Proposals for uniform collection of biospecimens from neoadjuvant breast cancer clinical trials: timing and specimen types

Summary In this Personal View, we outline proposals for uniform collection of biospecimens obtained in neoadjuvant breast cancer trials undertaken by the Breast International Group (BIG) and the National Cancer Institute-sponsored North American Breast Cancer Group (NABCG). These proposals aim to st...

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Published inThe lancet oncology Vol. 12; no. 12; pp. 1162 - 1168
Main Authors Loi, Sherene, MD, Symmans, W Fraser, Prof, Bartlett, John MS, Prof, Fumagalli, Debora, MD, Veer, Laura Van't, Prof, Forbes, John F, Prof, Bedard, Philippe, MD, Denkert, Carsten, MD, Zujewski, JoAnne, MD, Viale, Giuseppe, Prof, Pusztai, Lajos, Prof, Esserman, Laura J, Prof, Leyland-Jones, Brian R, Prof
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Published England Elsevier Ltd 01.11.2011
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Abstract Summary In this Personal View, we outline proposals for uniform collection of biospecimens obtained in neoadjuvant breast cancer trials undertaken by the Breast International Group (BIG) and the National Cancer Institute-sponsored North American Breast Cancer Group (NABCG). These proposals aim to standardise collection of high-quality specimens, with respect to both type and timing, to enhance and allow integration of results obtained from neoadjuvant trials done by several groups. They should be considered in parallel with recommendations for tissue-specimen collection and handling previously developed by BIG and NABCG. We propose that tumour tissue (formalin-fixed, paraffin-embedded and samples dedicated for molecular studies) should be taken at baseline, 1–3 weeks after the start of treatment, and at definitive surgery, with clear prioritisation in the study protocol of number, order, and preservation of samples to be gathered. This step should be accompanied by blood collection (plasma, serum, and whole blood) whenever possible. We advocate strongly a move towards one diagnostic and research biopsy procedure in all women with breast cancers potentially suitable for neoadjuvant treatment. If possible, patients should be referred at the outset to specialised centres to give them the opportunity to participate in neoadjuvant clinical trials, thereby avoiding several biopsy procedures.
AbstractList Summary In this Personal View, we outline proposals for uniform collection of biospecimens obtained in neoadjuvant breast cancer trials undertaken by the Breast International Group (BIG) and the National Cancer Institute-sponsored North American Breast Cancer Group (NABCG). These proposals aim to standardise collection of high-quality specimens, with respect to both type and timing, to enhance and allow integration of results obtained from neoadjuvant trials done by several groups. They should be considered in parallel with recommendations for tissue-specimen collection and handling previously developed by BIG and NABCG. We propose that tumour tissue (formalin-fixed, paraffin-embedded and samples dedicated for molecular studies) should be taken at baseline, 1–3 weeks after the start of treatment, and at definitive surgery, with clear prioritisation in the study protocol of number, order, and preservation of samples to be gathered. This step should be accompanied by blood collection (plasma, serum, and whole blood) whenever possible. We advocate strongly a move towards one diagnostic and research biopsy procedure in all women with breast cancers potentially suitable for neoadjuvant treatment. If possible, patients should be referred at the outset to specialised centres to give them the opportunity to participate in neoadjuvant clinical trials, thereby avoiding several biopsy procedures.
In this Personal View, we outline proposals for uniform collection of biospecimens obtained in neoadjuvant breast cancer trials undertaken by the Breast International Group (BIG) and the National Cancer Institute-sponsored North American Breast Cancer Group (NABCG). These proposals aim to standardise collection of high-quality specimens, with respect to both type and timing, to enhance and allow integration of results obtained from neoadjuvant trials done by several groups. They should be considered in parallel with recommendations for tissue-specimen collection and handling previously developed by BIG and NABCG. We propose that tumour tissue (formalin-fixed, paraffin-embedded and samples dedicated for molecular studies) should be taken at baseline, 1-3 weeks after the start of treatment, and at definitive surgery, with clear prioritisation in the study protocol of number, order, and preservation of samples to be gathered. This step should be accompanied by blood collection (plasma, serum, and whole blood) whenever possible. We advocate strongly a move towards one diagnostic and research biopsy procedure in all women with breast cancers potentially suitable for neoadjuvant treatment. If possible, patients should be referred at the outset to specialised centres to give them the opportunity to participate in neoadjuvant clinical trials, thereby avoiding several biopsy procedures.
Author Zujewski, JoAnne, MD
Symmans, W Fraser, Prof
Esserman, Laura J, Prof
Forbes, John F, Prof
Denkert, Carsten, MD
Pusztai, Lajos, Prof
Leyland-Jones, Brian R, Prof
Viale, Giuseppe, Prof
Loi, Sherene, MD
Bartlett, John MS, Prof
Fumagalli, Debora, MD
Veer, Laura Van't, Prof
Bedard, Philippe, MD
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Snippet Summary In this Personal View, we outline proposals for uniform collection of biospecimens obtained in neoadjuvant breast cancer trials undertaken by the...
In this Personal View, we outline proposals for uniform collection of biospecimens obtained in neoadjuvant breast cancer trials undertaken by the Breast...
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SubjectTerms Biomarkers
Biopsy
Biopsy - standards
Breast cancer
Breast Neoplasms - diagnosis
Breast Neoplasms - therapy
Cancer therapies
Clinical trials
Clinical Trials as Topic - standards
Female
Fixatives - standards
Formaldehyde - standards
Hematology, Oncology and Palliative Medicine
Humans
Molecular Diagnostic Techniques - standards
Neoadjuvant Therapy
Paraffin Embedding - standards
Patients
Practice Guidelines as Topic
Predictive Value of Tests
Specimen Handling - standards
Time Factors
Tissue Fixation - standards
Womens health
Title Proposals for uniform collection of biospecimens from neoadjuvant breast cancer clinical trials: timing and specimen types
URI https://www.clinicalkey.es/playcontent/1-s2.0-S1470204511701176
https://dx.doi.org/10.1016/S1470-2045(11)70117-6
https://www.ncbi.nlm.nih.gov/pubmed/21684810
https://www.proquest.com/docview/908423986
https://search.proquest.com/docview/901644198
Volume 12
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