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Kiesewetter B, Cherny NI, Boissel N, Cerisoli F, Dafni U, de Vries EGE, Ghia P, Gökbuget N, González-Calle V, Huntly B, Jäger U, Latino NJ, Douillard JY, Malcovati L, Mateos MV, Ossenkoppele GJ, Porkka K, Raderer M M.D, Ribera JM, Scarfò L, Wester R, Zygoura P, Sonneveld P.
EHA evaluation of the ESMO-Magnitude of Clinical Benefit Scale version 1.1 (ESMO-MCBS v1.1) for haematological malignancies.
ESMO Open 2020 January; 5 (1) pii: e000611. doi: 10.1136/esmoopen-2019-000611.


Molina-Vila MA, Stahel RA, Dafni U, Jordana-Ariza N, Balada-Bel A, Garzón-Ibáñez M, García-Peláez B, Mayo-de-Las-Casas C, Felip E, Fontecedro AC, Gautschi O, Peters S, Massutí B, Palmero R, Aix SP, Carcereny E, Früh M, Pless M, Popat S, Cuffe S, Bidoli P, Kammler R, Roschitzki-Voser H, Tsourti Z, Karachaliou N, Rosell R; results from the European Thoracic Oncology Platform (ETOP) BELIEF trial.
Evolution and clinical impact of EGFR mutations in circulating free DNA in the BELIEF trial.
Journal of Thoracic Oncology 2019 December; pii: S1556-0864(19)33715-3.

Wagner A D, Oertelt-Prigione S, Adjei A, Buclin T, Cristina V, Csajka C, Coukos G, Dafni U, Dotto G P, Ducreux M, Fellay J, Haanen J, Hocquelet A, Lemmens V, Letsch A, Mauer M, Moehler M, Peters S, Özdemir B C.
Gender Medicine and Oncology: A call for learning from each other. Report and consensus of an ESMO Workshop.
Annals of Oncology 2019 December; 30 (12): 1914-1924. doi: 10.1093/annonc/mdz414.

Thunnissen E, Kerr K M, Dafni U, Bubendorf L, Finn S P, Soltermann A, Biernat W, Cheney R, Verbeken E, Warth A, Marchetti A, Speel E M, Pokharel S, Quinn A M, Monkhorst K, Navarro A, Madsen L B, Tsourti Z, Geiger T, Kammler R, Peters S, Stahel R, for the Lungscape Consortium.
Programmed death-ligand 1 expression influenced by tissue sample size. Scoring based on tissue microarrays’ and cross-validation with resections, in patients with, stage I-III, non-small cell lung carcinoma of the European Thoracic Oncology Platform Lungscape cohort. Modern Pathology 2019 November; doi: 10.1038/s41379-019-0383-9.

Dafni U, Cherny N, de Vries E.
Correcting the Conclusion in a Study of Frameworks for Measurement of Absolute or Relative Clinical Survival Benefit.
JAMA Oncology 2019 October; 5 (12): 1807. doi:10.1001/jamaoncol.2019.4091.

Dafni U, Tsourti Z, Alatsathianos I.
Breast Cancer Statistics in the European Union: Incidence and Survival across European Countries.
Breast Care 2019 October; 14: 344-352. doi: 10.1159/000503219.

Dafni U, Tsourti Z, Vervita K, Peters S.
Immune checkpoint inhibitors, alone or in combination with chemotherapy, as first-line treatment for advanced non-small cell lung cancer.
A systematic review and network meta-analysis.
Lung Cancer 2019 August; 134: 127-140. doi: 10.1016/j.lungcan.2019.05.029.

Peters S, Felip E, Dafni U, Belka C, Guckenberger M, Irigoyen A, Nadal E, Becker A, Vees H, Pless M, Martinez-Marti A, Tufman A, Lambrecht M, Andratschke N, Piguet AC, Kassapian M, Roschitzki-Voser H, Rabaglio-Poretti M, Stahel RA, Vansteenkiste J, De Ruysscher D.
Safety evaluation of nivolumab added concurrently to radiotherapy in a standard first line chemo-radiotherapy regimen in stage III non-small cell lung cancer – The ETOP NICOLAS trial.
Lung Cancer 2019 July; 133: 83-87. doi: 10.1016/j.lungcan.2019.05.001.

