{"title":"Safety and Treatment Continuity of Switching Between CDK4/6 Inhibitors for Metastatic Breast Cancer Due to Adverse Events: An Exploratory Single-Center Study in Japan.","authors":"Makiko Go, Michio Kimura, Shiori Yamada, Keitaro Kamei, Yoshihiro Noguchi, Eiseki Usami, Tomoaki Yoshimura","doi":"10.1159/000548801","DOIUrl":"https://doi.org/10.1159/000548801","url":null,"abstract":"<p><p>Palbociclib and abemaciclib, CDK4/6 inhibitors with a shared primary mechanism of action, differ in their adverse effect profiles. We encountered several cases of switching between CDK4/6 inhibitors following treatment discontinuation owing to adverse events (AEs) in clinical practice. In this study, we evaluated the safety and treatment continuity of switching between palbociclib and abemaciclib for hormone receptor-positive HER2-negative metastatic or recurrent breast cancer (HR+/HER2-MBC) in patients prescribed these agents between January 1, 2018, and August 31, 2024, at Ogaki Municipal Hospital. Patients who did not discontinue treatment owing to AEs were defined as the non-AE group (79 patients), those who switched to another CDK4/6 inhibitor after treatment discontinuation owing to AEs were defined as the AE-switch group (16 patients), and those who did not switch to another CDK4/6 inhibitor after treatment discontinuation owing to AEs as the AE-stop group (13 patients). The main AEs for which treatment was discontinued included neutropenia, interstitial lung disease, increased AST and ALT levels, gastrointestinal symptoms, and skin disorders. Switching only caused recurrent neutropenia, with no serious recurrence being observed for the other AEs. The median progression-free survival in the non-AE, AE-switch, and AE-stop groups was 392, 1,043, and 203 days (p = 0.00858), and the median overall survival was 1,598, 3,725, and 1,701 days (p = 0.269), respectively. These results suggest that switching following the emergence of AEs may be useful in terms of safety and treatment continuity of CDK4/6 inhibitor therapy for HR+/HER2-MBC. However, since this study was an exploratory analysis based on real-world data from a single center in Japan, further validation through large-scale, prospective, multicenter clinical trials is warranted.</p>","PeriodicalId":19497,"journal":{"name":"Oncology","volume":" ","pages":"1-17"},"PeriodicalIF":1.8,"publicationDate":"2025-10-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145225696","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
OncologyPub Date : 2025-09-29DOI: 10.1159/000548317
Giuseppe Di Lorenzo, Antonio Verde, Luca Scafuri, Raffaele Baio, Francesco Grillone, Francesco Passaro, Felice Crocetto, Dario Bruzzese, Antonella Ferraioli, Eleonora Monteleone, Sabrina Rossetti, Vittorino Montanaro, Giacomo Metta, Francesco Prata, Antonio Ruffo, Giuseppe Romeo, Raffaele Balsamo, Armando Calogero, Oriana Strianese, Francesco Maiorino, Alfredo Tartarone, Matteo Ferro, Pierluigi Bove, Aniello Donnarumma, Paolo Verze, Rocco Papalia, Sisto Perdonà, Vittorio Riccio, Emma Costa, Concetta Scocca, Antonio Aliberti, Francesca Cappuccio, Carlo Buonerba
{"title":"Development and validation of the PREVES-HOR Questionnaire: a patient-reported measure of hormone-therapy-related quality of life in prostate-cancer patients undergoing androgen-deprivation therapy.","authors":"Giuseppe Di Lorenzo, Antonio Verde, Luca Scafuri, Raffaele Baio, Francesco Grillone, Francesco Passaro, Felice Crocetto, Dario Bruzzese, Antonella Ferraioli, Eleonora Monteleone, Sabrina Rossetti, Vittorino Montanaro, Giacomo Metta, Francesco Prata, Antonio Ruffo, Giuseppe Romeo, Raffaele Balsamo, Armando Calogero, Oriana Strianese, Francesco Maiorino, Alfredo Tartarone, Matteo Ferro, Pierluigi Bove, Aniello Donnarumma, Paolo Verze, Rocco Papalia, Sisto Perdonà, Vittorio Riccio, Emma Costa, Concetta Scocca, Antonio Aliberti, Francesca Cappuccio, Carlo Buonerba","doi":"10.1159/000548317","DOIUrl":"https://doi.org/10.1159/000548317","url":null,"abstract":"<p><strong>Background: </strong>The burden of androgen-deprivation therapy (ADT) is only partially captured by legacy prostate-cancer questionnaires, which devote few items to hormonal sequelae. PREVES-HOR is a 29-item, distress-anchored instrument developed to quantify androgen deprivation therapy (ADT)-specific physical, emotional, cognitive, sexual and body-image morbidity from a patient-centered, subjective perspective. We report the pre-specified Phase-1 psychometric evaluation.