Department of Medical Oncology, Adrz Hospital, Goes, The Netherlands.
Department of Medical Oncology, Hospital Foch, Suresnes, France.
ESMO Open. 2023 Feb;8(1):100773. doi: 10.1016/j.esmoop.2022.100773. Epub 2023 Jan 10.
During the European Society for Medical Oncology (ESMO) Congress 2022, outcome data of a great number of clinical trials were presented. For the attending medical oncologist, it is important to structure these data in a way that facilitates a trade-off between treatment burden and benefit.
To illustrate this, we carried out a narrative non-systematic review of 12 selected oral presentations with potential impact on future daily practice, focusing on trial methodology, possible study flaws, reported clinical benefit and implementability.
The selected presentations encompassed 10 phase III trials, 1 randomized phase II trial and 1 phase II trial. In 7 out of 12 trials, quality of life and/or patient-reported outcomes had been evaluated. None of the trials, which reported progression-free survival (PFS) data, provided information, which could exclude informative censoring bias. In none of the trials reporting overall survival (OS) data, potential flaws due to undesirable crossover and imbalance between study groups regarding post-progression treatments were addressed. For the 11 reviewed randomized trials, the ESMO-Magnitude of Clinical Benefit Scale (MCBS) grade achieved with the new intervention was calculated based on the presented data. The MCBS grade varied from 1 to 5.
Our review confirms the high-quality standard of current cancer research and the clinical relevance of the research questions answered. However, during presentation of PFS and/or OS data, factors known to affect PFS and OS analysis should be structurally addressed. In order to keep cancer care affordable and sustainable, it could be considered to include an ESMO-MCBS threshold in the drug appraisal process of regulatory authorities.
在 2022 年欧洲肿瘤内科学会（ESMO）大会上，呈现了大量临床试验的结果数据。对于参会的肿瘤内科医生而言，以一种有助于在治疗负担和获益之间进行权衡的方式来组织这些数据非常重要。
为了说明这一点，我们对具有未来日常实践潜在影响的 12 个精选口头报告进行了叙述性非系统性综述，重点关注试验方法、可能的研究缺陷、报告的临床获益和可实施性。
所选报告涵盖了 10 项 III 期试验、1 项随机 II 期试验和 1 项 II 期试验。在 12 项试验中有 7 项评估了生活质量和/或患者报告的结局。在报告无进展生存期（PFS）数据的试验中，均未提供可排除信息性删失偏倚的信息。在报告总生存期（OS）数据的试验中，均未解决由于研究组之间的交叉和后进展治疗不平衡而导致的潜在缺陷。对于 11 项已审查的随机试验，根据呈现的数据计算了新干预措施获得的 ESMO-临床获益量表（MCBS）等级。MCBS 等级从 1 到 5 不等。
我们的综述证实了当前癌症研究的高质量标准和回答的临床问题的相关性。然而，在呈现 PFS 和/或 OS 数据时，应该结构性地解决已知影响 PFS 和 OS 分析的因素。为了保持癌症治疗的可负担性和可持续性，可以考虑在监管机构的药物评估过程中纳入 ESMO-MCBS 阈值。
