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Do clinical trials truly mirror their target population?: An external validity analysis of national register versus trial data from the Swedish prospective SENOMIC trial on sentinel node micrometastases in breast cancer
Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Medicinska och farmaceutiska vetenskapsområdet, centrumbildningar mm, Centre for Clinical Research, County of Västmanland. Vastmanland Cty Hosp, Dept Surg, SE-72189 Vasteras, Sweden.
Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Medicinska och farmaceutiska vetenskapsområdet, centrumbildningar mm, Centre for Clinical Research, County of Västmanland. Vastmanland Cty Hosp, Dept Surg, SE-72189 Vasteras, Sweden.
Karolinska Univ Hosp, Dept Breast & Endocrine Surg, Stockholm, Sweden;Karolinska Inst, Dept Mol Med & Surg, Stockholm, Sweden.
Karolinska Inst, Dept Mol Med & Surg, Stockholm, Sweden;Capio St Gorans Hosp, Dept Surg, Stockholm, Sweden.
2019 (English)In: Breast Cancer Research and Treatment, ISSN 0167-6806, E-ISSN 1573-7217, Vol. 177, no 2, p. 469-475Article in journal (Refereed) Published
Abstract [en]

Purpose: Increasing evidence suggests that completion axillary lymph node dissection (ALND) may be omitted in breast cancer patients with limited axillary nodal metastases. However, the representativeness of trial participants for the original clinical practice population, and thus, the generalizability of published trials have been questioned. We propose the use of background data from national registers as a means to assess whether trial participants mirror their target population and to strengthen the generalizability and implementation of trial outcomes.

Methods: The Swedish prospective SENOMIC trial, omitting a completion ALND in breast cancer patients with sentinel lymph node micrometastases, reached full target accrual in 2017. To assess the generalizability of trial results for the target population, a comparative analysis of trial participants versus cases reported to the Swedish National Breast Cancer Register (NKBC) was performed.

Results: Comparing 548 trial participants and 1070 NKBC cases, there were no significant differences in age, tumor characteristics, breast surgery, or adjuvant treatment. Only the mean number of sentinel lymph nodes with micrometastasis per individual was lower in trial participants than in register cases (1.06 vs. 1.09, p=0.037).

Conclusions: Patients included in the SENOMIC trial are acceptably representative of the Swedish breast cancer target population. There were some minor divergences between trial participants and the NKBC population, but taking these into consideration, upcoming trial outcomes should be generalizable to breast cancer patients with micrometastases in their sentinel lymph node biopsy.

Place, publisher, year, edition, pages
SPRINGER , 2019. Vol. 177, no 2, p. 469-475
Keywords [en]
Breast cancer, Sentinel node biopsy, Micrometastases, Axillary lymph node dissection, Cohort study, Register
National Category
Surgery Cancer and Oncology
Identifiers
URN: urn:nbn:se:uu:diva-392124DOI: 10.1007/s10549-019-05328-3ISI: 000477675700020PubMedID: 31236811OAI: oai:DiVA.org:uu-392124DiVA, id: diva2:1348200
Available from: 2019-09-03 Created: 2019-09-03 Last updated: 2019-09-03Bibliographically approved

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Andersson, YvetteBergkvist, Leif

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