U.S. approves Merck immune-stimulating drug for melanoma

U.S. regulators on Thursday approved the use of Merck & Co Inc’s immuno-oncology drug Keytruda, also known as pembrolizumab, as a treatment for patients with advanced melanoma who are no longer responding to other therapies.

U.S. approves Merck immune-stimulating drug for melanoma

The decision marks the first U.S. approval for a promising new class designed to help the body’s own immune system fend off cancer by blocking a protein known as Programmed Death receptor (PD-1), or a related target known as PD-L1, used by tumors to evade disease-fighting cells.

For Tom Stutz, a 74-year-old retired lawyer living in Southern California, the Merck drug has meant a new lease on life. “I was really ready to mail it in,” before entering a pembrolizumab trial in April 2012 after melanoma had spread to his lungs, liver and back, he said.

Stutz, who still receives an infusion of the drug every three weeks, said he has “gone from not being able to turn over in bed, to being able to play tennis three days a week, and ride a bike 25 miles a day.”

He said side effects amounted to some itching.

“This is not a drug that attacks the cancer directly. It enables the immune system to do the job that it is capable of doing,” said Dr. Louis Weiner, director of the Lombardi Comprehensive Cancer Center at Georgetown University. “This is the first beachhead that’s been taken. It’s going to be all out assault on many different types of cancer.”

Merck and others, including Bristol-Myers Squibb, Roche Holding AG and AstraZeneca Plc, are racing to develop PD-1 pathway drugs as treatments for a variety of cancers, including lung cancer. Some analysts expect the new class could generate more than $30 billion in annual sales worldwide by 2025.

Melanoma, the deadliest form of skin cancer, kills around 10,000 Americans each year, according to the National Cancer Institute.

The FDA said clinical trials of Keytruda showed that it shrank tumors in around 24 percent of patients with advanced melanoma whose disease worsened after prior treatment.

The agency had designated the drug a “breakthrough therapy,” and approved it nearly two months ahead of an Oct. 28 decision deadline. Reuters reported exclusively last week that the approval was likely to come far earlier than the deadline [L1N0R52D3].

Keytruda is the sixth new melanoma drug approved by the FDA since 2011.

“This is a patient population with few options … We are highly encouraged by the response rate and the duration of response,” said Dr Rick Pazdur, director of the Office of Hematology and Oncology in the FDA’s drug evaluation center. “The true benefit of these drugs may be in patients who do not have metastatic disease, but are at risk of recurrence.”

Merck said one of its first priorities was to see whether the drug is effective in patients with earlier-stage cancer.

Keytruda will be priced at about $12,500 per month, which “is consistent with other innovative oncology medicines,” Merck said. For patients with advanced melanoma, the median duration of treatment has been 6.2 months.

Common side effects of Keytruda seen during clinical trials included fatigue, cough, nausea, itchy skin, rash and diarrhea. Because it stimulates the immune system, Keytruda has the potential for severe immune-mediated side effects, including liver problems and colitis.

Merck is studying the drug in more than 30 different types of tumors, said Roger Perlmutter, head of research at the pharmaceutical company. Merck expects to present data from studies in lung, bladder and gastric cancers at a European medical meeting later this month.

Perlmutter said Merck’s next FDA filing for Keytruda will depend on which trials “yield the most powerful results.”

Bristol expects to complete by the end of this year a “rolling” submission for FDA approval of its drug, Opdivo, or nivolumab, for certain patients with late-stage lung cancer. The company also plans to file an FDA application by the end of this month for use of the drug, which is approved in Japan, for patients with advanced melanoma.

Source: reuters


Sunscreen that protects DNA from UV rays

Sunscreen that protects DNA from UV rays

The experiment at the Department of Energy’s SLAC National Accelerator Laboratory focused on thymine, one of four DNA building blocks.

Ever heard of a molecular sunscreen? It is a defence mechanism that the molecular building blocks that make up DNA mount to prevent the damage by ultraviolet rays, reveals new research.

The DNA forming molecules absorb ultraviolet light so strongly that sunlight should deactivate them. But a “relaxation response” protects these molecules and the genetic information they encode from UV damage, the researchers said.

