A pap smear reveals a group of HPV-infected koilocytes on the bottom right and two normal intermediate squamous cells at the top and left. Cervical, anal and penile tumors are caused primarily by a strain of the human papilloma virus, which is readily preventable by vaccination. (Ed Uthman / Wikimedia Commons)

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HEALTH

The Public Health Ministry’s plan to seek cabinet approval for a 600 million baht budget for human papilloma virus vaccination to help prevent cervical cancer for all Prathom 6 (Grade 6) girls has come under fire.

Yot Teerawattananon, director of the Public Health Ministry’s Health Intervention and Technology Assessment Programme (HITAP), told the Bangkok Post he did not oppose the government’s plan to add the HPV vaccine to the national vaccine programme but said the proposed budget of 600 million baht “is too high”.

“The price of the HPV vaccine shouldn’t actually exceed 190 baht per shot,” said Dr Yot, citing a HITAP study report on the “proper” price of the HPV vaccine.

Dr Yot also said some African countries pay only 150 baht per shot.

The ministry, led by its deputy Surawit Khonsomboon, yesterday held a meeting with health agencies to analyse if it is worthwhile to add the HPV vaccine to the national vaccine programme following his announcement last month.

Dr Surawit said the ministry would ask the cabinet to approve the budget. If it is passed, about 400,000 girls at Prathom 6 level nationwide will get free HPV vaccinations. It is expected to cost 500 baht per shot but every girl needs to receive three shots, leading to the budget of 600 million baht.

Dr Yot said some studies into the cost of the HPV vaccine had been tainted by money received from vaccine manufacturers. The ministry should check the credibility of the research and “not be fooled” by those studies.

He said that if the budget needs to be that high, there is no need to continue with the plan because the HPV vaccine can only prevent two out of the hundreds of strains of viruses that cause cervical cancer.

He said the screening test uses a pap smear and visual inspection with acetic acid, and is the most effective way to detect cervical cancer.

Those who received vaccinations still need to do screening tests every five years and studies in other countries found that women who had been vaccinated are less likely to go for testing after receiving their shots.

Dr Yot was invited to attend the meeting but he could not show up yesterday because he was at another meeting in Cha-am district of Phetchaburi.

At the ministry’s meeting, Dr Somboon Kunathikom, president of the Royal Thai College of Obstetricians and Gynaecologists, said the proper price should be 400-500 baht.

Dr Wichai Termrungruanglert, from Chulalongkorn University, said his institute had conducted a study based on the GDP of the country.

It found the proper price of the HPV vaccine was between 1,600 baht to 2,000 baht per shot.

However, Dr Surawit said he would call another meeting next week to get the median and average prices of the HPV vaccine before proposing it to the cabinet and he would also talk with the plan’s opponents.

Cervical cancer is the No.2 cause of death among Thai women. Each year, more than 5,000 women die of cervical cancer and about 10,000 new cases are reported, he said.

He said receiving the HPV vaccine could reduce HPV infections among Thai women by 70-80%.

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Editor’s Choice

Main Category: Ear, Nose and Throat

Also Included In: Cancer / Oncology;  Radiology / Nuclear Medicine

Article Date: 15 May 2012 – 6:00 PDT

New research from Denmark, presented at the 31st Conference of the European Society for Radiotherapy and Oncology (ESTRO31), revealed that even though the human papilloma virus (HPV) can trigger throat cancer, non-smoking or light smoking HPV-positive patients respond well to radiotherapy treatment alone without requiring harmful chemotherapy in addition.

Dr Pernille Lassen, a resident in medical and radiation oncology and researcher at the University Hospital in Aarhus, Denmark said that the study findings demonstrated that in comparison with HPV-negative patients, those who were HPV-positive with advanced oropharyngeal cancer were observed to have considerably better control of the tumor at its primary site, disease-specific survival after five years and overall survival. After analyzing the patients’ smoking history, the team found that HPV-positive patients who smoked the equivalent of 20 cigarettes a day for less than ten years had better results than HPV-negative patients who smoked the same amount for longer than 10 years.


 Dr. Lassen declared:

“We consider the present findings an important contribution to the ongoing debate on how to treat patients according to known independent prognostic factors, in this case tumor HPV-status and smoking history. These findings confirm the highly significant independent influence of HPV status on tumor control and survival in advanced oropharyngeal cancer that is treated with radiotherapy alone, without chemotherapy.

Our results suggest that the use of radiotherapy alone may be a safe treatment strategy in patients who are light or non-smokers, while sparing them the side effects associated with chemotherapy. However, it is too soon to select patients for a specific treatment based on these factors; we still need more data.”


 
Oropharyngeal cancer, i.e. cancer of the oropharynx or throat, including the soft palate and base of tongue is a relatively rare form of cancer, caused mainly by smoking and heavy drinking. The tumor can be triggered by HPV, yet poor diet is also linked to a higher risk. According to the International Agency on Cancer, every year, about 400,000 people worldwide are diagnosed with lip and oral/pharyngeal cancers.

