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The generalisabilit...
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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- de Boniface, J. (författare)
- Karolinska Institutet,Capio St. Görans Sjukhus
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- Ahlgren, J. (författare)
- Örebro University
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- Andersson, Yvette (författare)
- Uppsala University,Uppsala universitet,Centrum för klinisk forskning, Västerås,Vastmanland Cty Hosp, Dept Surg, Vasteras, Sweden,Uppsala University Hospital
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- Bergkvist, Leif (författare)
- Uppsala University,Uppsala universitet,Centrum för klinisk forskning, Västerås
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- Frisell, J. (författare)
- Karolinska Institutet
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- Lundstedt, Dan, 1970 (författare)
- Gothenburg University,Göteborgs universitet,Institutionen för kliniska vetenskaper, Avdelningen för onkologi,Institute of Clinical Sciences, Department of Oncology,Sahlgrens Univ Hosp, Univ Gothenburg,Inst Clin Sciences, Sahlgrenska Acad,Dept Oncology, Gothenburg, Sweden,Sahlgrenska University Hospital,Sahlgrenska Academy
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- Olofsson Bagge, Roger, 1978 (författare)
- Gothenburg University,Göteborgs universitet,Wallenberg Centre for Molecular and Translational Medicine,Univ Gothenburg, Wallenberg Centre Mol, Translat Med, Gothenburg, Sweden;Sahlgrens Univ Hosp, Sahlgrenska Acad Univ Gothenburg, Inst Clin Sciences, Dept Surg, Gothenburg, Sweden,Sahlgrenska University Hospital, Wallenberg Laboratory
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Ryd?n, L. (författare)
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- Sund, Malin (författare)
- Umeå University,Umeå universitet,Kirurgi,Surgery Center, Norrland University Hospital, Umeå, Sweden,Norrland Univ Hosp, Surg Ctr, Umea, Sweden;Umea Univ, Dept Surg, Perioperat Sci, Surg, Umea, Sweden
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Christiansen, P. (författare)
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Christiansen, P. (författare)
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Tvedskov, T. F. (författare)
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Offersen, B. V. (författare)
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Reimer, T. (författare)
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K?hn, T. (författare)
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Kontos, M. (författare)
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Gentilini, O. (författare)
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Reitsamer, R. (författare)
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- Rydén, Lisa (författare)
- Lund University,Lunds universitet,Bröstcancerkirurgi,Forskargrupper vid Lunds universitet,LUCC: Lunds universitets cancercentrum,Övriga starka forskningsmiljöer,Breast Cancer Surgery,Lund University Research Groups,LUCC: Lund University Cancer Centre,Other Strong Research Environments,Skåne University Hospital
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Karolinska Institutet Capio St Görans Sjukhus (creator_code:org_t)
- 2020-01-27
- 2020
- Engelska.
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Ingår i: Breast Cancer Research and Treatment. - : Springer Science and Business Media LLC. - 0167-6806 .- 1573-7217. ; 180:1, s. 167-176
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https://doi.org/10.1...
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https://umu.diva-por... (primary) (Raw object)
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http://dx.doi.org/10... (free)
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https://gup.ub.gu.se...
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https://doi.org/10.1...
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https://urn.kb.se/re...
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Abstract
Ämnesord
Stäng
- 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
Ämnesord
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Cancer och onkologi (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Cancer and Oncology (hsv//eng)
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Kirurgi (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Surgery (hsv//eng)
Nyckelord
- Breast cancer
- Omission of axillary dissection
- Clinical trial
- Sentinel
- lymph node biopsy
- axillary dissection
- phase-iii
- radiotherapy
- survival
- surgery
- biopsy
- women
- Oncology
- Breast cancer
- Sentinel lymph node biopsy
Publikations- och innehållstyp
- ref (ämneskategori)
- art (ämneskategori)
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Till lärosätets databas
- Av författaren/redakt...
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de Boniface, J.
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Ahlgren, J.
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Andersson, Yvett ...
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Bergkvist, Leif
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Frisell, J.
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Lundstedt, Dan, ...
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visa fler...
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Olofsson Bagge, ...
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Ryd?n, L.
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Sund, Malin
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Christiansen, P.
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Tvedskov, T. F.
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Offersen, B. V.
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Reimer, T.
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K?hn, T.
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Kontos, M.
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Gentilini, O.
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Reitsamer, R.
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Rydén, Lisa
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