</p><p><strong>Methods: </strong>Italian-speaking men receiving ADT were consecutively enrolled. Participants completed PREVES-HOR plus external comparators for fatigue (REST), mood (HEAL-BDLC), sleep (PEACE) and well-being (WHO-5). Internal consistency was estimated with Cronbach's α and McDonald's ω; convergent validity with Spearman correlations; dimensionality with exploratory factor analysis (polychoric matrix, principal-axis factoring, oblimin rotation, parallel analysis).</p><p><strong>Results: </strong>One-hundred-forty-five patients were analyzed. PREVES-HOR showed excellent reliability (α = 0.95; McDonald's ω = 0.97; domain α/ω 0.80-0.95). Six factors-Physical Fatigue & Pain, Emotional Well-being, Mental Clarity, Quality of Life, Relationships and Stress, Sexual Health and Body-Image-accounted for 79 % of variance, with a dominant general-distress factor (~50 %). All but four items had communalities ≥ 0.40 and cross-loadings < 0.30. Total PREVES-HOR correlated strongly with fatigue (REST ρ = 0.69) and depression/anxiety (HEAL-BDLC ρ = 0.78), and inversely with well-being (WHO-5 ρ = -0.49) and sleep quality (PEACE ρ = -0.37), confirming convergent but non-redundant validity.</p><p><strong>Conclusions: </strong>Phase-1 findings support PREVES-HOR's content validity, internal coherence and ability to detect clinically meaningful distress overlooked by broader instruments such as EPIC or FACT-P. Its forced-choice format eliminated missing data but will be reconsidered, along with responsiveness, test-retest stability and cross-cultural adaptation, in the ongoing 1,000-patient Phase-2/3 program. Pending confirmation, PREVES-HOR may become a complementary tool for individualizing supportive care and evaluating ADT-modifying interventions.</p>","PeriodicalId":19497,"journal":{"name":"Oncology","volume":" ","pages":"1-29"},"PeriodicalIF":1.8,"publicationDate":"2025-09-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145192330","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Risk factors for the exacerbation of esophageal varices in patients receiving atezolizumab plus bevacizumab therapy for unresectable hepatocellular carcinoma.","authors":"Hitomi Takada, Leona Osawa, Yasuyuki Komiyama, Masaru Muraoka, Yuichiro Suzuki, Mitsuaki Sato, Shoji Kobayashi, Takashi Yoshida, Shinichi Takano, Shinya Maekawa, Atsunori Tsuchiya, Nobuyuki Enomoto","doi":"10.1159/000548667","DOIUrl":"https://doi.org/10.1159/000548667","url":null,"abstract":"<p><strong>Introduction: </strong>Atezolizumab plus bevacizumab (AB) therapy is an effective systemic therapy for unresectable hepatocellular carcinoma (u-HCC). However, exacerbations of esophageal varices (EV) often occur, and EV management should be clarified to attain a better prognosis in patients with u-HCC. Our research aimed to explore the actual situation of EV exacerbation and its risk factors in patients receiving AB therapy.</p><p><strong>Methods: </strong>We recruited 82 patients receiving AB therapy for u-HCC. All patients underwent esophagogastroduodenoscopy (EGD) within 3 months before AB induction to assess EV presence. The emergence of EV findings requiring urgent or planned endoscopic treatment defined EV exacerbation. The frequency and risk factors for EV exacerbation after AB introduction were analyzed.