Proceedings of the American Cancer Society and National Cancer Institute National Conference on Nutrition in Cancer, June 29--July 1, 1978, Seattle, Washington.
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Congresses as Topic↗
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Workshop report from the Division of Cancer Etiology, National Cancer Institute, National Institutes of Health. Protease inhibitors as cancer chemopreventive agents.
This workshop was organized to discuss the current state of research on anticarcinogenic protease inhibitors with regard to their potential use as human cancer chemopreventive agents. Previous studies have indicated that protease inhibitors can be powerful anticarcinogenic agents for animals and cells in culture and that human populations known to have high concentrations of protease inhibitors in the diet have low overall cancer mortality rates. In the workshop discussions, emphasis was placed on certain dietary protease inhibitors, such as the soybean-derived Bowman-Birk inhibitor and chymotrypsin inhibitor 1 from potatoes and some of the highly purified protease inhibitors of microbial origin provided by the Japan Society for the Promotion of Science, which have already been shown to contain anticarcinogenic activity in laboratory studies. Potential adverse side effects of dietary protease inhibitors were also considered, specifically, their possible effects on the pancreas and in causing decreased growth rates in young organisms. It was pointed out that the pancreata of a few species, notably rats and chicks, are extraordinarily sensitive to dietary protease inhibitors. Rats fed diets containing high concentrations of soybean-derived protease inhibitors (raw soy flour) had enlarged pancreata; increased pancreatic growth is thought to accelerate cancer development in the pancreas. The effect of raw soy flour on the growth of the rat pancreas has not been shown to occur in most other species tested (examples include hamsters, mice, dogs, pigs, and monkeys) and is not expected to occur in humans. There is no evidence that dietary protease inhibitors have adverse effects on the human pancreas. In fact, it has been observed that human populations with high levels of dietary protease inhibitors have decreased rates of pancreatic cancer. Dietary concentrations of protease inhibitors which have been shown to be anticarcinogenic have not produced decreased growth rates in animals or any type of pancreatic pathology. In general, there was a high level of enthusiasm at the workshop for the further development of protease inhibitors as chemopreventive agents. Recommendations for future research include: (a) research and development of sources of protease inhibitors; (b) analysis of human foods for protease inhibitor content; (c) evaluation of cancer incidence data in relation to protease inhibitor content and characteristics in the diet of human populations; (d) animal studies on the efficacy of protease inhibitors in cancer prevention; and (e) studies on the mechanism of action of anticarcinogenic protease inhibitors.
Humans↗
Workshop report from the Division of Cancer Etiology, National Cancer Institute, National Institutes of Health. Current perspectives and future trends in hormonal carcinogenesis.
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Animals↗
Mechanisms in myeloid tumorigenesis 1988. Workshop at the National Cancer Institute, National Institutes of Health. Bethesda, MD, USA, March 22, 1988. Proceedings.
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Animals↗
Digital mammography and related technologies: a perspective from the National Cancer Institute.
The National Cancer Institute held a workshop entitled "Breast Imaging: State-of-the-Art and Technologies of the Future" in September 1991. This article describes some of the presentations given at the workshop as well as relevant data in the literature and discusses their implications. The workshop faculty identified digital mammography as the evolving technology with the greatest potential impact on management of breast cancer. On the basis of the workshop findings and literature review, the author proposed to form the National Digital Mammography Development Group, which will stimulate research in digital mammography and its integration with related technologies: image processing for improved lesion contrast, automated computer-aided diagnosis for enhanced breast cancer detection and characterization, and teleradiology for facilitated radiologic consultation with recognized experts in the field. It is expected that the National Digital Mammography Development Group will facilitate transfer of advanced digital imaging technology to breast cancer clinics.
Female↗
Role of the National Cancer Institute in the National Cancer Program on Environmental Carcinogens.
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Carcinogens, Environmental↗
Long-term chemical carcinogenesis experiments for identifying potential human cancer hazards: collective database of the National Cancer Institute and National Toxicology Program (1976-1991).
