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  1. Article: Expert Discussion: ASCO 2021.

    Paluch-Shimon, Shani / Gelmon, Karen A / Eniu, Alexandru / Gligorov, Joseph

    Breast care (Basel, Switzerland)

    2021  Volume 16, Issue 4, Page(s) 429–432

    Language English
    Publishing date 2021-07-23
    Publishing country Switzerland
    Document type Journal Article
    ZDB-ID 2202236-3
    ISSN 1661-3805 ; 1661-3791
    ISSN (online) 1661-3805
    ISSN 1661-3791
    DOI 10.1159/000518369
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  2. Article ; Online: The educational contribution of the college of the European school of oncology (ESCO): A survey analysis of the first three years.

    Hall, Corinne / Eniu, Alexandru / Rassy, Elie / Cavalli, Franco / Costa, Alberto / Peccatori, Fedro / Rolfo, Christian / Pavlidis, Nicholas

    Critical reviews in oncology/hematology

    2023  Volume 192, Page(s) 104145

    Abstract: In July 2020, the European School of Oncology (ESO) launched ESCO www.esco.org - the College of the European School of Oncology. ESCO provides young oncologists with a structured educational pathway and access to dedicated career development benefits. ... ...

    Abstract In July 2020, the European School of Oncology (ESO) launched ESCO www.esco.org - the College of the European School of Oncology. ESCO provides young oncologists with a structured educational pathway and access to dedicated career development benefits. The College is organized into three progressive levels which members reach by earning credits that are awarded to them as they follow the pathway and actively improve their oncology careers. In this article, we present and evaluate the success of ESCO and highlight how its stimulating structure and personalized career development opportunities satisfy and encourage oncologists (medical, surgical and radiation) to continue to develop and improve their knowledge and skills.
    MeSH term(s) Humans ; Medical Oncology ; Educational Status ; Surveys and Questionnaires ; Oncologists
    Language English
    Publishing date 2023-10-01
    Publishing country Netherlands
    Document type Journal Article ; Review
    ZDB-ID 605680-5
    ISSN 1879-0461 ; 0737-9587 ; 1040-8428
    ISSN (online) 1879-0461
    ISSN 0737-9587 ; 1040-8428
    DOI 10.1016/j.critrevonc.2023.104145
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  3. Article: Breast Cancer: Reimbursement Policies and Adoption of New Therapeutic Agents by National Health Systems.

    Trapani, Dario / Curigliano, Giuseppe / Eniu, Alexandru

    Breast care (Basel, Switzerland)

    2019  Volume 14, Issue 6, Page(s) 373–381

    Abstract: Background: Breast cancer is a cause of morbidity for more than half a million of patients in Europe, resulting in broad societal impacts that affect patients, families, and societies from a human, emotional, economic, and financial perspective. ... ...

    Abstract Background: Breast cancer is a cause of morbidity for more than half a million of patients in Europe, resulting in broad societal impacts that affect patients, families, and societies from a human, emotional, economic, and financial perspective. Expenditure for cancer medicines represents one of the principal driving costs of healthcare. The aim of this review is to describe the European policy and regulatory landscape of innovation uptake in breast oncology - with emphasis on value in cancer healthcare.
    Summary: In Europe, several reimbursement models or policy tools have been developed by countries to compose their benefit packages. The most commonly applied scheme is the product-specific eligibility model, prioritizing selected medicines and their indications. Mixed models are commonly developed, addressing the protection of more vulnerable people, ensuring protection from impoverishment caused by cancer and containing disparities. However, the risk to incur significant out-of-pocket expenses for essential or newer medicines for cancer is still substantial in Europe, especially in low- and middle-income countries, determining greater financial distress and poorer outcome for patients. Value-based priority setting is an essential mechanism to ensure timely access to the most valuable medicines for breast cancer patients. Estimations of the value of medicines can be provided within health technology assessment services and networks and informed by benefit scales and tools.
    Key messages: There is ample room for reciprocal support across the diverse cultural and legal realities in Europe. The aim is common: save cancer patients from premature death by ensuring the timely access to the best care, protecting from financial hardships and distress to leave no cancer patient behind in poverty. Steps are to be taken to promote value-based priority setting, paving the way toward universal health coverage in Europe, where health of people is protected, and affordable best quality care is the only standard pursued and acceptable.
    Language English
    Publishing date 2019-09-24
    Publishing country Switzerland
    Document type Journal Article ; Review
    ZDB-ID 2202236-3
    ISSN 1661-3805 ; 1661-3791
    ISSN (online) 1661-3805
    ISSN 1661-3791
    DOI 10.1159/000502637
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  4. Article ; Online: Envisioning Academic Global Oncologists: Proposed Competencies for Global Oncology Training From ASCO.