Kerr KM, Thunnissen E, Dafni U, Finn SP, Bubendorf L, Soltermann A, Verbeken E, Biernat W, Warth A, Marchetti A, Speel EM, Pokharel S, Quinn AM, Monkhorst K, Navarro A, Madsen LB, Radonic T, Wilson J, De Luca G, Gray SG, Cheney R, Savic S, Martorell M, Muley T, Baas P, Meldgaard P, Blackhall F, Dingemans AM, Dziadziuszko R, Vansteenkiste J, Weder W, Polydoropoulou V, Geiger T, Kammler R, Peters S, Stahel R; Lungscape Consortium.
A retrospective cohort study of PD-L1 prevalence, molecular associations and clinical outcomes in patients with NSCLC: Results from the European Thoracic Oncology Platform (ETOP) Lungscape Project. Lung Cancer 2019 May; 131: 95-103. doi: 10.1016/j.lungcan.2019.03.012.

Dziadziuszko R, Smit EF, Dafni U, Wolf J, Wasąg B, Biernat W, Finn SP, Kammler R, Tsourti Z, Rabaglio M, Ruepp B, Roschitzki-Voser H, Stahel RA, Felip E, Peters S.
Afatinib in non-small cell lung cancer with HER2 mutations: results of the prospective, open-label phase II NICHE trial of European Thoracic Oncology Platform (ETOP).
J Thorac Oncol. 2019 Feb; pii: S1556-0864(19)30148-0. doi: 10.1016/j.jtho.2019.02.017. https://doi.org/10.1016/j.jtho.2019.02.017

Cherny NI, de Vries EGE, Dafni U, Garrett-Mayer E, McKernin SE, Piccart M, Latino NJ, Douillard JY, Schnipper LE, Somerfield MR, Bogaerts J, Karlis D, Zygoura P, Vervita K, Pentheroudakis G, Tabernero J, Zielinski Ch, Wollins DS, Schilsky RL.
Comparative Assessment of Clinical Benefit Using the ESMO-Magnitude of Clinical Benefit Scale Version 1.1 and the ASCO Value Framework Net Health Benefit Score.
Journal of Clinical Oncology 2019 Feb; 37 (4): 336-349. doi: 10.1200/JCO.18.00729.


Banerjee S, Dafni U, Allen T, Arnold D, Curigliano G, Garralda E, Garassino MC, Haanen J, Hofstädter-Thalmann E, Robert C, Sessa C, Tsourti Z, Zygoura P, Peters S.
Gender-related challenges facing oncologists: the results of the ESMO Women for Oncology Committee survey.
ESMO Open 2018 Sep 21; 3 (6): e000422. doi: 10.1136/esmoopen-2018-000422.

Hofstädter-Thalmann E, Dafni U, Allen T, Arnold A, Banerjee S, Curigliano G, Garralda E, Garassino MC, Haanen J, Robert C, Sessa C, Tsourti Z, Zygoura P, Peters S.
Report on the status of women occupying leadership roles in oncology.
ESMO Open 2018 Sep 21; 3 (6): e000423. doi: 10.1136/esmoopen-2018-000423.

Rulle U, Tsourti Z, Casanova R, Deml KF, Verbeken E, Thunnissen E, Warth A, Cheney R, Sejda A, Speel EJ, Madsen LB, Nonaka D, Navarro A, Sansano I, Marchetti A, Finn SP, Monkhorst K, Kerr KM, Haberecker M, Wu C, Zygoura P, Kammler R, Geiger T, Gendreau S, Schulze K, Vrugt B, Wild P, Moch H, Weder W, Ciftlik AT, Dafni U, Peters S, Bubendorf L, Stahel RA, Soltermann A.
Computer-based intensity measurement assists pathologists in scoring PTEN immunohistochemistry – Clinical associations in NSCLC patients of the ETOP Lungscape cohort
J Thorac Oncol. 2018 Dec; 13 (12): 1851-1863. doi: 10.1016/j.jtho.2018.08.2034.

