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1,012 results on '"Zielinski C"'

1. 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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2. Palbociclib in combination with endocrine therapy versus capecitabine in hormonal receptor-positive, human epidermal growth factor 2-negative, aromatase inhibitor-resistant metastatic breast cancer: a phase III randomised controlled trial—PEARL

Author

Martin, M., Zielinski, C., Ruiz-Borrego, M., Carrasco, E., Turner, N., Ciruelos, E.M., Muñoz, M., Bermejo, B., Margeli, M., Anton, A., Kahan, Z., Csöszi, T., Casas, M.I., Murillo, L., Morales, S., Alba, E., Gal-Yam, E., Guerrero-Zotano, A., Calvo, L., de la Haba-Rodriguez, J., Ramos, M., Alvarez, I., Garcia-Palomo, A., Huang Bartlett, C., Koehler, M., Caballero, R., Corsaro, M., Huang, X., Garcia-Sáenz, J.A., Chacón, J.I., Swift, C., Thallinger, C., and Gil-Gil, M.

Published
2021
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6. Time to treat the climate and nature crisis as one indivisible global health emergency.

Author

Abbasi, K., Ali, P., Barbour, V., Benfield, T., Bibbins-Domingo, K., Hancocks, S., Horton, R., Laybourn-Langton, L., Mash, R., Sahni, P., Sharief, W. M., Shehab, A., Yonga, P., and Zielinski, C.

Subjects
CLIMATE change, WORLD health, MIDDLE-income countries
Abstract

This editorial is being published simultaneously in multiple journals. It highlights now as the time to treat the climate and nature crisis as one indivisible global health emergency. [ABSTRACT FROM AUTHOR]

Published
2023
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10. Time to treat the climate and nature crisis as one indivisible global health emergency.

Author

Abbasi, K., Ali, P., Barbour, V., Benfield, T., Bibbins‐Domingo, K., Hancocks, S., Horton, R., Laybourn‐Langton, L., Mash, R., Sahni, P, Sharief, W. M., Yonga, P., and Zielinski, C.

Subjects
CLIMATE change, WORLD health, INDIGENOUS Australians, ENVIRONMENTAL research
Abstract

Over 200 health journals have issued a joint statement calling on the United Nations, political leaders, and health professionals to recognize that climate change and biodiversity loss are interconnected crises that must be addressed together. The statement emphasizes that the current approach of treating these issues separately is a dangerous mistake. The impacts of these crises on human health are significant and include disruptions to social and economic systems, shortages of land, shelter, food, and water, and the spread of infectious diseases. The health community must advocate for the restoration of biodiversity and the mitigation of climate change, and political leaders must recognize the threats to health and the potential benefits of addressing these crises. The statement concludes by urging the World Health Organization to declare the climate and nature crisis as a global health emergency. [Extracted from the article]

Published
2024
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28. 1536P HERIZON: A phase II study of HER-Vaxx (IMU-131), a HER2-targeting peptide vaccine plus standard of care chemotherapy in patients with HER2+ advanced stomach cancer - Dose-dependent anti-cancer antibodies correlating with improved clinical outcome

Author

Tobias, J., Kundi, M., Garner-Spitzer, E., Zielinski, C., Maglakelidze, M., Andric, Z.G., Petrovic, Z., Nagarkar, R., Chawla, T., Chong, L.O., Nixon, B., Yavrom, S., Ede, N., and Wiedermann, U.

Published
2023
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31. 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. Cherny, N.I.

Subjects
health care economics and organizations
Abstract

Background: The European Society for Medical Oncology-Magnitude of Clinical Benefit Scale (ESMO-MCBS) is a validated, widely used tool developed to score the clinical benefit from cancer medicines reported in clinical trials. ESMO-MCBS scores assume valid research methodologies and quality trial implementation. Studies incorporating flawed design, implementation, or data analysis may generate outcomes that exaggerate true benefit and are not generalisable. Failure to either indicate or penalise studies with bias undermines the intention and diminishes the integrity of ESMO-MCBS scores. This review aimed to evaluate the adequacy of the ESMO-MCBS to address bias generated by flawed design, implementation, or data analysis and identify shortcomings in need of amendment. Methods: As part of a refinement of the ESMO-MCBS, we reviewed trial design, implementation, and data analysis issues that could bias the results. For each issue of concern, we reviewed the ESMO-MCBS v1.1 approach against standards derived from Helsinki guidelines for ethical human research and guidelines from the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use, the Food and Drugs Administration, the European Medicines Agency, and European Network for Health Technology Assessment. Results: Six design, two implementation, and two data analysis and interpretation issues were evaluated and in three, the ESMO-MCBS provided adequate protections. Seven shortcomings in the ability of the ESMO-MCBS to identify and address bias were identified. These related to (i) evaluation of the control arm, (ii) crossover issues, (iii) criteria for non-inferiority, (iv) substandard post-progression treatment, (v) post hoc subgroup findings based on biomarkers, (vi) informative censoring, and (vii) publication bias against quality-of-life data. Conclusion: Interpretation of the ESMO-MCBS scores requires critical appraisal of trials to understand caveats in trial design, implementation, and data analysis that may have biased results and conclusions. These will be addressed in future iterations of the ESMO-MCBS. © 2021 The Author(s)

