Category Archives: Cancer

Costco recalls frozen berries linked to hepatitis outbreak

The Food and Drug Administration is investigating an outbreak of hepatitis A linked to a frozen organic berry mix sold by an Oregon company. The FDA and the federal Centers for Disease Control and Prevention said Friday that 30 illnesses are linked to Townsend Farms Organic Anti-Oxidant Blend, which contains pomegranate seed mix. Illnesses were reported in Colorado, New Mexico, Nevada, Arizona and California. Several of those who fell ill reported buying the berry mix at Costco, according to CDC. A Costco spokesman said Friday that the company has removed the product from stores and is attempting to contact members who purchased the product since late February. Hepatitis A is a contagious liver disease that can last from a few weeks to several months. People often contract it when an infected food handler prepares food without appropriate hand hygiene. Food already contaminated with the virus can also cause outbreaks. The government has not announced a recall, but the CDC recommended that retailers and other food service operators should not sell or serve Townsend Farms Organic Anti-Oxidant Blend. Nine of the people who have been sickened were hospitalized, according to the CDC. Preliminary tests from two cases suggest this is a hepatitis A strain rarely seen in North America, but is found in the North Africa and Middle East regions. The FDA said it is inspecting the processing facilities of Townsend Farms of Fairview, Ore., which sold the mix. Bill Gaar, a lawyer for Townsend Farms, said the frozen organic blend bag includes pomegranate seeds from Turkey, and are only used in the product associated with the outbreak. “We do have very good records, we know where the (pomegranate seeds) came from, we're looking into who the broker is and we're sourcing it back up the food chain to get to it,” Gaar said. He said Townsend Farms believes Costco is the only customer who bought the product, though they are checking to see if any other retailers may have sold it. Hepatitis A illnesses occur within 15 to 50 days of exposure to the virus. Symptoms include fatigue, abdominal pain, jaundice, abnormal liver tests, dark urine and pale stool. Vaccination can prevent illness if given within two weeks of exposure, and those who have already been vaccinated are unlikely to become ill, according to CDC. CDC said all of the victims are older than 18, ranging from 25 to 71 years old. The first illnesses were reported at the end of April. The same genotype of hepatitis A was identified in an outbreak in Europe linked to frozen berries this year, the CDC said, as well as a 2012 outbreak in British Columbia related to a frozen berry blend with pomegranate seeds from Egypt. In addition to the United States and Turkey, the agency said the Townsend Farms berries also included products from Argentina and Chile.source : http://www.foxnews.com/health/2013/06/03/costco-recalls-berries-linked-to-hepatitis-outbreak/

