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July/August 2006 Issue
• Cancer Research Round Up |
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Cancer Research Round Up By Ilene Raymond Results of 3,700 cancer research studies were presented at the 42nd annual meeting of the American Society of Clinical Oncology (ASCO) in Atlanta, Georgia. Conference highlights are presented below, based on interviews with Giovanni Abbadessa, M.D., an oncologist and cancer researcher at the Sbarro Institute for Cancer Research and Molecular Medicine in Philadelphia, Pennsylvania. Experimental agent lapatinib (Tykerb) delayed progress of breast cancer almost twice as long as patients whose cancer had progressed following treatment with trastuzumab (Herceptin). For about a quarter of breast cancers, there is an over expression of the protein HER2, a normally occurring protein in breast cells. Tumors that produce too much HER2 (called HER2-positive) tend to grow faster and return earlier. Treatment for HER2-positive breast cancer often includes chemotherapy and injections of Herceptin (Trastuzumab), a drug that binds to part of the protein outside cancer cells, but in cases where patients who are HER2 positive no longer respond to herceptin, lapatinib (Tykerb) increased the disease free survival rate significantly. Lapatinib works on the same receptors as Herceptin, but acts by binding to the protein inside the cells. The Phase III study enrolled 321 patients: half received lapatinib and capecitabine, a drug that interferes and eventually destroys cancer cells, while the other half only capecitabine. Early reports for the first group showed disease free survival (37 vs. 20 weeks). “Report results show that lapadatinib can prove an alternative treatment for patients whose cancer becomes resistant to trastuzumab,” says Abbedessa. Dr. E. Geyer, director of Breast Medical Oncology at the Allegheny General Hospital (Pittsburgh, PA), conducted the study. The osteoporosis drug Raloxifene (Evista) works as well as tamoxifen (Nolvadex) in reducing the risk of breast cancer for postmenopausal women at an increased risk for the disease. Results of the large Study of Tamoxifen and Raloxifene (STAR) released by the National Surgical Adjuvant Breast and Bowel Project (NSABP) reveal that both drugs cut the risk of developing invasive breast cancer by half. In addition, women who took raloxifene over four years had 36 percent fewer uterine cancers and 29 percent fewer blood clots than women who took tamoxifen alone. Thrombosis, or blood clots, are a risk of both drugs, while a rise in uterine cancers rates can be a rare side effect of tamoxifen. The STAR study, which has been ongoing since 1991, involves 19,747 postmenopausal women at an increased risk of breast cancer. New findings reveal that postmenopausal women treated with an aromase inhibitor after an adjuvant course of three years of tamoxifen following surgery for breast cancer, show a delay in the progression of the disease and a better rate of survival compared to those who stayed on tamoxifen alone. Following breast cancer surgery, women with estrogen-based cancers often take the anti-estrogen drug tamoxifen for five years. Tamoxifen, however, does not prevent all recurrences of cancer, and some women develop a resistance to the drug. The 4,724 women from 37 countries in the study had taken tamoxifen for two or three years following breast cancer surgery and were free of cancer. Half continued on tamoxifen, while the other group switched to exemestane, an inhibitor that works by inactivating the aromatase enzyme used by the body to make estrogens, particularly after menopause. After a median of 4.8 years, women who switched to exemestane had a 15 percent lower risk of dying than those who continued to take tamoxifen. Yoga may improve quality of life and psychological well being of breast cancer radiation patients. In a study performed at the M.D. Anderson Cancer Center in Houston, Texas and Swami Vivekananda Yoga Anusandhana Samsthana yoga center in Bangalore, 61 women receiving daily radiation treatments for breast cancer were randomly assigned to yoga treatment or a control group that offered no structured activities. Results of a questionnaire showed that patients in the yoga group felt better physically and mentally. While the results were positive, additional studies are planned to pinpoint if the favorable effects on well-being are specific to yoga or might be due to other factors, such as the “perception (by the yoga group) that the hospital was taking better care of them,” says Abbadessa. A meta-analysis of five large clinical trials found that adjuvant chemotherapy extended survival for patients with stage II or stage III non-small cell lung cancer (NSCLC). The benefit did not differ with different chemotherapy regimens, and was not affected by variables such as age, gender, or tumor type. All of the 4,584 patients in Lung Adjuvant Cisplatin Evaluation (LACE) study had undergone surgery to remove tumors. They were divided into two groups: those who had received chemotherapy or observation only and those who received chemo and radiation or radiation only. Chemotherapy produced a 5.8 percent increase in survival after three years of treatment and a 5.5 percent increase after five years. No benefit was seen for stage IA or IB lung cancers, in contrast to previous results with shorter follow-up of the patients (3 years). Elderly patients with early-stage non-small cell lung cancer who received chemotherapy following surgery lived longer than those who'd had surgery alone. In a retrospective review, Canadian investigators noted that of the 482 participants in an earlier study, 155 were older than 65 and 327 were aged 65 or younger. In