By using data from the Danish Head and Neck Cancer Group (DAHANCA) database, Lassen and her team evaluated the results from 181 patients with advanced oropharyngeal cancer, i.e. cancer that had metastasized to the lymph nodes and beyond, who were treated between 1992 and 2005. The patients underwent accelerated radiotherapy treatment consisting of six fractions of radiation over a five-day period to shorten the overall treatment time. In conjunction with the radiotherapy, the patients also received Nimorazole, a radiotherapy-sensitizing agent that makes cancer cells more receptive to the effects of radiation, but no chemotherapy. To establish the patients’ HPV status, the researchers analyzed samples of the tumor tissue.


Dr. Lassen explained:

“Although HPV status is known to be an independent prognostic factor determining tumor control and survival in radiotherapy for head and neck cancer, it is still not clear what the best treatment is for these patients. Data from the DAHANCA randomized trials has given us the opportunity to look at a group of patients, with known HPV and smoking status, who received radiotherapy without chemotherapy.”

103 of the 181 patients, or 57% were diagnosed with HPV positive tumors. The findings demonstrated that 81% of HPV-positive patients had better control of the tumor at its primary site, compared with 48% of HPV-negative patients, whilst disease specific survival and the overall survival rate for HPV-positive patients were 90% and 77%, compared with 56% and 38% respectively in those who were HPV-negative. After accounting for the participants’ smoking history, the team observed that non-smoking HPV-positive patients or light smokers had considerably better outcomes, with a probability of tumor control at its primary site of 91%, disease-specific survival 96% and overall survival of 90% after their radiotherapy treatment was completed, compared with HPV-positive heavy smokers, who scored 77%, 81% and 63% respectively after 5 years.

Of those with HPV-negative tumors, all except for two of the 78 patients had a smoking history of 20 cigarettes a day for longer than 10 years. Regardless of how many years they smoked, their results were considerably worse, with a disease-specific survival of 50 to 52%, compared with those of HPV-positive patients. The DAHANCA 19 trial, as well as various other randomized trials are currently investigating treating patients according to their respective HPV status.

Dr. Lassen comments:

“This will give us important information. In the meantime, we will try to identify more patients with advanced oropharyngeal cancer and known smoking status in the DAHANCA database, in order to enlarge the present cohort, making the data more robust.”


 President of ESTRO, Professor Vincenzo Valentini, a radiation oncologist at the Policlinico Universitario A. Gemelli in Rome, Italy, declared:

“This study confirms the highly significant independent influence of HPV expression on tumor control and survival in advanced oropharyngeal cancer treated with radiotherapy, with larger benefit in non-smoking patients, even in a non-chemotherapy setting. This study suggests it would be worthwhile testing the use of a moderately accelerated radiotherapy schedule as a single modality in these patients.”

Written By Petra Rattue
Copyright: Medical News Today
Not to be reproduced without permission of Medical News Today

• Additional
• References
• Citations

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Public release date: 10-May-2012
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Contact: Emma Mason
wordmason@mac.com
European Society for Radiotherapy and Oncology (ESTRO)

Barcelona, Spain: New findings from a large Danish database of cancer patients suggest that, even though the human papilloma virus (HPV) can trigger throat cancer, patients who are HPV-positive and are light smokers, or don’t smoke at all, have a good response to treatment using radiotherapy alone, without the addition of chemotherapy with its consequent toxic side-effects.

Presenting her research at the 31st conference of the European Society for Radiotherapy and Oncology (ESTRO 31) [1] today [Thursday], Dr Pernille Lassen, a resident in medical and radiation oncology and researcher at Aarhus University Hospital, Aarhus, Denmark, said that HPV-positive patients with advanced oropharyngeal cancer (cancer of the oropharynx or throat, including the soft palate and base of tongue) had significantly better control of the tumour at its primary site, disease-specific survival after five years and overall survival than patients who were HPV-negative.

Further analysis, which looked at smoking history, showed that HPV-positive patients who had a history of less than 10 pack years (one pack year is the equivalent of 20 cigarettes a day for one year) had better outcomes than HPV-negative patients and those with a smoking history of more than 10 pack years.

“We consider the present findings an important contribution to the ongoing debate on how to treat patients according to known independent prognostic factors, in this case tumour HPV-status and smoking history,” said Dr Lassen. “These findings confirm the highly significant independent influence of HPV status on tumour control and survival in advanced oropharyngeal cancer that is treated with radiotherapy alone, without chemotherapy. Our results suggest that the use of radiotherapy alone may be a safe treatment strategy in patients who are light or non-smokers, while sparing them the side-effects associated with chemotherapy. However, it is too soon to select patients for a specific treatment based on these factors; we still need more data.”

Oropharyngeal cancer is uncommon. Figures from the International Agency on Cancer show that lip and oral/pharyngeal cancers affect approximately 400,000 people worldwide each year [2]. The main causes are smoking and drinking heavily; HPV is a known trigger for the tumour, and a poor diet is also linked to an increased risk.