Gene flaws surprisingly common in black women with breast cancer

Gene flaws that raise the risk of breast cancer are surprisingly common in black women with the disease, according to the first comprehensive testing in this racial group. The study found that one-fifth of these women have BRCA mutations, a problem usually associated with women of Eastern European Jewish descent but recently highlighted by the plight of Angelina Jolie. The study may help explain why black women have higher rates of breast cancer at young ages - and a worse chance of survival. Doctors say these patients should be offered genetic counseling and may want to consider more frequent screening and prevention options, which can range from hormone-blocking pills to breast removal, as Jolie chose to do. “We were surprised at our results,” said the study leader, Dr. Jane Churpek, a cancer specialist at the University of Chicago. Too few black women have been included in genetic studies in the past and most have not looked for mutations to the degree this one did, “so we just don't have a good sense” of how much risk there is, she said. Churpek gave results of the study Monday at an American Society of Clinical Oncology conference in Chicago. The researchers include Mary-Claire King, the University of Washington scientist who discovered the first breast cancer predisposition gene, BRCA1. Jolie revealed a few weeks ago that she carries a defective BRCA1 gene, giving her up to an 87 percent risk of developing breast cancer and up to a 54 percent risk for ovarian cancer. The actress's mother had breast cancer and died of ovarian cancer, and her maternal grandmother also had ovarian cancer. An aunt recently died of breast cancer. Children of someone with a BRCA mutation have a 50 percent chance of inheriting it. In the U.S., about 5 to 10 percent of breast cancers are thought to be due to bad BRCA genes. Among breast cancer patients, BRCA mutations are carried by 5 percent of whites and 12 percent of Eastern European (Ashkenazi) Jews. The rates in other groups are not as well known. The study involved 249 black breast cancer patients from Chicago area hospitals. Many had breast cancer at a young age, and half had a family history of the disease. They were given complete gene sequencing for all 18 known breast cancer risk genes rather than the usual tests that just look for a few specific mutations in BRCA genes. Gene flaws were found in 56, or 22 percent, of study participants; 46 of them involved BRCA1 or BRCA2 and the rest were less commonly mutated genes. Harmful mutations were found in 30 percent of black women with “triple-negative breast cancer” - tumors whose growth is not fueled by estrogen, progesterone or the gene that the drug Herceptin targets. Doctors have long known that these harder-to-treat cases are more common in black women. The National Cancer Institute, the Breast Cancer Research Foundation and Komen for the Cure paid for the study. It included many younger women and those with a family history of cancer, and they are known to have higher rates of gene mutations that raise risk, said Rebecca Nagy, a genetics counselor at Ohio State University and president of the National Society of Genetic Counselors. Still, “it has always stumped us” to see black families with lots of breast cancer but no mutations that can be found in ordinary testing for BRCA genes, she said. That was the situation for Alicia Cook, 44, a Chicago woman whose grandmother died of breast cancer, mother died of ovarian cancer and two sisters have had breast cancer. When she was first diagnosed with breast cancer nearly 10 years ago, a test for BRCA mutations was negative. Doctors said, “I'm sure there's something going on genetically” but they didn't have the tools to find it, Cook said. Last year, she had a recurrence and a sister who was diagnosed with the disease learned she carried a BRCA1 mutation. Cook was retested for the same mutation and found to have it. Now she is telling her relatives in hopes that more of them will seek genetic counseling and be aware of their risk. “You don't want to put people in fear, but knowledge is power,” she said.source : http://www.foxnews.com/health/2013/06/03/gene-flaws-common-in-black-women-with-breast-cancer/

New cancer drug shows promise for treating advanced melanoma

The results were presented at the 2013 meeting of the American Society of Clinical Oncology today in Chicago by Dr. Antoni Ribas, professor of medicine in the UCLA division of hematology-oncology, who led the research. Following Ribas’ presentation, the study was published online ahead of press in the New England Journal of Medicine. The results are from the first clinical trial of the drug lambrolizumab (MK3475), which was discovered and developed by Merck…

