Now, you’ve conducted a phase II study, it’s a combination of an anti-VEGF, sunitinib, with chemotherapy in a group of patients with renal cell carcinoma. Tell me first of all which group of patients and why were you looking at a combination of a targeted therapy plus chemo?

Certainly. So the group of patients that we conducted this study in was in patients with sarcomatoid RCC or poor risk RCC. These are patients who historically have very clinically aggressive disease that doesn’t respond well to standard therapies, standard VEGF therapies. So it’s certainly an unmet need in regards to the management for these patients.

How much of a response were they getting to single agents, things like gemcitabine and sunitinib, the components of your combination?

With gemcitabine single agent gemcitabine was associated with response rates of about 10% and VEGF targeted therapy was associated with response rates of around 19%.

So tell me about the study please, what did you do?

In this study we actually took patients with either sarcomatoid or poor risk disease. There was no randomisation, all patients were treated with gemcitabine at 1000mg on day 1 and day 8 of every 21 day cycle. They received sunitinib at 37.5mg daily, two weeks on, one week off. They were followed for response, that was the primary objective of the study. What we found was actually in patients with sarcomatoid disease, we had about 39 patients in that category, the response rate was 26%. For patients with poor risk disease the response rate was 24%.

So what are your conclusions from this?

Actually this study, in addition with the phase I study that led to the standard doses to be used in this study, has led to a randomised phase III that’s being put on by one of the co-operative groups where patients are randomised, all patients receive sunitinib and then they’re randomised to receive the gemcitabine. So that should really be the definitive study to answer whether our findings actually are going to change our standard of practice.

Clearly it is difficult to know what to do if you have a patient with poor risk renal cancer, what’s your guidance coming out of this? Obviously you’ve not got all the answers yet but what practical messages could you give to doctors?

I think for patients who have sarcomatoid RCC or clinically aggressive disease and you really need tumour shrinkage, I think reaching for a chemotherapeutic agent such as gemcitabine and combining it with Sutent, like we have in the study, could offer objective responses that are really needed for those patients.

What about the actual choice of VEGF agent that you are using? Could you use a different one?

In this study we used sunitinib, it is conceivable that you could potentially use pazopanib or conceivable that you could use a monoclonal antibody but that’s not what this study did so I can’t comment directly on that.

So to summarise the hope coming out of this at the moment, what would you say in a few words?

For patients with sarcomatoid or poor risk disease who have clinically aggressive disease the combination of gemcitabine with sunitinib was tolerable and led to objective responses in those patients.