Oxaliplatin-associated shock in stage III colorectal cancer patients: real-world evidence in Taiwan.

IF 3.4 3区 医学 Q2 PHARMACOLOGY & PHARMACY Therapeutic Advances in Drug Safety Pub Date : 2024-07-30 eCollection Date: 2024-01-01 DOI:10.1177/20420986241266439
Ling-Yi Wang, Hui-Hsia Hsieh, Sung-Chao Chu, Wei-Chuan Chang, Yi-Ting Kuo, Tien-Yuan Wu
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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.

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III 期结直肠癌患者与奥沙利铂相关的休克:台湾的实际证据。
背景:奥沙利铂相关休克(简称休克)是一种罕见但危及生命的不良事件:这项开创性的队列研究旨在定量研究奥沙利铂的使用与III期结直肠癌(CRC)患者休克之间的关系,确定休克的潜在独立风险因素,并评估奥沙利铂治疗期间的休克周期:该研究采用巢式病例对照(NCC)设计来评估奥沙利铂与休克之间的关系,并采用病例交叉的方法来解决未测量的混杂因素:所有新诊断的 III 期 CRC 患者均来自 CRC 健康数据库(2012-2016 年)。采用条件逻辑回归法计算奥沙利铂与休克发生率的几率比(OR)和95%置信区间(CI):在6932名奥沙利铂接受者中,有331人发生休克。在所有休克病例中,通过风险设定抽样筛选出了 3309 名对照者。使用奥沙利铂导致休克的风险增加一倍(调整后 OR:2.08,95% CI:1.23-3.52)。男性(调整后 OR:1.33,95% CI:1.05-1.69)和心脏病(调整后 OR:1.65,95% CI:1.17-2.32)是两个独立的风险因素。病例交叉分析显示,风险超过四倍(OR:4.4,95% CI:1.67-11.62)。在331例休克病例中,共有22例在休克发生后2天内接触过奥沙利铂,从周期到休克的中位时间为第7个周期:结论:使用奥沙利铂会明显增加III期CRC患者休克的风险。男性和心脏病是两个独立的风险因素。
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来源期刊
Therapeutic Advances in Drug Safety
Therapeutic Advances in Drug Safety Medicine-Pharmacology (medical)
CiteScore
6.70
自引率
4.50%
发文量
31
审稿时长
9 weeks
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.
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