Some women can have orgasms during child birth, study suggests

When Elena Skoko gave birth to her daughter three years ago, she felt pain. But she also felt something else: waves of pleasure so ecstatic they compared to an orgasm. “I had this wavy sensation of blissful waves going through me,” said Skoko, a singer and author of “Memoirs of a Singing Birth” (lulu.com, 2012). Though childbirth is frequently spoken of in terms of pain and punishment, some women do experience what are known as orgasmic or ecstatic births. A new survey, available online May 3 in the journal Sexologies, finds that midwives report witnessing orgasms in about 0.3 percent of births. Anatomically, orgasmic birth is no surprise, said Barry Komisaruk, a professor of psychology at Rutgers University in New Jersey who studies orgasm. In fact, the intense stimulation of the vaginal canal in childbirth may work to block pain whether that stimulation is felt as sexual or not. [Awkward Anatomy: 10 Odd Facts About the Female Body] Orgasmic birth: Yes, really Anecdotal reports of orgasm during birth have long circulated in the natural childbirth community. These reports reached perhaps their widest audience yet in 2009 with the documentary “Orgasmic Birth: The Best-Kept Secret,” directed by childbirth educator Debra Pascali-Bonaro. People are often skeptical of the concept of pleasure during birth, Pascali-Bonaro told LiveScience. Some see the idea of sexual feelings during childbirth as unacceptable, she said. “People see 'birth' and 'orgasmic' together on paper, and it pushes all their buttons on sexuality,” Pascali-Bonaro said. In addition, she said, many women in America give birth in settings where they aren't able to move around freely because of fetal monitoring devices, where they have little labor support and where they aren't allowed water to drink in case of a C-section (food and beverages aren't permitted before surgery). All of these limitations make a pleasurable birth experience less likely and less imaginable for women who've had babies, she said. The new study, conducted by psychologist Thierry Postel of Blainville-sur-Mer, France, is among the first to try to put hard numbers on how many women experience moments of ecstasy in birth. Postel contacted 956 French midwives, asking them to complete an online questionnaire about orgasmic birth. He got 109 complete responses for midwives, who, combined, had assisted 206,000 births in their careers. Postel focused on midwives rather than doctors or nurses, because midwives witness many births firsthand and are reliable observers, he wrote. He also asked midwives to forward the surveys to recent mothers if they saw fit. The results “established the fact that obstetrical pleasure exists,” Postel wrote. Midwives reported 668 cases in which mothers told midwives they'd felt orgasmic sensations in birth. In another 868 cases, midwives said they'd seen mothers demonstrate signs of pleasure during childbirth. Finally, nine mothers completed questionnaires confirming they'd experienced an orgasm during birth. If anything, Pascali-Bonaro said, the survey likely underestimates the number of women who've experienced pleasure in birth by asking primarily midwives rather than mothers about their experiences. In one screening of her film, Pascali-Bonaro said an obstetrician stood up to say he'd never witnessed anything remotely orgasmic in his years of delivering babies. “Three rows behind him a woman jumped up and said, 'Doctor, I gave birth with you three years ago, and I had a very orgasmic birth, with an orgasm, but what makes you think I would tell you?'” Pascali-Bonaro said. The anatomy of orgasmic birth Skeptics of orgasmic birth abound “I've also heard that men can enjoy a similar experience by having an intimate encounter with a 20-ton press,” a commenter appropriately named “Skeptic” posted on a 2008 New York Times article about Pascali-Bonaro's movie. But research suggests that orgasm during birth comes down to simple anatomy. “It's stimulation of the birth canal, stimulation of the cervix, the vagina and the clitoris and uterine contractions,” Komisaruk told LiveScience. “A lot of women say during sexual orgasms uterine contractions feel pleasurable.” Every woman's anatomy is different, Komisaruk said, so some women may experience pleasure during childbirth while others feel only the pain. [5 Surprising Facts About Pain] “There are so many factors that could make the difference between a pleasurable response and a terribly stressful, aversive experience that you can't generalize it,” he said. “There's no reason to try to generalize. Different people have different pain thresholds. Different people have different attitudes. If a woman has a fear of sexuality, if she starts having a pleasurable sensation she may feel this is completely inappropriate psychologically, and that itself could be an aversive effect.” In other words: No pressure. “Our message is not at all that this should be a performance standard,” Pascali-Bonaro said. Rather, she said, her goal is to see women given the full range of options for birth and the support they need to experience moments of joy and bliss during the process. The science of pain and pleasure Whether or not orgasmic birth is in the cards, the anatomy involved brings good news for laboring women. Komisaruk and his colleagues have found that sexual stimulation and orgasm reduce sensitivity to pain. (Sex can even cure migraines, according to a March 2013 study.) In 1988, Komisaruk and his co-researchers published a study in the Journal of Sex Research that found when women stimulated their vaginas or clitorises, they became less sensitive to painful stimulation but not to other tactile stimulation. In 1990, the researchers followed up with a study that found women in labor had reduced pain sensitivity during labor compared with before and after. (The women in the study used Lamaze breathing techniques rather than drugs to control pain.)[Blossoming Body: 8 Odd Changes That Occur During Pregnancy] In rats, Komisaruk has found that vaginal stimulation blocks the release of a pain transmitter called Substance P right at the level of the spinal cord. In other words, the sensory neurons tasked with transmitting their message of “ouch!” to the central nervous system are stymied from the get-go. “It's an actual physiological, very primordial system of the genital system blocking pain input,” Komisaruk said. In addition, two regions of the brain that become active during orgasm, the anterior cingulate cortex and the insula, are also active during painful experiences. “There's something very intriguing going on between pain and pleasure,” said Komisaruk. Komisaruk holds a patent on the substance that blocks the pain in rats, called vasoactive intestinal peptide. A few pharmaceutical companies have shown interest, he said, but none have yet been willing to shell out the money it would take to test the substance for use as a pain medication in humans. Out of the laboratory and in the delivery room, clitoral and nipple stimulation provide pain relief for some women during labor, Pascali-Bonaro said. Some even use vibrators during labor to decrease pain. “It's such a culture where some women actually feel shamed that they have pleasure, because the expectation is pain,” Pascali-Bonaro said. “We have to change that.” For Skoko, who sang in order to get through her contractions, accepting sensuality into the birthing room was key. “The moment I realized my body is behaving sensually spontaneously and not obstructing that feeling, and just going with this feeling of my sensual body, my labor just went fast ahead,” said Skoko, who gave birth at the Yayasan Bumi Sehat natural birth center in Bali, Indonesia, where she lives part-time. “I had pain, but was not afraid of it, because I was dealing with it,” Skoko said. “It was fun, because I could laugh through it.” Copyright 2013 LiveScience, a TechMediaNetwork company. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.source : http://www.foxnews.com/health/2013/06/03/yes-orgasms-during-birth-are-real-study-suggests/

