The findings from a clinical trial, TOMBOLA (Trial of Management of Borderline and Other Low-Grade Abnormal Smears), showed that 70 per cent of women testing positive for HPV after a low grade smear did not develop cancer during the three year trial.
Each year millions of women in the UK have a smear test as part of the Cervical Screening Programme. Six in every 100 women will have a cervical smear that shows minor cell changes in the cervix, referred to as ‘borderline’ or ‘mild’. The MRC research found that it is difficult to distinguish between the small minority of women who have minor cell changes which might progress to cancer from the great majority of women who have minor cell changes who will not develop cancer.
In the three year trial, over 4,000 women who had initial smear tests which were classified as ‘borderline’ or ‘mild’ were tested for HPV. 1,755 women (43.5 per cent) had a positive HPV test. Yet of these women 1,234 (70 per cent) did not develop precancerous disease during the trial.
The TOMBOLA trial also found that a single test for 14 types of HPV strongly associated with a higher risk of cervical cancer did not help decide the best form of follow-up treatment, except perhaps in women over 40 years.
Dr Maggie Cruickshank, of the Department of Obstetrics & Gynaecology at the University of Aberdeen and one of the authors of the study, said: “It has been suggested that testing for HPV as part of the cervical screening programme could be a useful tool to help doctors pinpoint which women are at risk of cancer. But the TOMBOLA trial results show the risk of being diagnosed with cancer following a positive HPV test might be more of a lottery. Of the women who actually needed treatment for precancerous disease over the course of the study, 91 out of 393 (23 per cent) had a negative HPV test at the start of the trial. For younger women, HPV testing after a low grade smear could lead to unnecessary investigations and intervention.”
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The research, “The role of the human papillomavirus testing in the management of women with low-grade abnormalities: multicentre randomised controlled trial” is published in ‘BJOG: International Journal of Obstetrics and Gynaecology’ (18 March 2010).
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• A copy of the paper is available to download from the BJOG website – Cotton S, Sharp L, Little J, Cruickshank M, Seth R, Smart L, Duncan I, Harrild K, Neal K, Waugh N, The TOMBOLA (Trial Of Management of Borderline and Other Low-grade Abnormal smears) Group. The role of human papillomavirus testing in the management of women with low-grade abnormalities: multicentre randomised controlled trial. BJOG 2010; DOI: 10.1111/j.1471-0528.2010.02519.x.
• The BJOG podcast, Should HPV testing be used in the management of low grade abnormalities of the cervix?, featuring Vanessa Harry (Subspecialty Fellow in Gynaecological Oncology St Bartholomew’s Hospital, London), Maggie Cruickshank (Senior Lecturer at the University of Aberdeen), Patrick Walker (Consultant Gynaecologist at the Royal Free Hospital, London) and Amanda Herbert (Consultant in Cytopathology at Guy’s and St Thomas’ Hospital, London) is available at www.yada-yada.co.uk/Blackwell/BJOG/BJOG_2010_final.html
• ‘BJOG: An International Journal of Obstetrics and Gynaecology’ is owned by the Royal College of Obstetricians and Gynaecologists (RCOG) but is editorially independent and published monthly by Wiley-Blackwell. The journal features original, peer-reviewed, high-quality medical research in all areas of obstetrics and gynaecology worldwide.