</p><p><strong>Results: </strong>Of the participants, 49% had EV findings on preinduction EGD. Within the observation period, 17% had EV exacerbation, and 7.2% experienced rupture. Among those with EV exacerbation, 7 had positive red color signs, and 1 had formal deterioration to F3. In EV rupture, 4 had eruptive hemorrhage, 1 had gushing hemorrhage, and 1 had a white plug. Independent factors requiring therapeutic intervention for EV exacerbation were EV treatment history, drug-resistant ascites effusion, esophageal intramural vessel (EIV) diameter >3.3 mm, and left gastric vein (LGV) diameter >4.9 mm on computed tomography (CT) scan.</p><p><strong>Conclusion: </strong>Patients with EV treatment history, drug-resistant ascites effusion, and EIV and LGV diameters >3.3 and 4.9 mm via CT, respectively, may require careful monitoring for possible EV exacerbation, enabling better EV management, adequate AB therapy, and finally, prolonged patient survival.</p>","PeriodicalId":19497,"journal":{"name":"Oncology","volume":" ","pages":"1-25"},"PeriodicalIF":1.8,"publicationDate":"2025-09-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145192281","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Utility of Comprehensive Cancer Genome Profiling Testing in Elderly Cancer Patients.","authors":"Hiroyuki Okuyama, Hiroki Sakuyama, Yoriyuki Tahara, Sena Tsukamoto, Ikuhiro Kita, Kotone Nomura, Akitsu Murakami, Yoshihiro Okita, Takamasa Nishiuchi, Akihito Tsuji","doi":"10.1159/000548585","DOIUrl":"https://doi.org/10.1159/000548585","url":null,"abstract":"<p><strong>Introduction: </strong>Comprehensive cancer genome profiling (CGP) testing was approved in Japan in 2019, leading to increasing opportunities for CGP testing in elderly cancer patients. However, these patients may be unable to undergo treatment due to poor organ function. Therefore, we investigated the usefulness and challenges of CGP testing in elderly cancer patients.</p><p><strong>Methods: </strong>Patients who underwent CGP testing at our hospital between December 2019 and November 2024 were eligible for inclusion in the study. The usefulness of the test was compared between elderly (age, ≥75 years) and non-elderly patients.</p><p><strong>Results: </strong>Of the total 423 patients, 89 (21%) were elderly. In the comparison between elderly and non-elderly patients, insurance-approved drugs were available for 3 (3%) and 21 (6%) patients, respectively, and 2 elderly patients were unable to receive the drug due to poor general condition. There were 34 (38%) and 152 (46%) patients who were candidates for clinical trials, and 1 (3%) and 3 (2%) patients who participated in clinical trials, respectively, with no statistically significant difference between the two groups.</p><p><strong>Conclusion: </strong>There was no difference in the rate of access to insurance-approved drugs or clinical trials between elderly and non-elderly cancer patients, which suggests that CGP testing is also useful in elderly patients. More effective drugs may help reduce unnecessary toxicity. As elderly patients may be at higher risk of being unable to receive treatment due to deterioration of their general condition, CGP testing should be performed early.</p>","PeriodicalId":19497,"journal":{"name":"Oncology","volume":" ","pages":"1-12"},"PeriodicalIF":1.8,"publicationDate":"2025-09-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145150427","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Differences in Safety Signal Detection Between Osimertinib and First- and Second-Generation EGFR-TKIs: A Pharmacovigilance Study Using a Spontaneous Reporting System.","authors":"Tomoya Sugimoto, Yoshihiro Noguchi, Rikuto Masuda, Tomohiko Harada, Yukio Toyama, Mitsuru Saguchi, Tomoaki Yoshimura","doi":"10.1159/000548593","DOIUrl":"https://doi.org/10.1159/000548593","url":null,"abstract":"<p><strong>Aims: </strong>This study aimed to evaluate the trends in safety signal detection of osimertinib compared with other epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs) through volcano plot analysis, using data from the Japanese Adverse Drug Event Report (JADER) and FDA Adverse Event Reporting System (FAERS). The overall objective of this study was to identify the potential risks associated with osimertinib-induced adverse events.