Avastin fails studies in new brain tumor patients

New research raises fresh questions about which cancer patients benefit from Avastin, a drug that lost its approval for treating breast cancer nearly two years ago. Avastin did not prolong life when used as a first treatment for people with brain tumors like the one U.S. Sen. Edward Kennedy died of several years ago, two studies found. In one, patients who were expected to benefit the most from Avastin based on genetic testing had the worst survival rates. Side effects also were more common with Avastin. The drug is approved for treating brain tumors that have recurred for people who already tried chemotherapy or radiation. But that approval was based on studies suggesting it briefly delayed the worsening of the disease. No definitive study shows it helps those patients live longer, either. Something similar happened with breast cancer: Avastin won the Food and Drug Administration's approval after studies suggested it delayed disease progression. But when later research showed it did not prolong life and brought more side effects, its approval for breast cancer was revoked. However, many cancer experts say the same thing should not happen now, and that Avastin should retain its approval for brain cancer patients whose disease has recurred. “I would definitely not want the FDA to take that away from patients,” said Dr. Deepa Subramaniam, director of the brain tumor center at Georgetown Lombardi Comprehensive Cancer Center in Washington, D.C. “That's very different from the breast cancer story,” where there are many other drugs that can be tried, she said. She had no role in the new studies, which were discussed Sunday at an American Society of Clinical Oncology conference in Chicago. Avastin, made by Swiss-based Roche's Genentech unit, acts by depriving tumors of a blood supply. It's also sold for treating certain colon, lung and kidney tumors. Another study discussed Sunday and released previously showed it helped women with advanced cervical cancer live nearly four months longer. The new brain cancer studies tested it as initial treatment for glioblastoma, the most common and deadly type of tumor. About 10,000 Americans each year are diagnosed with these tumors, which are nearly always incurable. In one study, 637 patients received standard chemotherapy plus radiation, and half also received Avastin. Both groups lived about 16 months, and those on Avastin had more side effects - mostly low blood counts, blood clots and high blood pressure. “Our study would strongly suggest that it is not beneficial to do it as front-line treatment but to reserve it as second-line or salvage therapy,” said study leader Dr. Mark Gilbert of the University of Texas MD Anderson Cancer Center in Houston. Federal grants and Genentech paid for the study, and Gilbert consults for the company. More troubling, independent experts said, is that patients who were expected to do the best based on genetic and other tests surprisingly had a worse survival trend - 16 months versus 25 months for others in the study. New research needs to be done to better define which patients benefit, said Rakesh Jain, a brain tumor expert at Massachusetts General Hospital in Boston. “We just cannot give these agents to every patient,” he said. A second study that tested Avastin as initial therapy with radiation and the drug Temodar found it did not prolong life, but patients on Avastin went nearly five months longer before their tumors appeared to worsen. Avastin costs about $43,000 plus doctor infusion charges for a course of treatment for people whose brain tumors have recurred.source : http://www.foxnews.com/health/2013/06/03/avastin-fails-studies-in-new-brain-tumor-patients/

