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365 results on '"Symmans, WF"'

1. Recommendations for standardized pathological characterization of residual disease for neoadjuvant clinical trials of breast cancer by the BIG-NABCG collaboration

Author

Bossuyt, V, Provenzano, E, Symmans, WF, Boughey, JC, Coles, C, Curigliano, G, Dixon, JM, Esserman, LJ, Fastner, G, Kuehn, T, Peintinger, F, von Minckwitz, G, White, J, Yang, W, Badve, S, Denkert, C, MacGrogan, G, Penault-Llorca, F, Viale, G, Cameron, D, collaboration, Breast International Group-North American Breast Cancer Group, Earl, Helena, Alba, Emilio, Lluch, Ana, Albanell, Joan, Amos, Keith, Biernat, Wojciech, Bonnefoi, Hervé, Buzdar, Aman, Cane, Paul, Pinder, Sarah, Carson, Lesley, Dickson-Witmer, Diana, Gong, Gyungyub, Green, Jimmy, Hsu, Chih-Yi, Tseng, Ling-Ming, Kroep, Judith, Leitch, A Marilyn, Sarode, Venetia, Mamounas, Eleftherios, Marcom, Paul Kelly, Nuciforo, Paolo, Paik, Soonmyung, Peg, Vicente, Peston, David, Pierga, Jean-Yves, Quintela-Fandino, Miguel, Salgado, Roberto, Sikov, William, Thomas, Jeremy, Unzeitig, Gary, and Wesseling, Jelle

Subjects
Biomedical and Clinical Sciences, Oncology and Carcinogenesis, Clinical Research, Breast Cancer, Cancer, Antineoplastic Combined Chemotherapy Protocols, Breast Neoplasms, Chemotherapy, Adjuvant, Clinical Trials as Topic, Female, Humans, Neoadjuvant Therapy, Neoplasm Staging, Neoplasm, Residual, Practice Guidelines as Topic, Prognosis, breast cancer, neoadjuvant systemic therapy, residual disease, pathologic complete response, pathologic assessment, response evaluation, Breast International Group-North American Breast Cancer Group (BIG-NABCG) collaboration, Oncology & Carcinogenesis, Clinical sciences, Oncology and carcinogenesis
Abstract

Neoadjuvant systemic therapy (NAST) provides the unique opportunity to assess response to treatment after months rather than years of follow-up. However, significant variability exists in methods of pathologic assessment of response to NAST, and thus its interpretation for subsequent clinical decisions. Our international multidisciplinary working group was convened by the Breast International Group-North American Breast Cancer Group (BIG-NABCG) collaboration and tasked to recommend practical methods for standardized evaluation of the post-NAST surgical breast cancer specimen for clinical trials that promote accurate and reliable designation of pathologic complete response (pCR) and meaningful characterization of residual disease. Recommendations include multidisciplinary communication; clinical marking of the tumor site (clips); and radiologic, photographic, or pictorial imaging of the sliced specimen, to map the tissue sections and reconcile macroscopic and microscopic findings. The information required to define pCR (ypT0/is ypN0 or ypT0 yp N0), residual ypT and ypN stage using the current AJCC/UICC system, and the Residual Cancer Burden system were recommended for quantification of residual disease in clinical trials.

Published
2015

2. Long-term efficacy and safety of addition of carboplatin with or without veliparib to standard neoadjuvant chemotherapy in triple-negative breast cancer: 4-year follow-up data from BrighTNess, a randomized phase 3 trial

Author

Geyer CE Jr, Sikov WM, Huober J, Rugo HS, Wolmark N, O'Shaughnessy J, Maag D, Untch M, Golshan M, Ponce Lorenzo J, Metzger O, Dunbar M, Symmans WF, Rastogi P, Sohn J, Young R, Wright GS, Harkness C, McIntyre K, Yardley D, and Loibl S

Subjects
phase 3, triple-negative breast cancer, veliparib, carboplatin [(max 6)], neoadjuvant chemotherapy
Abstract

BACKGROUND: Primary analyses of the phase 3 BrighTNess trial showed addition of carboplatin with/without veliparib to neoadjuvant chemotherapy significantly improved pathological complete response (pCR) rates with manageable acute toxicity in patients with triple-negative breast cancer (TNBC). Here, we report 4.5-year follow-up data from the trial. DESIGN: Women with untreated stage II-III TNBC were randomized (2:1:1) to paclitaxel (weekly for 12 doses) plus either: (a) carboplatin (every 3 weeks for four cycles) plus veliparib (twice daily); (b) carboplatin plus veliparib placebo; or (c) carboplatin placebo plus veliparib placebo. All patients then received doxorubicin and cyclophosphamide (AC) every 2?3 weeks for four cycles. The primary endpoint was pCR. Secondary endpoints included event-free survival (EFS), overall survival (OS), and safety. Since the co-primary endpoint of increased pCR with carboplatin plus veliparib with paclitaxel versus carboplatin with paclitaxel was not met, secondary analyses are descriptive. RESULTS: Of 634 patients, 316 were randomized to carboplatin plus veliparib with paclitaxel, 160 to carboplatin with paclitaxel, and 158 to paclitaxel. With median follow-up of 4.5 years, the hazard ratio [HR] for EFS for carboplatin plus veliparib with paclitaxel versus paclitaxel was 0.63 (95% confidence interval [CI] 0.43?0.92, P=0.02), but 1.12 (95% CI 0.72?1.72, P=0.62) for carboplatin plus veliparib with paclitaxel versus carboplatin with paclitaxel. In post hoc analysis, HR for EFS was 0.57 (95% CI 0.36?0.91, P=0.02) for carboplatin with paclitaxel versus paclitaxel. OS did not differ significantly between treatment arms, nor did rates of myelodysplastic syndromes, acute myeloid leukemia, or other secondary malignancies. CONCLUSION: Improvement in pCR with addition of carboplatin was associated with long-term EFS benefit with a manageable safety profile, and without increasing the risk of second malignancies, while adding veliparib did not impact EFS. These findings support the addition of carboplatin to weekly paclitaxel followed by AC neoadjuvant chemotherapy for early stage TNBC.

