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SPECIAL SECTION |
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BREAST CANCER PREVENTION TRIAL TO REQUIRE FEWER PARTICIPANTS |
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 Top Breast Cancer Prevention Trial... Efficient Outpatient Setting...Women who Test Negative...Who should have access...ASCO Statement on Genetic...Oncor Buys License for...Guilford Buys Rights to...NCI to Sponsor Clinical...Firm Buys Rights to... |
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Originally, the recruitment target was 16,000 women at high risk of developing breast cancer. Now, NCI officials concluded that 13,000 women will be needed to determine whether the drug tamoxifen delays the onset of breast cancer in women at high risk of developing the disease. A smaller number of participants will be needed since women who enrolled in the trial were at over twice the originally estimated risk of developing the disease, sources said. Currently, the enrollment in the trial is over 12,000. The new, lower enrollment target can be expected to be reached by the end of the year.
Sources said the women who enrolled in the study had about a 5.5% risk of developing breast cancer in any year during the trial. That was more than double the original estimate of relative risk of 2.5%, sources said. The trial is open to women over age 35. The participants’ risk is evaluated on the basis of the number of first-degree relatives who have been diagnosed with the disease, age at childbirth, frequency of breast biopsies, age of first menstrual period and the presence of lobular carcinoma in situ.
The trial, conducted by the National Surgical Adjuvant Breast & Bowel Project, has been criticized by several women’s groups for subjecting asymptomatic women to tamoxifen’s side effects which include endometrial cancer. Three years ago, in the midst of the controversy surrounding NSABP, the trial received negative publicity nationwide, which resulted in a drop in enrollment. Also at that time, the trial’s requirements and informed consent documents were altered to reflect the previously unknown risks. 
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EFFICIENT OUTPATIENT SETTING PROVIDES COST SAVINGS OVER HOME CARE, OCHSNER STUDY FINDS |
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TopBreast Cancer Prevention Trial...Efficient Outpatient Setting...Women who Test Negative...Who should have access...ASCO Statement on Genetic...Oncor Buys License for...Guilford Buys Rights to...NCI to Sponsor Clinical...Firm Buys Rights to... |
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With the increasing demands for cost controls, patient care has shifted from traditional locales such as inpatient hospital settings to ambulatory and home care settings. In previous studies evaluating the cost of chemotherapy administration, the outpatient clinic (ambulatory) setting was found to provide significant cost savings and greater patient and family satisfaction compared with treatment in the hospital. The current study was designed to measure major cost elements of home and ambulatory treatment. The costs included personnel (treating and support staff), drugs and supplies, and overhead (space and utilities).
Four chemotherapy regimens for colon, breast and lung cancer, and three supportive care measures (blood transfusion, i.v. hydration and i.v. antibiotic treatment) were evaluated. Home care was an average 109% more expensive compared to the ambulatory care setting. Average costs were $982 home care versus $471 in the ambulatory setting. To control for lower drug costs found in the ambulatory setting, costs were also examined independent of pharmaceutical drugs; home care remained an average of 140% more expensive.
One hundred patients receiving chemotherapy and supportive care in an ambulatory care setting were surveyed to determine satisfaction using a visual analog scale. Overall, patients were highly satisfied with ambulatory care setting, with an average rating of 98 out of 100.
"In this study we are able to review the actual cost differences between home and ambulatory care," said Patrick Grusenmeyer, Administrative Director at the Ochsner Cancer Institute. "We were surprised to find that the ambulatory care setting was significantly cheaper than home care and was less expensive for each type of treatment or supportive care measure examined. This study demonstrates that it is possible to provide high quality, cost effective oncologic care that eliminates hospitalization, is cheaper than home care and results in extremely high patient satisfaction."
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WOMEN WHO TEST NEGATIVE FOR BRCA1 DROP PLANS FOR MASTECTOMY, STUDY FINDS |
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TopBreast Cancer Prevention Trial...Efficient Outpatient Setting...Women who Test Negative...Who should have access...ASCO Statement on Genetic...Oncor Buys License for...Guilford Buys Rights to...NCI to Sponsor Clinical...Firm Buys Rights to... |
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All the families were under evaluation for at least six years and some of them for as long as 30 years. Extensive counseling of family members was conducted about the natural history of hereditary breast-ovarian cancer, the meaning and significance of the BRCA1 gene, and available screening and treatment strategies, including prophylactic surgery. Liabilities of BRCA1 disclosure were also discussed, including the potential for fear, anxiety, family disruption, cost of testing and counseling, and discrimination by insurance companies and employers.
