Safety, immunogenicity, and efficacy of quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine in women aged 24-45 years: a randomised, double-blind trial

Source: The Lancet, Volume 373, Issue 9679, Pages 1949 - 1957, 6 June 2009 Author: Prof Nubia Muñoz MD et al. Background Although the peak incidence of human papillomavirus (HPV) infection occurs in most populations within 5—10 years of first sexual experience, all women remain at risk for acquisition of HPV infections. We tested the safety, immunogenicity, and efficacy of the quadrivalent HPV (types 6, 11, 16, 18) L1 virus-like-particle vaccine in women aged 24—45 years. Methods Women aged 24—45 years with no history of genital warts or cervical disease were enrolled from community health centres, academic health centres, and primary health-care providers into an ongoing multicentre, parallel, randomised, placebo-controlled, double-blind study. Participants were allocated by computer-generated schedule to receive quadrivalent HPV vaccine (n=1911) or placebo (n=1908) at day 1, and months 2 and 6. All study site investigators and personnel, study participants, monitors, and central laboratory personnel were blinded to treatment allocation. Coprimary efficacy endpoints were 6 months' or more duration of infection and cervical and external genital disease due to HPV 6, 11, 16, 18; and due to HPV 16 and 18 alone. Primary efficacy analyses were done in a per-protocol population, but intention-to-treat analyses were also undertaken. This study is registered with ClinicalTrials.gov, number NCT00090220. Findings 1910 women received at least one dose of vaccine and 1907 at least one dose of placebo. In the per-protocol population, efficacy against the first coprimary endpoint (disease or infection related to HPV 6, 11, 16, and 18) was 90·5% (95% [...]

Researchers confirm link between HPV and head and neck cancer but survey shows public ignorance on role of oral sex

Source: Medicalnewstoday.com Author: Olwen Glynn Owen Human papillomavirus (HPV) is an important causative agent in squamous cell cancers of head and neck (HNSCC) a new meta-analysis presented at the American Society of Clinical Oncology (ASCO) confirms; but a separate European survey at the same meeting reveals the public is woefully ignorant about it and possible ways to avoid it. Lack of public awareness about the possible link between HPV-related head and neck cancer and oral sex with multiple partners presents a case for making vaccinations against HPV more widely available to boys as well as girls before they become sexually active, commented leading expert Professor Jean-Louis Lefebvre of Centre Oscar Lambret, Lille, France. Researchers led by Farshid Dayyani at the MD Anderson Cancer Center, Houston, Texas, looked at a total of almost 7000 patients who developed head and neck cancer over the past 20 years to gauge the prevalence of HPV - a possible causative agent. They included studies which had tested for the virus in serum or in tumour tissue by PCR and found almost a quarter of patients (24.2%) had HPV positive tumours. Of these the vast majority (86.8%) were positive for HPV 16, the virus also associated with cervical cancer. Overall, the researchers concluded that being HPV positive increased the risk of developing head and neck cancer by 40 per cent. But being HPV16 positive increased the risk more than fourfold (4.47 times higher) compared to HPV16 negative patients. However, people with HPV-associated head and neck cancer lived [...]

2009-06-19T07:40:26-07:00June, 2009|Oral Cancer News|

‘Poor knowledge’ on cervical cancer

Source: The Press Association Author: Staff More than one in three girls does not know the causes of cervical cancer despite the "Jade Goody effect", a new poll suggests. A total of 38% of girls said they were unaware of the causes even though Goody - a former Big Brother star - raised the profile of the disease. Goody died in March aged 27 after a battle with the cancer, which had spread around her body. Anecdotal evidence from across the NHS suggests the number of women attending cervical screening has shot up as a result of her story. The poll of girls aged 12 to 18 was carried out for GlaxoSmithKline, which makes the Cervarix vaccine to protect against Human papillomavirus (HPV), which causes most cases of cervical cancer. Of the 255 girls questioned, 5% thought "sexual promiscuity" caused cervical cancer. Another 11% said "a type of virus" caused it but only 6% knew the HPV virus did. When the findings were compared with a survey of 139 girls aged 16 to 18 carried out before Goody was diagnosed, 40% said they did not know what caused the disease and 6% pointed to HPV. This could suggest that knowledge about HPV has not increased despite Goody's diagnosis. The more recent survey also found that 40% of girls thought a family history of the disease was a major factor in getting cervical cancer. Girls aged 12 to 13 are currently being vaccinated against HPV as part of an NHS campaign. [...]

2009-06-08T17:11:12-07:00June, 2009|Oral Cancer News|

Samuel Broder: Why Isn’t There a Gardasil for Men?

