Abstract：
BACKGROUND: The Common Terminology Criteria for Adverse Events (CTCAE) is used as a tool to evaluate the adverse events (AE) of chemotherapy in cancer patients. Since CTCAE by medical providers underestimates AE more than patient-reported outcomes (PRO), the National Cancer Institute developed PRO-CTCAE. The present study investigated differences between symptoms detected using CTCAE by medical providers and PRO-CTCAE by breast cancer patients.
METHODS: Patients received chemotherapy comprising epirubicin and cyclophosphamide pre- or postoperatively. AE were evaluated using 4 questionnaires:PRO-CTCAE, CTCAE, the European Organization for Research and Treatment of Cancer-Quality of Life Questionnaire (EORTC-QLQ-30), and Hospital Anxiety and Depression Scale (HADS) after 1, 2, and 3 courses of chemotherapy.
RESULTS: Forty-two patients were registered. Regarding the recognition of psychological symptoms, such as fatigue, anxiety, and discouragement, and subjective symptoms, including heart palpitations and shortness of breath, PRO using PRO-CTCAE was significantly higher than medical provider-recognized outcomes using CTCAE. Concerning the recognition of regimen-specific symptoms, such as vomiting, nausea, and decreased appetite, medical provider- recognized outcomes were the same or higher than PRO. In QLQ-C30, the physical and role functions, fatigue and dyspnea significantly worsened after 2 and 3 courses of chemotherapy. J. Med. Invest. 71 : 82-91, February, 2024.
METHODS: Patients received chemotherapy comprising epirubicin and cyclophosphamide pre- or postoperatively. AE were evaluated using 4 questionnaires:PRO-CTCAE, CTCAE, the European Organization for Research and Treatment of Cancer-Quality of Life Questionnaire (EORTC-QLQ-30), and Hospital Anxiety and Depression Scale (HADS) after 1, 2, and 3 courses of chemotherapy.
RESULTS: Forty-two patients were registered. Regarding the recognition of psychological symptoms, such as fatigue, anxiety, and discouragement, and subjective symptoms, including heart palpitations and shortness of breath, PRO using PRO-CTCAE was significantly higher than medical provider-recognized outcomes using CTCAE. Concerning the recognition of regimen-specific symptoms, such as vomiting, nausea, and decreased appetite, medical provider- recognized outcomes were the same or higher than PRO. In QLQ-C30, the physical and role functions, fatigue and dyspnea significantly worsened after 2 and 3 courses of chemotherapy. J. Med. Invest. 71 : 82-91, February, 2024.
摘要：
背景：不良事件通用术语标准（CTCAE）被用作评估癌症患者化疗不良事件（AE）的工具。由于医疗提供商的CTCAE比患者报告的结果(PRO)更低估了AE，国家癌症研究所开发了PRO-CTCAE。本研究调查了医疗提供者使用CTCAE检测到的症状与乳腺癌患者使用PRO-CTCAE检测到的症状之间的差异。
方法：患者术前或术后接受包含表柔比星和环磷酰胺的化疗。AE使用4份问卷进行评估：PRO-CTCAE，CTCAE,欧洲癌症研究和治疗组织-生活质量问卷（EORTC-QLQ-30），化疗1、2和3个疗程后，医院焦虑和抑郁量表（HADS）。
结果：登记了42例患者。关于心理症状的识别，比如疲劳，焦虑,和沮丧，和主观症状，包括心悸和呼吸急促，使用PRO-CTCAE的PRO显着高于使用CTCAE的医疗提供者认可的结果。关于方案特异性症状的识别，比如呕吐，恶心,食欲下降，医疗提供者认可的结果与PRO相同或高于PRO。在QLQ-C30中，身体和角色功能，2个和3个疗程的化疗后，疲劳和呼吸困难明显恶化。J.Med.投资。71:82-91,二月,2024.
方法：患者术前或术后接受包含表柔比星和环磷酰胺的化疗。AE使用4份问卷进行评估：PRO-CTCAE，CTCAE,欧洲癌症研究和治疗组织-生活质量问卷（EORTC-QLQ-30），化疗1、2和3个疗程后，医院焦虑和抑郁量表（HADS）。
结果：登记了42例患者。关于心理症状的识别，比如疲劳，焦虑,和沮丧，和主观症状，包括心悸和呼吸急促，使用PRO-CTCAE的PRO显着高于使用CTCAE的医疗提供者认可的结果。关于方案特异性症状的识别，比如呕吐，恶心,食欲下降，医疗提供者认可的结果与PRO相同或高于PRO。在QLQ-C30中，身体和角色功能，2个和3个疗程的化疗后，疲劳和呼吸困难明显恶化。J.Med.投资。71:82-91,二月,2024.
