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ROCKVILLE, Maryland-The US Food and Drug Administration has announced a major new initiative to revise its regulations governing pharmaceutical manufacturing and product quality. Focused on the agency’s current Good Manufacturing Practice (cGMP) program, the new effort seeks to improve public health promotion and protection. It will apply to veterinary and human drugs, including vaccines and other human biological drug products.

NIAGARA-ON-THE-LAKE, Ontario, Canada-Survivors of childhood brain tumors appear to have a high risk for non-neurological late effects such as endocrine disorders, according to a report (abstract 7) presented at the 7th International Conference for Long-Term Complications of Treatment of Children and Adolescents for Cancer, hosted by Roswell Park Cancer Institute.

ORLANDO-A promising approach in vector vaccine development is the use of a combination of vaccination strategies that enhance T-cell responses for specific tumor-associated antigens, said Jeffrey Schlom, PhD, chief of the Laboratory of Tumor Immunology and Biology, Center for Cancer Research, National Cancer Institutes, Bethesda, Maryland.

WASHINGTON-The imaging methods presently used to detect, diagnose, and stage breast tumors have significant flaws, as shown by the roughly 75% of breast biopsies that return normal results. These "completely unnecessary" procedures impose "huge costs" and "unnecessary trauma," said Craig S. Levin, PhD, assistant professor of radiology, University of California, San Diego, and the Department of Nuclear Medicine, San Diego VA Medical Center.

ORLANDO-Treatment of unre-sectable hepatocellular carcinoma (HCC) with 90-yttrium-embedded glass micro-spheres (TheraSphere, MDS Nordion) appears to be safe, effective, and less toxic than the alternative, transarterial che-moembolization (TACE).

In his article, Dr. Grunberg charts the history of our understanding of chemotherapy-induced nausea and vomiting, and the discovery and development of drugs for its prevention. He places appropriate emphasis on the serotonin (5-HT3) antagonists-notably, ondansetron, granisetron, and dolasetron-which have revolutionized the field over the past decade.

Quon and Harrison have performed a considerable service to patients with head and neck cancers by reminding the oncology community that a state-of-the-art treatment team must include state-of-the-art brachytherapy

Soft tissue sarcomas in adults are rare malignancies with diverse histologies that have historically been classified together, mostly for convenience. In truth,

Studies on human erythropoietin (EPO) demonstrated that there is a direct relationship between the sialic acid-containing carbohydrate content of the molecule and its serum half-life and in vivo biological activity, but an

Nausea and vomiting are the toxicities of chemotherapy most feared by the cancer patient. However, increased understanding of the mechanisms of nausea and vomiting has led to greatly improved control of this toxicity.

Drs. Quon and Harrison have written an excellent review on the role of brachytherapy in the management of head and neck cancer. Brachytherapy is a time-honored technique, and the authors have carefully reviewed the pertinent literature extolling its virtues. However, there are many papers that fail to document efficacy of brachytherapy over conventional techniques, demonstrating that, similar to surgery, the technique is both patient- and operator-dependent.

Brachytherapy is a therapeutic modality that may provide a significant improvement in the therapeutic ratio when appropriately applied, and hence, is an appealing treatment strategy for the head and neck. For several

Malignant small bowel tumors are extremely rare, accounting for 0.1% to 0.3% of all malignancies. Fewer than 2,400 new cases of small bowel malignancy are reported in the United States each year.[1] Malignant tumors, which account for about two-thirds of all primary small bowel tumors, consist of four primary subtypes: adenocarcinoma, carcinoid tumor, lymphoma, and sarcoma (or gastrointestinal [GI] stromal tumor). Each malignancy is characterized by unique predisposing factors, anatomy, and biology. The prevalence, pattern, and relevance of both regional lymph node and distant metastases differ. As a result, the study of malignant small bowel tumors, taken as an aggregate, is fraught with difficulty.

BOSTON-The elderly may suffer more from the side effects of chemotherapy, but toxicity should not necessarily prevent them from receiving life-saving or palliative treatment, according to two speakers at the 14th international meeting of the Multinational Association for Supportive Care in Cancer (MASCC) and International Association for Oral Oncology.

WASHINGTON-A National Cancer Institute (NCI) summary of the link between diet and health among African-American men shows the impact of their eating habits and how increased consumption of fruits and vegetables can reduce the risk of many diseases, including some cancers.

ORLANDO-"Vaccines based on characterized tumor antigens have the advantage of potential tumor specificity from the start," Ronald Levy, MD, chief, Division of Oncology, Stanford University School of Medicine, said at an ASCO satellite symposium on cancer vaccines. Development of such vaccines requires definition and isolation of a specific target, and production of the purified target antigen, he said.

