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1,517 results on '"Piccart, M"'

201. Trastuzumab versus observation for HER2 nonamplified early breast cancer with circulating tumor cells (EORTC 90091-10093, BIG 1-12, Treat CTC): a randomized phase II trial

Author

Ignatiadis, M., primary, Litière, S., additional, Rothe, F., additional, Riethdorf, S., additional, Proudhon, C., additional, Fehm, T., additional, Aalders, K., additional, Forstbauer, H., additional, Fasching, P.A., additional, Brain, E., additional, Vuylsteke, P., additional, Guardiola, E., additional, Lorenz, R., additional, Pantel, K., additional, Tryfonidis, K., additional, Janni, W., additional, Piccart, M., additional, Sotiriou, C., additional, Rack, B., additional, and Pierga, J.-Y., additional

Published
2018
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203. Trasutuzumab versus observation for high-risk, non-metastatic, HER2 non-amplified breast cancer with Circulating Tumor Cells (EORTC 90091-10093 Treat CTC): A European, multicenter, randomized phase 2 trial

Author

Ignatiadis, M., primary, Litiere, S., additional, Rothe, F., additional, Riethdorf, S., additional, Proudhon, C., additional, Fehm, T., additional, Aalders, K., additional, Forstbauer, H., additional, Fasching, P., additional, Brain, E., additional, Vuylsteke, P., additional, Guardiola, E., additional, Lorenz, R., additional, Pantel, K., additional, Tryfonidis, K., additional, Janni, W., additional, Piccart, M., additional, Sotiriou, C., additional, Rack, B., additional, and Pierga, J.Y., additional

Published
2018
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204. Abstract OT3-05-08: PALLAS: PALbociclib CoLlaborative Adjuvant Study: A randomized phase 3 trial of palbociclib with standard adjuvant endocrine therapy versus standard adjuvant endocrine therapy alone for HR+/HER2- early breast cancer

Author

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

Published
2018
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206. Abstract P2-09-07: Low levels of HER2 extracellular domain (ECD) compared to intracelluar domain (ICD) in NeoALTTO may segregate benefit from lapatinib and trastuzumab in breast cancer

Author

Rimm, DL, primary, Carvajal-Hausdorf, D, additional, Harbeck, N, additional, Fumagalli, D, additional, Rodrik-Outmezguine, V, additional, delaPena, L, additional, deAzambuja, E, additional, Huober, J, additional, Baselga, J, additional, Piccart, M, additional, Holmes, E, additional, and Pusztai, L, additional

Published
2018
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207. Abstract P2-05-04: Deregulation of A-to-I RNA editing is associated with poor prognosis in HER2+ breast cancers in the neoALTTO trial

Author

Venet, D, primary, Rothé, F, additional, Dupont, F, additional, Maetens, M, additional, Fumagalli, D, additional, Salgado, R, additional, Bradbury, I, additional, Pusztai, L, additional, Harbeck, N, additional, Izquierdo, M, additional, de la Pena, L, additional, Ignatiadis, M, additional, de Azambuja, E, additional, Huober, J, additional, Nuciforo, P, additional, Baselga, J, additional, Piccart, M, additional, Loi, S, additional, and Sotiriou, C, additional

Published
2018
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208. Abstract PD3-03: Circulating tumor DNA in HER2 amplified breast cancer: A translational research substudy of the NeoALTTO phase 3 trial

Author

Ignatiadis, M, primary, Silva, MJ, additional, Campbell, C, additional, Bradbury, I, additional, de Azambuja, E, additional, Maetens, M, additional, Fumagalli, D, additional, Rodrik-Outmezguine, V, additional, Di Cosimo, S, additional, Rosa, D, additional, Chia, S, additional, Wardley, A, additional, Ueno, T, additional, Janni, W, additional, Huober, J, additional, Baselga, J, additional, Piccart, M, additional, Sotiriou, C, additional, Loi, S, additional, Rothé, F, additional, and Dawson, S, additional

Published
2018
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209. Abstract P1-07-02: Withdrawn

Author

Rutgers, E, primary, Aalders, K, additional, Poncet, C, additional, Bogaerts, J, additional, Delaloge, S, additional, Rubio, I, additional, Thompson, A, additional, Tryfonidis, K, additional, van 't Veer, L, additional, Piccart, M, additional, and Cardoso, F, additional

Published
2018
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210. Abstract P1-13-07: Incidence and management of diarrhea with adjuvant pertuzumab and trastuzumab in HER2-Positive breast cancer

Author

Bines, J, primary, de Azambuja, E, additional, Zardavas, D, additional, Procter, M, additional, Restuccia, E, additional, Viale, G, additional, Suter, T, additional, Arahmani, A, additional, van Dooren, V, additional, Clark, E, additional, Eng-Wong, J, additional, Gelber, R, additional, Piccart, M, additional, von Minckwitz, G, additional, and Baselga, J, additional

Published
2018
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211. Abstract GS1-04: Copy number aberration analysis to predict response to neoadjuvant anti-HER2 therapy: Results from the NeoALTTO phase III trial

Author

Sotiriou, C, primary, Rothé, F, additional, Maetens, M, additional, Fumagalli, D, additional, Brown, DN, additional, Salgado, R, additional, Bradbury, I, additional, Pusztai, L, additional, Harbeck, N, additional, Ignatiadis, M, additional, Sarp, S, additional, de la Pena, L, additional, de Azambuja, E, additional, Huober, J, additional, Nuciforo, P, additional, Baselga, J, additional, Piccart, M, additional, Loi, S, additional, and Venet, D, additional

Published
2018
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213. Abstract P1-07-15: Withdrawn

Author

Desmedt, C, primary, Fornili, M, additional, Poncet, C, additional, Clatot, F, additional, Orenti, A, additional, Boracchi, P, additional, Di Leo, A, additional, Viale, G, additional, de Azambuja, E, additional, Sotiriou, C, additional, Crown, J, additional, Francis, PA, additional, Bonnefoi, H, additional, Piccart, M, additional, and Biganzoli, E, additional

Published
2018
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214. Abstract PD5-04: Ki67 changes and PEPI score in the LORELEI trial: A phase II randomized, double-blind study of neoadjuvant letrozole plus taselisib versus letrozole plus placebo in postmenopausal women with ER-positive/HER2-negative early-stage breast cancer

Author

de Azambuja, E, primary, Saura, C, additional, Nuciforo, P, additional, Frantal, S, additional, Oliveira, M, additional, Zardavas, D, additional, Jallitsch-Halper, A, additional, de la Pena, L, additional, Dubsky, P, additional, Lombard, JM, additional, Vuylsteke, P, additional, Castaneda Altamirano, C, additional, Sanchez, C, additional, Ballestrero, A, additional, Colleoni, M, additional, Santos Borges, G, additional, Ciruelos, E, additional, Bardia, A, additional, Fornier, M, additional, Boer, K, additional, Wilson, TR, additional, Stout, TJ, additional, Hsu, JY, additional, Shi, Y, additional, Piccart, M, additional, Baselga, J, additional, and Gnant, M, additional

Published
2018
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215. Abstract P2-09-03: Identifying clinically relevant subgroups of women with HER2-positive breast cancer: An analysis of Neo-ALTTO using the 41-gene TRAR score

Author

Di Cosimo, S, primary, Triulzi, T, additional, De Cecco, L, additional, Pizzamiglio, S, additional, de Azambuja, E, additional, Fumagalli, D, additional, Pusztai, L, additional, Harbeck, N, additional, Izquierdo, M, additional, de la Pena, L, additional, Huober, J, additional, Baselga, J, additional, Piccart, M, additional, Verderio, P, additional, and Tagliabue, E, additional

