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Article: Dose Optimization in Oncology Drug Development: The Emerging Role of Pharmacogenomics, Pharmacokinetics, and Pharmacodynamics.

Papachristos, Apostolos / Patel, Jai / Vasileiou, Maria / Patrinos, George P

2023 Volume 15, Issue 12

Abstract: Drugs' safety and effectiveness are evaluated in randomized, dose-ranging trials in most therapeutic areas. However, this is only sometimes feasible in oncology, and dose-ranging studies are mainly limited to Phase 1 clinical trials. Moreover, although ... ...

Abstract	Drugs' safety and effectiveness are evaluated in randomized, dose-ranging trials in most therapeutic areas. However, this is only sometimes feasible in oncology, and dose-ranging studies are mainly limited to Phase 1 clinical trials. Moreover, although new treatment modalities (e.g., small molecule targeted therapies, biologics, and antibody-drug conjugates) present different characteristics compared to cytotoxic agents (e.g., target saturation limits, wider therapeutic index, fewer off-target side effects), in most cases, the design of Phase 1 studies and the dose selection is still based on the Maximum Tolerated Dose (MTD) approach used for the development of cytotoxic agents. Therefore, the dose was not optimized in some cases and was modified post-marketing (e.g., ceritinib, dasatinib, niraparib, ponatinib, cabazitaxel, and gemtuzumab-ozogamicin). The FDA recognized the drawbacks of this approach and, in 2021, launched Project Optimus, which provides the framework and guidance for dose optimization during the clinical development stages of anticancer agents. Since dose optimization is crucial in clinical development, especially of targeted therapies, it is necessary to identify the role of pharmacological tools such as pharmacogenomics, therapeutic drug monitoring, and pharmacodynamics, which could be integrated into all phases of drug development and support dose optimization, as well as the chances of positive clinical outcomes.
Language	English
Publishing date	2023-06-18
Publishing country	Switzerland
Document type	Journal Article ; Review
ZDB-ID	2527080-1
ISSN	2072-6694
ISSN	2072-6694
DOI	10.3390/cancers15123233
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Article ; Online: Metabolic Profiles of Cancer Stem Cells and Normal Stem Cells and Their Therapeutic Significance.

Stouras, Ioannis / Vasileiou, Maria / Kanatas, Panagiotis F / Tziona, Eleni / Tsianava, Christina / Theocharis, Stamatis

Cells

2023 Volume 12, Issue 23

Abstract: Cancer stem cells (CSCs) are a rare cancer cell population, responsible for the facilitation, progression, and resistance of tumors to therapeutic interventions. This subset of cancer cells with stemness and tumorigenic properties is organized in niches ... ...

Abstract	Cancer stem cells (CSCs) are a rare cancer cell population, responsible for the facilitation, progression, and resistance of tumors to therapeutic interventions. This subset of cancer cells with stemness and tumorigenic properties is organized in niches within the tumor microenvironment (TME) and presents altered regulation in a variety of metabolic pathways, including glycolysis, oxidative phosphorylation (OXPHOS), as well as lipid, amino acid, and iron metabolism. CSCs exhibit similarities as well as differences when comparedto normal stem cells, but also possess the ability of metabolic plasticity. In this review, we summarize the metabolic characteristics of normal, non-cancerous stem cells and CSCs. We also highlight the significance and implications of interventions targeting CSC metabolism to potentially achieve more robust clinical responses in the future.
MeSH term(s)	Humans ; Neoplasms/pathology ; Neoplastic Stem Cells/pathology ; Glycolysis ; Metabolic Networks and Pathways ; Metabolome ; Tumor Microenvironment
Language	English
Publishing date	2023-11-22
Publishing country	Switzerland
Document type	Journal Article ; Review
ZDB-ID	2661518-6
ISSN	2073-4409 ; 2073-4409
ISSN (online)	2073-4409
ISSN	2073-4409
DOI	10.3390/cells12232686
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Article ; Online: Thyroid disease assessment and management: summary of NICE guidance.