Edited by John Mendolsohn, MD, Peter M. Howley, MD, Mark A. Israel, MD, and Lance A. Liotta, MD, PhD, The Molecular Basis of Cancer is designed for students, researchers, and physicians in a variety of disciplines. It does not provide a detailed description of the clinical manifestations of human neoplasia. There is, instead, an extensive presentation of the scientific basis of cancer development and therapy. The book includes the contributions of 61 authors, virtually all of whom are recognized experts in their respective fields, from throughout the United States and Europe. The references are comprehensive and relatively current, given the lag time in going to press. The book will certainly benefit both basic scientists and clinicians alike.

On the following pages are examples of commonly used scales for evaluating quality of life and symptoms associated with anemia in patients with cancer. Please note that some of the scales are copyrighted (and marked as such herein) and may not be reproduced in anyway without the express written consent of the copyright holders.

The anemia of chronic disease traditionally is defined as a hypoproliferative anemia of no apparent cause that occurs in association with an inflammatory, infectious, or neoplastic disorder, and resolves when the underlying disorder is corrected. Disordered iron metabolism as manifested by a low serum iron, decreased serum transferrin, decreased transferrin saturation, increased serum ferritin, increased reticuloendothelial iron stores, increased erythrocyte-free protoporphyrin, and reduced iron absorption, is a characteristic feature of the anemia of chronic disease and has been thought to be a major factor contributing to the syndrome.

In its hormonal role, erythropoietin is produced by the kidney in response to hypoxic stress and signals the bone marrow to increase the number of circulating erythrocytes. It has become clear in recent years, however, that erythropoietin and its receptor are members of a cytokine superfamily that mediates diverse functions in nonhematopoietic tissues. Nonhormonal erythropoietin actions include a critical role in the development, maintenance, protection, and repair of the central nervous system (CNS).

This article examines the relationships between chemotherapy-induced anemia, fatigue, and psychological distress among anemic cancer patients with solid tumors.

The clinical development of recombinant human erythropoietin (rHuEPO) has had a remarkable impact on the clinical practice of oncology. A decade ago, randomized, placebo-controlled trials in anemic cancer patients demonstrated that rHuEPO resulted in an improvement in hemoglobin and hematocrit, a reduction in transfusion requirements, and improvement in quality-of-life (QOL) end points. Based on these trials, recombinant erythropoietin was approved for the treatment of anemia in patients with nonmyeloid malignancies in whom the anemia was caused by the effect of chemotherapy.

Symptom burden is certainly not a new concept in the literature on disease and treatment, but recent developments in our understanding of how to measure symptoms and their impact make it possible to cast symptom burden as a reasonable summary measure of both disease- and treatment-outcome status. We discuss the use of symptom burden as an alternative to quality-of-life measures or as a supplement to these measures.

Barriers to use of erythropoietic therapy in cancer patients include nonresponse in a sizable proportion, resultant lowering of cost-effectiveness, and inconvenience. Darbepoetin alfa represents the outcome of efforts to develop agents with improved erythropoietic potency.

Fatigue is common in patients with cancer. Fatigue is very distressing to patients, who often view it as an indication that their disease is progressing or that treatment is ineffective.

One of the most fundamental challenges to multicellular life is the delivery of sufficient oxygen and metabolic substrate to all cells and the rapid elimination of acid formed during cellular respiration. Thus it is logical to wonder whether anemia, by compromising these pathways, might contribute to the progression of cancer.

Anemia in cancer patients is associated with a decline in energy levels, activity levels, and quality of life, and these variables improve when hemoglobin levels rise. Importantly, the impact of improved hemoglobin levels on response to chemotherapy, radiation therapy, and survival time is under study.

Erythropoietin is the primary physiological regulator of erythropoiesis, and it exerts its effect by binding to cell surface receptors. It has recently been shown that both erythropoietin and its receptor are found in the human cerebral cortex, and that, in vitro, the cytokine is synthesized by astrocytes and neurons, has neuroprotective activity, and is up-regulated following hypoxic stimuli. In animal models, exogenous recombinant human erythropoietin has been reported to be beneficial in treating experimental global and focal cerebral ischemia and reducing nervous system inflammation

There is a growing recognition in oncology of the importance of maintaining or improving patients’ quality of life (QOL) throughout the disease course. With this goal in mind, many clinical trials in oncology now seek to evaluate QOL end points.

Anemia is the most common hematologic abnormality seen in patients with cancer. Anemia is associated with debilitating symptoms and poorer health-related quality of life and may result in less than optimal disease/treatment outcomes.