The carcinogenicity database used for this paper originated in the late 1960s by the National Cancer Institute (NCI) and since 1978 has been continued and made more comprehensive by the National Toxicology Program (NTP). The extensive files contain, among other sets of information, detailed pathology data on more than 400 long-term (most often 24-month) chemical carcinogenesis studies, comprising nearly 1600 individual experiments having at least 10 million tissue sections that have been evaluated for toxicity and carcinogenicity.(ABSTRACT TRUNCATED AT 250 WORDS)
Animals↗
Therapy: state-of-the-art assessment of quality. The National Cancer Institute perspective.
The National Cancer Institute (NCI) has a broad spectrum of responsibilities that range from support of basic laboratory research to the clinical testing of new therapeutics and, finally, the dissemination of results of this research to the practicing physician and the public. The reduction of cancer mortality is largely dependent on the responsibility for widespread application of state-of-the-art cancer treatments. A major cancer control focus of the NCI over the last decade has been the development and implementation of programs designed to improve awareness, access and application of state-of-the-art cancer treatment. In addition to the computerized Physician Data Query system, three targeted programs, the Cooperative Group Outreach Program (CGOP), the Community Hospital Oncology Program (CHOP), and the Community Clinical Oncology Program (CCOP) have all been aimed at establishing mechanisms to facilitate the transfer of new patient care technology; and, thereby, provide the highest quality cancer treatment in the community setting. An evaluation was conducted to determine if patterns and outcomes of cancer care management changed over time, and whether this could be related to the presence of CGOP, CHOP, and CCOP. Measurement of required program implementation was relatively straightforward. However, measurement of resultant changes in "quality of care" and the factors that influence physician performance are complex and controversial. Critical elements in the treatment of breast, colon, rectum, and small cell lung cancer were used as tracers to measure changes in the patterns of care in communities where programs were implemented. Results from this study highlight issues in state-of-the-art assessment of quality, such as the difficulty in defining quality cancer care, relationships between process and outcome indicators, and the problems of documentation and missing data. Assurance of quality cancer care requires the interaction of health care professionals with knowledge of the most up-to-date cancer research results working in a health care delivery system that encourages and rewards application of these results.
Clinical Trials as Topic↗
Education and training programs at the National Cancer Institute: 1938-1982.
The National Cancer Institute (NCI) has supported cancer research training and clinical cancer education since 1938, the latter in a variety of forms. These include direct clinical fellowships, followed by institutional grants designed to improve the education of students concerning cancer in medical and dental schools, and subsequently in teaching hospitals. The institutional grants went through three stages between 1948 and 1982, and have recently entered a fourth. Undergraduate Cancer Training Grants supported cancer teaching for medical and dental students. Clinical Cancer Training Grants expanded teaching activities to include post-resident trainees and medical and dental practitioners. Clinical Cancer Education Grants further extended cancer education and emphasized goals, objectives and evaluation, and focused on areas of weakness in cancer teaching such as epidemiology and cancer, cancer prevention and the role of radiation therapy. The various pressures within and without NCI that have influenced the development of these grant programs are discussed. Some cancer education activities supported by Cancer Control programs, both at NCI and another agency of the Public Health Service, are briefly mentioned. Aspects of the grant review process, program monitoring, and the impact of a professional organization developed in direct response to the first institutional cancer education grant program are described.
Cancer Care Facilities↗
Superiority of alternating non-cross-resistant chemotherapy in extensive small cell lung cancer. A multicenter, randomized clinical trial by the National Cancer Institute of Canada.