Vasileiou, Melina / Gilbert, James / Fishburn, Sarah / Boelaert, Kristien

BMJ (Clinical research ed.)

2020 Volume 368, Page(s) m41

MeSH term(s)	Antithyroid Agents/pharmacology ; Drug Monitoring/methods ; Hormone Replacement Therapy/methods ; Hormone Replacement Therapy/standards ; Humans ; Iodine Radioisotopes/pharmacology ; Patient Selection ; Symptom Assessment ; Thyroid Diseases/classification ; Thyroid Diseases/diagnosis ; Thyroid Diseases/drug therapy ; Thyroid Diseases/etiology ; Thyroid Function Tests/methods ; Thyroid Gland/diagnostic imaging ; Thyroid Hormones/blood ; Thyroid Hormones/pharmacology ; Thyroidectomy/methods
Chemical Substances	Antithyroid Agents ; Iodine Radioisotopes ; Thyroid Hormones
Language	English
Publishing date	2020-01-29
Publishing country	England
Document type	Journal Article ; Practice Guideline
ZDB-ID	1362901-3
ISSN	1756-1833 ; 0959-8154 ; 0959-8146 ; 0959-8138 ; 0959-535X ; 1759-2151
ISSN (online)	1756-1833
ISSN	0959-8154 ; 0959-8146 ; 0959-8138 ; 0959-535X ; 1759-2151
DOI	10.1136/bmj.m41
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Article ; Online: The Use of Isoflavones as Lung Cancer Chemoprevention Agents and their Implications in Treatment through Radio Sensitization.

Athanasiou, Efstratios / Papageorgiou, Savvas / Dafni, Marianna Foteini / Kelesis, Ioannis / Vasileiou, Maria / Tatsiou, Theodora / Kouveloglou, Vasiliki / Kanatas, Panagiotis / Stouras, Ioannis / Gatsis, Athanasios / Agiassoti, Vasiliki Taxiarchoula / Nasimpian, Petros / Dafnoudis, Dimitrios / Degaita, Kyriaki / Verras, Georgios Ioannis / Alexiou, Athanasios / Papadakis, Marios / Kamal, Mohammad Amjad

Current medicinal chemistry

2024

Abstract: Epidemiological trends in cancer research show that lung cancer can affect up to 1 in 15 men and 1 in 17 women. With incidence rates as high as these and significant associated mortality and morbidity, it is no wonder that lung cancer is one of the main ... ...

Abstract	Epidemiological trends in cancer research show that lung cancer can affect up to 1 in 15 men and 1 in 17 women. With incidence rates as high as these and significant associated mortality and morbidity, it is no wonder that lung cancer is one of the main areas of research focused on cancer. Advances in targeted treatments and specialized irradiation protocols have allowed the treatment of more advanced cases. However, as the patient numbers grow, so does the need for cancer-preventive strategies. The present narrative review focuses on soy isoflavones' role in the chemoprevention of lung cancer and their possible role in therapeutic adjuncts. Laboratory studies on lung cancer cell lines have shown that isoflavones can induce apoptosis, tamper with the expression of proliferative molecular pathways, and even reduce tumor angiogenesis. Additionally, population-level studies have emerged that correlate the consumption of isoflavonoids with reduced risk for the development of lung cancer. Interestingly enough, the literature also contains small-scale studies with evidence of isoflavones being effective chemotherapeutic adjuncts that are currently understudied. Our literature review underlines such findings and provides a call for the enhancement of research regarding naturally occurring dietary products with possible anticarcinogenic effects.
Language	English
Publishing date	2024-02-01
Publishing country	United Arab Emirates
Document type	Journal Article
ZDB-ID	1319315-6
ISSN	1875-533X ; 0929-8673
ISSN (online)	1875-533X
ISSN	0929-8673
DOI	10.2174/0109298673278897231229121524
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Article ; Online: Understanding Patient-Ventilator Asynchrony Using Diaphragmatic Ultrasonography.

