Maastricht Delphi Consensus on Event Definitions for Classification of Recurrence in Breast Cancer Research

M. Moossdorff; L.M. van Roozendaal; L.J.A. Strobbe; S. Aebi; D.A. Cameron; J.M. Dixon; A.E. Giuliano; B.G. Haffty; B.E. Hickey; C.A. Hudis; V.S. Klimberg; B. Koczwara; T. Kühn; M.E. Lippman; A. Lucci; M. Piccart; B.D. Smith; V.C.G. Tjan-Heijnen; C.J.H. van de Velde; K.J. Van Zee; J B. Vermorken; G. Viale; A.C. Voogd; I.L. Wapnir; J.R. White; M.L. Smidt

doi:10.1093/jnci/dju288

Maastricht Delphi Consensus on Event Definitions for Classification of Recurrence in Breast Cancer Research

M. Moossdorff^*, L.M. van Roozendaal, L.J.A. Strobbe, S. Aebi, D.A. Cameron, J.M. Dixon, A.E. Giuliano, B.G. Haffty, B.E. Hickey, C.A. Hudis, V.S. Klimberg, B. Koczwara, T. Kühn, M.E. Lippman, A. Lucci, M. Piccart, B.D. Smith, V.C.G. Tjan-Heijnen, C.J.H. van de Velde, K.J. Van ZeeJ B. Vermorken, G. Viale, A.C. Voogd, I.L. Wapnir, J.R. White, M.L. Smidt

^*Corresponding author for this work

Research output: Contribution to journal › Article › Academic › peer-review

Abstract

BACKGROUND: In breast cancer studies, many different endpoints are used. Definitions are often not provided or vary between studies. For instance, "local recurrence" may include different components in similar studies. This limits transparency and comparability of results. This project aimed to reach consensus on the definitions of local event, second primary breast cancer, regional and distant event for breast cancer studies. METHODS: The RAND-UCLA Appropriateness method (modified Delphi method) was used. A Consensus Group of international breast cancer experts was formed, including representatives of all involved clinical disciplines. Consensus was reached in two rounds of online questionnaires and one meeting. RESULTS: Twenty-four international breast cancer experts participated. Consensus was reached on 134 items in four categories. Local event is defined as any epithelial breast cancer or ductal carcinoma in situ (DCIS) in the ipsilateral breast, or skin and subcutaneous tissue on the ipsilateral thoracic wall. Second primary breast cancer is defined as epithelial breast cancer in the contralateral breast. Regional events are breast cancer in ipsilateral lymph nodes. A distant event is breast cancer in any other location. Therefore, this includes metastasis in contralateral lymph nodes and breast cancer involving the sternal bone. If feasible, tissue sampling of a first, solitary, lesion suspected for metastasis is highly recommended. CONCLUSION: This project resulted in consensus-based event definitions for classification of recurrence in breast cancer research. Future breast cancer research projects should adopt these definitions to increase transparency. This should facilitate comparison of results and conducting reviews as well as meta-analysis.

Original language	English
Article number	288
Number of pages	7
Journal	Journal of the National Cancer Institute
Volume	106
Issue number	12
DOIs	https://doi.org/10.1093/jnci/dju288
Publication status	Published - Dec 2014

Keywords

END-POINTS
CLINICAL-TRIALS
COMMON LANGUAGE
GUIDELINES

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10.1093/jnci/dju288

Cite this

Moossdorff, M., van Roozendaal, L. M., Strobbe, L. J. A., Aebi, S., Cameron, D. A., Dixon, J. M., Giuliano, A. E., Haffty, B. G., Hickey, B. E., Hudis, C. A., Klimberg, V. S., Koczwara, B., Kühn, T., Lippman, M. E., Lucci, A., Piccart, M., Smith, B. D., Tjan-Heijnen, V. C. G., van de Velde, C. J. H., ... Smidt, M. L. (2014). Maastricht Delphi Consensus on Event Definitions for Classification of Recurrence in Breast Cancer Research. Journal of the National Cancer Institute, 106(12), Article 288. https://doi.org/10.1093/jnci/dju288

