Survival and axillary recurrence following sentinel node-positive breast cancer without completion axillary lymph node dissection: the randomized controlled SENOMAC trial
Identifieur interne : 000143 ( Main/Exploration ); précédent : 000142; suivant : 000144Survival and axillary recurrence following sentinel node-positive breast cancer without completion axillary lymph node dissection: the randomized controlled SENOMAC trial
Auteurs : Jana De Boniface [Suède] ; Jan Frisell [Suède] ; Yvette Andersson [Suède] ; Leif Bergkvist [Suède] ; Johan Ahlgren [Suède] ; Lisa Rydén [Suède] ; Roger Olofsson Bagge [Suède] ; Malin Sund [Suède] ; Hemming Johansson [Suède] ; Dan Lundstedt [Suède]Source :
- BMC Cancer [ 1471-2407 ] ; 2017.
Abstract
The role of axillary lymph node dissection (ALND) has increasingly been called into question among patients with positive sentinel lymph nodes. Two recent trials have failed to show a survival difference in sentinel node-positive breast cancer patients who were randomized either to undergo completion ALND or not. Neither of the trials, however, included breast cancer patients undergoing mastectomy or those with tumors larger than 5 cm, and power was debatable to show a small survival difference.
The prospective randomized SENOMAC trial includes clinically node-negative breast cancer patients with up to two macrometastases in their sentinel lymph node biopsy. Patients with T1-T3 tumors are eligible as well as patients prior to systemic neoadjuvant therapy. Both breast-conserving surgery and mastectomy, with or without breast reconstruction, are eligible interventions. Patients are randomized 1:1 to either undergo completion ALND or not by a web-based randomization tool. This trial is designed as a non-inferiority study with breast cancer-specific survival at 5 years as the primary endpoint. Target accrual is 3500 patients to achieve 80% power in being able to detect a potential 2.5% deterioration of the breast cancer-specific 5-year survival rate. Follow-up is by annual clinical examination and mammography during 5 years, and additional controls after 10 and 15 years. Secondary endpoints such as arm morbidity and health-related quality of life are measured by questionnaires at 1, 3 and 5 years.
Several large subgroups of breast cancer patients, such as patients undergoing mastectomy or those with larger tumors, have not been included in key trials; however, the use of ALND is being questioned even in these groups without the support of high-quality evidence. Therefore, the SENOMAC Trial will investigate the need of completion ALND in case of limited spread to the sentinel lymph nodes not only in patients undergoing any breast surgery, but also in neoadjuvantly treated patients and patients with larger tumors.
Url:
DOI: 10.1186/s12885-017-3361-y
PubMed: 28549453
PubMed Central: 5446737
Affiliations:
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lymph node dissection: the randomized controlled SENOMAC trial</title><author><name sortKey="De Boniface, Jana" sort="De Boniface, Jana" uniqKey="De Boniface J" first="Jana" last="De Boniface">Jana De Boniface</name><affiliation wicri:level="1"><nlm:aff id="Aff1"><institution-wrap><institution-id institution-id-type="ISNI">0000 0004 0623 9776</institution-id><institution-id institution-id-type="GRID">grid.440104.5</institution-id><institution>Department of Surgery,</institution><institution>Capio St Göran’s Hospital,</institution></institution-wrap>Stockholm, Sweden</nlm:aff><country xml:lang="fr">Suède</country><wicri:regionArea>Stockholm</wicri:regionArea></affiliation><affiliation wicri:level="1"><nlm:aff id="Aff2"><institution-wrap><institution-id institution-id-type="ISNI">0000 0004 1937 0626</institution-id><institution-id institution-id-type="GRID">grid.4714.6</institution-id><institution>Department of Molecular Medicine and Surgery,</institution><institution>Karolinska 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Science, Lund University,</institution></institution-wrap>Lund, Sweden</nlm:aff><country