Prognosis and cardiotoxicity associated to adjuvant trastuzumab for breast cancer: real world study in a public health system.

Ana Elisa Ribeiro da Silva Cabello, César Cabello, Susana Oliveira Botelho Ramalho, Otávio Rizzi Coelho, Otávio Rizzi Coelho-Filho, Helymar da Costa Machado, Délio Marques Conde, Luiz Carlos Zeferino
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Abstract

Objective: To analyze the prognosis of patients with breast cancer who developed trastuzumab-induced cardiotoxicity and to analyze factors associated with and resulting from cardiotoxicity.

Methods: This was a retrospective cohort study that included 255 HER2-positive breast cancer patients who received adjuvant trastuzumab therapy. The inclusion criteria were a diagnosis of HER2-positive breast cancer and adjuvant trastuzumab therapy; disease stage I-III; <70 years; and a baseline echocardiogram showing a left ventricular ejection fraction (LVEF) ≥ 55%. The Kaplan-Meier method, the log-rank test, and the Cox proportional hazards model were used.

Results: In all, 15.3% (39/255) of patients presented with cardiotoxicity. Treatment was suspended in 92.3% (36/39) of patients who presented with cardiotoxicity during trastuzumab treatment. The treatment was suspended in 46 of 255 patients and it was permanently interrupted in 84.8% (33/46) of these patients, with 84.8% (28/33) due to cardiotoxicity. Cardiotoxicity was not associated with disease-free survival (DFS) (hazard ratio (HR) = 1.48; 95% confidence interval (CI = 0.79-2.78) or overall survival (OS) (HR = 1.68; 95%CI= 0.83-3.41). Patients with clinical stage III and whom trastuzumab therapy was suspended (all causes) had worse DFS; (HR = 3.19; 95% CI=1.77-5.74) and (HR = 1.83; 95% CI=1.01-3.32) respectively. Those with clinical stage III and whom trastuzumab therapy was permanently interrupted had worse OS; (HR = 3.80; 95% CI =1.82-7.94), and (HR = 2,26; 95% CI =1.09-4.68 respectively.

Conclusion: Cardiotoxicity was not associated with DFS or OS. Clinical stage III, Suspension and permanent interruption of treatment regardless of the cause were associated with worse DFS and OS in breast cancer patients.

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辅助曲妥珠单抗治疗乳腺癌的预后和心脏毒性:公共卫生系统的真实世界研究。
目的:分析曲妥珠单抗引起的乳腺癌患者心脏毒性的预后,分析心脏毒性的相关因素和导致因素。方法:这是一项回顾性队列研究,包括255名接受辅助曲妥珠单抗治疗的her2阳性乳腺癌患者。纳入标准为her2阳性乳腺癌诊断和辅助曲妥珠单抗治疗;I-III期疾病;结果:15.3%(39/255)的患者出现心脏毒性。92.3%(36/39)在曲妥珠单抗治疗期间出现心脏毒性的患者暂停治疗。255例患者中有46例暂停治疗,其中84.8%(33/46)患者永久中断治疗,其中84.8%(28/33)患者因心脏毒性而中断治疗。心脏毒性与无病生存期(DFS)无关(风险比(HR) = 1.48;95%置信区间(CI = 0.79-2.78)或总生存期(OS) (HR = 1.68;95% ci = 0.83 - -3.41)。临床III期和暂停曲妥珠单抗治疗(所有原因)的患者的DFS更差;(hr = 3.19;95% CI=1.77-5.74)和(HR = 1.83;95% CI=1.01-3.32)。临床III期患者和曲妥珠单抗治疗被永久中断的患者有更差的OS;(hr = 3.80;95% CI =1.82-7.94), (HR = 2,26;95% CI =1.09-4.68。结论:心脏毒性与DFS或OS无关。临床III期,暂停和永久中断治疗与乳腺癌患者更差的DFS和OS相关。
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