Latest messages for CancerCompass discussion http://www.cancercompass.com/message-board/message/all,37419,0.htm Tue, 24 Nov 2009 00:00:00 GMT Tue, 24 Nov 2009 00:00:00 GMT http://backend.userland.com/rss RSS.NET: http://www.rssdotnet.com/ Hey Ray: The G. Kolata article must have stroke a nerve big time, as the NCI have put out a response already, by none other than it's director: John E. Niederhuber. I have not had time to analize it yet but this is it so you can read it.Mario Putting Some Perspective on Research and Risk Dr. John E. Niederhuber For as long as there has been a National Cancer Institute, its leaders have attempted to strike a delicate balance between the potentially huge payoffs of risk-taking science and the benefits of more measured progress that comes from incremental research. It is, I believe, a healthy tension that should always be part of discovery—perhaps most importantly when it involves our work on a disease such as cancer. The work we do in our laboratories, we always hope, can eventually be used to help our patients. To me, that puts each experiment I plan in my lab in a different light.This past Sunday, an article on the front page of The New York Times, “Grant System Leads Cancer Researchers to Play It Safe,” argued that our sense of balance has become skewed. Writer Gina Kolata posited that grants awarded by NCI—and the American Cancer Society and other organizations, as well—have become “a way to keep research laboratories going year after year with the understanding that the focus will be on small projects unlikely to take significant steps toward curing cancer.”“The institute’s reviewers,” she continued, “choose such projects because, with too little money to finance most proposals, they are timid about taking chances on ones that might not succeed.”Ms. Kolata’s arguments are not especially new. Around the world, many different systems have been designed to provide financial support to scientists. I dare say, despite its weaknesses and perceived faults, the NIH peer-review system remains the envy of the world—and one of the most duplicated.Despite the high regard for our grant support structure, NIH, in an effort to continue to refine and better the system, last year released a report and an implementation plan for improving peer review. This year-long process sought input from every corner of the research community to examine the review system and address longstanding concerns that the process was too slow and biased against innovation and clinical research. Knowing the NIH system as a grantee, reviewer, and now institute director, I am particularly disappointed in the Times story. As I stressed to Ms. Kolata in a lengthy interview, an accurate account of how cancer funding priorities are set cannot be expressed in just a few simple phrases. It is a story of nuance and of leadership in moments of change, evolving technology, and scientific opportunity. Research, by its very nature, is always about new ideas, creativity, and hope.From 2004 to 2008, as NCI’s budget increases hovered below the rate of biomedical inflation, most investigators wisely chose to put their best science forward in their R01 grant proposals, and they found other ways to generate resources for higher-risk, higher-reward projects. This is no more than simple logic. In turn, as riskier efforts mature, those that prove worthy tend to work their way into one’s principal grants. In other words, I suggested in the interview, scientists are not more risk-averse today; they are simply more careful about where they place risk.Importantly, NCI counts on its division and center leaders to carefully study all grants that have received peer-review scores. NCI routinely searches through every grant that is above the year’s payline in order to fund exciting, innovative projects—and, yes, even risky applications—with potential value. For example, in fiscal year 2008, NCI used approximately $80 million to fund such innovative exceptions for grants that were above the payline. Likewise, each September, I personally review all new investigator grants that have not been funded to make sure we support as much worthy and innovative science as we have applications for, even if they fall outside the cutoff scores assigned by peer review. What is the evidence that NCI places a high priority on high-risk, innovative science? Perhaps the answer can be found in the growing number of NCI grantees who receive national and international recognition for research excellence. Just last week, Dr. Chad Mirkin 1 of Northwestern University was named the 2009 winner of the $500,000 Lemelson-MIT Prize, which is sometimes referred to as the “Oscar for inventors.” Dr. Mirkin is an NCI-funded investigator, as is Dr. Joseph DeSimone from the University of North Carolina, who won that same award last year. Also last week, two Stanford University graduate students won the inaugural IEEE Presidents’ Change the World Competition. Their work is also sponsored by NCI. Over the years, there have been 39 Nobel laureates who have been supported by NCI.