THE MILLION WOMEN STUDY

HomeNewsletters

Newsletter - January 2004

First Million Women Study results on breast cancer and hormone replacement therapy published

Follow-up of over 1 million women in the Million Women Study has confirmed findings from other recent studies that women currently using hormone replacement therapy (HRT) are more likely to develop breast cancer than those not using HRT. Past users are not at an increased risk. In the first paper on breast cancer and the effects of HRT, published in August, we were able to show that this effect is substantially greater for combined (oestrogen-progestagen) HRT than for oestrogen only HRT, and that the effects were similar for all specific types and doses of oestrogen and progestagen, for oral, transdermal and implanted HRT and for continuous and sequential patterns of use (Million Women Study Collaborators (2003) Lancet 362:419-427). Current users of oestrogen-progestagen HRT were at 2-fold increased risk of developing breast cancer and current users of oestrogen-only HRT were at 1.3-fold risk. The risk increased with increasing duration of use; 10 years’ use of oestrogen-progestagen HRT is estimated to result in 19 extra breast cancers per 1000 women aged 50-65, in addition to the 32 per 1000 expected in never users. This suggests that the use of HRT by women aged 50-64 in the UK over the past 10 years may have resulted in an extra 20,000 breast cancers. More information is needed on the effects of HRT on mortality from breast cancer and on the risk of other cancers, in particular endometrial cancer, but these results suggest that the benefits and risks of oestrogen-only versus oestrogen-progestagen HRT may need to be reassessed.

Future plans

Two new Million Women Study investigations are under way. Surgeon in training Dr. Toral Gathani has joined the Million Women Study to help assess patterns of treatment for breast cancer, and will use information on pathology to look at how HRT use may affect breast cancer of different types. The Million Women Study is also being extended to collect DNA samples from several thousand women, to allow us to consider genetic factors as well as environmental factors like HRT when looking at disease risk. Pilot studies for this Disease Susceptibility study will begin this year.

Million Women Study celebrates again!

The Million Women Study celebrated another milestone in May 2003: questionnaire scanning has been completed for all 1,384,461 million women recruited. We hope to have completed the collection of primary follow-up questionnaires for all the recruited women by March 2004.

Screening centres continue to provide information

Moya Simmonds, Elizabeth Hilton and Barbara Crossley are continuing to collect details of breast cancers diagnosed in Million Women Study participants. This information on pathology and clinical details will form a vital part of the next stage of Million Women Study analyses. The Million Women Study co-ordinating centre staff would like to thank staff at screening centres for their continuing support.

News from the Collaborators’ Meeting

The fifth annual Million Women Study Collaborators’ Meeting, was held at Lincoln’s Inn Fields on 16th June 2003. Recent findings were presented on breast cancer and cervix cancer from the Million Women Study, and on breast cancer in relation to alcohol and tobacco from the Collaborative Group on Hormonal Factors in Breast Cancer. We would like to thank Martin Vessey and Julietta Patnick for chairing the meeting.


Newsletter - February 2003

First major publication from the Million Women Study: Use of hormone replacement therapy is influenced more strongly by medical factors than by lifestyle

The first major paper from the Million Women Study collaborators was published in December 2002 and is being distributed to each screening centre. It is based on data from over 1,000,000 women across Britain and demonstrates that use of hormone replacement therapy (HRT) is common among women aged 50-64 nationwide (see map below). Overall, 33% of women in the study were currently using HRT and a further 17% had used it in the past. Use varied markedly according to a woman’s medical history. For example, 66% of women who had had both ovaries removed were currently using HRT, compared to 6% current use among women with breast cancer and 24% use among women who had had a stroke. There was considerably less variation in use according to factors such as deprivation, education, exercise or alcohol consumption. This in-depth understanding of patterns of use of HRT will inform future analyses of the effect of HRT on the risk of disease.
Richard Doll Building

We’re still collecting information!

The Million Women Study is still collecting information from NHS Breast Screening Units about breast cancers diagnosed in participants. Moya Simmonds, Elizabeth Hilton and Barbara Crossley are visiting collaborating screening centres around the country to ensure that high quality follow-up data continues to be obtained. Thanks are due to all screening centre staff for their fantastic ongoing cooperation with the project!