The experiment at the Department of Energy’s SLAC National Accelerator Laboratory focused on thymine, one of four DNA building blocks.

Researchers hit thymine with a short pulse of ultraviolet light and used a powerful X-ray laser to watch the molecule’s response.

A single chemical bond stretched and snapped back into place within 200 quadrillionths of a second, setting off a wave of vibrations that harmlessly dissipated the destructive UV energy.

Researchers had noticed years ago that thymine seemed resistant to damage from UV rays in sunlight, which cause sunburn and skin cancer.

Theorists proposed that thymine got rid of the UV energy by quickly shifting shape.

But they differed on the details, and previous experiments could not resolve what was happening.

“As soon as the thymine swallows the light, the energy is funnelled as quickly as possible into heat, rather than into making or breaking chemical bonds,” said lead researcher Markus Guehr from Stanford University in the US.

“It is like a system of balls connected by springs; when you elongate that one bond between two atoms and let it loose, the whole molecule starts to tremble,” he explained.

The findings appeared in the journal Nature Communications.

Source: Khaleej times


9 Ways to Prevent Skin Cancer

melanoma-monday

1. Reduce Sun Exposure

Especially between 11 am and 4 pm, when the sun’s UV rays are the strongest or when UV index is 3 or more.

2. Shade your Skin

  • Seek shade under trees, or create your own shade with a hat, shirt, or umbrella.
  • Wear clothing to cover your arms and legs. Make sure the fabric has a tight weave. Fabric that is wet or has a loose weave will allow more light to penetrate through to the skin.
  • Wear a wide brimmed hat and sunglasses with UV protection.

3. Beware of clouds

Up to 80% of the sun’s rays can penetrate light clouds, mist and fog. You can still get a sunburn on a cloudy day.

4. Remember about Reflection

Water, sand, snow and concrete can reflect up to 80% of the sun’s damaging rays.

5. Slop on the Sunscreen

Use sunscreens with an SPF of 15 or more that contain both UVA and UVB protection.

Apply sunscreen 15-30 minutes before going outside, and reapply every 2 hours (more often when working, playing, or swimming).

6. Avoid tanning salons and sunlamps

These lights emit mostly UVA radiation – up to 2 – 5 times as much as natural sunlight. UVA radiation causes sunburn, premature aging of the skin and skin cancer.

The UVB radiation from tanning lights is the main cause of sunburn and skin cancer and also contributes to premature skin aging.

For more information see youth tanning (link to being modified by the school team)

7. Protect Children

The most harmful effects of sun exposure occur during early childhood. Keep babies under 1 year out of direct sunlight. Once infants turn 6 months of age, begin using a sunscreen for added protection. It’s important to protect your child’s eyes by using plastic lens sunglasses that protect against UVA and UVB rays.

  • Children should have arms and legs covered when out in the sun.
  • Instead of wearing baseball caps, they should wear hats with a wide brim, which provides more sun protection.
  • When children are playing in the water, make sure to use waterproof sunscreen.

8. Protect your Eyes

Radiation from the sun can damage cells in the structures of your eyes. UV radiation from the sun may increase the risk of developing cataracts later in life. UV radiation can also contribute to the development of skin cancer on the eyelid or on the surface of the eye. This damage can be prevented by protecting your eyes with sunglasses that protect against 100% UVA and UVB rays. Wearing a hat with a wide brim all the way around when out in the sun. Legionnaire style caps (caps with a flap a back flap) are also recommended to help protect the neck, ears and face.

9. Spot Check Your Moles

  • Examine your moles and freckles every month to check for any changes. See your health care provider immediately if you notice:
  • a mole or discolouration that appears suddenly or begins to change
  • a sore that does not heal
  • areas of skin that are red and bumpy, bleed or are itchy

Source: health unit


Blue Pill May Boost Risk of Deadly Skin Cancer, Study Finds

Men who use Viagra to get a boost in the bedroom could find that the little blue pill also increases the risk of developing melanoma, the deadliest form of skin cancer, a preliminary study finds.

Researchers found that men who took sildenafil, best known as Viagra, were about 84 percent more likely to develop melanoma than men who didn’t take the drug.

