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by Tom Swartz and Bruce Shriver
In this issue's column: Researchers Urge Monitoring Of Bone Health During Chemotherapy In laboratory tests on mice, researchers have found that a medication often used to reduce toxic side effects of chemotherapy induced bone loss and helped tumors grow in bone. So the researchers at Washington University School of Medicine in St. Louis are recommending increased awareness of bone health during cancer treatments. The medication studied is a growth factor commonly used to help cancer patients recover healthy blood counts after chemotherapy, which can destroy white blood cells. Low levels of white blood cells leave patients susceptible to infection. "This growth factor encourages bone breakdown, and any therapy that decreases bone density could potentially enhance tumor growth in bone," says senior author Katherine Weilbaecher, M.D., assistant professor of medicine and of cell biology and physiology. "But there are things that can be done to counteract this. Physicians should carefully monitor their cancer patient's bone health with regular bone density scans (DEXA) and prescribe medications to prevent bone loss when needed. And patients should consume enough calcium and vitamin D and get sufficient exercise to maintain strong bones." Weilbaecher and her colleagues found that when they gave mice an eight-day course of the growth factor, called granulocyte colony-stimulating factor (G-CSF), the mice lost bone mass and experienced increased bone tumor growth when injected with cancer cells. Their study appears in the journal Blood and is now available online. G-CSF is known by the trade names Neupogen, Neulasta and Granocyte. Clinical use of G-CSF has recently increased because by speeding blood cell regrowth it allows patients to undergo more intensive chemotherapy regimens in which anticancer agents are given at more frequent intervals. "We are not at all advocating ending G-CSF use," says Weilbaecher, an oncologist with the Siteman Cancer Center at Washington University School of Medicine and Barnes-Jewish Hospital. "G-CSF seems to have significant benefits for some cancer patients." Although G-CSF had a strong effect on bone metastasis in the experimental mice, early clinical trials in humans using G-CSF with chemotherapy have so far shown no adverse effects on survival and no increase in bone metastasis. In the laboratory mice studied, G-CSF increased the number and activity of bone cells called osteoclasts, which reabsorb bone material as part of the normal process of bone turnover. The resulting loss of bone density created a favorable environment for bone tumor growth. When the researchers injected melanoma or breast cancer cells into mice, those getting G-CSF developed a two-fold increase in tumor burden, a measure of the size and severity of tumors, compared to those that did not receive G-CSF. Interestingly, mice treated with a bisphosphonate, an anti-osteoporosis agent that inhibits osteoclasts, were resistant to the effects of G-CSF on bone tumor growth. Weilbaecher is currently investigating bisphosphonates as a means to prevent tumor metastasis to bone in breast cancer patients. "We used G-CSF as a tool to understand the implications for tumor growth when osteoclast activity is revved up," Weilbaecher says. "But G-CSF isn't unique in its effect. For example, antihormone therapies used to treat breast and prostate cancer also can decrease bone mineral density. We would like to see clinical trials instigated to study the effects of such cancer therapies on bone health and tumor metastasis."