Alcohol, tobacco and breast cancer

Reliable evidence about how alcohol and tobacco affect a woman’s risk of breast cancer was published in December 2002 (Collaborative Group on Hormonal Factors in Breast Cancer. British Journal of Cancer 2002; 87:1234-1245). The Collaborative Group on Hormonal Factors presented data on over 58,000 women with breast cancer and over 95,000 controls and found that the risk of breast cancer increases by 7% for every unit of alcohol consumed per day. Cigarette smoking had no significant effect on risk.

June 2003: Fifth annual meeting of the Million Women Study collaborators

The fifth annual meeting of the Million Women Study collaborators will take place on June 16th 2003, from 11.00am to 3.30pm, at 44 Lincoln’s Inn Fields, in London. There will be talks about the progress of the study, and some recent findings from the Million Women Study will be presented. Topics will include breast cancer, family history, cervix cancer, alcohol and tobacco.

There is an invitation and acceptance form attached to this newsletter. We very much hope that you can make it to London for the meeting.


Newsletter - October 2002

US trial of HRT terminated early

Part of the Women’s Health Initiative, the largest randomized trial of hormone replacement therapy ever conducted, was stopped prematurely in July 2002 (Writing Group for the Women’s Health Initiative Investigators, JAMA 2002; 288: 321-333). The main reason reported for stopping was that the trial showed more harm than benefit with use of combined oestrogen plus progestagen HRT. Women randomised to HRT experienced significantly higher rates of breast cancer, coronary heart disease, stroke and thrombosis and significantly lower rates of colorectal cancer and hip fracture than women randomised to placebo; however, the harmful effects outweighed the beneficial ones. A recent review of the evidence on HRT from randomised trials to date finds an overall increase in breast cancer, stroke and pulmonary embolism in users which is not offset by reductions in colorectal cancer and hip fracture, (Beral V, Banks E, Reeves G. Lancet 2002; 360: 942-44).

These findings highlight the importance of studies like the Million Women Study in addressing unanswered questions, especially those relating to the effect of the different types of HRT on various health outcomes, the effect of HRT on the risk of death from various causes and on the risk of rarer conditions, such as cancer of the ovary.

Cervix cancer

The Million Women Study is expanding to include the investigation of factors affecting the risk of a woman having an abnormal cervical smear and her risk of cervix cancer. Factors to be examined include reproductive factors, lifestyle and use of hormones such as the oral contraceptive pill and HRT.

The next Million Women Study Collaborators’ Meeting: a date for your diaries

The next Million Women Study Collaborators’ meeting will take place on the 16th June 2003 at Lincoln’s Inn Fields, London. Invitations to the meeting will be sent out closer to the time.

New web address

The Million Women Study has a new web address which is considerably easier to remember than the last one! Go to:
www.millionwomenstudy.org

for the latest information on the study.
MRC logo

New publications

There are two new publications from the Million Women Study; the first indicates women who attend breast cancer screening come from less deprived areas and are more likely to use HRT than non-attenders, but are similar in terms of use of other prescription medications. The second paper investigates the factors relating to the risk of a “false positive” breast cancer screen and demonstrates the importance of a woman’s screening history, menopausal status and previous breast operations in influencing this risk. The references are as follows:

Comparison of various characteristics of women who do and do not attend for breast cancer screening. Banks E, Beral V, Cameron R, Hogg A, Langley N, Barnes I, Bull D, Reeves G, English R, Taylor S, Elliman J, Harris CL. Breast Cancer Research 2002;4 (1):R1.1-R1.6

Predictors of outcome of mammography in the National Health Service Breast Screening Programme. Banks E, Reeves G, Beral V, Bull D, Crossley B, Simmonds M, Hilton E, Bailey S, Barrett N, Rockall L, Wallis MG, Wilson M. Journal of Medical Screening 2002; 9 (2): 74-82


Newsletter - August 2001

Study shows women are accurate in reporting use of HRT and treatment for various illnesses

For women taking part in the Million Women Study, details regarding their use of HRT come directly from the answers they give on their questionnaires. In order to investigate how accurately women report use of HRT, a study of 570 women participating in the Million Women Study was conducted at two general practices in Swindon and Witney. The study compared what women had written on their questionnaires with the medications that they had been prescribed. The results show that women are extremely accurate in reporting their use of HRT, with agreement of over 95% between questionnaire and prescription record data for current use of HRT, ever use of HRT and type of HRT (oestrogen alone, combined oestrogen/ progestogen). Women’s reports of receiving treatment for conditions such as hypertension, diabetes, thyroid disease and asthma also showed excellent agreement with prescription of medication for these conditions. These results mean that data from the Million Women Study questionnaires provide a solid basis for looking at the effects of use of HRT on health.

