African Americans Face Higher Risk Of Lung Cancer Than Other Races, Study Says

African Americans who smoke face a higher risk of developing lung cancer than smokers of other races, indicating that genes “might help explain the racial differences long seen in the disease,” according to a study in Thursday’s New England Journal of Medicine, the AP/Detroit Free Press reports (Chang, AP/Detroit Free Press, 1/26). In the largest study on the topic to date, researchers from the University of Southern California and the University of Hawaii followed 183,000 study participants over an eight-year period beginning in 1993. Over the course of the study, 1,979 enrollees developed lung cancer. Among African-American men who smoked, there were 264 cases of lung cancer per 100,000 individuals, compared with 264 cases among native Hawaiian men, 158 cases among white men, 121 cases among Japanese-American men and 79 cases among Latino men. The study, which did not include other ethnic groups, found that women overall had lower incidences of lung cancer, but ethnic disparities generally “followed the same pattern,” the Wall Street Journal reports (Bulkeley, Wall Street Journal, 1/26). Overall, whites who smoked up to one pack of cigarettes daily had a 43% to 55% lower risk of developing lung cancer than blacks who smoked the same amount. Latinos and Japanese Americans were 60% to 80% less likely than blacks to develop lung cancer if they smoked up to a pack a day, according to the study (AP/Detroit Free Press, 1/26). The disparities — which persisted even after researchers considered factors such as diet, socioeconomic status and occupation — disappeared among participants who were the heaviest smokers, likely because the damage caused by smoking at that level overwhelmed other factors, according to lead author Christopher Haiman, an assistant professor at the Keck School of Medicine at USC.

Comments
Haiman said the study could not rule out the possibility that the findings resulted from unidentified environmental factors but noted that there could be “differences in how [African Americans] metabolize nicotine, which would influence smoking behaviors such as the depth and frequency of inhalation of tobacco smoke.” He added, “There could be genetic factors on how they metabolize tobacco smoke” (Stein, Washington Post, 1/26). In an editorial accompanying the study, Neil Risch, director of the Institute for Human Genetics at the University of California-San Francisco, said the results of the study “provide an example of how ethnicity can interact with environmental factors in terms of the risk of disease.” He added that the findings could help doctors diagnose and treat some illnesses (Wall Street Journal, 1/26).

Reaction
Esteban Gonzalez Burchard, an assistant professor at the UCSF School of Medicine, said, “If this happens with tobacco, what about other drugs? Tobacco is a drug. What about the drugs we give to patients, such as cancer medications or heart medications or lung medication? There could be important biologic differences that help to explain the differences we see in disease prevalence, severity and mortality, as well as response to therapies.” However, Jeffrey Kahn, a bioethicist at the University of Minnesota, said he is concerned that the findings could lead to discrimination, noting that “[t]he danger would be to sort of view lung cancer as a minority disease, and so something we don’t have to worry as much about.” Troy Duster, a professor of sociology at New York University, said, “This feeds into the 19th-century notion that these categories really separate people in terms of their physical and biological characteristics. The reason why black people may be getting cancer more has to do with a combination of forces, not just their biologic makeup.” M. Gregg Bloche, a health law and policy professor at Georgetown University, said the study should encourage more research into understanding the role of genetics in how different races react to medicines, adding, “The biggest danger here is ideology on both sides getting in the way of trying to understand this phenomenon” (Washington Post, 1/26).

The study is available online. The editorial is available online.

“Reprinted with permission from http://www.kaisernetwork.org. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at http://www.kaisernetwork.org/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.

IV HYCAMTIN(R) Receives European Marketing Approval As Treatment For Relapsed Small Cell Lung Cancer

GlaxoSmithKline (GSK) announced that the European Commission (EC) has granted Marketing Authorisation for HYCAMTIN(R) (topotecan powder for concentrate for solution for infusion) for the treatment of patients with relapsed small cell lung cancer (SCLC) for whom re-treatment with the first-line regimen is not considered appropriate. HYCAMTIN(R) is the first drug to be approved in Europe that is specifically indicated for the treatment of relapsed SCLC. Data from the HYCAMTIN(R) clinical trials show that treatment with HYCAMTIN(R) is associated with prolonged survival and quality of life compared to best supportive care in patients battling the disease.

The marketing authorisation follows a positive opinion in November 2005 by the European Committee for Human Medicinal Products (CHMP) for HYCAMTIN(R).

HYCAMTIN(R) is a compound already familiar to oncologists as a treatment for relapsed ovarian cancer. The chemotherapeutic agent belongs to a class of drugs known as topoisomerase I (topo-I) inhibitors, and works by inducing DNA damage which results in the death of dividing cells. Because two thirds of patients with SCLC already have extensive disease at the time of diagnosis and nearly all patients with extensive disease eventually relapse, approval of HYCAMTIN(R) is a significant step forward in widening options for patients.

“The oral form of HYCAMTIN(R) has shown promising and unexpected results in improving symptoms and lengthening the life of patients with relapsed SCLC, a disease that is traditionally associated with a grave outlook for patients,” says Dr. Mary O’Brien, Head of the Lung Cancer Unit, The Royal Marsden NHS Foundation Trust, UK. “This approval of intravenous HYCAMTIN(R) will now provide physicians and our patients an important new treatment option in SCLC.”

“HYCAMTIN(R) appears to provide greater symptom improvement than CAV. The regimen has no neurotoxicity and in a randomised study, SCLC patients experienced a significant improvement in breathing difficulties and anorexia,” says Dr J. von Pawel, Head, Department of Oncology, Asklepios Kliniken Munchen-Gaunting, Germany and an investigator in the study. “HYCAMTIN(R) is an important step forward in terms of improving the quality of life for SCLC patients and essentially allows them to make the best use of the time they have left.”