Published
2022

3. Acquisition of cancer stem cell properties during EMT requires cell division

Author

Symmans Wf, Tieling Zhou, Robiya Joseph, Mika Pietilä, Fu C, Sendurai A. Mani, Rama Soundararajan, Abhijeet Deshmukh, Suhas Vasaikar, Castaneda M, and den Hollander P

Subjects
medicine.anatomical_structure, Cell division, Cancer stem cell, Cell, Mesenchymal stem cell, Cancer cell, Carcinoma, medicine, Cancer research, Biology, Stem cell, medicine.disease, Metastasis
Abstract

Cancer cells acquire stem cell and mesenchymal properties during epithelial-to-mesenchymal transition (EMT), facilitating metastasis and chemoresistance [1-6]. In this study, we find that mammary epithelial cells quickly develop mesenchymal phenotype in response to EMT-inducing signals; however, acquiring stemness takes several days and always requires a preceding mesenchymal program. In addition, we observe that carcinoma cells, over a period of time, switch their cell division from symmetrical differentiated type to symmetrical self-renewal type. Importantly, epithelial cells can gain mesenchymal properties without undergoing cell division, but cell disivion is vital for these cells to gain stem cell properties during EMT. The EMT-induced stemness signature (SC-sig) is capable of predicting progression-free and overall-survival of breast cancer patients but not the EMT-induced mesenchymal signature (M-sig). Collectively, our findings demonstrate that the use of mesenchymal markers alone is insufficient to identify tumors with metastatic and chemoresistance potential and emphasize that the markers of EMT-induced stem cell program are central for clinical prediction. Most importantly, our data, for the first time, demonstrate that acquisition of stem cell properties during EMT depends on cell division but not the mesenchymal program.

Published
2021
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4. The tale of TILs in breast cancer: A report from The International Immuno-Oncology Biomarker Working Group

Author

El Bairi, K, Haynes, HR, Blackley, E, Fineberg, S, Shear, J, Turner, S, de Freitas, JR, Sur, D, Amendola, LC, Gharib, M, Kallala, A, Arun, I, Azmoudeh-Ardalan, F, Fujimoto, L, Sua, LF, Liu, S-W, Lien, H-C, Kirtani, P, Balancin, M, El Attar, H, Guleria, P, Yang, W, Shash, E, Chen, I-C, Bautista, V, Do Prado Moura, JF, Rapoport, BL, Castaneda, C, Spengler, E, Acosta-Haab, G, Frahm, I, Sanchez, J, Castillo, M, Bouchmaa, N, Zin, RRM, Shui, R, Onyuma, T, Husain, Z, Willard-Gallo, K, Coosemans, A, Perez, EA, Provenzano, E, Ericsson, PG, Richardet, E, Mehrotra, R, Sarancone, S, Ehinger, A, Rimm, DL, Bartlett, JMS, Viale, G, Denkert, C, Hida, AI, Sotiriou, C, Loibl, S, Hewitt, SM, Badve, S, Symmans, WF, Kim, RS, Pruneri, G, Goel, S, Francis, PA, Inurrigarro, G, Yamaguchi, R, Garcia-Rivello, H, Horlings, H, Afqir, S, Salgado, R, Adams, S, Kok, M, Dieci, MV, Michiels, S, Demaria, S, Loi, S, El Bairi, K, Haynes, HR, Blackley, E, Fineberg, S, Shear, J, Turner, S, de Freitas, JR, Sur, D, Amendola, LC, Gharib, M, Kallala, A, Arun, I, Azmoudeh-Ardalan, F, Fujimoto, L, Sua, LF, Liu, S-W, Lien, H-C, Kirtani, P, Balancin, M, El Attar, H, Guleria, P, Yang, W, Shash, E, Chen, I-C, Bautista, V, Do Prado Moura, JF, Rapoport, BL, Castaneda, C, Spengler, E, Acosta-Haab, G, Frahm, I, Sanchez, J, Castillo, M, Bouchmaa, N, Zin, RRM, Shui, R, Onyuma, T, Husain, Z, Willard-Gallo, K, Coosemans, A, Perez, EA, Provenzano, E, Ericsson, PG, Richardet, E, Mehrotra, R, Sarancone, S, Ehinger, A, Rimm, DL, Bartlett, JMS, Viale, G, Denkert, C, Hida, AI, Sotiriou, C, Loibl, S, Hewitt, SM, Badve, S, Symmans, WF, Kim, RS, Pruneri, G, Goel, S, Francis, PA, Inurrigarro, G, Yamaguchi, R, Garcia-Rivello, H, Horlings, H, Afqir, S, Salgado, R, Adams, S, Kok, M, Dieci, MV, Michiels, S, Demaria, S, and Loi, S

Abstract

The advent of immune-checkpoint inhibitors (ICI) in modern oncology has significantly improved survival in several cancer settings. A subgroup of women with breast cancer (BC) has immunogenic infiltration of lymphocytes with expression of programmed death-ligand 1 (PD-L1). These patients may potentially benefit from ICI targeting the programmed death 1 (PD-1)/PD-L1 signaling axis. The use of tumor-infiltrating lymphocytes (TILs) as predictive and prognostic biomarkers has been under intense examination. Emerging data suggest that TILs are associated with response to both cytotoxic treatments and immunotherapy, particularly for patients with triple-negative BC. In this review from The International Immuno-Oncology Biomarker Working Group, we discuss (a) the biological understanding of TILs, (b) their analytical and clinical validity and efforts toward the clinical utility in BC, and (c) the current status of PD-L1 and TIL testing across different continents, including experiences from low-to-middle-income countries, incorporating also the view of a patient advocate. This information will help set the stage for future approaches to optimize the understanding and clinical utilization of TIL analysis in patients with BC.

