Effect of neoadjuvant chemotherapy on health-related quality of life in patients with muscle-invasive bladder cancer: results from JCOG0209, a randomized phase III study
Effect of neoadjuvant chemotherapy on health-related quality of life in patients with muscle-invasive bladder cancer: results from JCOG0209, a randomized phase III study
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DOI：
10.1093/jjco/hyaa123
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发表时间：
2020-12-01
影响因子：
2.4
通讯作者：
Nishiyama, Hiroyuki
中科院分区：
文献类型：
--
作者：
Kitamura, Hiroshi;Hinotsu, Shiro;Nishiyama, Hiroyuki
背景：尽管新辅助化疗为肌层浸润性膀胱癌提供了生存获益，但新辅助化疗对健康相关生活质量的影响尚未通过随机试验进行研究。本研究的目的是根据患者报告的结果数据，比较接受新辅助化疗后接受根治性膀胱切除术或单独根治性膀胱切除术的肌层浸润性膀胱癌患者的健康相关生活质量。方法：患者随机接受两个周期的新辅助甲氨蝶呤、阿霉素、长春花碱和顺铂，然后接受根治性膀胱切除术或单独根治性膀胱切除术。在方案治疗前、新辅助化疗后、根治性膀胱切除术后以及登记后 1 年，使用癌症治疗功能评估-膀胱（第 4 版）问卷测量健康相关的生活质量。 结果：总共分析了 99 名患者。两组之间术后健康相关生活质量没有发现统计学上的显着差异。在新辅助化疗组中，新辅助化疗后的身体健康、功能健康、癌症治疗功能评估-一般总分、体重减轻、腹泻、食欲、身体外观、造口器具尴尬和癌症治疗总功能评估-膀胱的评分均显着低于基线评分。然而，除了造口器具的尴尬之外，两组在根治性膀胱切除术后和注册后1年之间在这些领域的得分没有差异。结论：尽管新辅助化疗期间健康相关生活质量下降，但根治性膀胱切除术后新辅助化疗对健康相关生活质量没有明显的负面影响。这些数据支持这样的观点，即新辅助化疗可以被视为肌层浸润性膀胱癌患者在健康相关生活质量方面的护理标准。
Background: Although neoadjuvant chemotherapy provides survival benefits in muscle-invasive bladder cancer, the impact of neoadjuvant chemotherapy on health-related quality of life has not been investigated by a randomized trial. The purpose of this study is to compare healthrelated quality of life in patients with muscle-invasive bladder cancer who received neoadjuvant chemotherapy followed by radical cystectomy or radical cystectomy alone based on patientreported outcome data.Methods: Patients were randomized to receive two cycles of neoadjuvant methotrexate, doxorubicin, vinblastine, and cisplatin followed by radical cystectomy or radical cystectomy alone. Healthrelated quality of life was measured using the Functional Assessment of Cancer Therapy-Bladder (version 4) questionnaire before the protocol treatments, after neoadjuvant chemotherapy, after radical cystectomy and 1 year after registration.Results: A total of 99 patients were analysed. No statistically significant differences in postoperative health-related quality of life were found between the arms. In the neoadjuvant chemotherapy arm, the scores after neoadjuvant chemotherapy were significantly lower than the baseline scores in physical well-being, functional well-being, Functional Assessment of Cancer Therapy-General total, weight loss, diarrhoea, appetite, body appearance, embarrassment by ostomy appliance and total Functional Assessment of Cancer Therapy-Bladder. However, there was no difference in scores for these domains, except for embarrassment by ostomy appliance, between the two arms after radical cystectomy and 1 year after registration.Conclusions: Although health-related quality of life declined during neoadjuvant chemotherapy, no negative effect of neoadjuvant chemotherapy on health-related quality of life was apparent after radical cystectomy. These data support the view that neoadjuvant chemotherapy can be considered as a standard of care for patients with muscle-invasive bladder cancer regarding health-related quality of life.