Jennens R R, Giles G G, Fox R M
Department of Haematology and Medical Oncology, Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia.
Intern Med J. 2006 Apr;36(4):216-20. doi: 10.1111/j.1445-5994.2006.01033.x.
Elderly patients are underrepresented in chemotherapy trials for advanced colorectal cancer (CRC) and non-small-cell lung cancer (NSCLC). However, the change in underrepresentation over time has not been documented.
This study aimed to quantify (i) the change in the median age of patients enrolled in clinical trials for metastatic CRC and NSCLC between 1982-1991 and 1992-2001 compared with the general colorectal and lung cancer population, and (ii) the proportion of trials with an upper age limit for eligibility.
A retrospective review of data from the Victorian Cancer Registry and all large published randomized chemotherapy trials for advanced CRC and NSCLC between 1982 and 2001 was conducted.
The median age of patients with CRC enrolled in clinical trials remained constant between the two decades (62.0 and 62.2 years), whereas the median age of the CRC population increased from 68.4 to 70.2 years, increasing the median age difference from 6.4 to 8.0 years. The median age of patients with lung cancer in clinical trials increased from 59.8 to 61.8 years, whereas the median age of the lung cancer population increased from 67.4 to 70.4 years, widening the age difference from 7.6 to 8.6 years. More trials set an upper age limit for eligibility in the first decade than in the second decade for both CRC (51 vs 29%, P = 0.04) and NSCLC (68 vs 41%, P = 0.03).
International clinical trials for CRC and NSCLC are becoming increasingly unsuitable for application to Australian patients because of the increasing age discrepancy, despite fewer trials restricting eligibility by age.
在晚期结直肠癌（CRC）和非小细胞肺癌（NSCLC）的化疗试验中，老年患者的代表性不足。然而，这种代表性不足随时间的变化情况尚未有文献记载。
本研究旨在量化：（i）1982 - 1991年与1992 - 2001年期间，转移性CRC和NSCLC临床试验入组患者的中位年龄与总体结直肠癌和肺癌人群相比的变化；（ii）设定了年龄上限作为入组资格标准的试验比例。
对维多利亚癌症登记处的数据以及1982年至2001年间所有已发表的关于晚期CRC和NSCLC的大型随机化疗试验数据进行回顾性分析。
在这两个十年间，CRC临床试验入组患者的中位年龄保持不变（分别为62.0岁和62.2岁），而CRC人群的中位年龄从68.4岁增加到70.2岁，中位年龄差从6.4岁增加到8.0岁。肺癌临床试验患者的中位年龄从59.8岁增加到61.8岁，而肺癌人群的中位年龄从67.4岁增加到70.4岁，年龄差从7.6岁扩大到8.6岁。对于CRC（51%对29%，P = 0.04）和NSCLC（68%对41%，P = 0.03），设定年龄上限作为入组资格标准的试验在第一个十年比第二个十年更多。
由于年龄差异不断增大，尽管限制年龄入组资格的试验减少，但CRC和NSCLC的国际临床试验越来越不适用于澳大利亚患者。