Published
2021

5. The path to a better biomarker: application of a risk management framework for the implementation of PD-L1 and TILs as immuno-oncology biomarkers in breast cancer clinical trials and daily practice

Author

Gonzalez-Ericsson, P, Stovgaard, ES, Sua, LF, Reisenbichler, E, Kos, Z, Carter, JM, Michiels, S, Le Quesne, J, Nielsen, TO, Laenkholm, A-V, Fox, SB, Adam, J, Bartlett, JMS, Rimm, DL, Quinn, C, Peeters, D, Dieci, M, Vincent-Salomon, A, Cree, I, Hida, A, Balko, JM, Haynes, HR, Frahm, I, Acosta-Haab, G, Balancin, M, Bellolio, E, Yang, W, Kirtani, P, Sugie, T, Ehinger, A, Castaneda, CA, Kok, M, McArthur, H, Siziopikou, K, Badve, S, Fineberg, S, Gown, A, Viale, G, Schnitt, SJ, Pruneri, G, Penault-Llorca, F, Hewitt, S, Thompson, EA, Allison, KH, Symmans, WF, Bellizzi, AM, Brogi, E, Moore, DA, Larsimont, D, Dillon, DA, Lazar, A, Lien, H, Goetz, MP, Broeckx, G, El Bairi, K, Harbeck, N, Cimino-Mathews, A, Sotiriou, C, Adams, S, Liu, S-W, Loibl, S, Chen, I-C, Lakhani, SR, Juco, JW, Denkert, C, Blackley, EF, Demaria, S, Leon-Ferre, R, Gluz, O, Zardavas, D, Emancipator, K, Ely, S, Loi, S, Salgado, R, Sanders, M, Gonzalez-Ericsson, P, Stovgaard, ES, Sua, LF, Reisenbichler, E, Kos, Z, Carter, JM, Michiels, S, Le Quesne, J, Nielsen, TO, Laenkholm, A-V, Fox, SB, Adam, J, Bartlett, JMS, Rimm, DL, Quinn, C, Peeters, D, Dieci, M, Vincent-Salomon, A, Cree, I, Hida, A, Balko, JM, Haynes, HR, Frahm, I, Acosta-Haab, G, Balancin, M, Bellolio, E, Yang, W, Kirtani, P, Sugie, T, Ehinger, A, Castaneda, CA, Kok, M, McArthur, H, Siziopikou, K, Badve, S, Fineberg, S, Gown, A, Viale, G, Schnitt, SJ, Pruneri, G, Penault-Llorca, F, Hewitt, S, Thompson, EA, Allison, KH, Symmans, WF, Bellizzi, AM, Brogi, E, Moore, DA, Larsimont, D, Dillon, DA, Lazar, A, Lien, H, Goetz, MP, Broeckx, G, El Bairi, K, Harbeck, N, Cimino-Mathews, A, Sotiriou, C, Adams, S, Liu, S-W, Loibl, S, Chen, I-C, Lakhani, SR, Juco, JW, Denkert, C, Blackley, EF, Demaria, S, Leon-Ferre, R, Gluz, O, Zardavas, D, Emancipator, K, Ely, S, Loi, S, Salgado, R, and Sanders, M

Published
2020

6. Application of a risk-management framework for integration of stromal tumor-infiltrating lymphocytes in clinical trials

Author

Hudecek, J, Voorwerk, L, van Seijen, M, Nederlof, I, de Maaker, M, van den Berg, J, van de Vijver, KK, Sikorska, K, Adams, S, Demaria, S, Viale, G, Nielsen, TO, Badve, SS, Michiels, S, Symmans, WF, Sotiriou, C, Rimm, DL, Hewitt, SM, Denkert, C, Loibl, S, Loi, S, Bartlett, JMS, Pruneri, G, Dillon, DA, Cheang, MCU, Tutt, A, Hall, JA, Kos, Z, Salgado, R, Kok, M, Horlings, HM, Hudecek, J, Voorwerk, L, van Seijen, M, Nederlof, I, de Maaker, M, van den Berg, J, van de Vijver, KK, Sikorska, K, Adams, S, Demaria, S, Viale, G, Nielsen, TO, Badve, SS, Michiels, S, Symmans, WF, Sotiriou, C, Rimm, DL, Hewitt, SM, Denkert, C, Loibl, S, Loi, S, Bartlett, JMS, Pruneri, G, Dillon, DA, Cheang, MCU, Tutt, A, Hall, JA, Kos, Z, Salgado, R, Kok, M, and Horlings, HM

Abstract

Stromal tumor-infiltrating lymphocytes (sTILs) are a potential predictive biomarker for immunotherapy response in metastatic triple-negative breast cancer (TNBC). To incorporate sTILs into clinical trials and diagnostics, reliable assessment is essential. In this review, we propose a new concept, namely the implementation of a risk-management framework that enables the use of sTILs as a stratification factor in clinical trials. We present the design of a biomarker risk-mitigation workflow that can be applied to any biomarker incorporation in clinical trials. We demonstrate the implementation of this concept using sTILs as an integral biomarker in a single-center phase II immunotherapy trial for metastatic TNBC (TONIC trial, NCT02499367), using this workflow to mitigate risks of suboptimal inclusion of sTILs in this specific trial. In this review, we demonstrate that a web-based scoring platform can mitigate potential risk factors when including sTILs in clinical trials, and we argue that this framework can be applied for any future biomarker-driven clinical trial setting.

Published
2020

7. Report on computational assessment of Tumor Infiltrating Lymphocytes from the International Immuno-Oncology Biomarker Working Group

