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PubMed1997

Therapy of hepatitis C: re-treatment with alpha interferon.

The long-term benefit of interferon therapy in chronic hepatitis C is limited. During therapy, serum alanine aminotransferase (ALT) levels decrease to normal and hepatitis C virus (HCV) RNA decreases in 40% to 60% of patients. However, most patients relapse after therapy withdrawal, so that no more than 15% to 25% achieve a sustained response. Re-treatment has been evaluated in studies using different regimens and forms of alpha interferon in different cohorts of patients at different times after initial therapy. Both end-of-treatment and sustained responses to re-treatment correlate with the type of response achieved during the initial course. Patients who do not respond or have only a partial response to the initial course of interferon have an extremely low rate of sustained response when re-treated, independently of the regimen used. Combining data from 13 studies, sustained responses occurred in no patients who were re-treated with 3 million units (MU) three times weekly for 6 months, and in only 2% to 3% of patients re-treated with higher doses and/or for longer periods. In contrast, a significant number of patients who responded during the initial course but subsequently relapsed have a sustained response when re-treated with interferon alone. Combining data from 11 published studies on patients who relapsed after an initial course, sustained responses occurred in 15% (95% confidence interval [CI], 10%-20%) of patients re-treated with 3 MU three times weekly for 6 months, in 29% (CI, 17%-40%) re-treated with a higher dose for 6 months, and in 43% (CI, 34%/50%) re-treated for at least 12 months. On the other hand, patients who relapsed after a 12-month course of interferon had only 4% rate (range, 0%-8%) of sustained response when re-treated. The best predictor of sustained response to re-treatment in patients who had relapsed was a negative serum HCV-RNA test by polymerase chain reaction at the end of the first course. These results, which have been confirmed in a recent prospective, randomized controlled trial, indicate that nonresponders to interferon should not be re-treated with interferon alone, whereas patients who relapse after a 6-month course of alpha interferon therapy have an indication to be re-treated for at least 12 months, especially if serum HCV RNA was negative at the end of the first course of treatment.

Antiviral Agents↗
PubMed1997

Therapy of hepatitis C: other options.

Because current standard therapy of chronic hepatitis C with alpha interferon is less than ideal, numerous other approaches have been studied. Iron in the liver, particularly that found in vascular endothelial cells of portal tracts, has been associated with decreased responsiveness to alpha interferon therapy. Iron reduction alone, generally achieved by therapeutic phlebotomy, regularly has been associated with biochemical improvement (decrease in serum alanine aminotransferase), but not with virological improvement. Iron reduction has been reported to increase the therapeutic response to alpha interferon. Most studies of this combination have been conducted in patients who had not responded to interferon alone; in these patients, improved responsiveness has been observed in some, but not all studies. In patients not previously treated, iron reduction was found in a recent trial to improve the sustained biochemical and virological response rate from 5% to 29%. Hepatic iron and chronic hepatitis C increase oxidative stress in the liver and are associated with decreases in hepatic glutathione levels. In one report, administration of N-acetyl cysteine, a sulfhydryl donor, led to improved response to interferon in chronic hepatitis C. Several cytokines and immunomodulators have undergone limited study; perhaps the most promising of these is thymosin alpha-1. In one small study, amantadine was found to produce some response in patients who previously had failed to respond to interferon. Ursodiol improves serum aminotransferase levels in chronic hepatitis C but has no antiviral effect, nor has it been found to improve histologic abnormalities. The future of therapy of chronic hepatitis C will likely include measures to decrease oxidative stress and injury and multidrug combinations, including inhibitors of the hepatitis C viral protease and RNA polymerase.

Adjuvants, Immunologic↗
PubMed1997

Therapy of hepatitis C: cost-effectiveness analysis.

The natural history of untreated chronic hepatitis C is controversial, and direct knowledge of the long-term clinical and economic outcomes of current alpha interferon treatment regimens remains limited. Decision analytic models using available information on outcome probabilities and associated health care costs in the United States have been developed but are available only in abstract form. They suggest that chronic hepatitis C is a life-shortening disease and that alpha interferon treatment, for 6 or 12 months, despite its up-front costs and failure to induce a prolonged therapeutic response in most patients, increases life expectancy (which nevertheless is still reduced). It does so with a marginal cost-effectiveness well within the acceptable range of medical interventions in the United States. Even empiric therapy, without regard to viral level, genotype, and baseline histology, is within an acceptable cost-effectiveness range. Improving the response rate is likely to make treatment even more cost-effective and possibly cost-saving. Discounting at 3% would also lower the marginal cost-effectiveness; treatment of younger patients would likely lead to cost-savings. Future needs include the development of better databases and cost data for estimating outcomes.

Antiviral Agents↗
PubMed2003

Hepatitis C research.

Explore the source record for details and available documents.

