><title>Conclusions:</title>
<p>Older patients with T1N0 breast cancer can be treated by conservative breast surgery and no axillary dissection without adversely affecting breast cancer mortality or overall survival. The very low cumulative incidence of axillary events suggests that even sentinel node biopsy is unnecessary in these patients. Axillary dissection should be reserved for the small proportion of patients who later develop overt axillary disease.</p>
</sec>
</abstract>
<abstract abstract-type="toc"><p>Reported is a 5-year outcomes in 219 older women with early breast cancer and clinically negative axillary nodes, treated by quadrantectomy and tamoxifen, and prospectively randomized to axillary dissection or not. Breast cancer mortality and overall survival did not differ between arms; axillary dissection can thus be avoided in such patients.</p>
</abstract>
</article-meta>
</front>
</pmc>
</record>
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