European approval was principally based on three key Phase III studies. The first study (protocol 090) compared the safety and efficacy of HYCAMTIN(R) to the triple combination cyclophosphomide, doxorubicin and vincristine (CAV) in patients with sensitive SCLC. Median overall survival was comparable between the two arms of the study (25.0 versus 24.7 weeks, p = 0.80).

The second study (protocol 396) compared the safety and efficacy of an oral formulation of topotecan versus IV HYCAMTIN(R) in patients with sensitive SCLC. Median overall survival was comparable between the two arms (33.0 versus 35.0 weeks, Hazard Ratio = 0.98) and both treatments were generally well-tolerated.

The third study (protocol 478) was conducted to prove the survival benefit of second-line chemotherapy for relapsed SCLC patients. The study was conducted using oral HYCAMTIN(R) plus best supportive care and compared safety and efficacy to best supportive care (BSC) alone. Median overall survival for HYCAMTIN(R) plus BSC was 25.9 weeks compared to 13.9 weeks for patients who received BSC alone (p = 0.01).

Mike Unger, Chief Executive, The Roy Castle Lung Cancer Foundation, UK comments, “Small cell lung cancer is a particularly devastating disease, with a very serious outlook for those suffering from it. SCLC comprises 25% of all lung cancers and at the moment there are very few treatment options. The approval of HYCAMTIN(R) by the European Committee for Human Medicinal Products is a very exciting development and will give support and benefits to many patients in the UK and across Europe. The Foundation looks forward to further clinical research and experience concerning HYCAMTIN(R).”

“HYCAMTIN(R) offers an important new therapeutic option for patients in Europe who are faced with managing this devastating disease,” said Andrew Witty, President, Pharmaceuticals Europe, GSK. “This approval is another example of GSK’s continued commitment to researching and developing an industry leading oncology portfolio to address the unmet medical needs of cancer patients around the world.”

About Small Cell Lung Cancer

Lung cancer is the most common cancer in the world attributing to 13.2% of all cancer cases.[i] About 20 out of every 100 cases diagnosed are small cell lung cancer.[ii] Of all those diagnosed with small-cell lung cancer, around one in three have limited disease at the time of diagnosis. Two out of three already have extensive disease at the time of diagnosis. Of those who have limited disease and have chemotherapy, between 35 – 40% will be alive two years later. People with extensive disease are also treated with chemotherapy, but unfortunately the survival rate is even lower. Most only survive another ten to twelve months.[iii]

Globally the highest rates of lung cancer in men are found in Europe, especially eastern Europe, and North America. For women, the highest rates are found in North America and European countries such as Denmark, Hungary, Iceland and the UK.[iv]

About HYCAMTIN(R)

HYCAMTIN(R) (topotecan powder for concentrate for solution for infusion) is a chemotherapeutic agent that belongs to a class of drugs known as topoisomerase I (topo-I) inhibitors. Topo-I is an enzyme essential for the replication of DNA, and therefore cell division, in both normal and cancer cells. Interaction between topo-I and HYCAMTIN(R) results in damage to the cell’s cancerous genetic material and the death of dividing cancer cells.

HYCAMTIN(R) is already registered in the European Union, and 59 other countries around the world for the treatment of relapsed ovarian cancer following platinum-based therapy. More than 230,000 patients have been treated with HYCAMTIN(R) since its launch in 1996. More information on HYCAMTIN(R) can be found at www.emea.eu.int

For further product information please access the Electronic Medicines Compendium at www.medicines.org.uk

Important Safety Information

HYCAMTIN(R) can suppress the body’s ability to produce blood cells, in particular the white blood cells which fight infection. This condition is known as neutropenia. The clotting elements (platelets) can also be decreased, a condition known as thrombocytopenia. HYCAMTIN(R) is contraindicated in patients who have a history of hypersensitivity reactions to topotecan or any of its ingredients. HYCAMTIN(R) should not be used in patients who are pregnant or breast-feeding, or in those with severe bone marrow depression.

About GlaxoSmithKline

GlaxoSmithKline (NYSE: GSK) is one of the world’s leading research-based pharmaceutical and healthcare companies. GlaxoSmithKline is committed to improving the quality of human life by enabling cancer patients to do more, feel better and live longer. For more information, visit http://www.gsk.com.

[i] Boyle P, Ferlay J. Cancer incidence and mortality in Europe 2004. Annals of Oncology, 2005. 16: 481-488
[ii] Onkos Plus Study #5, Small Cell Lung Cancer, December 2004, pg 7
[iii] www.cancerhelp.org.uk/help/default.asp?page=2965#small, accessed January 2006
[iv] GLOBOCAN 2002. Cancer Incidence, Mortality and Prevalence Worldwide (2002 estimates), 2005

http://www.gsk.com

Community Oncology Alliance Gathers In Washington To Address Crisis In Access To Cancer Care

The Board and Officers of The Community Oncology Alliance — representing cancer clinics caring for over 85% of the USA’s cancer patients — will gather with hundreds of oncologists, nurses, and allied health professionals in Washington, DC for the First Annual Community Oncology Conference at the Marriott Wardman Park Hotel February 8- 10, 2006. The three day conference will focus on the crisis in cancer care caused by the Medicare Modernization Act (MMA) which sought to modernize reimbursement for cancer drugs and essential cancer care services by reforming the payment systems for oncology.