“Well, that is great,” you might say, “but what about making a difference for patients?” I think it’s important to remember that ingenuity, coupled with persistence, is almost always the hallmark of NCI-supported clinical. Take for example Dr. Michael R. Grever from Ohio State University, an NCI grantee who is conducting early phase trials with a drug called flavopiridol 2. Once abandoned by industry because of potentially lethal toxicity, Dr. Grever persisted in his belief that the drug had potential benefits for cancer patients if the toxicities could be overcome. This clinical research is showing strongly positive results in chronic lymphocytic leukemia patients. There are many more such stories, including work on immunotoxins and re-engineered T cells to clear patients of advanced melanoma.In my interview for the Times story, I suggested to Ms. Kolata that the very nature of cancer science is beginning to undergo fundamental change and that not all scientific risk takes place in the realm of the classic R01 or similar grants. Consider, if you will, our initiatives in cataloguing the cancer genome, which are in fact the next generation of a project once deemed highly risky by the scientific community. The Cancer Genome Atlas 3 will increasingly require competitively awarded, task-driven science conducted by teams of researchers in order to understand the biologic function of genetic alterations associated with cancer that can be targeted by new therapeutic interventions. A sure thing? Certainly not. If we are to succeed, though, the road to new interventions, to new methods of individual prevention, and to the earliest detection, will require scientists to work as a team. Clearly, it is a different view of risk and reward.In the months and years ahead, we will witness innovative, creative science in new centers of excellence like NCI’s forthcoming Physical Science-Oncology Centers 4, where physicists, chemists, mathematicians, and biologists will come together to develop entirely new perspectives on the physical forces involved in cancer. (Notably, 7 Nobel laureates either applied for or helped review this program, and 24 National Academy of Science members and 9 National Academy of Engineering members were included in the groups that applied to form centers.) My take is that this is certainly not business as usual.We will also watch the progress of our existing programs in nanotechnology research, proteomics, and molecular analysis—all cutting-edge projects that will in turn, because of their boldness, benefit the entire research community. When NCI began each of these initiatives over 6 years ago, there were many critics.To be sure, transformative science will still happen in individual laboratories. NCI will continue to foster aggressive programs to train and support young investigators, whose new ideas will fuel the field for years to come. Those of us running active laboratories commonly acknowledge that the creativity and surprise discoveries most often come from the young people in our labs—students and fellows—and that is how it should be. We will look to our Specialized Programs of Research Excellence 5 (SPOREs) for new knowledge and its translation to the clinic. We will closely watch the recipients of the Challenge Grants and Grand Opportunities grants made possible by economic stimulus funds. We will always monitor, always adjust, and always seek the right balance. Our progress depends on it. Do we have enough resources? Of course not. We will never have enough money to do everything we want to do—or could do. Ours is not a bad system, but rather a responsible one. We strive to be good stewards of the people’s investment. From my desk, I am not seeing exciting, risky science going unsupported or witnessing stifled creativity in our programs. I see extremely dedicated scientists donating and sacrificing tremendous amounts of personal time to serve on review panels and to do their very best to make good judgments. They need to be given our loudest applause. That’s the story I wish I had read on Sunday.In the end, it is about the power of research and the promise of hope.Dr. John E. NiederhuberDirector, National Cancer Institute   Marioseeker Tue, 30 Jun 2009 00:00:00 GMT Ray: I hear you. It's the middle ages it seems.