IGCS 2010, 23-26 October, Prague

The influence of trabectedin on overall survival in ovarian cancer

Professor Nicoletta Colombo – European Institute of Oncology, Milan, Italy

Yesterday you spoke about some new therapy in ovarian cancer, can you outline this?

The drug I spoke about is trabectedin, this is a new drug which has recently been approved for use in ovarian cancer by the European authority, EMEA. The approval is actually in combination with pegylated liposomal doxorubicin in patients with platinum sensitive recurrent ovarian cancer. So this is for the relapsed patients and in fact this association, this combination, has proved to be more effective than single agent pegylated liposomal doxorubicin in this population.

The data I presented yesterday actually were something more than what is available. This is a sub-group analysis of a particular population and of patients with relapse between 6-12 months since last treatment with platinum. Because we know that this population, we call this population partially platinum sensitive, because they do respond to platinum  but, of course, their outcome is not as good as the outcome of patients with a longer platinum free interval. Therefore, there is there unmet need for this population. So this sub-group analysis was an exploratory analysis of the main trial with trabectedin, showed that the association, the combination of PLD and trabectedin, is particularly effective in this sub-group of patients with the partially platinum sensitive disease. Probably this is because, one hypothesis is that by using this combination we can prolong what we call the platinum free interval with a non-platinum agent and then this may eventually lead to a better efficacy of platinum when it would be reintroduced at time of further relapse.

What was impressive in this analysis is that there was an advantage, not only in progression free survival for these patients but also in overall survival. So these patients with the 6-12 months platinum free interval had an advantage, not only in progression free but also in overall survival with the use of trabectedin and PLD. So this is, of course, speculation because this is a retrospective analysis, so what we plan right now is a prospective randomised trial and for those patients with a relapse between 6-12 months, these patients will be randomised to receive what is the standard treatment, which is carboplatin and PLD, or this new combination, which is trabectedin and PLD. Then at time of relapse, these patients will again be treated with platinum. So we want to explore if this extension of the platinum free interval will translate into a better overall survival because the endpoint of this study is, in fact, the overall survival.

And this is on-going, this is open now?

This is about to start. It will be an international, multi-centre trial; actually it will be done, not only in Europe, but probably in all the world. The leading group is the MaNGO group in Italy but of course we’ll see the participation of several co-operative groups all around the world.

And I know where you are, at the European Institute of Oncology, there is the special ovarian cancer centre.

Yes, we do have the ovarian cancer centre which is a multidisciplinary team dealing with ovarian cancer. So we can offer patients with ovarian cancer all they need, or we try to offer them all they need for the treatment of their disease.

Thank you.