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2. Understanding breast cancer complexity to improve patient outcomes: The St Gallen International Consensus Conference for the Primary Therapy of Individuals with Early Breast Cancer 2023

Author

Aebi, S., Al-Foheidi, M., André, F., Anikusko, M., Badwe, R., Barrio, A.V., Barrios, C., Bergh, J., Bonnefoi, H., Bretel Morales, D., Brucker, S., Burstein, H.J., Caldas, C., Cameron, D., Cardoso, F., Cardoso, M.J., Carey, L., Chia, S., Coles, C., Cortes, J., Curigliano, G., de Boniface, J., Delaloge, S., DeMichele, A., Denkert, C., Fastner, G., Fitzal, F., Francis, P., Gamal, H., Gentilini, O., Gnant, M., Gradishar, W., Gulluoglu, B., Harbeck, N., Heil, J., Huang, C.-S.H., Huober, J., Jiang, Z., Kaidar-Person, O., Kok, M., Lee, E.-S., Loi, S., Loibl, S., Martin, M., Meattini, I., Morrow, M., Partridge, A., Penault-Llorca, F., Piccart, M., Pierce, L., Poortmans, P., Regan, M., Reis-Filho, J., Rubio, I., Rugo, H., Rutgers, E., Saura, C., Senkus, E., Shao, Z., Singer, C., Spanic, T., Thuerlimann, B., Toi, M., Tolaney, S., Turner, N., Tutt, A., Vrancken Peeters, M.-J., Watanabe, T., Weber, W., Wildiers, H., Xu, B., Regan, M.M., Weber, W.P., and Thürlimann, B.

Published
2023
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5. Biases in study design, implementation, and data analysis that distort the appraisal of clinical benefit and ESMO-Magnitude of Clinical Benefit Scale (ESMO-MCBS) scoring

Author

Gyawali, B., de Vries, E.G.E., Dafni, U., Amaral, T., Barriuso, J., Bogaerts, J., Calles, A., Curigliano, G., Gomez-Roca, C., Kiesewetter, B., Oosting, S., Passaro, A., Pentheroudakis, G., Piccart, M., Roitberg, F., Tabernero, J., Tarazona, N., Trapani, D., Wester, R., Zarkavelis, G., Zielinski, C., Zygoura, P., and Cherny, N.I.

Published
2021
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8. Tailoring the optimal duration of the extended adjuvant endocrine therapy in patients with early-stage breast cancer. A systematic review and meta-analysis of randomized clinical trials

Author

Pala, L, De Pas, T, Pagan, E, Sala, I, Catania, C, Zattarin, E, Arnone, P, Grassi, M, Colleoni, M, Wolff, A, Cortes, J, Piccart, M, Gelber, R, Viale, G, Bagnardi, V, Conforti, F, Pala L., De Pas T., Pagan E., Sala I., Catania C., Zattarin E., Arnone P., Grassi M. M., Colleoni M., Wolff A. C., Cortes J., Piccart M., Gelber R. D., Viale G., Bagnardi V., Conforti F., Pala, L, De Pas, T, Pagan, E, Sala, I, Catania, C, Zattarin, E, Arnone, P, Grassi, M, Colleoni, M, Wolff, A, Cortes, J, Piccart, M, Gelber, R, Viale, G, Bagnardi, V, Conforti, F, Pala L., De Pas T., Pagan E., Sala I., Catania C., Zattarin E., Arnone P., Grassi M. M., Colleoni M., Wolff A. C., Cortes J., Piccart M., Gelber R. D., Viale G., Bagnardi V., and Conforti F.

Abstract

Background: Controversy exists regarding the optimal duration of the extended adjuvant endocrine treatment (ET) in patients with early-stage breast-cancer (eBC). We performed a systematic review and trial-level meta-analysis of all randomized clinical trials (RCTs) comparing a “limited-extended” adjuvant ET (defined as more than 5 but less than 7.5 years of treatment overall) versus a “full-extended” adjuvant ET (defined as more than 7.5 years of treatment overall) in eBC. Methods: To be eligible, RCTs had to i) compare a “limited-extended” adjuvant ET versus a “full-extended” adjuvant ET in patients with eBC; and ii) report disease-free survival (DFS) hazard ratio (HR) according to the disease nodal-status [i.e., nodal-negative (N-ve) versus nodal-positive (N + ve)]. The primary endpoint was to assess the difference in efficacy of full-versus limited-extended ET, measured in terms of the difference in DFS log-HR, according to the disease nodal-status. Secondary endpoint was the difference in efficacy of full-versus limited-extended ET according to tumor size (i.e., pT1 vs pT2/3/4), histological grade (i.e., G1/G2 vs G3), patients’ age (i.e., ≤60 vs > 60 years) and previous type of ET (i.e., aromatase inhibitors vs tamoxifen vs switch strategy). Results: Three phase III RCTs fulfilled the inclusion criteria. A total of 6689 patients were included in the analysis, of which 3506 (53%) had N + ve disease. The full-extended ET provided no DFS-benefit as compared with the limited-extended ET in patients with N-ve disease (pooled DFS-HR = 1.04, 95%CI: 0.89 to 1.22; I2 = 18%). Conversely, in patients with N + ve disease the full-extended ET significantly improved DFS, with a pooled DFS-HR of 0.85 (95%CI: 0.74 to 0.97; I2 = 0%). There was a significant interaction between the disease nodal-status and the efficacy of the full-versus limited-extended ET (p-heterogeneity = 0.048). The full-extended ET provided no significant DFS-benefit as compared with the limited-extended

Published
2023

9. Everolimus plus exemestane for hormone-receptor-positive, human epidermal growth factor receptor-2-negative advanced breast cancer: overall survival results from BOLERO-2 †

Author

Piccart, M, Hortobagyi, GN, Campone, M, Pritchard, KI, Lebrun, F, Ito, Y, Noguchi, S, Perez, A, Rugo, HS, Deleu, I, Burris, HA, Provencher, L, Neven, P, Gnant, M, Shtivelband, M, Wu, C, Fan, J, Feng, W, Taran, T, and Baselga, J