Author

Amgad, M, Stovgaard, ES, Balslev, E, Thagaard, J, Chen, W, Dudgeon, S, Sharma, A, Kerner, JK, Denkert, C, Yuan, Y, AbdulJabbar, K, Wienert, S, Savas, P, Voorwerk, L, Beck, AH, Madabhushi, A, Hartman, J, Sebastian, MM, Horlings, HM, Hudecek, J, Ciompi, F, Moore, DA, Singh, R, Roblin, E, Balancin, ML, Mathieu, M-C, Lennerz, JK, Kirtani, P, Chen, I-C, Braybrooke, JP, Pruneri, G, Demaria, S, Adams, S, Schnitt, SJ, Lakhani, SR, Rojo, F, Comerma, L, Badve, SS, Khojasteh, M, Symmans, WF, Sotiriou, C, Gonzalez-Ericsson, P, Pogue-Geile, KL, Kim, RS, Rimm, DL, Viale, G, Hewitt, SM, Bartlett, JMS, Penault-Llorca, F, Goel, S, Lien, H-C, Loibl, S, Kos, Z, Loi, S, Hanna, MG, Michiels, S, Kok, M, Nielsen, TO, Lazar, AJ, Bago-Horvath, Z, Kooreman, LFS, van der Laak, JAWM, Saltz, J, Gallas, BD, Kurkure, U, Barnes, M, Salgado, R, Cooper, LAD, Amgad, M, Stovgaard, ES, Balslev, E, Thagaard, J, Chen, W, Dudgeon, S, Sharma, A, Kerner, JK, Denkert, C, Yuan, Y, AbdulJabbar, K, Wienert, S, Savas, P, Voorwerk, L, Beck, AH, Madabhushi, A, Hartman, J, Sebastian, MM, Horlings, HM, Hudecek, J, Ciompi, F, Moore, DA, Singh, R, Roblin, E, Balancin, ML, Mathieu, M-C, Lennerz, JK, Kirtani, P, Chen, I-C, Braybrooke, JP, Pruneri, G, Demaria, S, Adams, S, Schnitt, SJ, Lakhani, SR, Rojo, F, Comerma, L, Badve, SS, Khojasteh, M, Symmans, WF, Sotiriou, C, Gonzalez-Ericsson, P, Pogue-Geile, KL, Kim, RS, Rimm, DL, Viale, G, Hewitt, SM, Bartlett, JMS, Penault-Llorca, F, Goel, S, Lien, H-C, Loibl, S, Kos, Z, Loi, S, Hanna, MG, Michiels, S, Kok, M, Nielsen, TO, Lazar, AJ, Bago-Horvath, Z, Kooreman, LFS, van der Laak, JAWM, Saltz, J, Gallas, BD, Kurkure, U, Barnes, M, Salgado, R, and Cooper, LAD

Abstract

Assessment of tumor-infiltrating lymphocytes (TILs) is increasingly recognized as an integral part of the prognostic workflow in triple-negative (TNBC) and HER2-positive breast cancer, as well as many other solid tumors. This recognition has come about thanks to standardized visual reporting guidelines, which helped to reduce inter-reader variability. Now, there are ripe opportunities to employ computational methods that extract spatio-morphologic predictive features, enabling computer-aided diagnostics. We detail the benefits of computational TILs assessment, the readiness of TILs scoring for computational assessment, and outline considerations for overcoming key barriers to clinical translation in this arena. Specifically, we discuss: 1. ensuring computational workflows closely capture visual guidelines and standards; 2. challenges and thoughts standards for assessment of algorithms including training, preanalytical, analytical, and clinical validation; 3. perspectives on how to realize the potential of machine learning models and to overcome the perceptual and practical limits of visual scoring.

Published
2020

8. Pitfalls in assessing stromal tumor infiltrating lymphocytes (sTILs) in breast cancer

Author

Kos, Z, Roblin, E, Kim, RS, Michiels, S, Gallas, BD, Chen, W, van de Vijver, KK, Goel, S, Adams, S, Demaria, S, Viale, G, Nielsen, TO, Badve, SS, Symmans, WF, Sotiriou, C, Rimm, DL, Hewitt, S, Denkert, C, Loibl, S, Luen, SJ, Bartlett, JMS, Savas, P, Pruneri, G, Dillon, DA, Cheang, MCU, Tutt, A, Hall, JA, Kok, M, Horlings, HM, Madabhushi, A, van der Laak, J, Ciompi, F, Laenkholm, A-V, Bellolio, E, Gruosso, T, Fox, SB, Araya, JC, Floris, G, Hudecek, J, Voorwerk, L, Beck, AH, Kerner, J, Larsimont, D, Declercq, S, Van den Eynden, G, Pusztai, L, Ehinger, A, Yang, W, AbdulJabbar, K, Yuan, Y, Singh, R, Hiley, C, al Bakir, M, Lazar, AJ, Naber, S, Wienert, S, Castillo, M, Curigliano, G, Dieci, M-V, Andre, F, Swanton, C, Reis-Filho, J, Sparano, J, Balslev, E, Chen, I-C, Stovgaard, EIS, Pogue-Geile, K, Blenman, KRM, Penault-Llorca, F, Schnitt, S, Lakhani, SR, Vincent-Salomon, A, Rojo, F, Braybrooke, JP, Hanna, MG, Soler-Monso, MT, Bethmann, D, Castaneda, CA, Willard-Gallo, K, Sharma, A, Lien, H-C, Fineberg, S, Thagaard, J, Comerma, L, Gonzalez-Ericsson, P, Brogi, E, Loi, S, Saltz, J, Klaushen, F, Cooper, L, Amgad, M, Moore, DA, Salgado, R, Kos, Z, Roblin, E, Kim, RS, Michiels, S, Gallas, BD, Chen, W, van de Vijver, KK, Goel, S, Adams, S, Demaria, S, Viale, G, Nielsen, TO, Badve, SS, Symmans, WF, Sotiriou, C, Rimm, DL, Hewitt, S, Denkert, C, Loibl, S, Luen, SJ, Bartlett, JMS, Savas, P, Pruneri, G, Dillon, DA, Cheang, MCU, Tutt, A, Hall, JA, Kok, M, Horlings, HM, Madabhushi, A, van der Laak, J, Ciompi, F, Laenkholm, A-V, Bellolio, E, Gruosso, T, Fox, SB, Araya, JC, Floris, G, Hudecek, J, Voorwerk, L, Beck, AH, Kerner, J, Larsimont, D, Declercq, S, Van den Eynden, G, Pusztai, L, Ehinger, A, Yang, W, AbdulJabbar, K, Yuan, Y, Singh, R, Hiley, C, al Bakir, M, Lazar, AJ, Naber, S, Wienert, S, Castillo, M, Curigliano, G, Dieci, M-V, Andre, F, Swanton, C, Reis-Filho, J, Sparano, J, Balslev, E, Chen, I-C, Stovgaard, EIS, Pogue-Geile, K, Blenman, KRM, Penault-Llorca, F, Schnitt, S, Lakhani, SR, Vincent-Salomon, A, Rojo, F, Braybrooke, JP, Hanna, MG, Soler-Monso, MT, Bethmann, D, Castaneda, CA, Willard-Gallo, K, Sharma, A, Lien, H-C, Fineberg, S, Thagaard, J, Comerma, L, Gonzalez-Ericsson, P, Brogi, E, Loi, S, Saltz, J, Klaushen, F, Cooper, L, Amgad, M, Moore, DA, and Salgado, R

