Quality-of-Life End Points in Oncology Drug Trials
October 1st 1999Health-related quality of life (HRQL) is a multidimensional construct that represents the patient’s perspective on valued aspects of health and functioning. Over the last several years, the pharmaceutical industry, as well as health care providers and the patient advocacy community, have shown increasing interest in HRQL as an outcome measure. Pharmaceutical companies and other sponsors of cancer clinical trials are seeking novel approaches with which to establish the benefits of treatment and to differentiate their products from other marketed products. Health care providers hope to provide cancer patients with therapies that positively affect their quality of life. To date, however, most oncology drug approvals have been based on traditional end points, such as survival and tumor response rate. This article will focus on some of the lessons learned from recent reviews of HRQL data and will describe some of the many challenges that lie ahead. ONCOLOGY 13(10):1439-1442, 1999]
ONYX-015 Shows Promise in Therapy of Several Cancers
October 1st 1999NEW YORK-Researchers have seen encouraging early results in head and neck and other cancers with use of the attenuated adenovirus, ONYX-015, David H. Kirn, MD, vice president of clinical research, Onyx Pharmaceuticals, (Richmond, Calif), said at Current Concepts in Cancer Therapy II, a symposium sponsored by Long Ridge Associates.
Cancer Prevention Strategies Involve Individuals and Society
October 1st 1999ARLINGTON, Va-There are certainly things we can do individually to avoid getting cancer, yet other preventive measures must be taken by society at large, Devra Lee Davis, PhD, of the World Resources Institute, Washington, said at the Second Comprehensive Cancer Care Conference. The meeting was sponsored by the University of Texas Houston Medical School and the Center for Mind-Body Medicine, in collaboration with the NCI and the National Center for Complementary and Alternative Medicine.
Postoperative Depression May Go Unrecognized and Untreated in Brain Tumor Patients
October 1st 1999Depression is the most common postoperative complication seen in patients who have undergone surgery for brain tumors, but it is seldom recognized or treated, according to preliminary findings of a study presented at the annual meeting of the
Lowering Drug Prices for Non-Medicare Patients
September 1st 1999All of the talk about a potential Medicare drug benefit has overshadowed the question of what can be done to lower drug costs for non Medicare patients, who, after all, constitute the majority in this country. With this in mind, Rep. Bernie Sanders
Talking to Members of Congress About Cancer Issues
September 1st 1999WASHINGTON-“Meeting with members of Congress to push an issue can seem intimidating, but the key is to remember that legislators are people, too, and to treat the encounter as the beginning of a relationship,” Robin Carle said at the 1999 Kidney Cancer Association (KCA) annual convention.
Modified SPECT Scintimammography Proves More Accurate
September 1st 1999NEW ORLEANS-A modification of SPECT (single proton emission computed tomography) scintimammog-raphy with the radionuclide technetium sestamibi is a promising adjunct to equivocal mammograms that are difficult to interpret, said David H. Feiglin, MD, professor of radiology, SUNY Health Science Center, Syracuse. He presented the findings of his collaborative study at the American Roentgen Ray Society annual meeting.
Experts Brief Capitol Hill on Trial Costs Survey
September 1st 1999WASHINGTON-Call it “Fear of Filing.” A survey by the American Society of Clinical Oncology (ASCO) indicates that third-party payers, including Medicare, are more willing to cover patient-care costs in cancer clinical trials than is commonly assumed. Yet often physicians won’t discuss enrollment in such trials with patients out of fear that insurers will deny payment.
Computer Technique Gives New Life to Thermal Breast Imaging
September 1st 1999NEW ORLEANS-“To paraphrase Madison Avenue, this is not your father’s thermal imaging,” said Yuri R. Parisky, MD, associate professor of radiology, University of Southern California Norris Cancer Center and Hospital. He was referring to a new form of computer-enhanced thermal breast imaging that he and his colleagues at USC are studying, along with investigators at the TRW Center for Medical Image Analysis, Ogden, Utah, and Howard University, Washington, DC.
Kytril Indicated to Prevent RT-Induced Nausea and Vomiting
September 1st 1999PHILADELPHIA-SmithKline Beecham announced in a press release that the FDA has approved Kytril (granisetron HCl) Tablets, its 5-HT3 receptor antagonist, for the prevention of nausea and vomiting associated with radiation, including total body irradiation (TBI) and fractionated abdominal radiation. Kytril Tablets (2 mg, once daily) are currently indicated for the prevention of nausea and vomiting associated with emetogenic cancer therapies.