Subjects
Clinical Research, Cancer, Breast Cancer, Clinical Trials and Supportive Activities, Aging, 6.1 Pharmaceuticals, Evaluation of treatments and therapeutic interventions, Androstadienes, Breast Neoplasms, Double-Blind Method, ErbB Receptors, Everolimus, Female, Humans, Placebos, Sirolimus, Survival Analysis, everolimus, hormone-receptor-positive breast cancer, exemestane, overall survival, Oncology and Carcinogenesis, Oncology & Carcinogenesis
Abstract

BackgroundThe BOLERO-2 study previously demonstrated that adding everolimus (EVE) to exemestane (EXE) significantly improved progression-free survival (PFS) by more than twofold in patients with hormone-receptor-positive (HR(+)), HER2-negative advanced breast cancer that recurred or progressed during/after treatment with nonsteroidal aromatase inhibitors (NSAIs). The overall survival (OS) analysis is presented here.Patients and methodsBOLERO-2 is a phase III, double-blind, randomized international trial comparing EVE 10 mg/day plus EXE 25 mg/day versus placebo (PBO) + EXE 25 mg/day in postmenopausal women with HR(+) advanced breast cancer with prior exposure to NSAIs. The primary end point was PFS by local investigator assessment; OS was a key secondary end point.ResultsAt the time of data cutoff (3 October 2013), 410 deaths had occurred and 13 patients remained on treatment. Median OS in patients receiving EVE + EXE was 31.0 months [95% confidence interval (CI) 28.0-34.6 months] compared with 26.6 months (95% CI 22.6-33.1 months) in patients receiving PBO + EXE (hazard ratio = 0.89; 95% CI 0.73-1.10; log-rank P = 0.14). Poststudy treatments were received by 84% of patients in the EVE + EXE arm versus 90% of patients in the PBO + EXE arm. Types of poststudy therapies were balanced across arms, except for chemotherapy (53% EVE + EXE versus 63% PBO + EXE). No new safety concerns were identified.ConclusionsIn BOLERO-2, adding EVE to EXE did not confer a statistically significant improvement in the secondary end point OS despite producing a clinically meaningful and statistically significant improvement in the primary end point, PFS (4.6-months prolongation in median PFS; P < 0.0001). Ongoing translational research should further refine the benefit of mTOR inhibition and related pathways in this treatment setting.Trial registration numberNCT00863655.

Published
2014

10. Incidence and time course of everolimus-related adverse events in postmenopausal women with hormone receptor-positive advanced breast cancer: insights from BOLERO-2

Author

Rugo, HS, Pritchard, KI, Gnant, M, Noguchi, S, Piccart, M, Hortobagyi, G, Baselga, J, Perez, A, Geberth, M, Csoszi, T, Chouinard, E, Srimuninnimit, V, Puttawibul, P, Eakle, J, Feng, W, Bauly, H, El-Hashimy, M, Taran, T, and Burris, HA

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Oncology and Carcinogenesis, Cancer, Clinical Research, Clinical Trials and Supportive Activities, Patient Safety, Breast Cancer, Evaluation of treatments and therapeutic interventions, 6.1 Pharmaceuticals, Adult, Aged, Aged, 80 and over, Breast Neoplasms, Disease-Free Survival, Drug-Related Side Effects and Adverse Reactions, Everolimus, Female, Humans, Middle Aged, Neoplasm Staging, Postmenopause, Sirolimus, TOR Serine-Threonine Kinases, advanced breast cancer, everolimus, mammalian target of rapamycin, safety, Oncology & Carcinogenesis, Clinical sciences, Oncology and carcinogenesis
Abstract

BackgroundIn the BOLERO-2 trial, everolimus (EVE), an inhibitor of mammalian target of rapamycin, demonstrated significant clinical benefit with an acceptable safety profile when administered with exemestane (EXE) in postmenopausal women with hormone receptor-positive (HR(+)) advanced breast cancer. We report on the incidence, time course, severity, and resolution of treatment-emergent adverse events (AEs) as well as incidence of dose modifications during the extended follow-up of this study.Patients and methodsPatients were randomized (2:1) to receive EVE 10 mg/day or placebo (PBO), with open-label EXE 25 mg/day (n = 724). The primary end point was progression-free survival. Secondary end points included overall survival, objective response rate, and safety. Safety evaluations included recording of AEs, laboratory values, dose interruptions/adjustments, and study drug discontinuations.ResultsThe safety population comprised 720 patients (EVE + EXE, 482; PBO + EXE, 238). The median follow-up was 18 months. Class-effect toxicities, including stomatitis, pneumonitis, and hyperglycemia, were generally of mild or moderate severity and occurred relatively early after treatment initiation (except pneumonitis); incidence tapered off thereafter. EVE dose reduction and interruption (360 and 705 events, respectively) required for AE management were independent of patient age. The median duration of dose interruption was 7 days. Discontinuation of both study drugs because of AEs was higher with EVE + EXE (9%) versus PBO + EXE (3%).ConclusionsMost EVE-associated AEs occur soon after initiation of therapy, are typically of mild or moderate severity, and are generally manageable with dose reduction and interruption. Discontinuation due to toxicity was uncommon. Understanding the time course of class-effect AEs will help inform preventive and monitoring strategies as well as patient education.Trial registration numberNCT00863655.