Recruitment is complete

Recruitment for the Million Women Study is now complete and staff at the co-ordinating centre estimate that the total number of women taking part is 1.3 million. This means that over one quarter of women in the UK aged 50-64 is taking part in the study and it is now officially the largest study of its kind in the world. Staff at the co-ordinating centre are busy entering the 13 tonnes of questionnaires into the Million Women Study database- so far, 900,000 questionnaires have been scanned and entered.

October 2001: fourth annual meeting of the Million Women Study collaborators

The fourth annual meeting of the Million Women Study collaborators will take place on October 15th 2001, from 11.00am to 3.30pm, at 44 Lincoln’s Inn Fields, in London. There will be talks about the progress of the study, and some recent findings from the Million Women Study will be presented. Topics will include the treatment and experiences of women with breast cancer, endogenous hormone levels and the risk of breast cancer, characteristics of users of HRT and diet in the Million Women Study. There is an invitation and acceptance form attached to this newsletter. We very much hope that you can make it to London for the meeting.

University of Oxford

The Million Women Study is expanding!

The main focus of the Million Women Study is investigating the relationship between use of hormone replacement therapy (HRT) and the risk of breast cancer. We are pleased to announce that the study has recently received extra support from the Medical Research Council to expand the scope of the study to examine the relationship between the use of HRT and conditions such as fractures, heart disease, stroke and venous thrombosis (blood clots). This expansion means the study will be able to provide important information about the overall risks and benefits of HRT.


Newsletter - February 2001

ONE MILLION WOMEN RECRUITED!

The Million Women Study has recruited one million women! 1 in 4 women in the UK aged 50 to 64 are now involved, making the Million Women Study the largest ever study of women’s health. The news was welcomed by the study’s principal investigator, Professor Valerie Beral, who said “No one has studied the health of 1,000,000 women in this way before, but thanks to the enthusiasm of women throughout the country, it will now be possible to answer many important questions surrounding hormone replacement therapy and women’s health.” Principal investigator Dr Emily Banks added “This great achievement would not have been possible without the efforts of breast cancer screening staff throughout the UK. It really is fantastic to think that centres recruited women into the largest cohort study of women’s health in the world at the same time as providing a first class screening service. Congratulations are due to everyone involved.”

University of Oxford Logo

Study progress

Recruitment of women into the study has finished at most screening centre and 750,000 recruitment questionnaires have now been scanned into the Million Women Study database. Many women are now receiving a yellow follow-up questionnaire to allow the study to keep track of their health, to update information about HRT and other factors, and to ask new questions about factors such as diet. Women who report a diagnosis of breast cancer will also receive a supplementary questionnaire asking them for details such as how the tumour was found, any treatment they have had, current symptoms and more details about hormone use and family history.

Report from the 3rd collaborators’ meeting

The third Million Women Study collaborators’ meeting was held on October 16th 2000 at Lincoln’s Inn Fields, London. The meeting was opened by Judith Church, MP and chaired by Julietta Patnick and Martin Vessey. Certificates were presented to screening centres which have completed recruitment. Presentations included talk on MWS progress and disease incidence (Valerie Beral), the effect of hormone replacement therapy (HRT) on recall rates in the NHSBSP (Emily Banks), effect of HRT on incidence of fractures (Isobel Barnes), diet and HRT use (Elizabeth Spencer) and preliminary results on breast cancers (Valerie Beral).

Judith Church visits Million Women Study co-ordinating centre

Judith Church MP, secretary of the All-Party Parliamentary Group on Breast Cancer, and a keen supporter of the Million Women Study, visited the Million Women Study co-ordinating centre in Oxford in October to see for herself the scale of the operation.

MWS online

The Million Women Study web site is receiving about 300 hits a month. You can visit the web site at: http://www.icnet.uk/research/studies/mws/ for latest news and copies of all Million Women Study newsletters.