Published
2018
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217. Abstract P1-13-09: Withdrawn

Author

Ignatiadis, M, primary, Litiere, S, additional, Rothe, F, additional, Riethdorf, S, additional, Proudhon, C, additional, Fehm, T, additional, Aalders, K, additional, Forstbauer, H, additional, Fasching, P, additional, Brain, E, additional, Vuylsteke, P, additional, Guardiola, E, additional, Lorenz, R, additional, Pantel, K, additional, Tryfonidis, K, additional, Janni, W, additional, Piccart, M, additional, Sotiriou, C, additional, Rack, B, additional, and Pierga, J-Y, additional

Published
2018
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219. The AURORA pilot study for molecular screening of patients with advanced breast cancer-a study of the breast international group

Author

Maetens, M, Brown, D, Irrthum, A, Aftimos, P, Viale, G, Loibl, S, Laes, J-F, Campbell, PJ, Thompson, A, Cortes, J, Seiler, S, Vinnicombe, S, Oliveira, M, Rothe, F, Bareche, Y, Fumagalli, D, Zardavas, D, Desmedt, C, Piccart, M, Loi, S, Sotiriou, C, Maetens, M, Brown, D, Irrthum, A, Aftimos, P, Viale, G, Loibl, S, Laes, J-F, Campbell, PJ, Thompson, A, Cortes, J, Seiler, S, Vinnicombe, S, Oliveira, M, Rothe, F, Bareche, Y, Fumagalli, D, Zardavas, D, Desmedt, C, Piccart, M, Loi, S, and Sotiriou, C

Abstract

Several studies have demonstrated the feasibility of molecular screening of tumour samples for matching patients with cancer to targeted therapies. However, most of them have been carried out at institutional or national level. Herein, we report on the pilot phase of AURORA (NCT02102165), a European multinational collaborative molecular screening initiative for advanced breast cancer patients. Forty-one patients were prospectively enroled at four participating centres across Europe. Metastatic tumours were biopsied and profiled using an Ion Torrent sequencing platform at a central facility. Sequencing results were obtained for 63% of the patients in real-time with variable turnaround time stemming from delays between patient consent and biopsy. At least one clinically actionable mutation was identified in 73% of patients. We used the Illumina sequencing technology for orthogonal validation and achieved an average of 66% concordance of substitution calls per patient. Additionally, copy number aberrations inferred from the Ion Torrent sequencing were compared to single nucleotide polymorphism arrays and found to be 59% concordant on average. Although this study demonstrates that powerful next generation genomic techniques are logistically ready for international molecular screening programs in routine clinical settings, technical challenges remain to be addressed in order to ensure the accuracy and clinical utility of the genomic data.

Published
2017

220. 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., Piccart, M., 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.

Abstract

The number of cancer patients in Europe is rising and significant advances in basic and applied cancer research are making the provision of optimal care more challenging. The concept of cancer as a systemic, highly heterogeneous and complex disease has increased the awareness that quality cancer care should be provided by a multidisciplinary team (MDT) of highly qualified healthcare professionals. Cancer patients also have the right to benefit from medical progress by receiving optimal treatment from adequately trained and highly skilled medical professionals. Built on the highest standards of professional training and continuing medical education, medical oncology is recognised as an independent medical specialty in many European countries. Medical oncology is a core member of the MDT and offers cancer patients a comprehensive and systemic approach to treatment and care, while ensuring evidence-based, safe and cost-effective use of cancer drugs and preserving the quality of life of cancer patients through the entire ‘cancer journey'. Medical oncologists are also engaged in clinical and translational research to promote innovation and new therapies and they contribute to cancer diagnosis, prevention and research, making a difference for patients in a dynamic, stimulating professional environment. Medical oncologists play an important role in shaping the future of healthcare through innovation and are also actively involved at the political level to ensure a maximum contribution of the profession to Society and to tackle future challenges. This position paper summarises the multifarious and vital contributions of medical oncology and medical oncologists to today's and tomorrow's professional cancer care

Published
2017

221. 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., Cameron, D. A., 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.

Abstract

The present analysis, carried out in the context of a randomized phase III trial, confirms superior outcomes for breast cancer patients for whom chemotherapy induces pathological complete response (pCR) after adjusting for other important prognostic factors. In contrast, when tumours do not achieve pCR, patients have a higher risk of relapse. This effect is observed in all intrinsic subtypes and justifies the current interest in post-neoadjuvant trials

Published
2017

222. Doxorubicin versus doxorubicin and cisplatin in endometrial carcinoma: definitive results of a randomised study (55872) by the EORTC Gynaecological Cancer Group

Author

Aapro, M. S., van Wijk, F. H., Bolis, G., Chevallier, B., van der Burg, M. E. L., Poveda, A., de Oliveira, C. F., Tumolo, S., Scotto di Palumbo, V., Piccart, M., Franchi, M., Zanaboni, F., Lacave, A. J., Fontanelli, R., Favalli, G., Zola, P., Guastalla, J. P., Rosso, R., Marth, C., Nooij, M., Presti, M., Scarabelli, C., Splinter, T. A. W., Ploch, E., Beex, L. V. A., ten Bokkel Huinink, W., Forni, M., Melpignano, M., Blake, P., Kerbrat, P., Mendiola, C., Cervantes, A., Goupil, A., Harper, P. G., Madronal, C., Namer, M., Scarfone, G., Stoot, J. E. G. M., Teodorovic, I., Coens, C., Vergote, I., Vermorken, J. B., Aapro, M. S., van Wijk, F. H., Bolis, G., Chevallier, B., van der Burg, M. E. L., Poveda, A., de Oliveira, C. F., Tumolo, S., Scotto di Palumbo, V., Piccart, M., Franchi, M., Zanaboni, F., Lacave, A. J., Fontanelli, R., Favalli, G., Zola, P., Guastalla, J. P., Rosso, R., Marth, C., Nooij, M., Presti, M., Scarabelli, C., Splinter, T. A. W., Ploch, E., Beex, L. V. A., ten Bokkel Huinink, W., Forni, M., Melpignano, M., Blake, P., Kerbrat, P., Mendiola, C., Cervantes, A., Goupil, A., Harper, P. G., Madronal, C., Namer, M., Scarfone, G., Stoot, J. E. G. M., Teodorovic, I., Coens, C., Vergote, I., and Vermorken, J. B.

Abstract

Background: Combination chemotherapy yields better response rates which do not always lead to a survival advantage. The aim of this study was to investigate whether the reported differences in the efficacy and toxicity of monotherapy with doxorubicin (DOX) versus combination therapy with cisplatin (CDDP) in endometrial adenocarcinoma lead to significant advantage in favour of the combination. Patients and methods: Eligible patients had histologically-proven advanced and/or recurrent endometrial adenocarcinoma and were chemo-naïve. Treatment consisted of either DOX 60 mg/m2 alone or CDDP 50 mg/m2 added to DOX 60 mg/m2, every 4 weeks. Results: A total of 177 patients were entered and median follow-up is 7.1 years. The combination DOX-CDDP was more toxic than DOX alone. Haematological toxicity consisted mainly of white blood cell toxicity grade 3 and 4 (55% versus 30%). Non-haematological toxicity consisted mainly of grade 3 and 4 alopecia (72% versus 65%) and nausea/vomiting (36 % versus 12%). The combination DOX-CDDP provided a significantly higher response rate than single agent DOX (P <0.001). Thirty-nine patients (43%) responded on DOX-CDDP [13 complete responses (CRs) and 26 partial responses (PRs)], versus 15 patients (17%) on DOX alone (8 CR and 7 PR). The median overall survival (OS) was 9 months in the DOX-CDDP arm versus 7 months in the DOX alone arm (Wilcoxon P = 0.0654). Regression analysis showed that WHO performance status was statistically significant as a prognostic factor for survival, and stratifying for this factor, treatment effect reaches significance (hazard ratio = 1.46, 95% confidence interval 1.05-2.03, P = 0.024). Conclusions: In comparison to single agent DOX, the combination of DOX-CDDP results in higher but acceptable toxicity. The response rate produced is significantly higher, and a modest survival benefit is achieved with this combination regimen, especially in patients with a good performance status

Published
2017

223. Locally advanced/inflammatory breast cancers treated with intensive epirubicin-based neoadjuvant chemotherapy: are there molecular markers in the primary tumour that predict for 5-year clinical outcome?

