In my presentation I spoke about guidelines for the treatment of advanced breast cancer in low and middle income countries. First, the magnitude of the problem is important because of the total number of 1.67 million cases of breast cancer in 2012, as reported by Globocan, 45% of them occur in low and middle income countries.  The recent advances in treatment and improvement in outcome have been seen in high income countries but not much in low and middle income countries. One of the reasons is, of course, non-availability of many issues that are taken for granted in Europe and the United States and high income countries. We see lots of advanced cancers at presentation; it is about 60-80% of cases of advanced breast cancer in low and middle income countries, however, because of awareness campaigns and some forms of screening we reported that in Lebanon, for instance, the advanced cases are down to 35% only and the rates of mastectomy have decreased also. So we have seen improvement because of awareness campaigns and because of some screening that people do. Very often it’s opportunistic screening but we have seen some important advances there.

Now, when it comes to treatment, we spoke about availability, like we have to start, of course, diagnostic availability. It’s not always available; surgery is not always available, there are many places in the world where they do not have surgery infrastructure, they do not have trained surgeons. This is important and the Lancet Oncology Commission for Global Surgery have recommended an investment in surgery because not only it improves outcome but also it has economic benefits, the same thing for radiation therapy which is not available everywhere. There are countries in Africa, the whole country probably has one radiation therapy available for treatment. So those are deficiencies.

When it comes to chemotherapy, there are deficiencies because you may not have enough medical oncologists to deliver the treatment and there are set-ups for chemotherapy that have to be available as well. As for the supportive care, that’s also still fragmented and needs to be improved in the majority of low and middle income countries.

So what to do? You have lots of deficiencies in resources and manpower but we still recommend to treat the patients. So what do we do, how do we treat patients? Guidelines from the NCCN, from ASCO, from ESMO may not be applicable because the resources are not available. So the breast health global initiative embarked on a process of stratifying guidelines according to resources, stratifying countries according to resources and issuing guidelines accordingly.

The basis of the guidelines, according to resources, is not to offer sub-optimal treatment but it is really to offer the best we can, to do the best we can, with the resources that we have while working on improving our resources. This is very important. So there are countries in Africa, sub-Saharan Africa, they may have only surgery, they may not have surgery. So for the treatment of early breast cancer we do recommend, for instance, to have surgery. So we divided countries, instead of saying high income, low income, instead of saying industrialised nations, developing countries, we say basic level of resources, limited level of resources, advanced level of resources and the other one is maximum.

So, for locally advanced breast cancer we recommend according to the Breast Health Global Initiative, and also the ABC guidelines, the Advanced Breast Cancer guidelines from the European School of Oncology and ESMO, the guidelines do recommend neoadjuvant treatment. It is OK to give preoperative treatment for locally advanced breast cancer and in the low resource level you can use only adriamycin cyclophosphamide or you can use CMF. Now at a limited level of resources you may go for more available treatment, maybe if taxanes are available. Now taxanes have become generic so they have become cheaper although we still think that the quality of the generics should be reinforced, should be enforced, make sure you have good quality and the prices should go down as well.

Now, if the tumour is HER2 positive the recommendation according to ABC and all other guidelines is to add trastuzumab for neoadjuvant treatment. Trastuzumab has been placed just a few months ago on the Essential Medication List of the WHO and UICC, EML, Essential Medication List, for early breast cancer. Inevitably it’s going to be used; when you have locally advanced breast cancer you might do it because it gives you up to 60% complete pathological response. So we did go over in my presentation about the pricing of those new compounds. We have to find ways of making those new important revolutionary drugs available to women worldwide, of course while maintaining the interest in research and development. So pricing of medications is a big debate, you have the market value but you have also other ways to make it available. There are efforts in the United Kingdom with the NICE guidelines that introduce quality and quantity of benefit from treatment. But of course the system does not always work: they have the Cancer Drug Fund that supports when you cannot give Herceptin, for instance, or other drugs according to the guidelines. We have a system that looks at value, the value of the drug. In Italy they apply this, you start the treatment for a few months and if it works, if you have a positive benefit, you continue. There is a way according to the expected value of the drug it is priced. The other way, maybe, is because those drugs are used for a long time, start with the higher price but then go down as we go along. So these are negotiations that are important between big pharma and societies worldwide to make sure that the drug is available to the majority of people. Pharmaceutical companies do have lots of investments, they employ a lot of people in Europe, for instance the EFPIA said that they employ more than 700,000 people in Europe, so it’s important that they contribute to the economy, they do a lot of research and development. But to make drugs available for people worldwide it needs efforts from low and middle income countries. They have to have some systems to protect patent rights but also there has to be ways of offering that drug in a reasonable price for those countries.

In the recommendations of the Breast Health Global Initiative and ABC and other guidelines, when we have patients with metastatic breast cancer if they are hormone receptor positive we do not need to jump to chemotherapy right away. Only if the patient has what we call a visceral crisis, like has a disease that is widespread that’s progressing rapidly and needs chemotherapy we go for chemotherapy. But otherwise we should go for hormonal therapy and tamoxifen remains an important drug for premenopausal and postmenopausal women; it’s cheap and it’s available everywhere. For metastatic cancer patients in low and middle income countries we recommend ovarian function suppression, often oophorectomy, because in higher, enhanced levels or a higher level of income people use LHRH analogues, subcutaneous injections once a month. This requires lots of visits to the doctors and higher expenses so you can do well with ovarian function, oophorectomy, for instance, suppression or ablation. That’s an important part of the treatment.

When it comes to chemotherapy you have to use the chemotherapy that is available to you but you have to have trained personnel, trained nurses, it’s very important to have good doctors on the ground. Sometimes the treatment is not given by medical oncologists but we have to have people trained to deliver that treatment. You can do well with adriamycin cyclophosphamide. And, as I said, probably also you can add taxanes but you have oral treatments, for capecitabine for instance, you have oral treatments that are not very expensive but the prices have to be offered at a lower level in those countries that also need to support themselves and deliver the treatment and also monitor side effects.