{"title":"Oxaliplatin-associated shock in stage III colorectal cancer patients: real-world evidence in Taiwan.","authors":"Ling-Yi Wang, Hui-Hsia Hsieh, Sung-Chao Chu, Wei-Chuan Chang, Yi-Ting Kuo, Tien-Yuan Wu","doi":"10.1177/20420986241266439","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Oxaliplatin-associated shock (referred to as shock) is a rare but life-threatening adverse event.</p><p><strong>Objectives: </strong>This pioneering cohort study aimed to quantitatively investigate the association between oxaliplatin use and shock in patients with stage III colorectal cancer (CRC), identify potential independent risk factors for shock, and assess the cycle-to-shock during oxaliplatin treatment.</p><p><strong>Design: </strong>The study utilized a nested case-control (NCC) design to assess the association between oxaliplatin and shock and employed a case-crossover approach to address unmeasured confounders.</p><p><strong>Methods: </strong>All newly diagnosed stage III CRC patients were identified from the CRC Health Database (2012-2016). Conditional logistic regression was used to calculate odds ratios (OR) and 95% confidence intervals (CIs) for oxaliplatin's link to shock incidence.</p><p><strong>Results: </strong>Among 6932 oxaliplatin recipients, 331 suffered shock. In all, 3309 controls were selected <i>via</i> risk-set sampling for the shock cases. Oxaliplatin use is associated with a doubled risk of shock (adjusted OR: 2.08, 95% CI: 1.23-3.52). Two independent risk factors were male sex (adjusted OR: 1.33, 95% CI: 1.05-1.69) and heart diseases (adjusted OR: 1.65, 95% CI: 1.17-2.32). The case-crossover analysis revealed a more than fourfold risk (OR: 4.4, 95% CI: 1.67-11.62). In total, 22 of 331 shock cases were exposed to oxaliplatin within 2 days of shock onset, with a median cycle-to-shock time at the seventh cycle.</p><p><strong>Conclusion: </strong>Oxaliplatin use significantly increased shock risk in stage III CRC patients. Male sex and heart disease are two independent risk factors.</p>","PeriodicalId":23012,"journal":{"name":"Therapeutic Advances in Drug Safety","volume":"15 ","pages":"20420986241266439"},"PeriodicalIF":3.4000,"publicationDate":"2024-07-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11289823/pdf/","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Therapeutic Advances in Drug Safety","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1177/20420986241266439","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2024/1/1 0:00:00","PubModel":"eCollection","JCR":"Q2","JCRName":"PHARMACOLOGY & PHARMACY","Score":null,"Total":0}
引用次数: 0
Abstract
Background: Oxaliplatin-associated shock (referred to as shock) is a rare but life-threatening adverse event.
Objectives: This pioneering cohort study aimed to quantitatively investigate the association between oxaliplatin use and shock in patients with stage III colorectal cancer (CRC), identify potential independent risk factors for shock, and assess the cycle-to-shock during oxaliplatin treatment.
Design: The study utilized a nested case-control (NCC) design to assess the association between oxaliplatin and shock and employed a case-crossover approach to address unmeasured confounders.
Methods: All newly diagnosed stage III CRC patients were identified from the CRC Health Database (2012-2016). Conditional logistic regression was used to calculate odds ratios (OR) and 95% confidence intervals (CIs) for oxaliplatin's link to shock incidence.
Results: Among 6932 oxaliplatin recipients, 331 suffered shock. In all, 3309 controls were selected via risk-set sampling for the shock cases. Oxaliplatin use is associated with a doubled risk of shock (adjusted OR: 2.08, 95% CI: 1.23-3.52). Two independent risk factors were male sex (adjusted OR: 1.33, 95% CI: 1.05-1.69) and heart diseases (adjusted OR: 1.65, 95% CI: 1.17-2.32). The case-crossover analysis revealed a more than fourfold risk (OR: 4.4, 95% CI: 1.67-11.62). In total, 22 of 331 shock cases were exposed to oxaliplatin within 2 days of shock onset, with a median cycle-to-shock time at the seventh cycle.
Conclusion: Oxaliplatin use significantly increased shock risk in stage III CRC patients. Male sex and heart disease are two independent risk factors.
期刊介绍:
Therapeutic Advances in Drug Safety delivers the highest quality peer-reviewed articles, reviews, and scholarly comment on pioneering efforts and innovative studies pertaining to the safe use of drugs in patients.
The journal has a strong clinical and pharmacological focus and is aimed at clinicians and researchers in drug safety, providing a forum in print and online for publishing the highest quality articles in this area. The editors welcome articles of current interest on research across all areas of drug safety, including therapeutic drug monitoring, pharmacoepidemiology, adverse drug reactions, drug interactions, pharmacokinetics, pharmacovigilance, medication/prescribing errors, risk management, ethics and regulation.