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5. 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., 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
2017
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7. Tailoring therapies—improving the management of early breast cancer: St Gallen International Expert Consensus on the Primary Therapy of Early Breast Cancer 2015

Author

Coates, A.S., Winer, E.P., Goldhirsch, A., Gelber, R.D., Gnant, M., Piccart-Gebhart, M., Thürlimann, B., Senn, H.-J., André, Fabrice, Baselga, José, Bergh, Jonas, Bonnefoi, Hervé, Burstein, Harold, Cardoso, Fatima, Castiglione-Gertsch, Monica, Coates, Alan S., Colleoni, Marco, Curigliano, Giuseppe, Davidson, Nancy E., Di Leo, Angelo, Ejlertsen, Bent, Forbes, John F., Galimberti, Viviana, Gelber, Richard D., Gnant, Michael, Goldhirsch, Aron, Goodwin, Pamela, Harbeck, Nadia, Hayes, Daniel F., Huober, Jens, Hudis, Clifford A., Ingle, James N., Jassem, Jacek, Jiang, Zefei, Karlsson, Per, Morrow, Monica, Orecchia, Roberto, Kent Osborne, C., Partridge, Ann H., de la Peña, Lorena, Piccart-Gebhart, Martine J., Pritchard, Kathleen I., Rutgers, Emiel J.T., Sedlmayer, Felix, Semiglazov, Vladimir, Shao, Zhi-Ming, Smith, Ian, Thürlimann, Beat, Toi, Masakazu, Tutt, Andrew, Viale, Giuseppe, von Minckwitz, Gunter, Watanabe, Toru, Whelan, Timothy, Winer, Eric P., and Xu, Binghe

Published
2015
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10. 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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12. Impact of HIV infection on baseline characteristics and survival of women with breast cancer: a systematic review and meta-analysis

Author

Brandão, M, Bruzzone, M, Franzoi, MA, de Angelis, C, Eiger, D, Caparica, R, Piccart-Gebhart, M, Buisseret, L, Ceppi, M, Dauby, N, Carrilho, C, Lunet, N, de Azambuja, E, Lambertini, M, and Instituto de Saúde Pública da Universidade do Porto

Subjects
meta-analysis, cancer staging, breast neoplasms, HIV, women's health, survival
Abstract

Background: As women living with HIV (WLWH) become older, their risk of developing breast cancer increases. Nonetheless, literature is conflicting regarding tumor stage, distribution of subtypes and overall survival among WLWH vs. HIV-negative women with breast cancer. We assessed differences in clinicopathological characteristics and overall survival between these two groups. Methods: Systematic review and meta-analysis using MEDLINE, Scopus, ISI Web of Knowledge, LILACS, SciELO and conference abstracts up to 1 January 2020. Cross-sectional/cohort studies comparing baseline characteristics (stage and/or subtypes) and/or overall survival of WLWH vs. HIV-negative women with breast cancer were included. We performed random-effects meta-analyses to estimate summary statistics and subgroup analyses according to region of the world. Results: Eighteen studies [4 from North America, 14 from sub-Saharan Africa (SSA)] were included, with 3174 WLWH and 2 394 598 HIV-negative women. WLWH from North America and SSA were more likely to present with stage III/IV disease compared with HIV-negative women - pooled odds ratio (pOR) 1.76 [95% confidence interval (CI):1.58-1.95] and pOR 1.23 (95% CI: 1.06-1.42), respectively. WLWH from SSA were also less likely to have estrogen receptor-positive/HER2-negative tumors (pOR 0.81; 95% CI: 0.66-0.99). After adjustment, WLWH had worse overall survival compared with HIV-negative women, both in North America [pooled adjusted hazard ratio (aHR) 2.45; 95% CI: 1.11-5.41] and SSA (aHR 1.43; 95% CI: 1.06-1.92). Conclusion: Compared with HIV-negative women, WLWH are diagnosed with breast cancer at a more advanced stage and have a worse overall survival. These results should raise awareness regarding the detection and survival gap among WLWH with breast cancer and further studies are needed to decipher the reasons behind these disparities. N.D. is a postdoctorate clinical master specialist of the F.R.S-FNRS. L.B. is supported by ‘Les Amis de l’Institut Bordet’ Foundation. D.E. acknowledges the support of the European Society for Medical Oncology (ESMO) for a research fellowship (2018–2019) at Institut Jules Bordet (Brussels, Belgium).

