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Cancers
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Drug Utilization, Safety and Effectiveness of Anti-Cancer Drugs for Solid...
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Drug Utilization, Safety and Effectiveness of Anti-Cancer Drugs for Solid Tumors: A Focus on Special Populations

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

Deadline for manuscript submissions: 5 September 2025 | Viewed by 7224

Special Issue Editors

Dr. Andrea Spini

E-Mail Website
Guest Editor
1. Department of Medicine, Surgery and Neuroscience, University of Siena, 53100 Siena, Italy
2. Azienda Ospedaliera Universitaria Senese, Viale Mario Bracci 16, 53100 Siena, Italy
Interests: pharmacoepidemiology; pharmacovigilance; real-word evidence; real-word data; cancer; solid tumors; biologics; anti-cancer drugs; routinely-collected electronic healthcare data
Dr. Sandra Donnini

E-Mail Website
Guest Editor
Department of Life Sciences, University of Siena, 53100 Siena, Italy
Interests: drug utilization; pharmacovigilance; angiogenesis; anti-cancer drugs; ALDH; inflammation; nutraceuticals

Special Issue Information

Dear Colleagues,

In the last decade, the pharmacological treatment of most parts of advanced/metastatic solid tumors has been revolutionized by the approval of novel anti-cancer pharmacotherapies such as target therapies and immunotherapies. However, the marketing authorizations of anti-cancer therapies are usually based on the results of randomized controlled trials with a low number of patients, with a short duration of exposure and with stringent selection criteria. Special populations such as women, children, elderly, pregnant women, racial/ethnic minorities and patients with concurrent diseases are absent or underrepresented in clinical trials concerning cancer. Safety and effectiveness, as well as drug utilization of anti-cancer drugs in clinical practice, may be different than expected. Pharmacoepidemiology and pharmacovigilance studies can help improving this lack of knowledge. On the one hand, the use of routinely collected electronical healthcare data to conduct pharmacoepidemiology studies has advantages in terms of the inclusion of a large number of patients underrepresented in clinical trials. On the other hand, data coming from spontaneous reporting systems are fundamental to observe the safety profile of anticancer drugs and to detect safety signals in the broad population. The present Special Issue aims to fill the knowledge gap on the use, the safety and the effectiveness of anti-cancer drugs used in the treatment of solid tumors in clinical practice. Articles that focus on special populations will be prioritized for inclusion in this Special Issue. Original research articles such as pharmacoepidemiologic studies and pharmacovigilance studies, as well as reviews and meta-analysis, will be welcome.

Bullet points:

1) Safety of target-therapies and immunotherapies in pediatric patients with solid tumors;

2) Effectiveness of target-therapies and immunotherapies in pediatric patients with solid tumors;

3) Safety of immunotherapy in women and men with solid tumors;

4) Effectiveness of immunotherapy in women and men with solid tumors;

5) Sex difference in terms of drug utilization of anti-neoplastic drugs;

6) Drug utilization of anti-neoplastic drugs among elderly patients and in those with concomitant diseases.

Dr. Andrea Spini
Dr. Sandra Donnini
Guest Editors

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 100 words) can be sent to the Editorial Office for announcement on this website.

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

  • drug utilization
  • safety
  • effectiveness
  • anti-cancer drugs
  • cancer
  • tumor
  • observational studies
  • pharmacoepidemiology
  • observational study
  • pharmacovigilance
  • spontaneous reporting system
  • children
  • pediatric
  • elderly
  • female
  • women
  • gender
  • minorities
  • pregnancy
  • immunotherapy
  • chemotherapy
  • target-therapy
  • personalized medicine

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Published Papers (4 papers)