Author

Bonnefoi, H., Diebold-Berger, S., Therasse, P., Hamilton, A., van de Vijver, M., MacGrogan, G., Shepherd, L., Amaral, N., Duval, C., Drijkoningen, R., Larsimont, D., Piccart, M., Bonnefoi, H., Diebold-Berger, S., Therasse, P., Hamilton, A., van de Vijver, M., MacGrogan, G., Shepherd, L., Amaral, N., Duval, C., Drijkoningen, R., Larsimont, D., and Piccart, M.

Abstract

Background: Locally advanced and/or inflammatory breast cancer (LABC) is a heterogeneous disease. Molecular markers may help to understand this heterogeneity. This paper reports the results of a study assessing the potential prognostic or predictive value of HER-2, p53, cyclinD1, MIB1, ER and PgR expression by immunohistochemistry from patients included in an EORTC-NCIC-SAKK trial. Patients and methods: A total of 448 patients with a cytological or histological diagnosis of LABC were randomised into a trial comparing two anthracycline-based neoadjuvant regimens. Chemotherapy was followed by standard locoregional therapy. Survival was comparable in both arms. We collected and analysed centrally paraffin-embedded tumour specimens from 187 (72.5%) of 258 patients that had a histological diagnosis. Results: Of the patients included in this molecular marker study 114 relapsed and 91 died. In the multivariate analysis p53 positivity was associated with a shorter progression-free survival [hazard ratio (HR) = 1.96; 95% CI 1.33-2.91; P = 0.0008) and a shorter overall survival (HR = 1.98; 95% CI 1.28-3.06; P = 0.002). PgR positivity predicted for a longer overall survival (HR = 0.54; 95% CI 0.35-0.83; P = 0.0045). Conclusions: p53 was an independent factor predicting for survival. In order to clarify whether p53 is a pure prognostic and/or a predictive factor, a phase III trial is being conducted (EORTC 10994/BIG 00-01 study) using functional assay in yeast from frozen tumour samples

Published
2017

225. N-(Phosphonacetyl)-L-Aspartate (PALA): Current Status

Author

Rozencweig, M., Abele, R., Piccart, M., Von Hoff, D. D., Muggia, F. M., Allfrey, V. G., editor, Allgöwer, M., editor, Berenblum, I., editor, Bergel, F., editor, Bernard, J., editor, Bernhard, W., editor, Blokhin, N. N., editor, Bock, H. E., editor, Braun, W., editor, Bucalossi, P., editor, Chaklin, A. V., editor, Chorazy, M., editor, Cunningham, G. J., editor, Della Porta, G., editor, Denoix, P., editor, Dulbecco, R., editor, Eagle, H., editor, Eker, R., editor, Good, R. A., editor, Grabar, P., editor, Harris, R. J. C., editor, Hecker, E., editor, Herbeuval, R., editor, Higginson, J., editor, Hueper, W. C., editor, Isliker, H., editor, Kieler, J., editor, Kirsten, W. H., editor, Klein, G., editor, Koprowski, H., editor, Koss, L. G., editor, Macbeth, R. A., editor, Martz, G., editor, Mathé, G., editor, Mühlbock, O., editor, Old, L. J., editor, Potter, V. R., editor, Sabin, A. B., editor, Sachs, L., editor, Saxén, E. A., editor, Schmidt, C. G., editor, Spiegelman, S., editor, Szybalski, W., editor, Tagnon, H., editor, Tissières, A., editor, Uehlinger, E., editor, Wissler, R. W., editor, Rentchnick, P., editor, Senn, H. J., editor, Mathé, Georges, editor, and Muggia, Franco M., editor

Published
1980
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226. Analysing data from patient-reported outcome and quality of life endpoints for cancer clinical trials: a start in setting international standards

Author

Bottomley, A., Pe, M., Sloan, J., Basch, E., Bonnetain, F., Calvert, M., Campbell, A., Cleeland, C., Cocks, K., Collette, L., Dueck, A.C., Devlin, N., Flechtner, H.H., Gotay, C., Greimel, E., Griebsch, I., Groenvold, M., Hamel, J.F., King, M., Kluetz, P.G., Koller, M., Malone, D.C., Martinelli, F., Mitchell, S.A., Moinpour, C.M., Musoro, J., O'Connor, D., Oliver, K., Piault-Louis, E., Piccart, M., Pimentel, F.L., Quinten, C., Reijneveld, J.C., Schurmann, C., Smith, A.W., Soltys, K.M., Taphoorn, M.J.B., Velikova, G., Coens, C., Setting Int Stand Analyzing, Neurology, and CCA - Quality of Life

Subjects
medicine.medical_specialty, Clinical Trials as Topic, business.industry, Cancer clinical trial, Alternative medicine, MEDLINE, Cancer, medicine.disease, 03 medical and health sciences, 0302 clinical medicine, Quality of life (healthcare), Oncology, 030220 oncology & carcinogenesis, Family medicine, Neoplasms, medicine, Quality of Life, Humans, Patient-reported outcome, 030212 general & internal medicine, Risks and benefits, Patient Reported Outcome Measures, business, Health policy
Abstract

Measures of health-related quality of life (HRQOL) and other patient-reported outcomes generate important data in cancer randomised trials to assist in assessing the risks and benefits of cancer therapies and fostering patient-centred cancer care. However, the various ways these measures are analysed and interpreted make it difficult to compare results across trials, and hinders the application of research findings to inform publications, product labelling, clinical guidelines, and health policy. To address these problems, the Setting International Standards in Analyzing Patient-Reported Outcomes and Quality of Life Endpoints Data (SISAQOL) initiative has been established. This consortium, directed by the European Organisation for Research and Treatment of Cancer (EORTC), was convened to provide recommendations on how to standardise the analysis of HRQOL and other patient-reported outcomes data in cancer randomised trials. This Personal View discusses the reasons why this project was initiated, the rationale for the planned work, and the expected benefits to cancer research, patient and provider decision making, care delivery, and policy making.

