Patients' self-assessment versus investigators' evaluation in a phase III trial in non-castrate metastatic prostate cancer (GETUG-AFU 15)
Patients' self-assessment versus investigators' evaluation in a phase III trial in non-castrate metastatic prostate cancer (GETUG-AFU 15)
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DOI：
10.1016/j.ejca.2013.11.034
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发表时间：
2014-03-01
影响因子：
8.4
通讯作者：
Fizazi, Karim
中科院分区：
文献类型：
--
作者：
Gravis, Gwenaelle;Marino, Patricia;Fizazi, Karim
背景：毒性是评价癌症治疗的关键参数，但临床医生可能低估了毒性。我们在一项治疗非阉割转移性前列腺癌的多中心III期试验中调查了患者和医生在报告雄激素剥夺治疗（ADT）联合或不联合多西他赛的不良事件方面的差异。方法：纳入的385例患者在治疗开始后3个月和6个月完成26项症状问卷，其中18项症状也由医生评估，在医疗记录中报告，并使用国家癌症研究所的通用毒性标准进行分级。阳性和阴性协议，以及Kappa一致性coefficients calculated. Findings：数据分别为220和165例患者在3个月和6个月。医生系统性地低估了患者的症状。5种最常报告症状的阳性一致率（分别为3个月和6个月）为：潮热61.0%和64.3%，疲乏50.0%和43.6%，性功能障碍29.4%和31.1%，体重增加/减轻24.4%和14.4%，关节/肌肉疼痛16.7%和19.3%。对于患者最常报告为令人不安或非常令人不安的症状，临床医生未报告的比例为50.8%，（潮热）至89.5%（关节/肌肉疼痛），从48.2%（潮热）至88.4%解释：医生经常没有报告治疗相关的症状，即使是最常见和最令人不安的症状。在临床试验中应采用患者对毒性的自我评价，以改善肿瘤学中的药物评估过程。资助：法国卫生部和国家癌症研究所（PHRC），赛诺菲-安万特，阿斯利康和安进。(C)2013爱思唯尔有限公司保留所有权利。
Background: Toxicity, which is a key parameter in the evaluation of cancer treatments, can be underestimated by clinicians. We investigated differences between patients and physicians in reporting adverse events of androgen deprivation therapy (ADT) with or without docetaxel in a multicentre phase III trial in non-castrate metastatic prostate cancer.Methods: The 385 patients included were invited to complete a 26-symptom questionnaire 3 and 6 months after the start of treatment, among which eighteen symptoms were also assessed by physicians, reported in medical records and graded using the Common Toxicity Criteria of the National Cancer Institute. Positive and negative agreements as well as Kappa concordance coefficients were computed.Findings: Data were available for 220 and 165 patients at 3 and 6 months respectively. Physicians systematically under-reported patients' symptoms. Positive agreement rates (at respectively 3 and 6 months) for the five most commonly reported symptoms were: 61.0% and 64.3% hot flushes, 50.0% and 43.6% fatigue, 29.4% and 31.1% sexual dysfunction, 24.4% and 14.4% weigh gain/loss, 16.7% and 19.3% for joint/muscle pain. For symptoms most frequently reported as disturbing or very disturbing by patients, the clinicians' failure to report them ranged from 50.8% (hot flushes) to 89.5% (joint/muscle pain) at 3 months, and from 48.2% (hot flushes) to 88.4% (joint/muscle pain) at 6 months.Interpretation: Physicians often failed to report treatment-related symptoms, even the most common and disturbing ones. Patients' self-evaluation of toxicity should be used in clinical trials to improve the process of drug assessment in oncology.Funding: French Health Ministry and Institut National du Cancer (PHRC), Sanofi-Aventis, Astra-Zeneca, and Amgen. (C) 2013 Elsevier Ltd. All rights reserved.