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  1. Article ; Online: Characteristics and Survival Outcomes of Patients With Metastatic

    Hackshaw, Allan / Fajardo, Otto / Dafni, Urania / Gelderblom, Hans / Garrido, Pilar / Siena, Salvatore / Taylor, Matthew H / Bordogna, Walter / Nikolaidis, Christos

    JCO precision oncology

    2024  Volume 8, Page(s) e2300334

    Abstract: Purpose: RET: Methods: Data for RET TKI-naïve patients with metastatic solid tumors (excluding NSCLC) who had ≥one Foundation Medicine comprehensive genomic profiling test (January 1, 2011-March 31, 2022) were obtained from a deidentified nationwide ( ...

    Abstract Purpose: RET
    Methods: Data for RET TKI-naïve patients with metastatic solid tumors (excluding NSCLC) who had ≥one Foundation Medicine comprehensive genomic profiling test (January 1, 2011-March 31, 2022) were obtained from a deidentified nationwide (US-based) clinicogenomic database. The primary objective of this study was to compare the overall survival (OS) of patients with
    Results: The study population included 26 patients in the
    Conclusion: These data suggest that
    MeSH term(s) Humans ; Carcinoma, Non-Small-Cell Lung/drug therapy ; Carcinoma, Non-Small-Cell Lung/genetics ; Carcinoma, Non-Small-Cell Lung/pathology ; Lung Neoplasms/drug therapy ; Lung Neoplasms/genetics ; Lung Neoplasms/pathology ; Proto-Oncogene Proteins c-ret/genetics ; Standard of Care ; Prognosis
    Chemical Substances Proto-Oncogene Proteins c-ret (EC 2.7.10.1) ; RET protein, human (EC 2.7.10.1)
    Language English
    Publishing date 2024-01-25
    Publishing country United States
    Document type Journal Article
    ISSN 2473-4284
    ISSN (online) 2473-4284
    DOI 10.1200/PO.23.00334
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  2. Article ; Online: Landmark analysis at the 25-year landmark point.

    Dafni, Urania

    Circulation. Cardiovascular quality and outcomes

    2011  Volume 4, Issue 3, Page(s) 363–371

    Abstract: This statistical primer presents the landmark analysis method, exploring its appropriate use and interpretation while recognizing its limitations. This observational method is used for comparing time-to-event outcome between groups determined during ... ...

    Abstract This statistical primer presents the landmark analysis method, exploring its appropriate use and interpretation while recognizing its limitations. This observational method is used for comparing time-to-event outcome between groups determined during study follow-up. The goal of the landmark method is to estimate in an unbiased way the time-to-event probabilities in each group conditional on the group membership of patients at a specific time point, the landmark time. The need that led to its development, the impact of the method, and its pros and cons, along with available alternative approaches, are presented. Simulations explore its performance, using realistic parameters from a recent cardiovascular study. As long as the limitations of the method are recognized and the interpretation of its results clearly reflect their "conditional" nature, landmark analysis, 25 years from its introduction, can still be of value.
    MeSH term(s) History, 20th Century ; History, 21st Century ; Humans ; Models, Statistical ; Observer Variation ; Outcome Assessment (Health Care)/history ; Outcome Assessment (Health Care)/methods ; Probability ; Prognosis ; Research Design ; Survival Analysis ; Time Factors
    Language English
    Publishing date 2011-05
    Publishing country United States
    Document type Historical Article ; Journal Article ; Review
    ZDB-ID 2483197-9
    ISSN 1941-7705 ; 1941-7713
    ISSN (online) 1941-7705
    ISSN 1941-7713
    DOI 10.1161/CIRCOUTCOMES.110.957951
    Database MEDical Literature Analysis and Retrieval System OnLINE

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    Zs.A 6744: Show issues Location:
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  3. Article ; Online: 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.

    Dafni, Urania / Tsourti, Zoi / Vervita, Katerina / Peters, Solange

    Lung cancer (Amsterdam, Netherlands)

    2019  Volume 134, Page(s) 127–140

    Abstract: This network meta-analysis (NMA), based on 12 phase-III studies with 9,236 metastatic NSCLC patients, aims to compare the efficacy of treatments including at least one immune-checkpoint inhibitor (ICI) with or without chemotherapy, as frontline therapy ... ...

