Gannon Melissa Ruth, Dodwell David, Miller Katie, Medina Jibby, Clements Karen, Horgan Kieran, Park Min Hae, Cromwell David Alan
Department of Health Services Research & Policy, London School of Hygiene & Tropical Medicine, London, UK.
Clinical Effectiveness Unit, The Royal College of Surgeons of England, London, UK.
BMJ Oncol. 2023 Sep 4;2(1):e000081. doi: 10.1136/bmjonc-2023-000081. eCollection 2023.
Although adjuvant trastuzumab-based treatment (TBT) improves survival for patients with HER2-positive early invasive breast cancer (EIBC), risk of toxicity grows as patient age increases. We examined use of TBT and associated severe acute toxicity event (SATE) rates to understand the real-world impact.
Women (50+ years), newly diagnosed with HER2-positive EIBC in England, 2014-2019, were identified from Cancer Registry data, linked to the Systemic Anti-Cancer Therapy dataset for TBT information. SATEs were measured using hospital administrative data. Statistical models were developed to identify potential predictors of SATE.
Among 5087 women who received trastuzumab, with median duration 11.7 months, 47.4% (95% CI 46.0% to 48.7%) completed treatment. Women aged 70+ years made up 20.2% of patients aged 50+ who received adjuvant TBT in routine care, compared with 5% of women aged 50+ across trials. 32.8% (95% CI 31.5% to 34.1%) had a record of any SATE. 6.8% (95% CI 6.1% to 7.5%) had a cardiovascular SATE. Congestive cardiac failure rate was 0.5% (95% CI 0.3% to 0.7%). High deprivation, anthracycline use, increasing frailty were associated with increased odds of any SATE. Older age, sequential chemotherapy, history of myocardial infarction/chronic pulmonary disorder/liver disease were associated with increased odds of cardiovascular SATE. Among two-thirds of women not eligible for trial cohorts SATE rates were lower than for trial-eligible patients, explained by baseline differences in patients.
Evidence of treatment-related SATE among patients treated in routine care is needed to inform treatment decisions and counsel older patients. This study provides information on SATE rates for adjuvant TBT, and common types, overall and by age for such discussions.
尽管基于曲妥珠单抗的辅助治疗（TBT）可提高HER2阳性早期浸润性乳腺癌（EIBC）患者的生存率，但毒性风险会随着患者年龄的增加而升高。我们研究了TBT的使用情况及相关严重急性毒性事件（SATE）发生率，以了解其在现实世界中的影响。
从癌症登记数据中识别出2014 - 2019年在英格兰新诊断为HER2阳性EIBC的50岁及以上女性，并将其与系统抗癌治疗数据集相链接以获取TBT信息。使用医院管理数据来衡量SATE。建立统计模型以识别SATE的潜在预测因素。
在5087名接受曲妥珠单抗治疗的女性中，治疗持续时间中位数为11.7个月，47.4%（95%CI 46.0%至48.7%）完成了治疗。在接受常规辅助TBT治疗的50岁及以上患者中，70岁及以上的女性占20.2%，而在各项试验中，该年龄段女性占50岁及以上女性的5%。32.8%（95%CI 31.5%至34.1%）有任何SATE记录。6.8%（95%CI 6.1%至7.5%）发生心血管SATE。充血性心力衰竭发生率为0.5%（95%CI 0.3%至0.7%）。高贫困程度、使用蒽环类药物、身体虚弱程度增加与发生任何SATE的几率增加相关。年龄较大、序贯化疗、有心肌梗死/慢性肺部疾病/肝病病史与发生心血管SATE的几率增加相关。在三分之二不符合试验队列条件的女性中，SATE发生率低于符合试验条件的患者，这可由患者的基线差异来解释。
需要了解在常规治疗中接受治疗的患者中与治疗相关的SATE证据，以便为治疗决策提供信息并为老年患者提供咨询。本研究提供了辅助TBT的SATE发生率信息，以及此类讨论的总体和按年龄划分的常见类型信息。
