The generalisability of randomised clinical trials: an interim external validity analysis of the ongoing SENOMAC trial in sentinel lymph node-positive breast cancer
Purpose None of the key randomised trials on the omission of axillary lymph node dissection (ALND) in sentinel lymph-positive breast cancer have reported external validity, even though results indicate selection bias. Our aim was to assess the external validity of the ongoing randomised SENOMAC tria...
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| Published in | Breast cancer research and treatment Vol. 180; no. 1; pp. 167 - 176 |
|---|---|
| Main Authors | , , , , , , , , |
| Format | Journal Article |
| Language | English |
| Published |
New York
Springer US
01.02.2020
Springer Springer Nature B.V |
| Subjects | |
| Online Access | Get full text |
| ISSN | 0167-6806 1573-7217 1573-7217 |
| DOI | 10.1007/s10549-020-05537-1 |
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| Abstract | Purpose
None of the key randomised trials on the omission of axillary lymph node dissection (ALND) in sentinel lymph-positive breast cancer have reported external validity, even though results indicate selection bias. Our aim was to assess the external validity of the ongoing randomised SENOMAC trial by comparing characteristics of Swedish SENOMAC trial participants with non-included eligible patients registered in the Swedish National Breast Cancer Register (NKBC).
Methods
In the ongoing non-inferiority European SENOMAC trial, clinically node-negative cT1–T3 breast cancer patients with up to two sentinel lymph node macrometastases are randomised to undergo completion ALND or not. Both breast-conserving surgery and mastectomy are eligible interventions. Data from NKBC were extracted for the years 2016 and 2017, and patient and tumour characteristics compared with Swedish trial participants from the same years.
Results
Overall, 306 NKBC cases from non-participating and 847 NKBC cases from participating sites (excluding SENOMAC participants) were compared with 463 SENOMAC trial participants. Patients belonging to the middle age groups (
p
= 0.015), with smaller tumours (
p
= 0.013) treated by breast-conserving therapy (50.3 versus 47.1 versus 65.2%,
p
< 0.001) and less nodal tumour burden (only 1 macrometastasis in 78.8 versus 79.9 versus 87.3%,
p
= 0.001) were over-represented in the trial population. Time trends indicated, however, that differences may be mitigated over time.
Conclusions
This interim external validity analysis specifically addresses selection mechanisms during an ongoing trial, potentially increasing generalisability by the time full accrual is reached. Similar validity checks should be an integral part of prospective clinical trials.
Trial registration: NCT 02240472, retrospective registration date September 14, 2015 after trial initiation on January 31, 2015 |
|---|---|
| AbstractList | None of the key randomised trials on the omission of axillary lymph node dissection (ALND) in sentinel lymph-positive breast cancer have reported external validity, even though results indicate selection bias. Our aim was to assess the external validity of the ongoing randomised SENOMAC trial by comparing characteristics of Swedish SENOMAC trial participants with non-included eligible patients registered in the Swedish National Breast Cancer Register (NKBC).PURPOSENone of the key randomised trials on the omission of axillary lymph node dissection (ALND) in sentinel lymph-positive breast cancer have reported external validity, even though results indicate selection bias. Our aim was to assess the external validity of the ongoing randomised SENOMAC trial by comparing characteristics of Swedish SENOMAC trial participants with non-included eligible patients registered in the Swedish National Breast Cancer Register (NKBC).In the ongoing non-inferiority European SENOMAC trial, clinically node-negative cT1-T3 breast cancer patients with up to two sentinel lymph node macrometastases are randomised to undergo completion ALND or not. Both breast-conserving surgery and mastectomy are eligible interventions. Data from NKBC were extracted for the years 2016 and 2017, and patient and tumour characteristics compared with Swedish trial participants from the same years.METHODSIn the ongoing non-inferiority European SENOMAC trial, clinically node-negative cT1-T3 breast cancer patients with up to two sentinel lymph node macrometastases are randomised to undergo completion ALND or not. Both breast-conserving surgery and mastectomy are eligible interventions. Data from NKBC were extracted for the years 2016 and 2017, and patient and tumour characteristics compared with Swedish trial participants from the same years.Overall, 306 NKBC cases from non-participating