Published
2014

11. Methodological and reporting standards for quality-of-life data eligible for European Society for Medical Oncology-Magnitude of Clinical Benefit Scale (ESMO-MCBS) credit

Author

Oosting, S. F., Barriuso, J., Bottomley, A., Galotti, M., Gyawali, B., Kiesewetter, B., Latino, N. J., Martinelli, F., Pe, M., Pentheroudakis, G., Roitberg, F., Vachon, H., de Vries, E. G.E., Piccart, M., Cherny, N. I., and Guided Treatment in Optimal Selected Cancer Patients (GUTS)

Subjects
quality of life, Oncology, ESMO-MCBS, guidelines, Hematology, checklist
Abstract

Background: The European Society for Medical Oncology-Magnitude of Clinical Benefit Scale (ESMO-MCBS) has been developed to grade clinical benefit of cancer therapies. Improvement in quality of life (QoL) is considered relevant, especially in the non-curative setting. This is reflected by an upgrade of the preliminary ESMO-MCBS score if QoL is improved compared to the control arm or a downgrade if an improvement in progression-free survival is not paralleled by an improvement in QoL or overall survival. Given the importance of QoL for the final score, a need to ensure the robustness of QoL data was recognised. Design: A checklist was created based on existing guidelines for QoL research. Field testing was carried out using clinical trials that either received an adjustment of the preliminary ESMO-MCBS score based on QoL or had QoL as the primary endpoint. Several rounds of revision and re-testing of the checklist were undertaken until a final consensus was reached. Results: The final checklist consists of four items and can be applied if three prerequisites are met: (i) QoL is at least a secondary endpoint, (ii) evidence of reliability and validity of the instrument is provided, and (iii) a statistically and clinically significant improvement in QoL is observed. The four items on the checklist pertain to the (i) hypothesis, (ii) compliance and missing data, (iii) presentation of the results, and (iv) statistical and clinical relevance. Field testing revealed that a clear QoL hypothesis and correction for multiple testing were mostly lacking, while the main statistical method was always described. Conclusions: Implementation of the ESMO-MCBS QoL checklist will facilitate objective and transparent decision making on QoL data within the ESMO-MCBS scoring process. Trials published until 1 January 2025 will have to meet the prerequisites and at least two items for crediting QoL benefit in the final ESMO-MCBS score. Trials published thereafter will have to meet all four items.

Published
2023

13. ESMO-Magnitude of Clinical Benefit Scale for haematological malignancies (ESMO-MCBS:H) version 1.0

Author

Kiesewetter, B, Dafni, U, de Vries, EGE, Barriuso, J, Curigliano, G, González-Calle, V, Galotti, M, Gyawali, B, Huntly, BJP, Jäger, U, Latino, NJ, Malcovati, L, Oosting, SF, Ossenkoppele, G, Piccart, M, Raderer, M, Scarfò, L, Trapani, D, Zielinski, CC, Wester, R, Zygoura, P, Macintyre, E, Cherny, NI, ESMO-MCBS Working Group and Extended Working Group, Huntly, Brian [0000-0003-0312-161X], and Apollo - University of Cambridge Repository

Subjects
clinical trials, quality of life, clinical benefit, ESMO-MCBS, haematological malignancies, value frameworks
Abstract

BACKGROUND: The European Society for Medical Oncology (ESMO)-Magnitude of Clinical Benefit Scale (MCBS) has been accepted as a robust tool to evaluate the magnitude of clinical benefit reported in trials for oncological therapies. However, the ESMO-MCBS hitherto has only been validated for solid tumours. With the rapid development of novel therapies for haematological malignancies, we aimed to develop an ESMO-MCBS version that is specifically designed and validated for haematological malignancies. METHODS: ESMO and the European Hematology Association (EHA) initiated a collaboration to develop a version for haematological malignancies (ESMO-MCBS:H). The process incorporated five landmarks: field testing of the ESMO-MCBS version 1.1 (v1.1) to identify shortcomings specific to haematological diseases, drafting of the ESMO-MCBS:H forms, peer review and revision of the draft based on re-scoring (resulting in a second draft), assessment of reasonableness of the scores generated, final review and approval by ESMO and EHA including executive boards. RESULTS: Based on the field testing results of 80 haematological trials and extensive review for feasibility and reasonableness, five amendments to ESMO-MCBS were incorporated in the ESMO-MCBS:H addressing the identified shortcomings. These concerned mainly clinical trial endpoints that differ in haematology versus solid oncology and the very indolent nature of nevertheless incurable diseases such as follicular lymphoma, which hampers presentation of mature data. In addition, general changes incorporated in the draft version of the ESMO-MCBS v2 were included, and specific forms for haematological malignancies generated. Here we present the final approved forms of the ESMO-MCBS:H, including instructions. CONCLUSION: The haematology-specific version ESMO-MCBS:H allows now full applicability of the scale for evaluating the magnitude of clinical benefit derived from clinical studies in haematological malignancies.

Published
2023
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15. Obesity-associated changes in molecular biology of primary breast cancer.

Author

Nguyen, H.L., Geukens, T., Maetens, M., Aparicio, S., Bassez, A., Borg, A., Brock, J., Broeks, A., Caldas, C., Cardoso, F., Schepper, M. De, Delorenzi, M., Drukker, C.A., Glas, A.M., Green, A.R., Isnaldi, E., Eyfjörð, J., Khout, H., Knappskog, S., Krishnamurthy, S., Lakhani, S.R., Langerod, A., Martens, J.W.M., McCart Reed, A.E., Murphy, L., Naulaerts, S., Nik-Zainal, S., Nevelsteen, I., Neven, P., Piccart, M., Poncet, C., Punie, K., Purdie, C., Rakha, E.A., Richardson, A., Rutgers, E., Vincent-Salomon, A., Simpson, P.T., Schmidt, M.K., Sotiriou, C., Span, P.N., Tan, K.T.B., Thompson, A., Tommasi, S., Baelen, K. van, Vijver, M. van de, Laere, S. van, n't Veer, L. va, Viale, G., Viari, A., Vos, H., Witteveen, A.T., Wildiers, H., Floris, G., Garg, A.D., Smeets, Ann, Lambrechts, D., Biganzoli, E., Richard, F., Desmedt, C., Nguyen, H.L., Geukens, T., Maetens, M., Aparicio, S., Bassez, A., Borg, A., Brock, J., Broeks, A., Caldas, C., Cardoso, F., Schepper, M. De, Delorenzi, M., Drukker, C.A., Glas, A.M., Green, A.R., Isnaldi, E., Eyfjörð, J., Khout, H., Knappskog, S., Krishnamurthy, S., Lakhani, S.R., Langerod, A., Martens, J.W.M., McCart Reed, A.E., Murphy, L., Naulaerts, S., Nik-Zainal, S., Nevelsteen, I., Neven, P., Piccart, M., Poncet, C., Punie, K., Purdie, C., Rakha, E.A., Richardson, A., Rutgers, E., Vincent-Salomon, A., Simpson, P.T., Schmidt, M.K., Sotiriou, C., Span, P.N., Tan, K.T.B., Thompson, A., Tommasi, S., Baelen, K. van, Vijver, M. van de, Laere, S. van, n't Veer, L. va, Viale, G., Viari, A., Vos, H., Witteveen, A.T., Wildiers, H., Floris, G., Garg, A.D., Smeets, Ann, Lambrechts, D., Biganzoli, E., Richard, F., and Desmedt, C.