    Bourlon, Maria T / Bhatt, Ami S / Lopes, Gilberto / Asirwa, Fredrick Chite / Eniu, Alexandru E / Loehrer, Patrick J / Shulman, Lawrence N / Close, Julia / Von Roenn, Jamie / Tibbits, Michal / Pyle, Doug / Gralow, Julie R

    JCO global oncology

    2024  Volume 10, Page(s) e2300157

    Abstract: Recognizing the rising incidence, prevalence, and mortality of cancer in low- and middle-resource settings, as well as the increasingly international profile of its membership, ASCO has committed to expanding its engagement at a global level. In 2017, ... ...

    Abstract Recognizing the rising incidence, prevalence, and mortality of cancer in low- and middle-resource settings, as well as the increasingly international profile of its membership, ASCO has committed to expanding its engagement at a global level. In 2017, the ASCO Academic Global Oncology Task Force sought to define the potential role for ASCO in supporting global oncology as an academic field. A set of recommendations to advance the status of global oncology as an academic discipline were created through a consensus-based process involving participation by a diverse group of global oncology and global health practitioners; these recommendations were then published. The recommendations included developing a set of global oncology competencies for trainees and faculty interested in a career in academic global oncology. Here, we describe the global oncology competencies developed by this task force. These competencies consist of knowledge and skills needed in general global health as well as cancer-specific care and research, including understanding global cancer health disparities, defining unique resources and needs in low- and middle-resource settings, and promoting international collaboration. Although the competencies were originally developed for US training programs, they are intended to be widely applicable globally. By formalizing the training of oncologists and supporting career pathways in the field of global oncology, we can make progress in achieving global equity in cancer care and control.
    MeSH term(s) Humans ; Medical Oncology ; Neoplasms/therapy
    Language English
    Publishing date 2024-04-11
    Publishing country United States
    Document type Journal Article
    ISSN 2687-8941
    ISSN (online) 2687-8941
    DOI 10.1200/GO.23.00157
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  5. Article: Comparison of the Real-World Reporting of Symptoms and Well-Being for the HER2-Directed Trastuzumab Biosimilar Ogivri With Registry Data for Herceptin in the Treatment of Breast Cancer: Prospective Observational Study (OGIPRO) of Electronic Patient-Reported Outcomes.

    Trojan, Andreas / Roth, Sven / Atassi, Ziad / Kiessling, Michael / Zenhaeusern, Reinhard / Kadvany, Yannick / Schumacher, Johannes / Kullak-Ublick, Gerd A / Aapro, Matti / Eniu, Alexandru

    JMIR cancer

    2024  Volume 10, Page(s) e54178

    Abstract: Background: Trastuzumab has had a major impact on the treatment of human epidermal growth factor receptor 2 (HER2)-positive breast cancer (BC). Anti-HER2 biosimilars such as Ogivri have demonstrated safety and clinical equivalence to trastuzumab (using ... ...