xml:lang="fr">Suède</country><wicri:regionArea>Lund</wicri:regionArea></affiliation><affiliation wicri:level="1"><nlm:aff id="Aff8"><institution-wrap><institution-id institution-id-type="GRID">grid.411843.b</institution-id><institution>Department of Surgery,</institution><institution>Skåne University Hospital,</institution></institution-wrap>Lund, Sweden</nlm:aff><country xml:lang="fr">Suède</country><wicri:regionArea>Lund</wicri:regionArea></affiliation></author><author><name sortKey="Olofsson Bagge, Roger" sort="Olofsson Bagge, Roger" uniqKey="Olofsson Bagge R" first="Roger" last="Olofsson Bagge">Roger Olofsson Bagge</name><affiliation wicri:level="1"><nlm:aff id="Aff9">Department of Surgery, Institute of Clinical Sciences, Sahlgrenska Academy at the University of Gothenburg, Sahlgrenska University Hospital, Gothenburg, Sweden</nlm:aff><country xml:lang="fr">Suède</country><wicri:regionArea>Department of Surgery, Institute of Clinical Sciences, Sahlgrenska Academy at the University of Gothenburg, Sahlgrenska University Hospital, Gothenburg</wicri:regionArea><wicri:noRegion>Gothenburg</wicri:noRegion></affiliation></author><author><name sortKey="Sund, Malin" sort="Sund, Malin" uniqKey="Sund M" first="Malin" last="Sund">Malin Sund</name><affiliation wicri:level="1"><nlm:aff id="Aff10"><institution-wrap><institution-id institution-id-type="ISNI">0000 0004 0623 991X</institution-id><institution-id institution-id-type="GRID">grid.412215.1</institution-id><institution></institution><institution>Surgery Center, Norrland University Hospital,</institution></institution-wrap>Umeå, Sweden</nlm:aff><country xml:lang="fr">Suède</country><wicri:regionArea>Umeå</wicri:regionArea></affiliation><affiliation wicri:level="1"><nlm:aff id="Aff11"><institution-wrap><institution-id institution-id-type="ISNI">0000 0001 1034 3451</institution-id><institution-id institution-id-type="GRID">grid.12650.30</institution-id><institution>Department of Surgical and Perioperative Science,</institution><institution>Umeå University,</institution></institution-wrap>Umeå, Sweden</nlm:aff><country xml:lang="fr">Suède</country><wicri:regionArea>Umeå</wicri:regionArea></affiliation></author><author><name sortKey="Johansson, Hemming" sort="Johansson, Hemming" uniqKey="Johansson H" first="Hemming" last="Johansson">Hemming Johansson</name><affiliation wicri:level="1"><nlm:aff id="Aff12"><institution-wrap><institution-id institution-id-type="ISNI">0000 0004 1937 0626</institution-id><institution-id institution-id-type="GRID">grid.4714.6</institution-id><institution>Department of Oncology-Pathology,</institution><institution>Clinical Trials Office, Karolinska Institutet,</institution></institution-wrap>Stockholm, Sweden</nlm:aff><country xml:lang="fr">Suède</country><wicri:regionArea>Stockholm</wicri:regionArea></affiliation></author><author><name sortKey="Lundstedt, Dan" sort="Lundstedt, Dan" uniqKey="Lundstedt D" first="Dan" last="Lundstedt">Dan Lundstedt</name><affiliation wicri:level="1"><nlm:aff id="Aff13"><institution-wrap><institution-id institution-id-type="ISNI">000000009445082X</institution-id><institution-id institution-id-type="GRID">grid.1649.a</institution-id><institution>Department of Oncology,</institution><institution>Sahlgrenska University Hospital,</institution></institution-wrap>Gothenburg, Sweden</nlm:aff><country xml:lang="fr">Suède</country><wicri:regionArea>Gothenburg</wicri:regionArea></affiliation></author></analytic><series><title level="j">BMC Cancer</title><idno type="eISSN">1471-2407</idno><imprint><date when="2017">2017</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><sec><title>Background</title><p>The role of axillary lymph node dissection (ALND) has increasingly been called into question among patients with positive sentinel lymph nodes. Two recent trials have failed to show a survival difference in sentinel node-positive breast cancer patients who were randomized either to undergo completion ALND or not. Neither of the trials, however, included breast cancer patients undergoing mastectomy or those with tumors larger than 5 cm, and power was debatable to show a small survival difference.