- No sense of urgency, Only business as usual. The  following article came out today. It's funny and tragic at the same time.Mario NYT: Grant system undercuts major cancer leaps Exploratory research that could lead to breakthroughs doesn't make the cutBy Gina KolataThe New York Timesupdated 12:56 p.m. ET, Sun., June 28, 2009Among the recent research grants awarded by the National Cancer Institute is one for a study asking whether people who are especially responsive to good-tasting food have the most difficulty staying on a diet. Another study will assess a Web-based program that encourages families to choose more healthful foods. Many other grants involve biological research unlikely to break new ground. For example, one project asks whether a laboratory discovery involving colon cancer also applies to breast cancer. But even if it does apply, there is no treatment yet that exploits it. The cancer institute has spent $105 billion since President Richard M. Nixon declared war on the disease in 1971. The American Cancer Society, the largest private financer of cancer research, has spent about $3.4 billion on research grants since 1946. Yet the fight against cancer is going slower than most had hoped, with only small changes in the death rate in the almost 40 years since it began. One major impediment, scientists agree, is the grant system itself. It has become a sort of jobs program, a way to keep research laboratories going year after year with the understanding that the focus will be on small projects unlikely to take significant steps toward curing cancer. “These grants are not silly, but they are only likely to produce incremental progress,” said Dr. Robert C. Young, chancellor at Fox Chase Cancer Center in Philadelphia and chairman of the Board of Scientific Advisors, an independent group that makes recommendations to the cancer institute. The institute’s reviewers choose such projects because, with too little money to finance most proposals, they are timid about taking chances on ones that might not succeed. The problem, Dr. Young and others say, is that projects that could make a major difference in cancer prevention and treatment are all too often crowded out because they are too uncertain. In fact, it has become lore among cancer researchers that some game-changing discoveries involved projects deemed too unlikely to succeed and were therefore denied federal grants, forcing researchers to struggle mightily to continue. Take one transformative drug, for breast cancer. It was based on a discovery by Dr. Dennis Slamon of the University of California, Los Angeles, that very aggressive breast cancers often have multiple copies of a particular protein, HER-2. That led to the development of herceptin, which blocks HER-2. Now women with excess HER-2 proteins, who once had the worst breast cancer prognoses, have prognoses that are among the best. But when Dr. Slamon wanted to start this research, his grant was turned down. He succeeded only after the grateful wife of a patient helped him get money from Revlon, the cosmetics company. Yet studies like the one on tasty food are financed. That study, which received a grant of $200,000 over two years, is based on the idea that since obesity is associated with an increased risk of cancer, understanding why people have trouble losing weight could lead to better weight control methods, which could lead to less obesity, which could lead to less cancer. “It was the first grant I ever submitted, and it was funded on the first try,” said the principal investigator, Bradley M. Appelhans, an assistant professor of basic medical sciences and psychology at the University of Arizona. Dr. Appelhans said he realized it would hardly cure cancer, but hoped that “it will provide knowledge that will incrementally contribute to more effective cancer prevention strategies.” Even top federal cancer officials say the system needs to be changed. “We have a system that works over all pretty well, and is very good at ruling out bad things — we don’t fund bad research,” said Dr. Raynard S. Kington, acting director of the National Institutes of Health, which includes the cancer institute. “But given that, we also recognize that the system probably provides disincentives to funding really transformative research.” The private American Cancer Society follows a similarly cautious path. Last year, it awarded $124 million in new research grants, with some money coming from large donors but most from events like walkathons and memorial donations. Dr. Otis W. Brawley, chief medical officer at the cancer society, said the whole cancer research effort remained too cautious. “The problem in science is that the way you get ahead is by staying within narrow parameters and doing what other people are doing,” Dr. Brawley said. “No one wants to fund wild new ideas.” He added that the problem of getting money for imaginative