Bellali T, Giannopoulou I, Tsourti Z, Malliarou M, Sarafis P, Minasidou E, Papadatou D.
Psychometric Properties of the Revised Death Attitude Profile in a Greek Sample of Nurses.
Journal of Nursing Measurement 2018, 26(2):264-277. doi: 10.1891/1061-3749.26.2.264

Cherny NI, Dafni U, Piccart M, Latino NJ, Douillard JY, Bogaerts J, Karlis D, Zygoura P, Pentheroudakis G, Tabernero J, Zielinski C, de Vries EGE.
Reply to the letter to the editor “ESMO-MCBS v1.1: statistical and patient relevant shortcomings” by Emprechtinger et al.
Annals of Oncology 2018 May 1, 29 (5):1335-1338. doi: 10.1093/annonc/mdy108.

Cherny NI, Dafni U, Bogaerts J, Latino NJ, Pentheroudakis G, Douillard JY, Tabernero J, Zielinski C, Piccart MJ, de Vries EGE.
RE: Magnitude of Clinical Benefit of Cancer Drugs Approved by the US Food and Drug Administration.
J Natl Cancer Inst. 2018 Oct 1; 110 (10): 1142-1143. doi: 10.1093/jnci/djy029.

Cherny NI, Dafni U, Bogaerts J, Latino NJ, Pentheroudakis G, Douillard JY, Tabernero J, Zielinski C, Piccart MJ, de Vries EGE.
Reply to the letter to the editor “Re-aligning the ASCO and ESMO clinical benefit frameworks or modern cancer therapies”.
Annals of Oncology 2018 Mar 1, 29 (3):774-775. doi: 10.1093/annonc/mdx747.

Filipits M, Dafni U, Gnant M, Polydoropoulou V, Hills M, Kiermaier A, De Azambuja E, Larsimont DP, Rojo F, Viale G, Toi M, Harbeck N, Pritchard KI, Gelber RD, Dinh P, Zardavas D, Leyland-Jones B, Piccart-Gebhart M, Dowsett M.
Association of p27 and cyclin D1 expression and benefit from adjuvant trastuzumab treatment in HER2-positive early breast cancer: a TransHERA study.
Clin Cancer Res. 2018 Jul 1;24(13):3079-3086. doi: 10.1158/1078-0432.CCR-17-3473.

Letovanec I, Finn S, Zygoura P, Smyth P, Soltermann A, Bubendorf L, Speel EJ, Marchetti A, Nonaka D, Monkhorst K, Hager H, Martorell M, Sejda A, Cheney R, Hernandez-Losa J, Verbeken E, Weder W, Savic S, Di Lorito A, Navarro A, Felip E, Warth A, Baas P, Meldgaard P, Blackhall F, Dingemans AM, Dienemann H, Dziadziuszko R, Vansteenkiste J, O’Brien C, Geiger T, Sherlock J, Schageman J, Dafni U, Kammler R, Kerr KM, Thunnissen E, Stahel R, Peters S; ETOP Lungscape Consortium.
Evaluation of NGS and RT-PCR methods for ALK rearrangement in European NSCLC patients: Results from the ETOP Lungscape Project.
Journal of Thoracic Oncology 2018; 13 (3): 413-425. doi: 10.1016/j.jtho.2017.11.117.

Cherny NI, Dafni U, Bogaerts J, Latino NJ, Pentheroudakis G, Douillard JY, Tabernero J, Zielinski C, Piccart MJ, de Vries EGE.
Reply to the letter to the editor ‘Toxicity adjustment in the ESMO-MCBS: a Gestalt approach?’ by Del Paggio.
Annals of Oncology 2018 Feb 1; 29 (2): 521-522. doi: 10.1093/annonc/mdx649.