Collaboration with Cancer Registries

The Million Women Study has begun collaboration with regional cancer registries to allow timely follow-up of participants for cancer. In particular, this collaboration will allow follow-up of recruits for interval breast cancers following breast screening in order to investigate the relationship between hormone replacement therapy and interval cancer.


Newsletter - July 2000

MILLION WOMEN STUDYONLINE!
Web site

The Million Women Study is now online and can be found at the following web site:

http://www.icnet.uk/research/studies/mws/

The site begins with general information about the study, and then goes on to outline the study aims and methods. You can view the first questionnaire that was sent out, and also the second update questionnaire. There is a section on information for participants, which includes answers to some of the most commonly asked questions about the study. There is information on study progress, with some early findings, and links to papers published so far and past newsletters. The next section gives details of those involved in the Million Women Study. Finally, there are links to other relevant web sites and a contact address for the study.

Please log on to the web site and have a look!

Lavinia Walker

Recruitment nearly finished

Many centres have finished sending out questionnaires and most others will finish within the next year. The study is currently on time and on target; this is thanks to the efforts of all collaborators, study staff and to women who completed a questionnaire.

Update on follow-up

The yellow follow-up questionnaire is currently being sent out from the Million Women Study co-ordinating centre in Oxford. A copy of this questionnaire was included with the last newsletter. If you would like to view this questionnaire online then please log on to the Million Women Study web site. The site also contains further information on the follow-up.

Breast Cancers

The annual Million Women Study follow-up through screening centres is now underway. Moya Simmonds, Elizabeth Hilton and Barbara Crossley have been visiting collaborating screening centres to gather information on breast cancers diagnosed in study participants. High quality data on over 2,000 breast cancers has been obtained to date, including information on tumour size, type, grade, invasive status and lymph nodes. Results based on these 2,000 cancers will be presented at the annual collaborators’ meeting in October (see below). Thanks are due to all screening centre staff for their fantastic ongoing co-operation in collecting this important data.

October 2000: third annual meeting of the Million Women Study collaborators.

The third annual meeting of the Million Women Study collaborators will take place on Monday the 16th of October 2000, from 11.00am to 3.30pm, at Lincoln’s Inn Fields, in London. There will be talks about the progress of the study, and some preliminary results from the Million Women Study will be presented. Topics will include breast cancer, diet, fractures and recall at screening. There will also be the opportunity for collaborators to discuss the study and to provide their input.

There is an invitation and acceptance form attached to this newsletter. We very much hope that you can make it to London for the meeting.


Newsletter - November 1999

Recruitment on target

Thanks to the superb efforts of breast screening centre staff and the outstanding participation of women throughout the UK, the Million Women Study will reach its target early in the next millennium.

Alison Clements

Report from the second Collaborators’ Meeting

The second Million Women Study Collaborators’ Meeting was held on Wednesday the 26th of May at Lincoln’s Inn Fields, London. It was opened by Judith Church, MP, who is secretary of the All-Party Parliamentary Group on Breast Cancer. She expressed her enthusiasm for the study and her gratitude to all of the collaborators for their contribution to it.The meeting was chaired by Julietta Patnick, Joan Austoker and Martin Vessey. The programme included presentations about the progress of the study (Valerie Beral and Emily Banks), the history of HRT (Emily Banks), factors affecting survival in breast cancer (Gillian Reeves) and clinical trials of hormone replacement therapy use (Madge Vickers).

Delegates to the meeting requested feedback from the Million Women Study regarding use of HRT and other questionnaire data from their centre.

Feedback

Enclosed with this newsletter is some feedback regarding study participants at individual centres, based on the data processed to date. Of the 401,028 women entered, 48% had used HRT at some time, with 32% being current users. There was not a huge amount of variation between centres, with a range of 38% – 56% for having ever used HRT, and 25% – 40% for current use of HRT.

Other statistics on factors such as hysterectomy and past oral contraceptive use are included, and if you would like to know which number represents your centre then please phone Becky Cameron on 01865 302223.

First publication from the Million Women Study

The first paper from the Million Women Study has now been published (a copy is enclosed with this newsletter). It describes the design and methods of the Million Women Study and the characteristics of the first 121,000 women recruited.

