高危晚期乳腺癌患者的PCI治疗

H. Shukur
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The second group included 24 patients who received PCI 25 Gray/10 fractions over 2 weeks carried 4 weeks after completion of chemotherapy with or without trastuzumab while hormone therapy is continuous for hormone-positive patients. All patients were primarily evaluated by brain CT scan with contrast or MRI which was part of the neurological assessment included before PCI then every 3 months in the first year, then every 6 months thereafter. Neuro-cognitive Functions (NCF) were estimated in both arms before and then 6 months and 1 year after PCI using Mini-Mental State Exam (MMSE). Health-related quality of life was assessed before and then 1 month and 3 months after PCI using Functional Assessment of Cancer Therapy-Brain (FACT-Br). Results , only four (16.6%) patients developed symptomatic brain metastases in the treatment arm compared to nine (37.5%) patients in the control arm, the median brain metastasis-free survival duration in the PCI arm was 22 months with a 95% CI (18.37-25.62) compared with 16 months with a 95% CI (13.78-18.21) with p = 0.011, figure (1). A brain metastases hazard ratio = 0.398, 95% CI (0.187.0.844) is significantly reduced by 60% in the PCI patients set when compared to no PCI arm at any given time over 30 months with p-value (0.016). All patients died due to progressive breast cancer. There were no death due to treatment. Three of the 24 patients experienced grade 3/4 toxicity (two grade 3 nausea and vomiting, one grade 4 nausea and vomiting). Grade 1 to 4 fatigue occurred in majority of the fifteen (62.5%) treated patients, but only in 3 (12.5%) grade 3 and 4 patients. Hair loss was virtually common as a consequence of chemotherapy, so no more alopecia was observed during PCI. Neurocognitive function in both groups was equal, without statistical differences between the MMSE scores between the two study arms (p=0.137). Most of the MMSE scores declined at a 6-month evaluation in the PCI group with a significant difference at a P value of 0.001, but resumed to the baseline value in the one-year evaluation without statistical difference between the two arms, P = 0.679. The initial levels of evaluation of the quality of life of the respondents in both groups were comparable, without statistical differences, P = 1.000. In the PCI group, most of the scores (FACT-Br) were reduced at the 1-month evaluation compared to no PCI group with a significant difference at a P value of 0.050, but returned almost to baseline at the 3-month evaluation without statistical differences between the two groups, (P=0.162). 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All patients were primarily evaluated by brain CT scan with contrast or MRI which was part of the neurological assessment included before PCI then every 3 months in the first year, then every 6 months thereafter. Neuro-cognitive Functions (NCF) were estimated in both arms before and then 6 months and 1 year after PCI using Mini-Mental State Exam (MMSE). Health-related quality of life was assessed before and then 1 month and 3 months after PCI using Functional Assessment of Cancer Therapy-Brain (FACT-Br). Results , only four (16.6%) patients developed symptomatic brain metastases in the treatment arm compared to nine (37.5%) patients in the control arm, the median brain metastasis-free survival duration in the PCI arm was 22 months with a 95% CI (18.37-25.62) compared with 16 months with a 95% CI (13.78-18.21) with p = 0.011, figure (1). 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引用次数: 0