    Abstract Background: Trastuzumab has had a major impact on the treatment of human epidermal growth factor receptor 2 (HER2)-positive breast cancer (BC). Anti-HER2 biosimilars such as Ogivri have demonstrated safety and clinical equivalence to trastuzumab (using Herceptin as the reference product) in clinical trials. To our knowledge, there has been no real-world report of the side effects and quality of life (QoL) in patients treated with biosimilars using electronic patient-reported outcomes (ePROs).
    Objective: The primary objective of this prospective observational study (OGIPRO study) was to compare the ePRO data related to treatment side effects collected with the medidux app in patients with HER2-positive BC treated with the trastuzumab biosimilar Ogivri (prospective cohort) to those obtained from historical cohorts treated with Herceptin alone or combined with pertuzumab and/or chemotherapy (ClinicalTrials.gov NCT02004496 and NCT03578731).
    Methods: Patients were treated with Ogivri alone or combined with pertuzumab and/or chemotherapy and hormone therapy in (neo)adjuvant and palliative settings. Patients used the medidux app to dynamically record symptoms (according to the Common Terminology Criteria for Adverse Events [CTCAE]), well-being (according to the Eastern Cooperative Oncology Group Performance Status scale), QoL (using the EQ-5D-5L questionnaire), cognitive capabilities, and vital parameters over 6 weeks. The primary endpoint was the mean CTCAE score. Key secondary endpoints included the mean well-being score. Data of this prospective cohort were compared with those of the historical cohorts (n=38 patients; median age 51, range 31-78 years).
    Results: Overall, 53 female patients with a median age of 54 years (range 31-87 years) were enrolled in the OGIPRO study. The mean CTCAE score was analyzed in 50 patients with available data on symptoms, while the mean well-being score was evaluated in 52 patients with available data. The most common symptoms reported in both cohorts included fatigue, taste disorder, nausea, diarrhea, dry mucosa, joint discomfort, tingling, sleep disorder, headache, and appetite loss. Most patients experienced minimal (grade 0) or mild (grade 1) toxicities in both cohorts. The mean CTCAE score was comparable between the prospective and historical cohorts (29.0 and 30.3, respectively; mean difference -1.27, 95% CI -7.24 to 4.70; P=.68). Similarly, no significant difference was found for the mean well-being score between the groups treated with the trastuzumab biosimilar Ogivri and Herceptin (74.3 and 69.8, respectively; mean difference 4.45, 95% CI -3.53 to 12.44; P=.28).
    Conclusions: Treatment of patients with HER2-positive BC with the trastuzumab biosimilar Ogivri resulted in equivalent symptoms, adverse events, and well-being as found for patients treated with Herceptin as determined by ePRO data. Hence, integration of an ePRO system into research and clinical practice can provide reliable information when investigating the real-world tolerability and outcomes of similar therapeutic compounds.
    Trial registration: ClinicalTrials.gov NCT05234021; https://clinicaltrials.gov/study/NCT05234021.
    Language English
    Publishing date 2024-04-04
    Publishing country Canada
    Document type Journal Article
    ISSN 2369-1999
    ISSN 2369-1999
    DOI 10.2196/54178
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  6. Article: A Pilot Project to Develop Checklist-Based Recommendations on the Requirements for Clinical Cancer Research Centers in Countries with Limited Resources.

    Eniu, Alexandru

    Breast care (Basel, Switzerland)

    2008  Volume 3, Issue 1, Page(s) 33–35

    Abstract: Clinical studies are the only controlled way of comparing a new treatment to existing standards. Unfortunately, less than 5% of patients in developed countries are enrolled in clinical trials, thus strongly limiting the possibility of answering important ...

    Abstract Clinical studies are the only controlled way of comparing a new treatment to existing standards. Unfortunately, less than 5% of patients in developed countries are enrolled in clinical trials, thus strongly limiting the possibility of answering important clinical questions. Large numbers of cancer patients are treated in countries with limited resources (CLR). Here, cancer centers that are able to provide good standard of care are capable of contributing by enrolling large numbers of eligible patients into clinical trials. We present a pilot project aimed at developing a set of checklists that include all elements of infrastructure, equipment, staff, and training that a center should possess in order to enroll patients into phase II, III, and IV clinical trials. These elements will be stratified in an incremental list to contain essential, desirable, and optional items. Also, requirements for staffing and training of research staff will be developed. The development of a continuous audit program will be proposed to ensure quality control, and each potential trial center will undergo an initial audit to evaluate its suitability. The checklists may also serve as a guide for centers wishing to participate in clinical trials. The ultimate goal of this project is to increase the number of trial centers in CLR for the benefit of patients, science, and society in general.
    Language English
    Publishing date 2008-02-22
    Publishing country Switzerland
    Document type Journal Article
    ZDB-ID 2202236-3
    ISSN 1661-3805 ; 1661-3791
    ISSN (online) 1661-3805
    ISSN 1661-3791
    DOI 10.1159/000114444
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  7. Article: Integrating biological agents into systemic therapy of breast cancer: trastuzumab, lapatinib, bevacizumab.

    Eniu, Alexandru

    Journal of B.U.ON. : official journal of the Balkan Union of Oncology

    2007  Volume 12 Suppl 1, Page(s) S119–26

    Abstract: Biologic agents represent an already proven addition in the armamentarium of anticancer weapons. Anti-HER2 therapy was the first to demonstrate survival benefit by associating a targeted agent to cytotoxic chemotherapy. Four major adjuvant trials-- ... ...

