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Cancers
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Development of Biomarkers and Antineoplastic Drugs in Solid Tumors
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Development of Biomarkers and Antineoplastic Drugs in Solid Tumors

A special issue of Cancers (ISSN 2072-6694). This special issue belongs to the section "Cancer Drug Development".

Deadline for manuscript submissions: 31 October 2026 | Viewed by 5777

Special Issue Editors

Dr. Rosa Falcone

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Guest Editor
Istituto Dermopatico dell’Immacolata, IDI-IRCCS, Rome, Italy
Interests: melanoma; biomarkers; drugs; immunotherapy; digital
Dr. Sofia Verkhovskaia

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Guest Editor Assistant
Istituto Dermopatico dell’Immacolata, IDI-IRCCS, Rome, Italy
Interests: melanoma; immunotherapy; target therapy; biomarkers; drugs
Dr. Michela Roberto

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Guest Editor Assistant
Policlinico Umbero I, Rome, Italy
Interests: genitourinary cancers; precision medicine; biomarkers

Special Issue Information

Dear Colleagues,

In recent decades, biomarkers’ discovery in oncology has run parallel to the development of novel antineoplastic agents.

Drug regulatory agencies have approved new compounds, combinations, or extensions of indications for already approved drugs. Clinicians have not abandoned chemotherapy but rather rejuvenated it by combining it with other agents (i.e., immunotherapy) or conjugating cytotoxic drugs to a monoclonal antibody. Immune checkpoint inhibitors, antibody–drug conjugates, and targeted agents have improved the survival outcomes of many patients suffering from different cancer types and modified toxicity profiles. Tumor-infiltrating lymphocyte cell therapy (TIL) and autologous vaccine therapy represent two pioneering examples of highly personalized treatments with unique properties for every patient.

Besides drug development, biomarkers play a crucial role in tumor diagnosis, predicting response to therapies, mechanisms of resistance, and prognosis. Tissues, fluid, and fecal samples represent the sources for biomarker identification. Gene signatures and cell-free DNA are routinely used in oncology practice to support clinicians in medical choices. Novel biomarkers (digital biomarkers, microbiome profiles, etc.) are currently under evaluation.

Dr. Rosa Falcone
Guest Editor

Dr. Sofia Verkhovskaia
Dr. Michela Roberto
Guest Editor Assistants

Manuscript Submission Information

Manuscripts should be submitted online at www.mdpi.com by registering and logging in to this website. Once you are registered, click here to go to the submission form. Manuscripts can be submitted until the deadline. All submissions that pass pre-check are peer-reviewed. Accepted papers will be published continuously in the journal (as soon as accepted) and will be listed together on the special issue website. Research articles, review articles as well as communications are invited. For planned papers, a title and short abstract (about 250 words) can be sent to the Editorial Office for assessment.

Submitted manuscripts should not have been published previously, nor be under consideration for publication elsewhere (except conference proceedings papers). All manuscripts are thoroughly refereed through a single-blind peer-review process. A guide for authors and other relevant information for submission of manuscripts is available on the Instructions for Authors page. Cancers is an international peer-reviewed open access semimonthly journal published by MDPI.

Please visit the Instructions for Authors page before submitting a manuscript. The Article Processing Charge (APC) for publication in this open access journal is 2900 CHF (Swiss Francs). Submitted papers should be well formatted and use good English. Authors may use MDPI's English editing service prior to publication or during author revisions.

Keywords

  • solid tumors
  • drugs
  • biomarkers
  • immunotherapy
  • targeted therapy
  • artificial intelligence

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Published Papers (3 papers)

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Research

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18 pages, 7251 KB  
Article
Assessment of the Effects of Single-Domain Anti-Idiotypic Distribution Enhancers on the Disposition of Trastuzumab and on the Efficacy of a PE24-Trastuzumab Immunotoxin
by Ping Chen, Yu Zhang, Brandon M. Bordeau and Joseph P. Balthasar
Cancers 2025, 17(9), 1468; https://doi.org/10.3390/cancers17091468 - 27 Apr 2025
Viewed by 1291
Abstract
Background/Objectives: Antibody-based therapies often exhibit limited distribution within solid tumors due to the “binding-site barrier” (BSB). Our group has developed and validated the use of anti-idiotypic distribution enhancers (AIDEs), which transiently block antibody binding, improving intra-tumoral distribution and efficacy. This study evaluated 1HE [...] Read more.
Background/Objectives: Antibody-based therapies often exhibit limited distribution within solid tumors due to the “binding-site barrier” (BSB). Our group has developed and validated the use of anti-idiotypic distribution enhancers (AIDEs), which transiently block antibody binding, improving intra-tumoral distribution and efficacy. This study evaluated 1HE and LG1, model anti-trastuzumab AIDEs, in combination with trastuzumab–PE24, a highly potent immunotoxin. Methods: The effects of 1HE on the whole-body disposition of radiolabeled trastuzumab were assessed in NCI-N87 tumor-bearing mice. Mechanistic pharmacokinetic/pharmacodynamic (PK/PD) modeling was employed to explore how AIDE binding kinetics influence antibody intra-tumoral distribution and immunotoxin potency. Trastuzumab–PE24 was developed by site-specific conjugation, enabled by self-splicing split intein, with cytotoxicity tested on various cell lines in vitro. The impact of 1HE and LG1 coadministration on trastuzumab–PE24 efficacy was evaluated in NCI-N87 xenograft-bearing mice. Results: 1HE coadministration decreased trastuzumab tumor maximum concentration, reducing tumor terminal slope by 8% and overall tumor exposure by 2.6%, without negatively affecting selectivity. Modeling predicted the optimal AIDE dissociation rate constant for trastuzumab–PE24 to be between 0.015 and 0.3 h−1. The coadministration of trastuzumab–PE24 with 1HE and LG1 improved anti-tumor efficacy and extended median survival to 60 days (p = 0.0002). Conclusions: AIDE coadministration led to minimal negative impacts on overall tumor exposure, consistent with model simulations. AIDE coadministration improved the efficacy of trastuzumab–PE24 in NCI-N87 xenografts. Modeling further predicted that repeated AIDE administration with trastuzumab–PE24 could induce complete tumor regression. These findings highlight the advantages of the AIDE strategy, particularly when coadministered with highly potent immunotoxins. Full article
(This article belongs to the Special Issue Development of Biomarkers and Antineoplastic Drugs in Solid Tumors)
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Review

