Preclinical Pharmacologic Basis for Clinical Use of rhIL-11 as an Effective Platelet-Support Agent
September 1st 2000Preclinical studies have shown that rhIL-11, also known as oprelvekin (Neumega), stimulates early and later stages of megakaryocytopoiesis (including proliferation and differentiation of megakaryocyte precursors and maturation of megakaryocytes), to
Tolerability and Side-Effect Profile of rhIL-11
September 1st 2000Safety data from two randomized phase II and one abbreviated phase III placebo-controlled, double-blind clinical studies in adult patients with nonmyeloid malignancies indicate that recombinant human interleukin-11 (rhIL-11, also known as oprelvekin [Neumega]) has an acceptable toxicity profile as therapy for the mitigation of chemotherapy-induced thrombocytopenia.
Commentary on Abstracts #341, #347, and #333
August 31st 2000Gómez-Bernal et al (abstract #341) report the results of a docetaxel (Taxotere)/vinorelbine (Navelbine) combination as second-line therapy for metastatic breast cancer. Both agents were administered on the same day and repeated every 14 days. The 52% objective response rate is impressive, since vinorelbine alone would be expected to produce a 20%–30% response rate in this setting, with docetaxel projected to achieve a 40% complete and partial remission rate. Therefore, the results suggest an additive interaction between the two agents.
Commentary on Abstracts #349 and #1259
August 31st 2000Evidence generated by controlled clinical trials over the past 4 decades indicated that combination chemotherapy produced superior results to single-agent cytotoxic therapy. Response rates and times to progression were superior with combination chemotherapy, and survival was also favorably altered by this approach. This paradigm has been recently challenged on the basis of the Norton-Simon hypothesis and by the development of more effective, new cytotoxic agents, specifically the taxanes.
Commentary on Abstracts #254 and #330
August 31st 2000Before the introduction of the taxanes into the management of breast cancer, the anthracyclines (and doxorubicin and epirubicin [Ellence] in particular) were considered the most active agents against this malignancy. The marked activity of single-agent taxanes suggested that their antitumor efficacy might match and perhaps exceed that of the anthracyclines. Several prospective randomized trials have confirmed these initial impressions. At intermediate doses (60 mg/m²), the activity of doxorubicin and paclitaxel (Taxol) was similar; at higher doses (75 mg/m²), doxorubicin appeared more effective. Conversely, docetaxel (Taxotere) was reported to be more active than doxorubicin in one trial.
House Backs Funding for Justice Department Tobacco Lawsuit
August 1st 2000WASHINGTON-The House voted to allow the Justice Department to tap funds from three other federal departments to help pay for pursuing a lawsuit against the tobacco industry. Attorney General Janet Reno had said that without funds from the Departments of Health and Human Services, Defense, and Veterans’ Affairs, the government would be unable to go forward with the suit to recover $20 billion in federal funds spent on treating tobacco-related illnesses.
FDA and Wireless Industry to Study Cell Phone Safety in Joint Project
August 1st 2000ROCKVILLE, Md-The FDA and the Cellular Telecommunications Industry Association (CTIA) have joined in a collaborative effort to examine the potential health effects of wireless telephones. FDA will provide research recommendations and oversight. CTIA will fund the studies, which will be done over the next 3 to 5 years by researchers who are not connected with FDA or the industry. Initial studies will focus on whether radiofrequent emissions from wireless phones pose any health threat. They will include both laboratory work and studies of mobile phone users.
Dr. Steven Gallinger Discusses the Clinical Implications of Microsatellite Instability Studies
August 1st 2000NEW ORLEANS-Colorectal cancer appears to be two distinct diseases at the molecular and natural history level, but what exactly does this mean in terms of clinical practice? Steven Gallinger, MD, of the Univesity of Toronto, attempted to answer that question in his overview of Dr. Elsaleh’s presentation on microsatellite instability (MSI).