Because it’s just one early study, no one is suggesting that men stop taking Viagra to treat erectile dysfunction, said Dr. Abrar Qureshi, professor and chair of the dermatology department in the Warren Alpert Medical School at Brown University.

“But people who are on the medication and who have a high risk for developing melanoma may consider touching base with their primary care providers,” said Qureshi, co-author of the study of nearly 26,000 men published Monday in JAMA Internal Medicine.

Viagra may increase the risk of melanoma because it affects the same genetic pathway that allows the skin cancer to become more invasive, Qureshi said. Those who took the drug weren’t at higher risk of other, less-dangerous skin cancers, such as basal cell or squamous cell cancers.

About 76,100 new melanoma cases are expected to be diagnosed in the U.S. in 2014, and about 9,710 people will die, including about 6,470 men.

Qureshi and colleagues at several sites in the U.S. and China analyzed data about Viagra use and skin cancer from the Health Professionals’ Follow-up Study, a long-term study of male doctors and other health care workers.

The average age of men in the study was 65 and about 6 percent had taken Viagra to treat erectile dysfunction. If men had ever used Viagra, the risk of developing melanoma was about double than for those who never used the drug. That finding held true even when the researchers adjusted for a family history of skin cancer, ultraviolet light exposure in the states where the men lived, other kinds of cancer and major illnesses and other factors.

Primary care doctors who treat older men taking Viagra should check their patients for signs of skin cancer, said Dr. June Robinson of Northwestern University’s Feinberg School of Medicine, who wrote an accompanying editorial.

She cautioned that the rate of increase in new melanoma cases in men actually slowed after Viagra entered the market in 1998, raising a “cautionary note” about the impact of sildenafil on melanoma.

“But its role in the biological behavior of melanoma in older men warrants further study,” she said.

Source: NBC news


Men living alone at high skin cancer death risk

Living alone? You may be at a higher risk of death from skin cancer, especially if you are male, an alarming study claims.

Single men of all ages are more likely to die of cutaneous malignant melanoma – a most aggressive form of skin cancer – as there are differences in prognosis depending on cohabitation status and gender.

“We are able to show that living alone among men is significantly associated with a reduced melanoma-specific survival, partially attributed to a more advanced stage at diagnosis,” said Hanna Eriksson from department of oncology-pathology at Karolinska Institutet in Sweden.

“Our study shows that this applies to men of all ages, regardless of their level of education and place of residence,” Eriksson added.

By using the unique data from the Swedish Melanoma Register, researchers from Karolinska Institutet and Linkoping University made a detailed study of the link between the prognosis of cutaneous malignant melanoma and whether the patient lives alone or with a partner.

The researchers examined the risk of dying from melanoma among more than 27,000 melanoma patients in relation to their cohabitation status at the time of diagnosis.

The analysis looked into factors already known to affect the prognosis such as the characteristics of the tumour, gender, educational level and body site of the tumour was.

The researchers also found that older women living alone have a more advanced disease at diagnosis but for single living women as a group, there was no effect on the melanoma-specific prognosis.

According to the researchers, one possible explanation, particularly for the men and older women diagnosed with melanoma in later stages, are differences in taking on board information about the disease.

But it could also relate to insufficient access to skin examinations, said the study published in the scientific Journal of Clinical Oncology.

Source: Times of India


Skin cancer: Genetic mutations ‘warn of risk’

Scientists say they have taken a step forward in understanding why some people are at greater risk of skin cancer because of their family history.

A newly identified gene mutation causes some cases of melanoma, a type of skin cancer, says a UK team. The discovery will pave the way for new screening methods, they report in Nature Genetics.

The risk of melanoma depends on several factors, including sun exposure, skin type and family history. Every year in the UK, almost 12,000 people are diagnosed with melanoma.

About one in 20 people with melanoma have a well-established family history of the disease. A team led by the Wellcome Trust Sanger Institute in Hinxton, UK, found that people with mutations in a certain gene were at extremely high risk of melanoma.

The mutations switch off a gene known as POT1, which protects against damage to packets of DNA, known as chromosomes.

Co-author Dr David Adams, from the Wellcome Trust Sanger Institute, said the discovery should lead to the ability to find out who in a family was at risk, and who should be screened for skin cancer.