and 847 NKBC cases from participating sites (excluding SENOMAC participants) were compared with 463 SENOMAC trial participants. Patients belonging to the middle age groups (p = 0.015), with smaller tumours (p = 0.013) treated by breast-conserving therapy (50.3 versus 47.1 versus 65.2%, p < 0.001) and less nodal tumour burden (only 1 macrometastasis in 78.8 versus 79.9 versus 87.3%, p = 0.001) were over-represented in the trial population. Time trends indicated, however, that differences may be mitigated over time.RESULTSOverall, 306 NKBC cases from non-participating and 847 NKBC cases from participating sites (excluding SENOMAC participants) were compared with 463 SENOMAC trial participants. Patients belonging to the middle age groups (p = 0.015), with smaller tumours (p = 0.013) treated by breast-conserving therapy (50.3 versus 47.1 versus 65.2%, p < 0.001) and less nodal tumour burden (only 1 macrometastasis in 78.8 versus 79.9 versus 87.3%, p = 0.001) were over-represented in the trial population. Time trends indicated, however, that differences may be mitigated over time.This interim external validity analysis specifically addresses selection mechanisms during an ongoing trial, potentially increasing generalisability by the time full accrual is reached. Similar validity checks should be an integral part of prospective clinical trials.CONCLUSIONSThis interim external validity analysis specifically addresses selection mechanisms during an ongoing trial, potentially increasing generalisability by the time full accrual is reached. Similar validity checks should be an integral part of prospective clinical trials.NCT02240472, retrospective registration date September 14, 2015 after trial initiation on January 31, 2015.TRIAL REGISTRATIONNCT02240472, retrospective registration date September 14, 2015 after trial initiation on January 31, 2015. PURPOSE: None of the key randomised trials on the omission of axillary lymph node dissection (ALND) in sentinel lymph-positive breast cancer have reported external validity, even though results indicate selection bias. Our aim was to assess the external validity of the ongoing randomised SENOMAC trial by comparing characteristics of Swedish SENOMAC trial participants with non-included eligible patients registered in the Swedish National Breast Cancer Register (NKBC). METHODS: In the ongoing non-inferiority European SENOMAC trial, clinically node-negative cT1-T3 breast cancer patients with up to two sentinel lymph node macrometastases are randomised to undergo completion ALND or not. Both breast-conserving surgery and mastectomy are eligible interventions. Data from NKBC were extracted for the years 2016 and 2017, and patient and tumour characteristics compared with Swedish trial participants from the same years. RESULTS: Overall, 306 NKBC cases from non-participating and 847 NKBC cases from participating sites (excluding SENOMAC participants) were compared with 463 SENOMAC trial participants. Patients belonging to the middle age groups (p = 0.015), with smaller tumours (p = 0.013) treated by breast-conserving therapy (50.3 versus 47.1 versus 65.2%, p < 0.001) and less nodal tumour burden (only 1 macrometastasis in 78.8 versus 79.9 versus 87.3%, p = 0.001) were over-represented in the trial population. Time trends indicated, however, that differences may be mitigated over time. CONCLUSIONS: This interim external validity analysis specifically addresses selection mechanisms during an ongoing trial, potentially increasing generalisability by the time full accrual is reached. Similar validity checks should be an integral part of prospective clinical trials. TRIAL REGISTRATION: NCT02240472, retrospective registration date September 14, 2015 after trial initiation on January 31, 2015. PurposeNone of the key randomised trials on the omission of axillary lymph node dissection (ALND) in sentinel lymph-positive breast cancer have reported external validity, even though results indicate selection bias. Our aim was to assess the external validity of the ongoing randomised SENOMAC trial by comparing characteristics of Swedish SENOMAC trial participants with non-included eligible patients registered in the Swedish National Breast Cancer Register (NKBC).MethodsIn the ongoing non-inferiority European SENOMAC trial, clinically node-negative cT1–T3 breast cancer patients with up to two sentinel lymph node macrometastases are randomised to undergo completion ALND or not. Both breast-conserving surgery and mastectomy are eligible interventions. Data from NKBC were extracted for the years 2016 and 2017, and patient and tumour characteristics compared with Swedish trial participants from the same years.ResultsOverall, 306 NKBC cases from non-participating and 847 NKBC cases from participating