Source: Health.usnews.com Author: Samuel Broder, M.D. There's an HPV vaccine for women; why don't men have one? Why was the vaccine against the cancer-causing, sexually transmitted HPV virus not approved for men at the same time it was for women? Is there any reason to think that men and women would react to it differently? Interesting question. First, a little background. Gardasil is a genetically engineered vaccine to immunize girls and women ages 9 to 26 against four types of human papillomavirus (HPV). HPV is the name given to a family of viruses, many of which can be transmitted from one partner to another through sexual activity. HPV may represent the most frequent sexually transmitted infection in the United States. It is estimated that over 6 million people become infected by a sexually related form of HPV every year. Some estimates suggest that over half of all sexually active males and females become infected at one point or another in their lifetimes. Certain types of HPV can sometimes evade the body's immune system and, when they do, establish a state of persistent infection. That in turn may cause certain cancers. Indeed, this is now recognized as the major cause of cervical cancer and related conditions, and vaccines that immunize people against HPV could make a dramatic impact against these diseases. Gardasil is the first vaccine in the United States approved for the prevention of cervical cancer and precancerous cell abnormalities in the cervix and also certain precancerous conditions in the [...]

2009-05-19T15:39:45-07:00May, 2009|Oral Cancer News|

Cancers with virus less lethal, study says

Source: Columbus Dispatch (dispatch.com) Author: Misti Crane Oral-cancer patients with tumors that contain human papillomavirus are more likely to survive than those whose cancer does not involve HPV, a study found. The Ohio State Comprehensive Cancer Center doctor who led the new study said future research should focus on the differences between the groups. Dr. Maura Gillison, a medical oncologist and head and neck cancer specialist, shared her findings as part of a preview of studies to be presented at the annual meeting of the American Society of Clinical Oncology in Orlando, Fla., this month. Details of her work were released with a handful of other studies, several of which highlighted an increasing focus on individualized cancer care. Chemotherapy patients are likely to cheer the findings from one of the studies shared yesterday: It found that ginger significantly reduces nausea. A study of patients at 23 private oncology practices compared nausea in those who took a placebo with those who took 0.5-gram, 1-gram and 1.5-gram doses of ginger in capsule form. All of the patients received standard anti-nausea medications. Those who took 0.5-gram or 1-gram doses of ginger reported about a 40 percent reduction in nausea, said lead researcher Julie Ryan of the University of Rochester. The study didn't look at foods or drinks that contain ginger, but Ryan said she suspects ginger in other forms also would be beneficial. She cautioned that some products contain ginger flavoring, not actual dried or fresh ginger. A gram of ground ginger is [...]

ASCO: HPV Infection Linked to Better Outcome in Oropharyngeal Cancer

Source: MedpageToday.com  Author: Michael Smith TORONTO, May 14 -- Patients with oropharyngeal cancer had a 50% lower five-year mortality risk when they also had human papillomavirus (HPV) infection, according to data from a randomized clinical trial. HPV-positive patients had a two-year overall survival of 88% compared with 66% for HPV-negative patients (P<0.001), said Maura Gillison, M.D., of Ohio State University in Columbus. The difference between groups increased with follow-up. HPV infection also was associated with a reduced risk of locoregional recurrence and second cancers, Dr. Gillison reported at a press briefing in advance of the American Society of Clinical Oncology annual meeting. Cancer of the oropharynx arises from two principal causes: chronic use of tobacco and alcohol or HPV infection. Previous studies had suggested that HPV status of a patient's tumor might have prognostic implications. "HPV-positive patients have important associations with other favorable prognostic factors," said Dr. Gillison. "They tend to be younger; they have smaller tumors; they present with better performance status. Therefore, improvement in survival for this patient population may be explained by these factors and not by HPV." To explore the role of HPV status in survival of oropharyngeal cancer, Dr. Gillison and colleagues reviewed data from a randomized clinical trial conducted by the Radiation Therapy Oncology Group. Its principal objective was to compare standard chemotherapy with an investigational regimen. The trial involved 721 patients. Of those, 60% had cancer of the oropharynx and 64% were HPV positive. The two-year results demonstrated a clear survival advantage associated [...]

2009-05-15T16:11:18-07:00May, 2009|Oral Cancer News|

Glaxo’s cervical cancer vaccine faces US battle

Source: Forbes.com Author: Linda A. Johnson New studies show GlaxoSmithKline PLC's vaccine Cervarix blocks the virus that causes cervical cancer, but if it wins approval for U.S. sales, it will face an uphill battle against Gardasil, which has owned the market here for three years. Cervarix, Glaxo's vaccine against human papilloma virus or HPV, already is approved in more than 90 other countries, but has been held up by delays in the United States. Several years ago, the British drugmaker was in a neck-and-neck race with rival Merck & Co., Gardasil's maker, to be first on the U.S. market, but it lost when Gardasil got approved in June 2006. Late in 2007, the Food and Drug Administration declined to approve approve Cervarix. GlaxoSmithKline submitted a new application on March 30 that included final data from an 18,000-woman study recently completed. Final results from that study and two others are being presented this weekend at a conference in Sweden on papillomavirus. FDA is expected to decide whether to approve Cervarix within several months. If it does, analyst Erik Gordon, a professor at the University of Michigan's Ross School of Business, said doctors who have prescribed Gardasil for a few years may see no reason to switch - unless GlaxoSmithKline convinces them its product is much more effective or has fewer side effects. Both vaccines target the two types of HPV that cause about 70 percent of cervical cancers, types 16 and 18, and data indicate both are about 98 percent effective. But Merck also [...]

