In the Netherlands, the clinical benefit of systemic anti-cancer treatments (SACTs) is assessed by the Committee for the Evaluation of Oncological Agents (cieBOM). For non-curative SACTs, the assessment is based on the hazard ratio (HR) for progression-free survival and/or overall survival (OS), and the difference in median survival. We evaluated the impact of different thresholds for effectiveness by reassessing the clinical benefit of SACTs. We reassessed SACTs that were initially assessed by cieBOM between 2015 and 2017. Four scenarios were formulated: replacing an “” approach (initial assessment) by an “” approach (used in all scenarios), changing the HR threshold from < 0.70 (initial assessment) to < 0.60, changing the threshold for the difference in median survival from > 12 weeks (initial assessment) to > 16 weeks, and including thresholds for OS rates. The outcomes of these scenarios were compared to the outcomes of the initial assessment. Reassessments were conducted for 41 treatments. Replacing the “” approach by an “” approach substantially decreased the number of positive assessments (from 33 to 22), predominantly affecting immunotherapies. This number further decreased (to 21 and 19, respectively) in case more restrictive thresholds for the HR and difference in median survival were used. Including thresholds for OS rates slightly mitigated the impact of applying an “” approach. The scenario-specific thresholds had a substantial impact; the number of negative assessments more than doubled. Since this was not limited to treatments with marginal survival benefits, understanding the potential challenges that may arise from applying more restrictive thresholds is essential.

中文翻译：

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评估荷兰全身抗癌治疗的临床效益：不同有效性阈值的影响

在荷兰，全身抗癌治疗 (SACT) 的临床益处由肿瘤药物评估委员会 (cieBOM) 进行评估。对于非治愈性 SACT，评估基于无进展生存期和/或总生存期 (OS) 的风险比 (HR) 以及中位生存期的差异。我们通过重新评估 SACT 的临床益处来评估不同有效性阈值的影响。我们重新评估了 cieBOM 在 2015 年至 2017 年间最初评估的 SACT。制定了四种方案：用“”方法（在所有方案中使用）替换“”方法（初始评估），将 HR 阈值从 < 0.70 更改（初始评估） ) 至 < 0.60，将中位生存期差异的阈值从 > 12 周（初始评估）更改为 > 16 周，并包括 OS 率阈值。将这些情景的结果与初始评估的结果进行比较。对 41 种治疗进行了重新评估。用“”方法取代“”方法大大减少了阳性评估的数量（从 33 到 22），主要影响免疫疗法。如果使用更严格的 HR 阈值和中位生存率差异，则该数字会进一步下降（分别降至 21 和 19）。包括 OS 率阈值稍微减轻了应用“”方法的影响。特定场景的阈值产生了重大影响；负面评价的数量增加了一倍多。由于这不仅限于具有边际生存效益的治疗，因此了解应用更严格的阈值可能带来的潜在挑战至关重要。