sites (excluding SENOMAC participants) were compared with 463 SENOMAC trial participants. Patients belonging to the middle age groups (p = 0.015), with smaller tumours (p = 0.013) treated by breast-conserving therapy (50.3 versus 47.1 versus 65.2%, p < 0.001) and less nodal tumour burden (only 1 macrometastasis in 78.8 versus 79.9 versus 87.3%, p = 0.001) were over-represented in the trial population. Time trends indicated, however, that differences may be mitigated over time.ConclusionsThis interim external validity analysis specifically addresses selection mechanisms during an ongoing trial, potentially increasing generalisability by the time full accrual is reached. Similar validity checks should be an integral part of prospective clinical trials.Trial registration: NCT 02240472, retrospective registration date September 14, 2015 after trial initiation on January 31, 2015 Purpose: None of the key randomised trials on the omission of axillary lymph node dissection (ALND) in sentinel lymph-positive breast cancer have reported external validity, even though results indicate selection bias. Our aim was to assess the external validity of the ongoing randomised SENOMAC trial by comparing characteristics of Swedish SENOMAC trial participants with non-included eligible patients registered in the Swedish National Breast Cancer Register (NKBC). Methods: In the ongoing non-inferiority European SENOMAC trial, clinically node-negative cT1-T3 breast cancer patients with up to two sentinel lymph node macrometastases are randomised to undergo completion ALND or not. Both breast-conserving surgery and mastectomy are eligible interventions. Data from NKBC were extracted for the years 2016 and 2017, and patient and tumour characteristics compared with Swedish trial participants from the same years. Results: Overall, 306 NKBC cases from non-participating and 847 NKBC cases from participating sites (excluding SENOMAC participants) were compared with 463 SENOMAC trial participants. Patients belonging to the middle age groups (p = 0.015), with smaller tumours (p = 0.013) treated by breast-conserving therapy (50.3 versus 47.1 versus 65.2%, p < 0.001) and less nodal tumour burden (only 1 macrometastasis in 78.8 versus 79.9 versus 87.3%, p = 0.001) were over-represented in the trial population. Time trends indicated, however, that differences may be mitigated over time. Conclusions: This interim external validity analysis specifically addresses selection mechanisms during an ongoing trial, potentially increasing generalisability by the time full accrual is reached. Similar validity checks should be an integral part of prospective clinical trials. Trial registration: NCT 02240472, retrospective registration date September 14, 2015 after trial initiation on January 31, 2015 None of the key randomised trials on the omission of axillary lymph node dissection (ALND) in sentinel lymph-positive breast cancer have reported external validity, even though results indicate selection bias. Our aim was to assess the external validity of the ongoing randomised SENOMAC trial by comparing characteristics of Swedish SENOMAC trial participants with non-included eligible patients registered in the Swedish National Breast Cancer Register (NKBC). In the ongoing non-inferiority European SENOMAC trial, clinically node-negative cT1-T3 breast cancer patients with up to two sentinel lymph node macrometastases are randomised to undergo completion ALND or not. Both breast-conserving surgery and mastectomy are eligible interventions. Data from NKBC were extracted for the years 2016 and 2017, and patient and tumour characteristics compared with Swedish trial participants from the same years. Overall, 306 NKBC cases from non-participating and 847 NKBC cases from participating sites (excluding SENOMAC participants) were compared with 463 SENOMAC trial participants. Patients belonging to the middle age groups (p = 0.015), with smaller tumours (p = 0.013) treated by breast-conserving therapy (50.3 versus 47.1 versus 65.2%, p < 0.001) and less nodal tumour burden (only 1 macrometastasis in 78.8 versus 79.9 versus 87.3%, p = 0.001) were over-represented in the trial population. Time trends indicated, however, that differences may be mitigated over time. This interim external validity analysis specifically addresses selection mechanisms during an ongoing trial, potentially increasing generalisability by the time full accrual is reached. Similar validity checks should be an integral part of prospective clinical trials. NCT02240472, retrospective registration date September 14, 2015 after trial initiation on January 31, 2015. Purpose None of the key randomised trials on the omission of axillary lymph node dissection (ALND) in sentinel lymph-positive breast