Another Australian first in the fight against cervical cancer a new vaccine

Another Australian first in the fight against cervical cancer: new vaccine for women 27-45 years.

In addition, new research finds an estimated one million Australian women have had an abnormal Pap smear at some time in their life.

For the first time Australian women aged 27-45 years can have access to a vaccine to help prevent cervical cancer(1,2). The new vaccine Cervarix* is now available for women aged 27-45 years. These women are not covered by the current Australian Government Cervical Cancer Vaccination Program.

Cervarix is approved by the Therapeutic Goods Administration (TGA) for women aged 10-45 years for the prevention of cervical cancer, precancerous lesions and cervical abnormalities caused by Human Papillomavirus (HPV) types 16/18. Types 16/18 are responsible for more than 70 percent of cervical cancers worldwide(1,3).

Professor Michael Quinn, Director of Gynaecological Oncology at Royal Women's Hospital Melbourne said "This is important news for older women up to the age of 45 years because sexually active women can remain at risk of HPV, the main cause of cervical cancer and abnormal Pap smears, throughout their lifetime(4-8)."

Cervical cancer and cervical abnormalities can have a large impact on our society. Each year approximately 30,000 Australian women are diagnosed with a cervical abnormality (abnormal Pap smear) and around half of these women face the anxiety and trauma of surgery to treat the abnormality(9,10). Despite the success of the National Cervical Screening Program, 700 Australian women are diagnosed with cervical cancer each year and sadly each week about four Australian women lose their lives from this disease(9).

HPV can have an impact on women of all ages, not just young women. The Australian Institute of Health and Welfare (AIHW) reports women aged 25-29 years have the highest incidence of severe (high-grade) abnormal Pap smears in Australia and the majority (two-thirds) of women who require surgical treatment each year are aged 25-44 years(9).

Dr Rachel Skinner, a principal investigator for Cervarix effectiveness studies with the Vaccine Trials Group of the Telethon Institute and the University of Western Australia said "There are many different types of HPV3. A woman may not have been exposed to the HPV types most commonly associated with cervical cancer, HPV 16 or HPV 183 in which case vaccination may protect her from the development of cervical abnormalities or cervical cancer."

To coincide with the launch of Cervarix, GSK has released new research(11) conducted with 5,000 Australian women (aged 18-45 years) uncovering current insights about cervical cancer, HPV, Pap smears and HPV vaccination.

Human Papillomavirus Vaccine Types16and18(Recombinant,AS04adjuvanted)
*Human Papillomavirus (HPV) Vaccine Types 16/18
(Recombinant, AS04 adjuvanted)

Results reveal that more than one-in-four women surveyed - or an estimated one million Australian women - reported having an abnormal Pap smear result at some time in their life(11). This illustrates just how common abnormal Pap smears are.

"In addition to their regular Pap smears, vaccination may not only help provide Australian women with further protection against cervical cancer but they may also benefit from a reduction in abnormal Pap smears and follow-up treatments," said Dr Skinner.

Of the women surveyed, eight-in-10 are concerned about developing cervical cancer and one-in-four (28 percent) mistakenly believe an abnormal Pap smear result automatically means cervical cancer(10).

Professor Quinn says women commonly suffer a high level of anxiety at the news of an abnormal Pap smear.
"The psychological impact of this can be distressing due to a lack of understanding of what a cervical abnormality means and the fear of developing cervical cancer(12,13). I believe further education is needed and healthcare professionals should encourage women to talk openly about these issues to facilitate greater support and knowledge," said Professor Quinn.

Cervarix, based on work of the 2006 Australian of the Year Professor Ian Frazer, has undergone extensive clinical studies involving 40,000 women around the world, including Australia1. Cervarix has been specifically designed to prevent cervical cancer and protects against the two HPV types most commonly associated with cervical cancer, HPV types 16/18, that cause 70 percent of cervical cancers worldwide(1,3).