Dr Lassen and her colleagues investigated the outcomes of 181 patients on the Danish Head and Neck Cancer Group (DAHANCA) database, who were treated between 1992-2005 for advanced oropharyngeal cancer – cancer that has spread from the primary site to lymph nodes and beyond. The patients received accelerated radiotherapy (six fractions of radiation over five days in order to reduce the overall length of treatment) together with Nimorazole, an agent that acts as a radiotherapy sensitizer, making cancer cells more receptive to the effects of radiation. No chemotherapy was given. Samples of tumour tissue were analysed to establish HPV status.

“Although HPV status is known to be an independent prognostic factor determining tumour control and survival in radiotherapy for head and neck cancer, it is still not clear what the best treatment is for these patients. Data from the DAHANCA randomised trials has given us the opportunity to look at a group of patients, with known HPV and smoking status, who received radiotherapy without chemotherapy,” explained Dr Lassen.

Out of the 181 patients, 103 had HPV positive tumours (57%). HPV-positive patients had better control of the tumour at its primary site (81% versus 48% of HPV-negative patients), disease-specific survival (90% versus 56%), and overall survival (77% versus 38%).

When the researchers took account of smoking history, HPV-positive, light or non-smokers, had very favourable outcomes. The probability of tumour control at its primary site was 91%, disease-specific survival was 96% and overall survival 90% five years after completion of radiotherapy. In comparison, the corresponding results for HPV-positive heavy smokers were 77%, 81% and 63% after five years.

All but two of the 78 patients with HPV-negative tumours had a smoking history of more than 10 pack years, and their outcome was significantly worse than HPV-positive patients, regardless of pack years. Disease-specific survival in this group was between 50-52%.

Several randomised trials, including the DAHANCA 19 trial, are now investigating treatment of patients according to HPV status. “This will give us important information,” said Dr Lassen. “In the meantime, we will try to identify more patients with advanced oropharyngeal cancer and known smoking status in the DAHANCA database, in order to enlarge the present cohort, making the data more robust.”

President of ESTRO, Professor Vincenzo Valentini, who is a radiation oncologist at the Policlinico Universitario A. Gemelli in Rome, Italy, commented: “This study confirms the highly significant independent influence of HPV expression on tumour control and survival in advanced oropharyngeal cancer treated with radiotherapy, with larger benefit in non-smoking patients, even in a non-chemotherapy setting. This study suggests it would be worthwhile testing the use of a moderately accelerated radiotherapy schedule as a single modality in these patients.”

###

Abstract no: OC 149, “Radiobiology proffered papers 2: head and neck” session at 16.15 hrs (CEST) on Thursday 10 May, room 120/121.

[1] This year the ESTRO conference is held in parallel with the World Congress of Brachytherapy, both taking place in Barcelona between May 9-13.

[2] GLOBOCAN 2008, Cancer incidence and mortality worldwide.

[3] This work was supported by grants from: The Danish Cancer Society, CIRRO-The Lundbeck Foundation Centre for Interventional Research in Radiation Oncology and The Danish Cancer Research Foundation

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Public release date: 10-May-2012
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Contact: Emma Mason
wordmason@mac.com
European Society for Radiotherapy and Oncology (ESTRO)

Barcelona, Spain: New findings from a large Danish database of cancer patients suggest that, even though the human papilloma virus (HPV) can trigger throat cancer, patients who are HPV-positive and are light smokers, or don’t smoke at all, have a good response to treatment using radiotherapy alone, without the addition of chemotherapy with its consequent toxic side-effects.

Presenting her research at the 31st conference of the European Society for Radiotherapy and Oncology (ESTRO 31) [1] today [Thursday], Dr Pernille Lassen, a resident in medical and radiation oncology and researcher at Aarhus University Hospital, Aarhus, Denmark, said that HPV-positive patients with advanced oropharyngeal cancer (cancer of the oropharynx or throat, including the soft palate and base of tongue) had significantly better control of the tumour at its primary site, disease-specific survival after five years and overall survival than patients who were HPV-negative.

Further analysis, which looked at smoking history, showed that HPV-positive patients who had a history of less than 10 pack years (one pack year is the equivalent of 20 cigarettes a day for one year) had better outcomes than HPV-negative patients and those with a smoking history of more than 10 pack years.

“We consider the present findings an important contribution to the ongoing debate on how to treat patients according to known independent prognostic factors, in this case tumour HPV-status and smoking history,” said Dr Lassen. “These findings confirm the highly significant independent influence of HPV status on tumour control and survival in advanced oropharyngeal cancer that is treated with radiotherapy alone, without chemotherapy. Our results suggest that the use of radiotherapy alone may be a safe treatment strategy in patients who are light or non-smokers, while sparing them the side-effects associated with chemotherapy. However, it is too soon to select patients for a specific treatment based on these factors; we still need more data.”

