Oncology NEWS International Vol 4 No 7

ODAC Recommends Accelerated FDA Approval of Ethyol for Cytoprotection

July 01, 1995

ROCKVILLE, Md--The Food and Drug Administration's Oncologic Drugs Advisory Committee (ODAC) has voted unanimously to recommend accelerated approval of Ethyol (amifostine injection) as a cytoprotective agent against cumulative renal toxicities associated with cyclophosphamide (Cytoxan, Neosar) and cisplatin (Pla-tinol) in patients with advanced solid tumors of non-germ-cell origin.

House Panel Holds Hearing on Self-Referral

July 01, 1995

WASHINGTON--The House of Representatives Ways and Means Subcommittee on Health heard opinions on what sort of final regulations should be issued concerning the recently expanded self-referral laws: namely, enforce the bill as written (HCFA's view) or add major exceptions to the bill (the AMA's view).

Health-Related Legislation

July 01, 1995

S5755, an amendment (no. 603) introduced by Sen. McConnell (R-KY), to reform the health-care liability system and improve health-care quality through establishment of quality assurance programs, was agreed to by voice vote.

Mitoguazone Appears Promising in HIV-Associated Refractory NHL

July 01, 1995

ASCO LOS ANGELES--In a multicenter phase II study of mitogua-zone (MGBG) in relapsed or refractory AIDS-related non-Hodgkin's lymphoma (NHL), more than one quarter of patients responded to the drug, and all of the complete responders experienced an increase in their CD4 counts, Alexandra M. Levine, MD, reported at ASCO.

Responses to Anti-HER2 MoAb Seen

July 01, 1995

ASCO LOS ANGELES--Two multi-institutional phase II studies of recombinant human anti-HER2/NEU antibody (rhuMAb HER2) in heavily pretreated stage IV breast cancer patients show some impressive responses, including some hepatic responses and a 25% response rate in patients given the antibody plus cisplatin (Platinol).

NCI Committed to Increasing Minority Participation in Clinical Trials

July 01, 1995

BETHESDA, Md--Acting NCI Director Edward Sondik announced that the institute is committed to increasing participation of minorities in clinical trials. However, cancer researchers have had only limited success in this effort, he said.

MoAb May Improve Detection of Colon And Rectal Cancer

July 01, 1995

BOSTON--A radiolabeled monoclonal antibody (MoAb) currently under investigation may improve detection of recurrent colorectal cancer, said Dr. Frederick Moffat, associate professor of surgery, University of Miami Medical School.

Zeneca Files NDA for Arimidex

July 01, 1995

WILMINGTON, Del--Zeneca Pharmaceuticals has filed a new drug application (NDA) for the use of Arimidex (anastrozole) tablets for the treatment of advanced breast cancer in postmenopausal women who have progressed following therapy with tamoxifen (Nolvadex).

Cord Blood is Used as Source of Stem Cells for Pediatric Transplantation

July 01, 1995

SAN DIEGO, Calif--Investigators have demonstrated that umbilical cord blood contains cells capable of instituting long-term, donor-derived hematopoiesis--with a very low probability of producing graft-versus-host disease (GVHD), John E. Wagner, MD, said at a conference sponsored by the University of California, San Diego Cancer Center and the UCSD School of Medicine.

Gemcitabine/Cisplatin Shows Good Response Rate And Favorable Toxicity Profile in Advanced NSCLC

July 01, 1995

ASCO LOS ANGELES--A phase II study of gemcitabine, a novel nucleoside analog, plus cisplatin (Platinol) in patients with stage III or IV non-small-cell lung cancer (NSCLC) showed an encouraging 42% response rate and 8-month median survival.

Molecular Markers Predict Clinical Outcome

July 01, 1995

PARIS, France--University of Chicago researchers have discovered that the combination of a molecular marker of tumor virulence and a marker of metastatic potential can be used to reliably predict outcome in women with node-negative breast cancer, Ruth Heimann, MD, PhD, reported at the annual meeting of the American Radium Society.

Cost Utility Study Shows Value of Aggressive Antiemetic Use

July 01, 1995

LONG BEACH, Calif-Cost utility studies are in their infancy and can yield very different results if incorrect assumptions about utility scores are made. For example, two different analyses of the same cost utility data suggested that the cost of a 5-HT3 antagonist in patients receiving emetic chemotherapy is either $4,000 per quality-adjusted life year (QALY), or 10 times that much.

Experts Debate Value of Whole Abdominal Radiation (WAR) Therapy in Ovarian Ca

July 01, 1995

PARIS, France--Postoperative whole abdominal radiation (WAR) therapy has no place in the management of ovarian cancer, David Gershenson, MD, of the University of Texas M.D. Anderson Cancer Center, said in a debate at the American Radium Society meeting.

