Pathological response after neoadjuvant chemotherapy in resectable non-small-cell lung cancers: proposal for the use of major pathological response as a surrogate endpoint.
Pathological response after neoadjuvant chemotherapy in resectable non-small-cell lung cancers: proposal for the use of major pathological response as a surrogate endpoint.
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DOI：
10.1016/s1470-2045(13)70334-6
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发表时间：
2014-01
期刊：
影响因子：
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通讯作者：
University of Texas MD Anderson Lung Cancer Collaborative Group
中科院分区：
文献类型：
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作者：
Hellmann MD;Chaft JE;William WN Jr;Rusch V;Pisters KM;Kalhor N;Pataer A;Travis WD;Swisher SG;Kris MG;University of Texas MD Anderson Lung Cancer Collaborative Group
可切除肺癌患者的预后改善已趋于稳定。使用总生存率作为主要终点的这种疾病的临床试验需要十年或更长时间才能完成，而且费用昂贵，并且限制了创新。生存的替代指标，例如对新辅助化疗的病理反应，有可能提高试验的效率并加快进展。新辅助化疗后残留存活肿瘤≤10%（此处称为主要病理反应）符合替代标准：它与生存改善密切相关，反映了治疗效果，并体现了治疗对生存获益的程度。我们支持在未来的可切除肺癌试验中将主要病理反应作为生存的替代终点。需要更多的前瞻性研究来确认个体组织学和分子亚组以及新疗法的主要病理反应的有效性和可重复性。
Improvements in outcomes for patients with resectable lung cancers have plateaued. Clinical trials in this disease using overall survival as the primary endpoint require a decade or longer to complete, are expensive, and limit innovation. A surrogate for survival, such as pathologic response to neoadjuvant chemotherapy, has the potential to improve the efficiency of trials and expedite advances. ≤10% residual viable tumor following neoadjuvant chemotherapy, termed here major pathologic response meets criteria for a surrogate: it strongly associates with improved survival, is reflective of treatment impact, and captures the magnitude of the treatment benefit on survival. We support the incorporation of major pathologic response as a surrogate endpoint for survival in future trials for resectable lung cancers. Additional prospective studies are needed to confirm the validity and reproducibility of major pathologic response within individual histologic and molecular subgroups and with novel therapeutics.