Christine

By Vindu Goel Mercury News Article Launched: 10/10/2007 01:36:35 AM PDT If you were dying of cancer and there were an experimental drug that could give you an extra six months to live, you'd want access to it. You'd still want it even if it had awful side effects, like turning your skin green and making your fingernails fall off - which can happen to people taking Xcytrin, a drug from a Sunnyvale company that shows promise for treating brain lesions caused by the spread of lung cancer. But is it the government's responsibility to make it easier for you to get such life-prolonging therapies, even if they cost tens of thousands of dollars a year? That's the question the Food and Drug Administration, Congress and the courts are wrestling with as some drugmakers and patient-rights groups crusade for more flexible rules in evaluating new drugs for terminal diseases. We all want the best medicine available for ourselves and our loved ones. Yet we don't want to subsidize ineffectual treatments by paying higher hospital bills and insurance premiums. And we certainly don't want the government rushing to approve drugs that aren't safe. The evidence suggests that when it comes to approving drugs for fatal diseases, especially cancer, regulators at the FDA are being too cautious. New cancer drugs take an average of seven years to get FDA approval, and 92 percent of all applications are rejected, according to a study by Tufts University. That's a longer review time and a lower approval rate than most drugs face. In the past year alone, the FDA has turned down or demanded more data on five experimental cancer drugs, including Provenge, a prostate cancer drug that got the thumbs-up from an FDA advisory panel. The agency's actions have riled Dr. Richard A. Miller, a Stanford oncologist and chief executive of Pharmacyclics, a small publicly held biotech company which has about a year of cash left and badly needs the FDA to approve Xcytrin, its first drug. Miller has launched a Web site, www.yourcanceryourchoice.com, to push for better patient access to new cancer drugs. In February, the FDA refused to accept his company's application to market Xcytrin. Its clinical trial data didn't pass a predefined test designed to determine whether the extra five months recipients lived was due to the drug or pure chance. Pharmacyclics is demanding a formal FDA review, saying some French doctors didn't follow the study protocols, which unfairly skewed the data. Miller argues that the FDA is holding drugmakers to rigid, outdated scientific and statistical standards. "If a person is going to die in a few months, it's a different risk-benefit proposition than for someone with a hangnail," he said. Steve Whitley, a sales manager at a Phoenix cement maker, thinks the trade-offs were worth it. When his wife, Cindy, was diagnosed with lung cancer that had spread to the brain, the couple quickly decided to sign her up for an Xcytrin drug trial. Instead of living the expected three to six months, she got 25 months to spend with him and their three children. "It meant two more years of birthdays and Christmases," Steve Whitley said. A 1992 law, passed in response to the U.S. AIDS epidemic, was supposed to speed approval of drugs for fatal diseases. But recently, the FDA has become more cautious just as drugmakers try to tackle more difficult diseases. One explanation is increased scrutiny of the FDA after Merck withdrew painkiller Vioxx in 2004 because of increased risk of heart attacks and strokes. The agency declined to comment on specific drugs but said it works hard with companies to design measures of effectiveness for each drug and disease. Once those criteria are set, companies have to hit the targets. "You need to win on what you think you're going to win on," said Dr. John Jenkins, director of the FDA's Office of New Drugs. Changing the rules in the middle of the process or selectively excluding some patients is "just not scientifically sound." The Abigail Alliance for Better Access to Developmental Drugs disagrees, calling for a new law that would allow patients to buy experimental drugs and overhaul the FDA's scientific and statistical approach. The advocacy group also has sued to force the FDA to give patients early access to drugs that have passed safety tests but are still being evaluated for effectiveness. Courts so far have backed the FDA. If I were dying, I'd want the chance to weigh the risks and decide with my doctor whether to try something that might help me. The FDA, so dedicated to its traditional scientific standards, could use a dose of compassion. As Whitley put it: "What's the risk? You're going to die."

Dr. Sean Kenniff Reporting (CBS4) POMPANO BEACH - When someone is diagnosed with cancer, it can have devastating effects on the body both mentally and physically. Several cancers can spread to the spine creating tumors that cause excruciating pain. The Food and Drug Administration recently approved a treatment for these tumors which provides some much needed relief and an improved quality of life. 36-year old Eric Plummer is a family man who loves spending time with his three small children. Recurring back pain was keeping him from playing with his kids. "I had a real kind of substantial back pain that I had been fighting that had gotten progressively worse over the years," said Plummer. Visits to the chiropractor didn't help. So Plummer had an MRI that revealed his problem was much more serious. "I've got bad news. We know why your back is hurting you and you've got cancer," said Plummer. The news came one day after Father's day. Plummer was diagnosed with lung cancer that had spread to the spine. "The L3 vertebra was so diseased by the cancer that there was risk of it collapsing," said Plummer. Interventional radiologist Dr. Charles Tate with Holy Cross Hospital in Fort Lauderdale suggested Plummer undergo a procedure called a vertebroplasty. It was recently improved to treat spine tumors which are extremely painful. "This procedure allows us to go in and kill a certain area where the tumor is located in the spine and replace that killed tumor with a material we call cement," said Tate. A wand delivers a radio frequency signal that vaporizes the tumor. The surgical cement is used to prevent the bone from collapsing which could cause paralysis. Tate says it not only reduces pain and builds bone; it also rebuilds hope. "I think for those people who suffer grievously from this particular problem, I think it's a potential godsend for them," said Tate. A godsend it was for Plummer, who's quality of life has improved tremendously. “The relief was immediate. I could bend over freely play with the kids it's been liberating," said Plummer. The best part is it's done on an outpatient basis. Patients can return home a few hours after the procedure.

