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1. Reply to ‘The St Gallen International Expert Consensus on the Primary Therapy of Early Breast Cancer 2017: the point of view of an International Panel of Experts in Radiation Oncology’ by Kirova et al.

Author

Dubsky, P, Curigliano, G, Burstein, H J, Winer, E P, Gnant, M, Loibl, S, Colleoni, M, Regan, M M, Piccart-Gebhart, M, Senn, H -J, Thürlimann, B, André, F, Baselga, J, Bergh, J, Bonnefoi, H, Brucker, S Y, Cardoso, F, Carey, L, Ciruelos, E, Cuzick, J, Denkert, C, Di Leo, A, Ejlertsen, B, Francis, P, Galimberti, V, Garber, J, Gulluoglu, B, Goodwin, P, Harbeck, N, Hayes, D F, Huang, C -S, Huober, J, Khaled, H, Jassem, J, Jiang, Z, Karlsson, P, Morrow, M, Orecchia, R, Osborne, K C, Pagani, O, Partridge, A H, Pritchard, K, Ro, J, Rutgers, E J T, Sedlmayer, F, Semiglazov, V, Shao, Z, Smith, I, Toi, M, Tutt, A, Viale, G, Watanabe, T, Whelan, T J, and Xu, B

Published
2018
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6. Customizing local and systemic therapies for women with early breast cancer:the St. Gallen International Consensus Guidelines for treatment of early breast cancer 2021

Author

Burstein, H. J., Curigliano, Giuseppe, Thürlimann, B., Weber, W. P., Poortmans, Philip, Regan, Meredith, Senn, H. J., Winer, E. P., Gnant, M., Aebi, Stephan, André, Fabrice, Barrios, Carlos, Bergh, Jonas, Bonnefoi, Herve, Bretel Morales, Denisse, Brucker, Sara, Burstein, Harold, Cameron, David, Cardoso, Fatima, Carey, Lisa, Chua, Boon, Ciruelos, Eva, Colleoni, Marco, Delaloge, Suzette, Denkert, Carsten, Dubsky, Peter, Ejlertsen, Bent, Fitzal, Florian, Francis, Prudence, Galimberti, Viviana, Gamal El Din Mohamed Mahmoud, Hebatallah, Garber, Judy, Gnant, Michael, Gradishar, William, Gulluoglu, Bahadir, Harbeck, Nadia, Huang, Chiun Sheng, Huober, Jens, Ilbawi, Andre, Jiang, Zefei, Johnston, Steven, Lee, Eun Sook, Loibl, Sibylle, Morrow, Monica, Partridge, Ann, Piccart, Martine, Prat, Aleix, Burstein, H. J., Curigliano, Giuseppe, Thürlimann, B., Weber, W. P., Poortmans, Philip, Regan, Meredith, Senn, H. J., Winer, E. P., Gnant, M., Aebi, Stephan, André, Fabrice, Barrios, Carlos, Bergh, Jonas, Bonnefoi, Herve, Bretel Morales, Denisse, Brucker, Sara, Burstein, Harold, Cameron, David, Cardoso, Fatima, Carey, Lisa, Chua, Boon, Ciruelos, Eva, Colleoni, Marco, Delaloge, Suzette, Denkert, Carsten, Dubsky, Peter, Ejlertsen, Bent, Fitzal, Florian, Francis, Prudence, Galimberti, Viviana, Gamal El Din Mohamed Mahmoud, Hebatallah, Garber, Judy, Gnant, Michael, Gradishar, William, Gulluoglu, Bahadir, Harbeck, Nadia, Huang, Chiun Sheng, Huober, Jens, Ilbawi, Andre, Jiang, Zefei, Johnston, Steven, Lee, Eun Sook, Loibl, Sibylle, Morrow, Monica, Partridge, Ann, Piccart, Martine, and Prat, Aleix

