IGCS 2010, 23-26 October, Prague
New system of staging for gynaecological cancers
Professor Sergio Pecorelli – University of Bescia, Italy
Recently FIGO has issued a new set of staging for gynaecological cancers, can you just give us a brief outline of this?
Well staging means, obviously, how you define the spread, the extent of a disease, a tumour. In the medical community usually everybody knows the TNM system which is tumour, lymph nodes and, of course, metastases. However, in gynaecology we were the first to define the spread of the tumour before the TNM and it started in the late ‘20s when cervical cancer was first defined in its staging as a clinical staging and it was done mainly because at that time there were only two types of treatment – one was surgery and the other one was radiation therapy. In fact it was the International Society for Radiation Therapy that decided to have a description of the extent of the tumour, called the staging, in order to compare data between different centres and that was how it started, 1928. Since then, the definition of the extent of the tumours in gynaecology has always been by itself, that is separate, from all of the other tumours even though there is a possibility of translating the FIGO, today called FIGO, staging into the TNM system. FIGO came after the Second World War and in the early ‘50s took over the staging, the classification of gynaecological cancer, so not only cervical but also all the other cancers one by one.
The committee which I chair has the task to relate and have a relationship with the scientific and clinical community worldwide in order to revise periodically the staging of all cancers. Obviously today there is an extremely important new concept in cancer and that is that we no longer rely upon only the TNM or the tumour, the extent of the tumour, the lymph nodes and the metastases but mainly, of course, upon the molecular classification of cancer which obviously links then to the type of treatment. So this committee deals also with an attempt, at least, to classify gynaecological cancer also by their molecular biology.
Recently, as you mentioned, the classification, the staging, of a few gynaecological cancers was revised, namely the endometrial cancer, vulva cancer, cervical cancer. And what is extremely important is the fact that a new classification was introduced for a new category which had never been staged, and that is the uterine sarcomas.
The vulva cancer is the one that probably had the most revisions. As you well know, vulva cancer is a rare disease and always when there is rarity there is a lot of dispute and a lot of discussion. Therefore, what happened was that having few cases it was not possible to define exactly the prognostic factors in a prospective way. Also because vulva cancer used to be a disease mainly of the elderly and most of the patients until a few years ago used to present when they were already old and at an advanced stage. Today things are completely different and also because of the histology we know that many of the vulva cancers now are also in the earlier age and they’re due to HPV, so the same cause of cervical cancer.
So the new classification of vulva cancer, it’s more proper today and it’s also of great prognostic significance. Endometrial and cervical cancer had minor changes. When you already have good classifications, obviously you try to tune what you have and they come out of a big debate. What is important is the fact that we are not only gynaecologists that decide upon this but we link with the International Society for Gynaecological Pathology and to all other categories of scientists and clinicians that are linked to gynaecological cancer.
Sarcomas are another matter; sarcomas are rare tumours too, of the uterine corpus. However, they need to be classified, also because today the therapy for uterine sarcomas is far from being standardised. Also here at the International Gynaecological Cancer Society meeting in Prague, there is one full session devoted to sarcomas, mainly because of this and the need of concentrating the efforts in order to treat this disease which was thought to be almost more or less one category and now we know very well that there are three different types, completely different from one another with different behaviour and so on. So what the committee does is, in fact, not only to revise the classification but look at all the literature and look at all the research in the field and try to also concentrate on what is of the utmost importance and relevance to the practical clinician and not only to research. There are other bodies that deal with research, clinical trials and so on; we mainly deal with everyday life and what we have to say is that since we have a staging classification for gynaecological cancer, finally it is possible to compare data, to discuss between us and to have a common standard to start from when we discuss about our tumours and the treatment.
Thank you. Dr Pecorelli, you are also the President of AIFA, which is the regulatory body equivalent to the FDA in Italy and you are speaking at this conference about some of the regulatory oncological drugs.
Yes, the work of regulators has always been thought of and looked at as a bureaucratic tool needed but always looked at with some kind of hesitance and also of intimidation sometimes. In fact, the regulatory agency has to do with efficacy and in a few words say yes or no, this drug works or doesn’t, and it’s called, therefore, efficacy; and also with safety because the drug has to be safe, of course, in order to be administered. But one important thing is that it is not only that and what we in our agency, but also the FDA, and we have excellent links between the Italian and the American FDA, is the fact that science has to be put into the regulatory world. There is a big change in the world of therapy, of drug therapy; the big change is that we are going from what is called one drug fits all, the blockbuster, to the personalised medicine. This is the real concept and this is a big change. If you think that in cancer 75% of the drugs do not work, that is you have only 25% of adequate drugs for that particular cancer or, in the best cases, 60% of the drugs do work and that is with the antidepressant, for instance. Well this means that we can no longer rely upon one drug for one disease.
Now, personalised medicine means a lot of research, means knowing the molecular biology of the tumours, knowing the targets, having new molecules and all that. What is interesting though is the fact that with this new type of pharmacogenomics, it is possible in fact to address each single target with a different molecule and it is possible to better personalise the therapy. However, today if we did this we would be broke, even more than we are now; there would be no sustainability. But in the future, if we go along this line we will have it and the prices and the expenses will necessarily go down. So it’s really a matter of transition now and we need desperately to find biomarkers which can be the right surrogate in order to understand if a drug works or not and we are really in a moment of great difficulties worldwide. You know very well about the health systems, United States, Europe, other countries, but even though you have an excellent national health system like you could have in the UK or in Europe, in ten or fifteen years if you go this way we are broke.
Because these drugs are so expensive to produce?
Yes, they are too expensive. To produce one drug today for cancer is $1.7 billion.
And then if you are treating just a small population?
The small population, of course, you cannot pay for your R&D; only three out of ten drugs that go to the market really pay for their R&D. So you understand that it’s really a big problem. So there should be a lot more links between what is the public research, which is the academia for real research, and the private research, which is the pharma, for the innovation drugs.
But I think this is how things are starting. Lots of the research is now university based and then the drug company comes in and they get closer.
Yes, it’s a lot of joint ventures. I think that one thing which is missing, probably, today still is the fact that as in any research, any field of research, if you want to have a joint venture, you’d better start both at the same time and not just jump in whenever.
Thank you.