摘要

背景:在接受曲妥珠单抗治疗的三阴性和2阳性乳腺癌患者中,脑转移的发生率很高。预防性颅脑照射的基本原理是在不造成不必要伤害的情况下调节或消除不明显的微转移。方法:本前瞻性研究探讨预防性颅脑照射对降低三阴性和her2阳性晚期颅脑外转移性乳腺癌患者脑转移频率的作用,共收集48例具有这种疾病情况的患者,分为2组,为期3年:第一组24例未接受PCI治疗。第二组包括24名接受PCI 25 Gray/10分数超过2周的患者,在化疗完成后4周接受曲妥珠单抗或不接受曲妥珠单抗,而激素阳性患者持续接受激素治疗。所有患者主要通过脑CT扫描对比或MRI进行评估这是PCI术前神经学评估的一部分第一年每3个月,之后每6个月。采用简易精神状态检查(MMSE)评估两组患者PCI前、PCI后6个月和1年的神经认知功能(NCF)。采用肿瘤治疗-脑功能评估(FACT-Br)对PCI术前、术后1个月和3个月的健康相关生活质量进行评估。结果,治疗组只有4例(16.6%)患者出现症状性脑转移,而对照组有9例(37.5%)患者出现症状性脑转移,PCI组无脑转移的中位生存时间为22个月,95% CI为18.37-25.62,95% CI为16个月,95% CI为13.78-18.21,p = 0.011,图(1)。脑转移风险比= 0.398。在超过30个月的任何给定时间,PCI患者组与未PCI组相比,95% CI(0.187.0.844)显著降低60%,p值(0.016)。所有患者均死于进展性乳腺癌。没有人因治疗而死亡。24例患者中有3例出现3/4级毒性(2例3级恶心和呕吐,1例4级恶心和呕吐)。15名接受治疗的患者中,大多数(62.5%)出现了1至4级疲劳,但只有3名(12.5%)出现了3级和4级疲劳。作为化疗的结果,脱发实际上很常见,因此PCI期间没有观察到更多的脱发。两组的神经认知功能相同,两个研究组的MMSE评分无统计学差异(p=0.137)。PCI组MMSE评分大部分在6个月时下降,P值为0.001,差异有统计学意义,但在1年评估时恢复到基线值,两组间无统计学差异,P = 0.679。两组被调查者生活质量的初始评价水平具有可比性,无统计学差异,P = 1.000。PCI组与无PCI组相比,大部分评分(FACT-Br)在1个月评估时降低,P值为0.050,差异有统计学意义,但在3个月评估时几乎恢复到基线水平,两组之间无统计学差异(P=0.162)。结论:PCI与公认的毒性有关,可降低脑继发性转移的发生率,延长无脑转移的中位生存期。这一结果是否可以解释为令人满意的治疗改善,需要额外的评估。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
PCI in High Risk Advanced Breast Cancer Patients
Background: A high incidence of brain metastases has been conveyed in patients with triple-negative and her 2-positive breast cancer receiving trastuzumab therapy. The rationale for prophylactic cranial irradiation is to regulate or eliminate unnoticeable micro-metastases without making unwanted harm. Methods: This prospective study investigated the role of prophylactic cranial irradiation for lowering the frequency of brain metastases for patients who had triple-negative and her2-positive advanced extra-cranial metastatic breast cancer including 48 succeeding patients, with this disease scenario were collected in this study & were categorized into 2 arms over 3 years period: The first arm consisted of 24 patients who did not receive PCI. The second group included 24 patients who received PCI 25 Gray/10 fractions over 2 weeks carried 4 weeks after completion of chemotherapy with or without trastuzumab while hormone therapy is continuous for hormone-positive patients. All patients were primarily evaluated by brain CT scan with contrast or MRI which was part of the neurological assessment included before PCI then every 3 months in the first year, then every 6 months thereafter. Neuro-cognitive Functions (NCF) were estimated in both arms before and then 6 months and 1 year after PCI using Mini-Mental State Exam (MMSE). Health-related quality of life was assessed before and then 1 month and 3 months after PCI using Functional Assessment of Cancer Therapy-Brain (FACT-Br). Results , only four (16.6%) patients developed symptomatic brain metastases in the treatment arm compared to nine (37.5%) patients in the control arm, the median brain metastasis-free survival duration in the PCI arm was 22 months with a 95% CI (18.37-25.62) compared with 16 months with a 95% CI (13.78-18.21) with p = 0.011, figure (1). A brain metastases hazard ratio = 0.398, 95% CI (0.187.0.844) is significantly reduced by 60% in the PCI patients set when compared to no PCI arm at any given time over 30 months with p-value (0.016). All patients died due to progressive breast cancer. There were no death due to treatment. Three of the 24 patients experienced grade 3/4 toxicity (two grade 3 nausea and vomiting, one grade 4 nausea and vomiting). Grade 1 to 4 fatigue occurred in majority of the fifteen (62.5%) treated patients, but only in 3 (12.5%) grade 3 and 4 patients. Hair loss was virtually common as a consequence of chemotherapy, so no more alopecia was observed during PCI. Neurocognitive function in both groups was equal, without statistical differences between the MMSE scores between the two study arms (p=0.137). Most of the MMSE scores declined at a 6-month evaluation in the PCI group with a significant difference at a P value of 0.001, but resumed to the baseline value in the one-year evaluation without statistical difference between the two arms, P = 0.679. The initial levels of evaluation of the quality of life of the respondents in both groups were comparable, without statistical differences, P = 1.000. In the PCI group, most of the scores (FACT-Br) were reduced at the 1-month evaluation compared to no PCI group with a significant difference at a P value of 0.050, but returned almost to baseline at the 3-month evaluation without statistical differences between the two groups, (P=0.162). Conclusions: PCI was linked with accepted toxicities & give rise to lower frequency of brain secondary metastasis with prolonged median brain metastasis-free survival duration. Whether, this result may be interpreted into satisfactory therapeutic improvement necessite an additional assessment.
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