“The reform was woefully short,” states Steve Coplon, Co-Executive Director of COA. “The Medicare Modernization Act overcorrected drug reimbursement to below cost and under corrected service reimbursement to below cost. Essentially, cancer clinics are now subsidizing cancer care for Medicare patients. A typical example occurred yesterday,” Coplon adds. “Our clinic is currently treating a patient with Non-Hodgkin’s Lymphoma. Current reimbursement for that care is $1,607 below our cost. The patient’s co-insurance is over $3,000. If the patient can’t afford the co-insurance, we will subsidize the treatment though the clinic will be reimbursed $4,600 below cost. In either case clinics cannot afford to subsidize this care.”

Similar situations are being reported by cancer clinics throughout the country, and as a result many patients are being shifted to hospital in-patient and/or outpatient settings which can result in more cost to Medicare, unnecessary treatment delays, long waits, and lower quality care. In some communities hospitals are not accepting these patients because cost greatly exceeds reimbursement. A number of oncology groups are further reporting that they can no longer treat Medicare patients — including a group in New Orleans, one group in Iowa, and another in Panama City, Florida. Many other similar reports have emerged from dozens of states.

“MMA was supposed to fix a broken payment system for oncology,” said Leonard Kalman, MD, a Miami based oncologist and President of COA. “Instead oncology reimbursement has been cut by $15.7 billion over 10 years — adversely impacting quality and access to care. This overcorrection needs to be fixed before the crisis gets out of hand any further.”

Representatives from COA are encouraged that their message is being heard in Washington. “COA has a voice at the table,” affirms Chief Administrative Officer, Dianne Kube. “We regularly meet with Congressional leadership, The White House, CMS, MedPAC, and other agencies addressing reimbursement for cancer care. In addition, we have legislation, HR 4098 — The Community Cancer Care Preservation Act, introduced by Congressman Jim Ramstad, Republican of Minnesota. This legislation addresses many of the deficiencies of MMA. Unfortunately, policy issues do not move as quickly as we would like.”

“For cancer clinics like ours in Memphis this means that patients are experiencing a regression in ‘The War on Cancer,’” declares Coplon. “Oncologists, nurses, and patients from around the country are deeply concerned that much of the progress in early diagnosis and treatment and much of the cost savings resulting from care in the office setting is now going to be lost as care shifts to hospitals or does not occur at all. Some patients have indicated that they will not go to the hospital for care. The real tragedy is that we have come so far in this fight and now MMA is forcing us to retreat rather than advance.”

The three day gathering in Washington will lay out strategies for policy change before the crisis exacerbates.

For additional information contact Dianne Kube, Community Oncology Alliance, 202-756-2258.

The Community Oncology Alliance (COA) is committed to fostering and protecting high quality, affordable and accessible cancer care for all Americans battling cancer. COA’s vision is to strongly promote initiatives that further enhance the quality and affordability of cancer care, which along with accessibility have been hallmarks of cancer treatment delivered in the community setting where over 80% of Americans with cancer are treated.

Community Oncology Alliance
www.communityoncology.org

Lung Cancer Survival Rates May Be Linked To Access To Care

New research suggests that the lower survival rates of blacks with lung cancer may be explained by access to care. The study, by Wake Forest University Baptist Medical Center researchers and colleagues is reported in the January issue of the Journal of Clinical Oncology.

“The results were intriguing,” said principal investigator A. William Blackstock, M.D., “When offered equivalent therapy, the outcome for black patients was the same as that of non-blacks.”

Historically, studies have shown that, across all stages of the disease, survival for black patients lags behind that of non-blacks. A number of potential explanations have been proposed, including later stage at diagnosis, differences in treatment, and differences in the biologic aggressiveness of the disease. Among the most controversial of these issues is whether race is an independent factor in survival.

Researchers evaluated, retrospectively, data from 995 patients with advanced small cell lung cancer who participated in one of four Cancer and Leukemia Group B (CALGB) studies. The patients were treated between 1990 and 2002 at 41 centers.

“From our analysis, we concluded that equal treatment in patients with advanced lung cancer yields equal outcome among patients with the same stage of disease regardless of race or ethnicity,” said Blackstock. “Although other factors may be important, perhaps the most relevant is access to standard cancer care.”

Differences in access to care, the quality of care received, and the impact of other health risks may explain the lower survival among African Americans. Continued efforts are needed to encourage disease awareness, promote early detection, implement prompt and appropriate treatment and increase minority participation in clinical trials, the researchers said.

Lung cancer remains the leading cause of cancer death in the United States. Approximately 172,000 Americans were diagnosed with lung cancer in 2005 and 20 percent of those had small-cell lung cancer. Although the incidence of advanced-stage lung cancer has increased in most racial/ethnic groups, the rate of increase has been greatest for African American patients.

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The study was funded by the National Cancer Institute.

Co-researchers were James Herndon II, Duke University, Electra D. Paskett, Ohio State University, Antonius Miller, Wake Forest University Baptist Medical Center, Christopher Lathan, Dana Farber Cancer Institute, Harvey B. Niell, University of Tennessee Memphis, Mark A. Socinski, UNC Chapel Hill, Everett Vokes, University of Chicago, and Mark R. Green, Medical University of South Carolina.

Contact: Jonnie Rohrer, jrohrer@wfubmc.edu, 336-716-6972, Karen Richardson, krchrdsn@wfubmc.ecu or Shannon Koontz, shkoontz@wfubmc.edu, 336-716-4587.