Consensus Development Conferences, NIH as Topic↗
PubMed1994

National Institutes of Health Consensus Development Conference Statement. Ovarian cancer: screening, treatment, and follow-up.

The National Institutes of Health Consensus Development Conference on Ovarian Cancer-Screening, Treatment, and Follow-up brought together epidemiologists; obstetrician/gynecologists; gynecologic, medical, and radiation oncologists; and the public to address the following questions: (1) What is the current status of screening and prevention in ovarian cancer? (2) What is the appropriate management of early-stage ovarian cancer? (3) What is the appropriate management of advanced epithelial ovarian cancer? (4) What is the appropriate follow-up after primary therapy? and (5) What are the directions for future research? The consensus panel concluded that there is no evidence available as yet that the current screening modalities of CA 125 and transvaginal ultrasonography can be effectively used for widespread screening to reduce mortality from ovarian cancer nor that their use will result in decreased rather than increased morbidity and mortality. They recommended that further prospective research be done to evaluate this very important issue. Women with stage IA grade 1 and most IB grade 1 ovarian cancer do not require postoperative adjuvant therapy. Many remaining stage I patients do require chemotherapy. Subsets of stage I must be fully defined and ideal treatment must be determined. Women with stages II, III, and IV epithelial ovarian cancer (other than low malignant potential tumors) should receive postoperative chemotherapy. Physicians should be encouraged to discuss clinical trial participation with women, and women should be encouraged to participate. All women should have access to accurate and complete information regarding ovarian cancer. Furthermore, there must be no barriers to women's access to qualified specialists, optimal therapy, and protocols. The full text of the consensus panel's statement follows.

Combined Modality Therapy↗
PubMed1994

Evaluation of reduced protocols for carcinogenicity testing of chemicals: report of a joint EPA/NIEHS workshop.

The current U.S. Environmental Protection Agency (EPA) and other national/international guidelines specify the use of two species and two sexes rodents (usually the rat and the mouse) for carcinogenicity testing of chemicals. In view of the enormous number of chemicals to be tested, the high cost of testing, and the large number of animals used in the present protocol, many academic, industrial, and government authorities are examining the possibility of using a reduced protocol (less than two species and two sexes of rodents) for carcinogenicity testing of chemicals. The use of a reduced protocol offers many advantages as well as some disadvantages. To pursue further the potential implications and impacts of using a reduced protocol for carcinogenicity testing on the processes of hazard identification and risk assessment, a workshop entitled "Evaluation of Reduced Protocols for Carcinogenicity Testing of Chemicals" was held at the Embassy Suites Hotel in Alexandria, Virginia on September 22 and 23, 1992. It was cosponsored by EPA's Office of Prevention, Pesticides and Toxic Substances (OPPTS) and the National Toxicology Program of the National Institutes of Environmental Health Sciences (NTP/NIEHS) and attended by more than 60 participants from government, industry, academia, and the general public. The Expert Consensus Panel and most of the participants supported the use of reduced protocols in carcinogenicity testing. However, it was recognized that reduced protocols may not be appropriate for the testing of all chemicals and that additional analyses/data may be needed for selection of the most appropriate reduced protocol for certain chemicals/chemical classes.

Animals↗
PubMedDate not supplied

Adjuvant therapy of breast cancer.

About 180,000 American women will be diagnosed with early stage breast cancer during 1993. In many of these patients breast cancer is a systemic disease at diagnosis and thus not curable by local treatment alone. The development of optimal forms of systemic adjuvant therapy has been a major area of research for more than 30 years. The two most widely employed types of adjuvant therapy, cytotoxic chemotherapy and tamoxifen, have been shown to improve relapse-free and overall survival in certain patient subsets. This review highlights recent advances in adjuvant therapy of early stage breast cancer and discusses current treatment guidelines.

Antineoplastic Agents↗
PubMedDate not supplied

Adjuvant therapy for colorectal carcinoma.

In Western industrialized countries, colorectal adenocarcinoma is the second most common solid malignant tumor. Despite radical surgery in 75% to 80% of all cases, about 50% of patients with colorectal carcinoma die of this tumor. The essential advances of the last years are the reduction in the surgical complication rate and postoperative mortality. Recent studies show that radiotherapy for rectal carcinoma and chemotherapy (5-Fluorouracil in combination with levamisole) for colon carcinoma as additional measures in certain subgroups can significantly improve results. However, such multimodality treatment concepts need adequate equipment and experience and should only be implemented, whenever possible, in controlled clinical trials.

Antineoplastic Combined Chemotherapy Protocols↗
PubMed2001

Adjuvant therapy for breast cancer--results from the USA consensus conference.

