Results from a study of more than 90,000 Italian women published by the Lancet Oncology found that testing for high-risk types of the human papillomavirus (HPV) DNA is significantly more effective in preventing invasive cervical cancer than cytology (Pap testing) alone. The trial used QIAGEN's digene® HPV Test (also known as the digene® HC2 HPV DNA Test), which detects the high-risk types of HPV that can cause cervical cancer.
The New Technologies for Cervical Cancer (NTCC) study assessed the benefits and risks of shifting to HPV testing from standard cytology (Pap testing) in cervical cancer screening programs to increase effectiveness in preventing invasive cervical cancer.
"Our study is the first, to our knowledge, to show a greater efficacy for HPV testing versus cytology for preventing invasive cancers in a developed country, where cytological screening has been in place for years and advanced cervical cancers are extremely rare among screened women," wrote study author Guglielmo Ronco and colleagues in the Unit for Cancer Epidemiology, Centro per la Prevenzione Oncologica in Turin, Italy. The NTCC study was conducted within organized screening programs with more than 70% of eligible women enrolled, which, according to study authors, suggests that "results are applicable to routine practice." The study was released online in advance of publication on the Lancet Oncology Website.
The two-phase, randomized trial showed "a significantly lower number of cases in the HPV group versus the cytology group over the two screening rounds, indicating that the HPV-based screening is more effective than cytology in preventing cervical cancer," wrote the study authors, who attributed the higher efficacy of HPV DNA testing to its earlier detection of clinically relevant lesions, which allowed for earlier treatment of precancers and prevention of invasive cancer. "For women aged 35 years or more, our results support the use of HPV DNA testing for primary screening at prolonged intervals, with cytology reserved for triage of HPV-positive women."
"This study clearly demonstrates that a decrease in advanced cervical cancer is achievable - and hence lives saved - when HPV screening using the digene HPV Test is implemented, regardless of the region and level of cervical cancer prevention program in place," said Peer Schatz, CEO of QIAGEN. "With cervical cancer prevention programs under evaluation by health ministries and government agencies across Europe and around the world to assess the most cost-effective strategies to protect women, this study could have significant implications. With our digene HPV test approved in the U.S. and Europe, and our careHPV test in development for use specifically in the developing world, we believe that regionally tailored cervical cancer prevention strategies that include HPV DNA testing can efficiently save millions of women's lives."
The NTCC study, which shows the ability of HPV testing to reduce invasive cervical cancer in an industrialized setting, complements an April 2009 study published in the New England Journal of Medicine demonstrating that in low-resource settings in rural India a single round of HPV testing significantly reduced the numbers of advanced cervical cancers and deaths, compared with other screening methods. Numerous studies of HPV testing have focused on clinical efficacy data and the high sensitivity of HPV testing to detection cervical lesions and cancers, while the NEJM and Lancet Oncology studies importantly show an actual reduction in the incidence of invasive cervical cancer.
NTCC Study Design and Results
In the NTCC study, two rounds of screening were performed in more than 90,000 women age 25-60. In phase one, women were randomly assigned to a control group with conventional cytology (Pap) only or to an intervention group where women had HPV DNA testing plus liquid-based cytology. In phase two, which was conducted two years later, with three to five years of follow-up, the control group received conventional cytology and the women in the intervention group received HPV testing alone.