Published
2021

17. Personalizing the treatment of women with early breast cancer: highlights of the St Gallen International Expert Consensus on the Primary Therapy of Early Breast Cancer 2013

Author

Goldhirsch, A., Winer, E. P., Coates, A. S., Gelber, R. D., Piccart-Gebhart, M., Thürlimann, B., Senn, H.-J., Albain, Kathy S., André, Fabrice, Bergh, Jonas, Bonnefoi, Hervé, Bretel-Morales, Denisse, Burstein, Harold, Cardoso, Fatima, Castiglione-Gertsch, Monica, Coates, Alan S., Colleoni, Marco, Costa, Alberto, Curigliano, Giuseppe, Davidson, Nancy E., Di Leo, Angelo, Ejlertsen, Bent, Forbes, John F., Gelber, Richard D., Gnant, Michael, Goldhirsch, Aron, Goodwin, Pamela, Goss, Paul E., Harris, Jay R., Hayes, Daniel F., Hudis, Clifford A., Ingle, James N., Jassem, Jacek, Jiang, Zefei, Karlsson, Per, Loibl, Sibylle, Morrow, Monica, Namer, Moise, Kent Osborne, C., Partridge, Ann H., Penault-Llorca, Frédérique, Perou, Charles M., Piccart-Gebhart, Martine J., Pritchard, Kathleen I., Rutgers, Emiel J.T., Sedlmayer, Felix, Semiglazov, Vladimir, Shao, Zhi-Ming, Smith, Ian, Thürlimann, Beat, Toi, Masakazu, Tutt, Andrew, Untch, Michael, Viale, Giuseppe, Watanabe, Toru, Wilcken, Nicholas, Winer, Eric P., and Wood, William C.

Published
2013
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18. Overall survival benefit for sequential doxorubicin–docetaxel compared with concurrent doxorubicin and docetaxel in node-positive breast cancer—8-year results of the Breast International Group 02-98 phase III trial†

Author

Oakman, C., Francis, P. A., Crown, J., Quinaux, E., Buyse, M., De Azambuja, E., Margeli Vila, M., Andersson, M., Nordenskjöld, B., Jakesz, R., Thürlimann, B., Gutiérrez, J., Harvey, V., Punzalan, L., DellʼOrto, P., Larsimont, D., Steinberg, I., Gelber, R. D., Piccart-Gebhart, M., Viale, G., and Di Leo, A.

Published
2013
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21. Nine-year survival outcome of neoadjuvant lapatinib with trastuzumab for HER2-positive breast cancer (NeoALTTO, BIG 1-06): final analysis of a multicentre, open-label, phase 3 randomised clinical trial.

Author

Nuciforo, P., primary, Townend, J., additional, Saura, C., additional, de Azumbaja, E., additional, Hilbers, F., additional, Manukyants, A., additional, Werutsky, G., additional, Bliss, J., additional, Moebus, V., additional, Colleoni, M., additional, Aspitia, A.Moreno, additional, Di Cosimo, S., additional, Van dooren, V., additional, Kroep, J., additional, Ferro, A., additional, Cameron, D., additional, Gelber, R., additional, Piccart-Gebhart, M., additional, and Huober, J., additional

Published
2020
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23. Estimating the magnitude of trastuzumab effects within patient subgroups in the HERA trial

Author

Untch, M., Gelber, R. D., Jackisch, C., Procter, M., Baselga, J., Bell, R., Cameron, D., Bari, M., Smith, I., Leyland-Jones, B., de Azambuja, E., Wermuth, P., Khasanov, R., Feng-yi, F., Constantin, C., Mayordomo, J. I., Su, C.-H., Yu, S.-Y., Lluch, A., Senkus-Konefka, E., Price, C., Haslbauer, F., Sahui, T. Suarez, Srimuninnimit, V., Colleoni, M., Coates, A. S., Piccart-Gebhart, M. J., and Goldhirsch, A.