Abstract

Stromal tumor-infiltrating lymphocytes (sTILs) are important prognostic and predictive biomarkers in triple-negative (TNBC) and HER2-positive breast cancer. Incorporating sTILs into clinical practice necessitates reproducible assessment. Previously developed standardized scoring guidelines have been widely embraced by the clinical and research communities. We evaluated sources of variability in sTIL assessment by pathologists in three previous sTIL ring studies. We identify common challenges and evaluate impact of discrepancies on outcome estimates in early TNBC using a newly-developed prognostic tool. Discordant sTIL assessment is driven by heterogeneity in lymphocyte distribution. Additional factors include: technical slide-related issues; scoring outside the tumor boundary; tumors with minimal assessable stroma; including lymphocytes associated with other structures; and including other inflammatory cells. Small variations in sTIL assessment modestly alter risk estimation in early TNBC but have the potential to affect treatment selection if cutpoints are employed. Scoring and averaging multiple areas, as well as use of reference images, improve consistency of sTIL evaluation. Moreover, to assist in avoiding the pitfalls identified in this analysis, we developed an educational resource available at www.tilsinbreastcancer.org/pitfalls.

Published
2020

9. Abstract P3-07-01: Towards a therapeutically relevant subtyping scheme for triple-negative breast cancer (TNBC), profiling results from A Randomized, TNBC Enrolling trial to confirm Molecular profiling Improves Survival (ARTEMIS)

Author

Seth, S, primary, Huo, L, additional, Rauch, G, additional, Lau, R, additional, Gilcrease, M, additional, Adrada, B, additional, Piwnica-Worms, H, additional, Symmans, WF, additional, Draetta, G, additional, Futreal, AP, additional, Moulder, S, additional, and Chang, JT, additional

Published
2019
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11. Abstract GS5-05: Resistance to neoadjuvant chemotherapy in triple negative breast cancer mediated by a reversible drug-tolerant state

Author

Echeverria, GV, primary, Ge, Z, additional, Seth, S, additional, Jeter-Jones, SL, additional, Zhang, X, additional, Zhou, X, additional, Cai, S, additional, Tu, Y, additional, McCoy, A, additional, Peoples, M, additional, Lau, R, additional, Shao, J, additional, Sun, Y, additional, Bristow, C, additional, Carugo, A, additional, Ma, X, additional, Harris, A, additional, Wu, Y, additional, Moulder, S, additional, Symmans, WF, additional, Marszalek, JR, additional, Heffernan, TP, additional, Chang, JT, additional, and Piwnica-Worms, H, additional

Published
2019
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12. Abstract P6-03-05: Risk of needle-track seeding with serial ultrasound guided biopsies in triple negative breast cancer

Author

Yam, C, primary, Santiago, L, additional, Candelaria, RP, additional, Adrada, BE, additional, Rauch, GM, additional, Hess, KR, additional, Litton, JK, additional, Piwnica-Worms, H, additional, Mittendorf, EA, additional, Ueno, NT, additional, Lim, B, additional, Murthy, RK, additional, Damodaran, S, additional, Helgason, T, additional, Huo, L, additional, Thompson, AM, additional, Gilcrease, MZ, additional, Symmans, WF, additional, Moulder, SL, additional, and Yang, W, additional

Published
2018
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13. Abstract P1-07-01: HLA class I expression is associated with tumor-infiltrating lymphocytes and response and survival after neoadjuvant chemotherapy in hormone receptor-positive, HER2-negative breast cancer

Author

Sinn, BV, primary, Weber, K, additional, Denkert, C, additional, Fasching, PA, additional, Schmitt, WD, additional, Thomas, K, additional, Ingold-Heppner, B, additional, van Mackelenbergh, M, additional, Symmans, WF, additional, Marmé, F, additional, Taube, E, additional, Müller, V, additional, Kunze, CA, additional, Schem, C, additional, Pfitzner, BM, additional, Stickeler, E, additional, von Minckwitz, G, additional, and Loibl, S, additional

Published
2018
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14. Abstract P1-07-22: Androgen receptor positivity is associated with nodal disease in triple negative breast cancer

Author

Yam, C, primary, Huo, L, additional, Hess, KR, additional, Litton, JK, additional, Yang, W, additional, Piwnica-Worms, H, additional, Mittendorf, EA, additional, Ueno, NT, additional, Lim, B, additional, Murthy, RK, additional, Damodaran, S, additional, Helgason, T, additional, Thompson, AM, additional, Santiago, L, additional, Candelaria, RP, additional, Rauch, GM, additional, Adrada, BE, additional, Symmans, WF, additional, Gilcrease, MZ, additional, and Moulder, SL, additional

Published
2018
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15. Abstract GS6-06: Identifying metastatic drivers in patient-derived xenograft models of triple negative breast cancer

Author

Powell, E, primary, Shao, J, additional, Picon, HM, additional, Ge, Z, additional, Echeverria, GV, additional, Peoples, M, additional, Bristow, C, additional, Cai, S, additional, Tu, Y, additional, McCoy, AM, additional, Piwnica-Worms, D, additional, Draetta, G, additional, Edwards, JR, additional, Moulder, SL, additional, Symmans, WF, additional, Heffernan, TP, additional, Liang, H, additional, and Piwnica-Worms, H, additional

Published
2018
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17. Accurate RNA Sequencing From Formalin-Fixed Cancer Tissue to Represent High-Quality Transcriptome From Frozen Tissue

Author

Li, J, Fu, C, Speed, TP, Wang, W, Symmans, WF, Li, J, Fu, C, Speed, TP, Wang, W, and Symmans, WF

Abstract

PURPOSE: Accurate transcriptional sequencing (RNA-seq) from formalin-fixation and paraffin-embedding (FFPE) tumor samples presents an important challenge for translational research and diagnostic development. In addition, there are now several different protocols to prepare a sequencing library from total RNA. We evaluated the accuracy of RNA-seq data generated from FFPE samples in terms of expression profiling. METHODS: We designed a biospecimen study to directly compare gene expression results from different protocols to prepare libraries for RNA-seq from human breast cancer tissues, with randomization to fresh-frozen (FF) or FFPE conditions. The protocols were compared using multiple computational methods to assess alignment of reads to reference genome, and the uniformity and continuity of coverage; as well as the variance and correlation, of overall gene expression and patterns of measuring coding sequence, phenotypic patterns of gene expression, and measurements from representative multigene signatures. RESULTS: The principal determinant of variance in gene expression was use of exon capture probes, followed by the conditions of preservation (FF versus FFPE), and phenotypic differences between breast cancers. One protocol, with RNase H-based rRNA depletion, exhibited least variability of gene expression measurements, strongest correlation between FF and FFPE samples, and was generally representative of the transcriptome from standard FF RNA-seq protocols. CONCLUSION: Method of RNA-seq library preparation from FFPE samples had marked effect on the accuracy of gene expression measurement compared to matched FF samples. Nevertheless, some protocols produced highly concordant expression data from FFPE RNA-seq data, compared to RNA-seq results from matched frozen samples.