but chancy proposals had worsened in recent years. There are more scientists seeking grants — they surged into the field in the 1990s when the National Institutes of Health budget doubled before plunging again. That makes many researchers, who need grants not just to run their labs but also sometimes to keep their faculty positions, even more cautious in the grant proposals they submit. And grant review committees become more wary about giving scarce money to speculative proposals. Philanthropies, which helped some researchers try outside-the-box ideas, are now having financial problems. And advances in technology have made research more expensive. “Scientists don’t like talking about it publicly,” because they worry that their remarks will be viewed as lashing out at the health institutes, which supports them, said Dr. Richard D. Klausner, a former director of the National Cancer Institute. But, Dr. Klausner added: “There is no conversation that I have ever had about the grant system that doesn’t have an incredible sense of consensus that it is not working. That is a terrible wasted opportunity for the scientists, patients, the nation and the world.” A Big Idea Without a Backer For 25 years, Eileen K. Jaffe received federal grants to run her lab. As a senior scientist at the Fox Chase Cancer Center, with a long list of published papers in prestigious journals, she is a respected, established researcher. Then Dr. Jaffe stumbled upon results that went against textbook explanations, suggesting that it might be possible to find an entirely new class of drugs that could disable proteins that fuel cancer cells. Now she wants to find chemicals that might be developed into such drugs. But her grant proposal was rejected out of hand by the institutes of health, not even discussed by a review panel. She had no preliminary data showing that the idea was likely to work, something reviewers always want to see, and the idea was just too unprecedented. Dr. Jaffe epitomizes the scientist who realizes that if she were to single-mindedly pursue her unorthodox idea, her “career may be ruined in the process,” in the words of Dr. Brawley of the American Cancer Society. Dr. Jaffe is just conceiving her project; it is much to soon to know whether it will result in a revolutionary drug. And even if she does find potential new drugs, it is not clear that they will be effective. Most new ideas are difficult to prove, and most potential new drugs fail. So Dr. Jaffe was not entirely surprised when her grant application to look for such cancer drugs was summarily rejected. “They said I don’t have preliminary results,” she said. “Of course I don’t. I need the grant money to get them.” Dr. Young, chancellor at Fox Chase, said Dr. Jaffe’s situation showed why people with bold new ideas often just give up. “You can’t prove it will work in advance,” he said. “If you could, it wouldn’t be a high-risk idea.” It is a long haul, Dr. Jaffe knows. And she has already had to downsize her lab. But, she said, she will persist. Angels Outside Government At the Dana-Farber Cancer Institute in Boston, Dr. Ewa T. Sicinska knew she would have a similar problem with her research. She wanted to grow human cancers in mice. Unlike Dr. Jaffe, though, Dr. Sicinska did not even apply for government money. It is not that the project was unimportant. “Rather than have to start a human clinical trial to test new drugs, we want to test them first in mice with real human tumors,” said Dr. George D. Demetri, who leads the research group supporting Dr. Sicinska. Researchers have studied mouse cancers but, they acknowledge, they are just not the same as human cancers — they are much easier to treat, and drugs that cure mice often do nothing in people. So, over the years, scientists have tried to implant human cancer cells in mice, but with little success. “Everyone told us that if you take tumors out of patients and put them in mice, they don’t grow,” Dr. Demetri said. The tumor cells usually were put in a plastic dish before being implanted in mice. “We said — wait a minute. The cells are not growing in the plastic dish. They probably are dying. What if we bypass the dish?’” With that idea in mind, Dr. Demetri, convinced it was too speculative to get federal money, tapped an unusual source, the Ludwig Fund. Endowed by Daniel K. Ludwig, one of the world’s richest men in the 1960s and 1970s, the fund supports unfettered cancer research at six medical centers in the United States, including Dana-Farber, to be used at the institutes’ discretion. That put Dr. Sicinska in a very different position from that of Dr. Jaffe. She could try something chancy without a grant. Dr. Sicinska used a quarter of a million dollars of Ludwig money for this