Abstract

Item does not contain fulltext, Obesity is associated with an increased risk of developing breast cancer (BC) and worse prognosis in BC patients, yet its impact on BC biology remains understudied in humans. This study investigates how the biology of untreated primary BC differs according to patients' body mass index (BMI) using data from >2,000 patients. We identify several genomic alterations that are differentially prevalent in overweight or obese patients compared to lean patients. We report evidence supporting an ageing accelerating effect of obesity at the genetic level. We show that BMI-associated differences in bulk transcriptomic profile are subtle, while single cell profiling allows detection of more pronounced changes in different cell compartments. These analyses further reveal an elevated and unresolved inflammation of the BC tumor microenvironment associated with obesity, with distinct characteristics contingent on the estrogen receptor status. Collectively, our analyses imply that obesity is associated with an inflammaging-like phenotype. We conclude that patient adiposity may play a significant role in the heterogeneity of BC and should be considered for BC treatment tailoring.

Published
2023

19. LBA17 Primary endpoint results of SYNERGY, a randomized phase II trial, first-line chemo-immunotherapy trial of durvalumab, paclitaxel, and carboplatin with or without the anti-CD73 antibody oleclumab in patients with advanced or metastatic triple-negative breast cancer (TNBC)

Author

Buisseret, L., primary, Loirat, D., additional, Aftimos, P.G., additional, Punie, K., additional, Maurer, C., additional, Debien, V., additional, Goncalves, A., additional, Ghiringhelli, F., additional, Taylor, D., additional, Clatot, F., additional, van den Mooter, T.F.A., additional, Ferrero, J-M., additional, Bonnefoi, H., additional, Canon, J-L., additional, Duhoux, F.P., additional, Bazan, F., additional, Kristanto, P., additional, de Azambuja, E., additional, Ignatiadis, M., additional, and Piccart, M., additional

Published
2022
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21. 139MO Identification of biologically-driven HER2-positive breast cancer subgroups associated with prognosis after adjuvant trastuzumab in the ALTTO trial

Author

Rediti, M., primary, Venet, D., additional, Joaquin Garcia, A., additional, Agbor-tarh, D., additional, Maetens, M., additional, Vincent, D., additional, Majjaj, S., additional, El-Abed, S., additional, Liu, M.C., additional, Di Cosimo, S., additional, Piccart, M., additional, Pusztai, L., additional, Loi, S., additional, Salgado, R.F., additional, Viale, G., additional, Rothé, F., additional, and Sotiriou, C., additional

Published
2022
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22. VP6-2022: Adjuvant pertuzumab and trastuzumab in patients with early HER-2 positive breast cancer in APHINITY: 8.4 years' follow-up

Author

Loibl, S., primary, Jassem, J., additional, Sonnenblick, A., additional, Parlier, D., additional, Winer, E., additional, Bergh, J., additional, Gelber, R.D., additional, Restuccia, E., additional, Im, Y-H., additional, Huang, C., additional, Dalenc, F., additional, Calvo, I., additional, Procter, M., additional, Caballero, C., additional, Clark, E., additional, Gomez Moreno, H.L., additional, Bliss, J., additional, Viale, G., additional, Bines, J., additional, and Piccart, M., additional

Published
2022
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25. Pathological complete response after neoadjuvant chemotherapy is an independent predictive factor irrespective of simplified breast cancer intrinsic subtypes: a landmark and two-step approach analyses from the EORTC 10994/BIG 1-00 phase III trial

Author

Bonnefoi, H., Litière, S., Piccart, M., MacGrogan, G., Fumoleau, P., Brain, E., Petit, T., Rouanet, P., Jassem, J., Moldovan, C., Bodmer, A., Zaman, K., Cufer, T., Campone, M., Luporsi, E., Malmström, P., Werutsky, G., Bogaerts, J., Bergh, J., and Cameron, D.A.

Published
2014
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27. The current and future role of the medical oncologist in the professional care for cancer patients: a position paper by the European Society for Medical Oncology (ESMO)

Author

Popescu, R.A., Schäfer, R., Califano, R., Eckert, R., Coleman, R., Douillard, J.-Y., Cervantes, A., Casali, P.G., Sessa, C., Van Cutsem, E., de Vries, E., Pavlidis, N., Fumasoli, K., Wörmann, B., Samonigg, H., Cascinu, S., Cruz Hernández, J.J., Howard, A.J., Ciardiello, F., Stahel, R.A., and Piccart, M.