Oropharyngeal cancer is uncommon. Figures from the International Agency on Cancer show that lip and oral/pharyngeal cancers affect approximately 400,000 people worldwide each year [2]. The main causes are smoking and drinking heavily; HPV is a known trigger for the tumour, and a poor diet is also linked to an increased risk.

Dr Lassen and her colleagues investigated the outcomes of 181 patients on the Danish Head and Neck Cancer Group (DAHANCA) database, who were treated between 1992-2005 for advanced oropharyngeal cancer – cancer that has spread from the primary site to lymph nodes and beyond. The patients received accelerated radiotherapy (six fractions of radiation over five days in order to reduce the overall length of treatment) together with Nimorazole, an agent that acts as a radiotherapy sensitizer, making cancer cells more receptive to the effects of radiation. No chemotherapy was given. Samples of tumour tissue were analysed to establish HPV status.

“Although HPV status is known to be an independent prognostic factor determining tumour control and survival in radiotherapy for head and neck cancer, it is still not clear what the best treatment is for these patients. Data from the DAHANCA randomised trials has given us the opportunity to look at a group of patients, with known HPV and smoking status, who received radiotherapy without chemotherapy,” explained Dr Lassen.

Out of the 181 patients, 103 had HPV positive tumours (57%). HPV-positive patients had better control of the tumour at its primary site (81% versus 48% of HPV-negative patients), disease-specific survival (90% versus 56%), and overall survival (77% versus 38%).

When the researchers took account of smoking history, HPV-positive, light or non-smokers, had very favourable outcomes. The probability of tumour control at its primary site was 91%, disease-specific survival was 96% and overall survival 90% five years after completion of radiotherapy. In comparison, the corresponding results for HPV-positive heavy smokers were 77%, 81% and 63% after five years.

All but two of the 78 patients with HPV-negative tumours had a smoking history of more than 10 pack years, and their outcome was significantly worse than HPV-positive patients, regardless of pack years. Disease-specific survival in this group was between 50-52%.

Several randomised trials, including the DAHANCA 19 trial, are now investigating treatment of patients according to HPV status. “This will give us important information,” said Dr Lassen. “In the meantime, we will try to identify more patients with advanced oropharyngeal cancer and known smoking status in the DAHANCA database, in order to enlarge the present cohort, making the data more robust.”

President of ESTRO, Professor Vincenzo Valentini, who is a radiation oncologist at the Policlinico Universitario A. Gemelli in Rome, Italy, commented: “This study confirms the highly significant independent influence of HPV expression on tumour control and survival in advanced oropharyngeal cancer treated with radiotherapy, with larger benefit in non-smoking patients, even in a non-chemotherapy setting. This study suggests it would be worthwhile testing the use of a moderately accelerated radiotherapy schedule as a single modality in these patients.”

###

Abstract no: OC 149, “Radiobiology proffered papers 2: head and neck” session at 16.15 hrs (CEST) on Thursday 10 May, room 120/121.

[1] This year the ESTRO conference is held in parallel with the World Congress of Brachytherapy, both taking place in Barcelona between May 9-13.

[2] GLOBOCAN 2008, Cancer incidence and mortality worldwide.

[3] This work was supported by grants from: The Danish Cancer Society, CIRRO-The Lundbeck Foundation Centre for Interventional Research in Radiation Oncology and The Danish Cancer Research Foundation

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ONE in six cancers is caused by potentially preventable or treatable infections, international research today reveals.

It has been estimated infections, including the human papilloma virus and hepatitis are responsible for two million new cases of cancer worldwide every year.

And, of the 7.5 million deaths from cancer worldwide in 2008, an estimated 1.5 million were due to potentially preventable or treatable infections.

The overwhelming majority of these cases of cancer occur in less developed regions, the research, which is published in The Lancet Oncology, found.

The study comes as scientists at Cardiff University have discovered the potential of using the body’s own cells, which normally attack common infections, to target cancer instead.

It is thought these T-cell receptors could be used to treat those cancers for which few disease-specific targets, which treatments can latch onto, are available.

James Noble, chief executive of biotech company Immunocore, which is involved in the T-cell research with Cardiff University, said: “The power of this new technology lies in its ability to be used for a host of cancers that are currently very difficult to treat.”

The Lancet Oncology research estimated that 16% of all cancers worldwide in 2008 were infection-related; the proportion of cancers related to infection was about three times higher in developing countries than in developed countries, like the UK.

Catherine de Martel and Martyn Plummer, from the International Agency for Research on Cancer, in France and lead authors of the study, said: “Infections with certain viruses, bacteria, and parasites are one of the biggest and preventable causes of cancer worldwide.

“Application of existing public-health methods for infection prevention, such as vaccination, safer injection practice, or antimicrobial treatments, could have a substantial effect on future burden of cancer worldwide.

“Many infection-related cancers are preventable, particularly those associated with human papilloma viruses (HPV), Helicobacter pylori, and hepatitis B and C viruses.”

It is estimated these four infections are responsible for 1.9 million cases of cancer worldwide, most of which are gastric, liver, and cervical cancers.