Wake Forest University Baptist Medical Center is an academic health system comprised of North Carolina Baptist Hospital and Wake Forest University Health Sciences, which operates the university’s School of Medicine. The system comprises 1,187 acute care, psychiatric, rehabilitation and long-term care beds and is consistently ranked as one of “America’s Best Hospitals” by U.S. News & World Report.

Contact: Karen Richardson
krchrdsn@wfubmc.edu
Wake Forest University Baptist Medical Center

Early Lung Cancer Diagnosis Facilitated With New Navigation Technology

U.S. hospitals are increasingly embracing the use of a novel imaging technology known as the superDimension(R)/Bronchus System (SDBS) which enables diagnosis of lung cancer at an earlier stage than the conventional technique.

“While flexible bronchoscopy is the preferred method for diagnosing lung cancer, most lesions are located in the peripheral areas of the lung which the standard bronchoscope can’t reach,” Doron Besser, MD, VP Medical Affairs of superDimension, Ltd. In Herzliya, Israel, said. “If a bronchoscopy is non-diagnostic, more invasive interventions such as transthoracic needle aspiration, mediastinoscopy or sometimes thoracotomy are required in order to establish a diagnosis. Such interventions may be associated with significant risks or even be unnecessary as the lesion may still be benign.”

The SDBS machine allows physicians to make a definitive diagnosis of suspicious lesions in the peripheral areas of the lung which are difficult to sample by conventional bronchoscopy, therefore setting the stage for earlier treatment and a better prognosis.

“Lung cancer has a notoriously dismal prognosis,” he noted. “An early diagnosis may boost the patient’s likelihood of survival as about 15 percent of patients diagnosed at stages III or IV are alive at five years versus about 70 percent diagnosed at a an earlier stage.”

The novel imaging system can navigate can be uniquely steered and navigated anywhere in the lungs in real-time and on a three-dimensional roadmap which provides a higher success rates and broadens the applicability of standard diagnostic bronchoscopy, Dr. Besser said.

The SDBS procedure is typically performed in the bronchoscopy suite, and results are usually available within two hours. Notably, clinical studies have demonstrated an 80% success rate in diagnosing lung lesions and a 95% success rate in also performing staging.

The FDA-approved technology is already in use at the Cleveland Clinic, Mayo Clinic, Beth Israel Deaconess Medical Center, Johns Hopkins University Medical Center, and regional hospitals such as Columbus Regional Hospital.

SDBS is manufactured by superDimension Ltd., which has its world headquarters in Herzliya, Israel and its U.S. headquarters in Minneapolis. Lung cancer is the main cause of cancer mortality in the US. and is responsible for more deaths annually breast, colon, and prostate cancers combined. According to the American Cancer Society, the disease accounted for more than 163, 000 deaths in the U.S. last year.

SDBS can also be used for treating lung cancer, and initial clinical trials using internal radiation methodologies have shown promising results.

superDimension, Ltd.
8 Hamenofim St., POB 2045
46120 Herzliya
Israel
Tel. +972-(0)9-971-3700
Fax +972-(0)9-971-3701
info.il@superdimension.com

superDimension, Inc.
14500 Martin Drive
Minneapolis, MN 55344-2040
USA
Tel. +1-952-946-9919
Fax +1-952-946-6145
Toll Free 888-586-4767
info.us@superdimension.com

uperDimension (Europe) GmbH
Grossenbaumer Weg 5
40472 Duesseldorf
Germany
Tel. +49-(0)211-436156-0
Fax +49-(0)211-436156-29
info.de@superdimension.com

www.superdimension.com/contact.html

Written by: Jill Stein

Jill Stein is a Paris-based freelance medical writer.

Growing Evidence Of Sex-based Differences In Lung Cancer Highlighted At Roundtable Meeting

Women’s health and lung cancer advocacy groups, led by the Society for Women’s Health Research, vowed today to make lung cancer education and advocacy, especially among women, a top priority for their organizations in 2006 and beyond. The roundtable meeting took place at the National Press Club, where health experts and advocacy leaders discussed sex-based research advances in lung cancer and the challenges in elevating public dialogue about the deadly disease. Lung cancer is the number one cancer killer of women and women are approximately 1.5 times more likely to develop lung cancer than men.

“A growing number of women, including non-smokers, are diagnosed with lung cancer each year” said Phyllis Greenberger, president and CEO of the Society for Women’s Health Research. “We need to improve women’s awareness of this disease and we need more research to understand the impact of sex and gender on the development and treatment of lung cancer. The federal government can play an important role in this process by increasing funding for research and education targeted at the underserved population of women.”

Lung cancer claims the lives of more American women and men than the three most common cancers combined (colon, breast, and prostate) yet it receives a disproportionately low amount of media attention and government research funding. Approximately 350,000 people in the United States have lung cancer, and an estimated 173,000 were diagnosed in 2005. Non-small cell lung cancer is the most common form of lung cancer, accounting for approximately 87 percent of cases. While lung cancer incidence and mortality have been declining among men, there has been an alarming four-fold increase in lung cancer in women over the last 30 years.

Female smokers appear to be two to three times as susceptible to lung cancer as male smokers. Biological differences between the sexes may partially explain why women are more vulnerable to the cancer-causing effects of tobacco and other lung carcinogens. For example, the cells and DNA in women’s lungs may be more easily damaged by tobacco smoke.

At the meeting, advocacy group representatives listened to presentations by top cancer researchers detailing the rising risks of lung cancer among women as well as inroads that have been made in sex-based research. Roundtable discussion prompted the groups to make lung cancer awareness in women a top national health priority, including a drive to urge the government to increase funding for sex-based lung cancer research.