Abstract

The 17th St Gallen International Breast Cancer Consensus Conference in 2021 was held virtually, owing to the global COVID-19 pandemic. More than 3300 participants took part in this important bi-annual critical review of the ‘state of the art’ in the multidisciplinary care of early-stage breast cancer. Seventy-four expert panelists (see Appendix 1) from all continents discussed and commented on the previously elaborated consensus questions, as well as many key questions on early breast cancer diagnosis and treatment asked by the audience. The theme of this year's conference was ‘Customizing local and systemic therapies.’ A well-organized program of pre-recorded symposia, live panel discussions and real-time panel voting results drew a worldwide audience of thousands, reflecting the far-reaching impact of breast cancer on every continent. The interactive technology platform allowed, for the first time, audience members to ask direct questions to panelists, and to weigh in with their own vote on several key panel questions. A hallmark of this meeting was to focus on customized recommendations for treatment of early-stage breast cancer. There is increasing recognition that the care of a breast cancer patient depends on highly individualized clinical features, including the stage at presentation, the biological subset of breast cancer, the genetic factors that may underlie breast cancer risk, the genomic signatures that inform treatment recommendations, the extent of response before surgery in patients who receive neoadjuvant therapy, and patient preferences. This customized approach to treatment requires integration of clinical care between patients and radiology, pathology, genetics, and surgical, medical and radiation oncology providers. It also requires a dynamic response from clinicians as they encounter accumulating clinical information at the time of diagnosis and then serially with each step in the treatment plan and follow-up, reflecting patient experiences a

Published
2021

13. LBA12 PALLAS: A randomized phase III trial of adjuvant palbociclib with endocrine therapy versus endocrine therapy alone for HR+/HER2- early breast cancer

Author

Mayer, E.L., primary, Gnant, M.I., additional, DeMichele, A., additional, Martin, M., additional, Burstein, H., additional, Prat, A., additional, Rubovszky, G., additional, Miller, K.D., additional, Pfeiler, G., additional, Winer, E.P., additional, Zdenkowski, N., additional, Anderson, D., additional, Nowecki, Z., additional, Loibl, S., additional, Fohler, H., additional, Metzger, O., additional, Fumagalli, D., additional, Puyana Theall, K., additional, Fesl, C., additional, and Dueck, A., additional

Published
2020
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16. Third consensus on medical treatment of metastatic breast cancer

Author

Beslija, S., Bonneterre, J., Burstein, H. J., Cocquyt, V., Gnant, M., Heinemann, V., Jassem, J., Köstler, W. J., Krainer, M., Menard, S., Petit, T., Petruzelka, L., Possinger, K., Schmid, P., Stadtmauer, E., Stockler, M., Van Belle, S., Vogel, C., Wilcken, N., Wiltschke, C., Zielinski, C. C., and Zwierzina, H.

Published
2009

19. Second consensus on medical treatment of metastatic breast cancer

Author

Beslija, S., Bonneterre, J., Burstein, H., Cocquyt, V., Gnant, M., Goodwin, P., Heinemann, V., Jassem, J., Köstler, W. J., Krainer, M., Menard, S., Petit, T., Petruzelka, L., Possinger, K., Schmid, P., Stadtmauer, E., Stockler, M., Van Belle, S., Vogel, C., Wilcken, N., Wiltschke, C., Zielinski, C. C., and Zwierzina, H.

Published
2007

22. Extended adjuvant intermittent letrozole versus continuous letrozole in postmenopausal women with breast cancer (SOLE): a multicentre, open-label, randomised, phase 3 trial

Author

Colleoni M, Luo W, Karlsson P, Chirgwin J, Aebi S, Jerusalem G, Neven P, Hitre E, Graas MP, Simoncini E, Kamby C, Thompson A, Loibl S, Gavilá J, Kuroi K, Marth C, Müller B, O'Reilly S, Di Lauro V, Gombos A, Ruhstaller T, Burstein H, Ribi K, Bernhard J, Viale G, Maibach R, Rabaglio-Poretti M, Gelber RD, Coates AS, Di Leo A, Regan MM, Goldhirsch A, and SOLE Investigators

Published
2018

23. Abstract OT3-05-08: PALLAS: PALbociclib CoLlaborative Adjuvant Study: A randomized phase 3 trial of palbociclib with standard adjuvant endocrine therapy versus standard adjuvant endocrine therapy alone for HR+/HER2- early breast cancer

