THE SCIENTIFIC DISCOURSE ON PHARMACOLOGY, MECHANISMS OF ACTION, PHARMACOLOGICAL SAFETY, SIDE EFFECTS, AND TOXICITY OF ANTICANCER MEDICATIONS IN MODERN ONCOLOGY: PHARMACOVIGILANCE AND INTEGRATED APPROACHES TO EVIDENCE-BASED PHARMACOTHERAPY, PHARMACOGENOMIC

Authors

  • Nodar Sulashvili MD, PhD, Doctor of Pharmaceutical and Pharmacological Sciences In Medicine, Professor of Faculty of Medicine at Georgian International University GIU; Professor of Pharmacology of Faculty of Medicine at Georgian National University SEU; Professor of Medical and Clinical Pharmacology of Faculty of Medicine at BAU International University Batumi, Invited Professor/Lecturer of Scientific Research-Skills Center at Tbilisi State Medical University; Invited Lecturer of Clinical Pharmacology Department at Tbilisi State Medical University; Scientific Researcher, Best, Top Academic Scientist, Georgia, Europe, Worldwide; Associate Professor of Biochemistry and Pharmacology Direction of School of Health Sciences at The University of Georgia; Tbilisi, Georgia; Scientific Researcher of Yerevan State Medical University After Mk. Heratsi, Yerevan, Republic of Armenia; Former Clinical Pharmacologist of London Lewisham University Hospital, London, England, United Kingdom of Great Britain and Northern Ireland; https://orcid.org/0000-0002-9005-8577
  • Margarita Beglaryan MD, PhD, Doctor of Pharmaceutical Sciences, Academician, Professor of Yerevan State Medical University After Mkhitar Heratsi, Head of the Department of Pharmaceutical Management of Yerevan State Medical University After Mkhitar Heratsi; Yerevan, Republic of Armenia; https://orcid.org/0000-0003-3697-6390
  • Maka Buleishvili MD, PhD, Doctor of Medical Sciences, Professor of Faculty of Medicine at Georgian International University GIU, Dean of Faculty of Medicine at Georgian International University GIU, Professor of Faculty of Medicine at Georgian National University SEU, Professor of Faculty of Medicine at European University, Professor of Faculty of Medicine at Caucasus International University, Professor of Faculty of Medicine at Georgian-American University, Invited Lecturer of Tbilisi State Medical University, Tbilisi, Georgia; Professor of Faculty of Medicine at BAU International University Batumi, https://orcid.org/0009-0004-2657-8473
  • Mariam Darbaidze MD, PhD, Doctor of Biological Sciences, Professor of Georgian International University GIU, Vice Rector of Georgian International University GIU; Professor of Georgian National University SEU; Tbilisi, Georgia; https://orcid.org/0009-0005-0275-4222
  • Nana Gorgaslidze MD, PhD, Doctor of Pharmaceutical Sciences, Academician, Professor of Tbilisi State Medical University, Head of The Department of Social and Clinical Pharmacy, Tbilisi, Georgia. https://orcid.org/0000-0002-4563-5224
  • Nato Alavidze MD, PhD, Doctor of Pharmaceutical Sciences, Professor of Akaki Tsereteli State University, Faculty of Medicine, Department of Pharmacy, Kutaisi, Georgia; Professor, Head of The Medical Doctor Degree Program of Faculty of Healthcare Sciences at East European University, Tbilisi, Georgia. https://orcid.org/0000-0001-6695-5924
  • Irina Imerlishvili PhD, Doctor of Law, Professor, Rector of BAU International University Batumi; Professor of BAU International University Batumi; Professor at the International Black Sea University, Batumi-Tbilisi, Georgia; https://orcid.org/0009-0008-6862-7025