Soilemezi, Eleni / Vasileiou, Maria / Spyridonidou, Christina / Tsagourias, Matthew / Matamis, Dimitrios

American journal of respiratory and critical care medicine

2019 Volume 200, Issue 4, Page(s) e27–e28

MeSH term(s)	Diaphragm/diagnostic imaging ; Esophagus ; Humans ; Lung ; Pressure ; Respiration, Artificial/methods ; Ultrasonography
Language	English
Publishing date	2019-04-09
Publishing country	United States
Document type	Journal Article
ZDB-ID	1180953-x
ISSN	1535-4970 ; 0003-0805 ; 1073-449X
ISSN (online)	1535-4970
ISSN	0003-0805 ; 1073-449X
DOI	10.1164/rccm.201901-0054IM
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Article ; Online: National Institute for Health and Care Excellence (NICE) guidance on monitoring and management of Barrett's oesophagus and stage I oesophageal adenocarcinoma.

di Pietro, Massimiliano / Trudgill, Nigel J / Vasileiou, Melina / Longcroft-Wheaton, Gaius / Phillips, Alexander W / Gossage, James / Kaye, Philip V / Foley, Kieran G / Crosby, Tom / Nelson, Sophie / Griffiths, Helen / Rahman, Muksitur / Ritchie, Gill / Crisp, Amy / Deed, Stephen / Primrose, John N

Gut

2024

Abstract: Barrett's oesophagus is the only known precursor to oesophageal adenocarcinoma, a cancer with very poor prognosis. The main risk factors for Barrett's oesophagus are a history of gastro-oesophageal acid reflux symptoms and obesity. Men, smokers and those ...

Abstract	Barrett's oesophagus is the only known precursor to oesophageal adenocarcinoma, a cancer with very poor prognosis. The main risk factors for Barrett's oesophagus are a history of gastro-oesophageal acid reflux symptoms and obesity. Men, smokers and those with a family history are also at increased risk. Progression from Barrett's oesophagus to cancer occurs via an intermediate stage, known as dysplasia. However, dysplasia and early cancer usually develop without any clinical signs, often in individuals whose symptoms are well controlled by acid suppressant medications; therefore, endoscopic surveillance is recommended to allow for early diagnosis and timely clinical intervention. Individuals with Barrett's oesophagus need to be fully informed about the implications of this diagnosis and the benefits and risks of monitoring strategies. Pharmacological treatments are recommended for control of symptoms, but not for chemoprevention. Dysplasia and stage 1 oesophageal adenocarcinoma have excellent prognoses, since they can be cured with endoscopic or surgical therapies. Endoscopic resection is the most accurate staging technique for early Barrett's-related oesophageal adenocarcinoma. Endoscopic ablation is effective and indicated to eradicate Barrett's oesophagus in patients with dysplasia. Future research should focus on improved accuracy for dysplasia detection via new technologies and providing more robust evidence to support pathways for follow-up and treatment.
Language	English
Publishing date	2024-03-29
Publishing country	England
Document type	Journal Article
ZDB-ID	80128-8
ISSN	1468-3288 ; 0017-5749
ISSN (online)	1468-3288
ISSN	0017-5749
DOI	10.1136/gutjnl-2023-331557
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Article: Immunotherapy and radiotherapy for older patients with locally advanced rectal cancer unfit for surgery or decline surgery: a practical proposal by the International Geriatric Radiotherapy Group.

Frontiers in oncology

2024 Volume 14, Page(s) 1325610

Abstract: The standard of care for locally advanced rectal cancer is total neoadjuvant therapy followed by surgical resection. Current evidence suggests that selected patients may be able to delay or avoid surgery without affecting survival rates if they achieve a ...

