SynthesisESMO open2024
Sex differences in the pharmacokinetics of anticancer drugs: a systematic review.
Synthesis in ESMO open, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 23 papers, 1 of them a synthesis that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
23 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Model-based meta-analysis of individual patient data for the characterization of intravenous 5-fluorouracil population pharmacokinetics.Cancer chemotherapy and pharmacology · 2026Pooled it
- Metabolic Alterations in Blood and Saliva During the First Two Cycles of Adjuvant Chemotherapy Correlate with 5-FU Dose Reduction Requirement in Patients with Colorectal Cancer.European journal of drug metabolism and pharmacokinetics · 2026Article
- Target Attainment and Clinical and Biochemical Parameters Associated with the Pharmacokinetics of 12 Tyrosine Kinase Inhibitors.Clinical pharmacokinetics · 2026Article
- Sex-based differences in tolerability of developmental antibody-drug conjugates (ADCs) in non-small-cell lung cancer (NSCLC).ESMO open · 2026Article
- [Sex distribution in clinical studies in uro-oncology-status quo in Germany].Urologie (Heidelberg, Germany) · 2026Article
- Review
- Biological Sex Influences the Pharmacokinetics and Organ Dosimetry ofPharmaceuticals (Basel, Switzerland) · 2026Article
- Osimertinib-induced interstitial lung disease insights from faers signal detection and network toxicology analysis.BMC cancer · 2026Article
- Cardiovascular Mortality Risk After Cancer Diagnosis by County-Level Characteristics in the United States 2000-2021.Cancer medicine · 2026Article
- Trametinib Decreased Intracerebral Hemorrhages and Endothelial-to-Mesenchymal Transition in KRASStroke · 2026Article
- <p>Unveiling sex differences in pancreatic ductal adenocarcinoma: Current evidence and future directions (Review)</p>.International journal of oncology · 2026Review
- Advancing evidence-based regulation: Organization for the Study of Sex Differences and Society for Women's Health Research support FDA action on menopausal hormone therapy and encourage broader sex-informed drug label updates.Biology of sex differences · 2026Review
- Beyond XX and XY, Understanding Sex Differences in Leukemia.Medical sciences (Basel, Switzerland) · 2026Review
- An agent-based learning model integrating sex differences in renal cell carcinoma.Frontiers in immunology · 2026Article
- Prognostic outcome of extranodal marginal zone B-cell lymphoma: a nationwide cohort.Scientific reports · 2025Article
- Profiling the Preclinical Pharmacokinetics and Biodistribution of a Platinum(IV)-Based Oxaliplatin Prodrug OxaliTEX and Their Significance to Antitumor Response.Molecular pharmaceutics · 2025Article
- Sex differences in hepatic enzymes and transporters involved in pharmacokinetics.Liver research (Beijing, China) · 2025Review
- Sex and gender differences in cancer pathogenesis and pharmacology.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2025Review
- Chemotherapy-Induced Hematological Toxicity in Patients with Renal or Hepatic Impairment.Pharmaceutics · 2025Article
- Significant Improvement in Bioavailability and Therapeutic Efficacy of Mebendazole Oral Nano-Systems Assessed in a Murine Model with Extreme Phenotypes of Susceptibility toPharmaceutics · 2025Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
14 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundIn addition to the effect of body weight, a patient's sex can influence the pharmacokinetics (PK) of anticancer agents, and thereby their activity and safety. The magnitude and relevance of sex differences, however, are currently unclear.
methodsWe carried out a systematic review of published studies (clinical, n ≥ 10) on Food and Drug Administration (FDA)-approved (on 31 January 2022) anticancer drugs (excluding hormonal agents), aiming to identify significant PK differences between male and female patients. A difference of ≥20% on PK parameters (clearance or trough concentration) was considered significant. The methodological quality was assessed using the National Institutes of Health study quality assessment tool. This systematic review was conducted according to the PRISMA2020 guidelines and a previously published protocol, which was registered in the PROSPERO database (number 291008).
resultsData on 99 anticancer agents (for a total of 1643 abstracts and European Medicines Agency/FDA documents) were screened. The final dataset included 112 articles and 8 European Medicines Agency/FDA documents. The median size of a study cohort was 445 patients (range: 12-6468 patients). Significant PK differences (>+20% in clearance or apparent clearance in women) were identified for 14 drugs, and potentially significant PK differences (due to conflicting reports) for another 8 drugs. None of the studies included sex-based summaries to assess whether the observed differences in PK may impact the efficacy or safety profile.
conclusionsSignificant sex differences in PK have been identified including commonly used drugs of different classes, such as 5-fluorouracil, doxorubicin, paclitaxel, regorafenib, atezolizumab, and temozolomide. The risk-benefit ratio for such anticancer drugs is likely to be improved by the development of sex-specific dosing strategies. Additional sex-based PK-pharmacodynamic analyses are recommended during dose optimisation and are to be conducted in line with the FDA Project Optimus guidance. They should be reported even if no association between the patients' sex and the activity and/or toxicity of an anticancer drug has been identified.
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