    Abstract Biologic agents represent an already proven addition in the armamentarium of anticancer weapons. Anti-HER2 therapy was the first to demonstrate survival benefit by associating a targeted agent to cytotoxic chemotherapy. Four major adjuvant trials--Herceptin Adjuvant (HERA), National Surgical Adjuvant Breast and Bowel Project (NSABP) B-31, North Central Cancer Treatment Group (NCCTG) N9831, and Breast Cancer International Research Group (BCIRG) 006--including more than 13,000 women with HER-2-positive early breast cancer, have investigated different adjuvant treatment approaches with trastuzumab. These trials have shown that trastuzumab reduces the 3-year risk of recurrence by about half in this patient population. Accurate testing for HER2 amplification/overexpression is essential before treatment initiation. Patients progressing while on combined chemotherapy and trastuzumab may still benefit from continuation of trastuzumab with other agents; evidence also supports the use of the capecitabine/lapatinib combination in this setting, which improves response and time to further tumor progression. Antiangiogenic therapy with bevacizumab in association with weekly paclitaxel improves disease-free survival for metastatic breast cancer patients. Future studies will provide much needed data on predicting response to biologic therapies, revealing the mechanisms of resistance to such therapies and maximizing the patient's benefit.
    MeSH term(s) Angiogenesis Inhibitors/administration & dosage ; Antibodies, Monoclonal/administration & dosage ; Antibodies, Monoclonal, Humanized ; Antineoplastic Combined Chemotherapy Protocols/adverse effects ; Antineoplastic Combined Chemotherapy Protocols/therapeutic use ; Bevacizumab ; Breast Neoplasms/blood supply ; Breast Neoplasms/drug therapy ; Breast Neoplasms/genetics ; Breast Neoplasms/metabolism ; Breast Neoplasms/pathology ; Female ; Gene Expression Regulation, Neoplastic ; Genetic Testing ; Heart Diseases/chemically induced ; Humans ; Neoplasm Invasiveness ; Neoplasm Metastasis ; Neovascularization, Pathologic/metabolism ; Neovascularization, Pathologic/prevention & control ; Patient Selection ; Protein Kinase Inhibitors/administration & dosage ; Quinazolines/administration & dosage ; Receptor, ErbB-2/antagonists & inhibitors ; Receptor, ErbB-2/metabolism ; Trastuzumab ; Treatment Outcome ; Vascular Endothelial Growth Factor A/antagonists & inhibitors ; Vascular Endothelial Growth Factor A/metabolism
    Chemical Substances Angiogenesis Inhibitors ; Antibodies, Monoclonal ; Antibodies, Monoclonal, Humanized ; Protein Kinase Inhibitors ; Quinazolines ; VEGFA protein, human ; Vascular Endothelial Growth Factor A ; lapatinib (0VUA21238F) ; Bevacizumab (2S9ZZM9Q9V) ; ERBB2 protein, human (EC 2.7.10.1) ; Receptor, ErbB-2 (EC 2.7.10.1) ; pertuzumab (K16AIQ8CTM) ; Trastuzumab (P188ANX8CK)
    Language English
    Publishing date 2007-09
    Publishing country Greece
    Document type Journal Article ; Review
    ZDB-ID 2040386-0
    ISSN 2241-6293 ; 1107-0625
    ISSN (online) 2241-6293
    ISSN 1107-0625
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  8. Article ; Online: Changing the landscape of European School of Oncology-European Society for Medical Oncology masterclasses in clinical oncology during the COVID-19 pandemic.

    Pavlidis, Nicholas / Peccatori, Fedro A / Eniu, Alexandru / Rassy, Elie / Aapro, Matti / Cavalli, Franco / Lordick, Florian / Costa, Alberto

    Future oncology (London, England)

    2022  Volume 18, Issue 25, Page(s) 2857–2864

    Abstract: Aims: ...

    Abstract Aims:
    MeSH term(s) COVID-19 ; Humans ; Medical Oncology ; Pandemics ; Schools ; Surveys and Questionnaires
    Language English
    Publishing date 2022-06-20
    Publishing country England
    Document type Journal Article ; Review
    ZDB-ID 2274956-1
    ISSN 1744-8301 ; 1479-6694
    ISSN (online) 1744-8301
    ISSN 1479-6694
    DOI 10.2217/fon-2021-1477
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  9. Article ; Online: Allocation of authorship and patient enrollment among global clinical trials in oncology.