    Abstract This network meta-analysis (NMA), based on 12 phase-III studies with 9,236 metastatic NSCLC patients, aims to compare the efficacy of treatments including at least one immune-checkpoint inhibitor (ICI) with or without chemotherapy, as frontline therapy for advanced NSCLC patients. The NMA includes direct randomized evidence on treatments of interest along with indirect evidence from randomized studies with chemotherapy as the common comparator. Studies were identified by searching PubMed, and the abstracts of most recent main oncology congresses. The primary endpoint, Hazard-Ratio (HR) of Progression-free Survival (PFS), was estimated by a frequentist-approach NMA. Results are presented in the overall cohort (all-comers or PD-L1-positive) irrespective of histology, and by histology, PD-L1 expression level and sex. According to the primary PFS-NMA in the overall cohort, the combination of chemotherapy, first with pembrolizumab, second with atezolizumab exhibit significantly higher benefit than any other treatment examined. This superior PFS benefit is found for both squamous and non-squamous patients. Similarly for OS, the combination of pembrolizumab/chemotherapy, and atezolizumab/bevacizumab/chemotherapy-(ABC), followed by pembrolizumab-monotherapy and atezolizumab/chemotherapy, are the best treatments in the overall cohort, driven by the non-squamous histology. In the PD-L1-high patients again the combination of chemotherapy with atezolizumab or pembrolizumab, exhibit significant PFS benefit, followed by pembrolizumab-monotherapy. PFS benefit of these ICI/chemotherapy combinations are also found in PD-L1-negative and PD-L1-intermediate patients(1%≤PD-L1 < 50%). Of note, ABC is evaluated only for OS in non-squamous patients while the pembrolizumab-monotherapy PFS benefit and the atezolizumab/chemotherapy OS benefit are probably under-estimated since most of the data stems from non-significant interim analyses of ongoing studies [KN042;IM131/132/150]. In conclusion, the addition of chemotherapy to ICIs enhanced their treatment efficacy as first-line treatment for advanced NSCLC patients. The combination of chemotherapy with either pembrolizumab or atezolizumab show consistently higher efficacy than chemotherapy-alone or any other ICI-combination or monotherapy, particularly in non-squamous patients.
    MeSH term(s) Antineoplastic Agents, Immunological/administration & dosage ; Antineoplastic Agents, Immunological/adverse effects ; Antineoplastic Agents, Immunological/therapeutic use ; Antineoplastic Combined Chemotherapy Protocols/adverse effects ; Antineoplastic Combined Chemotherapy Protocols/therapeutic use ; B7-H1 Antigen/genetics ; Biomarkers, Tumor ; Carcinoma, Non-Small-Cell Lung/drug therapy ; Carcinoma, Non-Small-Cell Lung/etiology ; Carcinoma, Non-Small-Cell Lung/mortality ; Carcinoma, Non-Small-Cell Lung/pathology ; Female ; Gene Expression ; Humans ; Liver Neoplasms/secondary ; Lung Neoplasms/drug therapy ; Lung Neoplasms/etiology ; Lung Neoplasms/mortality ; Lung Neoplasms/pathology ; Male ; Molecular Targeted Therapy ; Mutation ; Neoplasm Metastasis ; Neoplasm Staging ; Prognosis
    Chemical Substances Antineoplastic Agents, Immunological ; B7-H1 Antigen ; Biomarkers, Tumor ; CD274 protein, human
    Language English
    Publishing date 2019-05-30
    Publishing country Ireland
    Document type Journal Article ; Meta-Analysis ; Systematic Review
    ZDB-ID 632771-0
    ISSN 1872-8332 ; 0169-5002
    ISSN (online) 1872-8332
    ISSN 0169-5002
    DOI 10.1016/j.lungcan.2019.05.029
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    Zs.MO 423: Show issues

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  4. Article: Breast Cancer Statistics in the European Union: Incidence and Survival across European Countries.

    Dafni, Urania / Tsourti, Zoi / Alatsathianos, Ioannis

    Breast care (Basel, Switzerland)

    2019  Volume 14, Issue 6, Page(s) 344–353

    Abstract: The current status and time trends in breast cancer incidence and survival in the 28 European Union countries (EU-28) is presented here. Rates reported are age adjusted and standardized (ASR). A high incidence and high survival rates were observed in the ...

