ESMO 2012, Vienna, Austria

The Neo ALTO Study, a combination therapy of lapatinib and trastuzumab and breast conservation surgery

Dr Carmen Criscitiello – European Institute of Oncology, Milan, Italy

Hello, we’re here in ESMO 2012. Dr Criscitiello, you presented some very interesting data and you were also in a press conference this morning; can you summarise your data?

Basically we started from the Neo ALTO trial, which is a randomised controlled trial that ran in 23 countries all over the world, and that trial showed that the combination of lapatinib and trastuzumab compared to either drug alone dramatically improved the rate of pathological complete response. However, we noticed that this impressive result did not translate into a higher rate of breast conservation, that’s why we decided to analyse different possible factors that may have affected the choice of surgery in patients enrolled in the Neo ALTO trial.

So in this trial, was there a name for this trial?

It was a sub-study of the Neo ALTO trial.

And so what did you do?

Basically we analysed all possible factors that may have influenced the choice of surgery and we analysed the association between the type of surgery and each single possible factor. Then we ran an adjusted model, so we analysed all these possible factors in an adjusted model, and we saw that planned surgery itself could be the biggest driver of the decision as to whether a patient is treated with breast conservation surgery or not. Two other factors that could really influence the choice of the type of surgery are the multicentricity or multifocality of the tumour at initial diagnosis and oestrogen receptor negativity, so the absence of oestrogen receptor status. Planned surgery itself could be influenced by tumour size in the geographic region where the treatment was given.

So what does this mean for the patient?

Basically what we saw is that the final decision was based on baseline characteristics rather than on characteristics after systemic therapy. So this means that one of the goals of the neoadjuvant therapy is not achieved because the neoadjuvant therapy aims to downstage a locally advanced disease but it tends to increase the rates of breast conservation as well. So we want to highlight these results and we want that medical oncologists and surgeons co-operate and bear in mind these results so that the final decision of surgical treatment could be taken taking into account the final characteristics. That way, I think that most patients could be spared from an aggressive surgical treatment so they could be spared from losing their whole breast.

Do you think also people will take into account molecular characteristics of the tumour as well? Could this influence the decision?

Yes. Molecular characteristics, pathological features, were taken into account as well. I mentioned before the oestrogen receptor status. Apparently it seems that the choice of mastectomy was more frequent for patients with the most aggressive features.

So basically each patient should be looked at individually before taking the decision?

Yes. I think that each single patient should be discussed in a multidisciplinary way before deciding on the type of treatment.

OK, thank you.

Thank you.