Among the advocacy groups joining the Society for Women’s Health Research to talk about ways to increase awareness of sex differences in lung cancer risk and treatment approaches were the American Society for Clinical Oncology, CancerCare, Intercultural Cancer Council, Joan’s Legacy, Lung Cancer Alliance, LUNGevity, National WomenЎ¦s Health Resource Center, Women Against Lung Cancer, and the Women’s Health Policy and Advocacy Program at Brigham and Women’s Hospital.

Individuals participating in the Roundtable committed to working together around the following lung cancer advocacy needs:

* Greater attention by the public, policy makers, and researchers in order to reduce lung cancer risks and rates of occurrence, improve diagnosis, and expand treatment options through research ЎV particularly for women of all cultures, races, ethnicities, and socioeconomic strata.

* Significant increases in public and private funding to support sex- and gender-based research and education.

* Health care provider education to reduce nihilism, pessimism, and stigma in the treatment of lung cancer patients.

A major goal is to significantly increase survivorship and reduce death from lung cancer by 2015.

Sex-Based Differences in Lung Cancer
Between 85 and 90 percent of men and women diagnosed with lung cancer are current or former tobacco users. Since tobacco smoke is the leading risk factor for developing lung cancer, it is important to understand how the various components of tobacco smoke, including nicotine and many carcinogens, are metabolized or chemically modified in the body in ways that contributed to lung cancer development.

The reproductive hormone estrogen may increase women’s susceptibility to developing lung cancer, but its exact role in this process is currently unknown. Estrogen binds to estrogen receptors in many tissues of the body, including lung tissue, which results in production of proteins involved in normal tissue growth. It has been postulated that the estrogenic environment in women and the differential expression of various forms of estrogen receptors in the lung tissue of women and men may contribute to sex differences in lung cancer susceptibility. Through the actions of these various forms of the estrogen receptor, estrogen may influence lung tumor growth in women by causing the synthesis of tumor-promoting proteins.

Also, estrogen may act directly on the DNA in lung cells to disrupt its normal function, resulting in uncontrolled growth of lung tissue. Some studies indicate that women who take menopausal hormone therapy have an increased risk for lung cancer.

“There is some exciting, emerging evidence of the role of estrogen in measuring the risk of and treating lung cancer,” said Joan H. Schiller, M.D., University of Wisconsin Comprehensive Cancer Center, and a presenter at the Advocacy Roundtable. “We are optimistic that this breakthrough science will translate into targeted lung cancer treatments for women and we can give this patient group the medical attention they need.” In addition to researching and treating lung cancer, Schiller is president of the board of directors for the advocacy group Women Against Lung Cancer.

Schiller is currently researching a novel approach to targeting lung cancer in women that relies on a chemotherapy agent that exploits the presence of estrogen in women and its effect on the metabolism of proteins in the cancer cell. Schiller is one of a team of investigators directing the international trial to evaluate the efficacy of a novel chemotherapy agent that appears to be more effective in the presence of estrogen-regulated proteins.

Research suggests that estrogen may facilitate lung cancer growth and metastasis, making the disease more aggressive in pre-menopausal women. However, the same estrogen-induced proteins that promote lung cancer may also facilitate delivery of a highly active therapeutic agent to tumor tissue, thus converting a negative risk factor (higher estrogen levels) into one that may benefit the patient.

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The Society for Women’s Health Research
The Society for Women’s Health Research is the nation’s only non-profit organization whose mission is to improve the health of all women through research, education, and advocacy. Founded in 1990, the Society brought to national attention the need for the appropriate inclusion of women in major medical research studies and the need for more information about conditions affecting women disproportionately, predominately, or differently than men. The Society advocates increased funding for research on women’s health; encourages the study of sex differences that may affect the prevention, diagnosis and treatment of disease; promotes the inclusion of women in medical research studies; and informs women, providers, policy makers and media about contemporary women’s health issues. Visit the Society’s Web site at http://www.womenshealthresearch.org/ for more information.

The Talk and Take Action: Women & Lung Cancer Advocacy Roundtable was supported by an educational grant from Cell Therapeutics, Inc. (CTI). Headquartered in Seattle, CTI is a biopharmaceutical company committed to developing an integrated portfolio of oncology products aimed at making cancer more treatable. The company recently launched a trial, known as PIONEER, for women with advanced lung cancer. For additional information, please visit http://www.cticseattle.com/.

Contact: Leslie Wheeler
Weber Shandwick Worldwide

Smokers And Former Smokers Should Be Screened For Lung Cancer, Even If They Don’t Have Symptoms

Smokers and former smokers should be screened for lung cancer even if they don’t have symptoms, according to a new study led by physician-scientists at NewYork-Presbyterian Hospital/Weill Cornell Medical Center. The findings, based on data from the largest clinical trial of lung-cancer computed tomography (CT) screening ever conducted, represent the first time tumor size and lung cancer stage have been linked in an asymptomatic population. Results of the study were published today in the Archives of Internal Medicine.

“The smaller the lung cancer is at diagnosis, the more likely it is to be stage 1 and curable,” says lead author Dr. Claudia Henschke, principal investigator of the International Early Lung Cancer Action Project (I-ELCAP); chief of the chest imaging division at NewYork-Presbyterian/Weill Cornell; and professor of radiology at Weill Cornell Medical College. “If small lung cancers are found, they may have a significantly improved chance of a cure.”

Dr. Henschke advises smokers to consider CT screening because they are at high risk of lung cancer. Former smokers remain at high risk for lung cancer for 20 or 30 years after they quit smoking and should consider annual CT screening. “CT screening has the potential to save lives in both of these groups,” she continues. “This new information should be most helpful in providing for an informed decision-making discussion between patients seeking CT screening for lung cancer and their physicians.”