Abstract	The standard of care for locally advanced rectal cancer is total neoadjuvant therapy followed by surgical resection. Current evidence suggests that selected patients may be able to delay or avoid surgery without affecting survival rates if they achieve a complete clinical response (CCR). However, for older cancer patients who are too frail for surgery or decline the surgical procedure, local recurrence may lead to a deterioration of patient quality of life. Thus, for clinicians, a treatment algorithm which is well tolerated and may improve CCR in older and frail patients with rectal cancer may improve the potential for prolonged remission and potential cure. Recently, immunotherapy with check point inhibitors (CPI) is a promising treatment in selected patients with high expression of program death ligands receptor 1 (PD- L1). Radiotherapy may enhance PD-L1 expression in rectal cancer and may improve response rate to immunotherapy. We propose an algorithm combining immunotherapy and radiotherapy for older patients with locally advanced rectal cancer who are too frail for surgery or who decline surgery.
Language	English
Publishing date	2024-02-22
Publishing country	Switzerland
Document type	Journal Article
ZDB-ID	2649216-7
ISSN	2234-943X
ISSN	2234-943X
DOI	10.3389/fonc.2024.1325610
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Article: Immunotherapy and Hypofractionated Radiotherapy in Older Patients with Locally Advanced Cutaneous Squamous-Cell Carcinoma of the Head and Neck: A Proposed Paradigm by the International Geriatric Radiotherapy Group.

Nguyen, Nam P / Thariat, Juliette / Gorobets, Olena / Vinh-Hung, Vincent / Kim, Lyndon / Blanco, Sergio Calleja / Vasileiou, Maria / Arenas, Meritxell / Mazibuko, Thandeka / Giap, Huan / Vincent, Felix / Chi, Alexander / Loganadane, Gokoulakrichenane / Mohammadianpanah, Mohammad / Rembielak, Agata / Karlsson, Ulf / Ali, Ahmed / Bose, Satya / Page, Brandi R

Cancers

2023 Volume 15, Issue 20

Abstract: Cutaneous skin carcinoma is a disease of older patients. The prevalence of cutaneous squamous-cell carcinoma (cSCC) increases with age. The head and neck region is a frequent place of occurrence due to exposure to ultraviolet light. Surgical resection ... ...

Abstract	Cutaneous skin carcinoma is a disease of older patients. The prevalence of cutaneous squamous-cell carcinoma (cSCC) increases with age. The head and neck region is a frequent place of occurrence due to exposure to ultraviolet light. Surgical resection with adjuvant radiotherapy is frequently advocated for locally advanced disease to decrease the risk of loco-regional recurrence. However, older cancer patients may not be candidates for surgery due to frailty and/or increased risk of complications. Radiotherapy is usually advocated for unresectable patients. Compared to basal-cell carcinoma, locally advanced cSCC tends to recur locally and/or can metastasize, especially in patients with high-risk features such as poorly differentiated histology and perineural invasion. Thus, a new algorithm needs to be developed for older patients with locally advanced head and neck cutaneous squamous-cell carcinoma to improve their survival and conserve their quality of life. Recently, immunotherapy with checkpoint inhibitors (CPIs) has attracted much attention due to the high prevalence of program death ligand 1 (PD-L1) in cSCC. A high response rate was observed following CPI administration with acceptable toxicity. Those with residual disease may be treated with hypofractionated radiotherapy to minimize the risk of recurrence, as radiotherapy may enhance the effect of immunotherapy. We propose a protocol combining CPIs and hypofractionated radiotherapy for older patients with locally advanced cutaneous head and neck cancer who are not candidates for surgery. Prospective studies should be performed to verify this hypothesis.
Language	English
Publishing date	2023-10-13
Publishing country	Switzerland
Document type	Journal Article
ZDB-ID	2527080-1
ISSN	2072-6694
ISSN	2072-6694
DOI	10.3390/cancers15204981
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Article: Ovarian non-Hodgkin lymphoma: case study.