the surgery plus chemotherapy group, there were 63 elderly and 150 younger patients. In the surgery alone group, there were 92 elderly and 177 younger patients. Researchers were interested in examining if age influenced the rate of overall survival of patients. Their findings showed that that older patients benefit as much from the chemotherapy treatments as do younger patients, despite their age and the lower dosages of chemotherapy they often receive. Dr. Abbadessa comments, “It was not that older patients did better than younger patients but that older patients did equally well, which should encourage doctors to treat older patients in an equal way.” Patients in the study received a combination of cisplatin and vinorelbine, which has been pointed out to be the most effective treatment, even if no phase III study proved it yet. Moreover, the results have not been stratified by stage and tumor dimensions, and according to other recent studies the presence of bigger tumors and stage II patients may have influenced positively the results. The study concurs with other results presented at the ASCO Conference, which show no advantage for adjuvant therapy in stage I NSCLC patients. On the other hand, this study also interestingly demonstrates how even low doses of adjuvant cisplatin-based chemotherapy improve survival in elderly stage IB-II NSCLC patients. A report analyzed the effect of prophylactic oophorectomy, removal of part or all of the ovaries, on women carrying BRCA1 or BRCA2 gene mutations, important risk factors for breast and ovarian cancers. The study, led by Dr. N. Kauff from Memorial Sloan-Kettering Cancer Center in New York, looked at 886 women with a BRAC1 or BRAC2 mutation over age 30. Women were divided into two groups: 561 cases who had their ovaries removed and 325 who did not. Overall, data showed a 47 percent reduction in the risk for breast cancer and an 89 percent drop in the risk for ovarian cancer among those who had undergone voluntary removal of their ovaries. In women with BRAC 1 mutation, prophylactic removal of the ovaries cut the risk of ovarian cancer by 87 percent, while the risk of breast cancer was reduced by 39 percent. For those with the BRAC2 mutation, however, breast cancer was reduced by 72 percent, while ovarian cancer was found in only two women who did not undergo surgery. Given the well known risk factors for ovarian and breast cancer for women with BRAC1 and BRAC2 mutations, women are given the choice of prophylactic surgery with the advice of doctors based on the risk of cancer associated with the mutation. “The study confirms the connection between prophylactic removal of the ovaries with a reduced risk of ovarian cancer,” says Abbadessa, “but also points out differences between the two genetic mutations in regard to the relative risk of breast and ovarian cancers.” “The results suggest that there may be an advantage to studying the combined effects of prophylactic oophorectomy and bilateral mastectomy for women with mutation in the BRAC2 gene.” For more on cancer reports see: |
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July/August 2006 Issue 
Life Lessons: Dr. Ignazio Marino By Ilene Raymond Ignazio Marino, MD, a bio-ethicist and transplant surgeon at Thomas Jefferson Hospital in Philadelphia, garnered global headlines earlier this year when he participated in a 'Dialogue on Life' published in the Italian journal L'Espresso, with one time papal candidate Cardinal Carlo Maria Martini. In a wide-ranging discussion that touched on ethical issues from abortion to euthanasia, Cardinal Martini allowed that in cases where one member of a married couple has HIV/AIDS, the use of condoms might be considered a 'lesser evil' by the Catholic Church, a view that caught the attention of influential papers including The New York Times as well as Catholic bloggers around the Web. In April 2006, after many years of practicing medicine in the United States, Marino was elected to the Italian Senate, where he now serves as the chairman of the health committee. Widely published in medical journals, Marino is also the author of Credere e Curare (To Believe and to Treat), a surprise bestseller in Italy that will soon be translated into English. How did the dialogue arise? Cardinal Martini had read my book and was interested in discussing areas where medicine and bioethics intersect and our common interest in problems facing medicine and the church. Did his views on condom use surprise you? Traditionally, condoms are not accepted in the church, but in Africa it is a means - perhaps the only means - of preventing the HIV virus. The church does not accept it but physicians know it works and the issue produces a significant problem for health workers and doctors. How can you tell people that you should not use a tool that will create a significant decrease in the disease? How can you do that when the disease affects 42 million people in sub Saharan Africa, most of who do not have access to medical treatment? The Bush Administration has tied its prevention to abstinence. Should doctors encourage abstinence? It's an incredibly unrealistic approach. Sexual activity is part of human relations. If one member of a couple is infected with the virus, it is unrealistic to think that they will practice abstinence. It won't happen and it will spread the infection. What was the response of the Church? The Vatican read the documents in L'Espresso and has tasked Cardinal Javier Lozano Barragan, president of the Pontifical Council for Pastoral Health, to work on a document that will address the issue. How did you become involved in bioethical issues? Overnight, technical issues in transplant medicine form bioethical issues. If you think about it, as a transplant