Published
2016

227. Effect of radiotherapy after mastectomy and axillary surgery on 10-year recurrence and 20-year breast cancer mortality: meta-analysis of individual patient data for 8135 women in 22 randomised trials

Author

Mcgale, P., Taylor, C., Correa, C., Cutter, D., Duane, F., Ewertz, M., Gray, R., Mannu, G., Peto, R., Whelan, T., Wang, Y., Wang, Z., Darby, S., Albain, K., Anderson, S., Arriagada, R., Barlow, W., Bergh, J., Bergsten Nordström, E., Bliss, J., Burrett, J. A., Buyse, M., Cameron, D., Carrasco, E., Clarke, M., Coleman, R., Coates, A., Collins, R., Costantino, J., Cuzick, J., Davidson, N., Davies, C., Davies, K., Delmestri, A., Di Leo, A., Dowsett, M., Elphinstone, P., Evans, V., Forbes, J., Gelber, R., Gettins, L., Geyer, C., Gianni, L., Gnant, M., Goldhirsch, A., Godwin, J., Gregory, C., Hayes, D., Hill, C., Ingle, J., Jakesz, R., James, S., Janni, W., Kaufmann, M., Kerr, A., Liu, H., Mackinnon, E., Martín, M., Mchugh, T., Morris, P., Norton, L., Ohashi, Y., Paik, S., Pan, H. C., Perez, E., Piccart, M., Pierce, L., Pritchard, K., Pruneri, G., Raina, V., Ravdin, P., Robertson, J., Rutgers, E., Shao, Y. F., Sparano, J., Swain, S., Valagussa, P., Viale, G., Von Minckwitz, G., Winer, E., Wiang, X., Wood, Abe O, W., Abe, R, Enomoto, K, Kikuchi, K, Koyama, H, Masuda, H, Nomura, Y, Ohashi, Y, Sakai, K, Sugimachi, K, Toi, M, Tominaga, T, Uchino, J, Yoshida, M, Haybittle, Jl, Leonard, Cf, Calais, G, Geraud, P, Collett, V, Davies, C, Delmestri, A, Sayer, J, Harvey, Vj, Holdaway, Im, Kay, Rg, Mason, Bh, Forbes, Jf, Wilcken, N, Bartsch, R, Dubsky, P, Fesl, C, Fohler, H, Gnant, M, Greil, R, Jakesz, R, Lang, A, Luschin-Ebengreuth, G, Marth, C, Mlineritsch, B, Samonigg, H, Singer, Cf, Steger, Gg, Stöger, H, Canney, P, Yosef, Hm, Focan, C, Peek, U, Oates, Gd, Powell, J, Durand, M, Mauriac, L, Di Leo, A, Dolci, S, Larsimont, D, Nogaret, Jm, Philippson, C, Piccart, Mj, Masood, Mb, Parker, D, Price, Jj, Lindsay, Ma, Mackey, J, Martin, M, Hupperets, Ps, Bates, T, Blamey, Rw, Chetty, U, Ellis, Io, Mallon, E, Morgan, Da, Patnick, J, Pinder, S, Olivotto, I, Ragaz, J, Berry, D, Broadwater, G, Cirrincione, C, Muss, H, Norton, L, Weiss, Rb, Abu-Zahra, Ht, Portnoj, Sm, Bowden, S, Brookes, C, Dunn, J, Fernando, I, Lee, M, Poole, C, Rea, D, Spooner, D, Barrett-Lee, Pj, Mansel, Re, Monypenny, Ij, Gordon, Nh, Davis, Hl, Cuzick, J, Lehingue, Y, Romestaing, P, Dubois, Jb, Delozier, T, Griffon, B, Mace Lesech, J, Brain, E, de La Lande, B, Mouret-Fourme, E, Mustacchi, G, Petruzelka, L, Pribylova, O, Owen, Jr, Harbeck, N, Jänicke, F, Meisner, C, Schmitt, M, Thomssen, C, Meier, P, Shan, Y, Shao, Yf, Wang, X, Zhao, Db, Chen, Zm, Pan, Hc, Howell, A, Swindell, R, Burrett, Ja, Clarke, M, Collins, R, Correa, C, Cutter, D, Darby, S, Davies, K, Elphinstone, P, Evans, V, Gettins, L, Godwin, J, Gray, R, Gregory, C, Hermans, D, Hicks, C, James, S, Kerr, A, Liu, H, Mackinnon, E, Lay, M, Mcgale, P, Mchugh, T, Morris, P, Peto, R, Taylor, C, Wang, Y, Albano, J, de Oliveira CF, Gervásio, H, Gordilho, J, Ejlertsen, B, Jensen, Mb, Johansen, H, Mouridsen, H, Palshof, T, Gelman, Rs, Harris, Jr, Hayes, D, Henderson, C, Shapiro, Cl, Winer, E, Christiansen, P, Ewertz, M, Møller, S, Mouridsen, Ht, Trampisch, Hj, Dalesio, O, de Vries EG, Rodenhuis, S, van Tinteren, H, Comis, Rl, Davidson, Ne, Robert, N, Sledge, G, Solin, Lj, Sparano, Ja, Tormey, Dc, Wood, W, Cameron, D, Dixon, Jm, Forrest, P, Jack, W, Kunkler, I, Rossbach, J, Klijn, Jg, Treurniet-Donker, Ad, van Putten WL, Rotmensz, N, Veronesi, U, Viale, G, Bartelink, H, Bijker, N, Bogaerts, J, Cardoso, F, Cufer, T, Julien, Jp, Rutgers, E, van de Velde CJ, Cunningham, Mp, Huovinen, R, Joensuu, H, Costa, A, Bonadonna, G, Gianni, L, Valagussa, P, Goldstein, Lj, Bonneterre, J, Fargeot, P, Fumoleau, P, Kerbrat, P, Luporsi, E, Namer, M, Eiermann, W, Hilfrich, J, Jonat, W, Kaufmann, M, Kreienberg, R, Schumacher, M, Bastert, G, Rauschecker, H, Sauer, R, Sauerbrei, W, Schauer, A, Blohmer, Ju, Costa, Sd, Eidtmann, H, Gerber, B, Jackisch, C, Loibl, S, von Minckwitz, G, de Schryver, A, Vakaet, L, Belfiglio, M, Nicolucci, A, Pellegrini, F, Pirozzoli, Mc, Sacco, M, Valentini, M, Mcardle, Cs, Smith, Dc, Stallard, S, Dent, Dm, Gudgeon, Ca, Hacking, A, Murray, E, Panieri, E, Werner, Id, Carrasco, E, Segui, Ma, Galligioni, E, Lopez, M, Erazo, A, Medina, Jy, Horiguchi, J, Takei, H, Fentiman, Is, Hayward, Jl, Rubens, Rd, Skilton, D, Scheurlen, H, Sohn, Hc, Untch, M, Dafni, U, Markopoulos, C, Fountzilas, G, Mavroudis, D, Klefstrom, P, Blomqvist, C, Saarto, T, Gallen, M, Tinterri, C, Margreiter, R, de Lafontan, B, Mihura, J, Roché, H, Asselain, B, Salmon, Rj, Vilcoq, Jr, André, F, Arriagada, R, Delaloge, S, Hill, C, Koscielny, S, Michiels, S, Rubino, C, A'Hern, R, Bliss, J, Ellis, P, Kilburn, L, Yarnold, Jr, Benraadt, J, Kooi, M, van de Velde AO, van Dongen JA, Vermorken, Jb, Castiglione, M, Coates, A, Colleoni, M, Collins, J, Forbes, J, Gelber, Rd, Goldhirsch, A, Lindtner, J, Price, Kn, Regan, Mm, Rudenstam, Cm, Senn, Hj, Thuerlimann, B, Bliss, Jm, Chilvers, Ce, Coombes, Rc, Hall, E, Marty, M, Buyse, M, Possinger, K, Schmid, P, Wallwiener, D, Foster, L, George, Wd, Stewart, Hj, Stroner, P, Borovik, R, Hayat, H, Inbar, Mj, Peretz, T, Robinson, E, Bruzzi, P, Del Mastro, L, Pronzato, P, Sertoli, Mr, Venturini, M, Camerini, T, De Palo, G, Di Mauro MG, Formelli, F, Amadori, D, Martoni, A, Pannuti, F, Camisa, R, Cocconi, G, Colozza, A, Passalacqua, R, Aogi, K, Takashima, S, Abe, O, Ikeda, T, Inokuchi, K, Sawa, K, Sonoo, H, Korzeniowski, S, Skolyszewski, J, Ogawa, M, Yamashita, J, Bastiaannet, E, van de Water, W, van Nes JG, Christiaens, R, Neven, P, Paridaens, R, Van den Bogaert, W, Braun, S, Martin, P, Romain, S, Janauer, M, Seifert, M, Sevelda, P, Zielinski, Cc, Hakes, T, Hudis, Ca, Wittes, R, Giokas, G, Kondylis, D, Lissaios, B, de la Huerta, R, Sainz, Mg, Altemus, R, Camphausen, K, Cowan, K, Danforth, D, Lichter, A, Lippman, M, O'Shaughnessy, J, Pierce, Lj, Steinberg, S, Venzon, D, Zujewski, Ja, D'Amico, C, Lioce, M, Paradiso, A, Chapman, Ja, Gelmon, K, Goss, Pe, Levine, Mn, Meyer, R, Parulekar, W, Pater, Jl, Pritchard, Ki, Shepherd, Le, Tu, D, Whelan, T, Ohno, S, Anderson, S, Bass, G, Brown, A, Bryant, J, Costantino, J, Dignam, J, Fisher, B, Geyer, C, Mamounas, Ep, Paik, S, Redmond, C, Swain, S, Wickerham, L, Wolmark, N, Baum, M, Jackson, Im, Palmer, Mk, Perez, E, Ingle, Jn, Suman, Vj, Bengtsson, No, Emdin, S, Jonsson, H, Lythgoe, Jp, Kissin, M, Erikstein, B, Hannisdal, E, Jacobsen, Ab, Varhaug, Je, Gundersen, S, Hauer-Jensen, M, Høst, H, Nissen-Meyer, R, Reinertsen, K, Mitchell, Ak, Robertson, Jf, Ueo, H, Di Palma, M, Mathé, G, Misset, Jl, Levine, M, Morimoto, K, Takatsuka, Y, Crossley, E, Harris, A, Talbot, D, Taylor, M, di Blasio, B, Ivanov, V, Paltuev, R, Semiglazov, V, Brockschmidt, J, Cooper, Mr, Falkson, Ci, Dowsett, M, Makris, A, Parton, M, Pennert, K, Powles, Tj, Smith, Ie, Gazet, Jc, Browne, L, Graham, P, Corcoran, N, Businico, A, Deshpande, N, di Martino, L, Douglas, P, Lindtner, A, Notter, G, Bryant, Aj, Ewing, Gh, Firth, La, Krushen-Kosloski, Jl, Anderson, H, Killander, F, Malmström, P, Rydén, L, Arnesson, Lg, Carstensen, J, Dufmats, M, Fohlin, H, Nordenskjöld, B, Söderberg, M, Carpenter, Jt, Murray, N, Royle, Gt, Simmonds, Pd, Albain, K, Barlow, W, Crowley, J, Gralow, J, Hortobagyi, G, Livingston, R, Martino, S, Osborne, Ck, Ravdin, Pm, Adolfsson, J, Bergh, J, Bondesson, T, Celebioglu, F, Dahlberg, K, Fornander, T, Fredriksson, I, Frisell, J, Göransson, E, Iiristo, M, Johansson, U, Lenner, E, Löfgren, L, Nikolaidis, P, Perbeck, L, Rotstein, S, Sandelin, K, Skoog, L, Svane, G, af Trampe, E, Wadström, C, Janni, W, Maibach, R, Thürlimann, B, Hakama, M, Holli, K, Isola, J, Rouhento, K, Saaristo, R, Brenner, H, Hercbergs, A, Yoshimoto, M, Paterson, Ah, Fyles, A, Meakin, Jw, Panzarella, T, Bahi, J, Reid, M, Spittle, M, Bishop, H, Bundred, Nj, Forsyth, S, Pinder, Se, Sestak, I, Deutsch, Gp, Kwong, Dl, Pai, Vr, Senanayake, F, Martin, Al, Boccardo, F, Rubagotti, A, Hackshaw, A, Houghton, J, Ledermann, J, Monson, K, Tobias, Js, Carlomagno, C, De Laurentiis, M, De Placido, S, Williams, L, Broglio, K, Buzdar, Au, Hsu, L, Love, Rr, Ahlgren, J, Garmo, H, Holmberg, L, Liljegren, G, Lindman, H, Wärnberg, F, Asmar, L, Jones, Se, Gluz, O, Liedtke, C, Nitz, U, Litton, A, Wallgren, A, Karlsson, P, Linderholm, Bk, Chlebowski, Rt, Caffier, H., McGale, P, Taylor, C, Correa, C, Cutter, D, Duane, F, Ewertz, M, Gray, R, Mannu, G, Peto, R, Whelan, T, Wang, Y, Wang, Z, Darby, S, Biomedische Technologie, RS: GROW - Oncology, RS: GROW - R3 - Innovative Cancer Diagnostics & Therapy, Mcgale, P, DE LAURENTIIS, Michelino, Other departments, CCA -Cancer Center Amsterdam, and Radiotherapy

