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2. 6th and 7th International consensus guidelines for the management of advanced breast cancer (ABC guidelines 6 and 7)

Author

Cardoso, Fatima, Paluch-Shimon, Shani, Schumacher-Wulf, Eva, Matos, Leonor, Gelmon, Karen, Aapro, Matti S., Bajpai, Jyoti, Barrios, Carlos H., Bergh, Jonas, Bergsten-Nordström, Elizabeth, Biganzoli, Laura, Cardoso, Maria João, Carey, Lisa A., Chavez-MacGregor, Mariana, Chidebe, Runcie, Cortés, Javier, Curigliano, Giuseppe, Dent, Rebecca A., El Saghir, Nagi S., Eniu, Alexandru, Fallowfield, Lesley, Francis, Prudence A., Franco Millan, Sandra X., Gilchrist, Jenny, Gligorov, Joseph, Gradishar, William J., Haidinger, Renate, Harbeck, Nadia, Hu, Xichun, Kaur, Ranjit, Kiely, Belinda, Kim, Sung-Bae, Koppikar, Smruti, Kuper-Hommel, Marion J.J., Lecouvet, Frédéric E., Mason, Ginny, Mertz, Shirley A., Mueller, Volkmar, Myerson, Claire, Neciosup, Silvia, Offersen, Birgitte V., Ohno, Shinji, Pagani, Olivia, Partridge, Ann H., Penault-Llorca, Frédérique, Prat, Aleix, Rugo, Hope S., Senkus, Elzbieta, Sledge, George W., Swain, Sandra M., Thomssen, Christoph, Vorobiof, Daniel A., Vuylsteke, Peter, Wiseman, Theresa, Xu, Binghe, Costa, Alberto, Norton, Larry, and Winer, Eric P.

Published
2024
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4. Adjuvant Olaparib for Patients with BRCA1- or BRCA2-Mutated Breast Cancer

Author

Tutt, Andrew NJ, Garber, Judy E, Kaufman, Bella, Viale, Giuseppe, Fumagalli, Debora, Rastogi, Priya, Gelber, Richard D, de Azambuja, Evandro, Fielding, Anitra, Balmaña, Judith, Domchek, Susan M, Gelmon, Karen A, Hollingsworth, Simon J, Korde, Larissa A, Linderholm, Barbro, Bandos, Hanna, Senkus, Elżbieta, Suga, Jennifer M, Shao, Zhimin, Pippas, Andrew W, Nowecki, Zbigniew, Huzarski, Tomasz, Ganz, Patricia A, Lucas, Peter C, Baker, Nigel, Loibl, Sibylle, McConnell, Robin, Piccart, Martine, Schmutzler, Rita, Steger, Guenther G, Costantino, Joseph P, Arahmani, Amal, Wolmark, Norman, McFadden, Eleanor, Karantza, Vassiliki, Lakhani, Sunil R, Yothers, Greg, Campbell, Christine, and Geyer, Charles E

Subjects
Digestive Diseases, Breast Cancer, Cancer, Clinical Research, Clinical Trials and Supportive Activities, 6.1 Pharmaceuticals, Evaluation of treatments and therapeutic interventions, Good Health and Well Being, Adult, Antineoplastic Agents, Breast Neoplasms, Chemotherapy, Adjuvant, Disease-Free Survival, Double-Blind Method, Female, Genes, BRCA1, Genes, BRCA2, Germ-Line Mutation, Humans, Mastectomy, Middle Aged, Phthalazines, Piperazines, Poly(ADP-ribose) Polymerase Inhibitors, Receptor, ErbB-2, OlympiA Clinical Trial Steering Committee and Investigators, Receptor, erbB-2, Medical and Health Sciences, General & Internal Medicine
Abstract