Naturally conceived quintuplets born in Czech Republic for first time

A 23-year-old Czech woman has given birth to quintuplets for the first time in the Czech Republic. Officials at Prague's Institute for the Care of Mother and Child say four boys - Deniel, Michael, Alex and Martin - and a girl - Terezka - were born by cesarean section on Sunday. Zbynek Stranak, chief doctor at the neonatal section of the institute says the birth took place “without any complications.” Stranak says that Alexandra Kinova and her five babies have been placed at an intensive care unit. He says the babies who were naturally conceived have a 95-percent chance to grow up healthy. The father was present at the birth. Kinova who is from Milovice, a town located northeast of Prague, already had a son.source : http://www.foxnews.com/health/2013/06/03/naturally-conceived-quintuplets-born-in-czech-republic-for-first-time/

Longer tamoxifen use reduces breast cancer recurrence

Breast cancer is less likely to recur if women previously treated for the disease take the drug tamoxifen for 10 years, instead of the recommended five years, according to a British study. The study was a component of a larger international trial, for which similar results were announced last year. “I think it's huge because it's the second trial to show a benefit for 10 years versus five years,” said Dr. Sandra Swain, medical director of the Cancer Institute at Washington Hospital Center and president of the American Society of Clinical Oncology, or ASCO. “It is important not only in the U.S., but for the world. It is a very inexpensive drug.” Tamoxifen, available as a low-cost generic, has long been used for younger, premenopausal, women with early-stage breast cancer that responds to estrogen. Most start taking the estrogen-blocking drug immediately after completing their initial surgery or chemotherapy. Around 70 percent of breast cancers are estrogen-receptor positive, meaning they are fueled by the hormone. ASCO guidelines now call for women at increased risk of breast cancer to take tamoxifen for five years. For postmenopausal women, the guidelines say raloxifene, an estrogen receptor modulator sold by Eli Lilly under the brand name Evista, may also be considered. The latest findings, presented at the annual ASCO meeting in Chicago this weekend, found that side effects increased with longer tamoxifen use, but concluded that overall benefits outweigh those risks. Researchers estimated that, compared with taking no tamoxifen, 10 years of the drug reduces breast cancer death rates by a third in the first 10 years and by half after that. “Until now, there have been doubts whether continuing tamoxifen beyond five years is worthwhile,” said lead study author Richard Gray, professor of medical statistics at the University of Oxford. Between 1991 and 2005, 6,953 women in the United Kingdom who had been taking tamoxifen for five years were randomly assigned to continue treatment or to stop immediately. Breast cancer recurred in 16.7 percent of the 10-year group, compared with 19.3 percent in the five-year group. Longer treatment also reduced the risk of dying from breast cancer. The women who continued tamoxifen treatment had a 25 percent lower recurrence rate and a 23 percent lower breast cancer mortality rate than the women who had been allocated to stop after only five years. The results were called “practice changing for premenopausal women with hormone receptor-positive breast cancer,” by Dr. Sylvia Adams, associate professor New York University School of Medicine. In the United States, postmenopausal women at high risk of breast cancer are usually offered drugs in a newer class known as aromatase inhibitors, such as Arimidex, sold by AstraZeneca. “For premenopausal women the standard of care will likely include 10 years of tamoxifen,” Dr. Adams said. “For women who enter menopause during that period, AIs are still an option. Tamoxifen will also be an option.” Rare but serious side effects of tamoxifen include increased risk of endometrial cancer (cancer of the lining of the uterus), blood clots and stroke. The British researchers said they observed no excess incidence of stroke with 10 years of tamoxifen therapy, although the endometrial cancer risk was higher. They estimated that for every endometrial cancer death that occurs as a side effect of long-term tamoxifen, 30 deaths from breast cancer would be prevented.source : http://www.foxnews.com/health/2013/06/03/longer-tamoxifen-use-reduces-breast-cancer-recurrence/