</p><p><strong>Method: </strong>Data were retrieved from the JADER (Q1 2004-Q1 2024) and FAERS (Q4 1997-Q2 2024) databases. The target drugs were osimertinib, gefitinib, erlotinib, and afatinib. Adverse event reports were standardized by converting all records in the database to the preferred terms (PTs) of the International Classification of Diseases and subsequently mapping them to the high-level terms (HLTs) of the Medical Dictionary for Regulatory Activities. Volcano plots of odds ratios and z-scores were generated to assess variations in detection trends between osimertinib and the above-mentioned three EGFR-TKIs. The top 20 HLTs that demonstrated significant safety signals were computed and compared.</p><p><strong>Result: </strong>The numbers of safety signals detected in the JADER for osimertinib compared to the aforementioned EGFR-TKIs following volcano plot analysis were 24, 20, and 16, whereas detected safety signals were 7, 43, and 14 in FAERS. In the JADER database, the most frequently reported adverse reactions for osimertinib included \"poisoning and toxicity\" and \"heart failure.\" Conversely, in the FAERS database, the predominant adverse reactions were \"death and sudden death\" and \"marrow depression and hypoplastic anaemias.\"</p><p><strong>Conclusion: </strong>This study confirmed an increased frequency of reports linking osimertinib to cardiotoxicity, bone marrow suppression, and anemia. However, interstitial pneumonia, previously considered a risk factor, was not identified. When evaluating risks influenced by racial and treatment-related factors, caution must be exercised regarding potential discrepancies between reported rates and true incidence.</p>","PeriodicalId":19497,"journal":{"name":"Oncology","volume":" ","pages":"1-20"},"PeriodicalIF":1.8,"publicationDate":"2025-09-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145150294","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
OncologyPub Date : 2025-09-04DOI: 10.1159/000548121
Vincenzo Macaione, Francesca Graziano, Francesca Polito, Gianluca Scalia, Laura Licitri, Marieme Khouyyi, Margherita Maria Torre, Selene Francesca Anna Drago, Alba Migliorato, Giovanni Federico Nicoletti, Salvatore Massimiliano Cardali, Domenico La Torre, M Apos Hammed Aguennouz
{"title":"Circulating miRNA expression in glioblastoma: a promising diagnostic panel.","authors":"Vincenzo Macaione, Francesca Graziano, Francesca Polito, Gianluca Scalia, Laura Licitri, Marieme Khouyyi, Margherita Maria Torre, Selene Francesca Anna Drago, Alba Migliorato, Giovanni Federico Nicoletti, Salvatore Massimiliano Cardali, Domenico La Torre, M Apos Hammed Aguennouz","doi":"10.1159/000548121","DOIUrl":"https://doi.org/10.1159/000548121","url":null,"abstract":"<p><p>Introduction Among malignant brain tumors, glioblastoma (GB) is one of the most common. An early diagnosis would benefit the prognosis: in this regard, the search for sensitive and specific biomarkers is particularly active. In fact, liquid biopsy has been proposed by many researchers as a valid and repeatable method of studying GB. Among the biomarkers researched in blood patient, microRNAs (miRNAs) are among the most encouraging. The aim of our research was to select blood miRNAs overexpressed in GB patients, to establish a reliable biomarkers panel for pathology. Methods We studied blood expression of 14 miRNAs in 30 subjects with GB, before and after surgery, and 30 healthy controls. Results Statistical analysis allowed us to select a panel of 3 miRNAs (miR-340-5p, miR-369-3p, miR-486-5p) with excellent diagnostic and prognostic accuracy in GB.</p>","PeriodicalId":19497,"journal":{"name":"Oncology","volume":" ","pages":"1-20"},"PeriodicalIF":1.8,"publicationDate":"2025-09-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145001028","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