After informed consent, the researchers performed DNA testing on 388 individuals, of whom 181 received their results (78 positive and 100 negative for BRCA1, and 3 ambiguous) in concert with genetic counseling. Patient responses to their BRCA1 results were extremely variable. For example, approximately 25% of the patients expressed moderate to grave concern for potential insurance discrimination. Emotional responses also varied. In the group who tested positive for BRCA1, 36% were sad or crying upon hearing the results, while 27% said they were not surprised at the result. Of those women who tested negative for the BRCA1 gene, 81% were "happy/relieved," while approximately 4% had "survival guilt."
Prior to receiving their BRCA1 results, many women were strongly considering prophylactic mastectomy or oophorectomy to lower their risk of developing cancer. In the group that tested positive for BRCA1, 32% had considered prophylactic mastectomy prior to hearing the results, and this percentage rose slightly to 35% after learning that they had the gene.
Of the women who tested negative for BRCA1, approximately 22% had strongly considered prophylactic mastectomy before knowing the results; this percentage dropped to zero after they learned that they did not have the gene. This percentage was duplicated in those women considering oophorectomy (40% before knowing the results, 0% after learning they were BRCA1 negative).
Lynch concluded that there is a compelling and ethical responsibility to provide DNA information to informed and consenting family members, but that testing should be done by highly qualified physicians. "A BRCA1 mutation positive result did not significantly alter the number of women strongly considering prophylactic mastectomy or oophorectomy," Barbara Weber, of the University of Pennsylvania Cancer Center, said in commenting on Lynch’s study at a press briefing. "However, those women who found out that they were negative for a BRCA1 mutation were able to avoid unnecessary surgery."
The availability of the DNA test for BRCA1 mutations has raised issues that go beyond clinical diagnosis, and involve legal, ethical and emotional aspects. "The genetic testing debate is likely to continue for some time, until long-term research on the impact of these tests can be conducted," Weber said. "In the short term, an open discussion about all aspects of genetic testing will assist physicians and the public in making informed decisions."
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WHO SHOULD HAVE ACCESS TO GENETIC INFORMATION? |
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TopBreast Cancer Prevention Trial...Efficient Outpatient Setting...Women who Test Negative...Who should have access...ASCO Statement on Genetic...Oncor Buys License for...Guilford Buys Rights to...NCI to Sponsor Clinical...Firm Buys Rights to... |
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The actual clinical benefits that genetic information confers have neither been fully explored nor confirmed, and it may be years before the medical community is confident in interpreting the implications of genetic status.
The ability to identify genes that increase risk for cancer and other disorders has outpaced the medical community’s ability to intervene constructively. This is the central dilemma that molecular genetics poses for oncology, Reilly said. Many questions need to be addressed in order to use genetic information in a meaningful way. For example, who should have access to genetic information? For what purposes should it be legitimately used? What impact will there be on the confidentiality of the patient-physician relationship?
In addition, Reilly discussed one of the more troubling aspects of genetic testing for cancer susceptibility - the potential threat to insurability and employment posed by the ability to discern genetic risk information. The strongly held public concerns about privacy issues may compromise and threaten research involving DNA, Reilly said.
"Genetic testing is a double-edged sword, because while we can help identify certain people who are at an increased risk of developing cancer, we can’t guarantee that this information will not be used improperly," Barbara Weber said. "Legislation to protect genetic risk information and confidentiality must be implemented if clinical research in this area is to continue."
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ASCO STATEMENT ON GENETIC TESTING |
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TopBreast Cancer Prevention Trial...Efficient Outpatient Setting...Women who Test Negative...Who should have access...ASCO Statement on Genetic...Oncor Buys License for...Guilford Buys Rights to...NCI to Sponsor Clinical...Firm Buys Rights to... |
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To assist ASCO’s 10,000 members in responding to the growing interest in genetic testing, the Society developed a statement to advise clinical oncologists about the critical issues that must be addressed if genetic testing is to be responsibly and effectively translated into the care of patients with cancer and their families.