Kerr KM, Dafni U, Schulze K, Thunnissen E, Bubendorf L, Hager H, Finn S, Biernat W, Vliegen L, Losa JH, Marchetti A, Cheney R, Warth A, Speel EJ, Blackhall F, Monkhorst K, Jantus Lewintre E, Tischler V, Clark C, Bertran-Alamillo J, Meldgaard P, Gately K, Wrona A, Vandenberghe P, Felip E, De Luca G, Savic S, Muley T, Smit EF, Dingemans AC, Priest L, Baas P, Camps C, Weder W, Polydoropoulou V, Geiger TR, Kammler R, Sumiyoshi T, Molina MA, Shames DS, Stahel RA, Peters S; ETOP Lung-scape Consortium.
Prevalence and clinical association of gene mutations through multiplex mutation testing in patients with NSCLC: results from the ETOP Lungscape Project.
Annals of Oncology 2018 Jan 1; 29 (1): 200-208. doi: 10.1093/annonc/mdx629.


Dafni U, Karlis D, Pedeli X, Bogaerts J, Pentheroudakis G, Tabernero J, Zielinski CC, Piccart MJ, de Vries EGE, Latino NJ, Douillard JY, Cherny NI.
Detailed statistical assessment of the characteristics of the ESMO Magnitude of Clinical Benefit Scale (ESMO-MCBS) threshold rules.
ESMO Open 2017; 2 (4): e000216.

Cherny NI, Dafni U, Bogaerts J, Latino NJ, Pentheroudakis G, Douillard JY, Tabernero J, Zielinski C, Piccart MJ, de Vries EGE.
ESMO-Magnitude of Clinical Benefit Scale Version 1.1.
Annals of Oncology 2017; 28 (10): 2340-2366.

Bubendorf L, Dafni U, Schobel M, Finn SP, Tischler V, Sejda A, Marchetti A, Thunnissen E, Verbeken EK, Warth A, Sansano I, Cheney T, Speel EJM, Daisuke Nonaka D, Monkhorst K, Hager H, Martorell M, Savic S, Kerr KM, Tan Q, Tsourti Z, Geiger TR, Kammler R, Schulze K, Das-Gupta A, Shames D, Peters S, Stahel RA; Lungscape Consortium.
Prevalence and clinical association of MET gene overexpression and amplification in patients with NSCLC: Results from the European Thoracic Oncology Platform (ETOP) Lungscape project.
Lung Cancer 2017; 111: 143-149.

Rosell R, Dafni U, Felip E, Curioni-Fontecedro A, Gautschi O, Peters S, Massuti B, Palmero R, Ponce Aix, S, Carcereny E, Fruh M, Pless M, Popat S, Kotsakis A, Cuffe S, Bidoli P, Favaretto A, Froesch P, Reguart N, Puente J, Coate L, Barlesi F, Rauch D, Thomas M, Camps, C, Gomez-Codina J, Majem M, Porta R, Shah R, Hanrahan, E. Kammler R, Ruepp B, Rabaglio M, Kassapian M, Karachaliou N, Tam R, Shames DS, Molina-Vila MA, Stahel RA;
BELIEF collaborative group.
Erlotinib and bevacizumab in patients with advanced non-small-cell lung cancer and activating EGFR mutations (BELIEF): an international, multicentre, single-arm, phase 2 trial.
Lancet Respiratory Medicine 2017; 5 (5): 435-444.

