Yoshino Ichiro
Department of General Thoracic Surgery, Chiba University Graduate School of Medicine, 1-8-1 Inohana, Chiba, 260-8670, Japan,
Surg Today. 2014 Feb;44(2):302-6. doi: 10.1007/s00595-013-0509-5. Epub 2013 Feb 11.
Effective adjuvant chemotherapy (Adj.C) for completely resected non-small cell lung cancer (NSCLC) was recently established. However, there may be some unresolved adverse effects, as have been observed in early stage populations or long-term survivors after other types of Adj.C. The substantial risk in such patients was examined by a mathematical method.
Variables X and Y were defined by two outcomes of Adj.C: X = the ability to eliminate micro-metastasis and Y = the development of effects that threaten life. Then, the following formula was generated: Survival benefit = (death rate) X - (death rate) X Y - (survival rate) Y. We then solved for X and Y and verified our findings using reported data from clinical trials.
By solving two simultaneous equations for the formula applied to the data for stage (1) IA and (2) IIIA in the LACE study (J Clin Oncol 26:5043-5051, 2008), X and Y were 2.6 and 1.9, respectively. When these values were applied in the formula for stage IB patients in the same study, the theoretical (-2.3 %) and reported values (2.5 %) were close. When these were applied for stage IB-IIIA patients in the IALT study (N Engl J Med 350:351-360, 2004), the theoretical (5.0 %) and reported values (4.1 %) were also similar.
Assuming a substantial risk provides an explanation for the stage-dependent outcomes of Adj.C for completely resected NSCLC.
近期已确立了针对完全切除的非小细胞肺癌(NSCLC)的有效辅助化疗(Adj.C)。然而,可能存在一些尚未解决的不良反应,正如在早期人群或其他类型辅助化疗后的长期幸存者中所观察到的那样。通过数学方法研究了此类患者的重大风险。
变量X和Y由辅助化疗的两个结果定义:X = 消除微转移的能力,Y = 出现威胁生命的效应。然后,得出以下公式:生存获益 = (死亡率)X - (死亡率)X Y - (生存率)Y。然后我们求解X和Y,并使用临床试验报告的数据验证了我们的发现。
通过对应用于LACE研究(《临床肿瘤学杂志》26:5043 - 5051,2008)中(1)IA期和(2)IIIA期数据的公式求解两个联立方程,X和Y分别为2.6和1.9。当将这些值应用于同一研究中IB期患者的公式时,理论值(-2.3%)和报告值(2.5%)接近。当将这些值应用于IALT研究(《新英格兰医学杂志》350:351 - 360,2004)中IB - IIIA期患者时,理论值(5.0%)和报告值(4.1%)也相似。
假设存在重大风险为完全切除的NSCLC辅助化疗的分期依赖性结果提供了解释。