Vaccine exemptions rising, tied to whooping cough

The number of New York parents who had their child skip at least one required vaccine due to religious reasons increased over the past decade, according to a new study. What's more, researchers found counties with high religious exemption rates also had more whooping cough cases - even among children that had been fully vaccinated. States set their own requirements on which vaccines a child must have received to enter school. All allow exemptions for medical reasons, and most, including New York, also permit parents with a religious objection to forgo vaccination. Less than half of states permit exemptions due to personal or philosophical beliefs. But those also can get counted under religious views in places with less strict exemption policies. “Particularly in New York State, I do believe that parents are using religious exemptions for their personal beliefs,” said Dr. Jana Shaw, who worked on the study at SUNY Upstate Medical University in Syracuse. “There's a lot of vaccine hesitancy.” Studies have shown cases of whooping cough, also known as pertussis, have been on the rise across the U.S. Researchers suspect that's due to the use of a new type of pertussis vaccine - which is safer, but less effective over the long run - and to more children missing or delaying vaccination. For their study, Shaw and her colleagues tracked data from the New York State Department of Health on both religious exemptions and new whooping cough cases. Children were reported as having a religious exemption if they had been allowed to skip at least one required vaccine for non-medical reasons. Between 2000 and 2011, the proportion of religiously exempt kids increased from 23 in 10,000 to 45 in 10,000, the study team reported Monday in Pediatrics. The number of counties where at least 1 percent of children had a religious exemption also increased, from four to 13. Most of those counties were in western or northern New York. Higher religious exemption rates were tied to more reported cases of whooping cough. In counties with at least 1 percent exemption, 33 out of every 100,000 children developed pertussis each year, compared to 20 per 100,000 in counties with fewer religious exemptions. 'Overwhelming evidence' on safety Children who had been fully vaccinated were also more likely to get sick in places with high exemption rates. No vaccine is 100 percent perfect, so infectious disease prevention relies on “herd immunity” - when enough kids are vaccinated that the infection can't spread. “If you have enough exempted children in your schools and neighborhood, they will put even vaccinated children at risk,” Shaw told Reuters Health. Saad Omer, a researcher at the Emory Vaccine Center in Atlanta, said the pattern of increasing non-medical exemptions has been seen in other states as well, including Michigan and California. Because of the general success of vaccination, “there is less disease to go around and there's less individual and collective experience. You don't hear about the disease that often,” he told Reuters Health. “When that happens, successive cohorts of parents start evaluating the real or perceived risk of vaccines more than the risk of disease.” But those perceived risks - such as a link between vaccines and autism - have not panned out. “If you look at the risk-benefit ratio between side effects of vaccines and the benefits they render, it's not even a close call. It's hugely, heavily in favor of vaccines,” said Omer, who wasn't involved in the new research. Shaw agreed. “Vaccines are extremely safe, in spite of what the Internet and other sources have argued,” she said. “We have overwhelming evidence that vaccines are safe.” Both Omer and Shaw said they don't think states and schools should pass judgment on parents' religious beliefs, but that it shouldn't be easy to get a vaccine exemption for convenience or personal preference. And, Omer added, “those who don't get (their kids) vaccinated should remember that it's not a benign choice. There are real disease risks.”source : http://www.foxnews.com/health/2013/06/03/vaccine-exemptions-rising-tied-to-whooping-cough/