Published
2008

24. introduction

Author

Piccart-Gebhart, M. J.

Published
2007

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

Published
2019
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29. Corrections to “Pathway level alterations rather than mutations in single genes predict response to HER2-targeted therapies in the neo-ALTTO trial”

Author

Shi, W., primary, Jiang, T., additional, Nuciforo, P., additional, Hatzis, C., additional, Holmes, E., additional, Harbeck, N., additional, Sotiriou, C., additional, Peña, L., additional, Loi, S., additional, Rosa, D.D., additional, Chia, S., additional, Wardley, A., additional, Ueno, T., additional, Rossari, J., additional, Eidtmann, H., additional, Armour, A., additional, Piccart-Gebhart, M., additional, Rimm, D.L., additional, Baselga, J., additional, and Pusztai, L., additional

Published
2019
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31. Abstract PD5-09: Immune parameters associated with survival in triple negative and HER2-positive breast cancer patients with 10 years of follow-up

Author

Solinas, C, primary, de Wind, A, additional, Van den Eynden, G, additional, Ameye, L, additional, Garaud, S, additional, De Silva, P, additional, Boisson, A, additional, Noel, G, additional, Langouo Fontsa, M, additional, Buisseret, L, additional, de Azambuja, E, additional, Francis, PA, additional, Di Leo, A, additional, Crown, JP, additional, Sotiriou, C, additional, Larsimont, D, additional, Paesmans, M, additional, Piccart-Gebhart, M, additional, and Willard-Gallo, K, additional

Published
2019
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32. Abstract P4-13-01: Endocrine treatment for hormone receptor-positive advanced breast cancer patients with endocrine-sensitive or endocrine-resistant disease: A systematic review and network meta-analysis

Author

Brandão, M, primary, Maurer, C, additional, Ziegelmann, P, additional, Pondé, N, additional, Ferreira, AR, additional, Martel, S, additional, Piccart-Gebhart, M, additional, Debiasi, M, additional, de Azambuja, E, additional, and Lambertini, M, additional

Published
2019
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33. Tailoring therapies—improving the management of early breast cancer: St Gallen International Expert Consensus on the Primary Therapy of Early Breast Cancer 2015

Author

Coates, A. S., Winer, E. P., Goldhirsch, A., Gelber, R. D., Gnant, M., Piccart-Gebhart, M., Thürlimann, B., Senn, H.-J, André, Fabrice, Baselga, José, Bergh, Jonas, Bonnefoi, Hervé, Burstein, Harold, Cardoso, Fatima, Castiglione-Gertsch, Monica, Coates, Alan S., Colleoni, Marco, Curigliano, Giuseppe, Davidson, Nancy E., Di Leo, Angelo, Ejlertsen, Bent, Forbes, John F., Galimberti, Viviana, Gelber, Richard D., Gnant, Michael, Goldhirsch, Aron, Goodwin, Pamela, Harbeck, Nadia, Hayes, Daniel F., Huober, Jens, Hudis, Clifford A., Ingle, James N., Jassem, Jacek, Jiang, Zefei, Karlsson, Per, Morrow, Monica, Orecchia, Roberto, Kent Osborne, C., Partridge, Ann H., de la Peña, Lorena, Piccart-Gebhart, Martine J., Pritchard, Kathleen I., Rutgers, Emiel J.T., Sedlmayer, Felix, Semiglazov, Vladimir, Shao, Zhi-Ming, Smith, Ian, Thürlimann, Beat, Toi, Masakazu, Tutt, Andrew, Viale, Giuseppe, von Minckwitz, Gunter, Watanabe, Toru, Whelan, Timothy, Winer, Eric P., and Xu, Binghe

Subjects
education
Abstract

The 14th St Gallen International Breast Cancer Conference (2015) reviewed new evidence on locoregional and systemic therapies for early breast cancer. This manuscript presents news and progress since the 2013 meeting, provides expert opinion on almost 200 questions posed to Consensus Panel members, and summarizes treatment-oriented classification of subgroups and treatment recommendations