NCI Awards HMO Group $16 Million for Cancer Studies
September 1st 1999BETHESDA, Md-The National Cancer Institute will provide $16 million over 4 years to the HMO Research Network to expand and strengthen its cancer research efforts and to initiate studies aimed at increasing effective cancer prevention and control among enrollees in health maintenance organizations.
Routine Endometrial Biopsy ‘of Limited Value’ in Tamoxifen Users
September 1st 1999ATLANTA-A prospective study, presented at the 35th Annual Meeting of the American Society of Clinical Oncology, has found the utility of routine endometrial biopsy among women with breast cancer treated with tamoxifen (Nolvadex) to be “limited at best.” Another study presented at the meeting finds sonography to be inadequate as a substitute for endometrial biopsy in healthy women receiving tamoxifen prophylaxis.
Sponsors Optimistic Medicare Cancer Clinical Trials Coverage Act Will Pass
September 1st 1999WASHINGTON-Congressional backers of “The Medicare Cancer Clinical Trials Coverage Act” see its chances of passage improving, in part because of the active support of cancer advocacy groups and the direct involvement of oncologists . The legislation, actually two identical bills introduced in the House and Senate, would create a 5-year demonstration program in which Medicare would pay for patient care during cancer clinical trials and determine the true costs of such coverage.
Memorial Sloan-Kettering Opens Integrative Medicine Service
September 1st 1999NEW YORK-Barrie R. Cassileth, PhD, is chief of Memorial Sloan-Kettering Cancer Center’s new Integrative Medicine Service, which was officially opened April 1 of this year. As a researcher, educator, and planner, she has worked in psychosocial aspects of medicine and alternative and complementary therapies for more than 20 years.
Bladder Sparing Debated at Chicago ‘Shootout’
September 1st 1999CHICAGO-Although there has been a trend toward organ conservation in the treatment of cancer at many body sites, including the breast, head and neck, and esophagus, bladder sparing has been viewed differently, particularly in the United States.
Two-Vaccine Combination Stimulates Immune Response
September 1st 1999DENVER-A combination of two investigational HIV vaccines has produced anti-HIV immune responses in more than 90% of volunteers at least 1 year after vaccination, Robert Belshe, MD, of St. Louis University, said at the International Society for Sexually Transmitted Diseases Research meeting. “These preliminary data indicate both vaccines are safe, and side effects associated with the injections are generally mild,” Dr. Belshe said.
Chemoradiation an Effective But Toxic Therapy for Colorectal Cancer
September 1st 1999Chemoradiation is effective in controlling anal and rectal cancers but causes significant side effects and complications, according to three independent teams of colorectal surgeons in Australia and the United States.
Oncologists Likely to Get Small Medicare Increases
September 1st 1999Anyone who remembers the bruising political battle in 1997-1998over how Medicare would develop “resource-based” practice expenses can breathe a sign of relief over what is likely to be the painless shift to resource-based malpractice
Temozolomide, a New Molecule for Patients With Brain Tumors
September 1st 1999PHILADELPHIA-Temozolomide (Temodar) appears to be an effective, well-tolerated oral agent in the setting of recurrent malignant glioma. “Further testing is clearly warranted in this patient population, and it is an attractive candidate to be evaluated in the adjuvant setting for newly diagnosed patients,” said Michael D. Prados, MD, of the Brain Tumor Research Center, University of California, San Francisco.
‘Teamwork for Health’ Theme of VHL Disease Conference
September 1st 1999ATLANTA-What do 30 doctors, 20 nurses, 100 patients, and one magician have in common? A desire to make VHL stand for “Very Happy Life” as well as von Hippel-Lindau disease. These 150 people, including illusionist The Amazin’ Grayson (Grayson Smith of Memphis), attended the Sixth International Patient/Provider Conference on VHL, a 3-day meeting to build teamwork for management of VHL.
Northwest VA Cancer Research Center Opens in Portland, Oregon
September 1st 1999PORTLAND, Oregon-The US Department of Veterans Affairs has opened its new $30 million Northwest Veterans Affairs Cancer Research Center. The Center will house joint research projects of both the Portland VA Medical Center and the Oregon Health Sciences University (OHSU). Its primary focus will be the genetic basis and the biologic pathways of cancer.
Tamoxifen Reduces Cardiac Risk Factors in Healthy Women
September 1st 1999ATLANTA-As with postmenopausal hormone replacement, tamoxifen (Nolvadex) administration may be associated with reduced lipid levels. In addition, tamoxifen may also have beneficial effects on markers of inflammation considered to be novel cardiac risk factors, according to a poster presentation at the 35th Annual Meeting of the American Society of Clinical Oncology.