ASCO 2013
Biennial cervical cancer screening with vinegar reduces mortality
Dr Surendra Srinivas Shastri - Tata Memorial Hospital Mumbai, India
I joined this institution as Chief of the Prevention Division in 1998. Around that time, and even as of now, cervical cancer is the number one killer in terms of cancer among women in India. Unfortunately, we do not have a cervical cancer screening programme and that is true for most of the developing countries, the reason being that we are not able to set up Pap smears of good quality and to be provided as frequently as it’s required, as it is done in the North American countries and as it’s done in the European countries. The results that you get with a Pap smear are because of the good quality control labs and the frequency with which it is carried out which is definitely not possible.
Way back in 1992 and then later again in 2006 the Indian Council of Medical Research of the Government of India determined that Pap smear would not be feasible screening test for cervical cancer for the population at large. So we had to look at alternatives and then we looked at this method which is actually part of the routine colposcopy procedure in gynaecology. As gynaecologists we do colposcopy so one of the processes is to apply vinegar or acetic acid, 4% freshly prepared acetic acid, and look for any changes in the cervix. So what we essentially did is, because if this was to be made accessible to all women in rural India we could not possibly have trained doctors, we could not have trained nurses and we could not have colposcopes out there. So we tried to look at whether it’s possible to train primary healthcare workers who work in the rural areas to be able to apply acetic acid and see the change with just a naked eye visual inspection. And that’s what we did, we trained them for four months and we had a good quality control exercise. We had 5% of all women who were screened by the primary health workers who were also independently and randomly screened again with the same method, VIA, by an expert and the agreement rates between the experts and the primary health workers is about 95% which converts to a kappa statistic of about 0.84.
How did you initiate this?
If you look at the real challenges that we had at the ground level it was not about the process of providing Pap smears, of providing the VIA or the visual inspection acetic acid, the vinegar, but it was more about getting that information out there to the women in the community. Women everywhere are very intelligent, let me get this across, not just because you are a woman but in Indian women that is my experience. They understand everything and they’re very smart, even if society thinks they’re not empowered enough, that’s not really true, that’s the impression that they give the society. So in this case although the women wanted to know what it was all about, we could not gain entry into those communities because of certain cultural issues. We had to tackle the religious leaders, we had to tackle the political leaders who kind of have ownership of the community and we also had to talk to other educated opinion leaders in the community like the school-teachers and the headmasters of the schools. Once we had convinced them, once we had convinced them that it’s something good for your women, at the end of the day this is a woman who takes care of you and if you want her to live long enough to be able to keep taking care of you and your children like she’s doing right now, you need to do something about it. And that’s when they understood. They insisted that they would be part of any educational programme that we were going to carry out for the women, at least initially; they did that. Once we were able to convince them and gain their trust we got into the community and talked to these women.
We did one more thing, what we did is we asked the community whilst they were canvassed about it to actively participate in terms of providing volunteers at the time when we were setting up the screening camps. So young schoolgirls would be given a short lecture of about half an hour, the whole idea was to tell them what cervical cancer was all about and how it is killing a lot of women and how it’s likely to affect the mother and the aunt. They were then asked to go to the houses and get their aunts and mothers and other people for screening. We also asked the community to provide us at no cost places where we could set up the clinic. So this gave the community a sense of ownership of the programme; it also ensured us a great participation.
One more thing that it ensured was today we are speaking to the girls who are bringing their mothers for screening so tomorrow we wouldn’t have any problem getting these girls when they grow up for the screening. We probably don’t have to talk to them; they’ll come and demand those services.
What were the results?