BackgroundPoly(adenosine diphosphate-ribose) polymerase inhibitors target cancers with defects in homologous recombination repair by synthetic lethality. New therapies are needed to reduce recurrence in patients with BRCA1 or BRCA2 germline mutation-associated early breast cancer.MethodsWe conducted a phase 3, double-blind, randomized trial involving patients with human epidermal growth factor receptor 2 (HER2)-negative early breast cancer with BRCA1 or BRCA2 germline pathogenic or likely pathogenic variants and high-risk clinicopathological factors who had received local treatment and neoadjuvant or adjuvant chemotherapy. Patients were randomly assigned (in a 1:1 ratio) to 1 year of oral olaparib or placebo. The primary end point was invasive disease-free survival.ResultsA total of 1836 patients underwent randomization. At a prespecified event-driven interim analysis with a median follow-up of 2.5 years, the 3-year invasive disease-free survival was 85.9% in the olaparib group and 77.1% in the placebo group (difference, 8.8 percentage points; 95% confidence interval [CI], 4.5 to 13.0; hazard ratio for invasive disease or death, 0.58; 99.5% CI, 0.41 to 0.82; P

Published
2021

5. Designing clinical trials based on modern imaging and metastasis-directed treatments in patients with oligometastatic breast cancer: a consensus recommendation from the EORTC Imaging and Breast Cancer Groups

Author

Pasquier, David, Bidaut, Luc, Oprea-Lager, Daniela Elena, deSouza, Nandita M, Krug, David, Collette, Laurence, Kunz, Wolfgang, Belkacemi, Yazid, Bau, Maria Grazia, Caramella, Caroline, De Geus-Oei, Lioe-Fee, De Caluwé, Alex, Deroose, Christophe, Gheysens, Olivier, Herrmann, Ken, Kindts, Isabelle, Kontos, Michalis, Kümmel, Sherko, Linderholm, Barbro, Lopci, Egesta, Meattini, Icro, Smeets, Ann, Kaidar-Person, Orit, Poortmans, Philip, Tsoutsou, Pelagia, Hajjaji, Nawale, Russell, Nicola, Senkus, Elżbieta, Talbot, Jean-Noël, Umutlu, Lale, Vandecaveye, Vincent, Verhoeff, Joost J C, van Oordt, Willemien Menke-van der Houven, Zacho, Helle D, Cardoso, Fatima, Fournier, Laure, Van Duijnhoven, Frederieke, and Lecouvet, Frédéric E

Published
2023
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8. Abemaciclib plus endocrine therapy for hormone receptor-positive, HER2-negative, node-positive, high-risk early breast cancer (monarchE): results from a preplanned interim analysis of a randomised, open-label, phase 3 trial

Author

Johnston, Stephen R D, Toi, Masakazu, O'Shaughnessy, Joyce, Rastogi, Priya, Campone, Mario, Neven, Patrick, Huang, Chiun-Sheng, Huober, Jens, Jaliffe, Georgina Garnica, Cicin, Irfan, Tolaney, Sara M, Goetz, Matthew P, Rugo, Hope S, Senkus, Elzbieta, Testa, Laura, Del Mastro, Lucia, Shimizu, Chikako, Wei, Ran, Shahir, Ashwin, Munoz, Maria, San Antonio, Belen, André, Valérie, Harbeck, Nadia, and Martin, Miguel

Published
2023
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10. High expression of progesterone receptor may be an adverse prognostic factor in oestrogen receptor-negative/progesterone receptor-positive breast cancer: results of comprehensive re-evaluation of multi-institutional case series

Author

Kunc, Michał, Pęksa, Rafał, Cserni, Gabor, Iżycka-Świeszewska, Ewa, Łacko, Aleksandra, Radecka, Barbara, Braun, Marcin, Pikiel, Joanna, Litwiniuk, Maria, Pogoda, Katarzyna, Szwajkosz, Anna, Biernat, Wojciech, and Senkus, Elżbieta

Published
2022
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11. European Society for Radiotherapy and Oncology Advisory Committee in Radiation Oncology Practice consensus recommendations on patient selection and dose and fractionation for external beam radiotherapy in early breast cancer

Author

Meattini, Icro, Becherini, Carlotta, Boersma, Liesbeth, Kaidar-Person, Orit, Marta, Gustavo Nader, Montero, Angel, Offersen, Birgitte Vrou, Aznar, Marianne C, Belka, Claus, Brunt, Adrian Murray, Dicuonzo, Samantha, Franco, Pierfrancesco, Krause, Mechthild, MacKenzie, Mairead, Marinko, Tanja, Marrazzo, Livia, Ratosa, Ivica, Scholten, Astrid, Senkus, Elżbieta, Stobart, Hilary, Poortmans, Philip, and Coles, Charlotte E