Subjects
medicine.medical_specialty, medicine.medical_treatment, Breast Neoplasms, Rate ratio, Lower risk, Systemic therapy, Statistical significance, Medicine, Humans, Mastectomy, Randomized Controlled Trials as Topic, business.industry, Articles, General Medicine, Surgery, Radiation therapy, Axilla, Neoplasm Recurrence, medicine.anatomical_structure, Local, Meta-analysis, Lymphatic Metastasis, Lymph Node Excision, Female, Neoplasm Recurrence, Local, business, Breast Neoplasm, Human
Abstract

BACKGROUND: Postmastectomy radiotherapy was shown in previous meta-analyses to reduce the risks of both recurrence and breast cancer mortality in all women with node-positive disease considered together. However, the benefit in women with only one to three positive lymph nodes is uncertain. We aimed to assess the effect of radiotherapy in these women after mastectomy and axillary dissection.METHODS: We did a meta-analysis of individual data for 8135 women randomly assigned to treatment groups during 1964-86 in 22 trials of radiotherapy to the chest wall and regional lymph nodes after mastectomy and axillary surgery versus the same surgery but no radiotherapy. Follow-up lasted 10 years for recurrence and to Jan 1, 2009, for mortality. Analyses were stratified by trial, individual follow-up year, age at entry, and pathological nodal status.FINDINGS: 3786 women had axillary dissection to at least level II and had zero, one to three, or four or more positive nodes. All were in trials in which radiotherapy included the chest wall, supraclavicular or axillary fossa (or both), and internal mammary chain. For 700 women with axillary dissection and no positive nodes, radiotherapy had no significant effect on locoregional recurrence (two-sided significance level [2p]>0·1), overall recurrence (rate ratio [RR], irradiated vs not, 1·06, 95% CI 0·76-1·48, 2p>0·1), or breast cancer mortality (RR 1·18, 95% CI 0·89-1·55, 2p>0·1). For 1314 women with axillary dissection and one to three positive nodes, radiotherapy reduced locoregional recurrence (2pINTERPRETATION: After mastectomy and axillary dissection, radiotherapy reduced both recurrence and breast cancer mortality in the women with one to three positive lymph nodes in these trials even when systemic therapy was given. For today's women, who in many countries are at lower risk of recurrence, absolute gains might be smaller but proportional gains might be larger because of more effective radiotherapy.FUNDING: Cancer Research UK, British Heart Foundation, UK Medical Research Council.