Merck melanoma drug shrinks tumors in 38 percent of patients

A Merck & Co drug designed to unmask tumor cells and mobilize the immune system into fighting cancer helped shrink tumors in 38 percent of patients with advanced melanoma in an early-stage study, U.S. researchers said on Sunday. Based on the findings about the drug lambrolizumab, published in the New England Journal of Medicine and presented at the American Society of Clinical Oncology meeting in Chicago, Merck says it will move directly into a late-stage clinical trial, which will start in the third quarter. “This is a top priority at Merck,” Dr. Gary Gilliand, senior vice present and head of oncology at Merck Research Laboratories said in a meeting with investors. “We're going flat out to deliver benefit to patients with this novel mechanism.” The moves may heap pressure on market leader Bristol-Myers Squibb, maker of Yervoy - the only approved immune system drug for the treatment of advanced melanoma, the deadliest form of skin cancer. Bristol-Myers is conducting three phase-three studies of its own drug called nivolumab in advanced melanoma, and is studying the drug's effect on a range of other cancers, including lung cancer. Both nivolumab and lambrolizumab are part of a promising new class of drugs that disable programmed death 1 or PD-1, a protein that keeps the immune system from spotting and attacking cancer cells. “Even though it's (lambrolizumab) the second player in the field and even though it's all early, it impressed me,” said Dr. Antoni Ribas of the University of California Los Angeles' Jonsson Comprehensive Cancer Center, the lead author of the study. Last month, the U.S. Food and Drug Administration deemed the treatment a “breakthrough therapy,” a designation FDA cancer drugs chief Dr. Richard Pazdur described as “knock-your-socks-off therapies.” Results of an early-stage study of nivolumab in advanced melanoma released at the cancer meeting showed 31 percent of patients overall responded to different doses of the drug. Among those who took the 3 milligram per kilogram dose, 41 percent of patients responded. The drug response lasted an average of two years, and in many patients the drug kept working even after they stopped taking it. Analysts expect the drugs to generate billions of dollars in sales. Nivolumab alone is forecast to have sales of $1.2 billion in 2017, according to Wall Street analysts tracked by Thomson Reuters Pharma. Merck's study Merck's results are from the first clinical trial of lambrolizumab in advanced melanoma. They are based on analysis of 135 patients with metastatic melanoma who were divided into three groups with different treatment regimens. Overall, lambrolizumab resulted in 38 percent of patients having confirmed improvement of their cancer across all dose levels given after 12 weeks of treatment. But there was a wide range among doses, with only a 25 percent rate among patients who got the lowest dose and 52 percent among those who got the highest dose. In the highest dose group, 10 percent had a complete response, meaning their tumors could not be detected on scans. Side effects were generally mild and included fatigue, fevers, skin rash, loss of skin color and muscle weakness. More severe side effects were seen in 13 percent of patients, including inflammation of the lung or kidney and thyroid problems. “This study is showing the highest rate of durable melanoma responses of any drug we have tested thus far in this cancer, and it is doing it without serious side effects in the great majority of patients,” Ribas said. Merck said it plans to start a late-stage randomized trial of the drug in melanoma and in non-small cell lung cancer in the third quarter of this year. The company recently started a global, randomized mid-stage study of the drug versus standard chemotherapy in patients whose disease had progressed. And it is studying the drug as a treatment for triple negative breast, metastatic bladder and head and neck cancers. Researchers at the meeting marveled at responses to new immune system treatments after decades of failed studies among patients with melanoma. Only about one in five patients respond to Yervoy, approved in 2011 as the first immunotherapy to extend survival in patients with advanced melanoma. Yervoy works by blocking CTLA-4, a different molecule that also keeps the immune system from attacking cancer. Ribas said he has followed one patient on Yervoy for 12 years now. “She's not supposed to be around, and she's alive and well and melanoma free. That is why we've been doing these immunotherapies,” he said. With Yervoy, Ribas said these types of responses were few and far between. With the new PD-1 drugs, they are much more common, with fewer side effects. However, an early-stage Bristol-Myers' study released this month showed that 53 percent of patients who got a combination of Yervoy and nivolumab had at least a 50 percent reduction in tumor size, with fewer side effects. Tim Turnham, executive director of the Melanoma Research Foundation, said combination treatments would make a major difference for patients because they help overcome cancer's “sneaky” ability to evade treatment. But, at this point, he said, “Nobody knows which one is better.”source : http://www.foxnews.com/health/2013/06/03/merck-melanoma-drug-shrinks-tumors-in-38-percent-patients/