  • Naira Chichoyan MD, PhD, Doctor of Pharmaceutical Sciences, Professor of Yerevan State Medical University after Mk. Heratsi; Head of the Department of Pharmacognosy at Yerevan State Medical University after Mk. Heratsi; Yerevan, Republic of Armenia. https://orcid.org/0000-0003-3905-3372
  • Marika Sulashvili MD, Doctor of Family Medicine, Invited Lecturer of Tbilisi State Medical University, Lecturer of Department of Molecular and Medical Genetics, Invited Professor of Biochemistry and Molecular and Medical Genetics at The University of Georgia. Tbilisi, Georgia. https://orcid.org/0000-0002-6338-4262
  • Lasha Tchelidze MD, PhD Candidate, Tbilisi State Medical University, Director of the Georgian Association of Allergology and Clinical Immunology, Tbilisi, Georgia.
  • Marina Giorgobiani MD, PhD, Doctor of Medical Sciences, Academician, Professor of Tbilisi State Medical University, Faculty of Public Health; Department of Hygiene and Medical Ecology, Tbilisi, Georgia. https://orcid.org/0000-0003-0686-5227
  • Ada (Adel) Tadevosyan MD, PhD, Doctor of Medical Sciences, Academician, Professor of Yerevan State Medical University, Academician and Full Member of the International Academy of Sciences of Ecology and Life Safety (MANEB), Academician of the Republic Armenia Law Academy, Member of the Association of Psychiatrists of Armenia, World Association of Psychiatrists, International Association for Traumatic Stress, World Association for Biological Psychiatry, International Association "Stress and Behavior", Licensed Psychiatrist, Psychotherapist, Public Health Organizer; Tbilisi-Georgia, Yerevan-Armenia, Los Angeles-USA;
  • Igor Seniuk PhD, Doctor of Pharmaceutical Sciences, Dean of faculty of Pharmacy at National University of Pharmacy of Ukraine, Associate Professor of Biological Chemistry Department at National University of Pharmacy, Kharkiv, Ukraine. https://orcid.org/0000-0003-3819-7333
  • David Aphkhazava PhD, Doctor of Biological Sciences, Professor of Biochemistry at The University of Georgia, Tbilisi, Georgia. Orcid: https://orcid.org/0000-0001-6216-6477
  • Vira Kravchenko MD, PhD, Doctor of Biological Sciences, Academician, Professor, Head of The Biological Chemistry Department at National University of Pharmacy of Ukraine, Kharkiv, Ukraine. https://orcid.org/0000-0001-6335-2490
  • Magda Davitashvili PhD, Doctor of Biological Sciences, Professor, Academician, Georgian Academy of Ecological Sciences, Program Coordinator of Quality Assurance Office at Iakob Gogebashvili Telavi State University (TeSaU), Telavi, Georgia. https://orcid.org/0009-0005-4213-6533
  • Olga Shapoval MD, PhD, Doctor of Pharmaceutical Sciences, Associate Professor of Department of Pharmacology and Medical Prescription at Kharkiv State Medical University, Kharkiv, Ukraine; https://orcid.org/0000-0002-1971-2863
  • Natia Kvizhinadze MD, PhD, Doctor of Pharmaceutical Sciences, Professor of Tbilisi State Medical University, Department of Social and Clinical Pharmacy; Tbilisi, Georgia.
  • Nino Abuladze MD, PhD, Doctor of Pharmaceutical Sciences, Academician, Professor of Akaki Tsereteli State University, Faculty of Medicine, Department of Pharmacy, Kutaisi, Georgia. https://orcid.org/0000-0003-2189-7470
  • Rajkaran Singh Faculty of Medicine, Georgian National University SEU; Tbilisi, Georgia; https://orcid.org/0009-0000-4903-0145