Peters S, Stahel RA, Dafni U, Ponce Aix S, Massuti B, Gautschi O, Coate L, Lopez Martin A, van Heemst R, Berghmans T, Meldgaard P, Cobo Dols M, Garde Noguera J, Curioni-Fontecedro A, Rauch D, Mark MT, Cuffe S, Biesma B, van Henten AMJ, Juan Vidal O, Palmero Sanchez R, Villa Guzmanu JC, Collado Martin R, Peralta S, Insa A, Summers Y, Lang I, Horgan A, Ciardiello F, de Hosson S, Pieterman R, Groen HJM, van den Berg PM, Zielinski CC, Chittazhathu Kurian Kuruvilla Y, Gasca-Ruchti A, Kassapian M, Novello S, Torri V, Tsourti Z, Gregorc V, Smit EF; EMPHASIS-lung collaborative group.
Randomized phase III trial of erlotinib versus docetaxel in patients with advanced squamous cell non-small cell lung cancer failing first line platinum-based doublet chemotherapy stratified by Veristrat good versus Veristrat poor. The European Thoracic Oncology Platform (ETOP) EMPHASIS-lung trial.
Journal of Thoracic Oncology 2017; 12 (4): 752-762.


Gomez G, Plana-Ripoll O, Dafni U.
Selection of the primary end point in an observational cohort study.
Journal of Epidemiology and Community Health 2016; 70 (10): 950-953.

Loi S, Dafni U, Karlis D, Polydoropoulou V, Young BM, Willis S, Long B, de Azambuja E, Sotiriou C, Viale G, Ruschoff J, Piccart MJ, Dowsett M, Michiels S, Leyland-Jones B; August, 2016
Effects of Estrogen Receptor and Human Epidermal Growth Factor Receptor-2 Levels on the Efficacy of Trastuzumab: A Secondary Analysis of the HERA Trial.
JAMA Oncology 2016; 2 (8): 1040-1047.

Rolfo C, Caglevic C, Bretel D, Hong D, Raez LE, Cardona AF, Oton AB, Gomez H, Dafni U, Vallejos C, Zielinski C.
Cancer clinical research in Latin America: current situation and opportunities. Expert opinion from the first ESMO workshop on clinical trials, Lima, 2015.
ESMO Open. 2016; 1 (4): e000055.


Cherny NI, Sullivan R, Dafni U, Kerst JM, Sobrero A, Zielinski C, de Vries EG, Piccart MJ.
A standardised, generic, validated approach to stratify the magnitude of clinical benefit that can be anticipated from anti-cancer therapies: the European Society for Medical Oncology Magnitude of Clinical Benefit Scale (ESMO-MCBS).
Annals of oncology 2015; 26 (8): 1547-1573.

Psyrri A, Economopoulou P, Dafni U.
Reply to D. Adkins et al.
Journal of Clinical Oncology 2015; 33 (10): 1224-1225.


Peters S, Weder W, Dafni U, Kerr KM, Bubendorf L, Meldgaard P, O’Byrne KJ, Wrona A, Vansteenkiste J, Felip E, Marchetti A, Savic S, Lu S, Smit E, Dingemans AMC, Blackhall FH, Baas P, Camps C, Rosell R, and Stahel RA; ETOP Lungscape Investigators.
Lungscape: resected non-small cell lung cancer outcome by clinical and pathological parameters.
Journal of Thoracic Oncology 2014; 9 (11): 1675-1684.

Blackhall FH, Peters S, Bubendorf L, Dafni U, Kerr KM, Hager H, Soltermann A, O’Byrne KJ, Dooms C, Sejda A, Hernandez-Losa J, Marchetti A, Savic S, Tan Q, Thunnissen E, Speel EJM, Cheney R, Nonaka D, de Jong J, Martorell M, Letovanec I, Rosell R, and Stahel RA.
Prevalence and Clinical Outcomes for Patients with ALK-Positive Resected Stage I to III Adenocarcinoma: Results from the European Thoracic Oncology Platform Lungscape Project.
Journal of Clinical Oncology 2014; 32 (25): 2780-2787.

Bakalidou D, Voumvourakis K., Tsourti Z, Papageorgiou E, Poulios A, Giannopoulos S.
Validity and reliability of the Greek version of the Modified Fatigue Impact Scale in multiple sclerosis patients.
International Journal of Rehabilitation Research 2014; 37 (3): 271-276.

