Links to Exploration step
Le document en format XML
<record><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en">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</title><author><name sortKey="Cyr, Amy E" sort="Cyr, Amy E" uniqKey="Cyr A" first="Amy E" last="Cyr">Amy E. Cyr</name><affiliation><nlm:aff id="A1">Department of Surgery, Washington University School of Medicine, St Louis, MO</nlm:aff></affiliation></author><author><name sortKey="Tucker, Natalia" sort="Tucker, Natalia" uniqKey="Tucker N" first="Natalia" last="Tucker">Natalia Tucker</name><affiliation><nlm:aff id="A1">Department of Surgery, Washington University School of Medicine, St Louis, MO</nlm:aff></affiliation></author><author><name sortKey="Ademuyiwa, Foluso" sort="Ademuyiwa, Foluso" uniqKey="Ademuyiwa F" first="Foluso" last="Ademuyiwa">Foluso Ademuyiwa</name><affiliation><nlm:aff id="A2">Department of Medicine, Washington University School of Medicine, St Louis, MO</nlm:aff></affiliation></author><author><name sortKey="Margenthaler, Julie A" sort="Margenthaler, Julie A" uniqKey="Margenthaler J" first="Julie A" last="Margenthaler">Julie A. Margenthaler</name><affiliation><nlm:aff id="A1">Department of Surgery, Washington University School of Medicine, St Louis, MO</nlm:aff></affiliation></author><author><name sortKey="Aft, Rebecca L" sort="Aft, Rebecca L" uniqKey="Aft R" first="Rebecca L" last="Aft">Rebecca L. Aft</name><affiliation><nlm:aff id="A1">Department of Surgery, Washington University School of Medicine, St Louis, MO</nlm:aff></affiliation></author><author><name sortKey="Eberlein, Timothy J" sort="Eberlein, Timothy J" uniqKey="Eberlein T" first="Timothy J" last="Eberlein">Timothy J. Eberlein</name><affiliation><nlm:aff id="A1">Department of Surgery, Washington University School of Medicine, St Louis, MO</nlm:aff></affiliation></author><author><name sortKey="Appleton, Catherine M" sort="Appleton, Catherine M" uniqKey="Appleton C" first="Catherine M" last="Appleton">Catherine M. Appleton</name><affiliation><nlm:aff id="A3">Department of Radiology, Washington University School of Medicine, St Louis, MO</nlm:aff></affiliation></author><author><name sortKey="Zoberi, Imran" sort="Zoberi, Imran" uniqKey="Zoberi I" first="Imran" last="Zoberi">Imran Zoberi</name><affiliation><nlm:aff id="A4">Department of Radiation Oncology, Washington University School of Medicine, St Louis, MO</nlm:aff></affiliation></author><author><name sortKey="Thomas, Maria A" sort="Thomas, Maria A" uniqKey="Thomas M" first="Maria A" last="Thomas">Maria A. Thomas</name><affiliation><nlm:aff id="A4">Department of Radiation Oncology, Washington University School of Medicine, St Louis, MO</nlm:aff></affiliation></author><author><name sortKey="Gao, Feng" sort="Gao, Feng" uniqKey="Gao F" first="Feng" last="Gao">Feng Gao</name><affiliation><nlm:aff id="A1">Department of Surgery, Washington University School of Medicine, St Louis, MO</nlm:aff></affiliation><affiliation><nlm:aff id="A5">Division of Biostatistics, Washington University School of Medicine, St Louis, MO</nlm:aff></affiliation></author><author><name sortKey="Gillanders, William E" sort="Gillanders, William E" uniqKey="Gillanders W" first="William E" last="Gillanders">William E. Gillanders</name><affiliation><nlm:aff id="A1">Department of Surgery, Washington University School of Medicine, St Louis, MO</nlm:aff></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">PMC</idno><idno type="pmid">27212005</idno><idno type="pmc">4961625</idno><idno type="url">http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4961625</idno><idno type="RBID">PMC:4961625</idno><idno type="doi">10.1016/j.jamcollsurg.2016.04.048</idno><date when="2016">2016</date><idno type="wicri:Area/Pmc/Corpus">003996</idno><idno type="wicri:explorRef" wicri:stream="Pmc" wicri:step="Corpus" wicri:corpus="PMC">003996</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en" level="a" type="main">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</title><author><name sortKey="Cyr, Amy E" sort="Cyr, Amy E" uniqKey="Cyr A" first="Amy E" last="Cyr">Amy E. Cyr</name><affiliation><nlm:aff id="A1">Department of Surgery, Washington University School of Medicine, St Louis, MO</nlm:aff></affiliation></author><author><name sortKey="Tucker, Natalia" sort="Tucker, Natalia" uniqKey="Tucker N" first="Natalia" last="Tucker">Natalia Tucker</name><affiliation><nlm:aff id="A1">Department of Surgery, Washington University School of Medicine, St