Author

Mayer, E, primary, DeMichele, A, additional, Gnant, M, additional, Barry, W, additional, Pfeiler, G, additional, Metzger, O, additional, Burstein, H, additional, Miller, K, additional, Rastogi, P, additional, Loibl, S, additional, Goulioti, T, additional, Zardavas, D, additional, Fesl, C, additional, Koehler, M, additional, Huang-Bartlett, C, additional, Huang, X, additional, Piccart, M, additional, Winer, E, additional, and Wolff, A, additional

Published
2018
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25. Estimating the benefits of therapy for early-stage breast cancer: the St. Gallen International Consensus Guidelines for the primary therapy of early breast cancer 2019.

Author

Burstein, H J, Curigliano, G, Loibl, S, Dubsky, P, Gnant, M, Poortmans, P, Colleoni, M, Denkert, C, Piccart-Gebhart, M, Regan, M, Senn, H -J, Winer, E P, Thurlimann, B, and 2019, Members of the St. Gallen International Consensus Panel on the Primary Therapy of Early Breast Cancer

Subjects
*BREAST cancer, *PATIENT participation, *CANCER relapse, *SOCIOCULTURAL factors
Abstract

Background The 16th St. Gallen International Breast Cancer Conference 2019 in Vienna, Austria reviewed substantial new evidence on loco-regional and systemic therapies for early breast cancer. Design Treatments were assessed in light of their intensity, duration and side-effects, estimating the magnitude of clinical benefit according to stage and biology of the disease. The Panel acknowledged that for many patients, the impact of adjuvant therapy or the adherence to specific guidelines may have modest impact on the risk of breast cancer recurrence or overall survival. For that reason, the Panel explicitly encouraged clinicians and patients to routinely discuss the magnitude of benefit for interventions as part of the development of the treatment plan. Results The guidelines focus on common ductal and lobular breast cancer histologies arising in generally healthy women. Special breast cancer histologies may need different considerations, as do individual patients with other substantial health considerations. The panelists' opinions reflect different interpretation of available data and expert opinion where is lack of evidence and sociocultural factors in their environment such as availability of and access to medical service, economic resources and reimbursement issues. Panelists encourage patient participation in well-designed clinical studies whenever available. Conclusions With these caveats in mind, the St. Gallen Consensus Conference seeks to provide guidance to clinicians on appropriate treatments for early-stage breast cancer and guidance for weighing the realistic tradeoffs between treatment and toxicity so that patients and clinical teams can make well-informed decisions on the basis of an honest reckoning of the magnitude of clinical benefit. [ABSTRACT FROM AUTHOR]

Published
2019
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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. De-escalating and escalating treatments for early-stage breast cancer: the St. Gallen International Expert Consensus Conference on the Primary Therapy of Early Breast Cancer 2017.

Author

Curigliano, G., Burstein, H. J., Winer, E. P., Gnant, M., Dubsky, P., Loibl, S., Colleoni, M., Regan, M. M., Piccart-Gebhart, M., Senn, H.-J., and Thürlimann, B.

Subjects
*BREAST cancer conferences, *BREAST cancer treatment, *ADJUVANT treatment of cancer, *DIPHOSPHONATES
Abstract

The 15th St. Gallen International Breast Cancer Conference 2017 in Vienna, Austria reviewed substantial new evidence on loco-regional and systemic therapies for early breast cancer. Treatments were assessed in light of their intensity, duration and side-effects, seeking where appropriate to escalate or de-escalate therapies based on likely benefits as predicted by tumor stage and tumor biology. The Panel favored several interventions that may reduce surgicalmorbidity, including acceptance of 2mmmargins for DCIS, the resection of residual cancer (but not baseline extent of cancer) in women undergoing neoadjuvant therapy, acceptance of sentinel node biopsy following neoadjuvant treatment of many patients, and the preference for neoadjuvant therapy in HER2 positive and triple-negative, stage II and III breast cancer. The Panel favored escalating radiation therapy with regional nodal irradiation in high-risk patients, while encouraging omission of boost in low-risk patients. The Panel endorsed gene expression signatures that permit avoidance of chemotherapy in many patients with ER positive breast cancer. For women with higher risk tumors, the Panel escalated recommendations for adjuvant endocrine treatment to include ovarian suppression in premenopausal women, and extended therapy for postmenopausal women. However, low-risk patients can avoid these treatments. Finally, the Panel recommended bisphosphonate use in postmenopausal women to prevent breast cancer recurrence. The Panel recognized that recommendations are not intended for all patients, but rather to address the clinical needs of themajority of common presentations. Individualization of adjuvant therapy means adjusting to the tumor characteristics, patient comorbidities and preferences, and managing constraints of treatment cost and access that may affect care in both the developed and developing world. [ABSTRACT FROM AUTHOR]