    Abstract The current status and time trends in breast cancer incidence and survival in the 28 European Union countries (EU-28) is presented here. Rates reported are age adjusted and standardized (ASR). A high incidence and high survival rates were observed in the Northern and Western European countries, with the exception of the Baltic countries. The higher incidence is partly attributed to the higher prevalence of lifestyle risk factors, while the higher survival is attributed to better access to beneficial treatments and general health care. Most of the countries in Southern Europe or the former Eastern Bloc have not yet reached the high GDP per capita status (2017 purchasing power parity; PPP) of the earlier established Western democracies. The breast cancer incidence and survival are associated with the PPP level (both higher for the higher PPP category; 2017 PPP above USD 40,000). Overall, a trend toward higher survival rates was observed throughout this first period of the 21st century, with the incidence for most countries either stabilizing at the 2010 levels or decreasing further.
    Language English
    Publishing date 2019-10-08
    Publishing country Switzerland
    Document type Systematic Review
    ZDB-ID 2202236-3
    ISSN 1661-3805 ; 1661-3791
    ISSN (online) 1661-3805
    ISSN 1661-3791
    DOI 10.1159/000503219
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    Zs.A 6620: Show issues Location:
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  5. Article ; Online: Correcting the Conclusion in a Study of Frameworks for Measurement of Absolute or Relative Clinical Survival Benefit.

    Dafni, Urania / Cherny, Nathan I / de Vries, Elisabeth G E

    JAMA oncology

    2019  Volume 5, Issue 12, Page(s) 1807

    Language English
    Publishing date 2019-10-15
    Publishing country United States
    Document type Letter ; Comment
    ISSN 2374-2445
    ISSN (online) 2374-2445
    DOI 10.1001/jamaoncol.2019.4091
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  6. Article ; Online: Randomized phase II selection trial of FLASH and conventional radiotherapy for patients with localized cutaneous squamous cell carcinoma or basal cell carcinoma: A study protocol.

    Kinj, Rémy / Gaide, Olivier / Jeanneret-Sozzi, Wendy / Dafni, Urania / Viguet-Carrin, Stéphanie / Sagittario, Enea / Kypriotou, Magdalini / Chenal, Julie / Duclos, Frederic / Hebeisen, Marine / Falco, Teresa / Geyer, Reiner / Gonçalves Jorge, Patrik / Moeckli, Raphaël / Bourhis, Jean

    Clinical and translational radiation oncology

    2024  Volume 45, Page(s) 100743

    Abstract: Background: Cutaneous basal cell carcinoma (BCC) and squamous cell carcinoma (SCC) are the most prevalent skin cancers in western countries. Surgery is the standard of care for these cancers and conventional external radiotherapy (CONV-RT) with ... ...

    Abstract Background: Cutaneous basal cell carcinoma (BCC) and squamous cell carcinoma (SCC) are the most prevalent skin cancers in western countries. Surgery is the standard of care for these cancers and conventional external radiotherapy (CONV-RT) with conventional dose rate (0.03-0.06 Gy/sec) represents a good alternative when the patients or tumors are not amenable to surgery but routinely generates skin side effects. Low energy electron FLASH radiotherapy (FLASH-RT) is a new form of radiotherapy exploiting the biological advantage of the FLASH effect, which consists in delivering radiation dose in milliseconds instead of minutes in CONV-RT. In pre-clinical studies, when compared to CONV-RT, FLASH-RT induced a robust, reproducible and remarkable sparing of the normal healthy tissues, while the efficacy on tumors was preserved. In this context, we aim to prospectively evaluate FLASH-RT versus CONV-RT with regards to toxicity and oncological outcome in localized cutaneous BCC and SCC.
    Methods: This is a randomized selection, non-comparative, phase II study of curative FLASH-RT versus CONV-RT in patients with T1-T2 N0 M0 cutaneous BCC and SCC. Patients will be randomly allocated to low energy electron FLASH-RT (dose rate: 220-270 Gy/s) or to CONV-RT arm. Small lesions (T1) will receive a single dose of 22 Gy and large lesions (T2) will receive 30 Gy in 5 fractions of 6 Gy over two weeks.The primary endpoint evaluates safety at 6 weeks after RT through grade ≥ 3 toxicity and efficacy through local control rate at 12 months. Approximately 60 patients in total will be randomized, considering on average 1-2 lesions and a maximum of 3 lesions per patients corresponding to the total of 96 lesions required. FLASH-RT will be performed using the Mobetron® (IntraOp, USA) with high dose rate functionality.LANCE (NCT05724875) is the first randomized trial evaluating FLASH-RT and CONV-RT in a curative setting.
    Language English
    Publishing date 2024-02-08
    Publishing country Ireland
    Document type Journal Article
    ISSN 2405-6308
    ISSN (online) 2405-6308
    DOI 10.1016/j.ctro.2024.100743
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  7. Article ; Online: Combining cetuximab with chemoradiotherapy in locally advanced head and neck squamous cell carcinoma: is more better?