Teens Overlooked In Cancer Research Says McMaster Researcher McMaster University pediatric cancer specialist Dr. Ronald Barr says the teen gap in cancer care has been overlooked for far too long. Statistics show that gains in survival rates for teenagers and young adults (age 15 - 29) with cancer are dismal when compared to those for youngsters and older adults with the disease. "While there have been improvements in survival in children and older adults in recent decades there has been no such improvement in this age group in the past 25 years or so," said Barr, a professor of pediatrics of the Michael G. DeGroote School of Medicine at McMaster University and chief of hematology-oncology at McMaster Children's Hospital. Barr is one of the editors of the recently released monograph on the incidence, survival and mortality of 15 - 29 year-olds. Funded by the National Cancer Institute (NCI) in the United States, this monograph was a co-operative venture between the Children's Oncology Group (all 17 pediatric oncology centers in Canada and more than 200 American institutions) and the SEER (Survival Epidemiology and End Results) program. The monograph is the first to collect detailed information about cancer incidence and outcomes in adolescents and young adults. Barr is a member of the NCI and Lance Armstrong Foundation's new Progress Review Group whose sole purpose is identifying and prioritizing the scientific, medical and psychosocial barriers facing adolescent and young adult (AYA) cancer patients. They plan to develop strategies to better the odds for this age group. "The Lance Armstrong Foundation is very keen to advocate for young people with cancer and educate them in high schools, colleges and work places to the fact cancer can afflict people in their age group - and that when they get a lump they shouldn't say 'it's just a lump' but that it might be a form of cancer," Barr said. Barr co-chairs the Working Group on AYA within the International Society for Pediatric Oncology which will soon publish proceedings from its first workshop on AYA adolescent and young adults with cancer. He is also one of the authors and editors of an upcoming book on this issue. He said there are a variety of reasons why the outlook is so poor for this particular age group. Chief among them is the fact so few are participating in clinical trials - organized studies which test the value of various treatments, such as drugs or surgery in human beings. This lack of involvement correlates directly with their poor survival rates, he said. Young people's feelings of invincibility, coupled with a lack of awareness about their cancer risk, are other factors. And often family physicians aren't suspicious enough of teenagers' symptoms, interpreting a lump in the neck as an infection or leg pain as an athletic injury or growing pains, which delays an accurate diagnosis. Even more confusing, Barr said, is the fact that the types of cancer within the 15-29 age group occur at different frequencies across this age range, the most common types in teenagers being different from the most common types in young adults.
Osteosarcoma online provides up to date information of all areas concerning osteosarcoma from diagnosis to follow up care and current research. The information found on the Web site is provided by Indiana University Cancer Center health care professionals and scientists and is for informational purposes only. An excellent “Quick Facts” about osteosarcoma give basic information on the biology of osteosarcoma, treatment and prognosis. You can learn about the osteosarcoma research initiatives of the Indiana University Cancer Center as well as take time to read stories and journey through the lives of young people and their parents, who have been affected by Osteosarcoma. Information is also provided for family and friends of osteosarcoma patients. One can also find a list of current osteosarcoma clinical trials.
CoGenesys, Inc. announced that the company has submitted a Clinical Trial Application (CTA) to begin human studies in Europe of Neugranin™, a long-acting form of Granulocyte Colony Stimulating Factor (G-CSF), which is designed to decrease the incidence of infection in patients receiving myelosuppressive anti-cancer drugs. Pending CTA authorization, the Phase 1-2a clinical trial of Neugranin will be a randomized, multicenter, double-blind safety and tolerability trial in more than 60 patients with breast cancer. In the first phase of the study, subjects will receive a subcutaneous dose of Neugranin prior to receiving myelosuppressive chemotherapy (Doxorubicin/Docetaxel). In the second phase, patients will be given chemotherapy prior to dosing with Neugranin, while a positive control group will receive Neulasta(R), a pegylated form of G-CSF. Evaluations will include safety and tolerability, pharmacokinetic profiles, and, additionally, in the second phase, signals for effect. Martha A. Reitman, M.D., CoGenesys' Senior Vice President, Medical Affairs, stated, "We are pleased to announce the regulatory submission for the company's second clinical trial program. Previously, findings from in vitro and in vivo tests have suggested that Neugranin may have a profile comparable to that of Neulasta(R), the current market leader for the treatment of patients who have reduced white blood cells (neutropenia). With a competitive cost of goods profile, Neugranin may represent an affordable treatment alternative to prevent and treat chemotherapy-induced febrile neutropenia in cancer patients. Further, there may be an opportunity to consider the regulatory pathway for Neugranin as a "bio-similar" drug."
Neutropenia is the most common side effect associated with the administration of chemotherapy in cancer patients. Neutropenia can lead to serious infections and hospitalization, and the presence of fever in these patients often necessitates the reduction of the dose of chemotherapy or causes a delay in the administration of the next cycle of chemotherapy. The worldwide market for colony stimulating factors is expected to reach $5 billion by 2010. Three products have been approved for marketing in the United States: Amgen's Neupogen(R) and Neulasta(R), and Schering AG's Leukine(R). Neulasta(R) is the only long-acting G-CSF product presently approved in the world. Neulasta alone generated $2.2 billion in sales in 2005. CoGenesys believes that Neugranin has the potential to be the second long-acting G-CSF product to enter this very large market.