Published
2017
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29. P2-18-02: Cardiac Outcomes of Patients on Adjuvant Weekly Paclitaxel (T) and Trastuzumab (H) for Node Negative, HER2 Positive Breast Cancer (BCA).

Author

Dang, C, primary, Tolaney, S, additional, Najita, J, additional, Gelman, R, additional, Yardley, D, additional, Marcom, K, additional, Albain, K, additional, Rugo, H, additional, Miller, K, additional, Ellis, M, additional, Shapira, I, additional, Wolff, A, additional, Carey, L, additional, Vahdat, L, additional, Burdette-Radoux, S, additional, Budd, T, additional, Krop, I, additional, Burstein, H, additional, Hudis, C, additional, and Winer, E, additional

Published
2011
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32. Mutational analysis of the substrate binding pockets of the Rous sarcoma virus and human immunodeficiency virus-1 proteases

Author

Wlodawer, A., Skalka, A.M., Burstein, H., Shulenin, S., Leis, J., Bizub-Bender, D., Copeland, T., Cameron, C.E., Ridky, T.W., and Weber, I.T.

Abstract

Mutations, designed by analysis of the crystal structures of Rous sarcoma virus (RSV) and human immunodeficiency virus type 1 (HIV-1) protease (PR), were introduced into the substrate binding pocket of RSV PR. The mutations substituted nonconserved residues of RSV PR, located within 10 Å of the substrate, for those in structurally equivalent positions of HIV-1 PR. Changes in the activity of purified mutants were detected in vitro by following cleavage of synthetic peptides representing wild-type and modified RSV and HIV-1 gag and pol polyprotein cleavage sites. Substituting threonine for valine 104 (V104T), S107N, I44V, Q63M or deletion of residues 61-63 produced enzymes that were 2.5-7-fold more active than the wild type RSV PR. Substituting I42D, M73V, and A100L produced enzymes with lower activity, whereas a mutant that included both M73V and A100L was as active as wild type. Several substitutions altered the specificity for substrate. These include I42D and I44V, which contribute to the S2 and S2' subsites. These proteins exhibited HIV-1 PR specificity for P2- or P2'-modified peptide substrates but unchanged specificity with P4-, P3-, P1-, P1'-, and P3'- modified substrates. Changes in specificity in the S4 subsite were detected by deletion of residues 61-63. These results confirm the hypothesis that the subsites of the substrate binding pocket of the retroviral protease are capable of acting independently in the selection of substrate amino acids.

Published
1994
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37. Gastrointestinal and Cardiovascular Safety Profiles of Neratinib Monotherapy in Patients with Advanced ErbB2-Positive Breast Cancer.

Author

Burstein, H., primary, Sun, Y., additional, Dirix, L., additional, Jiang, Z., additional, Paridaens, R., additional, Tan, A., additional, Awada, A., additional, Ranade, A., additional, Jiao, S., additional, Schwartz, G., additional, Powell, C., additional, Turnbull, K., additional, Vermette, J., additional, Zacharchuk, C., additional, and Badwe, R., additional

Published
2009
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40. Dose-dense (DD) doxorubicin and cyclophosphamide (AC) followed by weekly paclitaxel (P) with trastuzumab (T) and lapatinib (L) in HER2/neu-positive breast cancer is not feasible due to excessive diarrhea: updated results.