Louis, MO</nlm:aff></affiliation></author><author><name sortKey="Ademuyiwa, Foluso" sort="Ademuyiwa, Foluso" uniqKey="Ademuyiwa F" first="Foluso" last="Ademuyiwa">Foluso Ademuyiwa</name><affiliation><nlm:aff id="A2">Department of Medicine, Washington University School of Medicine, St Louis, MO</nlm:aff></affiliation></author><author><name sortKey="Margenthaler, Julie A" sort="Margenthaler, Julie A" uniqKey="Margenthaler J" first="Julie A" last="Margenthaler">Julie A. Margenthaler</name><affiliation><nlm:aff id="A1">Department of Surgery, Washington University School of Medicine, St Louis, MO</nlm:aff></affiliation></author><author><name sortKey="Aft, Rebecca L" sort="Aft, Rebecca L" uniqKey="Aft R" first="Rebecca L" last="Aft">Rebecca L. Aft</name><affiliation><nlm:aff id="A1">Department of Surgery, Washington University School of Medicine, St Louis, MO</nlm:aff></affiliation></author><author><name sortKey="Eberlein, Timothy J" sort="Eberlein, Timothy J" uniqKey="Eberlein T" first="Timothy J" last="Eberlein">Timothy J. Eberlein</name><affiliation><nlm:aff id="A1">Department of Surgery, Washington University School of Medicine, St Louis, MO</nlm:aff></affiliation></author><author><name sortKey="Appleton, Catherine M" sort="Appleton, Catherine M" uniqKey="Appleton C" first="Catherine M" last="Appleton">Catherine M. Appleton</name><affiliation><nlm:aff id="A3">Department of Radiology, Washington University School of Medicine, St Louis, MO</nlm:aff></affiliation></author><author><name sortKey="Zoberi, Imran" sort="Zoberi, Imran" uniqKey="Zoberi I" first="Imran" last="Zoberi">Imran Zoberi</name><affiliation><nlm:aff id="A4">Department of Radiation Oncology, Washington University School of Medicine, St Louis, MO</nlm:aff></affiliation></author><author><name sortKey="Thomas, Maria A" sort="Thomas, Maria A" uniqKey="Thomas M" first="Maria A" last="Thomas">Maria A. Thomas</name><affiliation><nlm:aff id="A4">Department of Radiation Oncology, Washington University School of Medicine, St Louis, MO</nlm:aff></affiliation></author><author><name sortKey="Gao, Feng" sort="Gao, Feng" uniqKey="Gao F" first="Feng" last="Gao">Feng Gao</name><affiliation><nlm:aff id="A1">Department of Surgery, Washington University School of Medicine, St Louis, MO</nlm:aff></affiliation><affiliation><nlm:aff id="A5">Division of Biostatistics, Washington University School of Medicine, St Louis, MO</nlm:aff></affiliation></author><author><name sortKey="Gillanders, William E" sort="Gillanders, William E" uniqKey="Gillanders W" first="William E" last="Gillanders">William E. Gillanders</name><affiliation><nlm:aff id="A1">Department of Surgery, Washington University School of Medicine, St Louis, MO</nlm:aff></affiliation></author></analytic><series><title level="j">Journal of the American College of Surgeons</title><idno type="ISSN">1072-7515</idno><idno type="eISSN">1879-1190</idno><imprint><date when="2016">2016</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><sec id="S1"><title>Background</title><p id="P1">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.</p></sec><sec id="S2"><title>Study Design</title><p id="P2">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.</p></sec><sec id="S3"><title>Results</title><p id="P3">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.</p></sec><sec id="S4"><title>Conclusions</title><p id="P4">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.</p></sec></div></front></TEI><pmc article-type="research-article"><pmc-comment>The publisher of this article does not allow downloading of the full text in XML form.</pmc-comment>
<pmc-dir>properties manuscript</pmc-dir>
<front><journal-meta><journal-id journal-id-type="nlm-journal-id">9431305</journal-id><journal-id journal-id-type="pubmed-jr-id">8488</journal-id><journal-id journal-id-type="nlm-ta">J Am Coll Surg</journal-id><journal-id journal-id-type="iso-abbrev">J. Am. Coll. Surg.