Published
2014
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29. 3rd ESO–ESMO International Consensus Guidelines for Advanced Breast Cancer (ABC 3)

Author

Cardoso, F, Costa, A, Senkus, E, Aapro, M, André, F, Barrios, C H, Bergh, J, Bhattacharyya, G, Biganzoli, L, Cardoso, M J, Carey, L, Corneliussen-James, D, Curigliano, G, Dieras, V, El Saghir, N, Eniu, A, Fallowfield, L, Fenech, D, Francis, P, Gelmon, K, Gennari, A, Harbeck, N, Hudis, C, Kaufman, B, Krop, I, Mayer, M, Meijer, H, Mertz, S, Ohno, S, Pagani, O, Papadopoulos, E, Peccatori, F, Penault-Llorca, F, Piccart, M J, Pierga, J Y, Rugo, H, Shockney, L, Sledge, G, Swain, S, Thomssen, C, Tutt, A, Vorobiof, D, Xu, B, Norton, L, and Winer, E

Published
2017
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31. Male Breast Cancer

Author

Bernard-Marty, C., Azambuja, E., Dal Lago, L., Piccart, M. J., Cardoso, F., Piccart, Martine J., editor, Hung, Mien-Chie, editor, Solin, Lawrence J., editor, Cardoso, Fatima, editor, and Wood, William C., editor

Published
2006
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33. 69P Impact of statin use on survival outcomes of patients with HER2-positive early breast cancer in the APHINITY trial

Author

Maurer, C., primary, Agostinetto, E., additional, Ameye, L., additional, Lambertini, M., additional, Martel, S., additional, Ponde, N.F., additional, Brandão, M., additional, Poggio, F., additional, Ferreira, A.R., additional, Schiff, R., additional, De Angelis, C., additional, Gelber, R.D., additional, Dent, S., additional, Thomssen, C., additional, Piccart, M., additional, and de Azambuja, E., additional

Published
2022
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34. 98P Neo-CheckRay, radiation therapy and adenosine pathway blockade to potentiate benefit of immuno-chemotherapy in early stage luminal B breast cancer: Results of the safety run-in phase

Author

De Caluwe, A., primary, Romano, E., additional, Poortmans, P., additional, Gombos, A., additional, Laragione, A., additional, Agostinetto, E., additional, Nader Marta, G., additional, Picchia, S., additional, Vandekerkhove, C., additional, Ameye, L., additional, Craciun, L., additional, Veys, I., additional, Van Gestel, D., additional, Larsimont, D., additional, Sotiriou, C., additional, Piccart, M., additional, Ignatiadis, M., additional, and Buisseret, L., additional

Published
2022
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36. Tumor infiltrating lymphocyte stratification of prognostic staging of early-stage triple negative breast cancer

Author

Loi, S, Salgado, R, Adams, S, Pruneri, G, Francis, PA, Lacroix-Triki, M, Joensuu, H, Dieci, MV, Badve, S, Demaria, S, Gray, R, Munzone, E, Drubay, D, Lemonnier, J, Sotiriou, C, Kellokumpu-Lehtinen, PL, Vingiani, A, Gray, K, Andre, F, Denkert, C, Piccart, M, Roblin, E, Michiels, S, Loi, S, Salgado, R, Adams, S, Pruneri, G, Francis, PA, Lacroix-Triki, M, Joensuu, H, Dieci, MV, Badve, S, Demaria, S, Gray, R, Munzone, E, Drubay, D, Lemonnier, J, Sotiriou, C, Kellokumpu-Lehtinen, PL, Vingiani, A, Gray, K, Andre, F, Denkert, C, Piccart, M, Roblin, E, and Michiels, S

Abstract

The importance of integrating biomarkers into the TNM staging has been emphasized in the 8th Edition of the American Joint Committee on Cancer (AJCC) Staging system. In a pooled analysis of 2148 TNBC-patients in the adjuvant setting, TILs are found to strongly up and downstage traditional pathological-staging in the Pathological and Clinical Prognostic Stage Groups from the AJJC 8th edition Cancer Staging System. This suggest that clinical and research studies on TNBC should take TILs into account in addition to stage, as for example patients with stage II TNBC and high TILs have a better outcome than patients with stage I and low TILs.

Published
2022

37. Overall survival in the OlympiA phase Ill trial of adjuvant olaparib in patients with germime pathogenic variants in BRCA1/2 and high-risk, early breast cancer

Author

Geyer, C. E., Jr., Garber, J. E., Gelber, R. D., Yothers, G., Taboada, M., Ross, L., Rastogi, P., Cui, K., Arahmani, A., Aktan, G., Armstrong, A. C., Arnedos, M., Balmana, J., Bergh, J., Bliss, J., Delaloge, S., Domchek, S. M., Eisen, A., Elsafy, F., Fein, L. E., Fielding, A., Ford, J. M., Friedman, S., Gelmon, K. A., Gianni, L., Gnant, M., Hollingsworth, S. J., Im, S-A, Jager, A., Lakhani, S. R., Janni, W., Linderholm, B., Liu, T-W, Loman, N., Korde, L., Loibl, S., Lucas, P. C., Marme, F., de Duenas, E. Martinez, McConnell, R., Phillips, K-A, Piccart, M., Rossi, G., Schmutzler, R., Senkus, E., Shao, Z., Sharma, P., Singer, C. F., Spanic, T., Stickeler, E., Toi, M., Traina, T. A., Viale, G., Zoppoli, G., Park, Y. H., Yerushalmi, R., Yang, H., Pang, D., Jung, K. H., Mailliez, A., Fan, Z., Tennevet, I, Zhang, J., Nagy, T., Sonke, G. S., Sun, Q., Parton, M., Colleoni, M. A., Schmidt, M., Brufsky, A. M., Razaq, W., Kaufman, B., Cameron, D., Campbell, C., Tutt, A. N. J., Johannsson, O. Th, Geyer, C. E., Jr., Garber, J. E., Gelber, R. D., Yothers, G., Taboada, M., Ross, L., Rastogi, P., Cui, K., Arahmani, A., Aktan, G., Armstrong, A. C., Arnedos, M., Balmana, J., Bergh, J., Bliss, J., Delaloge, S., Domchek, S. M., Eisen, A., Elsafy, F., Fein, L. E., Fielding, A., Ford, J. M., Friedman, S., Gelmon, K. A., Gianni, L., Gnant, M., Hollingsworth, S. J., Im, S-A, Jager, A., Lakhani, S. R., Janni, W., Linderholm, B., Liu, T-W, Loman, N., Korde, L., Loibl, S., Lucas, P. C., Marme, F., de Duenas, E. Martinez, McConnell, R., Phillips, K-A, Piccart, M., Rossi, G., Schmutzler, R., Senkus, E., Shao, Z., Sharma, P., Singer, C. F., Spanic, T., Stickeler, E., Toi, M., Traina, T. A., Viale, G., Zoppoli, G., Park, Y. H., Yerushalmi, R., Yang, H., Pang, D., Jung, K. H., Mailliez, A., Fan, Z., Tennevet, I, Zhang, J., Nagy, T., Sonke, G. S., Sun, Q., Parton, M., Colleoni, M. A., Schmidt, M., Brufsky, A. M., Razaq, W., Kaufman, B., Cameron, D., Campbell, C., Tutt, A. N. J., and Johannsson, O. Th