Keywords:

Anticancer medications, Pharmacovigilance, Pharmacogenomics, Personalized medicine, Therapeutic drug monitoring

Abstract

Cancer pharmacotherapy represents one of the most rapidly evolving domains of contemporary clinical medicine, reflecting the progressive transition from broadly cytotoxic treatment strategies toward molecularly targeted, immunologically mediated, hormonally directed, cellular, and increasingly biomarker-guided therapeutic interventions. This transformation has expanded the therapeutic potential of oncology while simultaneously generating substantial pharmacological complexity concerning drug selection, mechanism-based treatment, dose optimization, treatment sequencing, drug–drug interactions, adverse drug reactions, cumulative toxicity, and individualized risk–benefit assessment. The present scientific discourse provides a comprehensive pharmacological examination of anticancer medications, integrating their classification, pharmacological properties, molecular and cellular mechanisms of action, pharmacokinetic and pharmacodynamic determinants, therapeutic efficacy, safety profiles, adverse effects, and clinically significant toxicities within the framework of modern oncology. Conventional cytotoxic agents, endocrine therapies, molecularly targeted small molecules, monoclonal antibodies, antibody–drug conjugates, immune checkpoint inhibitors, and other advanced systemic treatment modalities are considered as components of an increasingly heterogeneous pharmacotherapeutic landscape. Particular emphasis is placed on the mechanistic relationship between drug exposure, molecular targets, intracellular signaling pathways, cellular proliferation, apoptosis, DNA damage, angiogenesis, immune regulation, tumor microenvironment, therapeutic resistance, and clinical outcomes. The pharmacological safety of anticancer medications is examined as a multidimensional construct encompassing predictable dose-dependent toxicities, idiosyncratic adverse reactions, cumulative organ injury, delayed complications, immune-mediated toxicity, and clinically relevant interactions with concomitant therapies. Major toxicological manifestations, including hematological, gastrointestinal, hepatic, renal, cardiovascular, neurological, pulmonary, dermatological, endocrine, reproductive, and metabolic adverse effects, are considered in relation to their pathophysiological mechanisms, clinical severity, reversibility, and implications for continuation, modification, or discontinuation of treatment. Particular attention is directed toward the emerging spectrum of immune-related adverse events associated with modern immuno-oncology and toward the necessity of early recognition, systematic monitoring, multidisciplinary management, and appropriate pharmacotherapeutic intervention. Pharmacovigilance constitutes a central component of this integrated framework because the safety profile of anticancer medicines continues to evolve throughout clinical development, regulatory evaluation, routine clinical use, and post-marketing surveillance. Contemporary pharmacovigilance incorporates spontaneous adverse-event reporting, active surveillance, signal detection, disproportionality analysis, causality assessment, risk characterization, medication-error identification, real-world evidence, and continuous benefit–risk evaluation. These approaches facilitate the identification of uncommon, delayed, population-specific, or previously unrecognized safety signals and contribute to evidence-based risk minimization. The integration of pharmacovigilance with clinical pharmacology is therefore essential for transforming individual adverse-event observations into clinically actionable knowledge and for strengthening medication safety throughout the cancer treatment continuum. Pharmacogenomics and precision medicine further provide important scientific foundations for understanding interindividual variability in drug disposition, pharmacodynamic response, therapeutic efficacy, and susceptibility to toxicity. Genetic variation in drug-metabolizing enzymes, transporters, receptors, immune pathways, DNA-repair mechanisms, and other pharmacological determinants may substantially influence exposure and treatment outcomes for selected anticancer agents. Accordingly, incorporation of validated pharmacogenomic biomarkers, tumor molecular profiling, genomic alterations, patient-specific characteristics, comorbidities, organ function, concomitant medications, and previous treatment history can support more rational therapeutic selection and individualized risk stratification. Precision oncology consequently extends beyond tumor classification alone by incorporating both tumor-specific molecular determinants and host-specific pharmacological characteristics into therapeutic decision-making. Therapeutic drug monitoring represents an additional clinical pharmacology strategy for selected anticancer medicines in which measurable systemic exposure is associated with therapeutic response, toxicity, or clinically meaningful pharmacokinetic variability. Integration of drug-concentration measurements with pharmacokinetic and pharmacodynamic modeling may facilitate individualized dose adjustment, particularly in patients with altered organ function, significant drug interactions, unusual pharmacokinetic profiles, or a narrow therapeutic window. Although therapeutic drug monitoring is not universally applicable to all anticancer agents, its selective implementation may strengthen exposure-guided pharmacotherapy and complement conventional clinical and laboratory monitoring. The overarching objective of this integrated approach is to establish a coherent evidence-based framework connecting pharmacological classification, molecular mechanisms, pharmacokinetics, pharmacodynamics, pharmacogenomics, therapeutic drug monitoring, pharmacovigilance, precision medicine, and clinical decision-making. Such integration may improve the identification of optimal therapeutic regimens, reduce preventable medication-related harm, preserve treatment intensity when clinically appropriate, enhance adherence and quality of life, and facilitate earlier recognition and management of toxicity. Ultimately, contemporary anticancer pharmacotherapy should be understood as a dynamic, individualized, and continuously monitored process in which therapeutic efficacy cannot be separated from pharmacological safety. The systematic integration of mechanistic pharmacology with real-world safety surveillance, molecular diagnostics, pharmacogenomic evidence, exposure assessment, and multidisciplinary clinical judgment provides a scientifically rigorous foundation for optimizing the benefit–risk balance of anticancer medications and advancing evidence-based precision oncology.

Published

2026-08-30

How to Cite

Nodar Sulashvili, Margarita Beglaryan, Maka Buleishvili, Mariam Darbaidze, Nana Gorgaslidze, Nato Alavidze, Irina Imerlishvili, Naira Chichoyan, Marika Sulashvili, Lasha Tchelidze, Marina Giorgobiani, Ada (Adel) Tadevosyan, Igor Seniuk, David Aphkhazava, Vira Kravchenko, Magda Davitashvili, Olga Shapoval, Natia Kvizhinadze, Nino Abuladze, & Rajkaran Singh. (2026). THE SCIENTIFIC DISCOURSE ON PHARMACOLOGY, MECHANISMS OF ACTION, PHARMACOLOGICAL SAFETY, SIDE EFFECTS, AND TOXICITY OF ANTICANCER MEDICATIONS IN MODERN ONCOLOGY: PHARMACOVIGILANCE AND INTEGRATED APPROACHES TO EVIDENCE-BASED PHARMACOTHERAPY, PHARMACOGENOMIC. World Scientific Reports, (14). Retrieved from https://ojs.publisher.agency/index.php/WSR/article/view/9222

Issue

Section

Medical Sciences