From center stage in New York City with Jerry Seinfeld, to the streets of San Francisco, to Detroit radio blasts, Deborah Morosini, MD, is on a mission: to honor her sister, Dana Reeve, and all of those affected by lung cancer by speaking anywhere and everywhere she can to raise funds for research and the awareness of lung cancer. As the newest board member for the Bonnie J. Addario Lung Cancer Foundation, this mom of two teenage boys, and physician researcher for a major pharmaceutical on the East Coast, is trotting coast-to-coast to cities across the country with one message: “It is time to wipe out lung cancer. Nothing less is acceptable.” As the older sister of Dana, Deborah has made it her crusade to carry on her sister’s legacy of caring and compassion. As the third generation of doctors in her family – her father is a physician and her grandfather was a doctor too, Deborah works every day as a physician researcher at AstraZeneca trying to find cures for cancer. All of this comes together to make Deborah a powerful voice for our Foundation. You can hear her emotional plea that “lung cancer matters too,” on more than 1,000 radio stations across the country from Odessa, Texas to New York City. Here’s a glimpse at what Deborah is saying on Public Service Announcements on behalf of our Foundation: “Somebody just died…while you’re listening to me. And that somebody is somebody’s sister, brother, mom, dad, daughter, son or friend. 450 people die a day. 19 an hour. From Lung Cancer. Six-hundred and fifty thousand people will die of the world’s DEADLIEST cancer by the year 2010 if we don’t do something now. Where’s the outrage? Lung Cancer Matters Too. It’s not what you think. It’s not what you’ve heard. Don’t believe that if you don’t smoke you can NEVER get lung cancer. I’m Deborah Morosini and I lost my sister, Dana Reeve, to lung cancer. Please help us save lives at the Bonnie J. Addario Lung Cancer Foundation. Because we can.” Deborah is passionate with her message. You can hear it on the airwaves on behalf of our Foundation, and you can hear it in her voice. There is urgency about Deborah, a mission to talk about the tragedy of a lack of funding for research and awareness about this deadly killer. It drives her to the speaker circuit, hoping that if she shouts loud enough, someone will listen, somehow we can beat the mortality rates and battle the ignorance about the facts of lung cancer. And, she’s also on the appearance circuit getting our Foundation’s message out. During the months ahead, her mission accelerates: • On October 11, she’ll take the stage on an “Evening with Jerry Seinfeld,” at the Hammerstein Ballroom, 311 W. 34th St. in New York. Proceeds from the evening will benefit the Memorial Sloan-Kettering Cancer Center. The event is being organized by Stand Up For a Cure. • She’s also doing a pod cast for “Smoke Free Michigan,” for the American Cancer Society. Smoke Free is a grass roots statewide organization working for smoke-free environments wherever the public gathers in this Midwestern state. Deborah will make her plea. • And she’s coming to San Francisco in November as one of our guests for the Simply the Best Gala: On November 9, Deborah will accept an award in her sister’s behalf at our second annual “Simply the Best Dinner Gala II” at the Fairmont Hotel. SIMPLY THE BEST II celebrates the end of lung cancer through the eyes of the very best doctors, families and friends of our cause because lung cancer matters too. • On November 30, she will speak at the “State of the Art Lung Cancer Diagnosis and Treatment Medical and Advocacy Conference” at the Ritz Carlton Hotel in Dearborn, Michigan. Her presentation: “Icons of Survival: The Positive Legacy of Dana and Christopher Reeve.” Her participation will provide a valuable opportunity for lung health professionals and individuals affected by lung cancer to hear from the most highly respected experts in the field. The program is sponsored by the American Lung Association of Michigan and the Karmanos Cancer Institute. “I can’t speak enough; I can’t do enough, until we’re taken seriously and the tragedy of lung cancer is over,” says Deborah. Dr.Fred Marcus to Present the “Simply the Best Award” to Deborah Morosini “Lung cancer not only takes victims—it takes parts of whole families that can never be replaced.”–Dr. Fred Marcus As a physician specializing in Pathology, Dr. Deborah Morosoni has sat behind the microscope to make the very unfortunate diagnosis of lung cancer. Her first-hand experience–previously only from a distance–became up-close and very personal when her 44-year old younger sister, Dana Reeve, was diagnosed with lung cancer in August 2005. Dana was a very talented actor and singer who had never smoked a single cigarette. Dana’s professional career was put on an abrupt hold, when her husband, Christopher Reeve suffered a severe and debilitating Spinal Cord injury after a tragic fall from his horse. Dana dedicated her life to helping Christopher with his disability and the two of them founded the Christopher and Dana Reeve Foundation to help other victims of spinal cord injuries. A bright light went out on March 6, 2006, when Dana died from lung cancer. This very moment ignited a new light and on the very same day, Bonnie J. Addario began this Lung Cancer Foundation. Despite every effort to provide the best medical care for Dana, Deborah halted her career to help her sister in dealing with this illness. After Dana’s death, Deborah decided to go on a mission that would honor her sister and one day bring an end to the tragedy of lung cancer. Deborah decided that she would stand up for all those affected with lung cancer and do everything she can to call attention to the fact that lung cancer is the major cause of cancer deaths in this country and in this world and that every effort and as much funding as possible needs to be mobilized to eradicate lung cancer. Deborah’s enormous energy and passion for this mission is completely reflective of Dana’s care and compassion. Dana would be so proud of her sister’s dedication to this cause. As recipient of the very first “Simply the Best Award,”Dr. Fred Marcus has been searching his soul for just the right individual to bestow this great honor upon this year. Conceived to honor those like Marcus by Bonnie J. Addario, this award is intended to honor outstanding performance in the fight to end lung cancer. This award sends a powerful message, not only to the entire world audience that will soon know about the devastation of lung cancer through the work of this Foundation, but to the individual that receives it. It acknowledges and honors all they have done and all they are continuing to do to make this world a better place. BJALCF Board Member, Dr.Deborah Morosini, is the recipient of this year’s SIMPLY THE BEST award in honor of all of the spirit, compassion, dedication, boundless energy, and unfettered conviction she beholds, to save as many lives as she can through raising awareness of early detection, and ultimately the eradication of lung cancer. “Think how many things in this country have been considered hopeless before? At first they seem impossible, then they seem improbable, and then if you can summon the will and get the funding–they become inevitable.”–Christopher Reeve

Science Daily — Researchers at Cold Spring Harbor Laboratory (CSHL) have discovered three genes that interact with cancerous results in 20% of lung cancers. The three genes are located next to each other on human chromosome 14 and two are known to play key roles in fetal lung development. According to CSHL lead investigator David Mu, "lung cancer cells in adults can reactivate genes that are normally active in the earliest stages of lung development. We identified the mutation that triggers this abnormal re-activation of developmental genes and showed that if you turn off these genes, you stop the cancer." The CSHL research found that the three genes termed TTF1, NKX2-8, and PAX9 interact to reactivate what appears to be an early fetal gene expression pattern that results in cancer tumor growth. "The collaboration of these genes and the fact that they are so close together on the chromosome may explain why this mutation is so common in lung cancer," said CSHL investigator and co-author Scott Powers. In collaboration with Dr. William Gerald at the Memorial Sloan Kettering Cancer Center, the study finds that the mutation is more prevalent in late stage lung cancer and is possibly a risk factor for recurrence. The CSHL-led research demonstrates that the cancerous results of the mutation can be reversed. In the future, this may lead to new treatment options for patients. Cancer research that looks at one gene at a time ignores the fact that cancers are usually caused by multiple collaborating cancer genes. Mutations in these genes determine the clinical outcome of the cancerous growth and how the cancer responds to treatment. "At CSHL we are excited about the ability to apply direct genomic analysis to human cancers and discover more about how cancer genes interact," said Howard Hughes Medical Institute Investigator and CSHL Cancer Center Deputy Director Scott Lowe. Citation: Jude Kendall; Alex Krasnitz; B. Lakshmi; Scott Powers; David Mu; Qing Liu; Amy Bakleh; Ken C. Q. Nguyen, Cold Spring Harbor Laboratory and William L. Gerald Memorial Sloan--Kettering Cancer Center."Oncogenic cooperation and co-amplification of developmental transcription factor genes in lung cancer" Proceedings of the National Academy of Sciences DOI: 10.1073PNAS.0708286104 The research was supported by NCI Cancer Center Funds and the Joan's Legacy Foundation. Note: This story has been adapted from material provided by Cold Spring Harbor Laboratory.

Rocky Mountain News October 9, 2007 Question: I just read about a study which found that CT scans can find early, curable lung cancer. Do you recommend this test for smokers and former smokers? Dr. Weil's Answer: The study you refer to is an important one. Researchers at New York Presbyterian/Weill Cornell Medical Center in New York City recently published research results suggesting that 80 percent of deaths from lung cancer could be prevented with annual CT scans. The tests can find lung cancer early enough to treat and cure it. A total of 31,567 people in seven countries participated in the study. Those screened included smokers, former smokers and people considered at risk because they had been exposed to environmental toxins such as radon and secondhand smoke. The scans detected 484 lung cancers, 412 of them at a very early stage. Most of these cases were treated with surgery although some patients had chemotherapy or radiation or both instead. The question of whether everyone at high risk of lung cancer should be screened annually by CT is still controversial. This study makes a persuasive case because it included a large population and was well designed. But some experts argue that there should have been a control group of similar patients who weren't screened to demonstrate whether or not there really is a benefit to the annual CTs. My feeling is that the screening is a good idea for people at high risk. Lung cancer is the leading cause of cancer deaths in the United States and is responsible for more than 160,000 deaths every year. This study shows that screening could prevent 80 percent of those deaths if cancers were found early and treated appropriately. If you think you should have the test, talk to your physician and be sure to have it performed at a facility that has doctors who are experienced in lung scanning and has physicians who can help you decide upon treatment, if necessary. Be forewarned, however: The scans can cost hundreds of dollars, and most insurers don't cover them. To ask Weil a question, visit his Web site, drweil.com, and click "Ask Dr. Weil" and then "Ask Your Question."