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title = "Maastricht Delphi Consensus on Event Definitions for Classification of Recurrence in Breast Cancer Research",

abstract = "BACKGROUND: In breast cancer studies, many different endpoints are used. Definitions are often not provided or vary between studies. For instance, {"}local recurrence{"} may include different components in similar studies. This limits transparency and comparability of results. This project aimed to reach consensus on the definitions of local event, second primary breast cancer, regional and distant event for breast cancer studies. METHODS: The RAND-UCLA Appropriateness method (modified Delphi method) was used. A Consensus Group of international breast cancer experts was formed, including representatives of all involved clinical disciplines. Consensus was reached in two rounds of online questionnaires and one meeting. RESULTS: Twenty-four international breast cancer experts participated. Consensus was reached on 134 items in four categories. Local event is defined as any epithelial breast cancer or ductal carcinoma in situ (DCIS) in the ipsilateral breast, or skin and subcutaneous tissue on the ipsilateral thoracic wall. Second primary breast cancer is defined as epithelial breast cancer in the contralateral breast. Regional events are breast cancer in ipsilateral lymph nodes. A distant event is breast cancer in any other location. Therefore, this includes metastasis in contralateral lymph nodes and breast cancer involving the sternal bone. If feasible, tissue sampling of a first, solitary, lesion suspected for metastasis is highly recommended. CONCLUSION: This project resulted in consensus-based event definitions for classification of recurrence in breast cancer research. Future breast cancer research projects should adopt these definitions to increase transparency. This should facilitate comparison of results and conducting reviews as well as meta-analysis.",

keywords = "END-POINTS, CLINICAL-TRIALS, COMMON LANGUAGE, GUIDELINES",

author = "M. Moossdorff and {van Roozendaal}, L.M. and L.J.A. Strobbe and S. Aebi and D.A. Cameron and J.M. Dixon and A.E. Giuliano and B.G. Haffty and B.E. Hickey and C.A. Hudis and V.S. Klimberg and B. Koczwara and T. K{\"u}hn and M.E. Lippman and A. Lucci and M. Piccart and B.D. Smith and V.C.G. Tjan-Heijnen and {van de Velde}, C.J.H. and {Van Zee}, K.J. and Vermorken, {J B.} and G. Viale and A.C. Voogd and I.L. Wapnir and J.R. White and M.L. Smidt",

year = "2014",

month = dec,

doi = "10.1093/jnci/dju288",

language = "English",

volume = "106",

journal = "Journal of the National Cancer Institute",

issn = "0027-8874",

publisher = "Oxford University Press",

number = "12",

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Moossdorff, M, van Roozendaal, LM, Strobbe, LJA, Aebi, S, Cameron, DA, Dixon, JM, Giuliano, AE, Haffty, BG, Hickey, BE, Hudis, CA, Klimberg, VS, Koczwara, B, Kühn, T, Lippman, ME, Lucci, A, Piccart, M, Smith, BD, Tjan-Heijnen, VCG, van de Velde, CJH, Van Zee, KJ, Vermorken, JB, Viale, G, Voogd, AC, Wapnir, IL, White, JR & Smidt, ML 2014, 'Maastricht Delphi Consensus on Event Definitions for Classification of Recurrence in Breast Cancer Research', Journal of the National Cancer Institute, vol. 106, no. 12, 288. https://doi.org/10.1093/jnci/dju288

TY - JOUR

T1 - Maastricht Delphi Consensus on Event Definitions for Classification of Recurrence in Breast Cancer Research

AU - Moossdorff, M.

AU - van Roozendaal, L.M.

AU - Strobbe, L.J.A.

AU - Aebi, S.

AU - Cameron, D.A.

AU - Dixon, J.M.

AU - Giuliano, A.E.

AU - Haffty, B.G.