Published
2022
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17. High tumour-infiltrating lymphocytes correlate with distinct gene expression profile and favourable survival in single hormone receptor-positive breast cancer

Author

Ciarka, Aleksandra, primary, Kunc, Michał, additional, Popęda, Marta, additional, Łacko, Aleksandra, additional, Radecka, Barbara, additional, Braun, Marcin, additional, Pikiel, Joanna, additional, Litwiniuk, Maria, additional, Pogoda, Katarzyna, additional, Iżycka-Świeszewska, Ewa, additional, Zeller, Anna, additional, Niemira, Magdalena, additional, Pęksa, Rafał, additional, Biernat, Wojciech, additional, and Senkus, Elżbieta, additional

Published
2024
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19. Locally Advanced Breast Cancer

Author

Senkus, Elżbieta, Łacko, Aleksandra, Wyld, Lynda, editor, Markopoulos, Christos, editor, Leidenius, Marjut, editor, and Senkus-Konefka, Elżbieta, editor

Published
2018
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20. ESTRO ACROP consensus guideline for target volume delineation in the setting of postmastectomy radiation therapy after implant-based immediate reconstruction for early stage breast cancer

Author

Kaidar-Person, Orit, Vrou Offersen, Birgitte, Hol, Sandra, Arenas, Meritxell, Aristei, Cynthia, Bourgier, Celine, Cardoso, Maria Joao, Chua, Boon, Coles, Charlotte E., Engberg Damsgaard, Tine, Gabrys, Dorota, Jagsi, Reshma, Jimenez, Rachel, Kirby, Anna M., Kirkove, Carine, Kirova, Youlia, Kouloulias, Vassilis, Marinko, Tanja, Meattini, Icro, Mjaaland, Ingvil, Nader Marta, Gustavo, Witt Nystrom, Petra, Senkus, Elzbieta, Skyttä, Tanja, Tvedskov, Tove F., Verhoeven, Karolien, and Poortmans, Philip

Published
2019
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24. Olaparib efficacy in patients with germline BRCA ‐mutated, HER2 ‐negative metastatic breast cancer: Subgroup analyses from the phase III OlympiAD trial

Author

Senkus, Elżbieta, primary, Delaloge, Suzette, additional, Domchek, Susan M., additional, Conte, Pierfranco, additional, Im, Seock‐Ah, additional, Xu, Binghe, additional, Armstrong, Anne, additional, Masuda, Norikazu, additional, Fielding, Anitra, additional, Robson, Mark, additional, and Tung, Nadine, additional

Published
2023
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25. Abstract P2-23-06: Estrogen receptor-negative progesterone receptor-positive breast cancer is a molecularly distinct group characterized by the down-regulation of genes controlled by ESR1 and SUZ12

Author

Kunc, Michał, primary, Popęda, Marta, additional, Bieńkowski, Michał, additional, Braun, Marcin, additional, Łacko, Aleksandra, additional, Radecka, Barbara, additional, Pikiel, Joanna, additional, Litwiniuk, Maria, additional, Pogoda, Katarzyna, additional, Niemira, Magdalena, additional, Szałkowska, Anna, additional, Iżycka-Świeszewska, Ewa, additional, Cserni, Gabor, additional, Biernat, Wojciech, additional, and Senkus, Elżbieta, additional

Published
2023
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26. Abstract GS1-09: Abemaciclib plus endocrine therapy for HR+, HER2-, node-positive, high-risk early breast cancer: results from a pre-planned monarchE overall survival interim analysis, including 4-year efficacy outcomes

Author

Johnston, Stephen, primary, Toi, Masakazu, additional, O’Shaughnessy, Joyce, additional, Rastogi, Priya, additional, Campone, Mario, additional, Neven, Patrick, additional, Huang, Chiun Sheng, additional, Huober, Jens, additional, Jaliffe, Georgina Garnica, additional, Cicin, Irfan, additional, Tolaney, Sara, additional, Goetz, Matthew P., additional, Rugo, Hope, additional, Senkus, Elżbieta, additional, Testa, Laura, additional, Mastro, Lucia Del, additional, Shimizu, Chikako, additional, Wei, Ran, additional, Shahir, Ashwin, additional, Munoz, Maria, additional, Antonio, Belen San, additional, Andre, Valerie, additional, Harbeck, Nadia, additional, and Martín, Miguel, additional

Published
2023
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31. Are All Societies Ready for Digital Tools? Feasibility Study on the Use of Mobile Application in Polish Early Breast Cancer Patients Treated with Perioperative Chemotherapy.