New tool in fight against lung cancer Chicago Daily Herald Published: 10/8/2007 11:24 PM Whether they know it yet or not, countless numbers of Illinois residents have just been given a powerful weapon in the fight of their lives. On Aug. 27, state Sen. John Cullerton, D-Chicago, state Sen. Kwame Raoul, D-Chicago, and state Rep. Fred Crespo, D-Hoffman Estates, championed and ultimately won passage of Illinois Senate Bill 796, which created the landmark lung cancer research fund. This vital legislation will allow Illinois residents to allocate a portion of their 2007 state income tax to lung cancer research simply by checking a box on their tax return. Some may ask, "What's so important about the lung cancer research fund?" Its significance lies in its potential to advance cutting-edge research for the most lethal form of cancer, which this year alone will claim over 150,000 lives in the United States. Four years ago, it claimed the life of my energetic and brave father within a period of just 10 months. Often perceived and shunned as a smoker's disease, lung cancer is being increasingly diagnosed at alarming rates in non-smokers and former smokers, especially among women. Despite the grave statistics surrounding lung cancer -- it kills more Americans every year than breast, prostate and colorectal cancers combined; and 85 percent of those diagnosed with the disease will die within five years without new treatment methods -- the federal government spent just over $1,800 on research per lung cancer death in 2005. By comparison, the federal government spent $23,400 for each breast cancer death and $14,300 for each prostate cancer death. Making matters worse, lung cancer is often caught so late that there is a short window of time for effective treatment. Beginning this year, every Illinois taxpayer will have the power to help turn the tide against lung cancer. With the lung cancer research fund, broadminded legislators, volunteer advocates, and organizations such as the Respiratory Health Association of Metropolitan Chicago, have taken a big step forward in erasing the unfortunate stigma often associated with this silent killer. Jennifer A. Moran Chicago

URL for this article: http://online.wsj.com/article/SB119179920110451468.html Critics Question Objectivity Of Government Lung-Scan Study. Tobacco Companies Paid Key Researchers As Expert Witnesses By DAVID ARMSTRONG October 8, 2007; Page B1 In a dispute with broad implications for cancer treatment, patient advocates and congressional overseers are raising questions about the objectivity of a massive federal study that is supposed to determine whether annual CT scans of smokers' lungs can save lives. The nine-year study, called the National Lung Screening Trial, is tracking 50,000 smokers at a cost of $200 million, and is funded by the National Cancer Institute, or NCI. Due to be finished in 2009, the study is expected to have a major impact on whether regular CT scans for smokers will become a standard of care -- and whether tobacco companies could be forced to pay for them. The 90 million current and former smokers in the U.S. are all potential candidates for such screening. Since late last year, the Lung Cancer Alliance, a Washington, D.C., nonprofit that supports screening, has asserted in letters to the NCI and its parent, the National Institutes of Health, that two of the study's key researchers have conflicts of interest because they have accepted money from tobacco companies to be expert defense witnesses in lawsuits. The suits sought to force the companies to pay for annual CT screening. The Alliance, which is funded by individual donations and corporate grants, including $100,000 from General Electric Co., a maker of CT scanners, also charged the study has design flaws that could bias its outcome against screening. In recent months, staffers of the U.S. House Energy and Commerce Committee, which oversees medical research issues, have also begun making inquiries about the alleged conflicts and design issues, say people familiar with the matter. The question under consideration in the study is a complex one. CT, or computed tomography, scanning is adept at detecting abnormalities that might be cancerous. But once they are detected, potentially risky lung biopsies are usually needed to confirm the presence of cancer in the lung. Often, the biopsies turn up no cancer. Skeptics say patients may suffer health problems as a result of universal screening -- such as complications from biopsies or needless surgery -- offsetting any gains from enhanced detection. The researchers that the alliance and the congressional staffers are focused on are University of California Los Angeles radiologist Denise Aberle, one of the study's two national leaders; and Dartmouth College radiologist William Black, the principal investigator at one of the 30 study sites in the country. In a 2003 trial of a lawsuit brought in state court in Louisiana, Dr. Aberle testified for the American Tobacco Co., now part of Reynolds American Inc., that "it is reckless or irresponsible to promote" CT screening. Court transcripts in the Louisiana case show that Dr. Aberle's role as co-leader of the government study was highlighted repeatedly. American Tobacco lawyer Gary Long says that what made Dr. Aberle a good witness was "the fact she could talk about the national lung cancer screening trial that is ongoing." In a similar case in New York, Dr. Black provided an expert report for Philip Morris USA, a unit of Altria Group Inc., in which he warned that CT screening "may do more harm than good." Smokers lost their bid for screening in the Louisiana case. The New York case is still pending, as is similar case in Massachusetts. The lawsuits haven't been closely followed by the media, and the researchers' roles in the cases weren't widely known until the alliance discovered them. The NIH doesn't have conflict-of-interest rules for the nongovernment researchers it funds, and relies instead on the institutions where the researchers work to set guidelines. Universities generally require their faculty researchers to disclose consulting arrangements and other financial ties, and some schools ban some relationships outright. Dr. Aberle denies any bias and says she decided to testify because the screening plan proposed by the plaintiffs in the Louisiana case was "poorly constructed" and "incompletely conceived." Among the flaws, she said, was the lack of a plan for how the patients would be treated following a screening test, or any provision to track patients to find out if screening had any impact. Dr. Aberle and UCLA say her expert work in the case was permissible under UCLA rules. American Tobacco paid a total of $30,750 for Dr. Aberle's expert work in the Louisiana case, according to her and UCLA. The money, after taxes, was then deposited into a UCLA account. UCLA says she used the money for "academic enrichment," such as business-related travel and entertainment expenses or subscriptions to journals. Dr. Black said he agreed to be an expert witness because he "felt an obligation that someone needed to stand up and represent the other side of the screening issue." He added, "the other side is getting away with false statements -- that it is a proven technology and saves lives." Dr. Black now says his decision to get involved in the court case was "naive." He has returned the $700 he earned from Philip Morris and stopped working for the company because of his concern the expert work "would be used against me" and the study "by patient advocacy groups on the other side." Dartmouth declined to comment, but in a letter to the Lung Cancer Alliance said the work was permissible under its rules. In a written response to the Lung Cancer Alliance, the NCI said the expert witness work was appropriate. "Service as an expert witness, presenting independent analyses based on published medical literature, is a commonly accepted activity for physicians, researchers, and other experts and in the instance of the specific circumstances described did not violate the required disclosure guidelines of the organizations involved," NCI director John Niederhuber wrote. In an interview, an NCI spokesman said the institute has no way of knowing whether any other investigators in the 30-center study have financial ties to tobacco or scanning companies because it does not examine such potential conflicts. A spokeswoman for Siemens Medical Solutions, a big CT machine maker, said the company works on collaborative research projects with several research institutions but wouldn't say if it has any relationships with individual researchers working on this study. GE, another large CT vendor, declined to comment. David Rothman, the director of the Center on Medicine as a Profession at Columbia University medical school, said he was "stunned" to learn that the researchers in the government study had testified for tobacco companies and said the NIH should overhaul its rules to prohibit such work. The Lung Cancer Alliance and others also complain about the trial's design, in part because it compares patients receiving CT scans with those receiving X-rays. If abnormalities are detected by X-ray and a CT confirms cancer, the X-ray, not the CT, will be credited with the discovery. Critics also say that 50,000 patients are too few to detect a benefit. In its written response to the Alliance, the NCI said that the there are enough patients in the study and that the study is scientifically "very well designed." Write to David Armstrong at david.armstrong@wsj.com