2009-05-08T18:53:28-07:00May, 2009|Oral Cancer News|

The oral cancer battle

Source: www.ladowntownnews.com Author: Beth Dunham As people look for ways to cut corners and save money in this time of economic uncertainty, healthcare sometimes takes a back seat to other expenses — putting lives at risk. A visit to the dentist is crucial and could mean the difference between life and death; someone in the United States dies of oral cancer nearly every hour, according to the Oral Cancer Foundation. Early detection is crucial in the fight against oral cancer, an aggressive, deadly disease that hasn’t seen the same improvements in survival rates as other cancers, said Parish Sedghizadeh of the USC School of Dentistry. “Oral cancer has one of the highest mortality rates among cancers,” said Sedghizadeh, assistant professor of clinical dentistry at USC. “It’s usually not noticed until the later stages, when a recovery is less likely. People have heard of oral cancer, but they don’t know what it looks like.” The disease rarely causes pain or other noticeable symptoms until it reaches a very advanced stage, he said. And while many people stay vigilant for the symptoms of more common cancers, dental care access challenges and a lack of oral cancer education means that most patients don’t know the early signs of oral cancer. “Oral cancer will often start as a small red or white plaque or sore that doesn’t go away with time, unlike other normal mouth, tongue, or lip sores that usually heal within a week or so,” Sedghizadeh said. Even if the disease is [...]

Effect of HPV-associated p16INK4A expression on response to radiotherapy and survival in squamous cell carcinoma of the head and neck

Source: Journal of Clinical Oncology, Vol 27, No 12 (April 20), 2009: pp. 1992-1998 Authors: Pernille Lassen et al. Purpose: A subset of head and neck cancers is associated with the human papillomavirus (HPV). Viral infection is closely correlated with expression of p16INK4A in these tumors. We evaluated p16INK4A as a prognostic marker of treatment response and survival in a well-defined and prospectively collected cohort of patients treated solely with conventional radiotherapy in the Danish Head and Neck Cancer Group (DAHANCA) 5 trial. Patients and Methods: Immunohistochemical expression of p16INK4A was analyzed in pretreatment paraffin-embedded tumor blocks from 156 patients treated with conventional primary radiotherapy alone. The influence of p16INK4A status on locoregional tumor control, disease-specific survival, and overall survival after radiotherapy was evaluated. Results: p16INK4A positivity was found in 35 tumors (22%). Tumor-positivity for p16INK4A was significantly correlated with improved locoregional tumor control (5-year actuarial values 58% v 28%; P = .0005), improved disease-specific survival (72% v 34%; P = .0006), and improved overall survival (62% v 26%; P = .0003). In multivariate analysis, p16INK4A remained a strong independent prognostic factor for locoregional failure (hazard ratio [HR], 0.35; 95% CI, 0.19 to 0.64), disease-specific death (HR, 0.36; 95% CI, 0.20 to 0.64), and overall death (HR, 0.44; 95% CI, 0.28 to 0.68). Conclusion: Expression of p16INK4A has a major impact on treatment response and survival in patients with head and neck cancer treated with conventional radiotherapy. Authors: Pernille Lassen, Jesper G. Eriksen, Stephen Hamilton-Dutoit, Trine Tramm, Jan Alsner, Jens [...]

WHO issues position on vaccines

Source: africasciencenews.org Author: staff In accordance with its mandate to provide guidance to Member States on health policy matters, WHO has issued a series of regularly updated position papers on vaccines and vaccine combinations against diseases that have an international public health impact. These papers, which are concerned primarily with the use of vaccines in large-scale immunization programs, summarize essential background information on their respective diseases and vaccines, and conclude with the current WHO position concerning their use in the global context. The papers have been reviewed by a number of experts within and outside WHO and, since April 2006, they have been reviewed and endorsed by WHO’s Strategic Advisory Group of Experts (SAGE) on vaccines and immunization. The position papers are designed for use mainly by national public health officials and managers of immunization programs. However, they may also be of interest to international funding agencies, the vaccine manufacturing industry, the medical community, scientific media and the public. Genital HPV infections are primarily transmitted by sexual contact, predominantly but not exclusively through penetrative intercourse. HPVs are highly transmissible, and most sexually active men and women will acquire an HPV infection at some time in their lives. Whereas most HPV infections are transient and benign, persistent genital infection with certain viral genotypes can lead to the development of anogenital precancers and cancers. Currently, 2 HPV vaccines are widely marketed internationally. Using recombinant technology, both are prepared from purified L1 structural proteins that self-assemble to form HPV type-specific empty shells or [...]

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