Author

Suchodolska, Grażyna, Koelmer, Anna, Puchowska, Monika, and Senkus, Elżbieta

Subjects
PERIOPERATIVE care, PILOT projects, STATISTICS, KRUSKAL-Wallis Test, CANCER pain, FEVER, NAUSEA, DIARRHEA, STOMATITIS, MOBILE apps, CANCER chemotherapy, SELF-evaluation, DIZZINESS, CONSTIPATION, HEALTH outcome assessment, PATIENT satisfaction, MANN Whitney U Test, FISHER exact test, CANCER patients, VOMITING, DYSPNEA, QUESTIONNAIRES, CHI-squared test, DESCRIPTIVE statistics, CANCER fatigue, COUGH, DATA analysis software, DATA analysis, ANOREXIA nervosa, BREAST tumors, TELEMEDICINE, TELENURSING, EVALUATION, SYMPTOMS
Abstract

Background: The population of individuals affected by breast cancer is growing, and with advances in cancer treatment implemented into usual care, there is an urgent need to improve the recognition, monitoring and treatment of therapy-induced adverse effects. This study aims to explore the use of an in-app electronic questionnaire to assess and monitor chemotherapy-related symptoms in early breast cancer patients treated with perioperative chemotherapy. Method: Between December 2019 and June 2021, 72 female study participants used the mobile app Centrum Chorób Piersi UCK and completed an in-app questionnaire about the 14 most common chemotherapy-related symptoms. Replies including symptoms with a critical value triggered automatic email alerts to the nursing team. Results: Acceptance of the study was higher among younger women and patients originating from rural areas, while possible digital exclusion among patients >60 years was observed during the enrolment process. A total of 55 participants completed the electronic questionnaire at least once and generated 553 responses with 1808 specific problems reported. Fatigue (n = 428) was the most common problem, and fever (n = 5) the least reported problem. A total of 21 participants triggered alerts with responses containing symptoms with critical value assessment (n = 89). Significant negative correlation was observed between the number of responses and time from the first chemotherapy administration; however, the number of responses was not determined by any sociodemographic or medical factors. Significant positive correlations were identified between the number of communicated problems and participants' age. The usage of our electronic symptom assessment questionnaire decreased substantially after the period of active encouragement during the study enrolment. Conclusions: Not all societies are ready for innovative eHealth solutions. Patients' age should be carefully considered when app-based interventions are introduced to usual cancer care. Additional support is suggested for older patients to improve their awareness and participation in eHealth interventions. More research involving older participants is needed to explore and address their particular needs and perspectives on eHealth solutions. [ABSTRACT FROM AUTHOR]

Published
2023
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33. International guidelines for management of metastatic breast cancer (MBC) from the European School of Oncology (ESO)–MBC Task Force: Surveillance, staging, and evaluation of patients with early-stage and metastatic breast cancer

Author

Lin, Nancy U., Thomssen, Christoph, Cardoso, Fatima, Cameron, David, Cufer, Tanja, Fallowfield, Lesley, Francis, Prudence A., Kyriakides, Stella, Pagani, Olivia, Senkus, Elzbieta, Costa, Alberto, and Winer, Eric P.

Published
2013
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36. Management Strategies for Hyperglycemia Associated with the α-Selective PI3K Inhibitor Alpelisib for the Treatment of Breast Cancer

Author

Tankova, Tsvetalina, primary, Senkus, Elżbieta, additional, Beloyartseva, Maria, additional, Borštnar, Simona, additional, Catrinoiu, Doina, additional, Frolova, Mona, additional, Hegmane, Alinta, additional, Janež, Andrej, additional, Krnić, Mladen, additional, Lengyel, Zoltan, additional, Marcou, Yiola, additional, Mazilu, Laura, additional, Mrinakova, Bela, additional, Percik, Ruth, additional, Petrakova, Katarina, additional, Rubovszky, Gábor, additional, Tokar, Margarita, additional, and Vrdoljak, Eduard, additional

Published
2022
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37. De-escalation of axillary irradiation for early breast cancer – Has the time come?