project, buying mice without immune systems, which meant they could not reject human tumors, and housing them in a germ-free basement lab. She spent months learning to implant tumors in the mice and enlisted geneticists to study the implanted tumors, making sure they did not mutate beyond recognition. She spends her days in the lab, using a miniature ultrasound machine to scan the mice, hairless creatures with prominent ears. Four types of sarcomas — cancers of fat, muscle or bone — are growing in them and look genetically identical to the tumors removed from patients. Dr. Elias A. Zerhouni, former director of the National Institutes of Health, said he was not sure that a grant for the project would have been turned down. The N.I.H., he said, does finance research on mouse models for human cancer. But Dr. Demetri said he did not apply “because we have lots of experience in what’s fundable.” His mouse work, he said, is exploratory, and he cannot predict what he will find or when. He certainly could not lay out a road map of what he would do and promise results in a few years.Studies With a Different Goal Researchers like Dr. Appelhans, who is studying weight control and tasty foods, do not expect to change the outlook for cancer patients anytime soon. But, they say, that does not mean their work is unimportant. Dr. Appelhans will study 85 overweight or obese women, measuring how much the tastes and textures of food drive their eating. Then they will be given a weight loss diet and nutritional counseling. Dr. Appelhans will ask whether those who are most tempted by the tastes and textures also have the most trouble following the diet. As for the grant to assess a Web-based program to improve food choices, it is predicated on studies indicating that what people eat in childhood and adolescence may have an impact on cancer risk in middle and old age, said the grant recipient, Karen Weber Cullen, associate professor of pediatrics at Baylor College of Medicine. Some studies have found that people who reported having eaten fruits and vegetables when they were younger and maintaining a healthy weight were less likely to have cancer. Of course, it would not be feasible to follow participants for 30 or 40 years to see if their cancer risk was altered, Dr. Cullen noted. But, she added, “we try to achieve improvements in diet and physical activity behaviors that become permanent and will make a difference in later years.” In the study asking whether a molecular pathway that spurs the growth of colon cancer cells also encourages the growth of breast cancer cells, the principal investigator ultimately wants to find a safe drug to prevent breast cancer. She received a typical-size grant of a little more than $1 million for the five-year study. The plan, said the investigator, Louise R. Howe, an associate research professor at Weill Cornell Medical College, is first to confirm her hypothesis about the pathway in breast cancer cells. But even if it is correct, the much harder research would lie ahead because no drugs exist to block the pathway, and even if they did, there are no assurances that they would be safe. Dr. Howe said she hoped that she would find such drugs, or that companies would. Then she wants to develop a way to selectively deliver the drugs to precancerous breast cells. If it all works and the treatment is safe, women with precancerous conditions could avoid developing cancer. Dr. Howe has reviewed grants for the cancer institute herself, she said, and realizes that, among other things, those that get financed must have “a novel hypothesis that is credible based on what we know already.” Trying to Change the System The National Institutes of Health has started “pilot experiments” to see if there is a better way of getting financing for innovative projects, its acting director, Dr. Kington, said. They include “pioneer awards,” begun in 2004 for “ideas that have the potential for high impact but may be too novel, span too diverse a range of disciplines or be at a stage too early to fare well in the traditional peer review process.” But only 3 percent to 5 percent of the applicants get funded. Now the institutes have decided to set aside up to $25 million for “transformative R01 grants,” described as “proposing exceptionally innovative, high risk, original and/or unconventional research with the potential to create or overturn fundamental paradigms.” About 700 proposals have come in, but only a small number are expected to be financed, according to Dr. Keith R. Yamamoto, a molecular biologist and executive vice dean of the school of medicine at the University of California, San Francisco, and co-chairman of the committee that reviewed the proposals last week. “From reading the applications so