AU - Hickey, B.E.

AU - Hudis, C.A.

AU - Klimberg, V.S.

AU - Koczwara, B.

AU - Kühn, T.

AU - Lippman, M.E.

AU - Lucci, A.

AU - Piccart, M.

AU - Smith, B.D.

AU - Tjan-Heijnen, V.C.G.

AU - van de Velde, C.J.H.

AU - Van Zee, K.J.

AU - Vermorken, J B.

AU - Viale, G.

AU - Voogd, A.C.

AU - Wapnir, I.L.

AU - White, J.R.

AU - Smidt, M.L.

PY - 2014/12

Y1 - 2014/12

N2 - BACKGROUND: In breast cancer studies, many different endpoints are used. Definitions are often not provided or vary between studies. For instance, "local recurrence" may include different components in similar studies. This limits transparency and comparability of results. This project aimed to reach consensus on the definitions of local event, second primary breast cancer, regional and distant event for breast cancer studies. METHODS: The RAND-UCLA Appropriateness method (modified Delphi method) was used. A Consensus Group of international breast cancer experts was formed, including representatives of all involved clinical disciplines. Consensus was reached in two rounds of online questionnaires and one meeting. RESULTS: Twenty-four international breast cancer experts participated. Consensus was reached on 134 items in four categories. Local event is defined as any epithelial breast cancer or ductal carcinoma in situ (DCIS) in the ipsilateral breast, or skin and subcutaneous tissue on the ipsilateral thoracic wall. Second primary breast cancer is defined as epithelial breast cancer in the contralateral breast. Regional events are breast cancer in ipsilateral lymph nodes. A distant event is breast cancer in any other location. Therefore, this includes metastasis in contralateral lymph nodes and breast cancer involving the sternal bone. If feasible, tissue sampling of a first, solitary, lesion suspected for metastasis is highly recommended. CONCLUSION: This project resulted in consensus-based event definitions for classification of recurrence in breast cancer research. Future breast cancer research projects should adopt these definitions to increase transparency. This should facilitate comparison of results and conducting reviews as well as meta-analysis.

AB - BACKGROUND: In breast cancer studies, many different endpoints are used. Definitions are often not provided or vary between studies. For instance, "local recurrence" may include different components in similar studies. This limits transparency and comparability of results. This project aimed to reach consensus on the definitions of local event, second primary breast cancer, regional and distant event for breast cancer studies. METHODS: The RAND-UCLA Appropriateness method (modified Delphi method) was used. A Consensus Group of international breast cancer experts was formed, including representatives of all involved clinical disciplines. Consensus was reached in two rounds of online questionnaires and one meeting. RESULTS: Twenty-four international breast cancer experts participated. Consensus was reached on 134 items in four categories. Local event is defined as any epithelial breast cancer or ductal carcinoma in situ (DCIS) in the ipsilateral breast, or skin and subcutaneous tissue on the ipsilateral thoracic wall. Second primary breast cancer is defined as epithelial breast cancer in the contralateral breast. Regional events are breast cancer in ipsilateral lymph nodes. A distant event is breast cancer in any other location. Therefore, this includes metastasis in contralateral lymph nodes and breast cancer involving the sternal bone. If feasible, tissue sampling of a first, solitary, lesion suspected for metastasis is highly recommended. CONCLUSION: This project resulted in consensus-based event definitions for classification of recurrence in breast cancer research. Future breast cancer research projects should adopt these definitions to increase transparency. This should facilitate comparison of results and conducting reviews as well as meta-analysis.

KW - END-POINTS

KW - CLINICAL-TRIALS

KW - COMMON LANGUAGE

KW - GUIDELINES

U2 - 10.1093/jnci/dju288

DO - 10.1093/jnci/dju288

M3 - Article

SN - 0027-8874

VL - 106

JO - Journal of the National Cancer Institute

JF - Journal of the National Cancer Institute

IS - 12

M1 - 288

ER -