Bangkok--25 Jul--สปินเลอร์ แอนด์ แอสโซซิเอทส์
Roche’s new high-risk HPV DNA test helps redefine current screening standards to reduce cervical cancer rates which have not decreased in decades
Leading international women’s health experts, gathered in Hong Kong for the biennial Asia Oceania Research Organization on Genital Infections and Neoplasia (AOGIN) are calling for a review of Asia-specific guidelines for the management of cervical cancer, to reduce the high mortality rates of this preventable disease. Almost 500,000 women worldwide are diagnosed with cervical cancer each year.iHalf of them die from the disease, the majority in Asia.i In addition, Thailand’s 2010 census found that Thai females were diagnosed and died from cervical cancer at an average of 14 persons/day.iiThailand also had the fourth highest death rate from cervical cancer in Southeast Asia.iii
The leading cause of cervical cancer is Human Papillomavirus (HPV) which is responsible for more than 99 percent of allcases.iv,v,viThere are 14 high-risk HPV strains, of which, two strains— HPV 16 and 18 — are the highest risk and cause 70 percent of all cervical cancer cases.vii
Current primary screening programs using the Pap smear, which have been in place for 60years, look for changes in the cells on the cervix rather than HPV; and highly-skilled laboratory technicians are required to accurately interpret the results to identify if a woman has cervical cancer. The latest in diagnostic technology — the high-risk HPV DNA test — detects the presence of HPV in the body and does not require subjective analysis or interpretation.
Guidelines issued by the American Society for Colposcopy and Cervical Pathology (ASCCP), considered to be the benchmark for cervical cancer screening, now recommend co-testing with Pap smear and high-risk HPV testing. Experts in the region are calling for the modernization of screening practices in Asia Pacific to help prevent women here dying unnecessarily from this preventable disease.
Professor Annie Cheung, Co-chair of 2012 AOGIN and Pathologist in Charge in the Cervical Cytology Screening Laboratory at The University of Hong Kong, believes that with adequate resources, skilled laboratory teams and good public health infrastructure that enforces regular screening, Pap smear is successful in reducing the incidence and mortality of cervical cancer — however such resources are currently lacking in many countries in Asia Pacific.
“With the availability of cutting edge diagnostic technology that identifies women most at risk before they develop cervical cancer, we now have the opportunity — and the responsibility — to develop regional guidelines that include high-risk HPV DNA testing to increase sensitivity of cervical cancer screening. The high-risk HPV DNA test is also a good screening option for countries that lack the resource and infrastructure to implement effective Pap testing,” said Professor Cheung.
Cervical cancer remains the second most common cancer among women in many countries in the region and is the third most common cancer among women in the world.iWithout effective screening and prevention programs, rates of cervical cancer in Asia are expected to increase 40 percent by 2025.iThe Roche HPV test is currently the only FDA approved high-risk HPV test that can simultaneously detect HPV 16, HPV 18 and 12 other high-risk HPV strains in one test.
The ATHENA study, which was the largest US trial for cervical cancer screening and involved 47,000 women, found that women with HPV 16 or 18 are 35 times more likely to develop cervical pre-cancer than those without the virus.viii,ix
HPV 16 and 18 testing stratifies women based on their risk of developing cervical pre-cancer so doctors can provide a more appropriate management approach. Women without high-risk HPV are deemed safe and do not need to return for testing for 3-5 years.
Associate Professor WichaiTermrungruanglert, Director of Gynecologic Oncology Division, Department of Obstetrics and Gynecology, Faculty of Medicine at Chulalongkorn University believes that high-risk HPV testing is critical in reducing the incidence of cervical cancer in the region.
“Testing for high-risk HPV — especially HPV 16 and 18 — represents a new era in cervical cancer detection and prevention. The new cervical screening guidelines released by ASCCP earlier this year recommended the addition of high-risk HPV DNA testing for women 30 years and above, rather than using Pap smear alone. These changes aim to better protect women from developing cervical cancer and allow for longer intervals between screening which reduces overall healthcare costs,” said Associate Professor Wichai.
The ATHENA study also found that one in 10 women who tested positive for HPV 16 or 18 using the Roche HPV Test, had cervical pre-cancer even though their Pap smear results were normal.x
Tamika Felder, founder of US-based cervical cancer support group Tamika and Friends, was diagnosed with cervical cancer at age 25 and underwent a radical hysterectomy, radiation therapy and chemotherapy which saved her life but left her unable to have children.