far, there are really some fantastic things,” Dr. Yamamoto said. There also is new money from the federal economic stimulus package passed by Congress, which gives the National Institutes of Health $200 million for “challenge grants” lasting two years or less. But the N.I.H. has received about 21,000 applications for 200 challenge grants, and researchers who have applied concede there is not much hope. “I did submit one of these challenge grants recently, like the rest of the lemmings,” said Dr. Chi Dang, professor of medicine, cell biology, oncology and pathology at the Johns Hopkins University School of Medicine. But, he added, “there are many, many more applications than slots.” Some experienced scientists have found a way to offset the problem somewhat. They do chancy experiments by siphoning money from their grants. “In a way, the system is encrypted,” Dr. Yamamoto said, allowing those in the know to wink and do their own thing on the side. Great discoveries have been made with N.I.H. financing without manipulating the system, Dr. Klausner said. “But,” he added, “I actually believe that by and large it is despite, rather than because of, the review system.” This article, “Grant System Leads Cancer Researchers to Play It Safe ” first appeared in The New York Times. The article is part of the ongoing series "Forty Years War."Copyright © 2009 The New York Times URL: http://www.msnbc.msn.com/id/31596443/ns/health-the_new_york_  MSN Privacy . Legal© 2009 MSNBC.com   Marioseeker Sun, 28 Jun 2009 00:00:00 GMT  On 6/23/2009 Marioseeker wrote:This news could have big implications if this is repruduced in further studies. I understand it will be tested on several othes cancers also.Mario Here is the article:www.medscape.com From Medscape Medical News "Dramatic Outcomes" in Prostate Cancer Study, But Only 2 Patients So Far Zosia Chustecka June 23, 2009 — Mayo Clinic researchers have reported "dramatic outcomes" in a prostate cancer trial. The news was picked up by many media outlets, and even made the front page of a British newspaper with a headline proclaiming Cancer: shock breakthrough.But the news is based on results from only 2 patients.However exciting the news, the fact that the results are from only 2 patients makes them "very preliminary," Anthony Smith, MD, professor and chief of urology at the University of New Mexico School of Medicine in Albuquerque, told Medscape Oncology.Both patients had advanced prostate cancer that was considered inoperable and were participating in a phase 2 clinical trial of the investigational product ipilimumab, an antibody that targets cytotoxic T lymphocytes. They received androgen ablation therapy and then a single dose of ipilimumab. Both of the patients showed a dramatic reduction in tumor size on magnetic resonance imaging and a drop in the prostate-specific antigen levels. After some discussion with the physicians involved, the 2 patients then left the trial and went on to have surgery.But the operations turned up a surprise, according to a report on the Mayo Clinic Discovery's Edge Web site."I was cutting away scar tissue, trying to find cancer cells. The pathologist was checking samples as we proceeded and sent word back asking if we had the right patient. He had a hard time finding any cancer," said surgeon Michael Blute, MD, urologist at the Mayo Clinic in Rochester, Minnesota, and coinvestigator on the trial.I had never seen anything like this before. The pathologists were floored. "I had never seen anything like this before. The pathologists were floored," he added.With the second patient, there were 2 phone calls back from the pathologists, again checking if the correct patient was undergoing surgery.One of the patients went on to receive radiation therapy after the surgery. Both patients return to the Mayo Clinic for regular follow-up, but both are "free of cancer" and "feel fine," according to the report.The Mayo researchers said the results from these 2 patients need to be validated in further studies, and plans are underway to extend the trials.Approached for comment, Dr. Smith said that the results are "pretty interesting," but he also cautioned that many early trials that appear highly promising do not pan out once larger numbers of patients are involved. He wondered whether the enthusiasm over these preliminary results is "a little over the top."Another expert approached for comment, Kevin Kelly, DO, associate professor of medicine and head of the prostate and urologic cancers program at Yale University in New Haven, Connecticut, said the findings were "very interesting, but it is hard to make anything out of 2 cases."Stimulates Immune Response? Ipilimumab is a fully human antibody that binds to cytotoxic T lymphocyte-associated antigen 