cancer have reported external validity, even though results indicate selection bias. Our aim was to assess the external validity of the ongoing randomised SENOMAC trial by comparing characteristics of Swedish SENOMAC trial participants with non-included eligible patients registered in the Swedish National Breast Cancer Register (NKBC). Methods In the ongoing non-inferiority European SENOMAC trial, clinically node-negative cT1-T3 breast cancer patients with up to two sentinel lymph node macrometastases are randomised to undergo completion ALND or not. Both breast-conserving surgery and mastectomy are eligible interventions. Data from NKBC were extracted for the years 2016 and 2017, and patient and tumour characteristics compared with Swedish trial participants from the same years. Results Overall, 306 NKBC cases from non-participating and 847 NKBC cases from participating sites (excluding SENOMAC participants) were compared with 463 SENOMAC trial participants. Patients belonging to the middle age groups (p = 0.015), with smaller tumours (p = 0.013) treated by breast-conserving therapy (50.3 versus 47.1 versus 65.2%, p < 0.001) and less nodal tumour burden (only 1 macrometastasis in 78.8 versus 79.9 versus 87.3%, p = 0.001) were over-represented in the trial population. Time trends indicated, however, that differences may be mitigated over time. Conclusions This interim external validity analysis specifically addresses selection mechanisms during an ongoing trial, potentially increasing generalisability by the time full accrual is reached. Similar validity checks should be an integral part of prospective clinical trials. Trial registration: NCT 02240472, retrospective registration date September 14, 2015 after trial initiation on January 31, 2015 Purpose: None of the key randomised trials on the omission of axillary lymph node dissection (ALND) in sentinel lymph-positive breast cancer have reported external validity, even though results indicate selection bias. Our aim was to assess the external validity of the ongoing randomised SENOMAC trial by comparing characteristics of Swedish SENOMAC trial participants with non-included eligible patients registered in the Swedish National Breast Cancer Register (NKBC). Methods: In the ongoing non-inferiority European SENOMAC trial, clinically node-negative cT1–T3 breast cancer patients with up to two sentinel lymph node macrometastases are randomised to undergo completion ALND or not. Both breast-conserving surgery and mastectomy are eligible interventions. Data from NKBC were extracted for the years 2016 and 2017, and patient and tumour characteristics compared with Swedish trial participants from the same years. Results: Overall, 306 NKBC cases from non-participating and 847 NKBC cases from participating sites (excluding SENOMAC participants) were compared with 463 SENOMAC trial participants. Patients belonging to the middle age groups (p = 0.015), with smaller tumours (p = 0.013) treated by breast-conserving therapy (50.3 versus 47.1 versus 65.2%, p < 0.001) and less nodal tumour burden (only 1 macrometastasis in 78.8 versus 79.9 versus 87.3%, p = 0.001) were over-represented in the trial population. Time trends indicated, however, that differences may be mitigated over time. Conclusions: This interim external validity analysis specifically addresses selection mechanisms during an ongoing trial, potentially increasing generalisability by the time full accrual is reached. Similar validity checks should be an integral part of prospective clinical trials. None of the key randomised trials on the omission of axillary lymph node dissection (ALND) in sentinel lymph-positive breast cancer have reported external validity, even though results indicate selection bias. Our aim was to assess the external validity of the ongoing randomised SENOMAC trial by comparing characteristics of Swedish SENOMAC trial participants with non-included eligible patients registered in the Swedish National Breast Cancer Register (NKBC). In the ongoing non-inferiority European SENOMAC trial, clinically node-negative cT1-T3 breast cancer patients with up to two sentinel lymph node macrometastases are randomised to undergo completion ALND or not. Both breast-conserving surgery and mastectomy are eligible interventions. Data from NKBC were extracted for the years 2016 and 2017, and patient and tumour characteristics compared with Swedish trial participants from the same years. Overall, 306 NKBC cases from non-participating and 847 NKBC cases from participating sites (excluding SENOMAC participants) were compared with 463 SENOMAC trial participants. Patients belonging to the middle age groups (p = 0.015), with smaller tumours (p = 0.013) treated by breast-conserving therapy (50.3 versus 47.1 