“Before I was diagnosed, I had no signs or symptoms and was stunned and terrified when I was told I had cervical cancer. I know I was lucky to win my battle with the disease, but I am determined to see a day when no woman has to go through the same experience as me. Cervical cancer is a preventable disease. Every woman needs to know the link between HPV and cervical cancer and take control of their own health by going for screening,” said Ms Felder.
Unfortunately Tamika’s experience is not unique — HPV affects up-to 75 percent of women at some point in their life; however women generally don’t have symptoms of an infection, making regular testing for high-risk HPV — specifically HPV 16 and 18 — even more critical. If detected early and treated in the pre-cancer stage, 98 percent of cases can be cured, however once the disease has developed into cancer and spread to other organs, only one in five women survive past five years.xi
Reinforcing the need for updated screening guidelines was the announcement of the ‘new frontier’ in cervical cancer diagnosis which is set to revolutionize cervical cancer prevention and management when it launches in 2013. According to the updated ASCCP screening guidelines, women with normal Pap and high-risk HPV but not HPV 16 or 18 are sent home for ‘watchful waiting’ and tested again in one year’s time. The new test which complements the high-risk HPV test uses biomarkers P16 and Ki67 to objectively determine whether these women need to be sent immediately for colposcopy, reducing anxiety and helping to ensure that pre-cancer cases are caught in time.
Dr Christoph Majewski, Lifecycle Leader HPV and Microbiology of Roche Diagnostics, believes this new, holistic cervical cancer testing solution is a significant step forward in eradicating the disease.
“Roche Diagnostics is redefining the standard of care for cervical cancer testing. In addition to our high-risk HPV test which can identify HPV 16 and 18, along with 12 other high-risk HPV strains, Roche has recently acquired a highly differentiated test for diagnosing cervical cancer, using the novel p16 marker,” said Dr Majewski.
The new p16 test can provide peace of mind by eliminating watchful waiting and provide a safety net to maximize the cure rate for cervical pre-cancer. The launch of this new test means it is more important than ever for experts in the region to define the optimum standard for screening, diagnosing and treating cervical cancer,” concluded Dr Majewski.
About Roche
Headquartered in Basel, Switzerland, Roche is a leader in research-focused healthcare with combined strengths in pharmaceuticals and diagnostics. Roche is the world’s largest biotech company with truly differentiated medicines in oncology, virology, inflammation, metabolism and CNS. Roche is also the world leader in in-vitro diagnostics, tissue-based cancer diagnostics and a pioneer in diabetes management. Roche’s personalized healthcare strategy aims at providing medicines and diagnostic tools that enable tangible improvements in the health, quality of life and survival of patients. In 2011, Roche had over 80,000 employees worldwide and invested over 8 billion Swiss francs in R&D. The Group posted sales of 42.5 billion Swiss francs. Genentech, United States, is a wholly owned member of the Roche Group. Roche has a majority stake in Chugai Pharmaceutical, Japan. For more information: www.roche.com.
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i) Ferlay J et al. GLOBOCAN 2008 Cancer Incidence and Mortality Worldwide. IARC CancerBase No10; Lyon, France 2010
ii) IARC, Globocan 2008.
iii) WHO/ICO Information Centre on HPV and Cervical Cancer, Thailand Human Papillomavirus and Related Cancer Factsheet 2010 (Sep 15, 2010)
iv) Burd, Eileen M. Human Papillomavirus and Cervical Cancer. Clinical Microbiology Reviews. 2003; 16:1-17
v) Walboomers, Jan M.M., Marcel V. Jacobs, M. Michele Manos, et al. Human Papillomavirus is a Necessary Cause of Invasive Cervical Cancer Worldwide. Journal of Pathology. 1999; 189:12-19
vi) zurHausen, H. Papillomavirus and Cancer: From Basic Studies to Clinical Applications. Nat Rev Cancer. 2002; 2(5): 342-50
vii) Bosch FX, et al. J Natl Cancer InstMonogr2003; 31:3-13.
viii) Stoler M, et al.cobas 4800 HPV Test Performance for ?CIN2 and ?CIN3 detection in women with ASC-US: ATHENA results. 26th International Papillomavirus Conference. Montr?al, Canada, July 3—8, 2010; P-417.
ix) Wright T, et al. 26th IPV Conference. Montr?al, Canada, July 3—8, 2010. Abstract O-506.
x) Stoler, M, et al. (2011) ‘High-Risk Human Papillomavirus Testing in Women With ASC-US Cytology. Results From the ATHENA HPV Study’ Am J ClinPathol no.135 pp468-475
xi) Cancer Research UK. Cervical cancer statistics and outlook, available at http://www.cancerhelp.org.uk/type/cervical-cancer/treatment/cervical-cancer-statistics-and-outlook, last accessed 15 June 2011
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