Lung cancer remains the leading cause of cancer death in both men and women, killing more people than breast, prostate, and colon cancers combined, according to the American Cancer Society.

Stage 1 lung cancer has been shown to have better a cure rate than any other stage. When lung cancer is detected outside of screening, typically because of symptoms, it has often spread to the lymph nodes and beyond. At this point, the opportunity for curative resection or any effective treatment is greatly diminished.

The largest study ever undertaken to determine if annual screening by CT is effective, I-ELCAP screened 30,235 men and women at 38 institutions across the globe. The study released today evaluated 438 lung cancers identified in I-ELCAP and studied the relationship of cancer stage to tumor diameter in asymptomatic, latent lung cancers to determine if size is an indicator of prognosis. The researchers considered tumor diameter, consistency, and presence or absence of metastases at the time of diagnosis.

“This report confirms that small-sized lesions are a good indicator of early, curable cancer,” Dr. Henschke says. “Previously, concern regarding this relationship had led some to question the benefit of screening. This issue should no longer be of concern.”

The current lung cancer staging criteria considers tumors smaller than 30 millimeters (mm) without evidence of spread to be in stage 1A (National Cancer Institute-sponsored Surveillance, Epidemiology, and End Results — SEER — definitions, based on data from symptomatic cases). The study found more than 90 percent of the lesions that are smaller than 15 mm (about the size of a dime) are in stage 1A, and almost all of those are curable. The researchers found that 85 percent of 16 mm to 25 mm malignancies had no lymph node metastases and that 63 percent of the 26 mm to 35 mm had not metastasized. Because screening is useful for finding small, asymptomatic cancers, the researchers did not have many lesions larger than 35 mm to study.

“Screening allows us to find smaller lung cancers than what we typically find when patients are symptomatic,” says Dr. Henschke. “Clearly, the smaller the cancer the more curable it is, and stage 1 is the most hopeful. When found in later stages, the cure rate drops dramatically.”

“Therefore, our findings suggest that tumor diameter serves as a prognostic indicator for curability, perhaps even for micro-metastases not detectable by our current techniques,” she adds.

Since the early 1990s there have been remarkable advances in CT scanners, so that sub-millimeter “slicing” can now be applied to the entire chest in a single breath-hold; and as a result, lung cancer is being detected when it still is smaller than in cases diagnosable prior to 1986. While CT scans once yielded 30 images, current technology yields 900 images.

Dr. Henschke’s co-authors include Dr. Steven Markowitz (CBNS, City University of New York at Queens College, Queens, N.Y.), Dr. Shusuke Sone (Azumi Hospital, Nagano, Japan), Dr. Karl Klingler (LungenZentrum Hirslanden, Zurich, Switzerland), Dr. Melvyn Tockman (Lee Moffitt Cancer Center & Research Institute, Tampa, Fla.), Dr. Dorith Shaham (Hadassah Medical Center, Jerusalem, Israel), and the other I-ELCAP investigators. Also contributing to the study were NewYork-Presbyterian/Weill Cornell’s Dr. David F. Yankelevitz and Dr. Dorothy I. McCauley.

The original ELCAP study, which was led by Dr. Henschke and published in the July 1999 Lancet, determined that low-dose CT scans found more than 80 percent of the screening-detected cancers to be of stage I, the most curable stage of the cancer. An ELCAP study published in the August 2003 journal Chest, also led by Dr. Claudia Henschke, found that CT screening for lung cancer may not only improve a lung cancer patient’s chances for a cure, but is also likely to be cost-effective when compared with other widely accepted cancer screening methods.

The Radiological Society of North America (RSNA)

The Radiological Society of North America (RSNA) is an association of more than 37,000 radiologists, radiation oncologists, medical physicists, and related scientists committed to promoting excellence in radiology through education and by fostering research, with the ultimate goal of improving patient care. The Society is based in Oak Brook, Ill.

NewYork-Presbyterian Hospital/Weill Cornell Medical Center

NewYork-Presbyterian Hospital/Weill Cornell Medical Center, located in New York City, is one of the leading academic medical centers in the world, comprising the teaching hospital NewYork-Presbyterian and its academic partner, Weill Medical College of Cornell University. NewYork-Presbyterian/Weill Cornell provides state-of-the-art inpatient, ambulatory, and preventive care in all areas of medicine, and is committed to excellence in patient care, research, education, and community service. NewYork-Presbyterian, which is among U.S. News & World Report’s top ten hospitals nationally, also comprises NewYork-Presbyterian Hospital/Columbia University Medical Center and its academic affiliate, Columbia University College of Physicians and Surgeons.

NewYork-Presbyterian Hospital/Weill Cornell Medical Center
525 East 68th Street, Box 144
New York, NY 10021
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UK Smoking Ban – Macmillan Delighted At MPs’ Life Saving Action

Leading cancer care charity Macmillan Cancer Relief is delighted that MPs decided to save lives by voting for a full smoking ban in all pubs and clubs on Tuesday 14 February 2006.

Peter Cardy, Chief Executive, Macmillan Cancer Relief, said: “We are delighted that Parliament has seen sense and has taken the single most effective step it can to cut horrible, painful lung cancer deaths. As Macmillan Cancer Relief knows only too well, smoking and passive smoking cause nine out of 10 lung cancers. This move will, quite rightly, protect the health of staff working in pubs and membership clubs as well as their patrons.”