versus 65.2%, p < 0.001) and less nodal tumour burden (only 1 macrometastasis in 78.8 versus 79.9 versus 87.3%, p = 0.001) were over-represented in the trial population. Time trends indicated, however, that differences may be mitigated over time. This interim external validity analysis specifically addresses selection mechanisms during an ongoing trial, potentially increasing generalisability by the time full accrual is reached. Similar validity checks should be an integral part of prospective clinical trials. Purpose None of the key randomised trials on the omission of axillary lymph node dissection (ALND) in sentinel lymph-positive breast cancer have reported external validity, even though results indicate selection bias. Our aim was to assess the external validity of the ongoing randomised SENOMAC trial by comparing characteristics of Swedish SENOMAC trial participants with non-included eligible patients registered in the Swedish National Breast Cancer Register (NKBC). Methods In the ongoing non-inferiority European SENOMAC trial, clinically node-negative cT1–T3 breast cancer patients with up to two sentinel lymph node macrometastases are randomised to undergo completion ALND or not. Both breast-conserving surgery and mastectomy are eligible interventions. Data from NKBC were extracted for the years 2016 and 2017, and patient and tumour characteristics compared with Swedish trial participants from the same years. Results Overall, 306 NKBC cases from non-participating and 847 NKBC cases from participating sites (excluding SENOMAC participants) were compared with 463 SENOMAC trial participants. Patients belonging to the middle age groups ( p = 0.015), with smaller tumours ( p = 0.013) treated by breast-conserving therapy (50.3 versus 47.1 versus 65.2%, p < 0.001) and less nodal tumour burden (only 1 macrometastasis in 78.8 versus 79.9 versus 87.3%, p = 0.001) were over-represented in the trial population. Time trends indicated, however, that differences may be mitigated over time. Conclusions This interim external validity analysis specifically addresses selection mechanisms during an ongoing trial, potentially increasing generalisability by the time full accrual is reached. Similar validity checks should be an integral part of prospective clinical trials. Trial registration: NCT 02240472, retrospective registration date September 14, 2015 after trial initiation on January 31, 2015 |
| Audience | Academic |
| Author | Lundstedt, Dan Frisell, Jan de Boniface, Jana Ahlgren, Johan Sund, Malin Andersson, Yvette Bergkvist, Leif Olofsson Bagge, Roger Rydén, Lisa |
| Author_xml | – sequence: 1 givenname: Jana orcidid: 0000-0001-9518-0902 surname: de Boniface fullname: de Boniface, Jana email: jana.de-boniface@ki.se organization: Department of Surgery, Capio St Göran’s Hospital, Department of Molecular Medicine and Surgery, Karolinska Institutet – sequence: 2 givenname: Johan surname: Ahlgren fullname: Ahlgren, Johan organization: Department of Oncology, University of Örebro, Regional Oncologic Centre, Uppsala-Örebro Health Care Region – sequence: 3 givenname: Yvette surname: Andersson fullname: Andersson, Yvette organization: Department of Surgery, Västmanland County Hospital, Västmanland County Hospital, Center for Clinical Research, Uppsala University – sequence: 4 givenname: Leif surname: Bergkvist fullname: Bergkvist, Leif organization: Västmanland County Hospital, Center for Clinical Research, Uppsala University – sequence: 5 givenname: Jan surname: Frisell fullname: Frisell, Jan organization: Division of Cancer, Department of Breast, Endocrine Tumours and Sarcoma, Karolinska Universitety Hospital – sequence: 6 givenname: Dan surname: Lundstedt fullname: Lundstedt, Dan organization: Department of Oncology, Sahlgrenska University Hospital, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg – sequence: 7 givenname: Roger surname: Olofsson Bagge fullname: Olofsson Bagge, Roger organization: Wallenberg Centre for Molecular and Translational Medicine, University of Gothenburg, Department of Surgery, Institute of Clinical Sciences, Sahlgrenska University Hospital, Sahlgrenska Academy at the University of Gothenburg – sequence: 8 givenname: Lisa surname: Rydén fullname: Rydén, Lisa organization: Division of Surgery, Department of Clinical Sciences Lund, Lund University, Department of Surgery and Gastroenterology, Skåne University Hospital – sequence: 9 givenname: Malin surname: Sund fullname: Sund, Malin organization: Surgery Center, Norrland University Hospital, Department of Surgical and Perioperative Science/Surgery, Umeå University |