Published
2018

18. Abstract P6-11-04: The evaluation of ganitumab/metformin plus standard neoadjuvant therapy in high-risk breast cancer: Results from the I-SPY 2 trial

Author

Yee, D, primary, Paoloni, M, additional, van't Veer, L, additional, Sanil, A, additional, Yau, C, additional, Forero, A, additional, Chien, AJ, additional, Wallace, AM, additional, Moulder, S, additional, Albain, KS, additional, Kaplan, HG, additional, Elias, AD, additional, Haley, BB, additional, Boughey, JC, additional, Kemmer, KA, additional, Korde, LA, additional, Isaacs, C, additional, Minton, S, additional, Nanda, R, additional, DeMichele, A, additional, Lang, JE, additional, Buxton, MB, additional, Hylton, NM, additional, Symmans, WF, additional, Lyandres, J, additional, Hogarth, M, additional, Perlmutter, J, additional, Esserman, LJ, additional, and Berry, DA, additional

Published
2017
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20. Abstract OT2-01-14: Triple-negative first-line study: Neoadjuvant trial of nab-paclitaxel and atezolizumab, a PD-L1 inhibitor, in patients with triple negative breast cancer (TNBC) (NCT02530489)

Author

Litton, JK, primary, Moulder, S, additional, Helgason, T, additional, Clayborn, AR, additional, Rauch, GM, additional, Gilcrease, M, additional, Adrada, BE, additional, Huo, L, additional, Hess, KR, additional, Symmans, WF, additional, Thompson, A, additional, Tripathy, D, additional, and Mittendorf, EA, additional

Published
2017
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21. Abstract OT2-01-22: NCT02456857: A phase II trial of liposomal doxorubicin, bevacizumab and everolimus (DAE) in patients (pts) with localized triple-negative breast cancer (TNBC) with tumors predicted insensitive to standard neoadjuvant chemotherapy (NACT)

Author

Moulder, S, primary, Hess, K, additional, Rauch, M, additional, Astrada, B, additional, Litton, J, additional, Mittendorf, E, additional, Ueno, N, additional, Tripathy, D, additional, Lim, B, additional, Piwnica-Worms, H, additional, Thompson, A, additional, and Symmans, WF, additional

Published
2017
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23. Abstract P4-06-03: An annotated collection of pre- and post-therapy breast cancer patient-derived xenograft models built from fine needle aspiration samples aligned with ongoing clinical trials documenting response to treatment

Author

Echeverria, GV, primary, Chang, JT, additional, Cai, S, additional, Tu, Y, additional, McCoy, A, additional, Lau, R, additional, Redwood, A, additional, Kaffiabasabadi, S, additional, Rauch, GM, additional, Adrada, BE, additional, Jennifer, L, additional, Moulder, SL, additional, Symmans, WF, additional, and Piwnica-Worms, H, additional

Published
2017
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24. Abstract P6-11-02: Efficacy of Hsp90 inhibitor ganetespib plus standard neoadjuvant therapy in high-risk breast cancer: Results from the I-SPY 2 trial

Author

Forero, A, primary, Yee, D, additional, Buxton, MB, additional, Symmans, WF, additional, Chien, AJ, additional, Boughey, JC, additional, Elias, AD, additional, DeMichele, A, additional, Moulder, S, additional, Minton, S, additional, Kaplan, HG, additional, Albain, KS, additional, Wallace, AM, additional, Haley, BB, additional, Isaacs, C, additional, Korde, LA, additional, Nanda, R, additional, Lang, JE, additional, Kemmer, KA, additional, Hylton, NM, additional, Paoloni, M, additional, van't Veer, L, additional, Lyandres, J, additional, Perlmutter, J, additional, Hogarth, M, additional, Yau, C, additional, Sanil, A, additional, Berry, DA, additional, and Esserman, LJ, additional

Published
2017
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25. Abstract OT3-02-05: NCI-2016-00367: A phase IIB study of neoadjuvant ZT regimen (enzalutamide therapy in combination with weekly paclitaxel) for androgen receptor (AR)-positive triple-negative breast cancer (TNBC)

Author

Fujii, T, primary, Lim, B, additional, Helgason, T, additional, Hess, KR, additional, Gilcrease, MZ, additional, Willey, JS, additional, Tripathy, D, additional, Litton, JK, additional, Moulder, S, additional, Krishnamurthy, S, additional, Yang, W, additional, Reuben, JM, additional, Symmans, WF, additional, and Ueno, NT, additional

Published
2017
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26. Abstract OT1-03-21: PALLAS: PAlbociclib Collaborative Adjuvant Study: A randomized phase 3 trial of palbociclib with adjuvant endocrine therapy versus endocrine therapy alone for HR+/HER2- early breast cancer

Author

Mayer, E, primary, DeMichele, A, additional, Dubsky, P, additional, Barry, W, additional, Metzger, O, additional, Symmans, WF, additional, Burstein, H, additional, Miller, K, additional, Wolff, A, additional, Rastogi, P, additional, Loibl, S, additional, von Minckwitz, G, additional, Goulioti, T, additional, Zardavas, D, additional, Fesl, C, additional, Koehler, M, additional, Huang Bartlett, C, additional, Chen, L, additional, Piccart, M, additional, Winer, E, additional, and Gnant, M, additional

Published
2016
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27. Abstract P3-07-49: Residual cancer burden (RCB) with veliparib/carboplatin in the I-SPY2 trial

Author

Liu, MC, primary, Symmans, WF, additional, Yau, C, additional, Chen, Y-Y, additional, Rugo, HS, additional, Olopade, OF, additional, Datnow, B, additional, Chen, B, additional, Feldman, M, additional, Kallakury, B, additional, Hasteh, F, additional, Tickman, R, additional, Ritter, J, additional, Troxel, M, additional, Mhawech-Fauceglia, P, additional, Duan, X, additional, Berry, D, additional, Esserman, L, additional, and DeMichele, A, additional

Published
2016
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29. Predictive immunohistochemical biomarkers in the context of neoadjuvant therapy for breast cancer

Author

Generali, D, Symmans, Wf, Berruti, Alfredo, Fox, S. B., Generali, Daniele, Symmans, William F., Berruti, Alfredo, and Fox, Stephen B.