Source:Healthcare Exec Date:03/10/2007 11:38:48 Roche, the pharmaceutical giant, is to lower the price of the drug for a limited time while it is re-appraised by the National Institute for Clinical Excellence. The company says it is making the move to make sure patients are not denied the drug by Primary Care Trusts that are awaiting final NICE guidance. This decision has been made to prevent the phenomenon known as "NICE blight", where Health Authorities back decisions on funding of a product on the NICE work programme pending a decision by NICE, which is often issued months or even years after grant of a licence. By lowering the price to the same as its competitors, Roche hopes this process can be sidestepped. "We do not want to sit back and watch while blocks prevent patients gaining access to Tarceva, while NICE is re-evaluating its clinical and cost effectiveness," said John Melville, Roche General Manager in the UK. "We are confident that Tarceva is clinically and cost-effective. Yet, by matching the price of current second-line lung cancer chemotherapy, we have taken the issue of cost off the table, while NICE continues its deliberations." Professor Nick Thatcher, Professor of Medical Oncology, Christie Hospital Manchester commented: "I have had patients whose lives have been transformed by this treatment, who have seen an improvement in their prognosis and a reduction in some of the devastating symptoms that come with the disease. “I welcome Roche's interim measure and the chance to be given the same freedom as clinicians in Scotland, to prescribe this drug to patients whom I consider eligible for treatment."

http://www.healthcarerepublic.com/news/ ... er-deaths/ 03-Oct-07 A gene that increases susceptibility to breast cancer may also predict worse outcomes in lung cancer patients, a European study has shown. High levels of the BRCA1 breast cancer gene have been shown to double the risk of mortality over three years following surgery for non-small cell lung cancer (NSCLC). Outcomes in NSCLC patients could be improved by offering adjuvant chemotherapy to those with high levels of the gene, the researchers suggested. They analysed tumour samples taken from 126 Polish patients during surgery for NSCLC. They then measured levels of five genes believed to play a role in progression of NSCLC, including BRCA1. Of the five genes, only BRCA1 was found to be predictive of survival. Patients with high levels of BRCA1 expression had a 98 per cent increased risk of dying within three years of surgery, compared with patients with low levels of BRCA1. Event free survival in the 36 patients whose tumours had high levels of BRCA1 was 22 months on average. Additional study of NSCLC tumour samples from a separate group of 58 patients, confirmed that high BRCA1 expression more than doubled the risk of death. gpletters@haynet.com European J Cancer Supp. 2007; 5 (4); 358 www.ecco-org.eu

By Nic Fleming, Medical Correspondent, Telegraph UK Last Updated: 2:30am BST 02/10/2007 Lung cancer sufferers could be given access to a treatment believed to extend life expectancy after the Government's health watchdog agreed to review a previous decision to deny NHS patients the drug. Tarceva is a once-daily tablet designed to treat non-small cell lung cancer – the most common form of the disease – if initial attempts to treat it with chemotherapy fail. Trials suggest patients on the drug were 40 per cent more likely to survive for at least a year after treatment compared to placebo, and that 15 per cent of patients using the drug survived beyond two years. The National Institute for health and Clinical Excellence (Nice) ruled in March that Tarceva, which costs £1,600 per month or £6,800 for a typical course of treatment, was not cost-effective compared to the existing treatment docetaxel. But an appeal was lodged by charities Cancerbackup and the Roy Castle Lung Cancer Foundation, the Royal College of Physicians, the Association of Cancer Physicians and Roche, which makes the drug. The organisations argued that Nice had failed to take into account potential cost savings linked with a reduction in side effects for patients on Tarceva as opposed to docetaxel. A final decision for England and Wales will be made next year. Nice's Scottish equivalent has already ruled in favour of the drug.

29 Sep 2007 The Society for Women's Health Research gathered three lung cancer experts on Capitol Hill on September 17, 2007 to inform Congress on the need for increased funding to research lung cancer and its impact on women. "We focused on lung cancer today because lung cancer is the leading cause of cancer death for both women and men in America," said Phyllis Greenberger, M.S.W, president and CEO of the Society, a Washington, D.C. based advocacy organization. "A growing body of research is showing differences in susceptibility, progression and responsiveness to treatment in lung cancer between women and men." Laurie Fenton Ambrose, president and CEO of the Lung Cancer Alliance said, "More people are recognizing lung cancer, which has been stigmatized for so long as a self-imposed condition, as a disease. That's the good news." The bad news is that the five-year survival rate has only grown from 12 percent in 1971 to 15 percent today. According to the Lung Cancer Alliance, lung cancer kills over 70,800 women a year, 30,000 more than breast cancer. Yet lung cancer research is severely under funded. In 2006, the National Cancer Institute spent approximately $13,519 for research on breast cancer per death compared to only $1,638 on research per lung cancer death. Joan Schiller, M.D., chief of the Division of Hematology and Oncology and deputy director of the Simmons Comprehensive Cancer Center at the University of Texas Southwestern Medical Center in Dallas, pointed to the changing face of lung cancer. The death of actress and nonsmoker Dana Reeve in 2006 drew attention to the disturbing fact that nonsmokers account for 13-15 percent of new lung cancer cases each year. Unfortunately, there is little information on why nonsmokers develop lung cancer. Air pollution and exposure radon or asbestos have been linked to lung cancer risk, but most experts believe that second hand smoke is the leading risk for lung cancer among individuals who have never smoked. There is conflicting data about whether women nonsmokers are more susceptible to lung cancer than men, but a study in the Journal of Clinical Oncology last February found that about 20 percent of lung cancer cases in women occur in nonsmokers, compared to eight percent in men. Research is underway to examine whether the biological traits of being a woman or a man impacts lung cancer susceptibility. Jill Siegfried, Ph.D., professor and vice chair of pharmacology at the University of Pittsburg School of Medicine and co-director of the Lung and Esophageal Cancer program at the Pittsburgh Cancer Institute, spoke at the briefing about her research involving estrogen's role in lung cancer development. "We've learned that lung tumors have the ability to use estrogen pathways to stimulate growth," Siegfried said. "Anti-estrogens and aromatase inhibitors, drugs that prevent the body from responding to or making estrogen, may benefit lung cancer patients who have an active estrogen pathway." All of the experts agreed that more research is needed so that we can save lives with improved diagnosis and treatment. Society for Women's Health Research (SWHR) 1025 Connecticut Ave. NW, Ste. 701 Washington, DC 20036 United States http://www.womenshealthresearch.org -------------------------------------------------------------------------------- Article URL: http://www.medicalnewstoday.com/articles/84050.php

Happy Birthday Nick. I hope you had a wonderful day!