Clinical studies for Cervarix demonstrate it is generally well-tolerated(1,14). The most common reactions observed after vaccine administration were injection site reactions including pain, redness, swelling and general symptoms such as fatigue(1).

Cervarix is not intended for the treatment of HPV infections or cervical lesions present at the time of vaccination or to prevent the progression of established lesions. Cervarix may not prevent HPV infection and related clinical outcomes due to other cancer-causing HPV types(1).

Women should seek advice from their doctor to discuss the suitability of Cervarix for them.

It is important to note that regular Pap smears are still required for women who choose vaccination as the vaccine does not provide complete protection against all cervical cancer(1).

Cervarix is available from General Practitioners (GPs) and is priced at around $150 per dose. Cervarix is administered in three separate doses over a period of six months(1).

For more information on cervical cancer vaccination, women can visit www.AWomansWord.com.au .

Human Papillomavirus Vaccine Types16and18(Recombinant,AS04adjuvanted)
Human Papillomavirus Vaccine Types16and18(Recombinant,AS04adjuvanted)

Support for women:

Women seeking support for their gynaecological health condition can contact the Gynaecological Awareness Information Network (GAIN) - a not-for-profit organisation driving awareness and education on gynaecological health matters. Visit www.gain.org.au .

About GlaxoSmithKline
GlaxoSmithKline is one of the world's leading vaccine manufacturers. GSK employs more than 1,500 scientists who are devoted to discovering new vaccines and developing more cost-effective and convenient combination products to prevent infections that cause serious medical problems worldwide.
In 2006, GSK distributed more than 1.1 billion doses of vaccines to 169 countries in both the developed and the developing world - an average of 3 million doses a day.
Of those vaccine doses, approximately 136 million were doses of combination paediatric vaccines which protect the world's children from up to six diseases in one vaccine.
GSK is committed to improving the quality of human life by enabling people to do more, feel better and live longer.
References

1. Approved Cervarix Product Information - May 2007.

2. Approved Gardasil Product Information

3. Munoz N et al. Against which human papillomavirus types shall we vaccinate and screen? The international perspective. Int J Cancer 2004;111(2):278-85.

4. Baseman J, Koutsky L, The epidemiology of human papillomavirus infections, J Clin Virol 2005; 32S: S16-24

5. Herrero et al. Population-Based Study of Human Papillomavirus Infection and Cervical Neoplasia in Rural Costa Rica. J of Natl Cancer Inst 2000; 92(6):464-474

6. Franco et al. Epidemiology of Acquisition and clearance of cervical human papillomavirus infection in women from a high risk area for cervical cancer. J Infect Dis 1999; 180:1415-23

7. Sellors et al. Incidence, clearance and predictors of human papillomavirus in women. CMAJ . 2003 ; 168(4) : 421-5

8. Schiffman & Kruger Kjaer, Chapter 2: Natural History of Anogenital Human Papillomavirus Infection and Neoplasia J Natl Cancer Inst Monogr 2003; 31: 14-9

9. Australian Institute of Health and Welfare, Cervical screening in Australia 2003-2004, AIHW Canberra, August 2006

10. National Health & Medical Research Council (NH&MRC): Australian Government, Screening to prevent cervical cancer: guidelines for management of asymptomatic women with screen detected abnormalities, Commonwealth of Australia, 2005.

11. National consumer research conducted by Stollznow Research in July 2007 with 5,075 Australian women between the ages of 18 and 45 years via an online panel survey on behalf of GlaxoSmithKline Australia

12. Bell et al, Psychological response to cervical screening, Prevent Med 1995; 24: 610-16.

13. Basen-Engquist et al, Cervical cancer- Behavioural factors related to screening, diagnosis and survivor's quality of life, Cancer 2003; 98 (9 Suppl); 2009-2014

14. Paavonen J, Jenkins D, Bosch XF, Efficacy of a prophylactic adjuvanted bivalent L1 virus-like-particle vaccine against infection with human papillomavirus types 16/18 in young women: an interim analysis of a phase III double-blind, randomised controlled trial Lancet 2007

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