He told the BBC: “The mutations in this gene result in damage to the end of the chromosomes and chromosomal damage in general is linked to cancer formation – that’s the pathway for it.”

Early detection
A number of gene mutations have been identified as increasing the risk of melanoma, but others remain unknown.

Prof Tim Bishop, Director of the Leeds Institute of Cancer and Pathology, said the finding increased understanding of why some families had a high incidence of melanoma.

“Since this gene has previously been identified as a target for the development of new drugs, in the future it may be possible that early detection will facilitate better management of this disease,” he said.

The team found cancers such as leukaemia were common in these families, suggesting the gene may underlie other cancers and not just melanoma.

Dr Safia Danovi of Cancer Research UK said: “This is a step forward for people with a strong family history of melanoma, the most dangerous form of skin cancer.

“But it’s important to remember that, for most of us, avoiding sunburn and sunbeds is the best way to reduce the risk of this disease.”

Source: BBC


Skin cancer may up risk of other cancers

People who have had common skin cancers may be at an increased risk of developing melanoma and 29 other cancer types, a new study has warned. Individuals who had nonmelanoma skin cancer (NMSC) were at increased risk for subsequently developing other cancer types, and this association was much higher for those under 25 years of age, researchers said.

NMSC is the most common type of skin cancer. It is relatively easy to treat if detected early, and rarely spreads to other organs, they said. “Our study shows that NMSC susceptibility is an important indicator of susceptibility to malignant tumours and that the risk is especially high among people who develop NMSC at a young age,” said Rodney Sinclair, professor of medicine at the University of Melbourne in Australia.

“The risk increases for a large group of seemingly unrelated cancers; however, the greatest risk relates to other cancers induced by sunlight, such as melanoma,” said Sinclair. Compared with people who did not have NMSC, those who did were 1.36 times more likely to subsequently develop any cancer, including melanoma and salivary gland, bone, and upper gastrointestinal cancers.

Survivors younger than 25 years of age, however, were 23 times more likely to develop any cancer other than NMSC. In particular, they were 94 and 93 times more likely to get melanoma and salivary gland cancer, respectively. “Our study identifies people who receive a diagnosis of NMSC at a young age as being at increased risk for cancer and, therefore, as a group who could benefit from screening for internal malignancy,” said Sinclair.

Researchers hypothesised that people who develop skin cancers later in life do so as a result of accumulated Sun exposure, while those who develop skin cancer at a younger age may do so as a result of an increased susceptibility to cancer in general. To investigate this, they stratified the risk ratios by age and discovered that young people with NMSC are more cancer-prone.

The researchers constructed two cohorts: one of 502,490 people with a history of NMSC, and a cohort of 8,787,513 people who served as controls. They followed up with the participants electronically for five to six years, and 67,148 from the NMSC cohort and 863,441 from the control group subsequently developed cancers.

They found that for those who had NMSC, the relative risk for developing cancers of the bladder, brain, breast, colon, liver, lung, pancreas, prostate, and stomach remained consistently elevated for the entire period of the study, and the risk for cancers of the brain, colon, and prostate increased with time.

The study was published in the journal Cancer Epidemiology, Bio-markers & Prevention.

Source: Indian Express


Finland researchers develop handheld camera for early detection of skin cancer

VTT Technical Research Centre of Finland has developed a lightweight, handheld, ultra-precision hyperspectral camera for the detection of skin cancers and their precursors.

From the surface of the skin, the camera recognises early stages of cancer that are invisible to the naked eye.

Collaborators in the pilot study are the University of Jyvaskyla, the Paijat-Hame Central Hospital and the Skin and Allergy Hospital of Helsinki University Central Hospital. The preliminary results are promising, say the researchers.

The hand-held, mobile hyperspectral camera images the skin region in two seconds. The large field of view (12 cm2) enables the detection of large skin areas at once.

In the pilot study, the camera has been used to detect the skin areas with field cancerization i.e. areas of multiple skin cancer precursors, actinic keratoses, for early treatment of the affected areas.

The hyperspectral camera has also been used to detect the borders of poorly delineated skin tumours, such as lentigo malignas, which are difficult to detect by the naked eye, in order to avoid the need for re-excisions.

