Abstract：
BACKGROUND: Recent advances in the treatment of breast cancer have resulted in improved overall cancer survival; however, cancer therapy related cardiac dysfunction is considered a major adverse effect of several chemotherapeutic agents, particularly anthracyclines. Hence, there is a need to develop proper cardioprotective strategies to limit myocardial injury following chemotherapy.
OBJECTIVE: To evaluate the effect of statin therapy on prevention of anthracycline- induced cardiotoxicity in female patients with breast cancer.
METHODS: The current study is a prospective, randomized, single-blind, placebo-controlled trial in which we enrolled a total of 110 female patients with newly diagnosed breast cancer who received anthracycline based chemotherapy. Patients were randomly assigned in 1:1 ratio into two groups, study group in which patients received 40 mg of oral atorvastatin and control group in which patients received placebo. A comprehensive echocardiographic examination was performed to all patients prior to receiving the chemotherapy and after 6 months, assessment of LV ejection fraction was done by 3D-echocardiography. All echocardiographers were blinded to all the patients\' characteristics and assignment to either group.
RESULTS: The mean age of patients assigned to the control group was 49.8±10.51 years old, while patients assigned to the intervention group had mean age of 47.84± 9.16 years old, both the control group and the intervention group were similar in demographic data and baseline clinical characteristics. There was a highly significant difference between the two groups regarding both the absolute LVEF assessed by 3D- echocardiography at 6 months and the percentage of change compared to baseline values, patients assigned to the control group had mean LVEF of 52.92% at 6 months with percentage of change reaching -7.06%, while those assigned to the intervention group had mean LVEF reaching 56.22% at 6 months with a percentage of change reaching -3.64% (P-value: 0.008 and 0.004 for the absolute value and percentage of change respectively). There was a significant difference between the two groups regarding incidence of development of cancer therapy related cardiac dysfunction (CTRCD); defined as drop in LVEF more than 10% and to a value below 53% assessed by 3D echocardiography, among the control group 15 patients (30%) developed CTRCD after 6 months from starting Anthracyclines based chemotherapy, while, among the intervention group only 6 patients (12%) developed CTRCD. (P-value= 0.027) CONCLUSION: Prophylactic use of atorvastatin may prevent the development of cancer therapy related cardiac dysfunction in breast cancer patients receiving anthracycline based chemotherapy.
OBJECTIVE: To evaluate the effect of statin therapy on prevention of anthracycline- induced cardiotoxicity in female patients with breast cancer.
METHODS: The current study is a prospective, randomized, single-blind, placebo-controlled trial in which we enrolled a total of 110 female patients with newly diagnosed breast cancer who received anthracycline based chemotherapy. Patients were randomly assigned in 1:1 ratio into two groups, study group in which patients received 40 mg of oral atorvastatin and control group in which patients received placebo. A comprehensive echocardiographic examination was performed to all patients prior to receiving the chemotherapy and after 6 months, assessment of LV ejection fraction was done by 3D-echocardiography. All echocardiographers were blinded to all the patients\' characteristics and assignment to either group.
RESULTS: The mean age of patients assigned to the control group was 49.8±10.51 years old, while patients assigned to the intervention group had mean age of 47.84± 9.16 years old, both the control group and the intervention group were similar in demographic data and baseline clinical characteristics. There was a highly significant difference between the two groups regarding both the absolute LVEF assessed by 3D- echocardiography at 6 months and the percentage of change compared to baseline values, patients assigned to the control group had mean LVEF of 52.92% at 6 months with percentage of change reaching -7.06%, while those assigned to the intervention group had mean LVEF reaching 56.22% at 6 months with a percentage of change reaching -3.64% (P-value: 0.008 and 0.004 for the absolute value and percentage of change respectively). There was a significant difference between the two groups regarding incidence of development of cancer therapy related cardiac dysfunction (CTRCD); defined as drop in LVEF more than 10% and to a value below 53% assessed by 3D echocardiography, among the control group 15 patients (30%) developed CTRCD after 6 months from starting Anthracyclines based chemotherapy, while, among the intervention group only 6 patients (12%) developed CTRCD. (P-value= 0.027) CONCLUSION: Prophylactic use of atorvastatin may prevent the development of cancer therapy related cardiac dysfunction in breast cancer patients receiving anthracycline based chemotherapy.