Published
2016

228. Frequent incidence of BARD1-truncating mutations in germline DNA from triple-negative breast cancer patients

Author

De Brakeleer, S, De Greve, J, Desmedt, C, Joris, S, Sotiriou, C, Piccart, M, Pauwels, I, Teugels, E, Clinical sciences, Faculty of Medicine and Pharmacy, and Laboratory of Molecular and Medical Oncology

Subjects
endocrine system diseases, skin and connective tissue diseases
Abstract

Triple-negative breast cancer (TNBC) accounts for 10-20% of all breast cancers (BCs), and conventional chemotherapy is the only effective systemic treatment. Germline BRCA1/2 mutations are found in approximately 15% of TNBC patients. In the past, we have documented pathogenic mutations in BARD1, a BRCA1 interacting protein, in families at high risk for BC. In this study, we have analyzed germline DNA from 61 estrogen receptor negative patients (of which 42 were TNBC) for the presence of mutations in the BRCA1, BRCA2 and BARD1 gene. BRCA1/2 mutations were found in 8 out of 42 (19%) TNBC patients, but not in the ER-/HER2+ cohort. We also found four good candidate pathogenic BARD1 mutations in the TNBC cohort, including two protein-truncating mutations (p.Gln564Ter and p.Arg641Ter). Our data suggest that TNBC patients are enriched for pathogenic BARD1 germline mutations as compared to control samples and high BC risk families. Ten of the 42 investigated TNBC patients carry a BRCA pathway mutation (in BRCA1, BRCA2 or BARD1) rendering them susceptible to homologous recombination deficiency. These patients should become eligible for exploring the efficacy of poly (ADP-ribose) polymerase (PARP) inhibitors.

Published
2016

229. PYTHIA: A phase II study of palbociclib plus fulvestrant for pretreated patients with ER+/HER2- metastatic breast cancer

Author

Zardavas, D., primary, Regan, M., additional, Maibach, R., additional, Ruepp, B., additional, Hiltbrunner, A., additional, Blacher, L., additional, Gelber, R., additional, Gebhart, G., additional, Di Leo, A., additional, Hilbers, F., additional, Colleoni, M., additional, Zoppoli, G., additional, Bertelli, G., additional, Bliss, J., additional, Duhoux, F., additional, Piccart, M., additional, and Malorni, L., additional

Published
2017
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230. PALLAS: PALbociclib CoLlaborative adjuvant study: A randomized phase 3 trial of palbociclib with standard adjuvant endocrine therapy versus standard adjuvant endocrine therapy alone for HR+/HER2- early breast cancer

Author

Mayer, E.L., primary, Demichele, A.M., additional, Pfeiler, G., additional, Barry, W., additional, Metzger, O., additional, Rastogi, P., additional, Symmans, F., additional, Burstein, H.J., additional, Miller, K., additional, Loibl, S., additional, Schmatloch, S., additional, Goulioti, T., additional, Zardavas, D., additional, Fesl, C., additional, Koehler, M., additional, Huang Bartlett, C., additional, Huang, X., additional, Piccart, M., additional, Winer, E., additional, and Gnant, M., additional

Published
2017
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232. Adjuvant anti-HER2 therapy, treatment-induced amenorrhea (TIA) and survival in premenopausal patients (pts) with HER2-positive (HER2+) early breast cancer (EBC): Analysis from the ALTTO trial (BIG 2-06)

Author

Lambertini, M., primary, Campbell, C., additional, Bines, J., additional, Korde, L., additional, Izquierdo Delso, M.A., additional, Fumagalli, D., additional, Pritchard, K., additional, Wolff, A., additional, Jackisch, C., additional, Lang, I., additional, Untch, M., additional, Smith, I., additional, Boyle, F.M., additional, Xu, B., additional, Barrios, C.H., additional, Baselga, J., additional, Moreno-Aspitia, A., additional, Piccart, M., additional, Gelber, R., additional, and De Azambuja, E., additional

Published
2017
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233. Primary results of LORELEI: A phase II randomized, double-blind study of neoadjuvant letrozole (LET) plus taselisib versus LET plus placebo (PLA) in postmenopausal patients (pts) with ER+/HER2-negative early breast cancer (EBC)

Author

Saura, C., primary, de Azambuja, E., additional, Hlauschek, D., additional, Oliveira, M., additional, Zardavas, D., additional, Jallitsch-Halper, A., additional, de la Pena, L., additional, Nuciforo, P., additional, Ballestrero, A., additional, Fornier, M.N., additional, Boer, K., additional, Ciruelos, E., additional, Valero, V., additional, Wilson, T.R., additional, Stout, T.J., additional, Hsu, J.Y., additional, Shi, Y., additional, Piccart, M., additional, Gnant, M., additional, and Baselga, J., additional

Published
2017
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234. Characterisation of the HLA-DRB1*07:01 biomarker for lapatinib-induced liver toxicity during treatment of early-stage breast cancer patients with lapatinib in combination with trastuzumab and/or taxanes

Author

Spraggs, C F, primary, Parham, L R, additional, Briley, L P, additional, Warren, L, additional, Williams, L S, additional, Fraser, D J, additional, Jiang, Z, additional, Aziz, Z, additional, Ahmed, S, additional, Demetriou, G, additional, Mehta, A, additional, Jackson, N, additional, Byrne, J, additional, Andersson, M, additional, Toi, M, additional, Harris, L, additional, Gralow, J, additional, Zujewski, J A, additional, Crescenzo, R, additional, Armour, A, additional, Perez, E, additional, and Piccart, M, additional

Published
2017
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239. Abstract P5-14-01: Chemotherapy randomization of the EORTC 10041/ BIG 3-04 MINDACT (microarray in node-negative and 1 to 3 positive lymph node disease may avoid chemotherapy) trial

Author

Cardoso, F, primary, Piccart, M, additional, Rutgers, E, additional, Slaets, L, additional, van 't Veer, L, additional, Viale, G, additional, Pierga, J-Y, additional, Brain, E, additional, Causeret, S, additional, Golfinopoulos, V, additional, Goulioti, T, additional, Knox, S, additional, Matos, E, additional, Neijenhuis, P, additional, Nitz, U, additional, Passalacqua, R, additional, Rubio, IT, additional, Saghatchian, M, additional, Smilde, TJ, additional, Sotiriou, C, additional, Stork, L, additional, Straehle, C, additional, Thomas, G, additional, Thompson, A, additional, Vrijaldenhoven, S, additional, Vuylsteke, P, additional, Tryfonidis, K, additional, Bogaerts, J, additional, and Delaloge, S, additional

Published
2017
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242. Abstract S3-02: Plasma microRNA levels for predicting therapeutic response to neoadjuvant treatment in HER2-positive breast cancer: Results from Neo-ALTTO

Author

Di Cosimo, S, primary, Appierto, V, additional, Tiberio, P, additional, Verderio, P, additional, Pizzamiglio, S, additional, Bottelli, S, additional, Iorio, M, additional, Baselga, J, additional, Piccart, M, additional, Huober, J, additional, Brase, J, additional, de la Pena, L, additional, Fumagalli, D, additional, de Azambuja, E, additional, de Braud, F, additional, and Daidone, MG, additional

Published
2017
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243. Abstract P4-21-09: Cardiac biomarkers for early detection and prediction of trastuzumab and/or lapatinib-induced cardiotoxicity in patients with HER2 positive early breast cancer (BIG 1-06)

Author

de Azambuja, E, primary, Bradbury, I, additional, Ewer, M, additional, Campbell, C, additional, Zardavas, D, additional, Ameels, H, additional, Baselga, J, additional, Huober, J, additional, Izquierdo, M, additional, Bozovic-Spasojevic, I, additional, Maetens, M, additional, Harbeck, N, additional, Pusztai, L, additional, Piccart, M, additional, Rodeheffer, R, additional, and Sutter, T, additional

Published
2017
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245. Rare Cancers Europe (RCE) methodological recommendations for clinical studies in rare cancers: A European consensus position paper