We saw a participation which was close to 90%, a screening participation rate of 90% is not known even in developed countries so this was something amazing for us. All women, we had four rounds of screening so we had all women participate for at least one round of screening for 90% of the time. In fact, the whole exercise, at the end of the year if you are going to convert it to a programme, we’re probably looking at screening a woman once in five years or so. So we had a large participation rate. Following that we ensured, this is part of the study protocol, we ensured that those women who were positive by the test were brought by patient navigators to the hospital for confirmation of diagnosis and those who had a confirmed diagnosis were followed up for treatment by the patient navigator. So we had an amazing diagnosis confirmation rate, again upwards of 90%, and a treatment completion rate of close to about 78-82%.
You must understand that this is a community where cervical cancer screening, cervical cancer diagnosis and cervical cancer treatment, they were never available. It is a naïve community, so despite them having never had cervical cancer screening before, this is something which is unexpected even for us.
Give me an idea of how many lives could be saved because of this in developing countries.
I was very simple in my calculations in terms of what the GLOBOCAN 2008 predicts and what extrapolations we can do for the year 2010 and as per those figures if you were to have a country-wide cervical cancer screening programme in India we would save about 22,000 lives every year. And I was thinking only of other developing countries which do not have these kinds of facilities and I said that if we were to extend those facilities to other developing countries we might be able to save around 72,000 – 76,000 deaths across all countries. However, the person who spoke after me who was a discussant of the study mentioned that it’s not just the developing countries. There are many areas in developed countries which have very similar problems and if this were to be extended to even those areas, then you can probably save a quarter of a million lives.
How does this compare to results we see with Pap smear?
This particular study did not look at a non-inferiority between two methods but there are other studies, some of which we have been part of, which have looked at the HPV DNA testing, which have looked at the Pap smear testing, which have looked at VIA and compared all these methods. And VIA as a method is as sensitive or even more sensitive than the Pap smear. The specificity of VIA is, however, less than that of the Pap smear. Despite all this, if you listen to my study as I presented it yesterday, we had no over-diagnosis and for public health situations like we have in developing countries where the systems are already burdened with infectious diseases, to have over-diagnosis would be very harmful. So one more take home from this particular study: that with VIA we didn’t have any over-diagnosis so we were not doing any unnecessary diagnosis, unnecessary treatment which happens with most screening procedures, mammography is very famous for that.
What is the next step then?
What we did was as soon as we had the results of the study we started advocating with the government of India and the state governments in the country. Health is a state subject, however the policy comes from the federal government of India. So the federal government of India has decided to take up six districts in each state of India as phase I for the roll-out of this programme and the Tata Memorial Centre where I work is involved in the training and the quality control process of this whole roll-out. We expect about six months of training to get into this whole process and about two years for a single line of screening. This is about India. We have also allocated with the Ministry and the Minister of Health in the government of India to speak to his colleagues in developing countries to take up this and we would be happy through whatever medium to support that training programme too.
What does this mean for women that are diagnosed with cervical cancer?
That’s a very good question. In fact, one of the biggest challenges in countries like this is whether you are able to support treatment of those who are diagnosed as positive. Fortunately, in India at this point in time we have about 29 regional cancer centres which are fully funded by the government; we have several private institutions which are providing the treatment. So as far as India is concerned, I don’t see a problem of these women going for treatment. We of course will have to put in a lot of efforts for the follow-up once she is diagnosed, like we had the patient navigators in our study. So we probably need to train the primary health workers also to act as patient navigators to bring them to the health centres for treatment. I know that there are other countries which may not have these kinds of facilities; I know there are countries even in South Asia, there are countries in Africa which don’t have a pathologist or a surgeon for an entire district. So these places, they probably might take a longer time to be able to develop those kinds of facilities and I’m sure countries which have taken the lead, like India and China and of course developed countries, can help them do that.
What are your overall conclusions coming out of your data?
Number one, just because you cannot… we are not saying that Pap smear is not a good method. Wherever you have Pap smears already as an established method please go ahead, you have the quality control, you have the wherewithal to do the frequency. Where it’s not possible to provide Pap smears then visual inspection with acetic acid should be the primary screening method. This is going to save a lot of lives, it has no over-diagnosis so you’re not over-burdening the system.