Published
2021

38. Epirubicin and docetaxel with or without capecitabine as neoadjuvant treatment for early breast cancer: final results of a randomized phase III study (ABCSG-24)

Author

Steger, G. G., Greil, R., Lang, A., Rudas, M., Fitzal, F., Mlineritsch, B., Hartmann, B. L., Bartsch, R., Melbinger, E., Hubalek, M., Stoeger, H., Dubsky, P., Ressler, S., Petzer, A. L., Singer, C. F., Muss, C., Jakesz, R., Gampenrieder, S. P., Zielinski, C. C., Fesl, C., and Gnant, M.

Published
2014
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41. Consensus on the medical treatment of colon cancer

Author

Kornek, G., Scheithauer, W., Anghel, R., Bodoky, G., Ciardiello, F., Ciuleanu, T., Glynne-Jones, R., Gruenberger, T., Koza, I., Ocvirk, J., Petruzelka, L., Poston, G., Ramadori, G., Schmiegel, W., Segaert, S., Tabernero, J., Zwierzina, H., and Zielinski, C.

Published
2008
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43. A Randomized Open-Label Phase III Trial Evaluating the Addition of Denosumab to Standard First-Line Treatment in Advanced NSCLC: The European Thoracic Oncology Platform (ETOP) and European Organisation for Research and Treatment of Cancer (EORTC) SPLENDOUR Trial

Author

Peters, S. Danson, S. Hasan, B. Dafni, U. Reinmuth, N. Majem, M. Tournoy, K.G. Mark, M.T. Pless, M. Cobo, M. Rodriguez-Abreu, D. Falchero, L. Moran, T. Ortega Granados, A.L. Monnet, I. Mohorcic, K. Sureda, B.M. Betticher, D. Demedts, I. Macias, J.A. Cuffe, S. Luciani, A. Sanchez, J.G. Curioni-Fontecedro, A. Gautschi, O. Price, G. Coate, L. von Moos, R. Zielinski, C. Provencio, M. Menis, J. Ruepp, B. Pochesci, A. Roschitzki-Voser, H. Besse, B. Rabaglio, M. O'Brien, M.E.R. Stahel, R.A.

Abstract

Introduction: Receptor activator of NF-kB ligand stimulates NF-kB–dependent cell signaling and acts as the primary signal for bone resorption. Retrospective analysis of a large trial comparing denosumab versus zoledronic acid in bone metastatic solid tumors suggested significant overall survival (OS) advantage for patients with lung cancer with denosumab (p = 0.01). The randomized open-label phase III SPLENDOUR trial was designed to evaluate whether the addition of denosumab to standard first-line platinum-based doublet chemotherapy improved OS in advanced NSCLC. Methods: Patients with stage IV NSCLC were randomized in a 1:1 ratio to either chemotherapy with or without denosumab (120 mg every 3–4 wks), stratified by the presence of bone metastases (at diagnosis), Eastern Cooperative Oncology Group performance status, histology, and region. To detect an OS increase from 9 to 11.25 months (hazard ratio [HR] = 0.80), 847 OS events were required. The trial closed prematurely owing to decreasing accrual rate. Results: A total of 514 patients were randomized, with 509 receiving one or more doses of the assigned treatment (chemotherapy: 252, chemotherapy-denosumab: 257). The median age was 66.1 years, 71% were men, and 59% were former smokers. Bone metastases were identified in 275 patients (53%). Median OS (95% confidence interval [CI]) was 8.7 (7.6–11.0) months in the control arm versus 8.2 (7.5–10.4) months in the chemotherapy-denosumab arm (HR = 0.96; 95% CI: 0.78–1.19; one-sided p = 0.36). For patients with bone metastasis, HR was 1.02 (95% CI: 0.77–1.35), whereas for those without, HR was 0.90 (95% CI: 0.66–1.23). Adverse events grade 3 or greater were observed in 40.9%, 5.2%, 8.7% versus 45.5%, 10.9%, 10.5% of patients. Conditional power for OS benefit was less than or equal to 10%. Conclusions: Denosumab was well-tolerated without unexpected safety concerns. There was no OS improvement for denosumab when added to chemotherapy in the intention-to-treat population and the subgroups with and without bone metastases. Our data do not provide evidence of a clinical benefit for denosumab in patients with NSCLC without bone metastases. © 2020 International Association for the Study of Lung Cancer

Published
2020

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