Published
2017

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

Published
2018
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35. correction to: Pathway level alterations rather than mutations in single genes predict response to HER2-targeted therapies in the neo-ALTTO trial

Author

Shi, W., primary, Jiang, T., additional, Nuciforo, P., additional, Hatzis, C., additional, Holmes, E., additional, Harbeck, N., additional, Sotiriou, C., additional, Peña, L., additional, Loi, S., additional, Rosa, D.D., additional, Chia, S., additional, Wardley, A., additional, Ueno, T., additional, Rossari, J., additional, Eidtmann, H., additional, Armour, A., additional, Piccart-Gebhart, M., additional, Rimm, D.L., additional, Baselga, J., additional, and Pusztai, L., additional

Published
2018
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36. Abstract P2-09-01: T-cell receptor beta chain variable region (TRBV) expression patterns predict response to combined trastuzumab/lapatinib treatment in the NeoALTTO/BIG-1-06 trial

Author

Powles, R, primary, Redmond, D, additional, Sotiriou, C, additional, Loi, S, additional, Fumagalli, D, additional, Nuciforo, P, additional, Harbeck, N, additional, de Azambuja, E, additional, Sarp, S, additional, Di Cosimo, S, additional, Huober, J, additional, Baselga, J, additional, Piccart-Gebhart, M, additional, Elemento, O, additional, Hatzis, C, additional, and Pusztai, L, additional

Published
2018
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37. Abstract PD6-07: Clinical significance of CD73 expression in triple-negative breast cancer from the BIG 02-98 adjuvant phase III clinical trial

Author

Buisseret, L, primary, Pommey, S, additional, Allard, B, additional, Garaud, S, additional, Bergeron, MA, additional, Cousineau, I, additional, Ameye, L, additional, Paesmans, M, additional, Crown, JPA, additional, Di Leo, A, additional, Piccart-Gebhart, M, additional, Willard-Gallo, K, additional, Sotiriou, C, additional, and Stagg, J, additional

Published
2018
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38. Phase I trial combining temozolomide plus lapatinib for the treatment of brain metastases in patients with HER2-positive metastatic breast cancer: the LAPTEM trial

Author

de Azambuja, E., Zardavas, D., Lemort, M., Rossari, J., Moulin, C., Buttice, A., D'Hondt, V., Lebrun, F., Lalami, Y., Cardoso, F., Sotiriou, C., Gil, T., Devriendt, D., Paesmans, M., Piccart-Gebhart, M., Awada, A., de Azambuja, E., Zardavas, D., Lemort, M., Rossari, J., Moulin, C., Buttice, A., D'Hondt, V., Lebrun, F., Lalami, Y., Cardoso, F., Sotiriou, C., Gil, T., Devriendt, D., Paesmans, M., Piccart-Gebhart, M., and Awada, A.

Abstract

Background Brain metastases (BMs) pose a clinical challenge in breast cancer (BC). Lapatinib or temozolomide showed activity in BM. Our study assessed the combination of both drugs as treatment for patients with HER2-positive BC and BM. Methods Eighteen patients were enrolled, with sixteen of them having recurrent or progressive BM. Any type of previous therapy was allowed, and disease was assessed by gadolinium (Gd)-enhanced magnetic resonance imaging (MRI). The primary end points were the evaluation of the dose-limiting toxicities (DLTs) and the determination of the maximum-tolerated dose (MTD). The secondary end points included objective response rate, clinical benefit and duration of response. Results The lapatinib-temozolomide regimen showed a favorable toxicity profile because the MTD could not be reached. The most common adverse events (AEs) were fatigue, diarrhea and constipation. Disease stabilization was achieved in 10 out of 15 assessable patients. The estimated median survival time for the 16 patients with BM reached 10.94 months (95% CI: 1.09-20.79), whereas the median progression-free survival time was 2.60 months [95% confidence interval (CI): 1.82-3.37]. Conclusions The lapatinib-temozolomide combination is well tolerated. Preliminary evidence of clinical activity was observed in a heavily pretreated population, as indicated by the volumetric reductions occurring in brain lesions

Published
2017

39. Is risk of central nervous system (CNS) relapse related to adjuvant taxane treatment in node-positive breast cancer? Results of the CNS substudy in the intergroup phase III BIG 02-98 trial