Author

Senkus, Elżbieta, Cardoso, Maria Joao, Kaidar-Person, Orit, Łacko, Aleksandra, Meattini, Icro, Poortmans, Philip, and NOVA Medical School|Faculdade de Ciências Médicas (NMS|FCM)

Subjects
Radiation therapy, Breast cancer, Sentinel lymph node biopsy, Oncology, SDG 3 - Good Health and Well-being, Axillary de-escalation, Radiology Nuclear Medicine and imaging, Primary systemic therapy
Abstract

Introduction of sentinel lymph node biopsy, initially in clinically node-negative and subsequently in patients presenting with involved axilla and downstaged by primary systemic therapy, allowed for significant decrease in morbidity compared to axillary lymph node dissection. Concurrently, regional nodal irradiation was demonstrated to improve outcomes in most node-positive patients. Additionally, over the last decades, introduction of more effective systemic therapies has resulted in improvements not only at distant sites, but also in locoregional control, creating space for de-escalation of locoregional treatments. We discuss the data on de-escalation in axillary surgery and irradiation, both in patients undergoing upfront surgery and primary systemic therapy, with special emphasis on the feasibility of omission of nodal irradiation in patients undergoing primary systemic therapy. In view of the accumulating evidence, omission of axillary irradiation may be considered in clinically node-positive patients converting after primary systemic therapy to pathologically negative nodes on sentinel lymph node biopsy (preferably also with in-breast pCR), presenting with lower initial nodal stage, older age and were treated with breast-conserving surgery followed by whole breast irradiation. Omission of regional nodal irradiation in patients with aggressive tumor phenotypes achieving a pCR is under investigation. In patients undergoing preoperative endocrine therapy the adoption of axillary management strategies utilized in case of upfront surgery seems more suitable than those used in post chemotherapy-based primary systemic therapy setting. publishersversion published

Published
2021

42. Adjuvant Olaparib for Patients with BRCA1- or BRCA2-Mutated Breast Cancer

Author

Tutt, Andrew N J, Garber, Judy E, Kaufman, Bella, Viale, Giuseppe, Fumagalli, Debora, Rastogi, Priya, Gelber, Richard D, de Azambuja, Evandro, Fielding, Anitra, Balmaña, Judith, Domchek, Susan M, Gelmon, Karen A, Hollingsworth, Simon J, Korde, Larissa A, Linderholm, Barbro, Bandos, Hanna, Senkus, Elżbieta, Suga, Jennifer M, Shao, Zhimin, Pippas, Andrew W, Nowecki, Zbigniew, Huzarski, Tomasz, Ganz, Patricia A, Lucas, Peter C, Baker, Nigel, Loibl, Sibylle, McConnell, Robin, Piccart, Martine, Schmutzler, Rita, Steger, Guenther G, Costantino, Joseph P, Arahmani, Amal, Wolmark, Norman, McFadden, Eleanor, Karantza, Vassiliki, Lakhani, Sunil R, Yothers, Greg, Campbell, Christine, and Geyer, Charles E

Subjects
610 Medicine & health
Abstract

BACKGROUND Poly(adenosine diphosphate-ribose) polymerase inhibitors target cancers with defects in homologous recombination repair by synthetic lethality. New therapies are needed to reduce recurrence in patients with BRCA1 or BRCA2 germline mutation-associated early breast cancer. METHODS We conducted a phase 3, double-blind, randomized trial involving patients with human epidermal growth factor receptor 2 (HER2)-negative early breast cancer with BRCA1 or BRCA2 germline pathogenic or likely pathogenic variants and high-risk clinicopathological factors who had received local treatment and neoadjuvant or adjuvant chemotherapy. Patients were randomly assigned (in a 1:1 ratio) to 1 year of oral olaparib or placebo. The primary end point was invasive disease-free survival. RESULTS A total of 1836 patients underwent randomization. At a prespecified event-driven interim analysis with a median follow-up of 2.5 years, the 3-year invasive disease-free survival was 85.9% in the olaparib group and 77.1% in the placebo group (difference, 8.8 percentage points; 95% confidence interval [CI], 4.5 to 13.0; hazard ratio for invasive disease or death, 0.58; 99.5% CI, 0.41 to 0.82; P