Abstract

Background: The randomized, double-blind OlympiA trial compared 1 year of the oral poly(adenosine diphosphate-ribose) polymerase inhibitor, olaparib, to matching placebo as adjuvant therapy for patients with pathogenic or likely pathogenic variants in germline BRCA1 or BRCA2 (gBRCA1/2pv) and high-risk, human epidermal growth factor receptor 2-negative, early breast cancer (EBC). The first pre-specified interim analysis (IA) previously demonstrated statistically significant improvement in invasive disease-free survival (IDFS) and distant disease-free survival (DDFS). The olaparib group had fewer deaths than the placebo group, but the difference did not reach statistical significance for overall survival (OS). We now report the pre-specified second IA of OS with updates of IDFS, DDFS, and safety. Patients and methods: One thousand eight hundred and thirty-six patients were randomly assigned to olaparib or placebo following (neo)adjuvant chemotherapy, surgery, and radiation therapy if indicated. Endocrine therapy was given concurrently with study medication for hormone receptor-positive cancers. Statistical significance for OS at this IA required P < 0.015. Results: With a median follow-up of 3.5 years, the second IA of OS demonstrated significant improvement in the olaparib group relative to the placebo group [hazard ratio 0.68; 98.5% confidence interval (CI) 0.47-0.97; P = 0.009]. Four-year OS was 89.8% in the olaparib group and 86.4% in the placebo group (Delta 3.4%, 95% CI -0.1% to 6.8%). Four-year IDFS for the olaparib group versus placebo group was 82.7% versus 75.4% (Delta 7.3%, 95% CI 3.0% to 11.5%) and 4-year DDFS was 86.5% versus 79.1% (Delta 7.4%, 95% CI 3.6% to 11.3%), respectively. Subset analyses for OS, IDFS, and DDFS demonstrated benefit across major subgroups. No new safety signals were identified including no new cases of acute myeloid leukemia or myelodysplastic syndrome. Conclusion: With 35 years of median follow-up, OlympiA demonstrates statistical

Published
2022

38. Primary endpoint results of SYNERGY, a randomized phase II trial, first-line chemo-immunotherapy trial of durvalumab, paclitaxel, and carboplatin with or without the anti-CD73 antibody oleclumab in patients with advanced or metastatic triple-negative breast cancer (TNBC)

Author

Buisseret, L., Loirat, D., Aftimos, P. G., Punie, K., Maurer, C., Debien, V., Goncalves, A., Ghiringhelli, F., Taylor, D., Clatot, F., van den Mooter, T. F. A., Ferrero, J-M., Bonnefoi, H., Canon, J-L., Duhoux, F. P., Bazan, F., Kristanto, P., de Azambuja, E., Ignatiadis, M., Piccart, M., Buisseret, L., Loirat, D., Aftimos, P. G., Punie, K., Maurer, C., Debien, V., Goncalves, A., Ghiringhelli, F., Taylor, D., Clatot, F., van den Mooter, T. F. A., Ferrero, J-M., Bonnefoi, H., Canon, J-L., Duhoux, F. P., Bazan, F., Kristanto, P., de Azambuja, E., Ignatiadis, M., and Piccart, M.

Published
2022

39. Impact of statin use on survival outcomes of patients with HER2-positive early breast cancer in the APHINITY trial

Author

Maurer, C., Agostinetto, E., Ameye, L., Lambertini, M., Martel, S., Ponde, N. F., Brandao, M., Poggio, F., Ferreira, A. R., Schiff, R., De Angelis, C., Gelber, R. D., Dent, S., Thomssen, C., Piccart, M., de Azambuja, E., Maurer, C., Agostinetto, E., Ameye, L., Lambertini, M., Martel, S., Ponde, N. F., Brandao, M., Poggio, F., Ferreira, A. R., Schiff, R., De Angelis, C., Gelber, R. D., Dent, S., Thomssen, C., Piccart, M., and de Azambuja, E.

