Folprecht G, Cunningham D, Ross P, Glimelius B, Di Costanzo F, Wils J, Scheithauer W, Rougier P, Aranda E, Hecker H, Köhne C-H
University Hospital, Dresden, Germany.
Ann Oncol. 2004 Sep;15(9):1330-8. doi: 10.1093/annonc/mdh344.
Recently published population-based investigations showed elderly patients to be underrepresented in clinical trials and less often treated according to the standard therapy. Although there is evidence that elderly patients benefit from adjuvant (radio-) chemotherapy to the same extent as younger patients, no large series describes the influence of age on efficacy of chemotherapy in metastatic colorectal cancer.
We carried out a retrospective analysis using source data of 3825 patients who received 5-fluorouracil (5-FU)-containing treatment in 22 European trials and identified 629 patients with an age of > or = 70 years.
We found an equal overall survival in elderly patients [10.8 months, 95% confidence interval (CI) 9.7-11.8] and in younger patients (11.3 months, 95% CI 10.9-11.7; P = 0.31). Response rate did not differ between age groups > or = 70 and <70 years (23.9% and 21.1%; respectively; P = 0.14). Progression-free survival was marginally prolonged in elderly patients (5.5 months, 95% CI 5.2-5.8; compared with 5.3 months, 95% CI 5.1-5.5; P = 0.01). In both age groups, infusional 5-FU resulted in significantly increased response rates, overall survival and progression-free survival compared with bolus 5-FU.
'Fit' elderly patients benefit at least to the same extent from palliative chemotherapy with 5-FU as younger patients. Infusional 5-FU was shown to be more effective than bolus 5-FU in both age groups. Therefore, standardized palliative chemotherapy should generally be offered to elderly patients and they should not be excluded from clinical trials.
最近发表的基于人群的调查显示，老年患者在临床试验中的代表性不足，且较少按照标准疗法进行治疗。尽管有证据表明老年患者与年轻患者一样能从辅助（放）化疗中获益，但尚无大型系列研究描述年龄对转移性结直肠癌化疗疗效的影响。
我们利用22项欧洲试验中3825例接受含5-氟尿嘧啶（5-FU）治疗患者的源数据进行了一项回顾性分析，确定了629例年龄≥70岁的患者。
我们发现老年患者（10.8个月，95%置信区间[CI]9.7 - 11.8）和年轻患者（11.3个月，95%CI 10.9 - 11.7；P = 0.31）的总生存期相当。年龄≥70岁和＜70岁的年龄组之间缓解率无差异（分别为23.9%和21.1%；P = 0.14）。老年患者的无进展生存期略有延长（5.5个月，95%CI 5.2 - 5.8；相比之下，5.3个月，95%CI 5.1 - 5.5；P = 0.01）。在两个年龄组中，与推注5-FU相比，持续输注5-FU均导致缓解率、总生存期和无进展生存期显著提高。
“健康”的老年患者从含5-FU的姑息化疗中获益程度至少与年轻患者相同。在两个年龄组中，持续输注5-FU均显示比推注5-FU更有效。因此，一般应向老年患者提供标准化的姑息化疗，且不应将他们排除在临床试验之外。