Spicy food could provide compound to fight cancersThe compound that makes spicy food hot and generates the heat in muscle strain remedies could be the key to a new generation of cancer drugs which kill tumors with no side effects, a leading scientist has said. Capsaicin, the active component of chillies, has produced "startling" results in tests to kill a variety of tumor cells including pancreatic cancer, one of the most difficult versions of the disease to treat. Dr. Timothy Bates, who led the research at Nottingham University, said his team has discovered a potential Achilles heel for all cancers because capsaicin targets the "powerhouse", or energy source, of tumor cells. The discovery could lead to the production of drugs to cure a variety of cancers at a fraction of the cost of developing conventional medicines, as capsaicin is already consumed daily by millions of people. Capsaicin is also commonly used as an active ingredient in muscle rub creams and the treatments for psoriasis. Dr. Bates said: "This is incredibly exciting and may explain why people living in countries like Mexico and India, who traditionally eat a diet which is very spicy, tend to have lower incidences of many cancers that are prevalent in the Western world. We appear to have discovered a fundamental weakness with all cancer cells. Capsaicin specifically targets cancerous cells, leading to the possibility that a drug based on it would kill tumors with few or no side effects for the patient." When released onto cancer cells, capsaicin attacks the mitochondria in the cell, which is responsible for generating ATP, the major energy-producing chemical in the body. Capsaicin specifically binds to the protein within the mitochondria of tumor cells and triggers apoptosis, the process of natural cell death. Experiments by the Nottingham team found this took place in cancer cells without affecting surrounding healthy cells. The team applied the compound to human lung cancer cells, considered a gold standard test for anti-cancer drugs, and produced a "startling" rate of cell death. A similar rate was recorded on pancreatic cancer cells. The researchers said: "These results are highly significant as pancreatic cancer is one of the most difficult cancers to treat and has a five-year survival rate of less than one per cent." Dr. Bates said the fact that capsaicin, part of a group of food compounds called vanilloids, was a common part of the diet in many countries would dramatically reduce the number of regulatory hurdles that any anti-cancer drug would have to overcome. The Nottingham team is looking for industrial partners to start clinical trials. Josephine Querido, cancer information officer at Cancer Research UK, said: "This research does not suggest that eating vast quantities of chilli pepper will help prevent or treat cancer. The experiments showed that pepper extracts killed cancer cells grown in the laboratory, but these have not yet been tested to see if they are safe and effective in humans. It will be interesting to see how research on capsaicin progresses."
Study Examines Drug Delivery With Liposomes Several chemotherapy drugs can only be given at certain doses because they're highly toxic to healthy cells, and at those doses, the concentration of the drug that reaches cells in the tumor may be quite low. Scientists have been investigating the use of liposomes, hollow spheres of fat molecules, to deliver chemotherapy drugs directly to tumors. These liposomes melt and release their contents when exposed to heat. In a new study published in the Journal of the National Cancer Institute (Vol. 99, No. 1, pp. 53-63), Ana M. Ponce and Mark W. Dewhirst, D.V.M., Ph.D., of Duke University Medical Center, and colleagues injected doxorubicin-containing liposomes into rats bearing fibrosarcomas. The researchers monitored the rats continuously using magnetic resonance imaging to watch how the liposomes distributed in the body. They also tracked whether it was most effective to inject the liposomes before, during, or before and during heating of the tumor, which triggers the liposomes to dissolve and release the doxorubicin inside. Based on their results, the researchers conclude that the drug distribution was most effective when the liposomes were given while the tumor was being heated.
CyberKnife® Stereotactic Radiosurgery System Overview Stereotactic radiosurgery is a medical procedure that utilizes very accurately targeted, large doses of radiation. This noninvasive “operation” has proven to be an effective alternative to surgery or conventional radiation for treating many small tumors and a few other select medical disorders. This webpage presents an overview of the stereotactic radiosurgery procedure, an overview of radiation oncology in general, a searchable list of all cyberknife locations both domestic and international, in addition to other useful information for patients considering this type of treatment. The website is maintained by the CyberKnife® Society which was established in 2002 as an organization committed to bringing together diverse users worldwide to foster scholarly exchange and share other clinical information pertaining to CyberKnife® Radiosurgical ablation.