摘要：
背景：乳腺癌治疗的最新进展提高了总体癌症生存率；然而，癌症治疗相关的心功能不全被认为是几种化疗药物的主要不良反应，尤其是蒽环类药物.因此，有必要制定适当的心脏保护策略来限制化疗后的心肌损伤.
目的：评价他汀类药物预防蒽环类药物对女性乳腺癌患者心脏毒性的影响。
方法：当前的研究是前瞻性的，随机化，单盲,安慰剂对照试验,我们共纳入110例接受蒽环类化疗的新诊断乳腺癌女性患者.患者以1:1的比例随机分为两组，研究组患者接受40mg口服阿托伐他汀，对照组患者接受安慰剂。在接受化疗前和6个月后对所有患者进行全面的超声心动图检查，通过3D超声心动图评估LV射血分数.所有超声心动图医师均不了解所有患者的特征和分配给任何一组。
结果：对照组患者的平均年龄为49.8±10.51岁，而分配到干预组的患者平均年龄为47.84±9.16岁，对照组和干预组的人口统计学数据和基线临床特征相似.两组在6个月时通过3D超声心动图评估的绝对LVEF和与基线值相比的变化百分比方面均存在高度显着差异。分配到对照组的患者在6个月时的平均LVEF为52.92％，变化百分比达到-7.06％，而分配到干预组的患者在6个月时平均LVEF达到56.22％，变化百分比达到-3.64％（P值：绝对值和变化百分比分别为0.008和0.004）。在癌症治疗相关心功能不全（CTRCD）的发展发生率方面，两组之间存在显着差异；定义为通过3D超声心动图评估的LVEF下降超过10％且低于53％。在对照组中，15例患者（30%）在开始蒽环类药物化疗6个月后出现CTRCD，while,在干预组中,只有6例患者(12%)发生CTRCD.（P值=0.027）结论：：预防性使用阿托伐他汀可预防接受蒽环类化疗的乳腺癌患者癌症治疗相关心功能不全的发展。
目的：评价他汀类药物预防蒽环类药物对女性乳腺癌患者心脏毒性的影响。
方法：当前的研究是前瞻性的，随机化，单盲,安慰剂对照试验,我们共纳入110例接受蒽环类化疗的新诊断乳腺癌女性患者.患者以1:1的比例随机分为两组，研究组患者接受40mg口服阿托伐他汀，对照组患者接受安慰剂。在接受化疗前和6个月后对所有患者进行全面的超声心动图检查，通过3D超声心动图评估LV射血分数.所有超声心动图医师均不了解所有患者的特征和分配给任何一组。
结果：对照组患者的平均年龄为49.8±10.51岁，而分配到干预组的患者平均年龄为47.84±9.16岁，对照组和干预组的人口统计学数据和基线临床特征相似.两组在6个月时通过3D超声心动图评估的绝对LVEF和与基线值相比的变化百分比方面均存在高度显着差异。分配到对照组的患者在6个月时的平均LVEF为52.92％，变化百分比达到-7.06％，而分配到干预组的患者在6个月时平均LVEF达到56.22％，变化百分比达到-3.64％（P值：绝对值和变化百分比分别为0.008和0.004）。在癌症治疗相关心功能不全（CTRCD）的发展发生率方面，两组之间存在显着差异；定义为通过3D超声心动图评估的LVEF下降超过10％且低于53％。在对照组中，15例患者（30%）在开始蒽环类药物化疗6个月后出现CTRCD，while,在干预组中,只有6例患者(12%)发生CTRCD.（P值=0.027）结论：：预防性使用阿托伐他汀可预防接受蒽环类化疗的乳腺癌患者癌症治疗相关心功能不全的发展。