Author

Dang, C, primary, Lin, N, additional, Moy, B, additional, Come, S, additional, Lake, D, additional, Theodoulou, M, additional, Troso-Sandoval, T, additional, Dickler, M, additional, Gorsky, M, additional, D'Andrea, G, additional, Modi, S, additional, Seidman, A, additional, Drullinsky, P, additional, Partridge, A, additional, Schapira, L, additional, Wulf, G, additional, Gilewski, T, additional, Atieh, D, additional, Mayer, E, additional, Isakoff, S, additional, Sugarman, S, additional, Fornier, M, additional, Traina, T, additional, Bromberg, J, additional, Currie, V, additional, Robson, M, additional, Burstein, H, additional, Overmoyer, B, additional, Ryan, P, additional, Kuter, I, additional, Younger, J, additional, Schumer, S, additional, Tung, N, additional, Zarwan, C, additional, Schnipper, L, additional, Chen, C, additional, Winer, E, additional, Norton, L, additional, and Hudis, C, additional

Published
2009
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47. Analysis of substrate interactions of the Rous sarcoma virus wild type and mutant proteases and human immunodeficiency virus-1 protease using a set of systematically altered peptide substrates

Author

Leis, J., Wlodawer, A., Weber, I.T., Grinde, B., Burstein, H., Cameron, C.E., Skalka, A.M., and Bizub, D.

Subjects
virus diseases
Abstract

In the preceding study, mutant Rous sarcoma virus (RSV) proteases are described in which three amino acids found in the human immunodeficiency virus-1 (HIV-1) protease (PR) were substituted into structurally comparable positions (Grinde, B., Cameron, C. E., Leis, J., Weber, I., Wlodawer, A., Burstein, H., Bizub, D., and Skalka, A. M. (1992) J. Biol. Chem. 267, 9481- 9490). In this report, the activity of the wild type and these mutant PRs are compared using a set of RSV NC-PR peptide substrates with single amino acid substitutions in each of the P4 to P3' positions. With most substrates, the relative activities of the two active mutants followed that of the RSV PR. Substitutions in the P1 and P1' positions were an exception; in this case, the mutants behaved more like the HIV-1 PR. These results confirm predictions from structural analyses which indicate that residues 105 and 106 of the RSV PR are important in forming the S1 and S1' binding subsites. These results, further analyzed with the aid of computer modeling of the RSV PR with different substrates, provide an explanation for why only partial HIV-1 PR- like behavior was introduced into the above RSV PR mutants.

Published
1992
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48. Mutations that alter the activity of the Rous sarcoma virus protease

Author

Leis, J., Bizub, D., Skalka, A.M., Burstein, H., Wlodawer, A., Weber, I.T., Cameron, C.E., and Grinde, B.

Abstract

Mutations designed by analysis of the Rous sarcoma virus (RSV) and human immunodeficiency virus (HIV)-1 protease (PR) crystal structures were introduced into 1) the substrate binding pocket, 2) the substrate enclosing 'flaps,' and 3) surface loops of RSV PR. Each mutant PR was expressed in Escherichia coli. Changes in activity were detected by following cleavage of a truncated (NC-PR) precursor polypeptide in E. coli and cleavage of synthetic peptide substrates representing RSV and HIV-1 PR cleavage sites in vitro. Mutations in the substrate binding pocket exchanged amino acid residues located close to the substrate in the HIV-1 PR for structurally equivalent residues in the RSV PR. Changing histidine 65 to glycine (H65G) gave an inactive enzyme, while a double mutant R105P, G106V, as well as the triple mutant, H65G, R105P, G106V, produced enzymes which showed significant activity toward a substrate that represented a HIV-1 cleavage site. Mutating the catalytic aspartate (D37S) or an adjacent conserved alanine to threonine (A40T), produced inactive enzymes. In contrast, the substitution A40S was active, but showed a reduced rate of catalysis. Mutations in the flaps of conserved glycines (G69L, G70L) produced inactive PRs. Two extended RSV PR surface loops were shortened to the size found in HIV-1 PR and resulted in drastically reduced activity. These results have confirmed some of the basic predictions made from structural models but have also revealed unexpected roles and interactions in the protein.

Published
1992
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