Dana-Farber provides "favors" for donations made to The Jimmy Fund. I revised it a bit, but this is similar to what they print on the favors they provide: A gift has been made in your honor to the Lungevity Foundation in loving memory of "your mother's name". Here is a link to the website if you would like to take a look at it. http://www.jimmyfund.org/gif/favors/

Proof, in my opinion, that LC screening with CT scans works. TheStar.com Lung cancer poses deadliest threat - by far September 27, 2007 Elvira Cordileone Staff Reporter In the time it takes to read the next few paragraphs, someone will die of lung cancer somewhere in the world. The Global Lung Cancer Coalition says lung cancer consumes one human being every 30 seconds – more than breast and prostate cancer combined, with another 1.2 million new cases diagnosed every year. If everything goes well, Milton resident Sherry Walker, 57, won't be among the casualties. In June, surgeons made a crescent-shaped slice along the right side of her upper back, cracked open her ribs and removed the top lobe of one lung, where a 2.5-centimetre tumour festered. Tests later revealed a trace of cancerous cells in a single lymph node, putting her in stage two of the disease. Walker's early diagnosis came to light by a stroke of good fortune. In March, family doctor Helen Pyle told her about an early lung cancer screening study for people at high risk – former and current smokers included – at Princess Margaret Hospital. As a half-pack-a-day smoker for most of her adult life, she had no trouble qualifying for the study. The hospital is the only Canadian institution participating in an International Early Lung Cancer Action Program, which aims to prove that early detection saves lives. It uses a CT scan, which shows many cross-sectional images of the lungs from top to bottom. An X-ray shows only two views of the chest, front and side and can miss lung cancers. Since the program started in 2004, it has detected 20 lung cancers in 1,000 scans, of which the vast majority (78 per cent) were in stage one, says Heidi Roberts, principal investigator. This is when lung cancer has the best cure rate. Usually by the time symptoms appear, it's too late. Walker, who has now stopped smoking, had the 20-second, low-dose computed tomography (CT) scan in April. Two days later, she got a call telling her she needed an emergency biopsy. In the year before the diagnosis, Walker experienced a succession of colds, sore throats and fatigue so acute she even quit her beloved bowling league. Although two chest X-rays revealed nothing, she insists her little Shih Tzu, Maggie, knew better. "Maggie wouldn't leave my side. She would lie at the edge of the bed beside me, right up along my upper back," Walker recalls. "I remember thinking, `What is she doing?'" Walker's chemotherapy ends in November, and she now expects to die of something other than lung cancer at a ripe old age. She will be monitored with CT scans every three months. Lung cancer is the most common – and deadliest – of all cancers, according to Lung Cancer Canada. Last year, almost 23,000 Canadians were diagnosed with the disease and another 27,000 cases are expected to be diagnosed this year. "That 27,000 is the size of a small town," says Dallas Petroff, Lung Cancer Canada's executive director. "Visualize losing a small town every year and it's amazing there hasn't been more of an outcry." The Canadian Cancer Statistics 2007 report predicts the disease will claim about 9,000 Canadian women in 2007. By contrast, breast cancer deaths will number about 5,300 – even though twice as many women will be diagnosed with breast cancer as lung cancer. Early detection saves lives, says radiologist Heidi Roberts, Princess Margaret's principal investigator. Nevertheless, no regular screening programs exist to catch the disease early, when treatment is more successful and less invasive. Dr. James Gowling, chair of the Cancer Advocacy Coalition of Canada, also points out lung cancer research lacks the lavish funding raised by breast cancer advocacy. That's because most lung cancer patients don't live long enough to advocate for their disease, he says. "If you look at the amount of money spent on breast cancer, there's a 30-times' difference," says Gowling, a Cambridge-based hematologist and oncologist. In a recent telephone conversation from Seoul, Korea, while attending a biannual world conference on lung cancer, Gowling says lung cancer treatment is 20 years behind breast cancer. Finding tumour markers and developing drugs targeted to those markers requires a lot more research – and funding. "Lung cancer is a neglected and stigmatized disease," says Sunil Verma, a medical oncologist at Sunnybrook Hospital's Odette Cancer Centre. The stigma comes from its association with smoking. According to Lung Cancer Canada, 35 per cent of the people who get it are former smokers and 50 per cent are current smokers. But 15 per cent of those who get lung cancer never smoked. Susan Managbana belongs to the latter group. She never put a cigarette to her lips but has advanced lung cancer. Managbana, 45, came from Singapore on a visitor's visa in 2005. She met Toronto resident Peter Laidlaw, and they married last year. Her cancer came to light in a routine immigration chest X-ray. A biopsy in December revealed malignant cells had spread. Surgery wouldn't help. "I'd had no symptoms at all, only migraine," says Managbana. Nevertheless, she has a good quality of life today, thanks to an experimental drug called erlotinib, (trade name Tarceva), which inhibits cells from growing and multiplying. "The drug was effective very quickly," says Laidlaw. "In less than a week, the pain disappeared, the size of the tumour reduced and she's stable." But the couple faces another worry: The drug's clinical trials only admit people who've had chemotherapy, so they have to pay for the drug out of their own pockets. Laidlaw says it costs $1,900 a month – and he's self-employed as a consulting engineer and part-time vintner. There's no effective screening for lung cancer, and its symptoms, such as a persistent cough or back pain, are vague. Lung Cancer Canada reports about 85 per cent of people diagnosed with lung cancer die within five years of diagnosis. Walker insists the screening program saved her from early death, but the medical community is divided about whether screening reduces mortality rates. "It's a statistical feature (the doubters) are looking for," Roberts says. "They want a randomized trial for 10 years." She points to a study published in the New England Journal of Medicine last October that concluded 92 per cent of those discovered to have early stage lung cancer through CT scans who were treated survived 10 years after diagnosis. "I totally believe in this work," Roberts states. Verma goes further: "If we do detect it earlier, we can cure this cancer. But in more than half the cases, it's already advanced." For more information, visit the website at lungcancercanada.ca.

Daddy's little girl.... congratulations Nick. You're going to be a WONDERFUL father!

Attitude There once was a woman who woke up one morning, looked in the mirror, and noticed she had only three hairs on her head. "Well" she said, "I think I'll braid my hair today." So she did and she had a wonderful day. The next day she woke up, looked in the mirror and saw that she had only two hairs on her head. "Hmm," she said, "I think I'll part my hair down the middle today." So she did and she had a grand day. The next day she woke up, looked in the mirror and noticed that she had only one hair on her head. "Well," she said, "today I'm going to wear my hair in a pony tail." So she did and she had a fun, fun day. The next day she woke up, looked in the mirror and noticed that there wasn't a single hair on her head. "YEA!" she exclaimed, "I don't have to fix my hair my hair today!" Attitude is everything. Be kinder than necessary, for everyone you meet is fighting some kind of battle. Live simply, Love generously, Care deeply, Speak kindly, Leave the rest to God Life isn't about waiting for the storm to pass; it's about learning to dance in the rain. - authors unknown