</journal-id><journal-title-group><journal-title>Journal of the American College of Surgeons</journal-title></journal-title-group><issn pub-type="ppub">1072-7515</issn><issn pub-type="epub">1879-1190</issn></journal-meta><article-meta><article-id pub-id-type="pmid">27212005</article-id><article-id pub-id-type="pmc">4961625</article-id><article-id pub-id-type="doi">10.1016/j.jamcollsurg.2016.04.048</article-id><article-id pub-id-type="manuscript">NIHMS796611</article-id><article-categories><subj-group subj-group-type="heading"><subject>Article</subject></subj-group></article-categories><title-group><article-title>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</article-title></title-group><contrib-group><contrib contrib-type="author"><name><surname>Cyr</surname><given-names>Amy E</given-names></name><degrees>MD, FACS</degrees><xref ref-type="aff" rid="A1">1</xref></contrib><contrib contrib-type="author"><name><surname>Tucker</surname><given-names>Natalia</given-names></name><degrees>MD</degrees><xref ref-type="aff" rid="A1">1</xref></contrib><contrib contrib-type="author"><name><surname>Ademuyiwa</surname><given-names>Foluso</given-names></name><degrees>MD</degrees><xref ref-type="aff" rid="A2">2</xref></contrib><contrib contrib-type="author"><name><surname>Margenthaler</surname><given-names>Julie A</given-names></name><degrees>MD, FACS</degrees><xref ref-type="aff" rid="A1">1</xref></contrib><contrib contrib-type="author"><name><surname>Aft</surname><given-names>Rebecca L</given-names></name><degrees>MD, FACS</degrees><xref ref-type="aff" rid="A1">1</xref></contrib><contrib contrib-type="author"><name><surname>Eberlein</surname><given-names>Timothy J</given-names></name><degrees>MD, FACS</degrees><xref ref-type="aff" rid="A1">1</xref></contrib><contrib contrib-type="author"><name><surname>Appleton</surname><given-names>Catherine M</given-names></name><degrees>MD</degrees><xref ref-type="aff" rid="A3">3</xref></contrib><contrib contrib-type="author"><name><surname>Zoberi</surname><given-names>Imran</given-names></name><degrees>MD</degrees><xref ref-type="aff" rid="A4">4</xref></contrib><contrib contrib-type="author"><name><surname>Thomas</surname><given-names>Maria A</given-names></name><degrees>MD, PhD</degrees><xref ref-type="aff" rid="A4">4</xref></contrib><contrib contrib-type="author"><name><surname>Gao</surname><given-names>Feng</given-names></name><degrees>PhD</degrees><xref ref-type="aff" rid="A1">1</xref><xref ref-type="aff" rid="A5">5</xref></contrib><contrib contrib-type="author"><name><surname>Gillanders</surname><given-names>William E</given-names></name><degrees>MD, FACS</degrees><xref ref-type="aff" rid="A1">1</xref></contrib></contrib-group><aff id="A1"><label>1</label>Department of Surgery, Washington University School of Medicine, St Louis, MO</aff><aff id="A2"><label>2</label>Department of Medicine, Washington University School of Medicine, St Louis, MO</aff><aff id="A3"><label>3</label>Department of Radiology, Washington University School of Medicine, St Louis, MO</aff><aff id="A4"><label>4</label>Department of Radiation Oncology, Washington University School of Medicine, St Louis, MO</aff><aff id="A5"><label>5</label>Division of Biostatistics, Washington University School of Medicine, St Louis, MO</aff><author-notes><corresp id="CR1"><bold>Address correspondence to:</bold> Amy E Cyr, MD, Assistant Professor of Surgery, Washington University, Box 8109, 660 South Euclid Avenue, St. Louis, MO 63110, Phone (314) 747-8708, Fax (314) 222-6260, <email>cyra@wudosis.wustl.edu</email></corresp></author-notes><pub-date pub-type="nihms-submitted"><day>24</day><month>6</month><year>2016</year></pub-date><pub-date pub-type="epub"><day>20</day><month>5</month><year>2016</year></pub-date><pub-date pub-type="ppub"><month>8</month><year>2016</year></pub-date><pub-date pub-type="pmc-release"><day>01</day><month>8</month><year>2017</year></pub-date><volume>223</volume><issue>2</issue><fpage>399</fpage><lpage>407</lpage><pmc-comment>elocation-id from pubmed: 10.1016/j.jamcollsurg.2016.04.048</pmc-comment>
<abstract><sec id="S1"><title>Background</title><p id="P1">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.</p></sec><sec id="S2"><title>Study Design</title><p id="P2">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.</p></sec><sec id="S3"><title>Results</title><p id="P3">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.</p></sec><sec id="S4"><title>Conclusions</title><p id="P4">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.</p></sec></abstract></article-meta></front></pmc></record>Pour manipuler ce document sous Unix (Dilib)
EXPLOR_STEP=$WICRI_ROOT/Wicri/Sante/explor/LymphedemaV1/Data/Pmc/Corpus
HfdSelect -h $EXPLOR_STEP/biblio.hfd -nk 003996 | SxmlIndent | more
Ou
HfdSelect -h $EXPLOR_AREA/Data/Pmc/Corpus/biblio.hfd -nk 003996 | SxmlIndent | more
Pour mettre un lien sur cette page dans le réseau Wicri
{{Explor lien
|wiki= Wicri/Sante
|area= LymphedemaV1
|flux= Pmc
|étape= Corpus
|type= RBID
|clé=
|texte=
}}
| This area was generated with Dilib version V0.6.31. |  |