'Smarter' Drugs May Inhibit Tumor Growth By Blocking Angiogenesis or Matrix Metalloproteinase

July 01, 1995

TORONTO, Canada--Available cancer drugs have had little specificity, destroying both cancer cells and normal cells. Now, says Robert Kerbel, PhD, of Sunnybrook Health Science Centre, University of Toronto, "we have the potential to design 'smarter' drugs to help circumvent the problems of toxicity and resistance." At a media conference at the American Association for Cancer Research (AACR) annual meeting, Dr. Kerbel introduced two researchers who have pioneered development of approaches to inhibit cancer development without harming normal cells.

National Breast Cancer Coalition Steps up Washington Lobbying

July 01, 1995

WASHINGTON--The National Breast Cancer Coalition (NBCC) has announced its intention to lobby against congressional forces that want to reduce NIH funding. The coalition thus allies itself with professional societies that lobby Congress to increase federal funding for biomedical research.

Aggressive Therapy for Elderly Prostate Ca Patients Is On the Rise

July 01, 1995

LAS VEGAS--Use of aggressive therapy in elderly prostate cancer patients has increased despite a lack of clear evidence of benefit, Michigan investigators reported at the American Urological Association meeting.

Case Reviewers Can Help Resolve Disputes Re: Reimbursement

July 01, 1995

HACKENSACK, NJ-- Tough economic times can be blamed for the current game of roulette played by health-care insurers when it comes to coverage of experimental or off-label treatments, said Grace Powers Monaco, JD, director of the Medical Care Ombudsman Program, Medical Care Management Corp. Bethesda, Md. But overeager physicians, patients, and patient advocacy groups must also share some of the blame for the current tug of war, she said.

DaunoXome Is Recommended for Approval for Kaposi's Sarcoma

July 01, 1995

BOULDER, Colo--NeXstar Pharmaceuticals, Inc. has announced that the FDA's Oncologic Drugs Advisory Committee (ODAC) has recommended approval of DaunoXome, NeXstar's liposomal formulation of daunorubicin, as first-line therapy for Kaposi's sarcoma. ODAC made its recommendation upon review of the company's amended NDA, which included data from NeXstar's phase III study of 227 HIV-positive patients with advanced Kaposi's sarcoma.

Study Shows G-CSF To Be Cost Effective

July 01, 1995

LONG BEACH, Calif--Using five key indicators of the severity of illness to determine the cost effectiveness of growth factor use, researchers from Blue Cross of Western Pennsylvania found an average cost ratio of about 1:7 for the use of G-CSF (filgrastim, Neupogen) in stage IV breast cancer patients undergoing high-dose chemotherapy/autologous bone marrow transplantation.

Scientists Must Adapt to Reduced NIH Funds

July 01, 1995

NEW YORK--How much scientific research is enough? In the best of all possible worlds, an appropriate response might be, "one can never have too much of a good thing." But in the real world, the question must be rephrased: "How much research is possible with the resources available?"

Cancer Care Accounts for 5% of Direct US Health Expenditures

July 01, 1995

LONG BEACH, Calif--Neoplasms account for more than 5% of the $675 billion in direct annual US health-care expenditures, Thomas C. Tucker, MPH, said at the 1995 Quality of Life Symposium, sponsored by St. Mary Medical Hospital. This figure, derived from a 1990 National Center for Health Statistics Survey, does not include indirect costs, such as loss of wages, associated with morbidity and mortality.

NIH Establishes New Advisory Committee on Women's Health

July 01, 1995

BETHESDA, Md--An Advisory Committee on Research on Women's Health has been chartered to advise the NIH Office of Research on Women's Health. The committee is mandated to offer advice on how to enhance women's health research, ensure that women are included in NIH-supported studies, and improve opportunities for women in biomedical careers.

Only Cost Utility Analyses Include Quality of Life as an Outcome

July 01, 1995

LONG BEACH, Calif--Of the different types of economic analyses used in cost studies of medical therapies, only the cost utility analysis takes into account quality of life as an outcome, Jane Weeks, MD, said at the 1995 Quality of Life Symposium, sponsored by St. Mary Medical Center. To understand how this type of analysis works, physicians must add two new measurement units to their vocabulary: "utilities" and "quality-adjusted life years (QALYs)," she said.

Interleukin-11 to Enter Phase III

July 01, 1995

CAMBRIDGE, Mass--In a phase II study, Genetics Institute's recombinant human interleukin-11 (rhIL-11) restored platelets in throm-bocytopenic patients undergoing cancer chemotherapy to the extent that significantly fewer rhIL-11 treated patients required platelet transfusions, compared to placebo.