By LAURAN NEERGAARD WASHINGTON (AP) — You've finished the surgery, the radiation, the chemotherapy. You're a winner, a cancer survivor. Now what? A new push is on to provide patients with "survivor plans," long-awaited blueprints for the customized follow-up care they'll require for years. Few today get that careful send-off as they leave cancer specialists and head back to their regular doctors, even though the Institute of Medicine alerted the nation two years ago that these survivors' special needs weren't being met. Now a major doctors' group is creating easy-to-fill-out checklists that survivors can hand to future physicians — what checkups to get and when, what late side effects their treatment may trigger, what new symptoms to watch for. The American Society for Clinical Oncology recently posted the first such documents — for colorectal and breast cancer — on its Web site, free to copy and customize. ASCO is developing guides for other leading malignancies — lung cancer is next — and a more general plan for less common cancers. "We're at the cusp of a very dramatic change in the way we're going to be delivering coordinated care for cancer survivors," predicts Dr. Patricia Ganz of the University of California, Los Angeles, a cancer survivorship specialist who spearheaded the ASCO guides. Today, "the patient feels lost," she explains. "If everybody has the same marching orders, it will be a lot easier." There are roughly 10 million cancer survivors, a population rapidly growing thanks to advances in early detection and treatment. When active treatment ends, those people too often don't realize their simmering health risks. It's not just the possibility of the initial cancer returning or a new one forming. Treatment may have left infertility, memory or mobility damage, impaired organ function. Some side effects may not appear for years. Then there are psychosocial consequences, from depression to problems keeping health insurance. Consider the contrasts: Have a baby and you're sent home with care instructions, including when mom and child are to check in with their respective doctors. Have heart surgery, and likewise you receive nutrition and exercise rules, a list of worrisome symptoms and a checkup date. Cancer treatment typically is far lengthier and complicated. Yet oncologists until now have had no standard way to offer a similar guide. Doctors like Ganz have pioneered survivor plans at specially designated cancer centers, but few people are treated at such hospitals. "A lot of patients get dropped," says Dr. Aziza Shad, who directs Georgetown University Hospital's cancer survivorship program and writes survivor plans for her own patients. "I personally think it's the responsibility of every treating oncologist to have this information available," Shad adds. "You did the treatment. ... Your responsibility is also the aftercare." The new guides come in two parts. First is a detailed treatment summary: The cancer's type and stage; tests of lymph nodes, genes and other indicators of prognosis; how much chemotherapy patients actually received, as side effects often mean skipped or lowered doses. The second part is a consumer-friendly list of future exams and what symptoms to watch for. A written document is crucial because even when doctors patiently explain cancer treatment, "patients are notoriously overwhelmed and not hearing half of what was said," says Ellen Stovall of the National Coalition for Cancer Survivorship, herself a repeat survivor. How can it make a difference? Say a woman suffers some shortness of breath. Does her family doctor assume it's the 20 pounds she just gained — or do a more sophisticated heart exam because she's a breast cancer survivor? Certain chemotherapy can cause serious heart damage. Say a breast cancer survivor later gets lymphoma. Her new oncologist would need to know exactly how much of the powerful chemo adriamycin she received before to know if it was safe to try again. Ganz saw a patient last week who had beaten lymphoma at age 29 with chest radiation, but now has breast cancer in her 50s. She wanted just the tumor removed, but that requires radiation therapy and it's often impossible to radiate the same spot again. Amazingly, the hospital found her old radiation records — and doctors could tell the new rays wouldn't overlap the old, letting her keep her breast. And Georgetown's Shad recounts a child who disappeared from her clinic's follow-up care for five years — only to reappear with a drastically lopsided face. Radiation had stopped short the bone growth on one side of his body, something his new doctors hadn't anticipated in time to treat. "Thank god we have plastic surgery," she says with a sigh. The concern is whether busy oncologists will embrace the guides; they do create more work. Legislation is pending in Congress that would require Medicare to pay for cancer-survivor plans. "It's going to require a real shift in doctors thinking about how they spend their time with their patients and what they need to know," says Stovall — who urges patients to ask for the guides. EDITOR'S NOTE _ Lauran Neergaard covers health and medical issues for The Associated Press in Washington.

http://www.forbes.com/forbeslife/health ... 08311.html 09.19.07, 12:00 AM ET WEDNESDAY, Sept. 19 (HealthDay News) -- If the collective activity of 15 genes that protect against lung cancer is too quiet, it could mean that they're being suppressed -- a situation that may lead to lung malignancy, U.S. researchers warn. A team at the University of Toledo, in Ohio, say a test for these genes in lung cells collected via bronchoscopy could help identify people genetically at risk for lung cancer. The researchers analyzed the activity of these 15 genes in 25 people with lung cancer and 24 people without the disease. By doing so, they were able to correctly identify those with lung cancer 96 percent of the time. The findings were to be presented Tuesday at an American Association for Cancer Research Conference in Atlanta. The genes included in the analysis encode a protective antioxidant and DNA repair proteins found in lung airway cells. "Smoking causes about 90 percent of all lung cancer cases, yet only about 10 to 15 percent of heavy smokers will develop lung cancer," lead researcher Dr. James C. Willey, an associate professor of medicine and molecular biology at the University of Toledo's College of Medicine, said in a prepared statement. "We are looking for new techniques that will allow us to pick out the 10 to 15 percent of individuals at highest risk for lung cancer from the enormous pool of current and former smokers," he said. The findings from this study justify a larger, prospective study to determine whether this approach is useful in predicting lung cancer in current and former smokers, Willey and his colleagues believe

Source: American Association for Cancer Research Gene Chip Data Improved Therapy In Some Patients With Incurable Cancer Science Daily — Like many oncologists, Eric P. Lester, M.D., was faced with a dilemma: seven patients with advanced, incurable cancer, an arsenal of drugs that may or may not help them, and not enough solid proof about treatment efficacy to guide him. So Dr. Lester devised what he called a "simple-minded experiment" that illustrates the promise of personalized medicine. Using DNA microarray "chips," Dr. Lester analyzed his patients' tumors for expression of genes associated with good response to various anti-cancer drugs, and based his drug treatment plans on the results. Four out of seven patients with advanced cancer enrolled in the extremely limited study had a better outcome than expected. The finding shows that "a personalized molecular oncology approach, basing chemotherapy on relative gene expression in tumors, holds promise even at the relatively crude level employed here," said study investigator, Dr. Lester, president of Oncology Care Associates in St. Joseph, Mich. To obtain and analyze chip data, Dr. Lester worked with Craig Webb, Ph.D., Director of Translational Medicine at the Van Andel Research Institute in Grand Rapids, Mich. The study is unusual because oncologists don't yet base most of their treatment decisions on gene profiling, especially when it might involve pairing drugs together in a novel combination or using varied doses, Dr. Lester said. "Much of clinical medicine is an educated guess, and this was an attempt to come up with a better approach by using the technology of a gene chip to make multiple, highly educated guesses simultaneously," Dr. Lester said. Dr. Lester added that one of the seven participating patients died before the gene chip was used to direct therapy. Many current clinical trials involving gene expression examine effectiveness markers for individual drugs rather than combinations of drugs or different doses of agents used together for the first time. To truly help the most patients, Dr. Lester said, all potentially effective drugs and combinations must be matched up against the unique genetic profile of a patient's tumor, he said. "Effective cancer treatment depends on understanding the biology driving the cancer, but because each tumor is different, it is very hard to personalize care and do a rigorous scientific experiment at the same time." In this study, Dr. Lester said he "stayed within the envelope of a reasonable standard of care" in treating his patients. That standard is often based on what insurance companies will typically reimburse for treatment given published studies about the effectiveness of a drug on a certain tumor type, and whether or not the drug is federally approved for that indication. Dr. Lester and Webb surveyed the scientific literature and compiled a list of genes whose expression levels may predict response to a drug given the tumor type. In some cases, treatment strategies suggested by the chips varied significantly even for the same type of cancer. For example, one patient whose lung cancer had spread to his brain and bones achieved a "near complete response" when treated with two chemotherapy drugs, in addition to Tarceva and Avastin, while another lung cancer patient responded to third-line drugs such as etoposide. Acknowledging the risk involved with using novel combinations of drugs where no set safety profile exists, Dr. Lester said that "this is constantly done in medicine. People are taking antibiotics at the same time as using heart and cholesterol pills, and blood pressure medication." "This kind of polypharmacy will become more common in cancer, but at the moment, it is hard to figure out the difference between doses that are effective or that could be toxic," he said. The best way to get around such issues is to build a database of gene expression data and match them with patient outcomes, he said. "Now when I see new patients I am itching to look at what the genes can tell me," Dr. Lester said. "It is a smarter way to treat cancer." This finding was presented in Atlanta, Ga. at the American Association for Cancer Research's second International Conference on Molecular Diagnostics in Cancer Therapeutic Development. Note: This story has been adapted from a news release issued by American Association for Cancer Research.