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26 pages, 382 KB  
Review
Pharmacological Prevention in Breast Cancer: Current Evidence, Challenges, and Future Directions
by Samanta Sarti, Alessandro Adriano Viansone, Olga Serra, Chiara Casadei, Lorenzo Cecconetto, Giandomenico Di Menna, Alberto Farolfi, Caterina Gianni, Marita Mariotti, Filippo Merloni, Michela Palleschi, Marianna Sirico, Gabriele Zoppoli and Antonino Musolino
Cancers 2025, 17(22), 3597; https://doi.org/10.3390/cancers17223597 - 7 Nov 2025
Cited by 2 | Viewed by 2411
Abstract
Background/Objectives: Pharmacological prevention is an evidence-based strategy to reduce the incidence of hormone receptor-positive breast cancer in high-risk women. Despite strong data from randomized trials, clinical uptake remains low. This review aims to summarize the efficacy, safety, and clinical implementation of pharmacoprevention and [...] Read more.
Background/Objectives: Pharmacological prevention is an evidence-based strategy to reduce the incidence of hormone receptor-positive breast cancer in high-risk women. Despite strong data from randomized trials, clinical uptake remains low. This review aims to summarize the efficacy, safety, and clinical implementation of pharmacoprevention and explore novel approaches to improve uptake. Methods: A comprehensive literature review was conducted on pharmacologic agents used for breast cancer risk reduction, including selective estrogen receptor modulators (SERMs) and aromatase inhibitors (AIs). The review also examines risk assessment models, guideline recommendations, barriers to implementation, and emerging strategies such as low-dose therapies and digital decision aids. Results: Tamoxifen, raloxifene, and AIs significantly reduce the incidence of estrogen receptor-positive breast cancer in high-risk populations. However, adverse effects and poor awareness limit their use. Personalized risk models and newer approaches, including low-dose tamoxifen, digital health tools, and emerging agents such as SERDs and GLP-1 receptor agonists, may improve acceptability and adherence. Conclusions: Pharmacoprevention offers substantial benefits in appropriately selected women. Future efforts should focus on new drugs, precision risk stratification, individualized decision-making, and overcoming barriers to implementation to maximize the impact of preventive strategies in breast cancer control. Full article
(This article belongs to the Special Issue Development of Biomarkers and Antineoplastic Drugs in Solid Tumors)
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Other

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16 pages, 1462 KB  
Systematic Review
Application of Radiomics in Melanoma: A Systematic Review and Meta-Analysis
by Rosa Falcone, Sofia Verkhovskaia, Francesca Romana Di Pietro, Chiara Scianni, Giulia Poti, Maria Francesca Morelli, Paolo Marchetti, Federica De Galitiis, Matteo Sammarra and Armando Ugo Cavallo
Cancers 2025, 17(19), 3130; https://doi.org/10.3390/cancers17193130 - 26 Sep 2025
Cited by 1 | Viewed by 1560
Abstract
Background/Objectives: Radiomics is a powerful and emerging tool in oncology, with many potential applications in predicting therapy response and prognosis. To assess the current state of radiomics in melanoma, we conducted a systematic review of its various clinical uses. Methods: We [...] Read more.
Background/Objectives: Radiomics is a powerful and emerging tool in oncology, with many potential applications in predicting therapy response and prognosis. To assess the current state of radiomics in melanoma, we conducted a systematic review of its various clinical uses. Methods: We searched three databases: PubMed, Web of Science and Scopus. Each study was classified based on multiple variables, including patient number, metastasis number, therapy, imaging modality, clinical endpoints and analysis methods. The risk of bias in the systematic review was assessed with QUADAS-2, and the certainty of evidence in the meta-analysis with GRADE. Results: Forty studies involving 4673 patients and 24,561 lesions were included in the analysis. Metastatic disease was the most frequently studied clinical setting (85%). Immunotherapy was the most commonly investigated treatment, featured in half of the studies. Computed tomography (CT) was the preferred imaging modality, appearing in 17 studies (42.5%). Radiomic features were most often extracted using three-dimensional (3D) analysis (72.5%). Across 24 studies investigating the prediction of treatment response and survival, only 9 provided sufficient data (Area Under the Curve, AUC, and standard error, SE) for inclusion. A random-effects model estimated a pooled AUC of 0.83 (95% CI: 0.74 to 0.92), indicating strong discriminative performance of the radiomic models included. Low to moderate heterogeneity was observed (I2 = 28.6%, p = 0.4741). No evidence of publication bias was detected (p = 0.470). Conclusions: Radiomics is increasingly being explored in the context of melanoma, particularly in advanced disease settings and in relation to immunotherapy. Most studies rely on CT imaging and 3D feature extraction, while molecular integration remains limited. Despite promising findings with strong discriminative performance in predicting therapy response, further prospective, standardized studies with higher methodological rigor are needed to validate radiomic biomarkers and integrate them into clinical decision-making. Full article
(This article belongs to the Special Issue Development of Biomarkers and Antineoplastic Drugs in Solid Tumors)
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