    Rubagumya, Fidel / Fundytus, Adam / Keith-Brown, Sophie / Hopman, Wilma M / Gyawali, Bishal / Mukherji, Deborah / Hammad, Nazik / Pramesh, C S / Aggarwal, Ajay / Eniu, Alexandru / Sengar, Manju / Riechelmann, Rachel S R / Sullivan, Richard / Booth, Christopher M

    Cancer

    2023  Volume 129, Issue 18, Page(s) 2856–2863

    Abstract: Background: Oncology randomized controlled trials (RCTs) are increasingly global in scope. Whether authorship is equitably shared between investigators from high-income countries (HIC) and low-middle/upper-middle incomes countries (LMIC/UMIC) is not ... ...

    Abstract Background: Oncology randomized controlled trials (RCTs) are increasingly global in scope. Whether authorship is equitably shared between investigators from high-income countries (HIC) and low-middle/upper-middle incomes countries (LMIC/UMIC) is not well described. The authors conducted this study to understand the allocation of authorship and patient enrollment across all oncology RCTs conducted globally.
    Methods: A cross-sectional retrospective cohort study of phase 3 RCTs (published 2014-2017) that were led by investigators in HIC and recruited patients in LMIC/UMIC.
    Findings: During 2014-2017, 694 oncology RCTs were published; 636 (92%) were led by investigators from HIC. Among these HIC-led trials, 186 (29%) enrolled patients in LMIC/UMIC. One-third (33%, 62 of 186) of RCTs had no authors from LMIC/UMIC. Forty percent (74 of 186) of RCTs reported patient enrollment by country; in 50% (37 of 74) of these trials, LMIC/UMIC contributed <15% of patients. The relationship between enrollment and authorship proportion is very strong and is comparable between LMIC/UMIC and HIC (Spearman's ρ LMIC/UMIC 0.824, p < .001; HIC 0.823, p < .001). Among the 74 trials that report country enrollment, 34% (25 of 74) have no authors from LMIC/UMIC.
    Conclusions: Among trials that enroll patients in HIC and LMIC/UMIC, authorship appears to be proportional to patient enrollment. This finding is limited by the fact that more than half of RCTs do not report enrollment by country. Moreover, there are important outliers as a significant proportion of RCTs had no authors from LMIC/UMIC despite enrolling patients in these countries. The findings in this study reflect a complex global RCT ecosystem that still underserves cancer control outside high-income settings.
    MeSH term(s) Humans ; Authorship ; Cross-Sectional Studies ; Developing Countries ; Income ; Medical Oncology ; Randomized Controlled Trials as Topic ; Clinical Trials, Phase III as Topic
    Language English
    Publishing date 2023-06-29
    Publishing country United States
    Document type Journal Article
    ZDB-ID 1429-1
    ISSN 1097-0142 ; 0008-543X ; 1934-662X
    ISSN (online) 1097-0142
    ISSN 0008-543X ; 1934-662X
    DOI 10.1002/cncr.34919
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  10. Article: Extended Adjuvant Chemotherapy in Triple-Negative Breast Cancer.

    Locatelli, Marzia A / Curigliano, Giuseppe / Eniu, Alexandru

    Breast care (Basel, Switzerland)

    2017  Volume 12, Issue 3, Page(s) 152–158

    Abstract: Triple-negative breast cancer (TNBC) represents a heterogeneous breast cancer subtype with a poor prognosis. The optimal adjuvant chemotherapy regimen is still unknown. Although numerous large randomized trials have established the benefit of adjuvant ... ...

    Abstract Triple-negative breast cancer (TNBC) represents a heterogeneous breast cancer subtype with a poor prognosis. The optimal adjuvant chemotherapy regimen is still unknown. Although numerous large randomized trials have established the benefit of adjuvant anthracyclines and/or taxanes in TNBC, there is no preferred regimen for these patients. There is currently no guideline. Moreover, without knowing the optimal treatment backbone, it will not be possible to evaluate whether adding agents such as platinum or other novel therapies is beneficial for TNBC patients. Furthermore, the best duration of adjuvant treatment in TNBC is still unknown. This review will focus on results of clinical trials that analyzed the benefits of extending the duration of adjuvant treatment in TNBCs with maintenance treatments. We will further discuss promising results in favor of other new agents including capecitabine, metronomic treatment, and biological drugs.
    Language English
    Publishing date 2017-06-27
    Publishing country Switzerland
    Document type Journal Article ; Review
    ZDB-ID 2202236-3
    ISSN 1661-3805 ; 1661-3791
    ISSN (online) 1661-3805
    ISSN 1661-3791
    DOI 10.1159/000478087
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