By Brittany Levine, USA TODAY Mix Sharon Osbourne with Olivia Newton-John, toss in Grammy-winning artists and world-class figure skaters, and you've got Frosted Pink, a TV event to raise awareness of women's cancers and inspire action. The show, which airs Oct. 14 on ABC, has a simple message: Do something. Many of the performers and presenters have battled cancer in some way. Newton-John, a breast cancer survivor, plans to sing a song off her soon-to-be-released album Christmas Wish. "You need to concentrate on wellness, not just illness," she says. "I want to encourage women and tell them: Look, here I am. It's 15 years later, and I'm fine." Osbourne, a colon cancer survivor, says that being a part of Frosted Pink was a "no-brainer. Every man, woman and child is capable of getting cancer. Everyone. This isn't a select group. We're only one step away from it ourselves." Rena Inoue, a two-time Olympic champion, is a lung cancer survivor. Musical guests include country stars Rascal Flatts and Craig Morgan, who will perform songs they wrote about cancer. Joss Stone, Babyface, Anastacia (a breast cancer survivor) and Heart also will perform. The show will benefit the Gynecologic Cancer Foundation, National Breast Cancer Coalition, National Coalition for Cancer Survivorship and Ovarian Cancer National Alliance. Volunteers can work with the organizations or check out www.frostedpink.org for ideas on how to help in their own community. Already in the works is Pink With a Twist, a follow-up show featuring Olympic gymnasts. Both shows are the brainchild of Edge Entertainment's CEO Mike Burg. Burg, a Hodgkin's disease survivor, says the show is about doing "more than wearing a pink ribbon or a yellow bracelet." It's about launching a long-lasting and far-reaching system of support, he says.

The Shields Gazette By Angela Taggart Chief reporter LUNG cancer sufferer Jimmy Jenkyns is celebrating today after health chiefs decided to fund a life-prolonging drug. In an astonishing u-turn, South Tyneside Primary Care Trust (PCT) has said it will pay for two months worth of Tarceva for Mr Jenkyns. The 55-year-old has been paying for the drug himself at a cost of £1,700 a month for the last five months. And Tarceva has worked wonders for Mr Jenkyns, from Bainbridge Avenue, Simonside, South Shields. A scan in July showed the tumour on his lung had shrunk by a third and some secondary tumours had disappeared. Although not a cure, Tarceva is less invasive than chemotherapy and has been shown to give patients a better quality of life. The PCT had refused to fund the drug because it has not yet been approved by the National Institute for Health and Clinical Excellence (Nice). But Mr Jenkyns, who was diagnosed in April last year, and wife Deanne, 40, who run their own cleaning business, have led a high-profile campaign to make the drug available on the NHS. A delighted Mrs Jenkyns contacted the Gazette within minutes of hearing the news they had been hoping for. She said: "When they first told me I was a bit bewildered because we have fought for so long, but it has all been worth it. I hope Nice will now approve it. "I'm going to a Roy Castle Lung Cancer Foundation Conference next week and it will be lovely to say 'we fought for it and won'." Mr Jenkyns, a grandfather-of-one, is due another scan in two months, and hopes the PCT will continue to fund the drug if it shows it is still having an impact. "I'm over the moon that they have agreed to fund the drug, but I think they are still hedging their bets a bit," he said. "However, it is a boost for me and anybody else that is fighting for it." Dr Judy Thomas, executive director of public health for NHS South of Tyne and Wear, which covers South Tyneside Primary Care Trust, said: "This decision was made on an individual case basis only in response to personal circumstances presented by Mr Jenkyns. "It has no implications regionally on whether or not Tarceva is provided generally on the NHS."

Cell Therapeutics, Inc. (CTI) Receives SPA Approval from FDA and Launches Gender-Specific Phase III Trial for Advanced Non-Small Cell Lung Cancer Trial Lays Road Map for Potential Approval of XYOTAX® for Women with Advanced Non-Small Cell Lung Cancer September 24, 2007: 01:30 AM EST SEATTLE, Sept. 24 /PRNewswire-FirstCall/ -- Cell Therapeutics, Inc. (CTI) said today it has begun a confirmatory phase III clinical trial of combination chemotherapy for women with advanced non-small cell lung cancer (NSCLC) -- the most lethal cancer facing women today. The trial, known as PGT307, will focus exclusively on women with pre-menopausal estrogen levels -- a group whose survival is significantly shorter than post-menopausal women. XYOTAX (paclitaxel poliglumex) will be studied in combination with carboplatin versus paclitaxel/carboplatin in female NSCLC patients with performance status of 0, 1, or 2. Paclitaxel in combination with carboplatin is the most commonly used treatment for the estimated 200,000 Americans who are diagnosed with lung cancer each year. The company also announced it received special protocol assessment (SPA) approval from the U.S. Food and Drug Administration (FDA) on the design of the trial. "In our STELLAR 3 trial we saw a survival benefit in the 70 percent of women who were pre-menopausal, where the XYOTAX/carboplatin combination increased the overall survival of this group by 34 percent over the control arm," said James A. Bianco, M.D., President and CEO of CTI. "This was the basis for PGT307, which can potentially show the important relationship between levels of estrogen and XYOTAX' effectiveness in lung cancer. Lung cancer remains the number one cancer killer of women -- we must ensure that this patient population has access to effective therapies as soon as possible. A successful PGT307 trial will also mean a step forward for gender medicine --a concept too long ignored by the medical establishment." The PGT307 trial will enroll 450 patients. CTI plans to submit a marketing authorization application (MAA) in Europe in the first half of 2008 for XYOTAX as a single agent for first-line treatment of NSCLC in performance status 2 (PS2) patients based on results from its STELLAR 4 randomized phase III trial. PGT307 Clinical Trial Protocol The PGT307 clinical trial is recruiting women with advanced NSCLC who have pre-menopausal estrogen levels (>30pg/mL). The phase III trial is expected to enroll 450 patients. Each study arm of approximately 225 patients will be randomized to receive either XYOTAX 175mg/m2 plus carboplatin (AUC6) or paclitaxel 225mg/m2 plus carboplatin (AUC6) once every three weeks. Patients will be treated for up to six cycles. The primary endpoint is superior overall survival with several secondary endpoints including progression-free survival, disease control, clinical benefit, response rate, quality of life, and the safety and tolerability of the treatment arms. "An analysis of recent Eastern Cooperate Oncology Group (ECOG) studies presented at the World Conference on Lung Cancer shows that women under 45 years old, presumably pre-menopausal, have worse outcomes than older women who are over 60," said Jack W. Singer, M.D., Chief Medical Officer at CTI. "This data, coupled with the recent Southwest Oncology Group (SWOG) analysis that also showed women under 60 had shorter survival, underscores the potential importance of the survival advantage we observed with XYOTAX in younger women on the STELLAR trials." Singer added, "Preclinical studies show the influence of estrogen on the anti-tumor effect and metabolism of XYOTAX and provide the likely scientific basis for the clinical observation that women treated with XYOTAX, and in particular women with normal estrogen levels, had superior survival over women who were randomized to standard chemotherapy in the STELLAR clinical trials. Through our PGT307 study we hope to take a negative risk factor -- estrogen -- and turn it into one that potentially benefits patients." Laurie Fenton Ambrose, President of the Lung Cancer Alliance, noted, "We are excited to learn that CTI is moving forward on a new clinical trial for women with lung cancer. This is exactly the kind of research we need to help us better understand not only lung cancer's genetic differences, but to provide patients with improved treatment options." The Lung Cancer Alliance is a national non-profit organization dedicated solely to patient support and advocacy for people living with lung cancer or those at risk for the disease.