Published
2021
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43. Patterns of genomic change in residual disease after neoadjuvant chemotherapy for estrogen receptor-positive and HER2-negative breast cancer

Author

Chatzipli, Aikaterini, Bonnefoi, Herve, MacGrogan, Gaetan, Sentis, Julie, Cameron, David A, Poncet, Coralie, Abadie-Lacourtoisie, Sophie, Bodmer, Alexandre, Brain, Etienne, Cufer, Tanja, Campone, Mario, Luporsi, Élisabeth E., Moldovan, Cristian, Petit, Thierry, Piccart-Gebhart, Martine, Priou, Franck, Senkus, Elżbieta, Zaman, Khalil, Iggo, Richard, Chatzipli, Aikaterini, Bonnefoi, Herve, MacGrogan, Gaetan, Sentis, Julie, Cameron, David A, Poncet, Coralie, Abadie-Lacourtoisie, Sophie, Bodmer, Alexandre, Brain, Etienne, Cufer, Tanja, Campone, Mario, Luporsi, Élisabeth E., Moldovan, Cristian, Petit, Thierry, Piccart-Gebhart, Martine, Priou, Franck, Senkus, Elżbieta, Zaman, Khalil, and Iggo, Richard

Abstract

Background: Treatment of patients with residual disease after neoadjuvant chemotherapy for breast cancer is an unmet clinical need. We hypothesised that tumour subclones showing expansion in residual disease after chemotherapy would contain mutations conferring drug resistance. Methods: We studied oestrogen receptor and/or progesterone receptor-positive, HER2-negative tumours from 42 patients in the EORTC 10994/BIG 00-01 trial who failed to achieve a pathological complete response. Genes commonly mutated in breast cancer were sequenced in pre and post-treatment samples. Results: Oncogenic driver mutations were commonest in PIK3CA (38% of tumours), GATA3 (29%), CDH1 (17%), TP53 (17%) and CBFB (12%); and amplification was commonest for CCND1 (26% of tumours) and FGFR1 (26%). The variant allele fraction frequently changed after treatment, indicating that subclones had expanded and contracted, but there were changes in both directions for all of the commonly mutated genes. Conclusions: We found no evidence that expansion of clones containing recurrent oncogenic driver mutations is responsible for resistance to neoadjuvant chemotherapy. The persistence of classic oncogenic mutations in pathways for which targeted therapies are now available highlights their importance as drug targets in patients who have failed chemotherapy but provides no support for a direct role of driver oncogenes in resistance to chemotherapy. ClinicalTrials.gov: EORTC 10994/BIG 1-00 Trial registration number NCT00017095., SCOPUS: ar.j, DecretOANoAutActif, info:eu-repo/semantics/published

