Entry and evaluation of elderly patients in european organization for research and treatment of cancer (EORTC) new‐drug–development studies

Background. This study aimed to determine the extent to which elderly patients (≥65 years) currently are being entered in Phase II single-agent studies, and if advanced age is associated with increased toxicity. Methods. This analysis was based on the age distribution of 2344 patients with various solid tumors entering 16 phase II EORTC single-agent trials from January 1983 to February 1992. Results. Of the study group, 22% were 65 years or older and 8% were 70 years or older. Delay in dose administration and dose reduction were significantly higher for elderly patients compared with younger patients (P < 0.05). When adjusting for previous chemotherapy pretreatment, no difference between elderly and nonelderly patients was noted in the frequency of grade 3 and 4 hematological toxicity, nausea, vomiting, and diarrhea. A significant higher frequency of episodes of severe oral toxicity (P < 0.05) and alopecia were observed for elderly patients, but a higher proportion (P < 0.05) of elderly patients received drugs for which stomatitis was an established side effect. No significant difference in the frequency of complete plus partial responses was observed between older and younger patients (9% versus 7%). Treatment discontinuation significantly increased with age, ranging from 24% for those younger than 50 years to 33% among elderly patients (x for trend = 12.83, P < 0.001). There was not evidence that excess toxicity was an obstacle to treatment continuation for elderly patients, whereas treatment discontinuation did occur for the older age group more frequently because of loss to follow-up and treatment refusal. Conclusion. Selected elderly patients can and should enter new-drug-development protocols without an increased risk of more severe or frequent side effects. A priori exclusion based on an arbitrary chronologic age limit no longer should occur. Cancer 1995; 76:333–8.