What about older people? CLL is a disease where the median age at diagnosis is 70, but the median age for this trial was 61. I am on record as publishing an article entitled "FCR: No country for old men." Is this regimen safe for older people?
Although the median age was certainly younger, patients up to the age of 81 were treated in this trial. According to the figures 30% of patients were over 65 and 10% over 70. How did they fare?
Looking at response rates, the CR rate for FCR for under-65s was the same as for over-65s at 45% and 43% respectively, while the overall response rates were 89% and 93% respectively. For 3-year progression-free survival the figures were 64% for under-65s and 68% for over-65s, and for 3-year overall survivals they were 87% for under-65s and 88% for over-65s. But we have to remember that all patients entered into this trial had good performance scores with no significant co-morbidities. As you get older this tends not to apply. All we can say is that a selected group of older people who are physically fit do as well on FCR as younger people.
There is some evidence that older patients have less bone marrow reserve than younger patients which showed itself in the patients over-65 having slightly more hematological toxicity than younger patients. This did not show for any particular type of cytopenia, however bacterial infections were significantly commoner in the over-65s, at 4% rather than 1%. The older patients did not require more dose reductions than the younger ones though.
As the authors say, conclusions from this trial should not be generalised to physically unfit, elderly patients with chronic lymphocytic leukaemia.