Subjects
Cancer Research, Prognosi, Protein Array Analysis, Predictive Value of Test, Angiogenesis Inhibitors, Antineoplastic Agents, Breast Neoplasms, alpha Subunit, Antineoplastic Agent, Breast cancer, Predictive Value of Tests, Biomarkers, Tumor, Humans, Protein Array Analysi, Neovascularization, Pathologic, Clinical Trials as Topic, Tumor, Neovascularization, Pathologic, Medicine (all), Hypoxia-Inducible Factor 1, alpha Subunit, Cell Hypoxia, Female, Immunohistochemistry, Prognosis, Research Design, Neoadjuvant Therapy, Oncology, Primary Systemic Therapy, Hypoxia-Inducible Factor 1, Breast Neoplasm, Biomarkers, Angiogenesis Inhibitor, Human
Abstract

The adoption of personalized medicine has led to the search for prognostic and predictive markers that can be applied to individual patients to give optimal information for their clinical management. We have used samples from randomized clinical trials of hormonal and chemotherapy to identify relevant markers of sensitivity and resistance using a neoadjuvant approach by linking expression of a panel of proteins involved in growth factor receptor signaling, angiogenesis, estrogen receptor signaling, and hypoxia to individual patient response. We evaluated samples from randomized clinical trials of epirubicin with or without tamoxifen, and letrozole with or without metronomic cyclophosphamide, to study chemotherapy, hormonal therapy, and antiangiogenic effects. We present a proof of principle of this approach in identifying several key pathways that are associated with clinical and pathological response. Thus, we have shown that the hypoxia-inducible factor (HIF) pathway, mitogen activated protein kinase, and phosphorylated estrogen receptor-α can identify patients who are likely to respond to hormonal therapy and that HIF signaling is also a marker of resistance for anthracycline-based chemotherapy. To redress the role of HIF, we then evaluated samples from a randomized control trial of an anthracycline chemotherapy with and without erythropoietin. These studies demonstrate that the approach of using primary systemic therapy in breast can identify markers of response and potentially targets for rationale design of new therapies.

Published
2011

30. Abstract P6-06-37: Predicting improvements in survival based on improvements in pathologic response rate to neoadjuvant chemotherapy in different breast cancer subtypes

Author

Hatzis, C, primary, Gould, RE, additional, Zhang, Y, additional, Abu-Khalaf, M, additional, Chung, G, additional, Sanft, T, additional, Hofstatter, E, additional, DiGiovanna, M, additional, Shi, W, additional, Chagpar, A, additional, Symmans, WF, additional, and Pusztai, L, additional

Published
2013
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32. Abstract PD4-6: Combined analysis of gene expression, DNA copy number and mutation profiling data to display biological process anomalies in individual cancers

Author

Shi, W, primary, Balazs, B, additional, Qi, Y, additional, Györffy, B, additional, Wang, B, additional, Liu, C-G, additional, Shiang, CY, additional, Valero, V, additional, Moulder-Thompson, S, additional, Avritscher, R, additional, Powis, G, additional, Hortobagyi, GN, additional, Natowicz, R, additional, Wali, V, additional, Weinstein, J, additional, Symmans, WF, additional, and Pusztai, L, additional

Published
2013
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33. Abstract P3-01-04: Obesity induces functional transcriptomic changes enhancing the cancer hallmarks of estrogen receptor-positive breast cancer

Author

Fuentes-Mattei, E, primary, Phan, L, additional, Velazquez-Torres, G, additional, Zhang, F, additional, Chou, P-C, additional, Shin, J-H, additional, Choi, H-H, additional, Chen, J-S, additional, Chen, J, additional, Gully, C, additional, Carlock, C, additional, Zhao, R, additional, Qi, Y, additional, Zhang, Y, additional, Wu, Y, additional, Esteva, FJ, additional, Lou, Y, additional, McKeehan, WL, additional, Ensor, JE, additional, Hortobagyi, GN, additional, Pusztai, L, additional, Symmans, WF, additional, Lee, M-H, additional, and Yeung, S-CJ, additional

Published
2013
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34. Abstract P4-05-09: Estrogen receptor (ER) mRNA expression and molecular subtype distribution in breast cancers that are ER-negative but progesterone receptor-positive by immunohistochemistory

Author

Iwamoto, T, primary, Matsuoka, J, additional, Nogami, T, additional, Motoki, T, additional, Shien, T, additional, Taira, N, additional, Niikura, N, additional, Hayashi, N, additional, Doihara, H, additional, Symmans, WF, additional, and Pusztai, L, additional

Published
2013
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36. Abstract P1-07-06: Effect of biospecimen variables on proteomic biomarker assessment in breast cancer

Author

Meric-Bernstam, F, primary, Akcakanat, A, additional, Chen, H, additional, Sahin, A, additional, Tarco, E, additional, Carkaci, S, additional, Adrada, B, additional, Singh, G, additional, Anh-Do, K, additional, Garces, Z, additional, Mittendorf, EA, additional, Babiera, G, additional, Wagner, J, additional, Bedrosian, I, additional, Krishnamurthy, S, additional, Symmans, WF, additional, Gonzalez-Angulo, AM, additional, and Mills, G, additional

Published
2012
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38. Abstract S2-1: The role of sentinel lymph node surgery in patients presenting with node positive breast cancer (T0-T4, N1-2) who receive neoadjuvant chemotherapy – results from the ACOSOG Z1071 trial

Author

Boughey, JC, primary, Suman, VJ, additional, Mittendorf, EA, additional, Ahrendt, GM, additional, Wilke, LG, additional, Taback, B, additional, Leitch, AM, additional, Flippo-Morton, TS, additional, Byrd, DR, additional, Ollila, DW, additional, Julian, TB, additional, McLaughlin, SA, additional, McCall, L, additional, Symmans, WF, additional, Le-Petross, HT, additional, Haffty, BG, additional, Buchholz, TA, additional, and Hunt, KK, additional

Published
2012
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39. Abstract P1-07-09: Estrogen receptor positivity: 10% or 1%?