OncologyPub Date : 2025-09-04DOI: 10.1159/000548220
Junjie Huang, Claire Chenwen Zhong, Zhaojun Li, Yu Jiang, Zehuan Yang, Jinqiu Yuan, Jonathan Poon, Qi Dou, Martin Cs Wong
{"title":"Machine Learning Predictive Models for Survival in Gastric Cancer Patients with Diabetes: a population-based cohort study.","authors":"Junjie Huang, Claire Chenwen Zhong, Zhaojun Li, Yu Jiang, Zehuan Yang, Jinqiu Yuan, Jonathan Poon, Qi Dou, Martin Cs Wong","doi":"10.1159/000548220","DOIUrl":"https://doi.org/10.1159/000548220","url":null,"abstract":"<p><strong>Introduction: </strong>Our study aimed to identify risk factors associated with the survival of gastric cancer patients with Type 2 diabetes mellitus (T2DM) and create a risk-scoring system for predicting their survival probabilities.</p><p><strong>Methods: </strong>We gathered data from 1,912 individuals with both gastric cancer and T2DM from the Hong Kong Hospital Authority Data Collaboration Laboratory (HADCL), spanning from 2000 to 2020. We used conventional Cox proportional hazards regression and tree-based machine learning algorithms to construct models for prognosis risk prediction. In the best-performing model, risk factors were identified using SHAP (Shapley Additive Explanations) analysis, and the AutoScore-Survival package was used to develop a risk-scoring system.</p><p><strong>Results: </strong>Our findings indicate that older age at cancer diagnosis, longer duration of T2DM, higher body mass index (BMI), central obesity, lower levels of high-density lipoprotein cholesterol (HDL-C), and reduced serum potassium (serum-K) are associated with poorer prognosis for gastric cancer in patients with T2DM. The Random Survival Forests (RSF) model exhibited the best performance, achieving an AUC of 0.870 and a C-index of 0.78. Additionally, we developed two risk-scoring systems using predefined and tuned models, which yielded C-indices of 0.672 and 0.654, respectively, in the test set.</p><p><strong>Conclusion: </strong>This study enhances our understanding of gastric cancer prognosis in patients with T2DM by identifying significant risk factors and developing risk scoring systems. Further research is needed to elucidate the underlying mechanisms of these risk factors and to validate the risk scoring systems in clinical settings.</p>","PeriodicalId":19497,"journal":{"name":"Oncology","volume":" ","pages":"1-35"},"PeriodicalIF":1.8,"publicationDate":"2025-09-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145001043","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
OncologyPub Date : 2025-09-02DOI: 10.1159/000548260
Tse Kiat Soong, Sarah Shuyun Tang, Yi Xun Lim, Ngiam Kee Yuan, James Wai Kit Lee, Rajeev Parameswaran
{"title":"Managing the involved recurrent laryngeal nerve in thyroid cancer.","authors":"Tse Kiat Soong, Sarah Shuyun Tang, Yi Xun Lim, Ngiam Kee Yuan, James Wai Kit Lee, Rajeev Parameswaran","doi":"10.1159/000548260","DOIUrl":"https://doi.org/10.1159/000548260","url":null,"abstract":"<p><strong>Background: </strong>Recurrent laryngeal nerve palsy (RLNP) is not uncommon after thyroid surgery and can be debilitating. This is a retrospective cohort analysis of outcomes in patients with RLNP post-thyroidectomy for differentiated thyroid malignancy.</p><p><strong>Method: </strong>Clinicopathological details as well as outcomes of thyroidectomies for differentiated thyroid cancer in 862 patients performed over a period of 22 years (2001-2023) for nerve palsy were collected. The patients were stratified into two groups based on whether the recurrent laryngeal nerve (RLN) was amputated or preserved.