Published
2022

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

Author

El Bairi, K., Haynes, H. R., Blackley, E., Fineberg, S., Shear, J., Turner, S., de Freitas, J. R., Sur, D., Amendola, L. C., Gharib, M., Kallala, A., Arun, I., Azmoudeh-Ardalan, F., Fujimoto, L., Sua, L. F., 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, J. F., Rapoport, B. L., Castaneda, C., Spengler, E., Acosta-Haab, G., Frahm, I., Sanchez, J., Castillo, M., Bouchmaa, N., Md Zin, R. R., Shui, R., Onyuma, T., Husain, Z., Willard-Gallo, K., Coosemans, A., Perez, E. A., Provenzano, E., Ericsson, P. G., Richardet, E., Mehrotra, R., Sarancone, S., Ehinger, A., Rimm, D. L., Bartlett, J. M. S., Viale, G., Denkert, C., Hida, A. I., Sotiriou, C., Loibl, S., Hewitt, S. M., Badve, S., Symmans, W. F., Kim, R. S., Pruneri, G., Goel, S., Francis, P. A., Inurrigarro, G., Yamaguchi, R., Garcia-Rivello, H., Horlings, H., Afqir, S., Salgado, R., Adams, S., Kok, M., Dieci, M. V., Michiels, S., Demaria, S., Loi, S., Schelfhout, V., Arbzadeh, E., Bondanar, A., Reyes, S. A. G., Ruz, J. R., Kang, J., Xiang, L., Zimovjanova, M., Togores, P., Ozturk, T., Patil, A., Corpa, M., Whitehouse, A., Tan, B., de Paula, A., Rossetti, C., Lang-Schwarz, C., Mahon, S., Giacometti, C., Linderholm, B., Deman, F., Montagna, G., Gong, G., Pavcovich, M., Chaer, Y., Cabrero, I. A., de Brito, M. L., Ilieva, N., Fulop, A., Souza, M., Bilancia, D., Idowu, M., Johri, R., Szpor, J., Bachani, L., Schmitt, F., Giannotti, M., Kurebayashi, Y., Ramirez, B. E. A., Salido, E., Bortesi, L., Bonetto, S., Elomina, K., Lopez, P., Sharma, V., Edirisinghe, A., Mathur, D., Sahay, A., Mouloud, M. A., Giang, C. H., Mukolwe, E., Kiruka, E., Samberg, N., Abe, N., Brown, M., Millar, E., X. B., Li, Yuan, Z., Pasupathy, A., Miele, R., Luff, R., e Porfirio, M. M. A., Ajemba, O., Soni, R., Orvieto, E., Dimaio, M., Thomas, J., Merard, R., Subramaniam, M. M., Apolinario, T., Preda, O., Preda, R., Makanga, A., Maior, M. S., Li, L., Saghatchian, M., Saurine, T., Janssen, E., Cochran, J., Vlada, N., Cappellesso, R., Elfer, K., Hollick, M., Desai, S., Oner, G., Schreurs, A., Liu, S., Perera, R., Mercurio, P., Garcia, F., Hosny, K., Matsumoto, H., van Deurzen, C., Bianchini, G., Coban, I., Jahangir, A., Rahman, A., Stover, D., Luz, P., Martel, A., Waumans, Y., Stenzinger, A., Cortes, J., Dimitrova, P., Nauwelaers, I., Velasco, M., Fan, F., Akturk, G., Firer, M., Roxanis, I., Schneck, M., Wen, H., Cockenpot, V., Konstantinov, A., Calatrava, A., Vidya, M. N., Choi, H. J., Jank, P., Ciinen, A. H., Sabanathan, D., Floris, G., Hoeflmayer, D., Hamada, T., Laudus, N., Grigoriadis, A., Porcellato, I., Acs, B., Miglietta, F., Parrodi, J., Clunie, D., Calhoun, B., F. -I., Lu, Lefevre, A., Tabbarah, S., Tran, W., Garcia-murillas, I., Jelinic, P., Boeckx, C., Souza, S., Cebollero, M. C., Felip, E., Rendon, J. L. S., El Gabry, E., Saltz, J., Bria, E., Garufi, G., Hartman, J., Sebastian, M., Olofsson, H., Kooreman, L., Cucherousset, J., Mathieu, M. -C., Ballesteros-Merino, C., Siziopikou, P., Fong, J., Klein, M., Qulis, I. R. I., Wesseling, J., Bellolio, E., Araya, J. C., Naber, S., Cheang, M., Castellano, I., Ales, A., Laenkholm, A. -V., Kulka, J., Quinn, C., Sapino, A., Amendoeira, I., Marchio, C., Braybrooke, J., Vincent-Salomon, A., Korski, K. P., Sofopoulos, M., Stovgaard, E. I. S., Bianchi, S., Bago-Horvath, Z., Yu, C., Regitnig, P., Hall, S., Kos, Z., Sant, S., Tille, J. -C., Gallas, B., Bethmann, D., Savas, P., Mendes, L., Soler, T., van Seijen, M., Gruosso, T., Quintana, A., Giltnane, J., Van den Eynden, G., Duregon, E., de Cabo, R., Recamo, P. C., Gaboury, L., Zimmerman, J., Pop, C. S., Wernicke, A., Williams, D., Gill, A., Solomon, B., Thapa, B., Farshid, G., Gilham, L., Christie, M., O'Toole, S., Hendry, S., Fox, S. B., Luen, S. J., Lakhani, S. R., Fuchs, T., John, T., Brcic, I., Hainfellner, J., Sigurd, L., Preusser, M., Poortmans, P., Decaluwe, A., Carey, C., Colpaert, C., Larsimont, D., Peeters, D., Broeckx, G., van de Vijver, K., Buisseret, L., Dirix, L., Hertoghs, M., Piccart, M., Ignatiadis, M., Van Bockstal, M., Sirtaine, N., Vermeulen, P., de Wind, R., Declercq, S., Gevaert, T., Haibe-Kans, B., Nelson, B. H., Watson, P. H., Leung, S., Nielsen, T., Shi, L., Balslev, E., Thagaard, J., Almangush, A., Makitie, A., Joensuu, H., Lundin, J., Drubay, D., Roblin, E., Andre, F., Penault-Llorca, F., Lemonnier, J., Adam, J., Lacroix-Triki, M., Ternes, N., Radosevic-Robin, N., Klaushen, F., Weber, K., Harbeck, N., Gluz, O., Wienert, S., Cserni, G., Vingiani, A., Criscitiello, C., Solinas, C., Curigliano, G., Konishi, E., Suzuki, E., Yoshikawa, K., Kawaguchi, K., Takada, M., Toi, M., Ishida, M., Shibata, N., Saji, S., Kogawa, T., Sakatani, T., Okamoto, T., Moriya, T., Kataoka, T., Shimoi, T., Sugie, T., Mukohara, T., Shu, Y., Kikawa, Y., Kozuka, Y., Sayed, S., Rahayu, R., Ramsaroop, R., Senkus-Konefka, E., Chmielik, E., Cardoso, F., Ribeiro, J., Chan, J., Dent, R., Martin, M., Hagen, C., Guerrero, A., Rojo, F., Comerma, L., Nuciforo, P., Serrano, V. V., Camaea, V. P., Steenbruggen, T., Ciompi, F., Nederlof, I., Jan, Hudecek, van der Laak, J., van den Berg, J., Voorwerk, L., van de Vijver, M., de Maaker, M., Linn, S., Mckenzie, H., Somaiah, N., Tutt, A., Swanton, C., Hiley, C., Moore, D. A., Hall, J. A., Le Quesne, J., Jabbar, K. A., al Bakir, M., Hills, R., Irshad, S., Yuan, Y., Li, Z., Liu, M., Klein, J., Fadare, O., Thompson, A., Lazar, A. J., Gown, A., Lo, A., Garrido Castro, A. C., Madabhushi, A., Moreira, A., Richardson, A., Beck, A. H., Bellizzi, A. M., Wolff, A., Harbhajanka, A., Sharma, A., Cimino-Mathews, A., Srinivasan, A., Singh, B., Chennubhotla, C. S., Chauhan, C., Dillon, D. A., Zardavas, D., Johnson, D. B., Thompson, A. E., Brogi, E., Reisenbichler, E., Huang, E., Hirsch, F. R., Mcarthur, H., Ziai, J., Brock, J., Kerner, J., Zha, J., Lennerz, J. K., Carter, J. M., Reis-Filho, J., Sparano, J., Balko, J. M., Pogue-Geile, K., Steele, K. E., Blenman, K. R. M., Allison, K. H., Pusztai, L., Cooper, L., Estrada, V. M., Flowers, M., Robson, M., Rebelatto, M. C., Hanna, M. G., Goetz, M. P., Khojasteh, M., Sanders, M. E., Regan, M. M., Misialek, M., Amgad, M., Tung, N., Singh, R., Huang, R., Pierce, R. H., Leon-Ferre, R., Swain, S., Ely, S., Kim, S. -R., Bedri, S., Paik, S., Schnitt, S., D'Alfons, T., Kurkure, U., Bossuyt, V., Tong, W., Wang, Y., Dos Anjos, C. H., Gaire, F., Van Diest, P. J., El Bairi, Khalid [0000-0002-8414-4145], de Freitas, Juliana Ribeiro [0000-0003-4978-7273], Sur, Daniel [0000-0002-0926-4614], Amendola, Luis Claudio [0000-0002-6404-450X], Azmoudeh-Ardalan, Farid [0000-0003-4701-0532], Kirtani, Pawan [0000-0002-2343-7016], Yang, Wenxian [0000-0002-5349-9680], Castillo, Miluska [0000-0002-0111-3176], Provenzano, Elena [0000-0003-3345-3965], Mehrotra, Ravi [0000-0001-9453-1408], Ehinger, Anna [0000-0001-9225-7396], Rimm, David L [0000-0001-5820-4397], Bartlett, John MS [0000-0002-0347-3888], Denkert, Carsten [0000-0002-2249-0982], Hida, Akira I [0000-0002-4486-8819], Sotiriou, Christos [0000-0002-5745-9977], Hewitt, Stephen M [0000-0001-8283-1788], Badve, Sunil [0000-0001-8861-9980], Symmans, William Fraser [0000-0002-1526-184X], Goel, Shom [0000-0001-8329-9084], Francis, Prudence A [0000-0002-7207-9286], Horlings, Hugo [0000-0003-4782-8828], Salgado, Roberto [0000-0002-1110-3801], Demaria, Sandra [0000-0003-4426-0499], Loi, Sherene [0000-0001-6137-9171], Apollo - University of Cambridge Repository, UCL - SSS/IREC/SLUC - Pôle St.-Luc, UCL - (SLuc) Service d'anatomie pathologique, Imagerie Moléculaire et Stratégies Théranostiques (IMoST), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Clermont Auvergne (UCA), Centre Jean Perrin [Clermont-Ferrand] (UNICANCER/CJP), and UNICANCER