Author

Yi, M, primary, Huo, L, additional, Koenig, KB, additional, Mittendorf, EA, additional, Meric-Bernstam, F, additional, Kuerer, HM, additional, Bedrosian, I, additional, Symmans, WF, additional, Hortobagyi, GN, additional, Crow, JR, additional, Shah, RR, additional, and Hunt, KK, additional

Published
2012
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40. P1-07-09: Estrogen Receptor (ER) mRNA and ER-Related Gene Expression in Breast Cancers That Are 1%-10% ER-Positive by Immunohistochemistry.

Author

Iwamoto, T, primary, Booser, D, additional, Valero, V, additional, Murray, JL, additional, Koenig, K, additional, Esteva, FJ, additional, Ueno, NT, additional, Zhang, J, additional, Shi, W, additional, Qi, Y, additional, Matsuoka, J, additional, Hortobagyi, GN, additional, Hatzis, C, additional, Symmans, WF, additional, and Pusztai, L, additional

Published
2011
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42. Abstract P6-14-06: Prospective Testing of Three Different Gene-Signatures for Patient Selection for Dasatinib Therapy in Metastatic Breast Cancer

Author

Pusztai, L, primary, Moulder, S, additional, Litton, J, additional, Valero, V, additional, Ueno, N, additional, Melhem-Bertrandt, A, additional, Morrow, PK, additional, Dotter, K, additional, Mattair, D, additional, Strauss, L, additional, Hortobagyi, GN, additional, Qi, Y, additional, and Symmans, WF., additional

Published
2010
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43. Abstract PD07-03: A Genomic Predictor of Survival Following Taxane-Anthracycline Chemotherapy for Breast Cancer

Author

Symmans, WF, primary, Hatzis, C, additional, Valero, V, additional, Booser, DJ, additional, Esserman, L, additional, Martin, M, additional, Vidaurre, T, additional, Holmes, F, additional, Souchon, EA, additional, Lluch, A, additional, Cotrina, J, additional, Gomez, H, additional, Hubbard, R, additional, Ferrer-Lozano, J, additional, Dyer, R, additional, Buxton, M, additional, Gong, Y, additional, Wu, Y, additional, Ibrahim, N, additional, Andreopoulou, E, additional, Ueno, NT, additional, Hunt, K, additional, Yang, W, additional, Nazario, A, additional, DeMichele, A, additional, O'Shaughnessy, J, additional, Hortobagyi, GN, additional, and Pusztai L., M.D., additional

Published
2010
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49. Proposals for uniform collection of biospecimens from neoadjuvant breast cancer clinical trials: timing and specimen types.

Author

Loi S, Symmans WF, Bartlett JM, Fumagalli D, Veer LV, Forbes JF, Bedard P, Denkert C, Zujewski J, Viale G, Pusztai L, Esserman LJ, and Leyland-Jones BR

Abstract

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. [ABSTRACT FROM AUTHOR]

Published
2011
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50. Higher parity and shorter breastfeeding duration: association with triple-negative phenotype of breast cancer.

Author

Shinde SS, Forman MR, Kuerer HM, Yan K, Peintinger F, Hunt KK, Hortobagyi GN, Pusztai L, Symmans WF, Shinde, Shivani S, Forman, Michele R, Kuerer, Henry M, Yan, Kai, Peintinger, Florentia, Hunt, Kelly K, Hortobagyi, Gabriel N, Pusztai, Lajos, and Symmans, W Fraser

Subjects
AGE distribution, BREAST tumors, BREASTFEEDING, MENARCHE, RESEARCH funding, TIME, PHENOTYPES, PARITY (Obstetrics), HORMONE-dependent tumors
Abstract

Background: The combination of increased parity and shorter breastfeeding duration might increase the odds of the least differentiated triple-negative breast cancer (BC) phenotype, theoretically because an expanded progenitor cell population from each pregnancy would incompletely differentiate postpartum.Methods: Subjects consisted of a consecutive case series of 2473 women treated for invasive breast cancer between 2001 and 2006. Breast cancer phenotype (triple-negative BC, vs non-triple-negative BC) was compared with reproductive and demographic information. Odds ratios (OR) with 95% confidence intervals (CIs) for the association of breastfeeding duration (months per child) and parity with triple-negative BC were calculated after adjusting for ethnicity, age at menarche, family history, and age at diagnosis.Results: Compared with non-triple-negative BC, triple-negative BC was associated with shorter duration of breastfeeding per child (OR, 0.93; 95% CI, 0.90-0.97) and with higher parity (OR, 1.12; 95% CI, 1.06-1.20). By using multivariate logistic regression, triple-negative BC was independently associated with higher parity (OR, 2.76 [95% CI, 1.86-4.08] if ≥3 live births; OR, 1.89 [95% CI, 1.30-2.74] if ≤2 live births vs nulliparae), breastfeeding duration (OR, 0.55 [95% CI, 0.41-0.74] if >2 mo/child and OR, 0.58 [95% CI, 0.42-0.82] if ≤2 mo/child vs none), African American ethnicity (OR, 2.10; 95% CI, 1.52-2.92), and younger age at diagnosis (OR, 3.02 [95% CI, 2.03-4.47] if ≤40 years vs >60 years).Conclusions: Among women with invasive breast cancer, higher parity and the absence or short duration of breastfeeding were independently associated with triple-negative BC. Any duration of breastfeeding was found to be associated with lower probability of triple-negative BC, and the odds of this phenotype decreased with increasing duration of breastfeeding. [ABSTRACT FROM AUTHOR]

Published
2010
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