Cervical cancer accounted for around half of the infection-related burden of cancer in women, and in men liver and gastric cancers accounted for more than 80%.

In an accompanying commentary, Goodarz Danaei, from the Harvard School of Public Medicine, in the US said: “Their [the study’s] estimates show the potential for preventive and therapeutic programmes in less-developed countries to significantly reduce the global burden of cancer and the vast disparities across regions and countries.

“Since effective and relatively low-cost vaccines for HPV and hepatitis B are available, increasing coverage should be a priority for health systems in high-burden countries.”

All year eight schoolgirls are now offered vaccination against HPV strains 16 and 18 in Wales as part of a UK-wide programme to reduce the number of cases of cervical cancer. These two strains of HPV cause the vast majority of cases of cervical cancer.

The latest figures show uptake of the first HPV vaccine among year eight schoolgirls was 88% in Wales in 2010-11; 84% of those eligible had received all three doses. This is an increase of 4% on figures for 2009-10

A successful vaccination programme will not replace the current cervical screening women – screening is offered every three years to women aged 20 to 64 in Wales.

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Louisiana teenager Brittany Hill receives a vaccine booster shot. (Getty Images / May 7, 2012)

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Imaging surveillance is an acceptable alternative to surgical excision in patients with benign papilloma, diagnosed at breast core biopsy without cell abnormalities, a new study shows.

The study, conducted at the Breast Health Center of California Pacific Medical Center in San Francisco, included 119 papillomas diagnosed at core biopsy without abnormal cells. Imaging follow-up of a minimum of two years without surgical excision was performed on 66 lesions; no cancer was found in this group, said Jessica Leung, MD, FACR, lead author of the study. Surgical excision was done on the remaining 53 lesions, with 50 of those being benign. Ductal carcinoma in situ was diagnosed in the remaining three lesions, she said.

The “histological upgrade rate” (the core biopsy indicated the lesion was benign, but the surgical excision found cancer) was 2.5%, said Dr. Leung. This upgrade rate “approximates the 2% probability of malignancy that is widely accepted for these types of probably benign lesions,” she said.

“Currently there is disagreement over whether cancer can be reliably excluded by breast core biopsy,” said Dr. Leung. “The benefit of surgical excision is definitive tissue diagnosis and exclusion of cancer. The benefit of imaging surveillance is that it obviates unnecessary surgery, with its associated morbidity for nonmalignant lesions,” Dr. Leung said. “This study provides evidence that imaging surveillance is appropriate for these patients,” said Dr. Leung.

The incidence of benign papillomas without abnormal cells is uncommon –about 1.4% of imaging-guided core biopsies, noted Dr. Leung. Nevertheless, given the total number of core biopsies performed, the number of benign papillomas diagnosed is sufficiently high to warrant an evidence-based approach to their management. Papillomas are usually histologically complex lesions that are associated with a high degree of abnormal cells, she said.

Source: American Roentgen Ray Society

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Public release date: 3-May-2012
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Contact: Samantha Schmidt
703-858-4316
American Roentgen Ray Society

Imaging surveillance is an acceptable alternative to surgical excision in patients with benign papilloma, diagnosed at breast core biopsy without cell abnormalities, a new study shows.

The study, conducted at the Breast Health Center of California Pacific Medical Center in San Francisco, included 119 papillomas diagnosed at core biopsy without abnormal cells. Imaging follow-up of a minimum of two years without surgical excision was performed on 66 lesions; no cancer was found in this group, said Jessica Leung, MD, FACR, lead author of the study. Surgical excision was done on the remaining 53 lesions, with 50 of those being benign. Ductal carcinoma in situ was diagnosed in the remaining three lesions, she said.

The “histological upgrade rate” (the core biopsy indicated the lesion was benign, but the surgical excision found cancer) was 2.5%, said Dr. Leung. This upgrade rate “approximates the 2% probability of malignancy that is widely accepted for these types of probably benign lesions,” she said.

“Currently there is disagreement over whether cancer can be reliably excluded by breast core biopsy,” said Dr. Leung. “The benefit of surgical excision is definitive tissue diagnosis and exclusion of cancer. The benefit of imaging surveillance is that it obviates unnecessary surgery, with its associated morbidity for nonmalignant lesions,” Dr. Leung said. “This study provides evidence that imaging surveillance is appropriate for these patients,” said Dr. Leung.

The incidence of benign papillomas without abnormal cells is uncommon –about 1.4% of imaging-guided core biopsies, noted Dr. Leung. Nevertheless, given the total number of core biopsies performed, the number of benign papillomas diagnosed is sufficiently high to warrant an evidence-based approach to their management. Papillomas are usually histologically complex lesions that are associated with a high degree of abnormal cells, she said.

The study is being presented May 3 at the American Roentgen Ray Society Annual Meeting in Vancouver, Canada.