Subjects
Oncology, medicine.medical_treatment, [SDV]Life Sciences [q-bio], TRASTUZUMAB, Improved survival, MICROENVIRONMENT, Review Article, SUBTYPES, NEOADJUVANT CHEMOTHERAPY, 0302 clinical medicine, Breast cancer, Ecology,Evolution & Ethology, PROGNOSTIC-SIGNIFICANCE, Medicine and Health Sciences, Pharmacology (medical), TUMOR-INFILTRATING LYMPHOCYTES, Stage (cooking), RC254-282, Chemical Biology & High Throughput, 0303 health sciences, Human Biology & Physiology, Genome Integrity & Repair, Neoplasms. Tumors. Oncology. Including cancer and carcinogens, ASSOCIATION, 3. Good health, 030220 oncology & carcinogenesis, Biomarker (medicine), Life Sciences & Biomedicine, Genetics & Genomics, medicine.medical_specialty, chemical and pharmacologic phenomena, International Immuno-Oncology Biomarker Working Group, Predictive markers, 03 medical and health sciences, Signalling & Oncogenes, SDG 3 - Good Health and Well-being, Internal medicine, 692/53/2423, medicine, Radiology, Nuclear Medicine and imaging, In patient, 030304 developmental biology, Computational & Systems Biology, Science & Technology, IDENTIFICATION, business.industry, review-article, Cancer, 03.01. Általános orvostudomány, Immunotherapy, Tumour Biology, medicine.disease, PREDICTIVE-VALUE, 692/4028/67/1347, Programmed death 1, business, FREE SURVIVAL
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. ispartof: NPJ BREAST CANCER vol:7 issue:1 ispartof: location:United States status: published

Published
2021

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