Aida Pharmaceuticals Receives Approval and Commences Phase II Trials of Potential Cancer Treatment Aida Pharmaceuticals, Inc., one of mainland China's leading pharmaceutical companies, announced on January 9th that the State Food and Drug Administration (SFDA) of China has officially approved the commencement of Phase II clinical trials of the genetic cancer treatment Rh-Apo2L. Aida Pharmaceuticals previously announced its plans to begin Phase II trials throughout mainland China this year. These trials will take place in approximately 20 hospitals in major metropolitan candidate areas. The Phase II trials will analyze the effect of Rh-Apo2L on two types of tumors chosen from the following cancers: advanced inert lymphoma, malignant melanoma, soft tissue sarcoma, pancreatic cancer, kidney cancer, non-small cell lung cancer and colorectal cancer. The trials will analyze the specific efficacy of Rh-Apo2L in approximately 100 patients. Additionally, the Company will continue to analyze the dosage and effectiveness of the drug as well as other drugs' interactions with Rh-Apo2L. Chairman of Aida Pharmaceuticals, Jin Biao stated, "This approval will allow us to contiguously move forward with our development plans for Rh-Apo2L. This potentially revolutionary cancer treatment has received a great deal of attention this year including awards and grants from the state and federal governments. Last quarter, Aida announced plans to build a GMP certified manufacturing facility for Rh-Apo2L. The facility will be built in the Jianggan Hi-Tech development zone in Hangzhou, China. We remain on track to break ground on the project early this year and we anticipate the phase I construction to be completed by year-end 2007. This facility will have the final capacity to produce up to eight million doses of Rh-Apo2L. We believe that we have the resources and man power to finish Phase II and Phase III trials in order to bring Rh-Apo2L to market by 2008. In its first year of production, pending all necessary approvals and allowances, we believe Rh-Apo2L will generate potential EBITDA of $50 million on potential sales of $75 million." Rh-Apo2L is a broad spectrum genetic cell apoptosis (cell- killing) agent, which the Company expects to be used for the treatment of a variety of cancerous tumors. Click here to learn more about Rh-Apo2L.
Advocacy groups as research organizations: the PXE International example Advocacy organizations for genetic diseases are increasingly becoming involved in biomedical research, particularly translational research, in order to meet the needs of the individuals that they serve. PXE International, an advocacy organization for the disease pseudoxanthoma elasticum, provides an example of how research can be accelerated by these groups. It has adopted methods that were pioneered by other advocacy organizations, and has integrated these along with new approaches into franchizable elements. In this article, the authors discuss the role of disease-specific advocacy organizations as meaningful contributors to the research enterprise, using PXE International as an example. The authors describe the challenges of rare-disease research and how advocacy organizations can respond to these challenges. They conclude with a discussion of the potential for translational research in general to benefit from the involvement of advocacy organizations. This is an interesting article for all sarcoma advocacy organizations for ideas on how to move research into tangible results.
Follow up after childhood cancer: A typology of young people's health care need The pediatric oncology community is focused on providing appropriate care to survivors of childhood cancer, given that despite increases in survival rates it is estimated that 60% will have one or more problems related to their disease or treatment. Agreement and consistency in how follow-up for this group of young people should be designed and delivered has not yet been reached and rarely have young people been asked to contribute to this discussion. This study aimed to find out what young people who are receiving long term follow-up for childhood cancer would like from their follow-up service. It aimed to illuminate the dimensions of care valued by young people as well as make explicit to professionals health care needs that must be met to provide optimum care into their adult life. The emphasis was on qualitative, participatory methods using reflexive and responsive approaches to give primacy to the voice of participants. Data were generated through a series of workshops, interviews and questionnaires. The findings were as follows. Forty young people (12 male: 30% and 28 female: 70%), participated in the study. Preliminary analysis yielded a descriptive typology that could serve as a basis for classifying and clarifying health care needs: defined as what the young people in this study wanted from a follow-up service. Five categories of health care need were identified: (1) need for a positive relationship with health care professionals; (2) need for information; (3) need for communication; (4) need for parents to be supported; and (5) need for health care professionals to have appropriate knowledge.
