We have a recommendation to treat elderly patients with colorectal cancer with either monotherapy of 5FU if they have some frailty or in fit patients or patients with very symptomatic disease we give them the doublet chemotherapy, so it was 5FU plus oxaliplatin or irinotecan. About bevacizumab we have just one randomised trial that has demonstrated a significant improvement of progression free survival in elderly patients over 70 but we have some concern about the tolerance and maintenance of autonomy on quality of life in these patients with bevacizumab. That’s why SIOG recommends new trials assessing not only traditional oncological endpoints as overall survival or progression free survival but also quality of life and maintenance of autonomy.
Can you tell us if there were any toxicities to note?
Of course in our trial and in the literature we assess all the types of toxicities. We did not find an excess of haematological toxicity in our trial with bevacizumab, not so digestive toxicity but cardiovascular toxicity but this is consistent with previous trials that found that there are more thromboembolic events and hypertension but these remain manageable.
What ages did your trial cover?
Our trial was specific for patients over 70 and we did not make a sub-stratification in our recruitment. In the literature there is some data to demonstrate that after 80 or 85 the prognosis could be worse and the chemotherapy less well tolerated. One thing that is clearly demonstrated is that a patient over 60 or 65 did not have a frailty that has to give a specific treatment. Between 65 and 75 we can treat patients as our younger patients in metastatic colorectal cancer.
Are there any plans to take this research forward into a non-metastatic setting?
Our trial was about bevacizumab in the metastatic setting. In the non-metastatic setting bevacizumab was explored by two large international randomised trials, not for the elderly but for every patient, and unfortunately it was clearly demonstrated that bevacizumab had no added value in non-metastatic.
Is this research something that could be acted on immediately?
Our trial was a phase II randomised trial so our effective was only of 102 patients so we cannot draw a large conclusion. We found that according to our criteria bevacizumab was efficient and safe. An interesting finding from a subgroup analysis showed that the bevacizumab benefit is maintained in patients with some frailty criteria as the nutrition or impaired autonomy. So that’s an important finding of this study, that we should not exclude or delay treatment with bevacizumab in patients with some frail characteristics. In these patients probably we don’t have a second chance, they probably have less second line chemotherapies, so if we want to use the best treatment option it should be used at the first line, at the beginning of the treatment.
Are there any other important findings?
We repair from a median time to autonomy or quality of life degradation and we did not observe a worse autonomy or worse quality of life under bevacizumab. So for these criteria bevacizumab could be considered safe. This is the added value of this trial to the previous trials that have already demonstrated that bevacizumab prolonged progression free survival.