HHS Officials Describe Their CAM Activities to House Committee
August 1st 2000WASHINGTON-The National Cancer Institute and the National Center for Complementary and Alternative Medicine (NCCAM) at the National Institutes of Health are jointly launching a “Quick Trials” research grants program that will enable more rapid evaluation of promising complementary and alternative medicine (CAM) therapies.
Resection Benefits High-Risk Liver Met Patients
August 1st 2000SAN DIEGO-Historically, cancer patients with liver metastases that were bilobar or noncolorectal, or who were simply elderly, have been considered inappropriate candidates for hepatic resection. A new study from the University of Chicago’s Pritzker School of Medicine suggests that these indications for resection should be liberalized.
NCI Is Sponsoring Chemoprevention Trials of COX-2 Inhibitor
August 1st 2000BETHESDA, Md-The National Cancer Institute (NCI), in collaboration with Searle (Skokie, Illinois, now a part of Pharmacia Corp, Peapack, New Jersey) and Pfizer Inc. (New York), is sponsoring a series of clinical trials testing celecoxib (Celebrex) for the prevention of a variety of cancerous and precancerous conditions.
Education Boosts Pain Control in a Cancer Hospital
August 1st 2000NEW ORLEANS-An educational intervention for both patients and health care professionals led to significant improvements in pain control at the RUSH Cancer Institute of RUSH-Presbyterian-St. Luke’s Medical Center, Chicago. David Frame, PharmD, reported the results at the 36th Annual Meeting of the American Society of Clinical Oncology (ASCO).
High-Dose Chemo/ABMT Ups Survival in High-Risk NHL
August 1st 2000CRETEIL, France-In a study of patients with high-risk aggressive non-Hodgkin’s lymphoma (NHL), those receiving high-dose chemotherapy and autologous bone marrow transplant (ABMT) after induction therapy lived longer than those receiving sequential chemotherapy, said Corinne Haioun, MD, of Hospital Henri Mondor, Créteil, France.
CT Option for Varian’s Respiratory Gating System
August 1st 2000PALO ALTO, Calif–Varian Medical Systems, Inc. has been given the go-ahead to begin marketing the new CT Option for its RPM (Real-time Position Management) Respiratory Gating System. The FDA determined that it is a class 1 device exempt from premarket notification requirements.
ColorectAlert Appears More Specific than FOBT Screening
August 1st 2000SAN DIEGO-A new type of colorectal cancer screening test appears to be as sensitive as fecal occult blood testing (FOBT) with higher specificity, according to a Canadian study. Norman E. Marcon, MD, of the Centre for Therapeutic Endoscopy and Endoscopic Oncology, Toronto, reported results of a study comparing the new test, ColorectAlert, with FOBT at an American Gastroenterological Association research forum held during the Digestive Disease Week conference
‘Critical Disconnect’ Between Cancer Research and Cancer Care
August 1st 2000BETHESDA, Md-The United States can be proud of its scientific progress against cancer, but the nation has failed to adequately address the equally important issue of access to and delivery of quality cancer care, according to the President’s Cancer Panel (PCP).
Study Validates Shorter Radiation Schedule
August 1st 2000NEW ORLEANS-A 3-week radiation schedule after lumpectomy is as effective as the standard 5-week schedule in terms of local control, overall survival, and cosmetic outcomes, Canadian researchers reported in a plenary presentation at the 36th Annual Meeting of the American Society of Clinical Oncology (ASCO).
Reasonable to Add Immunochemical FOBT to Sigmoidoscopy Screening
August 1st 2000SAN DIEGO-Based on preliminary test results, researchers at Kaiser Permanente Northern California and the University of California, San Francisco, believe that immunochemical fecal occult blood testing (IFOBT) would be a reasonable addition to a managed care plan’s flexible sigmoidoscopy colorectal cancer screening program, depending on patient preference, the practice setting, and cost constraints.
Clinton Tells Medicare to Pay for Clinical Trials
August 1st 2000The initial reaction to President Clinton’s June directive on Medicare payment for patient care costs in clinical trials was extremely positive. Senators Jay Rockefeller (D-WV) and Connie Mack (R-FL), who have long and unsuccessfully pushed a