He was speaking after MPs voted for a full smoking ban, in both licensed premises and membership clubs, during the Health Bill Report Stage Debate.

Each year there are more than 37,000 new cases of lung cancer in the UK and many more people die from head, neck, throat and mouth cancers. A ban on smoking will be implemented in April in Scotland, where lung cancer deaths are particularly high, the Republic of Ireland introduced a ban in 2004, and a ban has also been announced for Northern Ireland.

Macmillan campaigned for a full ban on smoking in all workplaces and enclosed public places in England, including all pubs and clubs. The full ban was backed by the Health Select Committee, who described proposals for a partial ban as ‘unfair, unjust, inefficient and unworkable’. The Joint Committee on Human Rights also warned that exemptions for pubs and clubs could breach human rights legislation.

Public opinion was also in favour of comprehensive smokefree legislation. A major You Gov Poll in Dec 2005 found 71 per cent in favour of making all workplaces smokefree, including pubs and restaurants.

About Macmillan Cancer Relief

Macmillan Cancer Relief provides the expert care and emotional support that makes a real difference to people living with cancer. We offer a range of innovative cancer services and are at the heart of improving cancer care throughout the UK.

For cancer information and support, contact the Macmillan CancerLine (Monday – Friday, 9.00am – 6.00pm) by freephone: 0808 808 2020, textphone: 0808 808 0121 or email: cancerline@macmillan.org.uk; or log on to http://www.macmillan.org.uk.

Macmillan Cancer Relief is a member of The UK Lung Cancer Coalition (UKLCC). This powerful coalition of the UK’s leading lung cancer experts, senior NHS and Department of Health professionals, charities and healthcare companies is the UK’s largest multi-interest group in lung cancer. It is the first time that all the major charities with an interest in the disease have joined forces to fight lung cancer.

HELP STOP PEOPLE DYING NEEDLESSLY FROM LUNG CANCER

Lung cancer claims the lives of 92 people a day but more could be saved if only it was detected earlier say Macmillan Cancer Relief and The Roy Castle Lung Cancer Foundation. To find out more visit http://www.macmillan.org.uk/lungcancer

Lung Cancer Spread Related To Tumor Size

Smaller tumors in the lungs appear to be less likely to have spread than larger tumors among patients with asymptomatic lung cancer, suggesting that early screening may be useful in detecting cancers that are still curable, according to a new article in the February 13 issue of Archives of Internal Medicine, one of the JAMA/Archives journals.

Cancers in the earliest stage, which have not yet spread beyond the lungs, are divided by size into stage IA (tumors less than 30 millimeters in diameter) and stage IB (tumors larger than 30 millimeters in diameter), according to background information in the article. The development of computed tomography (CT) scanning has allowed physicians to detect lung tumors at a smaller size, prompting some to call for more subdivisions of stage I cancers. Though tumor size has been linked to cancer prognosis in patients with symptoms, the relationship between tumor size, metastasis (cancer spread) and prognosis in asymptomatic individuals has been unclear, the authors write.

Claudia I. Henschke, M.D., Ph.D., New York Presbyterian Hospital-Weill Cornell Medical Center, New York, and colleagues from the International Early Lung Cancer Action Program screened 28,689 men and women for lung cancer at 38 institutions worldwide between 1993 and 2004. Four hundred sixty-four patients were diagnosed with lung cancer as the result of the screening. The researchers classified the participants’ lung cancers based on their type–small cell or non-small cell–as well as the size (diameter) of their tumors at diagnosis and whether or not they had metastasized. They also recorded the consistency of the tumors as solid, nonsolid or part-solid.

For the 436 patients with non-small cell cancers, which are less aggressive than small-cell cancers, the likelihood of metastasis increased along with tumor size. When the researchers analyzed the tumors by consistency, they found the association strongest for solid tumors, weaker for part-solid tumors and not apparent for nonsolid tumors. For the few (28) cases of small cell cancer, the relationship appeared strong for those tumors as well. The percentages of nonmetastasized cancer of all types were much higher than those reported in previous studies.

“The pattern confirmed herein suggests the usefulness of finding latent cancers at small sizes,” the authors conclude. “Most lung cancers without evidence of lymph node metastases are curable, with the curability rate being higher at smaller sizes. This suggests that tumor diameter also serves as a prognostic indicator for curability, perhaps even for micrometastases not detectable by our current techniques.”

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(Arch Intern Med. 2006; 166: 321-325. Available pre-embargo to media at http://www.jamamedia.org/.)

Contact: Jonathan Weil
JAMA and Archives Journals

Phase III Non-Small Cell Lung Cancer Trial Studying Nexavar (sorafenib) Tablets In Combination With Two Chemotherapeutic Agents

Bayer Pharmaceuticals Corporation (NYSE: BAY) and Onyx Pharmaceuticals, Inc. (Nasdaq: ONXX) today announced the initiation of a randomized, double-blind, placebo-controlled Phase III clinical trial studying Nexavar® (sorafenib) tablets administered in combination with the chemotherapeutic agents carboplatin and paclitaxel in patients with non-small cell lung cancer (NSCLC).

“Despite recent therapeutic advances, non-small cell lung cancer remains a devastating disease,” said Susan Kelley, M.D., vice president, Oncology, Bayer Pharmaceuticals Corporation. “In early clinical studies, we observed preliminary activity in a small number of non-small cell lung cancer patients who received Nexavar administered in this drug combination. We look forward to exploring Nexavar in this randomized trial.”

