Health-Related Quality of Life With Trastuzumab Monotherapy Versus Trastuzumab Plus Standard Chemotherapy as Adjuvant Therapy in Older Patients With HER2-Positive Breast Cancer
Health-Related Quality of Life With Trastuzumab Monotherapy Versus Trastuzumab Plus Standard Chemotherapy as Adjuvant Therapy in Older Patients With HER2-Positive Breast Cancer
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DOI：
10.1200/jco.20.02751
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发表时间：
2021-08-01
影响因子：
45.3
通讯作者：
Kawahara, Takuya
中科院分区：
文献类型：
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作者：
Taira, Naruto;Sawaki, Masataka;Kawahara, Takuya
我们报告了在CRYSTECT试验中的生活质量（QoL）结果，该试验比较了辅助曲妥珠单抗单药治疗与曲妥珠单抗联合化疗治疗老年人表皮生长因子受体2（HER 2）阳性乳腺癌（BC）患者。患者和方法70-80岁的人表皮生长因子受体2阳性乳腺癌患者随机接受曲妥珠单抗（T）或曲妥珠单抗联合化疗（T + C）。在基线和2、12和36个月后，使用癌症治疗功能评估-一般（FACT-G）、费城老年中心士气量表、医院焦虑和抑郁量表、患者神经毒性问卷和东京都老年学研究所能力指数评估QoL。比较基于个体相对于基线的变化，并通过Fisher检验或混合模型重复测量进行。结果在母研究的275例患者中，231例（84%）（平均年龄：74岁）被纳入分析。在2、12和36个月时，198、177和178例患者完成了调查，T组每个调查点的平均FACT-G评分分别为78.9、80.4、82.7和79.1，T + C组分别为79.5、74.5、78.4和78.5。与T + C组相比，2个月（31% vs 48%; P = 0.016）和12个月（19% vs 38%; P = 0.009）时显示QoL恶化（FACT-G较基线降低>= 5分）的患者比例显著降低。在T组中，2个月时医院焦虑和抑郁量表评分（P = .003）和严重感觉周围神经病变的比例（P = .001）显著较低，12个月时费城老年中心士气量表和东京都老年学研究所能力指数评分显著较高（P = .024，.042）。在36个月时，任何QoL项目均无显著差异。结论：辅助化疗对总体生活质量、士气和活动能力的不利影响至少持续12个月，但在36个月时未观察到。
PURPOSE We report findings on quality of life (QoL) in the RESPECT trial, which compared adjuvant trastuzumab monotherapy with trastuzumab plus chemotherapy in older patients with human epidermal growth factor receptor 2 (HER2)-positive breast cancer (BC). PATIENTS AND METHODS Patients age 70-80 years with human epidermal growth factor receptor 2-positive surgically treated breast cancer were randomly assigned to receive trastuzumab (T) or trastuzumab plus chemotherapy (T + C). QoL was assessed using the Functional Assessment of Cancer Therapy-General (FACT-G), Philadelphia Geriatric Center Morale Scale, Hospital Anxiety and Depression Scale, Patient Neurotoxicity Questionnaire, and Tokyo Metropolitan Institute of Gerontology Index of Competence at baseline and after 2, 12, and 36 months. Comparisons were based on individual changes from baseline and were performed by Fisher's test or mixed-model repeated-measures. RESULTS Among 275 patients in the parent study, 231 (84%) (average age: 74 years) were included in the analysis. At 2, 12, and 36 months, 198, 177, and 178 patients completed surveys, and the mean FACT-G scores at each survey point were 78.9, 80.4, 82.7, and 79.1 in group T and 79.5, 74.5, 78.4, and 78.5 in group T + C. Compared with group T + C, the proportion of patients showing QoL deterioration (>= 5 points decrease from baseline in FACT-G) was significantly lower at 2 months (31% v 48%; P = .016) and 12 months (19% v 38%; P = .009). In group T, the Hospital Anxiety and Depression Scale score (P = .003) and the proportion of severe sensory peripheral neuropathy (P = .001) were significantly lower at 2 months, and Philadelphia Geriatric Center Morale Scale and Tokyo Metropolitan Institute of Gerontology Index of Competence scores were significantly higher (P = .024, .042) at 12 months. At 36 months, there were no significant differences in any QoL items. CONCLUSION Detrimental effects of adjuvant chemotherapy on global QoL, morale, and activity capacity lasted for at least 12 months but were not observed at 36 months.