Author

Casali, Paolo G., Bruzzi, P., Bogaerts, Jan, Blay, Jean-Yves, Aapro, M. S., Adamou, A., Berruti, A., Bressington, J., Bruzzi, B., Capocaccia, R., Cardoso, Fatima, Celis, J. E., Cervantes, A., Ciardiello, F., Claussen, C., Coleman, M., Comis, S., Craine, S., Boltz, D. De, Lorenzo, F. De, P, Angelo Dei Tos, Gatta, G., Geissler, J., Giuliani, R., Grande, E., Gronchi, A., Jezdic, S., Jonsson, B., Jost, Lorenz M., Keulen, H., Lacombe, D., Lamory, G., Cam, Y. Le, Priolo, S. Leto di, Licitra, Lisa, Macchia, F., Margulies, A., Marreaud, S., McVie, G., Narbutas, S., Oliver, K., Pavlidis, Nicholas, Pelouchova, J., Pentheroudakis, George, Piccart, M., Pierotti, M. A., Pravettoni, G., Redmond, K., Riegman, P., Ruffilli, M. P., Ryner, D., Sandrucci, S., Seymour, M., Torri, V., Trama, A., Belle, S. Van, Vassal, G., Wartenberg, M., Watts, C., Wilson, A., Yared, W., Pavlidis, Nicholas [0000-0002-2195-9961], and Pentheroudakis, George [0000-0002-6632-2462]

Subjects
Research design, Pathology, Data base, Research methodology, Electronic medical record, Disease, Review, Procedures, Treatment response, Clinical trials, Rare cancers, Clinical Studies as Topic, Humans, Neoplasms, Rare Diseases, Research Design, Hematology, Oncology, Reimbursement, Priority journal, education.field_of_study, Clinical studies as topic, Rare diseases, Europe, Clinical decision making, Human, medicine.medical_specialty, Practice guideline, Case finding, Population, Health care quality, Reviews, Cancer research, Clinical study, SDG 3 - Good Health and Well-being, Conceptual framework, medicine, Tumor marker, Intensive care medicine, education, Antineoplastic activity, Flexibility (engineering), Surrogate endpoint, business.industry, Methodology, Rare cancer, Study design, Cancer survival, Clinical trial, Patient information, Clinical effectiveness, Position paper, Neoplasm, business, Rare disease
Abstract

While they account for one-fifth of new cancer cases, rare cancers are difficult to study. A higher than average degree of uncertainty should be accommodated for clinical as well as for population-based decision making. Rules of rational decision making in conditions of uncertainty should be rigorously followed and would need widely informative clinical trials. In principle, any piece of new evidence would need to be exploited in rare cancers. Methodologies to explicitly weigh and combine all the available evidence should be refined, and the Bayesian logic can be instrumental to this end. Likewise, Bayesian-design trials may help optimize the low number of patients liable to be enrolled in clinical studies on rare cancers, as well as adaptive trials in general, with their inherent potential of flexibility when properly applied. While clinical studies are the mainstay to test hypotheses, the potential of electronic patient records should be exploited to generate new hypotheses, to create external controls for future studies (when internal controls are unpractical), to study effectiveness of new treatments in real conditions. Framework study protocols in specific rare cancers to stepwisely test sets of new agents, as from the early post-phase I development stage, should be encouraged. Also the compassionate and the off-label settings should be exploited to generate new evidence, and flexible regulatory innovations such as adaptive licensing could convey new agents early to rare cancer patients, while generating evidence. Though validation of surrogate end points is problematic in rare cancers, the use of an updated notion of tumor response may be of great value in the single patient to optimize the use of therapies, all the more the new ones. Disease-based communities, involving clinicians and patients, should be regularly consulted by regulatory bodies when setting their policies on drug approval and reimbursement in specific rare cancers ., While they account for one-fifth of new cancer cases, rare cancers are difficult to study. A higher than average degree of uncertainty should be accommodated for clinical as well as for population-based decision making. Rules of rational decision making in conditions of uncertainty should be rigorously followed and would need widely informative clinical trials. In principle, any piece of new evidence would need to be exploited in rare cancers. Methodologies to explicitly weigh and combine all the available evidence should be refined, and the Bayesian logic can be instrumental to this end. Likewise, Bayesian-design trials may help optimize the low number of patients liable to be enrolled in clinical studies on rare cancers, as well as adaptive trials in general, with their inherent potential of flexibility when properly applied. While clinical studies are the mainstay to test hypotheses, the potential of electronic patient records should be exploited to generate new hypotheses, to create external controls for future studies (when internal controls are unpractical), to study effectiveness of new treatments in real conditions. Framework study protocols in specific rare cancers to sequentially test sets of new agents, as from the early post-phase I development stage, should be encouraged. Also the compassionate and the off-label settings should be exploited to generate new evidence, and flexible regulatory innovations such as adaptive licensing could convey new agents early to rare cancer patients, while generating evidence. Though validation of surrogate end points is problematic in rare cancers, the use of an updated notion of tumor response may be of great value in the single patient to optimize the use of therapies, all the more the new ones. Disease-based communities, involving clinicians and patients, should be regularly consulted by regulatory bodies when setting their policies on drug approval and reimbursement in specific rare cancers.

Published
2015

246. 70-Gene Signature as an Aid to Treatment Decisions in Early-Stage Breast Cancer.

Author

MINDACT Investigators, Benn, K., Bogaerts, J., Cardoso, F., Ciruelos, E., Corochan, S., Cuny, J., de la Pena, L., Delaloge, S., DeLorenzi, M., Dudek-Peric, A., Eekhout, I., Gluz, O., Golfinopoulos, V., Goulioti, T., Harbeck, N., Hilal, V., Knox, S., Lemonnier, J., Ławniczak, M., Marini, L., Matos, E., Morales, P., Murray, K., Nitz, U., Passalaqua, R., Piccart, M., Remmelzwaal, J., Rubio, I., Rutgers, E., Saghatchian, M., Slaets, L., Sotiriou, C., Straehle, C., Straley, M., Theron, N., Thompson, A., Tryfonidis, K., Todeschini, R., Urunkar, M., van 't Veer, L., Viale, G., Aalders, K., Bines, J., Bedard, P., Bozovic, I., Braga, S., Castaneda, C., Celebic, A., Colichi, C., Criscitiello, C., Dal Lago, L., Demonty, G., Drukker, C., Fei, F., Lia, M., Loi, S., Messina, C., Mook, S., Moulin, C., Sreseli, R., Therasse, P., Werutsky, G., Corachan, S., Wheeler, L., Dif, N., Rizzetto, G., Beauvois, M., Meirsman, L., Breyssens, H., Decker, N., Engelen, K., Akropovic, A., Harrison, J., Henot, F., Celis, M., De Jongh, B., Delmotte, I., Daubie, V., Goossens, R., Helsen, N., Hourt, L., Janssen, S., Soete, V., Vansevenant, K., Hermans, C., Hart, G., Brink, G., Floore, A., Sixt, B., Buyse, M., van't Veer, L.J., Pierga, J.Y., Brain, E., Causeret, S., Glas, A.M., Meulemans, B., Neijenhuis, P.A., Passalacqua, R., Ravdin, P., Rubio, I.T., Smilde, T.J., Stork, L., Thomas, G., Thompson, A.M., van der Hoeven, J.M., Vuylsteke, P., Bernards, R., MINDACT Investigators, Benn, K., Bogaerts, J., Cardoso, F., Ciruelos, E., Corochan, S., Cuny, J., de la Pena, L., Delaloge, S., DeLorenzi, M., Dudek-Peric, A., Eekhout, I., Gluz, O., Golfinopoulos, V., Goulioti, T., Harbeck, N., Hilal, V., Knox, S., Lemonnier, J., Ławniczak, M., Marini, L., Matos, E., Morales, P., Murray, K., Nitz, U., Passalaqua, R., Piccart, M., Remmelzwaal, J., Rubio, I., Rutgers, E., Saghatchian, M., Slaets, L., Sotiriou, C., Straehle, C., Straley, M., Theron, N., Thompson, A., Tryfonidis, K., Todeschini, R., Urunkar, M., van 't Veer, L., Viale, G., Aalders, K., Bines, J., Bedard, P., Bozovic, I., Braga, S., Castaneda, C., Celebic, A., Colichi, C., Criscitiello, C., Dal Lago, L., Demonty, G., Drukker, C., Fei, F., Lia, M., Loi, S., Messina, C., Mook, S., Moulin, C., Sreseli, R., Therasse, P., Werutsky, G., Corachan, S., Wheeler, L., Dif, N., Rizzetto, G., Beauvois, M., Meirsman, L., Breyssens, H., Decker, N., Engelen, K., Akropovic, A., Harrison, J., Henot, F., Celis, M., De Jongh, B., Delmotte, I., Daubie, V., Goossens, R., Helsen, N., Hourt, L., Janssen, S., Soete, V., Vansevenant, K., Hermans, C., Hart, G., Brink, G., Floore, A., Sixt, B., Buyse, M., van't Veer, L.J., Pierga, J.Y., Brain, E., Causeret, S., Glas, A.M., Meulemans, B., Neijenhuis, P.A., Passalacqua, R., Ravdin, P., Rubio, I.T., Smilde, T.J., Stork, L., Thomas, G., Thompson, A.M., van der Hoeven, J.M., Vuylsteke, P., and Bernards, R.