###

About ARRS

The American Roentgen Ray Society (ARRS) was founded in 1900 and is the oldest radiology society in the United States. Its monthly journal, the American Journal of Roentgenology, began publication in 1906. Radiologists from all over the world attend the ARRS Annual Meeting to take part in instructional courses, scientific paper presentations and scientific and commercial exhibits related to the field of radiology. The Society is named after the first Nobel Laureate in Physics, Wilhelm Röentgen, who discovered the X-ray in 1895.

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Public release date: 3-May-2012
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Contact: Samantha Schmidt
703-858-4316
American Roentgen Ray Society

Imaging surveillance is an acceptable alternative to surgical excision in patients with benign papilloma, diagnosed at breast core biopsy without cell abnormalities, a new study shows.

The study, conducted at the Breast Health Center of California Pacific Medical Center in San Francisco, included 119 papillomas diagnosed at core biopsy without abnormal cells. Imaging follow-up of a minimum of two years without surgical excision was performed on 66 lesions; no cancer was found in this group, said Jessica Leung, MD, FACR, lead author of the study. Surgical excision was done on the remaining 53 lesions, with 50 of those being benign. Ductal carcinoma in situ was diagnosed in the remaining three lesions, she said.

The “histological upgrade rate” (the core biopsy indicated the lesion was benign, but the surgical excision found cancer) was 2.5%, said Dr. Leung. This upgrade rate “approximates the 2% probability of malignancy that is widely accepted for these types of probably benign lesions,” she said.

“Currently there is disagreement over whether cancer can be reliably excluded by breast core biopsy,” said Dr. Leung. “The benefit of surgical excision is definitive tissue diagnosis and exclusion of cancer. The benefit of imaging surveillance is that it obviates unnecessary surgery, with its associated morbidity for nonmalignant lesions,” Dr. Leung said. “This study provides evidence that imaging surveillance is appropriate for these patients,” said Dr. Leung.

The incidence of benign papillomas without abnormal cells is uncommon –about 1.4% of imaging-guided core biopsies, noted Dr. Leung. Nevertheless, given the total number of core biopsies performed, the number of benign papillomas diagnosed is sufficiently high to warrant an evidence-based approach to their management. Papillomas are usually histologically complex lesions that are associated with a high degree of abnormal cells, she said.

The study is being presented May 3 at the American Roentgen Ray Society Annual Meeting in Vancouver, Canada.

###

About ARRS

The American Roentgen Ray Society (ARRS) was founded in 1900 and is the oldest radiology society in the United States. Its monthly journal, the American Journal of Roentgenology, began publication in 1906. Radiologists from all over the world attend the ARRS Annual Meeting to take part in instructional courses, scientific paper presentations and scientific and commercial exhibits related to the field of radiology. The Society is named after the first Nobel Laureate in Physics, Wilhelm Röentgen, who discovered the X-ray in 1895.

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SAN DIEGO, May 2, 2012 /PRNewswire/ – Trovagene, Inc. (TROV.PK) announced today that the Company has initiated development of a diagnostic test to determine the presence of high risk Human Papilloma Virus (HPV) subtypes from urine specimens. The proprietary test (U.S. patent application pending) might, once available, be particularly useful for the determination of carrier status in males.

The Company’s HPV detection assay is a unique, proprietary(1) method that preferentially amplifies a specific region of the HPV genome of high risk HPV types, but not of low risk types. In an explorative validation study the Company has compared the analytical performance of its assay, which uses urine as the sample, to a commercially available HPV test, which uses cytology samples and was performed according to the manufacturer’s protocol. Discordant results were resolved by Sanger DNA sequencing. The results showed that the Trovagene assay performed with a sensitivity of 93% and a specificity of 96%, whereas the commercially available LBC test had a sensitivity of 78% and a specificity of 86%.

Trovagene’s HPV assay is compatible with the throughput and reliability requirements of a clinical-diagnostic laboratory at very competitive cost levels. The Company believes that the detection of high risk HPV types through its urine-based assay could have valuable clinical utility for monitoring the high risk HPV carrier status of an individual. Such infections can lead to cervical cancer, head-and neck cancer(2), and other cancers.

Charlie Rodi, Ph.D., Trovagene’s Chief Technology Officer, stated that “the Company’s HPV assay technology is noteworthy for both its high performance and its ease of use. The urine sample can be collected in private and shipped at ambient temperatures to a diagnostic laboratory.” He also noted that although there is no HPV test currently recommended for use by men, that the Company’s urine-based test has the potential to determine male carrier status without resorting to methods that require scraping to collect cytology samples. Dr. Rodi added that the Company plans to begin offering the test in 2012.

1. WO2010051261, IPA No. PCT/US2009/062114, Indian Patent Application No. 3673/DELNP/2011

2. Chaturvedi AK, Engels EA, Pfeiffer RM, et al. Human papillomavirus and rising oropharyngeal cancer incidence in the United States (2011) Journal of Clinical Oncology 29(32): 4294-4301.

About Trovagene, Inc.

Headquartered in San Diego, California, Trovagene is developing its patented technology for the detection of transrenal DNA and RNA, short nucleic acid fragments, originating from normal and diseased cell death that cross the kidney barrier and can be detected in urine.