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Research

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20 pages, 2279 KiB  
Article
Racial Disparities in Breast Cancer Treatments and Adverse Events in the SEER-Medicare Data
by Robert Wieder and Nabil Adam
Cancers 2023, 15(17), 4333; https://doi.org/10.3390/cancers15174333 - 30 Aug 2023
Cited by 1 | Viewed by 1684 | Correction
Abstract
Despite lower incidence rates, African American (AA) patients have shorter survival from breast cancer (BC) than white (W) patients. Multiple factors contribute to decreased survival, including screening disparities, later presentation, and access to care. Disparities in adverse events (AEs) may contribute to delayed [...] Read more.
Despite lower incidence rates, African American (AA) patients have shorter survival from breast cancer (BC) than white (W) patients. Multiple factors contribute to decreased survival, including screening disparities, later presentation, and access to care. Disparities in adverse events (AEs) may contribute to delayed or incomplete treatment, earlier recurrence, and shortened survival. Here, we analyzed the SEER-Medicare dataset, which captures claims from a variety of venues, in order to determine whether the cancer care venues affect treatment and associated adverse events. We investigated a study population whose claims are included in the Outpatient files, consisting of hospital and healthcare facility venues, and a study population from the National Claims History (NCH) files, consisting of claims from physicians, office practices, and other non-institutional providers. We demonstrated statistically and substantively significant venue-specific differences in treatment rates, drugs administered, and AEs from treatments between AA and W patients. We showed that AA patients in the NCH dataset received lower rates of treatment, but patients in the Outpatient dataset received higher rates of treatment than W patients. The rates of recorded AEs per treatment were higher in the NCH setting than in the Outpatient setting in all patients. AEs were consistently higher in AA patients than in W patients. AA patients had higher comorbidity indices and were younger than W patients, but these variables did not appear to play roles in the AE differences. The frequency of specific anticancer drugs administered in cancer- and venue-specific circumstances and their associated AEs varied between AA and W patients. The higher AE rates were due to slightly higher frequencies in the administration of drugs with higher associated AE rates in AA patients than in W patients. Our investigations demonstrate significant differences in treatment rates and associated AEs between AA and W patients with BC, depending on the venues of care, likely contributing to differences in outcomes. Full article
(This article belongs to the Special Issue Drug Utilization, Safety and Effectiveness of Anti-Cancer Drugs for Solid Tumors: A Focus on Special Populations)
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12 pages, 923 KiB  
Article
Association between Proton Pump Inhibitor Use and the Risk of Female Cancers: A Nested Case-Control Study of 23 Million Individuals
by Nhi Thi Hong Nguyen, Chih-Wei Huang, Ching-Huan Wang, Ming-Chin Lin, Jason C. Hsu, Min-Huei Hsu, Usman Iqbal, Phung-Anh Nguyen and Hsuan-Chia Yang
Cancers 2022, 14(24), 6083; https://doi.org/10.3390/cancers14246083 - 10 Dec 2022
Cited by 3 | Viewed by 2557
Abstract
Background: Firm conclusions about whether long-term proton pump inhibitor (PPI) drug use impacts female cancer risk remain controversial. Objective: We aimed to investigate the associations between PPI use and female cancer risks. Methods: A nationwide population-based, nested case-control study was conducted within Taiwan’s [...] Read more.
Background: Firm conclusions about whether long-term proton pump inhibitor (PPI) drug use impacts female cancer risk remain controversial. Objective: We aimed to investigate the associations between PPI use and female cancer risks. Methods: A nationwide population-based, nested case-control study was conducted within Taiwan’s Health and Welfare Data Science Center’s databases (2000–2016) and linked to pathologically confirmed cancer data from the Taiwan Cancer Registry (1979–2016). Individuals without any cancer diagnosis during the 17 years of the study served as controls. Case and control patients were matched 1:4 based on age, gender, and visit date. Conditional logistic regression with 95% confidence intervals (CIs) was applied to investigate the association between PPI exposure and female cancer risks by adjusting for potential confounders such as the Charlson comorbidity index and medication usage (metformin, aspirin, and statins). Results: A total of 233,173 female cancer cases were identified, consisting of 135,437 diagnosed with breast cancer, 64,382 with cervical cancer, 19,580 with endometrial cancer, and 13,774 with ovarian cancer. After matching each case with four controls, we included 932,692 control female patients. The number of controls for patients with breast cancer, cervical cancer, endometrial cancer, and ovarian cancer was 541,748, 257,528, 78,320, and 55,096, respectively. The use of PPIs was significantly associated with reduced risk of breast cancer and ovarian cancer in groups aged 20–39 years (adjusted odds ratio (aOR): 0.69, 95%CI: 0.56–0.84; p < 0.001 and aOR: 0.58, 95%CI: 0.34–0.99; p < 0.05, respectively) and 40–64 years (aOR: 0.89, 95%CI: 0.86–0.94; p < 0.0001 and aOR: 0.87, 95%CI: 0.75–0.99; p < 0.05, respectively). PPI exposure was associated with a significant decrease in cervical and endometrial cancer risks in the group aged 40–64 years (with aOR: 0.79, 95%CI: 0.73–0.86; p < 0.0001 and aOR: 0.72, 95%CI: 0.65–0.81; p < 0.0001, respectively). In contrast, in elderly women, PPI use was found to be insignificantly associated with female cancers among users. Conclusions: Our findings, based on real-world big data, can depict a comprehensive overview of PPI usage and female cancer risk. Further clinical studies are needed to elucidate the effects of PPIs on female cancers. Full article
(This article belongs to the Special Issue Drug Utilization, Safety and Effectiveness of Anti-Cancer Drugs for Solid Tumors: A Focus on Special Populations)
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Review