Follow-up questionnaire

A yellow follow-up questionnaire has now been designed and will be sent out from the Million Women Study co-ordinating centre in Oxford. Participants will receive the questionnaire 2-3 years after recruitment. It will be used to ascertain changes in use of HRT, and to provide information on new illnesses diagnosed since screening. The questionnaire will also give other information on participants such as early life events, diet, vitamin use and more detailed family history. The final version has been included with this newsletter.

Follow up

Follow-up is proceeding very well and the co-ordinating centre now has information on over 1500 screen-detected breast cancers in participants. The quality of the data is very high and thanks to all collaborators who provided this information.


Newsletter - February 1999

Over 500,000 women recruited into the Million Women Study to date

Thanks to the efforts of breast screening centre staff and the enthusiasm of women throughout the UK, recruitment for the Million Women Study passed the 500,000 mark in November 1998.

“This really is a cause for celebration. The Million Women Study is now the biggest and most representative study of women in the screening age group in the world.” said Professor Valerie Beral. “The Million Women Study will soon be able to address so many of the outstanding questions about HRT and women’s health. The scale of this study and the level of co-operation shows just how important women think these issues are.”

Meanwhile, the Million Women Study Co-ordinating Centre staff would like to point out that 500,000 questionnaires amounts to 5 tonnes of paper!

Deb Burford

HERS study shows no cardiovascular benefit of HRT use

A randomised trial published in the Journal of the American Medical Association in August 1998 showed that HRT does not prevent further heart attacks in women who already have established heart disease. It also showed an excess of blood clots and gallbladder disease in women randomised to receive HRT.

May 1999: second annual meeting of Million Women Study collaborators

The second annual meeting of collaborators will be held on the 26th of May, 1999 at Lincoln’s Inn Fields, in London. There will be talks about the progress of the study, the history of HRT and factors affecting survival in women with breast cancer. It will be a chance for all participating staff to discuss the study and any suggestions are welcomed. There is an invitation and acceptance form attached to this newsletter. We very much hope that you can make it to London for the meeting.

Follow up

The follow-up for breast cancers diagnosed in women screened during the 1997/98 screening year is now underway. Participating centres can expect a visit from Million Women Study staff to obtain details about breast cancers diagnosed in study participants. So far, the follow-up has been running smoothly and once again, the quality of breast screening data has been excellent.

Desperately seeking oestrogen receptors

In addition to obtaining the usual follow-up information about breast cancers diagnosed at screening in Million Women Study participants, study staff will also be seeking information about the oestrogen receptor status of these cancers. This information should help to clarify if HRT has any effect on this important prognostic factor. If any breast screening centre staff know the best way to obtain this information on the cancers diagnosed at their centre, could they please contact their Million Women Study liaison person.

Publications from the Million Women Study

The study team has almost finished drafting a report describing the design of the study and the characteristics of the first 120,000 women recruited. It will soon be circulated to study collaborators for comments, prior to submission to a peer-reviewed journal.


Newsletter - June 1998

Report from the first Collaborators’ Meeting

The Million Women Study Collaborators’ Meeting was held on Wednesday the 20th of May at St Catherine’s College, Oxford, and was attended by over 120 delegates from breast screening centres, as well as quality assurance representatives and others. The meeting was chaired by Martin Vessey and Joan Austoker. The programme included presentations about HRT and breast cancer (Gillian Reeves), characteristics of HRT users and the effect of HRT on recall at breast screening (Emily Banks), risks and benefits of HRT (Valerie Beral) and treatment of breast cancer (Richard Peto). A copy of some of the information from the meeting is attached.

There were fruitful discussion sessions with participants and points raised included:

Future Collaborators’ Meetings

The plan is to hold a meeting of collaborators every year to present results and discuss progress, as well as discussing any issues relevant to collaborators. The next meeting is planned for May/June 1999, and will probably be held in London.

The staff at the Million Women Study co-ordinating centre would like to thank all of the collaborators and other delegates who attended the meeting, for making it such a success. The points raised by the delegates and the questions asked will add to the quality of the study. We hope you enjoyed the day as much as we did! We also thank all screening centre staff for their ongoing participation in the study. If any collaborators have any other suggestions or comments they would like to make about any aspect of the study, please call the freephone number 0800 262 872 or speak to your study liaison staff.