4, a molecule on T cells that plays a critical role in regulating natural immune responses, according to the manufacturer, Medarex.The product is not on the market yet, but is in clinical trials in other cancers, including melanoma and lung cancer. Results from phase 2 clinical trials in melanoma were discussed at the American Society for Clinical Oncology meeting last year, as reported by Medscape Oncology. One expert explained that patients were showing a pattern of responses that had never been seen before; another noted that the responses were different from those seen with chemotherapy, so different criteria to measure clinical activity and long-term benefit are needed. "Ipilimumab involves immune activation that begins early and builds an immune response over time," said Stephen Hodi, MD, from the Dana-Farber Cancer Institute in Boston, Massachusetts.Mayo investigator Dr. Blute said "it's important for us to understand the mechanism of favorable response in these patients." He suggested that the findings could have implications for other forms of cancer, including hormone-sensitive forms, such as breast and ovarian cancer.Medarex issued a news release commenting on the 2 ipilimumab patients. Both patients had "aggressive tumors that had grown well beyond the prostate into the abdominal area," the company noted. The news release explained that they received androgen-deprivation therapy, which removes testosterone and usually causes some initial reduction in tumor size. The patients then received a single dose of ipilimumab (administered by intravenous infusion over about 3 hours). This antibody "builds on the antitumor action of the hormone and causes a much larger immune response, resulting in massive death of the tumor cells," according to Medarex.The prostate cancer trial conducted at the Mayo Clinic was investigator initiated and funded by the institution and the US Department of Defense, but Medarex supplied the drug free of charge and supported safety monitoring during the trial. [CLOSE WINDOW]Authors and DisclosuresJournalistZosia Chustecka Zosia Chustecka is news editor for Medscape Hematology-Oncology and prior news editor of jointandbone.org, a Web site acquired by WebMD. A veteran medical journalist based in London, UK, she has won a prize from the British Medical Journalists Association and is a pharmacology graduate. She has written for a wide variety of publications aimed at the medical and related health professions. She can be contacted at ZChustecka@webmd.net.Zosia Chustecka has disclosed no relevant financial relationships.Medscape Medical News © 2009 Medscape, LLCSend press releases and comments to news@medscape.net. My RN wife said to me this could be wonder full if and when it finishes the FDA trials, and comes out. The problem is, it not just getting the doctors on bord to using it. But getting the drug reps on bord to sell it, to the doctors. My self I feel there to use to making the money on chemo and radiation. She may be right, as I heard about a few good treatments go the way of the Dodo bird just be cause they cant make as much money as Chemo and Radiation they were not as good as this though but we who have cancer live in hope I just wish to see the end of chemo to see what your oncologist  gos through trying to save your life have a look at this link to Cancer Doc I just want to give all oncologist readin this a big thank you for doing the best you can with the limeted resurce you have got to use http://cancerdoc.blogspot.com/2007/12/making-money-and-slogg Cheers Ray jcr65566 Sun, 28 Jun 2009 00:00:00 GMT This news could have big implications if this is repruduced in further studies. I understand it will be tested on several othes cancers also.Mario Here is the article:www.medscape.com From Medscape Medical News "Dramatic Outcomes" in Prostate Cancer Study, But Only 2 Patients So FarZosia Chustecka June 23, 2009 — Mayo Clinic researchers have reported "dramatic outcomes" in a prostate cancer trial. The news was picked up by many media outlets, and even made the front page of a British newspaper with a headline proclaiming Cancer: shock breakthrough.But the news is based on results from only 2 patients.However exciting the news, the fact that the results are from only 2 patients makes them "very preliminary," Anthony Smith, MD, professor and chief of urology at the University of New Mexico School of Medicine in Albuquerque, told Medscape Oncology.Both patients had advanced prostate cancer that was considered inoperable and were participating in a phase 2 clinical trial of the investigational product ipilimumab, an antibody that targets cytotoxic T lymphocytes. They received androgen ablation therapy and then a single dose of ipilimumab. Both of the