Pivotal Phase III Trial Design

The multicenter study will compare Nexavar when co-administered with two chemotherapeutic agents – carboplatin and paclitaxel – versus carboplatin and paclitaxel alone. The study, which is expected to enroll approximately 900 patients, will assess overall survival as the primary endpoint. Secondary endpoints include progression-free survival, tumor response and safety. Participating patients may not have received prior systemic anticancer treatment. Additionally, the study is open to patients with all histologies, or types, of NSCLC including those with squamous cell or adeno carcinomas. Patients will be randomized to receive 400 mg of oral Nexavar twice daily or matching placebo, in addition to carboplatin and paclitaxel for six cycles. Subsequently, patients will continue in a maintenance phase where Nexavar or placebo will be administered as a single agent. The study will be conducted at more than 130 sites in North America, South America, Europe and the Asia Pacific region.

Bayer and Onyx also reported today that the U.S. Food and Drug Administration (FDA) has completed a Special Protocol Assessment (SPA) for the Phase III NSCLC trial. A SPA is a written agreement on the design and size of a clinical trial intended to form the basis for a new drug application.

About Nexavar

Nexavar is the first oral multi-kinase inhibitor that targets both the tumor cell and tumor vasculature. In preclinical models, Nexavar targeted members of two classes of kinases known to be involved in both tumor cell proliferation (tumor growth) and tumor angiogenesis (tumor blood supply) – two important cancer growth activities. These kinases included RAF kinase, VEGFR-2, VEGFR-3, PDGFR-Йї, KIT, and FLT-3.

In 2005, Nexavar received FDA approval for the treatment of patients with advanced kidney cancer. It is currently in Phase III clinical trials for the treatment of advanced hepatocellular carcinoma (HCC), or liver cancer, and metastatic melanoma, or skin cancer and has been studied in more than 20 tumor types and in more than 4,000 patients to date. In addition to company-sponsored trials, there are a variety of Nexavar studies being sponsored by government agencies, cooperative groups and individual investigators.

About Non-Small Cell Lung Cancer (NSCLC)

Lung cancer is the leading cause of cancer death for both men and women – claiming more lives than colon, breast, and prostate cancers combined. There are nearly 175,000 new cases of lung cancer in the United States each year; approximately 75 percent of all diagnosed lung cancers are due to NSCLC. Annual deaths in the United States are estimated at 160,000.

Important Safety Considerations for Patients Taking Nexavar

Hypertension may occur early in the course of therapy and blood pressure should be monitored weekly during the first six weeks of therapy and treated as needed. Incidence of bleeding regardless of causality was 15% for Nexavar vs. 8% for placebo and the incidence of treatment-emergent cardiac ischemia/infarction was 2.9% for Nexavar vs. 0.4% for placebo. Most common treatment-emergent adverse events with Nexavar were diarrhea, rash/desquamation, fatigue, hand-foot skin reaction, alopecia, and nausea. Grade 3/4 adverse events were 38% for Nexavar vs. 28% for placebo. Women of child-bearing potential should be advised to avoid becoming pregnant and advised against breast-feeding. In cases of any severe or persistent side effects, temporary treatment interruption, dose modification or permanent discontinuation should be considered.

About Onyx Pharmaceuticals, Inc.

Onyx Pharmaceuticals, Inc. is engaged in the development of novel cancer therapies that target the molecular basis of cancer. With its collaborators, the company is developing small molecule drugs, including Nexavar with Bayer Pharmaceuticals Corporation. For more information about Onyx’s pipeline and activities, visit the company’s web site at: http://www.onyx-pharm.com.

About Bayer Pharmaceuticals Corporation

Bayer Pharmaceuticals Corporation (www.bayerpharma.com) is part of the worldwide operations of Bayer HealthCare AG, a subsidiary of Bayer AG.

Bayer HealthCare, with sales of approximately 8.5 billion Euro in 2004, is one of the world’s leading, innovative companies in the health care and medical products industry. The company combines the global activities of the Animal Health, Consumer Care, Diabetes Care, Diagnostics and Pharmaceuticals. Since January 1, 2006 the new Pharmaceuticals Division consists of the former Biological Products and Pharmaceuticals Division and now comprises three business units: Hematology/Cardiology, Oncology, and Pr

imary Care. Bayer HealthCare employed 35,300 people worldwide in 2004. Bayer Healthcare’s aim is to discover and manufacture innovative products that will improve human and animal health worldwide. The products enhance well-being and quality of life by diagnosing, preventing and treating disease.

Forward Looking Statements

This news release contains forward-looking statements based on current assumptions and forecasts made by Bayer Group management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer’s public reports filed with the Frankfurt Stock Exchange and with the U.S. Securities and Exchange Commission (including its Form 20-F). Bayer assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.

This news release also contains “forward-looking statements” of Onyx within the meaning of the federal securities laws. These forward-looking statements include without limitation, statements regarding the timing, progress and results of the clinical development, regulatory processes and commercialization efforts of Nexavar®. These statements are subject to risks and uncertainties that could cause actual results and events to differ materially from those anticipated. Reference should be made to Onyx’s Annual Report on Form 10-K for the year ended December 31, 2004, as amended, filed with the Securities and Exchange Commission under the heading “Additional Business Risks” and Onyx’s Quarterly Reports on Form 10-Q for a more detailed description of such factors. Readers are cautioned not to place undue reliance on these forward-looking statements that speak only as of the date of this release. Onyx undertakes no obligation to update publicly any forward-looking statements to reflect new information, events or circumstances after the date of this release except as required by law.

Nexavar® (sorafenib) tablets is a registered trademark of Bayer Pharmaceuticals Corporation.

http://www.news.bayer.com