    Psyrri, Amanda / Dafni, Urania

    Journal of clinical oncology : official journal of the American Society of Clinical Oncology

    2014  Volume 32, Issue 27, Page(s) 2929–2931

    MeSH term(s) Antineoplastic Combined Chemotherapy Protocols/therapeutic use ; Carcinoma, Squamous Cell/therapy ; Chemoradiotherapy ; Female ; Head and Neck Neoplasms/therapy ; Humans ; Male
    Language English
    Publishing date 2014-09-20
    Publishing country United States
    Document type Comment ; Editorial
    ZDB-ID 604914-x
    ISSN 1527-7755 ; 0732-183X
    ISSN (online) 1527-7755
    ISSN 0732-183X
    DOI 10.1200/JCO.2014.56.1902
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    Zs.A 1847: Show issues Location:
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    Zs.MO 650: Show issues

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  8. Article: Breast Cancer Statistics in the European Union: Incidence and Survival across European Countries

    Dafni, Urania / Tsourti, Zoi / Alatsathianos, Ioannis

    Breast Care

    2019  Volume 14, Issue 6, Page(s) 344–353

    Abstract: The current status and time trends in breast cancer incidence and survival in the 28 European Union countries (EU-28) is presented here. Rates reported are age adjusted and standardized (ASR). A high incidence and high survival rates were observed in the ...

    Institution Laboratory of Biostatistics, Faculty of Nursing, National and Kapodistrian University of Athens, Athens, Greece
    Frontier Science Foundation Hellas, Athens, Greece
    Abstract The current status and time trends in breast cancer incidence and survival in the 28 European Union countries (EU-28) is presented here. Rates reported are age adjusted and standardized (ASR). A high incidence and high survival rates were observed in the Northern and Western European countries, with the exception of the Baltic countries. The higher incidence is partly attributed to the higher prevalence of lifestyle risk factors, while the higher survival is attributed to better access to beneficial treatments and general health care. Most of the countries in Southern Europe or the former Eastern Bloc have not yet reached the high GDP per capita status (2017 purchasing power parity; PPP) of the earlier established Western democracies. The breast cancer incidence and survival are associated with the PPP level (both higher for the higher PPP category; 2017 PPP above USD 40,000). Overall, a trend toward higher survival rates was observed throughout this first period of the 21st century, with the incidence for most countries either stabilizing at the 2010 levels or decreasing further.
    Keywords Breast cancer ; Epidemiology ; Incidence ; Survival rate ; European Union
    Language English
    Publishing date 2019-10-08
    Publisher S. Karger AG
    Publishing place Basel, Switzerland
    Document type Article
    Note Systematic Review
    ZDB-ID 2202236-3
    ISSN 1661-3805 ; 1661-3791
    ISSN (online) 1661-3805
    ISSN 1661-3791
    DOI 10.1159/000503219
    Database Karger publisher's database

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  9. Article ; Online: Selection of the primary end point in an observational cohort study.