Christine, My father is gettng Carbo/Taxol/Avastin every three weeks. He had his 2nd round on Monday. His pre-meds include Benadryl and an anti-nausea. So far so good. He hasn't experienced any nausea or much fatigue for that matter (at least that he will admit to). His doctor told him to take anti-nausea pills as needed. However, based on what I've read here, I suggested he take them before he needs them. So, he takes one when he gets home, and continues to take them for 3 days after. We're not sure if they are the reason why he doesn't feel sick, but my dad doesn't want to stop taking them to find out. Oh, and he started to lose his hair after about two weeks. I hope your dad has an easy time with his treatments.

By Charles Bankhead, Staff Writer, MedPage Today Reviewed by Robert Jasmer, MD; Associate Clinical Professor of Medicine, University of California, San Francisco ATLANTA, Sept. 20 -- A protein expressed by virtually all lung cancers offers the potential for a serum biomarker that could lead to early diagnosis of more patients, investigators reported here. Detectable serum levels of human aspartyl (asparaginyl) β-hydroxylase (HAAH) were identified in 99% of a group of lung cancer patients, but none were seen in a cancer-free control group, Mark Semenuk reported at a molecular diagnostics conference sponsored by the American Association for Cancer Research. A serum test for HAAH "has great promise as an additional diagnostic tool for lung cancer, having the practicality and cost-effectiveness of conventional serologic screening," said Semenuk. "Elevated serum HAAH in conjunction with CT scanning may greatly facilitate early diagnosis of lung cancer at a stage in which cure rates are significantly higher and thus may contribute to increased patient survival." Patients with lung cancer have a five-year survival of 15%. However, survival increases to 50% with early diagnosis. Unfortunately, only about 15% of lung cancer cases are diagnosed at earlier, more curable stages with current diagnostic methods. A major obstacle to achieving better survival is the lack of a lab test for early diagnosis. X-ray and CT scanning are commonly used to diagnose lung cancer, but both imaging techniques have low sensitivity and higher cost compared with serologic techniques, Semenuk noted. HAAH is elevated in a variety of cancers, including lung cancer. Laboratory studies have shown the enzyme is present in more than 99% of tumor specimens but absent in adjacent normal tissues. The protein's near-ubiquitous association with tumors made it attractive for evaluation as a lung cancer biomarker. Semenuk and colleagues measured serum levels of HAAH in 160 patients with lung cancer, a control group of 93 people with no evidence of cancer, and 50 smokers with no evidence of cancer. Consistent with previous studies, HAAH was detected in serum samples from 99% of the lung cancer patients but none of the control group. Presence of the enzyme was associated with all cancer stages. The average serum HAAH level was 0 ng/mL in the smokers. Four smokers had serum levels exceeding the diagnostic threshold of 3 ng/mL, although they were not known to have cancer. The assay had a 90% specificity in the smokers. "We were encouraged by the low false-positive rate in smokers," said Semenuk. "Other serum cancer markers, such as CEA, are often elevated in smokers, leading to a high rate of false-positives." Although the test is not yet available, physicians can submit samples and get test results for free. Instructions for submitting samples are available online at www.panacea-labs.com. "Elevated levels of HAAH cannot confirm whether a person has lung cancer but can be used as a routine screening test for recommending further diagnostic evaluation," Semenuk emphasized. Work has already begun to determine the utility of HAAH as a diagnostic test for prostate cancer. Such a test might be used as a follow-up lab assessment of men who have elevated PSA levels, Semenuk suggested. A positive HAAH test might then identify patients who should be biopsied. Looking beyond the diagnostic potential of HAAH, Semenuk said the enzyme "has a lot of biology associated with it. It's not simply a marker that has no meaning other than being associated with cancer. The enzyme system is doing something in cancer cells, it could be subject to targeting for therapy." Semenuk is an employee of Panacea Pharmaceuticals in Gaithersburg, Md., developer of the assay for HAAH.

TORONTO, Sept. 20 /CNW/ - The Canadian Cancer Society is pleased to announce the launch of a new research initiative to fight lung cancer, the leading cause of cancer for men and women. The Ontario division of the Society will contribute $1.5 million to initiate a lung cancer research fund that will support research into every aspect of lung cancer with the ultimate goal of improving survival and enhancing the lives of people living with the disease. "We recognize the need to fund more research in lung cancer, the leading cause of cancer death in Canada," says Peter Goodhand, CEO, Ontario Division, Canadian Cancer Society. "Thanks to the efforts and generosity of our volunteers and donors in Ontario, we can now contribute this significant funding to research into this disease that has a devastating impact on many Canadians." The Board of Directors of the Canadian Cancer Society, Ontario Division, provided full support for this lung cancer research investment in January of this year. The $1.5 million investment is in Addition to the $24 million the Society in Ontario had already committed to cancer research in 2006/2007 through the Society's research partner, the National Cancer Institute of Canada (NCIC). "We felt it was vital that we boost cancer research across the spectrum of lung cancer from diagnosis to treatment to quality of life," says Stephen Roche, Chair, Board of Directors, Ontario Division, Canadian Cancer Society. In 2007, an estimated 23,300 new cases of lung cancer will be diagnosed and 19,900 will die from the disease. A report released in September by the Canadian Cancer Research Alliance highlighted the lack of funding for lung cancer stating that in 2005, the research investment in lung cancer was $7 million, representing less than 3% of the total research investment of $254 million made in that year. This report confirms the Society was moving in the right direction when it made this funding decision earlier this year. Although the initial investment for the lung cancer research fund comes from Ontario, researchers from across Canada will be invited to submit applications for funding granted by the NCIC. The Ontario Division continues to have a strong commitment to funding cancer research, having invested more than $250 million in the last decade and close to $575 million in the last 60 years. Nationally the Society has invested more than $1 billion to cancer research through the NCIC. The Canadian Cancer Society is a national community-based organization of volunteers whose mission is to eradicate cancer and to enhance the quality of life of people living with cancer. When you want to know more about cancer, visit our website www.cancer.ca or call our toll-free, bilingual Cancer Information Service at 1 888 939-3333. For further information: Christine Koserski, Media Relations, Ontario Division, Canadian Cancer Society: (416) 488-5402, ext. 2305