Poulopoulou S, Karlis D, Yiannoutsos CT, Dafni U.
Phase II design with sequential testing of hypotheses within each stage.
Journal of Biopharmaceutical Statistics 2014; 24 (4): 768-784.

Gomez G, Gomez-Mateu M, Dafni U.
Informed choice of composite end points in cardiovascular trials.
Circulation: Cardiovascular Quality and Outcomes 2014; 7 (1): 170-1788.


Zabaglo L, Stoss O, Ruschoff J, Zielinski D, Salter J, Arfi M, Bradbury I, Dafni U, Piccart-Gebhart M, Procter M, Dowsett M, for the HERA Trial Study Team
HER2 staining intensity in HER2-positive disease: relationship with FISH amplification and clinical outcome in the HERA trial of adjuvant trastuzumab.
Annals of Oncology 2013; 24 (11): 2761–2766.


Weder W, Stahel RA, Baas P, Dafni U, de Perrot M, McCaughan BC, Nakano T, Pass HI, Robinson BW, Rusch VW, Sugarbaker DJ, van Zandwijk N.
The MARS feasibility trial: conclusions not supported by data.
Lancet Oncology 2011; 12 (12): 1093-1094.

Dafni U.
Landmark analysis at the 25-year landmark point.
Circulation: Cardiovascular Quality and Outcomes 2011; 4 (3): 363-371.

Gianni L, Dafni U, Gelber R, Azambuja E, Muehlbauer S, Goldhirsch A, Untch M, Smith I, Baselga J, Jackisch C, Cameron D, Mano M, Pedrini J, Veronesi A, Mendiola C, Pluzanska A, Semiglazov V, Vrdoljak E, Eckart M, Shen Z, Skiadopoulos G, Procter M, Pritchard K, Piccart-Gebhart M, Bell R, for the Herceptin Adjuvant (HERA) Trial Study Team.
Treatment with trastuzumab for 1 year after adjuvant chemotherapy in patients with HER2-positive early breast cancer: a 4-year follow-up of a randomized controlled trial.
Lancet Oncology 2011; 12(3): 236-244.


Procter M, Suter T, Azambuja E, Dafni U, Van Dooren V, Muehlbauer S, Climent MA, Rechberger E, Tsang-Wu Liu W, Toi M, Coombes C, Dodwell D, Pagani O, Madrid J, Hall M, Chen S, Focan C, Muschol M, Van Veldhuisen D, Piccart-Gebhart M.
Longer-Term Assessment of Trastuzumab-Related Cardiac Adverse Events in the Herceptin Adjuvant (HERA) Trial.
Journal of Clinical Oncology 2010; 28 (21): 3422-3428.

Pectasides E, Egloff AM, Sasaki C, Kountourakis P, Burtness B, Fountzilas G, Dafni U, Zaramboukas T, Rampias T, Rimm D, Grandis J, Psyrri A.
Nuclear localization of signal transducer and activator of transcription 3 in head and neck squamous cell carcinoma is associated with a better prognosis.
Clinical Cancer Research 2010; 16 (8): 2427-2434.


Briasoulis E, Pappas P, Puozzo C, Tolis C, Fountzilas G, Dafni U, Marselos M, Pavlidis N.
Dose-ranging study of metronomic oral vinorelbine in patients with advanced refractory cancer.
Clinical Cancer Research 2009; 15 (20): 6454-6461.

Dowsett M, Procter M, McCaskill-Stevens W, Azambuja E, Dafni U, Rueschoff J, Jordan B, Dolci S, Abramovitz M, Stoss O, Viale G, Gelber R, Piccart-Gebhart M, Leyland-Jones B.
Disease-Free Survival According to Degree of HER2 Amplification for Patients Treated with Adjuvant Chemotherapy with or without 1 Year of Trastuzumab The HERA Trial.
Journal of Clinical Oncology 2009; 27 (18): 2962-2969.