Completing recruitment

Women should receive the Million Women Study questionnaire sent out at breast screening once only, so recruitment should take place over a full screening cycle (usually 2-3 years, depending on the centre). A number of centres are reaching the end of their screening cycle and are therefore about to complete the recruitment phase of the Million Women Study.

After the recruitment phase, centres will continue to be involved in the collaboration, follow-up of participants, and discussing results, participating in meetings, etc.

Follow-up for breast cancer and data quality
Faith Martin

Follow-up for the Million Women Study involves staff from the co-ordinating centre visiting each breast screening centre and matching up the names of women participating in the study with those diagnosed with breast cancer at screening. The follow-up of women recruited during the 1996/1997 screening year has been completed at many centres. A total of 47,040 women have been followed up, and 201 cancers were detected at screening in these women. One of the women diagnosed with cancer refused any form of investigation or intervention. Of the remaining 200 there was 100% reporting of tumour type, 100% reporting of invasive status and 100% reporting of size. Of the invasive tumours detected, 98% stated the grade of the tumour and 78% reported that axillary nodes had been examined histologically. 18% of these had positive nodes. Collaborators at the meeting said the percentage reporting histological examination of lymph nodes is likely to reflect surgical practice and is in keeping with the findings of the BASO audit.

This means that the breast cancer data provided by the breast screening centres for the Million Women Study is very high quality indeed, making future findings regarding breast cancer as reliable as possible.

Publications and reports

The study team will soon be preparing a report describing the Million Women Study design and the characteristics of the first 100,000 women recruited. The draft report will be circulated to collaborating centres to allow comments from collaborators before submission to a peer-reviewed journal.


Newsletter - February 1998

Million Women Study meeting: May 20th, in Oxford

A meeting for collaborators will take place on the 20th of May 1998, at St Catherine’s College in Oxford. There will be talks about HRT and breast cancer as well as an update on the progress of the study, with time for discussion of any issues participants would like to raise. An invitation to attend this meeting is included with this newsletter- We hope you can come.

Collaborative paper confirms HRT and breast cancer link

The largest ever analysis of the relationship between HRT and breast cancer was published in the Lancet on the 11th of October and confirmed the previously suspected link between HRT and breast cancer. A copy of that report is enclosed. The study was a collaboration which pooled over 90% of the world-wide studies of HRT and breast cancer, and was based on evidence from 52,705 women with breast cancer and 108,411 women without breast cancer. It showed that women who are currently taking HRT have a 2.3% increase in their risk of breast cancer with every year of use, but that the effect is reduced as soon as HRT is stopped and has largely, if not wholly disappeared after about 5 years. The breast cancers in women taking HRT were found to be less advanced than those found in women not taking HRT.

While this study has answered many questions about the relationship between HRT and breast cancer, many important questions remain. Most of the studies in the collaborative group report were on oestrogen-only types of HRT (such as Premarin), whereas the majority of women in the UK are using combined oestrogen and progestagen HRT (such as Prempak C and Trisequens). As yet there is not enough information on these types of HRT to know their effect on breast cancer risk. The Million Women Study should more than triple the total world-wide evidence on combined types of HRT and should also help to clarify why the cancers in women taking HRT are less advanced than those in women not taking HRT. It will also be able to provide much needed information on how HRT affects breast screening itself.

Progress: Recruitment continues, Scotland comes on board.

The Million Women Study questionnaire is now being sent out by over 55 breast screening centres and the study has received ethical approval from over 120 ethics committees nation-wide. There are now many centres in Scotland participating, with East Scotland, South West, South East, North and North East Scotland all taking part. Thanks to centres throughout the UK, over 280,000 questionnaires have been received in Oxford and the study is on target to recruit 1,000,000 women over the next 3 years. The study is now recruiting over 30,000 women per month, one of the fastest rates of recruitment of any study, anywhere in the world.

Joan Austoker

Pilot study results published

The results of the pilot studies prior to the Million Women Study were published in this month’s issue of the Journal of Epidemiology and Community Health (1998;52(2):116-119). The pilot studies involved over 6000 women and showed that the study questionnaire did not affect subsequent breast screening attendance. A reprint of this article is included with this newsletter. Thank you to the participating centres.


Older Newer