surgeon you literally are giving a person a second life. Recently, a front-page article in The Wall Street Journal said that some people have begun selling organs. On the transplant list at any time, you could have thousands of citizens waiting for an organ. More die every day. Everything about it involves ethical considerations. Do you support selling organs? I believe it is absolutely wrong to go in this direction. People who generously might want to contribute an organ, however, maybe after death, should be encouraged. In Philadelphia there is a beautiful organ procurement organization that achieves a high rate of donations by working with hospitals, family physicians and the generosity of individuals. Selling organs isn't right. It will result in a market where poorer people will sell their organs to richer individuals. The opposite will not take place, from rich to poor. Unless an organ for transplant is given as a gift, it should be illegal. Although you're now in Italy, most of your medical practice has been in the U.S. What do you think of the U.S. health care system? Overall, I became very uncomfortable with the American system of health care. In the twenty to 25 years since I started practicing medicine, there has grown an ever-larger separation between the patient and physician as human beings. My goal is to bring back values to the practice of medicine, to make being a doctor more than a job. The practice of medicine should be a mission. We should be able to put at the center universal human values and to treat people as human beings, not only patients. This lack of connection is shown in the increasing number of malpractice cases between physician and patients. Given your deep connection to patient care, why did you leave your medical practice for politics? Italy is at a very important phase in the development of health care. On paper our country has health care equity and promises that everyone will get equal care regardless of social status or income. But in fact, differences do exist. As the chairman of the health care committee I hope to address these inequities. So far, I've only taken a sabbatical from my practice at Thomas Jefferson. I continue to practice medicine one day a week in Italy and hope to add a day for surgery. What's your plan to improve Italian health care? Our first goal is to try to eliminate the differences in care. We are also going to try to make an analogy with the United States hospital system by implementing a health care oversight system where the quality of care and outcomes are connected to the accreditation of hospitals. We also need to improve access to treatment. We have great technology, but most of our hospitals are in the North of the country, leaving many in the South with substandard access. Right now, money is given for medical infrastructure, but it is sometimes not used for the right purposes. Any last thoughts? We need more cooperation and collaboration between the U.S. and Italy. We should create more chances to develop projects together. My dream is of a time when Italian doctors and scientists will not only leave our country to work, but will want to return to practice in Italy. To read the “Dialogue on Life” see: |
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July/August 2006 Issue 
A Boost for Italian Biomedical Research By Ilene Raymond The Human Health Foundation (HHF), a nonprofit organization designed to develop and fund biomedical research, was introduced this month during the annual Spoleto Festival in Italy by Antonio Giordano, MD, PhD, president and founder of the Sbarro Health Research Organization (www.shro.org). Funding for cancer research and other diseases has proven a problem for many Italian scientists, creating a widely acknowledged 'brain drain' among post-docs and researchers who leave to find funding for their work in other countries, most notably the United States. “Available money often goes to only a few Italian research centers, creating an 'oasis' in a desert,” says Giordano, who will serve as director of the scientific advisory board for HHF. “We hope to improve this situation in a way that is fair, balanced and based on initiative and merit.” HHF was founded by the Banca di Popolare di Spoleto (www.bpspoleto.it), a major corporate sponsor of the world-famous Spoleto Festival, a celebration of the arts held in the Umbria region of Italy during the first two weeks of July. “As a public institution, we have to protect our clients' money, but we also want to be involved in socially conscious investing,” says Giovannino Antonini Ph.D., president of the Spoleto bank. “With this in mind, the board and I felt it was important to contribute not only to the arts, but also to the sciences.” Along with developing new medical research centers, HHF will promote and support novel methods for the prevention, diagnosis and treatment of cancer and other illnesses; implement and design new initiatives to exchange and spread the results of new research; and design original programs to inform and increase public awareness of health and ethical issues that involve scientific research and cancer prevention. In a country where statistics on biomedical funding and accountability have been hard to come by, Giordano stresses that all of the HHF funds will be carefully monitored and accounted for, and “that the highest ethical commitment and responsibility will be placed on distributing funds.” “Our foundation will operate with complete budgetary transparency,” says Giordano. “We will utilize peer review and other initiatives pioneered and widely applied in the American system of grants to be sure that the most qualified research is funded based on merit.” |
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