Author

Pestalozzi, B. C., Francis, P., Quinaux, E., Dolci, S., Azambuja, E., Gelber, R. D., Viale, G., Balil, A., Andersson, M., Nordenskjöld, B., Gnant, M., Gutierrez, J., Láng, I., Crown, J. P. A., Piccart-Gebhart, M., Pestalozzi, B. C., Francis, P., Quinaux, E., Dolci, S., Azambuja, E., Gelber, R. D., Viale, G., Balil, A., Andersson, M., Nordenskjöld, B., Gnant, M., Gutierrez, J., Láng, I., Crown, J. P. A., and Piccart-Gebhart, M.

Abstract

Background: Breast cancer central nervous system (CNS) metastases are an increasingly important problem because of high CNS relapse rates in patients treated with trastuzumab and/or taxanes. Patients and methods: We evaluated data from 2887 node-positive breast cancer patients randomised in the BIG 02-98 trial comparing anthracycline-based adjuvant chemotherapy (control arms) to anthracycline-docetaxel-based sequential or concurrent chemotherapy (experimental arms). After a median follow-up of 5 years, 403 patients had died and detailed information on CNS relapse was collected for these patients. Results: CNS relapse occurred in 4.0% of control patients and 3.7% of docetaxel-treated patients. CNS relapse occurred in 27% of deceased patients in both treatment groups. CNS relapse was usually accompanied by neurologic symptoms (90%), and 25% of patients with CNS relapse died without evidence of extra-CNS relapse. Only 20% of patients survived 1 year from the diagnosis of CNS relapse. Prognosis of CNS relapse was worse for patients with meningeal carcinomatosis when compared with brain metastases. Unexpected findings included a higher rate of positive cerebrospinal fluid cytology (8% versus 3%) and more frequent use of magnetic resonance imaging for diagnosis (47% versus 30%) in the docetaxel-treated patients. Conclusion: There is no evidence that adjuvant docetaxel treatment is associated with an increased frequency of CNS relapse

Published
2017

44. Abstract P2-09-05: 12 years' median follow up (MFU) of BIG 1-98: Adjuvant letrozole, tamoxifen and their sequence for postmenopausal women with endocrine responsive early breast cancer

Author

Thürlimann, B, primary, Giobbie-Hurder, A, additional, Colleoni, M, additional, Jensen, M-B, additional, Ejlertsen, B, additional, de Azambuja, E, additional, Neven, P, additional, Láng, I, additional, Gladieff, L, additional, Bonnefoi, H, additional, Harvey, VJ, additional, Spazzapan, S, additional, Tondini, C, additional, Price, K, additional, Piccart-Gebhart, M, additional, Regan, MM, additional, Gelber, RD, additional, Coates, AS, additional, and Goldhirsch, A, additional

Published
2017
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45. Lapatinib with trastuzumab for HER2-positive early breast cancer (NeoALTTO): a randomised, open-label, multicentre, phase 3 trial

Author

Baselga, J, Bradbury, I, Eidtmann, H, Di Cosimo, S, de Azambuja, E, Aura, C, Gómez, H, Dinh, P, Fauria, K, Van Dooren, V, Aktan, G, Goldhirsch, A, Chang, T, Horváth, Z, Coccia-Portugal, M, Domont, J, Tseng, L, Kunz, G, Sohn, J, Semiglazov, V, Lerzo, G, Palacova, M, Probachai, V, Pusztai, L, Untch, M, Gelber, R, Piccart-Gebhart, M, Bidoli, P, Baselga J, Bradbury I, Eidtmann H, Di Cosimo S, de Azambuja E, Aura C, Gómez H, Dinh P, Fauria K, Van Dooren V, Aktan G, Goldhirsch A, Chang TW, Horváth Z, Coccia-Portugal M, Domont J, Tseng LM, Kunz G, Sohn JH, Semiglazov V, Lerzo G, Palacova M, Probachai V, Pusztai L, Untch M, Gelber RD, Piccart-Gebhart M, Bidoli P, Baselga, J, Bradbury, I, Eidtmann, H, Di Cosimo, S, de Azambuja, E, Aura, C, Gómez, H, Dinh, P, Fauria, K, Van Dooren, V, Aktan, G, Goldhirsch, A, Chang, T, Horváth, Z, Coccia-Portugal, M, Domont, J, Tseng, L, Kunz, G, Sohn, J, Semiglazov, V, Lerzo, G, Palacova, M, Probachai, V, Pusztai, L, Untch, M, Gelber, R, Piccart-Gebhart, M, Bidoli, P, Baselga J, Bradbury I, Eidtmann H, Di Cosimo S, de Azambuja E, Aura C, Gómez H, Dinh P, Fauria K, Van Dooren V, Aktan G, Goldhirsch A, Chang TW, Horváth Z, Coccia-Portugal M, Domont J, Tseng LM, Kunz G, Sohn JH, Semiglazov V, Lerzo G, Palacova M, Probachai V, Pusztai L, Untch M, Gelber RD, Piccart-Gebhart M, and Bidoli P