    Gómez, Guadalupe / Plana-Ripoll, Oleguer / Dafni, Urania

    Journal of epidemiology and community health

    2016  Volume 70, Issue 10, Page(s) 950–953

    Language English
    Publishing date 2016-10
    Publishing country England
    Document type Journal Article
    ZDB-ID 391868-3
    ISSN 1470-2738 ; 0142-467X ; 0141-7681 ; 0143-005X
    ISSN (online) 1470-2738
    ISSN 0142-467X ; 0141-7681 ; 0143-005X
    DOI 10.1136/jech-2015-206656
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    Zs.A 186: Show issues Location:
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  10. Article ; Online: The impact of erythropoiesis-stimulating agents administration concomitantly with adjuvant anti-HER2 treatments on the outcomes of patients with early breast cancer: a sub-analysis of the ALTTO study.

    Martins-Branco, Diogo / Kassapian, Marie / Debien, Véronique / Caparica, Rafael / Eiger, Daniel / Dafni, Urania / Andriakopoulou, Charitini / El-Abed, Sarra / Ellard, Susan L / Izquierdo, Miguel / Vicente, Malou / Chumsri, Saranya / Piccart-Gebhart, Martine / Moreno-Aspitia, Alvaro / Knop, Ann Søegaard / Lombard, Janine / de Azambuja, Evandro

    Breast cancer research and treatment

    2023  Volume 203, Issue 3, Page(s) 497–509

    Abstract: Purpose: To assess whether erythropoiesis-stimulating agents (ESA) administration impacts the outcomes of patients with HER2-positive early breast cancer (EBC).: Methods: ALTTO (NCT00490139) patients were categorized by ESA use during adjuvant anti- ... ...

    Abstract Purpose: To assess whether erythropoiesis-stimulating agents (ESA) administration impacts the outcomes of patients with HER2-positive early breast cancer (EBC).
    Methods: ALTTO (NCT00490139) patients were categorized by ESA use during adjuvant anti-HER2 treatment. Disease-free-survival (DFS), overall survival (OS), and time-to-distant recurrence (TTDR) were analyzed by ESA administration, with subgroup analyses according to prognostic factors. Log-rank tests and Cox modeling were performed. Adverse events (AEs) of ESA-interest were compared.
    Results: Among 8381 patients recruited in ALTTO, 123 (1.5%) received ESA concomitantly with study treatment. The median age of patients receiving ESA was 54 years, 39.0% premenopausal, most had tumor size > 2 cm (56.9%), node-positive (58.5%), and positive estrogen receptor expression (61.8%). Median follow-up was shorter in the ESA group [6.1 years (IQR 5.3-7.0) vs. 6.9 years (6.0-7.1); p < 0.001]. There was no DFS difference by ESA administration (log-rank p = 0.70), with 3- and 7-year DFS of 89.2% (95% CI 81.8-93.8%) and 81.6% (71.4-88.5%) in ESA group vs. 88.3% (87.6-89.0%) and 80.0% (79.1-80.9%) in No-ESA group. In subgroup analyses, the interaction of ESA administration with menopausal status was statistically significant (unadjusted p = 0.024; stratified p = 0.033), favoring premenopausal women receiving ESA. We observed no significant association of ESA administration with OS (log-rank p = 0.57; 7-year OS in ESA 88.6% vs. 90.0% in non-ESA) or TTDR. ESA-interest AEs were experienced by eight (6.5%) patients receiving ESA and 417 (5.1%) in the No-ESA group (p = 0.41).
    Conclusion: ESA administration to patients receiving adjuvant anti-HER2 treatment for HER2-positive EBC was safe and not associated with a negative impact on survival outcomes.
    MeSH term(s) Humans ; Female ; Middle Aged ; Breast Neoplasms/pathology ; Trastuzumab/adverse effects ; Receptor, ErbB-2/metabolism ; Erythropoiesis ; Treatment Outcome ; Disease-Free Survival ; Chemotherapy, Adjuvant/adverse effects ; Antineoplastic Combined Chemotherapy Protocols/adverse effects
    Chemical Substances Trastuzumab (P188ANX8CK) ; Receptor, ErbB-2 (EC 2.7.10.1)
    Language English
    Publishing date 2023-11-08
    Publishing country Netherlands
    Document type Journal Article
    ZDB-ID 604563-7
    ISSN 1573-7217 ; 0167-6806
    ISSN (online) 1573-7217
    ISSN 0167-6806
    DOI 10.1007/s10549-023-07159-9
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