This is the Scientific Surgery Archive, which contains all randomized clinical trials in surgery that have been identified by searching the top 50 English language medical journal issues since January 1998. Compiled by Jonothan J. Earnshaw, former Editor-in-Chief, BJS

Inconsistent selection and definition of local and regional endpoints in breast cancer research. BJS 2014; 101: 1657-1665.

Published: 13th October 2014

Authors: M. Moossdorff, L. M. van Roozendaal, R.‐J. Schipper, L. J. A. Strobbe, A. C. Voogd, V. C. G. Tjan‐Heijnen et al.

Background

Results in breast cancer research are reported using study endpoints. Most are composite endpoints (such as locoregional recurrence), consisting of several components (for example local recurrence) that are in turn composed of specific events (such as skin recurrence). Inconsistent endpoint selection and definition might lead to unjustified conclusions when comparing study outcomes. This study aimed to determine which locoregional endpoints are used in breast cancer studies, and how these endpoints and their components are defined.

Method

PubMed was searched for breast cancer studies published in nine leading journals in 2011. Articles using endpoints with a local or regional component were included and definitions were compared.

Results

Twenty‐three different endpoints with a local or regional component were extracted from 44 articles. Most frequently used were disease‐free survival (25 articles), recurrence‐free survival (7), local control (4), locoregional recurrence‐free survival (3) and event‐free survival (3). Different endpoints were used for similar outcomes. Of 23 endpoints, five were not defined and 18 were defined only partially. Of these, 16 contained a local and 13 a regional component. Included events were not specified in 33 of 57 (local) and 27 of 50 (regional) cases. Definitions of local components inconsistently included carcinoma in situ and skin and chest wall recurrences. Regional components inconsistently included specific nodal sites and skin and chest wall recurrences.

Conclusion

Breast cancer studies use many different endpoints with a locoregional component. Definitions of endpoints and events are either not provided or vary between trials. To improve transparency, facilitate trial comparison and avoid unjustified conclusions, authors should report detailed definitions of all endpoints.

Full text

You may also be interested in

Original article

Population‐based study of the effect of preoperative breast MRI on the surgical management of ductal carcinoma in situ. BJS 2019; 106: 1488-1494.

Authors: K. B. I. M. Keymeulen, S. M. E. Geurts, M. B. I. Lobbes, E. M. Heuts, L. E. M. Duijm, L. F. S. Kooreman et al.

Original article

Nationwide population‐based study of the impact of immediate breast reconstruction after mastectomy on the timing of adjuvant chemotherapy.

Authors: E. Heeg, J. X. Harmeling, B. E. Becherer, P. J. Marang‐van de Mheen, M. T. F. D. Vrancken Peeters, M. A. M. Mureau et al.

Original article

International multidisciplinary expert panel consensus on breast reconstruction and radiotherapy. BJS 2019; 106: 1327-1340.

Authors: M. B. Nava, J. R. Benson, W. Audretsch, P. Blondeel, G. Catanuto, M. W. Clemens et al.

Original article

Prognostic impact of repeat sentinel lymph node biopsy in patients with ipsilateral breast tumour recurrence. BJS 2019; 106: 574-585.

Authors: I. G. M. Poodt, G. Vugts, R. J. Schipper, R. M. H. Roumen, H. J. T. Rutten, A. J. G. Maaskant‐Braat et al.

Notes: No impact

Original article

Effect of preoperative injection of superparamagnetic iron oxide particles on rates of sentinel lymph node dissection in women undergoing surgery for ductal carcinoma in situ (SentiNot study). BJS 2019; 106: 720-728.

Authors: A. Karakatsanis, A.‐F. Hersi, L. Pistiolis, R. Olofsson Bagge, P. M. Lykoudis, S. Eriksson et al.

Original article

Short‐term cost‐effectiveness of one‐stage implant‐based breast reconstruction with an acellular dermal matrix versus two‐stage expander‐implant reconstruction from a multicentre randomized clinical trial. BJS 2019; 106: 586-595.

Authors: V. L. Negenborn, J. M. Smit, R. E. G. Dikmans, H. A. H. Winters, J. W. R. Twisk, P. Q. Ruhé et al.

Original article

Autologous fat transplantation alters gene expression patterns related to inflammation and hypoxia in the irradiated human breast. BJS 2019; 106: 563-573.

Authors: A. Lindegren, I. Schultz, I. Sinha, L. Cheung, A. A. Khan, M. Tekle et al.

Notes: Effects on fibrosis after radiotherapy

Original article

Sentinel lymph node biopsy in microinvasive ductal carcinoma in situ. BJS 2019; 106: 375-383.

Authors: F. Magnoni, G. Massari, G. Santomauro, V. Bagnardi, E. Pagan, G. Peruzzotti et al.

Original article

Patient‐level costs in margin re‐excision for breast‐conserving surgery. BJS 2019; 106: 384-394.

Authors: Y. Grant, R. Al‐Khudairi, E. St John, M. Barschkett, D. Cunningham, R. Al‐Mufti et al.

Notes: Reoperations expensive

Systematic review

Meta‐analysis of sentinel lymph node biopsy after neoadjuvant chemotherapy in patients with initial biopsy‐proven node‐positive breast cancer. BJS 2018; 105: 1541-1552.

Authors: S. R. Tee, L. A. Devane, D. Evoy, J. Rothwell, J. Geraghty, R. S. Prichard et al.

Notes: In selected patients using dual tracer

Original article

Feasibility study of combined dynamic imaging and lymphaticovenous anastomosis surgery for breast cancer‐related lymphoedema. BJS 2019; 106: 100-110.

Authors: A. A. Khan, I. Hernan, J. A. Adamthwaite, K. W. D. Ramsey

Notes: Effective in selected patients

Randomized clinical trial

INTEND II randomized clinical trial of intraoperative duct endoscopy in pathological nipple discharge. BJS 2018; 105: 1583-1590.

Authors: G. Gui, A. Agusti, D. Twelves, S. Tang, M. Kabir, C. Montgomery et al.

Notes: Identifies causative lesion