Chasiotis, I / Lambropoulos, M / Elmazis, C / Vasileiou, M / Mpouklis, A

European journal of gynaecological oncology

2012 Volume 32, Issue 6, Page(s) 708–709

Abstract: A 46-year-old woman presented at Kilkis Hospital with a mass 21.8 cm in diameter originating from the right ovary. Laparotomy was performed and the tumor was identified as a diffuse large B-cell lymphoma. A decision to start chemotherapy was made with ... ...

Abstract	A 46-year-old woman presented at Kilkis Hospital with a mass 21.8 cm in diameter originating from the right ovary. Laparotomy was performed and the tumor was identified as a diffuse large B-cell lymphoma. A decision to start chemotherapy was made with the R-CHOP regimen.
MeSH term(s)	Female ; Humans ; Lymphoma, Large B-Cell, Diffuse/diagnosis ; Lymphoma, Large B-Cell, Diffuse/diagnostic imaging ; Lymphoma, Large B-Cell, Diffuse/drug therapy ; Middle Aged ; Ovarian Neoplasms/diagnosis ; Ovarian Neoplasms/diagnostic imaging ; Ovarian Neoplasms/drug therapy ; Tomography, X-Ray Computed
Language	English
Publishing date	2012-02-03
Publishing country	China
Document type	Case Reports ; Journal Article
ZDB-ID	604589-3
ISSN	0392-2936
ISSN	0392-2936
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Zs.A 1679: Show issues

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Article ; Online: Is immunotherapy at reduced dose and radiotherapy for older patients with locally advanced non-small lung cancer feasible?-a narrative review by the international geriatric radiotherapy group.

Vinh-Hung, Vincent / Gorobets, Olena / Duerinkcx, Andre / Dutta, Suresh / Oboite, Eromosele / Oboite, Joan / Ali, Ahmed / Mazibuko, Thandeka / Karlsson, Ulf / Chi, Alexander / Lehrman, David / Mohammed, Omer Hashim / Mohammadianpanah, Mohammad / Loganadane, Gokoulakrichenane / Migliore, Natalia / Vasileiou, Maria / Nguyen, Nam P / Giap, Huan

Translational cancer research

2022 Volume 11, Issue 9, Page(s) 3298–3308

Abstract: Background and objective: The standard of care for locally advanced non-small cell lung cancer (NSCLC) is either surgery followed by adjuvant chemotherapy with or without radiotherapy or concurrent chemotherapy and radiotherapy. However, older patients ( ...

Abstract	Background and objective: The standard of care for locally advanced non-small cell lung cancer (NSCLC) is either surgery followed by adjuvant chemotherapy with or without radiotherapy or concurrent chemotherapy and radiotherapy. However, older patients (70 years old or above) with multiple co-morbidities may not be able to tolerate the combined treatment due to its toxicity. Since lung cancer prevalence increases significantly with age, a new algorithm needs to be investigated to allow curative treatment for those with locally advanced disease. Methods: A literature search of the literature was conducted through PubMed and Google Scholar using search terms such as locally advanced NSCLC, older cancer patients, immunotherapy with check point inhibitors (CPI), and image-guided radiotherapy (IGRT). Abstracts were screened, full articles fitting the article topic were reviewed, and duplicated and non-English articles were excluded. Key content and findings: Recently, CPI has been introduced and proven effective for selected patients with increased program death ligand 1 (PD-L1) expression (50% or above). A reduced dose for CPI (RDCPI) may be as effective as a full dose and may decrease treatment cost. New radiation technique such as IGRT may also minimize radiotherapy complication through normal lung and cardiac sparing. Conclusions: IGRT and RDCPI may be an innovative option for older patients with locally advanced NSCLC and high PD-L1 expression and needs to be investigated in future prospective studies.
Language	English
Publishing date	2022-09-28
Publishing country	China
Document type	Journal Article ; Review
ZDB-ID	2901601-0
ISSN	2219-6803 ; 2218-676X
ISSN (online)	2219-6803
ISSN	2218-676X
DOI	10.21037/tcr-22-821
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