Abstract

Background: The anti-HER2 monoclonal antibody trastuzumab and the tyrosine kinase inhibitor lapatinib have complementary mechanisms of action and synergistic antitumour activity in models of HER2-overexpressing breast cancer. We argue that the two anti-HER2 agents given together would be better than single-agent therapy. Methods: In this parallel groups, randomised, open-label, phase 3 study undertaken between Jan 5, 2008, and May 27, 2010, women from 23 countries with HER2-positive primary breast cancer with tumours greater than 2 cm in diameter were randomly assigned to oral lapatinib (1500 mg), intravenous trastuzumab (loading dose 4 mg/m 2, subsequent doses 2 mg/kg), or lapatinib (1000 mg) plus trastuzumab. Treatment allocation was by stratified, permuted blocks randomisation, with four stratification factors. Anti-HER2 therapy alone was given for the first 6 weeks; weekly paclitaxel (80 mg/m 2) was then added to the regimen for a further 12 weeks, before definitive surgery was undertaken. After surgery, patients received adjuvant chemotherapy followed by the same targeted therapy as in the neoadjuvant phase to 52 weeks. The primary endpoint was the rate of pathological complete response (pCR), analysed by intention to treat. This trial is registered with ClinicalTrials.gov, NCT00553358. Findings: 154 patients received lapatinib, 149 trastuzumab, and 152 the combination. pCR rate was significantly higher in the group given lapatinib and trastuzumab (78 of 152 patients [51·3; 95 CI 43·1-59·5]) than in the group given trastuzumab alone (44 of 149 patients [29·5; 22·4-37·5]; difference 21·1, 9·1-34·2, p=0·0001). We recorded no significant difference in pCR between the lapatinib (38 of 154 patients [24·7, 18·1-32·3]) and the trastuzumab (difference -4·8, -17·6 to 8·2, p=0·34) groups. No major cardiac dysfunctions occurred. Frequency of grade 3 diarrhoea was higher with lapatinib (36 patients [23·4]) and lapatinib plus trastuzumab (32 [21·1]) than with trastuzumab (t

Published
2012

46. Corrections to “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

André, F., Baselga, J., Bergh, J., Bonnefoi, H., Y. Brucker, S., 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., Xu, B., Curigliano, G., Burstein, H.J., P. Winer, E., Gnant, M., Dubsky, P., Loibl, S., Colleoni, M., Regan, M.M., Piccart-Gebhart, M., Senn, H.-J., and Thürlimann, B.

Published
2019
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47. Abstract S5-01: Whole exome sequencing of pre-treatment biopsies from the neoALTTO trial to identify DNA aberrations associated with response to HER2-targeted therapies

Author

Pusztai, L, primary, Shi, W, additional, Jiang, T, additional, Nuciforo, P, additional, Holmes, E, additional, Harbeck, N, additional, Sotiriou, C, additional, Rimm, D, additional, Hatzis, C, additional, de la Peña, L, additional, Armour, A, additional, Piccart-Gebhart, M, additional, and Baselga, J, additional

Published
2016
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48. HER2 staining intensity in HER2-positive disease: Relationship with FISH amplification and clinical outcome in the HERA trial of adjuvant trastuzumab

Author

Zabaglo, L. Stoss, O. Rüschoff, J. Zielinski, D. Salter, J. Arfi, M. Bradbury, I. Dafni, U. Piccart-Gebhart, M. Procter, M. Dowsett, M.