Developed by VTT on the basis of the Fabry-Perot interferometer, the hyperspectral camera captures images in up to 70 narrow wavelengths, whereas a regular camera uses only three.

The spectral image generated is a three-dimensional cube built of numerous layers of greyscale images, each of which has been taken within a limited wavelength range.

A spectrum for each pixel of the spectral image is formed by the images within the cube. Different biological tissues can be identified by their reflected spectra in hyperspectral images.

Computational methods are used to interpret these images, in order to determine the position and size of the tumour to be treated. In the ongoing pilot study, all results are being verified by histopathological sampling.

Patents have been granted for the hyperspectral camera in the US and in Finland. Heikki Saari, principal scientist at VTT, is the inventor of this patented device.

Skin cancer rates have been growing exponentially, due to population ageing and UV damage caused by excessive exposure to sunlight.

The camera is owned by the University of Jyvaskyla. It can also be used for various applications of a more general nature, according to a statement by VTT.

Source: India Medical Times


Man Has Skin Reaction to Tattoo — 20 Years Later

There have been many cases of people having allergic reactions just after getting a tattoo. But for one man in England, the reaction was delayed, coming 20 years after he got his tattoo, according to a new report of his case.

The 54-year-old man had recently completed chemotherapy for the blood cancer lymphoma, and had just undergone a bone-marrow transplant using his own cells. Six days later, when his immune system was still suppressed because of the procedure, he developed a fever.

Looking for the cause of the fever, doctors found newly formed skin lesions on the red-ink parts of his old tattoo, resembling the allergic reaction that some people experience when they get a new tattoo.

“While acute red-ink tattoo reactions are well documented, a case of a tattoo reaction with a delay of more than two decades has not been previously described,” said Dr. George Chapman, who treated the man.

Although most people who get such reactions to tattoo ink are allergic to one of the ingredients in the ink, this was likely not the case for this patient, said Chapman, of Churchill Hospital in England.

“Given this was a bone-marrow transplant of the patient’s own bone marrow, his immune system should be near identical (in terms of what his immune system reacts to, and what it has seen before) both before and after the transplant,” Chapman told Live Science in an email.

“I believe that immune-system suppression was the trigger for the reaction, Chapman said.

Most likely, the tattooing done decades ago had introduced bacteria into the man’s body, and those bacteria were held at bay by a healthy immune system, Chapman explained. But once the immune system was compromised by chemotherapy, those bacteria found an opportunity to cause problems.

In fact, three days later, when the patient’s immune system returned to normal, the lesions healed, leaving only peeling skin behind [Image of the tattoo reaction]

The patient declined a biopsy, so it remains unknown which bacteria may have caused the reaction.

However, it is also possible that the reaction was not due to an infection, Chapman said. Rather, an ingredient in the ink might have interacted with one of the chemotherapy drugs to form a new compound. This new molecule could have then appeared new to the immune system, and caused a reaction, Chapman said.

The report was published Jan. 10 in the journal BMJ Case Reports.

Source: Live science


Heavy drinking may ‘increase skin cancer risk by more than half

Heavy drinking can increase the risk of developing the deadliest form of skin cancer by more than half, researchers have warned.

Downing three or four drinks a day does more than make us careless about getting sunburnt, it causes biological changes which make the body more sensitive to sun, they say.

Even one drink a day can raise the chance of getting melanoma by 20 per cent; for heavier drinkers the risk is raised by 55 per cent.

Researcher Dr Eva Negri said the mix of UV rays and alcohol damaged the body’s immune responses.

She added: ‘This can lead to far greater cellular damage and subsequently cause skin cancers to form.

‘This study aimed to quantify the extent to which the melanoma risk is increased with alcohol intake and we hope that, armed with this knowledge, people can better protect themselves.’

The warnings, published in the British Journal of Dermatology, are based on a review of 16 other studies and 6,251 cases of melanoma.

The researchers admit they do not know exactly how drinking increases the cancer risk. But they found alcohol is turned into a chemical called acetaldehyde soon after it is consumed and that makes the skin more sensitive to sunlight.

Leading dermatologist Prof Chris Bunker said: ‘Brits haven’t always been known for their moderation when it comes to either alcohol or the sun but this research provides people with further information to make informed choices about their health.’

Source: Metro news