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26 pages, 636 KiB  
Review
Advances in Immunotherapy for Endometrial Cancer: Insights into MMR Status and Tumor Microenvironment
by Manel Albertí-Valls, Sara Olave, Anna Olomí, Anna Macià and Núria Eritja
Cancers 2024, 16(23), 3918; https://doi.org/10.3390/cancers16233918 - 22 Nov 2024
Abstract
Endometrial cancer is one of the most common gynecological malignancies, and while early-stage cases are highly treatable, recurrent or advanced EC remains challenging to manage. Immunotherapy, particularly immune checkpoint inhibitors, has revolutionized treatment approaches in oncology, and its application in EC has shown [...] Read more.
Endometrial cancer is one of the most common gynecological malignancies, and while early-stage cases are highly treatable, recurrent or advanced EC remains challenging to manage. Immunotherapy, particularly immune checkpoint inhibitors, has revolutionized treatment approaches in oncology, and its application in EC has shown promising results. Key to immunotherapy efficacy in EC is the tumor’s mismatch repair status, with MMR-deficient tumors demonstrating a higher tumor mutational burden and increased PD-L1 expression, making them more susceptible to immune checkpoint inhibitors (ICIs) such as pembrolizumab, durvalumab, and dostarlimab. However, not all mismatch repair-deficient (MMRd) tumors respond to ICIs, particularly those with a “cold” tumor microenvironment (TME) characterized by poor immune infiltration. In contrast, some MMR-proficient tumors with a “hot” TME respond well to ICIs, underscoring the complex interplay between MMR status, tumor mutational burden (TMB), and TME. To overcome resistance in cold tumors, novel therapies, including Chimeric Antigen Receptor (CAR) T cells and tumor-infiltrating lymphocytes are being explored, offering targeted immune-based strategies to enhance treatment efficacy. This review discusses the current understanding of immunotherapy in EC, emphasizing the prognostic and therapeutic implications of MMR status, TME composition, and emerging cell-based therapies. Full article
(This article belongs to the Special Issue Drug Utilization, Safety and Effectiveness of Anti-Cancer Drugs for Solid Tumors: A Focus on Special Populations)

Other

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22 pages, 2555 KiB  
Systematic Review
Safety of Anti-Angiogenic Drugs in Pediatric Patients with Solid Tumors: A Systematic Review and Meta-Analysis
by Andrea Spini, Valerio Ciccone, Pietro Rosellini, Marina Ziche, Ersilia Lucenteforte, Francesco Salvo and Sandra Donnini
Cancers 2022, 14(21), 5315; https://doi.org/10.3390/cancers14215315 - 28 Oct 2022
Cited by 7 | Viewed by 2208
Abstract
Cancer is a clinical condition that can benefit from anti-angiogenic drugs (AADs). Given the low prevalence and the heterogeneity of childhood cancers, information about the safety of these drugs in pediatric patients is partially assessed. The aim of this study was to evaluate [...] Read more.
Cancer is a clinical condition that can benefit from anti-angiogenic drugs (AADs). Given the low prevalence and the heterogeneity of childhood cancers, information about the safety of these drugs in pediatric patients is partially assessed. The aim of this study was to evaluate the safety of AADs in pediatric patients with solid tumors. Clinical trials and observational studies were searched in PubMed, ISI Web of Science, and ClinicalTrials database For each included study, adverse events (AEs) were extracted. A meta-analysis was conducted by pooling proportions of AEs using a random intercept logistic regression model. Seventy studies were retrieved. Most part were clinical trials (55 out of 70), and only fifteen observational studies were found. Overall, proportion of serious and non-serious AEs of AADs used as monotherapy was 46% and 89%, respectively. Proportions of serious AEs varied among drugs: sunitinib, 79%; lenvatinib, 64%; sorafenib, 48%; ramucirumab, 41%; pazopanib, 30%; and vandetanib, 27%. A higher proportion of non-serious hematological AEs was found in the patients receiving pazopanib with respect to sunitinib and lenvatinib. The safety profile of AADs has been extensively investigated for mostly drugs in phase I and II trials and is limited to acute toxicities. Overall, one out of two patients using AAD drugs in monotherapy experienced a serious AE despite proportions varied per single drugs. When AADs were combined with standard chemotherapy, the proportion of AEs varied in relation to the single combinations. Full article
(This article belongs to the Special Issue Drug Utilization, Safety and Effectiveness of Anti-Cancer Drugs for Solid Tumors: A Focus on Special Populations)
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