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| CitedBy_id | crossref_primary_10_1136_bmjopen_2023_075543 crossref_primary_10_1016_j_breast_2021_08_018 crossref_primary_10_1186_s12874_021_01343_5 crossref_primary_10_1016_j_ctrv_2023_102556 crossref_primary_10_1002_cncr_33960 crossref_primary_10_1016_j_radonc_2023_110069 crossref_primary_10_1093_jbi_wbab070 crossref_primary_10_1007_s10353_020_00665_w crossref_primary_10_1016_j_radonc_2024_110372 |
| Cites_doi | 10.1016/S1470-2045(14)70460-7 10.1097/BSD.0000000000000588 10.1016/j.clon.2015.07.005 10.1056/NEJMra1510059 10.1136/bmj.h2147 10.1016/j.breast.2012.06.013 10.1001/jama.2017.11470 10.1016/j.canep.2017.11.002 10.1016/S1470-2045(13)70035-4 10.1016/0021-9681(67)90041-0 10.1186/s12885-017-3361-y 10.1016/j.ejso.2016.12.011 10.1055/s-0042-122853 10.1016/j.archger.2017.05.017 10.1001/jama.2011.90 10.1016/S0140-6736(04)17670-8 10.1007/s10549-018-4820-0 |
| ContentType | Journal Article |
| Contributor | Offersen, Birgitte Vrou Kontos, Michalis Reimer, Toralf Reitsamer, Roland Filtenborg Tvedskov, Tove Christiansen, Peer Kühn, Thorsten Gentilini, Oreste |
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| Copyright | The Author(s) 2020 COPYRIGHT 2020 Springer Breast Cancer Research and Treatment is a copyright of Springer, (2020). All Rights Reserved. This work is published under http://creativecommons.org/licenses/by/4.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License. |
| Copyright_xml | – notice: The Author(s) 2020 – notice: COPYRIGHT 2020 Springer – notice: Breast Cancer Research and Treatment is a copyright of Springer, (2020). All Rights Reserved. This work is published under http://creativecommons.org/licenses/by/4.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License. |
| CorporateAuthor | the SENOMAC Trialists’ Group SENOMAC Trialists’ Group Bröstcancerkirurgi LUCC: Lunds universitets cancercentrum Kirurgi, Lund Övriga starka forskningsmiljöer Section V Institutionen för kliniska vetenskaper, Lund Profile areas and other strong research environments Lunds universitet Lund University Sektion V Breast Cancer Surgery Department of Clinical Sciences, Lund Other Strong Research Environments Faculty of Medicine Surgery (Lund) LUCC: Lund University Cancer Centre Medicinska fakulteten Profilområden och andra starka forskningsmiljöer |
| CorporateAuthor_xml | – name: the SENOMAC Trialists’ Group – name: SENOMAC Trialists’ Group – name: Övriga starka forskningsmiljöer – name: Faculty of Medicine – name: Medicinska fakulteten – name: Other Strong Research Environments – name: LUCC: Lund University Cancer Centre – name: Institutionen för kliniska vetenskaper, Lund – name: Lunds universitet – name: Bröstcancerkirurgi – name: Department of Clinical Sciences, Lund – name: Surgery (Lund) – name: Breast Cancer Surgery – name: Profilområden och andra starka forskningsmiljöer – name: Lund University – name: Sektion V – name: Profile areas and other strong research environments – name: Section V – name: Kirurgi, Lund – name: LUCC: Lunds universitets cancercentrum |
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| DOI | 10.1007/s10549-020-05537-1 |
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| Keywords | Omission of axillary dissection Clinical trial Breast cancer Sentinel lymph node biopsy |
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| References | Schwartz, Lellouch (CR14) 1967; 20 Loudon, Treweek, Sullivan, Donnan, Thorpe, Zwarenstein (CR17) 2015; 350 Donker, van Tienhoven, Straver, Meijnen, van de Velde, Mansel, Cataliotti, Westenberg, Klinkenbijl, Orzalesi, Bouma, van der Mijle, Nieuwenhuijzen, Veltkamp, Slaets, Duez, de Graaf, van Dalen, Marinelli, Rijna, Snoj, Bundred, Merkus, Belkacemi, Petignat, Schinagl, Coens, Messina, Bogaerts, Rutgers (CR3) 2014; 15 Thake, Lowry (CR18) 2017; 72 Dunn, Wilson, Sitas (CR19) 2017; 51 Gentilini, Veronesi (CR8) 2012; 21 Merali, Wilson (CR15) 2017; 30 de Boniface, Frisell, Andersson, Bergkvist, Ahlgren, Ryden, Olofsson Bagge, Sund, Johansson, Lundstedt (CR6) 2017; 17 Savolt, Peley, Polgar, Udvarhelyi, Rubovszky, Kovacs, Gyorffy, Kasler, Matrai (CR4) 2017; 43 Giuliano, Ballman, McCall, Beitsch, Brennan, Kelemen, Ollila, Hansen, Whitworth, Blumencranz, Leitch, Saha, Hunt, Morrow (CR10) 2017; 318 CR13 CR12 Galimberti, Cole, Zurrida, Viale, Luini, Veronesi, Baratella, Chifu, Sargenti, Intra, Gentilini, Mastropasqua, Mazzarol, Massarut, Garbay, Zgajnar, Galatius, Recalcati, Littlejohn, Bamert, Colleoni, Price, Regan, Goldhirsch, Coates, Gelber, Veronesi (CR1) 2013; 14 Reimer, Stachs, Nekljudova, Loibl, Hartmann, Wolter, Hildebrandt, Gerber (CR5) 2017; 77 Ford, Norrie (CR9) 2016; 375 Rothwell (CR16) 2005; 365 Andersson, Bergkvist, Frisell, de Boniface (CR11) 2018; 171 Goyal, Dodwell (CR7) 2015; 27 Giuliano, Hunt, Ballman, Beitsch, Whitworth, Blumencranz, Leitch, Saha, McCall, Morrow (CR2) 2011; 305 M Donker (5537_CR3) 2014; 15 V Galimberti (5537_CR1) 2013; 14 T Reimer (5537_CR5) 2017; 77 O Gentilini (5537_CR8) 2012; 21 Y Andersson (5537_CR11) 2018; 171 A Goyal (5537_CR7) 2015; 27 J de Boniface (5537_CR6) 2017; 17 D Schwartz (5537_CR14) 1967; 20 C Dunn (5537_CR19) 2017; 51 5537_CR13 M Thake (5537_CR18) 2017; 72 AE Giuliano (5537_CR10) 2017; 318 5537_CR12 K Loudon (5537_CR17) 2015; 350 AE Giuliano (5537_CR2) 2011; 305 PM Rothwell (5537_CR16) 2005; 365 A Savolt (5537_CR4) 2017; 43 Z Merali (5537_CR15) 2017; 30 I Ford (5537_CR9) 2016; 375 |
