Understanding the barriers to, and facilitators of, ovarian toxicity assessment in breast cancer clinical trials.
Understanding the barriers to, and facilitators of, ovarian toxicity assessment in breast cancer clinical trials.
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DOI：
10.1016/j.breast.2022.05.002
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发表时间：
2022-08
期刊：
影响因子：
--
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中科院分区：
文献类型：
--
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在乳腺癌（BC）临床试验中常规收集详细的毒性数据。然而，卵巢毒性很少被评估，尽管治疗引起的卵巢功能不全对生育力和长期健康有不利影响。确定抗癌药物BC试验中卵巢毒性评估的障碍和促进因素。半结构化的采访进行了有目的地选择利益相关者从多个国家参与不列颠哥伦比亚省临床试验（临床医生，消费者，制药公司代表，药品监管机构的成员）。参与者被要求描述评估卵巢毒性的感知益处和障碍。访谈内容逐字记录，用NVivo软件编码，并使用归纳专题分析法进行分析。主要主题达到饱和，最终样本量包括来自14个国家的25名参与者（9名临床医生，7名消费者，5名监管机构成员，4名制药公司代表）;一半是女性。主要报告的卵巢毒性评估障碍是很少考虑该问题。原因包括这些数据不如生存数据重要，并且不需要监管批准。总体而言，大多数参与者认为评估BC治疗对卵巢功能的影响是有价值的。建议增加卵巢毒性评估的策略是将其纳入临床试验设计指南和利益相关者的宣传。在包括绝经前妇女的BC临床试验中缺乏对测量卵巢毒性的考虑，这表明包括监管机构在内的利益相关者的指导方针和更强有力的宣传将促进其更频繁地纳入未来的试验，使妇女能够做出更明智的治疗决定。尽管其重要性，卵巢毒性很少在临床试验中评估。大多数人认为，在乳腺癌试验中评估卵巢毒性是有益的。评估卵巢毒性的主要障碍是缺乏优先顺序。其他障碍是资源和关于如何评估卵巢毒性的不确定性。指南和宣传可能有助于在未来的试验中更频繁地纳入。
Detailed toxicity data are routinely collected in breast cancer (BC) clinical trials. However, ovarian toxicity is infrequently assessed, despite the adverse impacts on fertility and long-term health from treatment-induced ovarian insufficiency. To determine the barriers to and facilitators of ovarian toxicity assessment in BC trials of anti-cancer drugs. Semi-structured interviews were conducted with purposively selected stakeholders from multiple countries involved in BC clinical trials (clinicians, consumers, pharmaceutical company representatives, members of drug-regulatory agencies). Participants were asked to describe the perceived benefits and barriers to evaluating ovarian toxicity. Interviews were transcribed verbatim, coded in NVivo software and analysed using inductive thematic analysis. Saturation of the main themes was reached and the final sample size included 25 participants from 14 countries (9 clinicians, 7 consumers, 5 members of regulatory agencies, 4 pharmaceutical company representatives); half were female. The main reported barrier to ovarian toxicity assessment was that the issue was rarely considered. Reasons included that these data are less important than survival data and are not required for regulatory approval. Overall, most participants believed evaluating the impact of BC treatments on ovarian function is valuable. Suggested strategies to increase ovarian toxicity assessment were to include it in clinical trial design guidelines and stakeholder advocacy. Lack of consideration about measuring ovarian toxicity in BC clinical trials that include premenopausal women suggest that guidelines and stronger advocacy from stakeholders, including regulators, would facilitate its more frequent inclusion in future trials, allowing women to make better informed treatment decisions. Despite its importance, ovarian toxicity is rarely assessed in clinical trials. Most believe that assessing ovarian toxicity in breast cancer trials is beneficial. The main barrier to the assessment of ovarian toxicity was lack of prioritisation. Other barriers are resources and uncertainty regarding how to assess ovarian toxicity. Guidelines and advocacy may facilitate more frequent inclusion in future trials.
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DOI：
10.1056/nejmoa1803164
发表时间：
2018-07-12
期刊：
The New England journal of medicine
影响因子：
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作者：
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DOI：
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