Trovagene has a dominant patent position as it relates to transrenal molecular testing. It has U.S. and European patent applications and issued patents that cover testing for HPV and other infectious diseases, cancer, transplantation, prenatal and genetic testing. In addition, it owns worldwide rights to nucleophosmin-1 (NPM1), an informative biomarker for acute myeloid leukemia (AML) and mutations in the SF3B1 gene, which have been shown to be associated with chemotherapy response in CLL (chronic lymphocytic leukemia) patients.

Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimated” and “intend,” among others. These forward-looking statements are based on Trovagene’s current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, substantial competition; our ability to continue as a going concern; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payer reimbursement; limited sales and marketing efforts and dependence upon third parties; and risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations. As with any medical diagnostic tests under development, there are significant risks in the development, regulatory approval and commercialization of new products. There are no guarantees that future clinical trials discussed in this press release will be completed or successful or that any product will receive regulatory approval for any indication or prove to be commercially successful. Trovagene does not undertake an obligation to update or revise any forward-looking statement.  Investors should read the risk factors set forth in Trovagene’s Form 10-K for the year ended December 31, 2011 and other periodic reports filed with the Securities and Exchange Commission.

Contacts

Trovagene, Inc.
Stephen Zaniboni
Chief Financial Officer
+1 (858) 496-7466
szaniboni@trovagene.com
http://www.trovagene.com

papilloma – Yahoo! News Search Results

OTTAWA — Why wouldn’t a parent rush to protect her child from getting cancer?

That question has public health officials stumped five years after the vaccine against the cancer-causing human papilloma virus was introduced.

Far fewer girls than expected are rolling up their sleeves.

Canadian health officials had hoped that 90 per cent of girls would be receiving the three-shot vaccine against the sexually transmitted virus by now. But just 59 per cent of Grade 8 Ontario girls were vaccinated in 2009-2010, the most recent year for which statistics are available. Similarly “disappointing” numbers have been recorded in other provinces.

Many theories attempt to explain the low inoculation rates, including the misplaced trust put in Dr. Google, which erroneously ties the vaccine to side-effects such as death, mental retardation and seizures, to name a few. Some say the vaccination program was rushed into place, and the ensuing suspicion about both speed and safety lingers among parents; others may fear that giving the vaccine to their daughters offers a licence to promiscuity.

“The vaccination rates are disappointingly low,” says Dr. Joan Robinson, chair of the Canadian Paediatric Society’s infectious diseases and immunization committee. “At the beginning, there was lots of misinformation out there and lots of parents didn’t understand why on earth we would be vaccinating little girls, as young as nine in some provinces, against sexually transmitted diseases.”

If there is one bright spot for public health officials, it is in Ottawa, which has the highest vaccination rate in Ontario, with 75 per cent of Grade 8 girls this school year receiving the first dose of the vaccine. In 2010-2011, 73 per cent of Ottawa’s Grade 8 girls had their first dose, and 69 per cent completed the final dose.

“I think everybody is grappling with the issue because almost five years later, we are at 70 per cent and that is still not that great and ideally we would like to be higher,” says Michelle Parks, Ottawa Public Health’s supervisor of school immunization clinics.

Public health officials elsewhere are seeking advice from Ottawa’s public health officials on how to raise vaccination rates. Meanwhile, Parks says the rates need to be higher if we hope to establish a “herd immunity” against the cancer- and wart-causing HPV strains.

Dr. Shelley Deeks, Public Health Ontario’s medical director of immunization and vaccine preventable diseases, says each year vaccination rates increase and she is still hopeful they will reach the 85 to 90 per cent “uptake” that the hepatitis B vaccine receives among Ontario school children.

Hepatitis B is also a sexually transmitted disease, “but people don’t look at it that way,” says Deeks, who also chairs the World Health Organization’s immunization practices advisory committee.

Deeks said Ontario Public Health has also had to find ways to get vaccinations to a group of girls from two Catholic school boards in Ontario — which she wouldn’t name — that wouldn’t let their Grade 8 girls be vaccinated.

“There is the whole ethical issue of whether a school board should be allowed to disallow public health into their schools for a publicly funded vaccination program,” she says.

HPV is the most common sexually transmitted disease. It’s estimated that 70 per cent of the adult population will be infected, according to Robinson, although she says most will clear the infection without developing warts or cancers. But they can still pass on the “amazingly contagious” virus that survives on the skin and can be transmitted through genital touching alone.

“So basically, if you have sex with more than one guy or even with one guy who has had sex with anybody else, the odds are fairly high that you will acquire HPV at some point in your lifetime,” Dr. Robinson explains.

Canada’s National Advisory Committee on Immunizations recommended that girls between the ages of nine and 13 be vaccinated before they become sexually active.

In 2007, girls began receiving Gardasil, produced by Merck. The free vaccine is given to Grade 4 girls in Quebec and Grade 5 girls in Alberta. Ontario decided to wait until girls were in Grade 8 to provide the vaccine.