| References_xml | – volume: 15 start-page: 1303 issue: 12 year: 2014 end-page: 1310 ident: CR3 article-title: Radiotherapy or surgery of the axilla after a positive sentinel node in breast cancer (EORTC 10981-22023 AMAROS): a randomised, multicentre, open-label, phase 3 non-inferiority trial publication-title: Lancet Oncol doi: 10.1016/S1470-2045(14)70460-7 – volume: 30 start-page: 404 issue: 9 year: 2017 end-page: 406 ident: CR15 article-title: Explanatory versus pragmatic trials: an essential concept in study design and interpretation publication-title: Clin Spine Surg doi: 10.1097/BSD.0000000000000588 – volume: 27 start-page: 692 issue: 12 year: 2015 end-page: 695 ident: CR7 article-title: POSNOC: A randomised trial looking at axillary treatment in women with one or two sentinel nodes with macrometastases publication-title: Clin Oncol doi: 10.1016/j.clon.2015.07.005 – volume: 375 start-page: 454 issue: 5 year: 2016 end-page: 463 ident: CR9 article-title: Pragmatic trials publication-title: N Engl J Med doi: 10.1056/NEJMra1510059 – volume: 350 start-page: h2147 year: 2015 ident: CR17 article-title: The PRECIS-2 tool: designing trials that are fit for purpose publication-title: BMJ doi: 10.1136/bmj.h2147 – volume: 21 start-page: 678 issue: 5 year: 2012 end-page: 681 ident: CR8 article-title: Abandoning sentinel lymph node biopsy in early breast cancer? A new trial in progress at the European Institute of Oncology of Milan (SOUND: Sentinel node vs Observation after axillary UltraSouND) publication-title: Breast doi: 10.1016/j.breast.2012.06.013 – volume: 318 start-page: 918 issue: 10 year: 2017 end-page: 926 ident: CR10 article-title: Effect of axillary dissection vs no axillary dissection on 10-year overall survival among women with invasive breast cancer and sentinel node metastasis: the ACOSOG Z0011 (Alliance) randomized clinical trial publication-title: JAMA doi: 10.1001/jama.2017.11470 – ident: CR12 – volume: 51 start-page: 113 year: 2017 end-page: 117 ident: CR19 article-title: Older cancer patients in cancer clinical trials are underrepresented. Systematic literature review of almost 5000 meta- and pooled analyses of phase III randomized trials of survival from breast, prostate and lung cancer publication-title: Cancer Epidemiol doi: 10.1016/j.canep.2017.11.002 – volume: 14 start-page: 297 issue: 4 year: 2013 end-page: 305 ident: CR1 article-title: Axillary dissection versus no axillary dissection in patients with sentinel-node micrometastases (IBCSG 23-01): a phase 3 randomised controlled trial publication-title: Lancet Oncol doi: 10.1016/S1470-2045(13)70035-4 – ident: CR13 – volume: 20 start-page: 637 issue: 8 year: 1967 end-page: 648 ident: CR14 article-title: Explanatory and pragmatic attitudes in therapeutical trials publication-title: J Chronic Dis doi: 10.1016/0021-9681(67)90041-0 – volume: 17 start-page: 379 issue: 1 year: 2017 ident: CR6 article-title: Survival and axillary recurrence following sentinel node-positive breast cancer without completion axillary lymph node dissection: the randomized controlled SENOMAC trial publication-title: BMC Cancer doi: 10.1186/s12885-017-3361-y – volume: 43 start-page: 672 issue: 4 year: 2017 end-page: 679 ident: CR4 article-title: Eight-year follow up result of the OTOASOR trial: the optimal treatment of the axilla-surgery or radiotherapy after positive sentinel lymph node biopsy in early-stage breast cancer: a randomized, single centre, phase III, non-inferiority trial publication-title: Eur J Surg Oncol doi: 10.1016/j.ejso.2016.12.011 – volume: 77 start-page: 149 issue: 2 year: 2017 end-page: 157 ident: CR5 article-title: Restricted axillary staging in clinically and sonographically node-negative early invasive breast cancer (c/iT1-2) in the context of breast conserving therapy: first results following commencement of the intergroup-sentinel-mamma (INSEMA) Trial publication-title: Geburtshilfe Frauenheilkd doi: 10.1055/s-0042-122853 – volume: 72 start-page: 99 year: 2017 end-page: 102 ident: CR18 article-title: A systematic review of trends in the selective exclusion of older participant from randomised clinical trials publication-title: Arch Gerontol Geriatr doi: 10.1016/j.archger.2017.05.017 – volume: 305 start-page: 569 issue: 6 year: 2011 end-page: 575 