Earlier statements by professional societies recommended limiting cancer genetic predisposition testing only to research studies. However, genetic testing is or will be commercially available outside of the context of clinical research. During the transition while testing is integrated into the standard medical care, physicians must exercise caution, Offit said.
Informed consent of the patient or family member is the cornerstone of the ASCO statement, including implications of a positive or negative result; risk of passing a mutation on to children; technical accuracy of the test; fees involved in counseling and testing; and risk of psychological distress. Testing should only be offered when individuals have a strong family history or very early age of onset of disease, the test can be adequately interpreted, and results will influence care of a patient or family member, the ASCO statement said. The statement also urges that counseling be offered to all individuals at hereditary risk for cancer. Additionally, patients and their families should be informed about the potential for genetic discrimination by insurers or employers.
To ensure that oncologists comply with these recommendations, ASCO is developing education programs specific to genetic testing for cancer susceptibility. Until these programs are available, ASCO is urging oncologists to obtain consultations from colleagues with expertise in cancer genetic testing.
ASCO supports legislative and regulatory efforts to ensure access to genetic testing, require coverage of and reimbursement for these services by public and private third-party payers, and improve the oversight of laboratories providing testing, Offit said. He said there is a critical need for research directed at specifying more precisely the clinical significance of mutations in cancer susceptibility genes, and endorsed the concept of a national registry and protocol with full confidentiality, such as that planned by the National Cancer Institute’s Cancer Genetics Working Group.
"ASCO firmly believes that any physician who offers genetic testing should be aware of and be able to communicate the benefits and potential risks of current testing procedures and range of prevention and treatment options available to patients and their families," John Glick, immediate past President of ASCO and Director of the University of Pennsylvania Cancer Center, said at a symposium on genetic testing. "ASCO acknowledges that genetic testing is best performed in the setting of long-term research outcome studies, but our policy also acknowledges the availability of commercial products. ASCO was under intense pressure to limit our statement on genetic testing to the use of such tests only in a research environment," said Glick. "However, we believe that limiting genetic testing only to a research setting is not practical and is not responsive to our obligation to patients and their families."
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ONCOR BUYS LICENSE FOR BREAST CANCER BLOOD TEST |
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TopBreast Cancer Prevention Trial...Efficient Outpatient Setting...Women who Test Negative...Who should have access...ASCO Statement on Genetic...Oncor Buys License for...Guilford Buys Rights to...NCI to Sponsor Clinical...Firm Buys Rights to... |
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The p43 test detects an early immunological event in the body’s response to the development of primary breast cancer that can be measured in patient blood, particularly with respect to women at high risk for breast cancer," said Chaya Moroz, who developed the test at Tel Aviv University Sackler School of Medicine.
According to a study of 3,400 women, including 900 patients with known breast cancer risk factors such as family history of the disease, elevated levels of the p43 protein were strongly correlated with the presence of in situ and stage I/II breast cancer, the company said.
In follow-up of patients after surgery by periodic clinical exams, the test showed that p43 protein levels declined after removal of precancerous or malignant tumors, the company said. Studies suggest that the measure of p43 also could be a predictor of tumor development and recurrence.
Oncor said it plans to conduct further multi-center clinical trials to complete a Pre-Market Approval application for submission to the FDA. The company’s INFORM HER-2/neu gene amplification test is under review by the FDA for use in the management of breast cancer.
In addition to its license agreement with the developers of the test, which include the National Health Institute of Israel, Chaya Moroz, Kupat Holim, and Leslie Misrock, Oncor also announced that patents covering the technology have been issued in the United States.
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GUILFORD BUYS RIGHTS TO POLYMER PATENT |
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TopBreast Cancer Prevention Trial...Efficient Outpatient Setting...Women who Test Negative...Who should have access...ASCO Statement on Genetic...Oncor Buys License for...Guilford Buys Rights to...NCI to Sponsor Clinical...Firm Buys Rights to... |
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The patent covers the use of Taxol®, campothecin, and other compounds for the treatment of solid tumors, using a broad range of polymer delivery systems.
