One of the biggest things that you take an interest in is in thyroid cancer, medullary thyroid cancer in particular. You’ve got a new study, tell me what were you trying to do in this new study which is, I gather, in the real world?
Yes it is. Medullary thyroid cancer is a very rare disease, in fact in Spain it is estimated that only 50 patients are newly diagnosed per year. We have reported our study in which we used vandetanib in a standard access programme to treat this advanced medullary thyroid cancer patients in Spain. In these 27 patients that we treated we have seen that the median PFS, the median progression free survival, for these patients is about 17 months, that is extremely high for this patient population.
Now, that was with what protocol and what are the characteristics of this study?
They are progressive, they are patients on progression when they start treatment with vandetanib. In fact, only 60% of the patients were treated with vandetanib for the first line setting but 40% of patients received vandetanib for the second or subsequent lines of treatment. We didn’t see any major differences in terms of activity.
What were the options for these patients otherwise?
Before vandetanib only chemotherapy but chemotherapy didn’t work at all in these patients, a median PFS of only 4-6 months.
Can you spell out, then, the increment in PFS, in progression free survival?
More than one year in difference in median PFS from chemotherapy, from retrospective studies in chemotherapy, to when offered vandetanib to these patients.
Now this is with a multi-kinase inhibitor, is it in any way difficult to give such a powerful drug inhibiting so many kinases?
We are learning how to deal with the side effects of vandetanib. Vandetanib is inducing skin toxicity, diarrhoea, mucositis, hypertension and QTc prolongation. However, we are knowing how to deal with all of these side effects and medical education and patient education is critical to deal with all of these side effects.
Now, it seems you’re getting really good results in the real world, how does that study fit in with the other studies of vandetanib in the use of medullary thyroid cancer?
You cannot compare the results from the SETA trial, that is the phase III pivotal trial that gave the approval for vandetanib in this indication, you cannot compare that with the results of these trials. However, there is a similar experience of the French group, the French colleagues have performed exactly the same analysis that we did and we found exactly the same figures in terms of PFS, in terms of response rate and in terms of dealing with side effects.
Will you interpret this for me in terms of what doctors need to do with their patients with this relatively rare cancer?
Yes, the French and the Spanish experience in the real-world setting with vandetanib is what the physicians can expect from the drug in the real world, when they are treating - when they treat these patients.
So they can expect it’s going to work?
They can expect vendatenib is working. They can expect a median PFS of about one year and a half, that is extremely high, and they can expect side effects but they are manageable.
What alternatives might these patients have in the future? Is there anything else coming down the road?
Yes, it’s coming cabozantinib is a drug that is from Exelixis, a biotech from California, and cabozantinib is in the regulatory process for authorisation and we will see in the future what is the best sequencing strategy to offer to our patients.
So what’s the clinical bottom line message for doctors right now?
MTC, medullary thyroid cancer, and the progression is a rare disease, they have to be referred if possible to centres with experience in the field. However, there is at least one tyrosine kinase inhibitor that is clearly impacting the natural history, it’s clearly impacting in the overall survival of these patients.