Abstract

The 70-gene signature test (MammaPrint) has been shown to improve prediction of clinical outcome in women with early-stage breast cancer. We sought to provide prospective evidence of the clinical utility of the addition of the 70-gene signature to standard clinical-pathological criteria in selecting patients for adjuvant chemotherapy. In this randomized, phase 3 study, we enrolled 6693 women with early-stage breast cancer and determined their genomic risk (using the 70-gene signature) and their clinical risk (using a modified version of Adjuvant! Online). Women at low clinical and genomic risk did not receive chemotherapy, whereas those at high clinical and genomic risk did receive such therapy. In patients with discordant risk results, either the genomic risk or the clinical risk was used to determine the use of chemotherapy. The primary goal was to assess whether, among patients with high-risk clinical features and a low-risk gene-expression profile who did not receive chemotherapy, the lower boundary of the 95% confidence interval for the rate of 5-year survival without distant metastasis would be 92% (i.e., the noninferiority boundary) or higher. A total of 1550 patients (23.2%) were deemed to be at high clinical risk and low genomic risk. At 5 years, the rate of survival without distant metastasis in this group was 94.7% (95% confidence interval, 92.5 to 96.2) among those not receiving chemotherapy. The absolute difference in this survival rate between these patients and those who received chemotherapy was 1.5 percentage points, with the rate being lower without chemotherapy. Similar rates of survival without distant metastasis were reported in the subgroup of patients who had estrogen-receptor-positive, human epidermal growth factor receptor 2-negative, and either node-negative or node-positive disease. Among women with early-stage breast cancer who were at high clinical risk and low genomic risk for recurrence, the receipt of no chemotherapy on the basis of t

Published
2016

250. Combined Tamoxifen and Luteinizing Hormone-Releasing Hormone (LHRH) Agonist Versus LHRH Agonist Alone in Premenopausal Advanced Breast Cancer: A Meta-Analysis of Four Randomized Trials

Author

Klijn, J. G. M., Blamey, R. W., Boccardo, F., Tominaga, T., Duchateau, L., Sylvester, R., Beex, L. V. A. M., Mauriac, L., Zijl, J. A., Veyret, C., Wildiers, J., Jassem, J., Piccart, M., Burghouts, J., Becqaert, D., Seynaeve, C., Mignolet, F., Namer, M., Julien, J. P., Garcia Conde, J., Dunser, M., Margreiter, R., Tjabbes, T., Roozendaal, K. J., Velden, P. C., Nortier, J. W. R., Blamey, R., Howell, A., Forbes, J., Kaufmann, M., Nordenskjold, B., Kvinnsland, S., Wilson, R. G., Jonat, W., Kleeberg, U. R., Eiermann, W., Hilfrich, J., Weitzel, H. K., Glas, U., Rutqvist, L. E., Rudenstam, C., Sander, S., Ryden, S., Honsson, P., Lonning, P. E., Loven, L., Russell, I. S., Olweny, C., Byrne, J. J., Snyder, R. D., Coates, A. S., Lowenthal, R. M., Jeal, P. N., Dalley, D. N., Janicke, F., Kleine, W., Michel, R. Th, Canobbio, L., Amoroso, D., Rubagotti, A., Bumma, C., D Aprile, M., Matteis, A., Di Carlo, A., Francini, G., Petrioli, R., Folco, U., Calligioni, E., Gallotti, P., Lopez, M., Mesiti, M., Pacini, P., Sassi, M., Sismondi, P., Paolo Zola, Ogita, M., Okazaki, M., Watanabe, T., Satomi, T., Hatazawa, C., Okuyama, N., Koyama, T., Kobayashi, M., Shimizu, T., Tabei, T., Sano, M., Makino, H., Ando, J., Kimura, M., Takeuchi, T., Aoyama, H., Koyama, H., Shin, E., Chou, G., and Medical Oncology

Subjects
Agonist, Oncology, endocrine system, Cancer Research, medicine.medical_specialty, Neoplasms, Hormone-Dependent, Antineoplastic Agents, Hormonal, medicine.drug_class, medicine.medical_treatment, Antineoplastic Agents, Breast Neoplasms, Buserelin, Gonadotropin-Releasing Hormone, Drug Therapy, SDG 3 - Good Health and Well-being, Neoplasms, Internal medicine, medicine, Humans, Neoplasm Metastasis, Hormone-Dependent, Randomized Controlled Trials as Topic, Hormonal, business.industry, Standard treatment, Goserelin, Oophorectomy, Cancer, Antiestrogen, medicine.disease, Survival Analysis, Drug Therapy, Combination, Female, Premenopause, Tamoxifen, Endocrinology, Combination, business, hormones, hormone substitutes, and hormone antagonists, medicine.drug
Abstract

PURPOSE: The logic behind the application of luteinizing hormone-releasing hormone (LHRH) agonists in combination with tamoxifen in premenopausal women is that LHRH agonists on the one hand suppress the tamoxifen-induced stimulation of the pituitary-ovarian function and, on the other hand, seem as effective as surgical castration. This meta-analysis combines all randomized evidence to compare the combined treatment with LHRH agonist alone with respect to overall survival, progression-free survival, and objective response in premenopausal women with advanced breast cancer. PATIENTS AND METHODS: Four clinical trials randomizing a total of 506 premenopausal women with advanced breast cancer to LHRH agonist alone or to the combined treatment of LHRH agonist plus tamoxifen were identified. Meta-analytic techniques were used to analyze individual patient data from these trials. RESULTS: With a median follow-up of 6.8 years, there was a significant survival benefit (stratified log-rank test, P = .02; hazards ratio [HR] = 0.78) and progression-free survival benefit (stratified log-rank test, P = .0003; HR = 0.70) in favor of the combined treatment. The overall response rate was significantly higher on combined endocrine treatment (stratified Mantel Haenszel test, P = .03; odds ratio = 0.67). CONCLUSION: The combination of LHRH agonist plus tamoxifen is superior to LHRH agonist alone in premenopausal women with advanced breast cancer. Therefore, if a premenopausal woman with advanced breast cancer is thought to be suitable for endocrine treatment, it is proposed that the combination of a LHRH agonist plus tamoxifen be considered as the new standard treatment.

Published
2001

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