The National Cancer Institute of Canada Clinical Trials Group conducted a prospective randomized study comparing standard chemotherapy with alternating chemotherapy in patients with extensive small cell lung cancer. "Standard" treatment consisted of cyclophosphamide (1000 mg/m2 body surface area); doxorubicin (50 mg/m2), and vincristine (2 mg) every 3 weeks for six courses. Alternating chemotherapy was cyclophosphamide, doxorubicin, and vincristine alternating with etoposide (100 mg/m2 on days 1 to 3) and cisplatin (25 mg/m2 on days 1 to 3) every 3 weeks for six treatment cycles. Two hundred eighty-nine patients were eligible and evaluable for response to therapy and survival. Best response was higher in patients on alternating chemotherapy (complete plus partial response, 80% compared with 63.2%; p less than 0.002). Progression-free survival for patients on alternating chemotherapy was superior (p less than 0.0001) as was overall survival (p = 0.03). Major toxicities were equally frequent in both treatment groups. These results show a modest superiority of alternating chemotherapy over standard therapy in extensive small cell lung cancer.
Adult↗
The National Cancer Institute's intervention trials.
The National Cancer Institute (NCI) has increased its emphasis in cancer prevention by undertaking a number of human intervention trials. Special emphasis is placed on chemoprevention, diet, and smoking and tobacco use. Some 24 clinical trials are ongoing in chemoprevention to assess the role of specific chemicals (natural and synthetic) in preventing, inhibiting, or reversing carcinogenesis. In diet and nutrition, several macronutrient trials are underway. The most significant of these is examining the relationship between dietary fat and breast cancer. In 1982, the NCI initiated a broad intervention research effort in smoking and tobacco use which has resulted in 46 prevention and clinical trials covering 25 states and more than 200 cities. More recently, a North American community-based intervention trial was begun to test cessation strategies for heavy smokers in 22 different sites. All of these intervention research efforts are testing strategies which later can be applied to large target population thereby supporting NCI's ambitious goal to reduce cancer mortality in this nation 50% by the year 2000.
Clinical Trials as Topic↗
Special report on Laetrile: the NCI Laetrile Review. Results of the National Cancer Institute's retrospective Laetrile analysis.
The National Cancer Institute, in response to widespread public interest, undertook a retrospective analysis of Laetrile treatment. Only cases thought to have shown objective benefit from Laetrile were solicited by mail request to 385,000 physicians and 70,000 other health professionals and by direct contact with pro-Laetrile groups. Although it is estimated that at least 70,000 Americans have used Laetrile, only 93 cases were submitted for evaluation. Twenty-six of these Laetrile cases had to be eliminated because of insufficient documentation, and an equal number of conventionally treated cases selected from the institute's files were added to the records to be analyzed. A panel of 12 oncologists, who had no knowledge of the actual treatments given, was then asked to evaluate the results of 160 courses of treatment (68 Laetrile, 68 chemotherapy, 24 "no treatment") in the abstracted records from 93 patients. The panel judged six Laetrile courses to have produced a response (two complete and four partial). These results allow no definite conclusions supporting the anti-cancer activity of Laetrile. The National Cancer Institute will use the data in deciding if further study is needed.
Amygdalin↗
Tobacco-use reduction among high-risk youth: recommendations of a National Cancer Institute Expert Advisory Panel.
The National Cancer Institute's efforts to prevent tobacco-related cancers have resulted in numerous activities to reduce smoking prevalence throughout the United States. Two decades of research activity has provided much of the information needed for interventions through channels such as mass media, physician/dentist training, self-help strategies, and school-based prevention programs. However, in the area of adolescent tobacco-use reduction, it has been consistently observed that youth who have the highest tobacco-use rates are among those least likely to be reached through school-based or other programs. Thus, these youth, often labeled "high-risk," are seen as a cornerstone for tobacco use prevention efforts. Although they pose a particularly difficult access problem, many valuable recommendations for strategies to identify and reach this group were made by a recent NCI-convened Expert Advisory Panel on the Prevention and Cessation of Tobacco Use by High-Risk Youth. The Panel considered this issue from three perspectives--methods of identifying these youth, strategies for reaching them with appropriate tobacco-use prevention/cessation programs, and identification of research needs. Their recommendations and conclusions are summarized in this article. Support for research addressing the prevention and cessation of tobacco use among high-risk youth is currently being considered by the NCI.