The FDA Oncologic Drugs Advisory Committee recently recommended approval of Guilford’s polymer brain cancer product, Gliadel Wafer (polifeprosan 20 with carmustine) for patients undergoing surgery for recurrent forms of glioblastoma multiforme.
The company is involved in a worldwide marketing collaboration with Rhone-Poulenc Rorer for the marketing of Gliadel and other polymer cancer products.
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NCI TO SPONSOR CLINICAL TRIALS OF MGI DRUG |
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TopBreast Cancer Prevention Trial...Efficient Outpatient Setting...Women who Test Negative...Who should have access...ASCO Statement on Genetic...Oncor Buys License for...Guilford Buys Rights to...NCI to Sponsor Clinical...Firm Buys Rights to... |
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"NCI support would expand future clinical trials of MGI 114 significantly," said Charles Blitzer, MGI Pharma President and CEO. "Clinical trials conducted under NCI sponsorship would complement our current research by evaluating various treatment regimens and the effectiveness of MGI 114 against different types of tumors."
Following completion of a clinical trials agreement, the company will provide MGI 114 for NCI trials. The company said it began its first phase I clinical trial of MGI 114 in cancer patients last December.
The acylfulvene compounds, derived from mushroom toxins, have a chemical structure distinct from current chemotherapeutic agents. Laboratory and animal studies have shown that the acylfulvenes have the potential to be uniquely and highly effective against certain solid tumors, including those that have become resistant to other chemotherapy drugs, as well as metastatic tumors that cannot be treated with conventional chemotherapy, the company said. In animal studies, the acylfulvenes appear to have a favorable side-effect profile in comparison to other anticancer drugs. Further testing will include laboratory, animal and human studies.
A U.S. patent covering the MGI 114 molecule was issued in June. In May, the company received a notice of allowance on another US patent covering additional acylfulvene analogs.
MGI Pharma licensed the worldwide patent rights to the acylfulvenes from the University of California. The company said it receives licensing revenues for the compounds from Dainippon Pharmaceuticals, and that it has initiated a search for a European partner.
In another development, the company said it has received approval from the Israeli Ministry of Health to market the company’s Salagen tablets. Megapharm Ltd., an independent pharmaceutical company based in Tel Aviv, will distribute Salagen tablets in Israel, beginning in late September, the company said.
The approval covers the use of Salagen for the treatment of symptoms of xerostomia caused by radiation therapy for cancer of the head and neck. Israel is the first country to approve the drug for the symptoms of Sjogren’s Syndrome, the company said.
Salagen tablets are currently on the market in the United States, the United Kingdom and Ireland. In January, the company announced that Chiron Therapeutics BV, a unit of Chiron Corporation, also had obtained regulatory approval and has been issued a license to sell Salagen Tablets in France and Greece. Marketing in France and Greece is expected to begin as soon as the company receives pricing approvals from these countries, the company said.
In the United States, the company has completed two phase III clinical trials in Sjogren’s Syndrome patients.
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FIRM BUYS RIGHTS TO TAXOL® BIOSYNTHESIS |
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TopBreast Cancer Prevention Trial...Efficient Outpatient Setting...Women who Test Negative...Who should have access...ASCO Statement on Genetic...Oncor Buys License for...Guilford Buys Rights to...NCI to Sponsor Clinical...Firm Buys Rights to... |
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Cytoclonal Pharmaceuticals said it has previously obtained exclusive worldwide rights to a fungus which produces Taxol®. The company said it is developing the patented fungal fermentation system as a low cost source of Taxol®.
Cytoclonal said it has two primary products: Taxol®, made by a proprietary fungal Taxol® Production System, and a lung cancer program based on a proprietary cancer gene (LCG) and a related monoclonal antibody being developed for diagnosis and treatment of lung cancer.
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FOOTNOTES |
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TopBreast Cancer Prevention Trial...Efficient Outpatient Setting...Women who Test Negative...Who should have access...ASCO Statement on Genetic...Oncor Buys License for...Guilford Buys Rights to...NCI to Sponsor Clinical...Firm Buys Rights to... |
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