Published
2021

44. Adjuvant olaparib for patients with BRCA1- Or BRCA2-mutated breast cancer

Author

Tutt, Andrew M, Garber, Judy Ellen, Kaufman, Bella, Viale, Giuseppe, Fumagalli, Debora, Rastogi, Priya, Gelber, Richard, de Azambuja, Evandro, Fielding, Anitra, Balmaña, Judith, Domchek, Susan S.M., Gelmon, Karen K.A., Hollingsworth, Simon S.J., Korde, Larissa, Linderholm, Barbro B.K., Bandos, Hanna, Senkus, Elżbieta, Suga, Jennifer Marie, Shao, Zhimin, Pippas, Andrew A.W., Nowecki, Zbigniew, Huzarski, Tomasz, Ganz, Patricia A, Lucas, Peter P.C., Baker, Nigel, Loibl, Sibylle, McConnell, Robin, Piccart-Gebhart, Martine, Schmutzler, Rita, Steger, Günther G.G., Costantino, Joseph P, Arahmani, Amal, Wolmark, Norman, McFadden, Eleanor, Karantza, Vassiliki, Lakhani, Sunil S.R., Yothers, Greg, Campbell, Christine, Geyer Jr. Charles C.E., Tutt, Andrew M, Garber, Judy Ellen, Kaufman, Bella, Viale, Giuseppe, Fumagalli, Debora, Rastogi, Priya, Gelber, Richard, de Azambuja, Evandro, Fielding, Anitra, Balmaña, Judith, Domchek, Susan S.M., Gelmon, Karen K.A., Hollingsworth, Simon S.J., Korde, Larissa, Linderholm, Barbro B.K., Bandos, Hanna, Senkus, Elżbieta, Suga, Jennifer Marie, Shao, Zhimin, Pippas, Andrew A.W., Nowecki, Zbigniew, Huzarski, Tomasz, Ganz, Patricia A, Lucas, Peter P.C., Baker, Nigel, Loibl, Sibylle, McConnell, Robin, Piccart-Gebhart, Martine, Schmutzler, Rita, Steger, Günther G.G., Costantino, Joseph P, Arahmani, Amal, Wolmark, Norman, McFadden, Eleanor, Karantza, Vassiliki, Lakhani, Sunil S.R., Yothers, Greg, Campbell, Christine, and Geyer Jr. Charles C.E.

Abstract

BACKGROUND Poly(adenosine diphosphate–ribose) polymerase inhibitors target cancers with defects in homologous recombination repair by synthetic lethality. New therapies are needed to reduce recurrence in patients with BRCA1 or BRCA2 germline mutation–associated early breast cancer. METHODS We conducted a phase 3, double-blind, randomized trial involving patients with human epidermal growth factor receptor 2 (HER2)–negative early breast cancer with BRCA1 or BRCA2 germline pathogenic or likely pathogenic variants and high-risk clinicopathological factors who had received local treatment and neoadjuvant or adjuvant chemotherapy. Patients were randomly assigned (in a 1:1 ratio) to 1 year of oral olaparib or placebo. The primary end point was invasive disease–free survival. RESULTS A total of 1836 patients underwent randomization. At a prespecified event-driven interim analysis with a median follow-up of 2.5 years, the 3-year invasive disease–free survival was 85.9% in the olaparib group and 77.1% in the placebo group (difference, 8.8 percentage points; 95% confidence interval [CI], 4.5 to 13.0; hazard ratio for invasive disease or death, 0.58; 99.5% CI, 0.41 to 0.82; P<0.001). The 3-year distant disease–free survival was 87.5% in the olaparib group and 80.4% in the placebo group (difference, 7.1 percentage points; 95% CI, 3.0 to 11.1; hazard ratio for distant disease or death, 0.57; 99.5% CI, 0.39 to 0.83; P<0.001). Olaparib was associated with fewer deaths than placebo (59 and 86, respectively) (hazard ratio, 0.68; 99% CI, 0.44 to 1.05; P=0.02); however, the between-group difference was not significant at an interim-analysis boundary of a P value of less than 0.01. Safety data were consistent with known side effects of olaparib, with no excess serious adverse events or adverse events of special interest. CONCLUSIONS Among patients with high-risk, HER2-negative early breast cancer and germline BRCA1 or BRCA2 pathogenic or likely pathogenic variants, adjuvant olaparib af, SCOPUS: ar.j, DecretOANoAutActif, info:eu-repo/semantics/published

Published
2021

50. Abstract PD4-03: OlympiAD extended follow-up for overall survival and safety: Olaparib versus chemotherapy treatment of physician’s choice in patients with a germline BRCA mutation and HER2-negative metastatic breast cancer

Author

Robson, Mark, primary, Im, Seock-Ah, additional, Senkus, Elżbieta, additional, Xu, Binghe, additional, Domchek, Susan, additional, Masuda, Norikazu, additional, Delaloge, Suzette, additional, Li, Wei, additional, Tung, Nadine, additional, Armstrong, Anne, additional, Bannister, Wendy, additional, Goessl, Carsten, additional, Allen, Allison, additional, and Conte, Pierfranco, additional

Published
2020
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