Subjects
skin and connective tissue diseases, neoplasms
Abstract

Background: Trastuzumab treatment improves survival of HER2-positive primary breast cancer. HER2 staining intensity varies widely in HER2-positive tumours. Patients and methods: We investigated whether differences in immunohistochemical (IHC) staining intensity for HER2 in HER2-positive tumors (IHC 3+ or FISH ratio ≥2.0) was associated with prognosis or benefit from trastuzumab treatment in patients randomized to 1 year or no trastuzumab in the HERceptin Adjuvant (HERA) trial. Median follow-up was 2 years. The nested case-control analysis, included 425 patients (cases) with a disease-free survival (DFS) event and two matched controls (no DFS event) per case. Tissue sections stained for HER2 were assessed for HER2 staining intensity by image analysis. Results: HER2 staining intensity varied widely and correlated with HER2 gene copy number (Spearman, r = 0.498, P < 0.001) or less closely with HER2/CEP17 FISH ratio (r = 0.396, P < 0.001). We found no significant difference in DFS in the observation arm according to staining intensity (odds ratio [OR] change per 10 unit change in intensity: 1.015, 95% confidence interval [CI] 0.930-1.108) and no impact of staining intensity on benefit derived from 1-year trastuzumab (OR: 1.017, 95% CI 0.925-1.120). Conclusions: Variability in HER2 staining in HER2-positive tumours has no role in clinical management with adjuvant trastuzumab. © The Author 2013. Published by Oxford University Press on behalf of the European Society for Medical Oncology All rights reserved.

Published
2013

49. Immunohistochemical versus molecular (BluePrint and MammaPrint) subtyping of breast carcinoma. Outcome results from the EORTC 10041/BIG 3-04 MINDACT trial.

Author

Viale, G., de Snoo, F. A., Slaets, L., Bogaerts, J., van ’t Veer, L., Rutgers, E. J., Piccart-Gebhart, M. J., Stork-Sloots, L., Glas, A., Russo, L., Dell’Orto, P., Tryfonidis, K., Litière, S., Cardoso, F., and for the MINDACT investigators

Abstract

Purpose: This study compares immunohistochemical (IHC) versus molecular subtyping (BluePrint and MammaPrint) in the population of patients enrolled in MINDACT and outcome based on molecular subtyping (MS) versus surrogate pathological subtyping (PS) as defined by the 2013 St. Gallen guidelines.Methods: MS classified patients in the following subtypes: Luminal A, Luminal B, HER-2-, and Basal-type. IHC/FISH for pathological subtyping (ER, PgR, HER-2, and Ki67) was centrally assessed in the European Institute of Oncology (n = 5806). Hazard ratios for distant-metastasis-free survival (DMFS) by subtype were adjusted for chemotherapy and endocrine therapy administration and thus independent of adjuvant treatment allocation.Results: PS Luminal cancers classified as HER-2+ or Basal-type by MS did not have a significantly lower DMFS than the Luminal-type cancers by MS (95.9%): HR = 1.40, 95% CI 0.75–2.60 (p = 0.294). More patients were identified with Luminal A disease by MS (63%) as compared with PS (47%) with comparable 5-year DMFS (≥96.0%). Among the 500 patients with PS TN cancers, MS identified 24 (5%) patients as Luminal-type with 5-year DMFS estimated at 100% versus 71.4% for MS HER-2+ or 90.1% for MS Basal-type.Conclusions: MS was able to re-stratify 54% of patients with a Luminal-B PS subtype to a low-risk Luminal A-type group with comparable outcome. Among TN EBC, 5% were classified as Luminal by MS with Luminal-like outcome. Molecular classification can help to identify a larger group of patients with low risk of recurrence compared with the more contemporarily used classification methodology including high-quality assessed Ki67. [ABSTRACT FROM AUTHOR]

Published
2018
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