AMA Honors Moul For 'US TOO' Support

July 01, 1995

BETHESDA, Md--Judd W. Moul, MD, director of the Center for Prostate Disease Research (CPDR), established by Congress in 1991, has been awarded the American Medical Association's Young Physicians Section Community Service Award for his role in helping to establish prostate cancer patient support groups within the military health-care system.

TACaxane/Platinum Regimens in Advanced NSCLC Raise Efficacy, Toxicity Questions

July 01, 1995

ASCO LOS ANGELES--Five studies presented at the American Society of Clinical Oncology (ASCO) meeting raise questions as to whether platinum/taxane combinations are better in non-small-cell lung cancer (NSCLC) than standard platinum/etoposide (VePesid) regimens, and if so, which platinum and which taxane used in combination are best with respect to efficacy, toxicity, and cost?

Colposcopy Cost Effective for Cervical Lesions

July 01, 1995

SAN FRANCISCO--For physicians who treat cervical lesions, abandonment of traditional colposcopy for one-step loop excision procedures could lead to excessive treatment and excessive expense, Philip Roland, MD, said at the Society of Gynecologic Oncologists meeting.

Board Wants Changes In Intramural Research

July 01, 1995

BETHESDA, Md--In an anxiously awaited report, the National Cancer Advisory Board (NCAB) Ad Hoc Working Group on the NCI Intramural Research Program (IRP) made dozens of recommendations for change in the way intramural research is administered and conducted at the Institute (see below).

Toll- Free Mammography Information

July 01, 1995

ROCKVILLE, Md--The Food and Drug Administration has announced that the National Cancer Information Center toll-free hotline, 1-800-4-CANCER, will now provide the names of all US radiology centers that are equipped to perform high-quality mammography.

Medco Research, Inc. and Repligen Corporation Have Agreed to Merge

July 01, 1995

CAMBRIDGE, Mass--Repligen Corporation and Medco Research, Inc. (Research Triangle Park, NC) have agreed to merge their two companies. The resulting company's product portfolio will serve three primary markets: cardiovascular disease, oncology, and immunology.

Chemo Plus RT Improves Survival in NSCLC

July 01, 1995

PARIS, France--Comparison of two sequential Radiation Therapy Oncology Group (RTOG) trials has shown that the addition of cisplatin (Platinol) and etoposide (VePesid) to hyperfractionated radiation therapy significantly boosts survival in patients with inoperable non-small-cell lung cancer (NSCLC), Ritsuko Komaki, MD, reported at the American Radium Society meeting.

Decision Model Analysis Shows Cost Impact of Growth Factors

July 01, 1995

LONG BEACH, Calif--There is no controversy in medical oncology that G-CSF decreases the risk of infection associated with neutropenia in patients receiving cytotoxic chemotherapy. But does it save money? To answer that question, John Glaspy, MD, MPH, and his colleagues at UCLA School of Medicine used a decision analysis model to determine the economic impact of G-CSF given as supportive care.

Ultrasound-Guided FNA Found to Be Highly Accurate

July 01, 1995

PARIS, France--Ultrasound-guided fine-needle aspiration (FNA) cytology has emerged as a highly accurate approach to diagnosing occult breast malignancies in women with suspicious mammograms, said Thomas Frazier, MD, of the Medical College of Pennsylvania. What's more, he said, the ultrasound method costs less than a tenth as much as needle-localized open biopsy.

Breast Preservation Seems Feasible in Chemohormonal Responders

July 01, 1995

PARIS, France--Radiation therapy is a reasonable alternative to mastectomy in women with stage IIIA and IIIB breast cancer who respond to aggressive chemohormonal therapy, a prospective trial conducted at the University of Michigan has found.

Technetium MIBI May Help Clarify Some Inconclusive Mammogram

July 01, 1995

BALTIMORE, Md--Both thallium-201 and technetium-99m are under study as agents for use in examining breast lesions for malignancy, Alan Waxman, MD, of Cedars-Sinai Medical Center, Los Angeles, said at a meeting on nuclear medicine sponsored by Johns Hopkins University.

Psychosocial Barriers to Pain Management Can Be Overcome

July 01, 1995

NEW YORK--Society throws up numerous barriers to effective management of cancer pain: Physicians who don't ask questions about pain because they weren't trained to do so or don't see it as their responsibility; patients who don't mention pain because they want their doctor to focus on their cancer; a regulatory system that places legal restrictions on opioid prescribing; and a health-care system that leaves many people uninsured or underinsured.