</p></sec><sec><title>Methods</title><p>The prospective randomized SENOMAC trial includes clinically node-negative breast cancer patients with up to two macrometastases in their sentinel lymph node biopsy. Patients with T1-T3 tumors are eligible as well as patients prior to systemic neoadjuvant therapy. Both breast-conserving surgery and mastectomy, with or without breast reconstruction, are eligible interventions. Patients are randomized 1:1 to either undergo completion ALND or not by a web-based randomization tool. This trial is designed as a non-inferiority study with breast cancer-specific survival at 5 years as the primary endpoint. Target accrual is 3500 patients to achieve 80% power in being able to detect a potential 2.5% deterioration of the breast cancer-specific 5-year survival rate. Follow-up is by annual clinical examination and mammography during 5 years, and additional controls after 10 and 15 years. Secondary endpoints such as arm morbidity and health-related quality of life are measured by questionnaires at 1, 3 and 5 years.</p></sec><sec><title>Discussion</title><p>Several large subgroups of breast cancer patients, such as patients undergoing mastectomy or those with larger tumors, have not been included in key trials; however, the use of ALND is being questioned even in these groups without the support of high-quality evidence. Therefore, the SENOMAC Trial will investigate the need of completion ALND in case of limited spread to the sentinel lymph nodes not only in patients undergoing any breast surgery, but also in neoadjuvantly treated patients and patients with larger tumors.</p></sec><sec><title>Trial registration</title><p><ext-link ext-link-type="uri" xlink:href="https://clinicaltrials.gov/ct2/show/NCT02240472?term=senomac&rank=1">NCT 02240472</ext-link>, retrospective registration date September 14, 2015 after trial initiation on January 31, 2015.</p></sec></div></front><back><div1 type="bibliography"><listBibl><biblStruct><analytic><author><name sortKey="Carter, Cl" uniqKey="Carter C">CL Carter</name></author><author><name sortKey="Allen, C" uniqKey="Allen C">C Allen</name></author><author><name sortKey="Henson, De" uniqKey="Henson D">DE Henson</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Fisher, B" uniqKey="Fisher B">B Fisher</name></author><author><name 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sortKey="Andersson, Yvette" sort="Andersson, Yvette" uniqKey="Andersson Y" first="Yvette" last="Andersson">Yvette Andersson</name><name sortKey="Andersson, Yvette" sort="Andersson, Yvette" uniqKey="Andersson Y" first="Yvette" last="Andersson">Yvette Andersson</name><name sortKey="Bergkvist, Leif" sort="Bergkvist, Leif" uniqKey="Bergkvist L" first="Leif" last="Bergkvist">Leif Bergkvist</name><name sortKey="De Boniface, Jana" sort="De Boniface, Jana" uniqKey="De Boniface J" first="Jana" last="De Boniface">Jana De Boniface</name><name sortKey="Frisell, Jan" sort="Frisell, Jan" uniqKey="Frisell J" first="Jan" last="Frisell">Jan Frisell</name><name sortKey="Frisell, Jan" sort="Frisell, Jan" uniqKey="Frisell J" first="Jan" last="Frisell">Jan Frisell</name><name sortKey="Johansson, Hemming" sort="Johansson, Hemming" uniqKey="Johansson H" first="Hemming" last="Johansson">Hemming Johansson</name><name sortKey="Lundstedt, Dan" sort="Lundstedt, Dan" uniqKey="Lundstedt D" first="Dan" last="Lundstedt">Dan Lundstedt</name><name sortKey="Olofsson Bagge, Roger" sort="Olofsson Bagge, Roger" uniqKey="Olofsson Bagge R" first="Roger" last="Olofsson Bagge">Roger Olofsson Bagge</name><name sortKey="Ryden, Lisa" sort="Ryden, Lisa" uniqKey="Ryden L" first="Lisa" last="Rydén">Lisa Rydén</name><name sortKey="Ryden, Lisa" sort="Ryden, Lisa" uniqKey="Ryden L" first="Lisa" last="Rydén">Lisa Rydén</name><name sortKey="Sund, Malin" sort="Sund, Malin" uniqKey="Sund M" first="Malin" last="Sund">Malin Sund</name><name sortKey="Sund, Malin" sort="Sund, Malin" uniqKey="Sund M" first="Malin" last="Sund">Malin Sund</name></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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