</p><p><strong>Results: </strong>Of the 1520 nerves in 862 patients at risk during thyroidectomy, a total of 71 (8.2%) (20M:51F) patients, with a median age of 54 (range: 19 - 83) suffered RLNP, which was temporary in 14 (1.6%), unilateral in 51 (5.9%) and bilateral in 6 (0.7%) patients. The RLN was amputated in 31 of 62 patients (50%). In 29 of 71(41%) patients the nerve was intentionally sacrificed due to gross disease infiltration while the RLN was inadvertently severed during dissection in 2 (3%) patients. Among cases with recurrent laryngeal nerve (RLN) transection, only five underwent primary repair or ansa cervicalis to RLN anastomosis. The only factor associated with amputation of the RLN was a larger tumour size (40.4 vs 24.7mm, p = 0.007). Preservation of voice quality was higher in the shave group in comparison to the amputation group ((93.5% vs 71.0%, p = 0.0426).</p><p><strong>Conclusion: </strong>Preservation of nerve or reconstruction in transectional injuries should be considered where possible to improve voice outcomes except in cases when the laryngotracheal complex is involved.</p>","PeriodicalId":19497,"journal":{"name":"Oncology","volume":" ","pages":"1-17"},"PeriodicalIF":1.8,"publicationDate":"2025-09-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144963724","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
OncologyPub Date : 2025-08-27DOI: 10.1159/000548191
Jia Yi Tan, Yong Hao Yeo, Qi Xuan Ang, Arya Mariam Roy, Nishi Shah, Jon E Arnason, Talal Hilal
{"title":"Association of Cardiovascular Comorbidities on in-Hospital Outcomes of CAR T-Cell Therapy Recipients in the United States.","authors":"Jia Yi Tan, Yong Hao Yeo, Qi Xuan Ang, Arya Mariam Roy, Nishi Shah, Jon E Arnason, Talal Hilal","doi":"10.1159/000548191","DOIUrl":"10.1159/000548191","url":null,"abstract":"<p><strong>Introduction: </strong>With expanding indications for chimeric antigen receptor T-cell (CAR-T) therapy, more patients with diverse clinical profiles are receiving treatment, some of whom may not have been eligible to enroll on the pivotal clinical trials. The impact of preexisting cardiovascular diseases (CVDs) on the outcomes of CAR-T recipients remains understudied.</p><p><strong>Methods: </strong>Our study aimed to evaluate the impact of preexisting CVD on in-hospital outcomes among patients who received CAR-T therapy using the Nationwide Readmissions Database (NRD) from 2018 to 2020. We analyzed patients aged ≥18 and compared outcomes between those with and without preexisting CVD, utilizing sampling weights for national estimates.</p><p><strong>Results: </strong>After weighting, the cohort included 4,950 patients: 2,312 (46.7%) and 2,638 (53.3%) with and without preexisting CV, respectively. Patients with preexisting CVD experienced significantly higher rates of acute heart failure (2.9% vs. 0.7%; p = 0.01), myocardial infarction (2.2% vs. 0.9%; p < 0.01), cerebrovascular accidents (1.4% vs. 0.7%; p < 0.01), and acute kidney injury (19.2% vs. 13.3%; p < 0.01). Rates of cardiogenic shock, cardiac arrest, and pulmonary embolism were comparable between these 2 groups. Multivariate analysis showed preexisting CVD was not associated with increased odds of early mortality {adjusted odd ratios (aOR) = 1.01 (95% confidence intervals [CIs], 0.69-1.49), p = 0.95}, prolonged index hospitalization (aOR = 0.94 [95% CI, 0.64-1.36], p = 0.73), non-home discharge (aOR 1.04 [95% CI, 0.79-1.38], p = 0.77), and 30-day readmission (aOR 0.99 [95% CI, 0.81-1.20], p = 0.91).</p><p><strong>Conclusion: </strong>Although there were significant differences in acute complications, our study reinforces that the presence of CVD does not adversely affect early mortality rates.</p>","PeriodicalId":19497,"journal":{"name":"Oncology","volume":" ","pages":"1-6"},"PeriodicalIF":1.8,"publicationDate":"2025-08-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144963641","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}