The three-course vaccine prevents four strains of the human papilloma virus, including HPV 16 and 18, thought to cause 70 per cent of cervical-cancer cases, as well as some cancers of the anus, vulva, vagina, penis, mouth and throat. The vaccine also prevents HPV types 6 and 11, responsible for 90 per cent of genital warts.

It’s expected that the vaccine will not only reduce cervical cancer deaths — there are about 400 each year in Canada, disproportionately found among immigrant and aboriginal populations — but also reduce the number of actual infections, the prevalence of genital warts, the developments of precancerous lesions, and the need for biopsies.

The HPV vaccination campaign was quickly launched after a $ 300-million contribution from the federal government and a strong lobbying campaign by Merck. In fact, one of the reasons that Ottawa’s Michelle Parks thinks it has higher inoculation rates is because it had its vaccination program going in 90 or so schools before much of the negative publicity, which early on included a cover story in Maclean’s with a headline that shouted “Our girls are not guinea pigs” and raised concerns about the vaccine’s safety record. More recently, former Republican presidential candidate Michelle Bachmann backtracked after stating she knew a mom whose daughter had become “mentally retarded” from the vaccine.

Parks, who has two daughters who have been vaccinated, diligently researched the adverse events linked to the vaccine. “I made sure I understood what I was giving. I wanted to make sure I was giving a safe vaccine,” she says.

“We have given close to 50,000 vaccines over the last four years, and very safely. If you Google, you see all kinds of scary things. They are not based on any scientific research and nothing has been tied to the vaccine in terms of safety,” she says.

Dr. Carolyn Pim, Ottawa’s associate medical officer of health, says she encourages parents and girls to do their own research but “be clear about the source of the information.”

“Assess whether what they are reading, in print form or on the Internet, is from a credible source and whether it can be substantiated by evidence or is it just a claim? It is easy to make claims that don’t have any basis.”

She says public health officials try to “present the information in as clear as way as possible and not in a coercive way, but try to be very transparent about what we know and what we don’t know.”

But she says after almost five years of use the National Advisory Committee on Immunization found it is a very effective vaccine, close to 100 per cent effective in preventing infection from the four strains in the vaccine. It’s also been shown to reduce rates of abnormal Pap tests, rates of colposcopies, rates of treatment for abnormalities of the cervix, Pim says. “These are not trivial things.”

She also says that the vaccine has a strong safety record. “There was no pattern of serious events that suggested any causal relationship to the vaccine,” Pim adds.

It is not yet known how long the vaccine will last. But she said so far, it appears to be long-lasting. Even five years later, those receiving the vaccine show a “robust response” to the virus.

Each year, a new group of parents has to make a decision. She acknowledges it’s challenging for a parent to weigh all the issues. “It’s very different, the way I react as a public health official and as a parent.” However, her 24-year-old daughter has been vaccinated.

Some critics maintain that using a mass vaccination campaign in children to prevent a relatively small number of cancers is not necessary. Robinson disagrees.

“Can you imagine if 450 women died every year of some horrible and obvious infectious disease? Can you imagine the public outcry if there was a vaccine available that we were not recommending for everyone?”

She says all sorts of women end up having Pap smears, colposcopies and other invasive procedures, because of HPV infection. She says this affects “sisters, mothers, cousins, all kinds of really good decent people who have had HPV.”

Factbox

• Human papilloma virus is the most common sexually transmitted disease.

• There are no publicly funded programs in Canada to vaccinate boys, but the vaccine is available to boys and men who wish to pay for it.

• 70 per cent of adults will catch the virus at some point in their lives. Most will clear the virus and never know they’ve had it, but some will go on to develop warts, precancerous conditions or cervical cancer.

• HPV has been linked to cancers of the cervix, anus, vulva, vagina, penis, mouth and throat.

• Canada’s National Advisory Committee on Immunization (NACI) has recommended that girls between the ages of 9 and 13 be vaccinated against HPV before they become sexually active.

• NACI also recommends the vaccine for girls and women aged 14 to 26, including those who have had abnormal Pap smears and cervical cancer.

• In January 2012, NACI also recommended the vaccine for boys and men aged 9–26 “for the prevention of anal intraepithelial neoplasia, anal cancer and anogenital wart.”

* In Canada, there are two vaccines available to prevent some of the 100 known strains of HPV. Gardasil, made by Merck, prevents four strains of the human papilloma virus, including HPV 16 and 18, thought to cause 70 per cent of cervical-cancer cases, as well as some cancers of the anus, vulva, vagina, penis, mouth and throat. The vaccine also prevents HPV types 6 and 11, responsible for 90 per cent of genital warts. It is approved for use in males and females.

• GlaxoSmithKline’s vaccine Cervarix, approved only for girls and women, prevents infection from HPV 16 and 18 strains, as well as HPV types 31 and 45. Cervarix does not protect against warts.

© Copyright (c) The Ottawa Citizen

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