patients showed a dramatic reduction in tumor size on magnetic resonance imaging and a drop in the prostate-specific antigen levels. After some discussion with the physicians involved, the 2 patients then left the trial and went on to have surgery.But the operations turned up a surprise, according to a report on the Mayo Clinic Discovery's Edge Web site."I was cutting away scar tissue, trying to find cancer cells. The pathologist was checking samples as we proceeded and sent word back asking if we had the right patient. He had a hard time finding any cancer," said surgeon Michael Blute, MD, urologist at the Mayo Clinic in Rochester, Minnesota, and coinvestigator on the trial.I had never seen anything like this before. The pathologists were floored. "I had never seen anything like this before. The pathologists were floored," he added.With the second patient, there were 2 phone calls back from the pathologists, again checking if the correct patient was undergoing surgery.One of the patients went on to receive radiation therapy after the surgery. Both patients return to the Mayo Clinic for regular follow-up, but both are "free of cancer" and "feel fine," according to the report.The Mayo researchers said the results from these 2 patients need to be validated in further studies, and plans are underway to extend the trials.Approached for comment, Dr. Smith said that the results are "pretty interesting," but he also cautioned that many early trials that appear highly promising do not pan out once larger numbers of patients are involved. He wondered whether the enthusiasm over these preliminary results is "a little over the top."Another expert approached for comment, Kevin Kelly, DO, associate professor of medicine and head of the prostate and urologic cancers program at Yale University in New Haven, Connecticut, said the findings were "very interesting, but it is hard to make anything out of 2 cases."Stimulates Immune Response? Ipilimumab is a fully human antibody that binds to cytotoxic T lymphocyte-associated antigen 4, a molecule on T cells that plays a critical role in regulating natural immune responses, according to the manufacturer, Medarex.The product is not on the market yet, but is in clinical trials in other cancers, including melanoma and lung cancer. Results from phase 2 clinical trials in melanoma were discussed at the American Society for Clinical Oncology meeting last year, as reported by Medscape Oncology. One expert explained that patients were showing a pattern of responses that had never been seen before; another noted that the responses were different from those seen with chemotherapy, so different criteria to measure clinical activity and long-term benefit are needed. "Ipilimumab involves immune activation that begins early and builds an immune response over time," said Stephen Hodi, MD, from the Dana-Farber Cancer Institute in Boston, Massachusetts.Mayo investigator Dr. Blute said "it's important for us to understand the mechanism of favorable response in these patients." He suggested that the findings could have implications for other forms of cancer, including hormone-sensitive forms, such as breast and ovarian cancer.Medarex issued a news release commenting on the 2 ipilimumab patients. Both patients had "aggressive tumors that had grown well beyond the prostate into the abdominal area," the company noted. The news release explained that they received androgen-deprivation therapy, which removes testosterone and usually causes some initial reduction in tumor size. The patients then received a single dose of ipilimumab (administered by intravenous infusion over about 3 hours). This antibody "builds on the antitumor action of the hormone and causes a much larger immune response, resulting in massive death of the tumor cells," according to Medarex.The prostate cancer trial conducted at the Mayo Clinic was investigator initiated and funded by the institution and the US Department of Defense, but Medarex supplied the drug free of charge and supported safety monitoring during the trial. [CLOSE WINDOW]Authors and DisclosuresJournalistZosia ChusteckaZosia Chustecka is news editor for Medscape Hematology-Oncology and prior news editor of jointandbone.org, a Web site acquired by WebMD. A veteran medical journalist based in London, UK, she has won a prize from the British Medical Journalists Association and is a pharmacology graduate. She has written for a wide variety of publications aimed at the medical and related health professions. She can be contacted at ZChustecka@webmd.net.Zosia Chustecka has disclosed no relevant financial relationships.Medscape Medical News © 2009 Medscape, LLCSend press releases and comments to news@medscape.net.  Marioseeker Tue, 23 Jun 2009 00:00:00 GMT