ident: CR2 article-title: Axillary dissection vs no axillary dissection in women with invasive breast cancer and sentinel node metastasis: a randomized clinical trial publication-title: JAMA doi: 10.1001/jama.2011.90 – volume: 365 start-page: 82 issue: 9453 year: 2005 end-page: 93 ident: CR16 article-title: External validity of randomised controlled trials: "to whom do the results of this trial apply?" publication-title: Lancet doi: 10.1016/S0140-6736(04)17670-8 – volume: 171 start-page: 359 issue: 2 year: 2018 end-page: 369 ident: CR11 article-title: Long-term breast cancer survival in relation to the metastatic tumor burden in axillary lymph nodes publication-title: Breast Cancer Res Treat doi: 10.1007/s10549-018-4820-0 – volume: 51 start-page: 113 year: 2017 ident: 5537_CR19 publication-title: Cancer Epidemiol doi: 10.1016/j.canep.2017.11.002 – volume: 318 start-page: 918 issue: 10 year: 2017 ident: 5537_CR10 publication-title: JAMA doi: 10.1001/jama.2017.11470 – volume: 72 start-page: 99 year: 2017 ident: 5537_CR18 publication-title: Arch Gerontol Geriatr doi: 10.1016/j.archger.2017.05.017 – volume: 77 start-page: 149 issue: 2 year: 2017 ident: 5537_CR5 publication-title: Geburtshilfe Frauenheilkd doi: 10.1055/s-0042-122853 – volume: 375 start-page: 454 issue: 5 year: 2016 ident: 5537_CR9 publication-title: N Engl J Med doi: 10.1056/NEJMra1510059 – ident: 5537_CR12 – ident: 5537_CR13 – volume: 43 start-page: 672 issue: 4 year: 2017 ident: 5537_CR4 publication-title: Eur J Surg Oncol doi: 10.1016/j.ejso.2016.12.011 – volume: 21 start-page: 678 issue: 5 year: 2012 ident: 5537_CR8 publication-title: Breast doi: 10.1016/j.breast.2012.06.013 – volume: 20 start-page: 637 issue: 8 year: 1967 ident: 5537_CR14 publication-title: J Chronic Dis doi: 10.1016/0021-9681(67)90041-0 – volume: 30 start-page: 404 issue: 9 year: 2017 ident: 5537_CR15 publication-title: Clin Spine Surg doi: 10.1097/BSD.0000000000000588 – volume: 27 start-page: 692 issue: 12 year: 2015 ident: 5537_CR7 publication-title: Clin Oncol doi: 10.1016/j.clon.2015.07.005 – volume: 365 start-page: 82 issue: 9453 year: 2005 ident: 5537_CR16 publication-title: Lancet doi: 10.1016/S0140-6736(04)17670-8 – volume: 350 start-page: h2147 year: 2015 ident: 5537_CR17 publication-title: BMJ doi: 10.1136/bmj.h2147 – volume: 14 start-page: 297 issue: 4 year: 2013 ident: 5537_CR1 publication-title: Lancet Oncol doi: 10.1016/S1470-2045(13)70035-4 – volume: 305 start-page: 569 issue: 6 year: 2011 ident: 5537_CR2 publication-title: JAMA doi: 10.1001/jama.2011.90 – volume: 15 start-page: 1303 issue: 12 year: 2014 ident: 5537_CR3 publication-title: Lancet Oncol doi: 10.1016/S1470-2045(14)70460-7 – volume: 17 start-page: 379 issue: 1 year: 2017 ident: 5537_CR6 publication-title: BMC Cancer doi: 10.1186/s12885-017-3361-y – volume: 171 start-page: 359 issue: 2 year: 2018 ident: 5537_CR11 publication-title: Breast Cancer Res Treat doi: 10.1007/s10549-018-4820-0 |
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None of the key randomised trials on the omission of axillary lymph node dissection (ALND) in sentinel lymph-positive breast cancer have reported... None of the key randomised trials on the omission of axillary lymph node dissection (ALND) in sentinel lymph-positive breast cancer have reported external... Purpose None of the key randomised trials on the omission of axillary lymph node dissection (ALND) in sentinel lymph-positive breast cancer have reported... PurposeNone of the key randomised trials on the omission of axillary lymph node dissection (ALND) in sentinel lymph-positive breast cancer have reported... PURPOSE: None of the key randomised trials on the omission of axillary lymph node dissection (ALND) in sentinel lymph-positive breast cancer have reported... Purpose: None of the key randomised trials on the omission of axillary lymph node dissection (ALND) in sentinel lymph-positive breast cancer have reported... |
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| SubjectTerms | axillary dissection Biopsy Breast cancer Cancer and Oncology Cancer och onkologi Cancer research Clinical Medicine Clinical Trial Clinical trials Kirurgi Klinisk medicin Lumpectomy lymph node biopsy Lymph nodes Lymphatic system Mastectomy Medical and Health Sciences Medicin och hälsovetenskap Medicine Medicine & Public Health NCT NCT02240472 Omission of axillary dissection Oncology Patients phase-iii radiotherapy Sentinel Sentinel lymph node biopsy Surgery survival Tumors Validity women |
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| Title | The generalisability of randomised clinical trials: an interim external validity analysis of the ongoing SENOMAC trial in sentinel lymph node-positive breast cancer |
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