The National Institutes of Health, USA sponsored a Consensus Development Conference on November 1-3, 2000 to review several major questions regarding the adjuvant treatment of breast cancer. A non-governmental group of oncology experts was selected to review clinical trial data and judge the evidence presented by 33 breast cancer researchers. Their conclusions resulted in the following recommendations: (1) Prognostic factors critical for determining risk of recurrence are age, axillary lymph node status, tumor size, histologic type and grade and hormone receptor status. (2) Tamoxifen, administered for 5 years, significantly improves long-term survival for women of all age groups with hormone receptor-positive tumors. Ovarian ablation also prolongs survival in premenopausal women. (3) Multi-agent chemotherapy of 4-6 months duration is associated with an improvement in survival in both hormone receptor-positive and -negative tumors. Anthracycline-containing regimens offer the greatest survival advantage. The role of taxanes is uncertain but they may be useful in selected patients with node-positive tumors. Women with small, node-negative tumors, women over age 70, and those with tumors of favorable histologic subtype (mucinous or tubular) may not require chemotherapy. (4) Adjuvant radiotherapy to the regional lymph nodes and chest wall following mastectomy is indicated for women with 4 or more axillary nodes. (5) Physicians should employ effective visual aids to help them present a complete and balanced view of the absolute benefits versus the side-effects of adjuvant treatments. Important avenues of future research were also discussed and suggestions were made.

Adult↗
PubMed2003

The reappraisal of gastrointestinal stromal tumors: from Stout to the KIT revolution.

For five decades gastrointestinal stromal tumors (GISTs) truly have represented one of the most confusing as well as neglected areas of both surgical pathology and clinical oncology. The recognition of the central role played by KIT expression in the development of the interstitial cell of Cajal and of the activating KIT mutations in the pathogenesis of GIST have been the keys for a more precise categorization of this long elusive clinicopathological entity. A Consensus Conference held at the National Institutes of Health in 2001 provided both an evidence-based definition and a practical scheme for the assessment of the risk of aggressive clinical behavior. This scheme is based on evaluation of the size and mitotic rate of the tumors, and its use is strongly advocated. On the basis of current data GISTs can be defined as a distinctive group of KIT-expressing mesenchymal neoplasms of the gastrointestinal tract, showing differentiation towards the interstitial cell of Cajal, also known as the gastrointestinal pacemaker cells. Metastatic GISTs have been a virtually incurable disease until the elucidation of the role of KIT mutations. STI-571 (imatinib mesylate) is a molecule that inhibits the function of various receptors with tyrosine kinase activity, such as abl, the bcr-abl chimeric product, platelet-derived growth factor receptor, and KIT. Following its successful use in the treatment of chronic myeloid leukemia, STI-571 has also proved extremely effective in targeting metastatic GIST. Data regarding the duration of the response to this therapy are not yet available, and therefore any overenthusiasm should be avoided. Nonetheless, the GIST story remains paradigmatic of a totally innovative approach to cancer therapy which until now is the most elegant translation of cancer biology experimental knowledge into clinical practice.

Antineoplastic Agents↗
PubMed2006

Alimentary tract mucositis in cancer patients: impact of terminology and assessment on research and clinical practice.

BACKGROUND AND SIGNIFICANCE: The field of terminology and assessment of oral and gastrointestinal mucosal injury caused by high-dose cancer therapies in cancer patients has undergone important evolution in recent years. The advances are important for several clinical and research reasons. These reasons include improved patient management and design and conduct of clinical trials based on molecularly targeted therapies. For several decades leading up to the 1980s, terminology was characterized by varying use of "mucositis" and "stomatitis" to describe oral mucosal inflammatory changes and ulceration caused by cancer treatments. In addition, oral mucositis was viewed principally as an epithelial event and one that likely did not intersect with causative mechanisms associated with gastrointestinal mucositis. The term "stomatitis" was directed to oral toxicities and seemed to isolate these conditions from parallel events occurring throughout the alimentary tract and potentially other tissues as well. These perspectives and varying use of these terms resulted in several dilemmas, including (1) difficulty in accurately reporting incidence and severity of oral mucositis and, (2) an under-appreciation of potential significance of alimentary tract mucosal toxicity relative to overall course of therapy, patient quality of life, and in some cases, survivorship. These and related components of the model relative to mucositis have undergone strategic shifts over the past 15 years. A 1989 National Institutes of Health Consensus Development Conference targeted oral mucositis research as one of the key areas for investigation relative to causation, clinical impact, and potential links with other complications in cancer patients. Research in this area over the past 15 years has evolved such that oral and gastrointestinal mucositis are now appropriately framed as a continuum of pathobiologic changes over time, with clinical impact that may well contribute to overall symptom clustering in selected patient cohorts. OBJECTIVES: This paper will review history, current status, and new research directions associated with terminology and assessment of mucosal injury in cancer patients in the context described above.

Bibliometrics↗