Medicare’s drug plan: huge price disparities for common cancer drugs In this study, the editors of Community Oncology chose seven oral cancer drugs and asked the authors to analyze differences in pricing among the drugs within three communities, each market a different size. The drugs were anastrozole (Arimidex), exemestane (Aromasin), imatinib (Gleevec), sunitinib (Sutent), erlotinib (Tarceva), temozolomide (Temodar), and thalidomide (Thalomid). The markets were Chicago, Illinois; Portland, Oregon; and Virginia Beach, Virginia. The results of this small study offer a stark illustration of the difficult nature of Medicare’s Part D program. The authors found that for both on-formulary and off-formulary drugs, there is significant pricing variation within markets, and that careful shopping can translate into big savings. The authors recommend that patients and cancer advocacy groups access sites like the Coalition to Advance Prescription Drug Education (CARExE) to review a region’s drug plan formularies, so that patients will be familiar with the most affordable drugs that match the patient needs. CARxE is a free tool that allows seniors and their caregivers to determine which Medicare drug plan best fits their needs. A senior visiting the CARxE Web site enters a zip code and his or her medications and receives a listing of drug plans operating in that zip code, the cost of those drugs—including the premium, deductible, co-payment, and total out-of-pocket expense—and each plan’s network pharmacies.
Palliative Management of Fatigue at the Close of Life Fatigue is the most common chronic symptom associated with cancer and other chronic progressive diseases. The assessment and treatment of fatigue at or near the end of life can be complex. Some of the challenges include its subjective nature, with great variability in its source, how it is expressed, and how it is perceived, requiring treatment to be based on patient report of frequency and severity; its multidimensional character; and the limited understanding of its pathophysiology. Using the case of an 82-year-old retired nurse with fatigue that could be explained by a number of concurrent conditions, including anemia, weight loss, depression and isolation, dyspnea, deconditioning, and medications, the authors of this article illustrate the clinical approach to assess and treat fatigue at the end of life. At the end of the article is a list of resources for end of life care.
Responding to Employment Concerns of Cancer Survivors The report on cancer survivorship recently released by the Institute of Medicine of the National Academies called on health care providers to become familiar with the employment rights of survivors, to offer them information about employment rights and programs, and to help minimize the adverse effects of cancer on employment. This review article is designed to help health care providers respond to the Institute of Medicine's recommendations by describing relevant employment and health insurance legal protections, nationally accessible services and information sources for survivors, functional limitations that may affect survivors' work, and a variety of rehabilitation services that may be helpful for survivors with disabling residual effects of cancer and its treatment. It also suggests directions for further efforts on the part of public and private cancer organizations, researchers, and clinicians to address the employment concerns of survivors.
From Tennis to Nunhood to Making a Difference At a morning church service, you might recognize Sister Andrea. She's Andrea Jaeger, the former top-ranked professional tennis player. Four months ago she became a Dominican nun. It seems a natural progression for Jaeger, who, for two decades, has been inspiring sick children, like those in a Fort Lauderdale, Fla., hospital when injuries ended her tennis career. Jaeger used her winnings to start a foundation and a camp for kids with cancer, giving them breaks from doctors and dreaded news. "Kids stop sharing when they're in pain and they're suffering," Jaeger says. "And if we can allow children to find their voice, lives will be changed." Alicia Harding was at the camp in 1994. "I had osterosarcoma," she says. Today, at 26, her health is back and she's working with Andrea to help others. Like Samantha Miller. "It gives me hope to let me know that there's someone else that made it," Miller says. Cancer survivor Tripp Robbins still considers the camp home. "This is the only place where I've been, you know in all of the world, that I feel total peace," Robbins says. Now an Army Ranger in Iraq, he and Andrea exchanged gifts. She gave him her Olympic ring. He gave her his dog tags. "This is Trip saying, 'I'm right there in your heart, and you're right there in mine' " Jaeger says. Sister Andrea is still a free spirit, and proving that devotion has no limit. When you touch a person's life once, in a pure way, genuine way, it's so powerful it can last forever," she says.
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