Adolescent↗
Clinical experimentation in magnetic resonance spectroscopy: a perspective from the National Cancer Institute.
This paper describes the National Cancer Institute activities in clinical MRS, including a recent international conference organized by the Diagnostic Imaging Research Branch, a research agenda developed by the conference faculty members of one of the research programs proposed by the author.
Humans↗
Historical overview of the National Cancer Institute Fermentation Program.
The background of the National Cancer Institute fermentation program is placed into the historical perspective of the entire NCI drug development program, which began as the Cancer Chemotherapy National Service Center and metamorphosed into the Chemotherapy Program and ultimately into the Division of Cancer Treatment.
Antibiotics, Antineoplastic↗
Check samples for laboratory self-assessment in DNA flow cytometry. The National Cancer Institute's Flow Cytometry Network experience.
The National Cancer Institute's Flow Cytometry Network (NCI-FCN) is attempting to facilitate the transfer of flow cytometry (FCM) of exfoliated bladder cells from the research laboratory to the clinical laboratory. Demonstrating interinstitutional consistency in FCM analysis of replicate specimens simulating clinical barbotage specimens, fixed to allow easy transportation and storage at room temperature was one specific objective. Simulated barbotage specimens were prepared by mixing cultured aneuploid bladder carcinoma cells with normal or mitogen-stimulated peripheral blood mononuclear cells in different ratios. The samples were fixed in 10% formalin for 30 minutes, stored in buffer, and enucleated with pepsin, pH 1.5, before staining with propidium iodide for FCM DNA analysis. Preservation in ethanol or other common DNA cytochemical reagents was found to be unsatisfactory. In contrast, the formalin-fixed samples showed excellent preservation of quantitative DNA fluorescence and coefficient of variation of histogram peaks for over 2 weeks. Exchange of eight fixed specimens among five network laboratories that analyzed them as "unknowns" showed good overall agreement on histogram data and interpretation, although some noteworthy interlaboratory differences were found. This technique could be used for self-assessment surveys of clinical laboratory performance in DNA FCM of bladder barbotage specimens.
Cell Count↗
A phase II study of recombinant tumor necrosis factor in renal cell carcinoma: a study of the National Cancer Institute of Canada Clinical Trials Group.
The National Cancer Institute (NCI) Canada Clinical Trials Group conducted a phase II study of recombinant tumor necrosis factor (rTNF) given intravenously daily for 5 days every other week, in measurable metastatic renal cell carcinoma. Two of 26 patients responded with responses lasting greater than 200 days. Toxicity was severe including rigors, fever, headache, fatigue, hypotension, and localized pain. We conclude that rTNF, given as described, has only modest antitumor activity in renal cell carcinoma and produces considerable toxicity. We plan no further studies of rTNF in this disease.
Adult↗
Historical and methodological developments in clinical trials at the National Cancer Institute.
The first randomized clinical trial at the National Cancer Institute (NCI), planned in 1954, commenced in 1955 for the treatment of patients with acute leukaemia. The programme in clinical trials at NCI had strong influence from the clinician and administrator, C. Gordon Zubrod, who introduced the randomized clinical trial at NCI and organized the co-operative clinical trials programme of the Cancer Chemotherapy National Service Center (CCNSC) beginning about 1955. The biostatistician, Marvin Schneiderman, collaborated on the first randomized trials in acute leukaemia and solid tumours and recruited the biostatisticians and statistical centres in the early phase of the co-operative clinical trials programme of the CCNSC. From the beginning, there was acceptance of the principles of the randomization of patients and the statistical analysis of data. The sequence of clinical trials for a new agent included the non-randomized phase I (dosage finding) and phase II (preliminary efficacy) trials as well as the phase III (comparison of treatments) trials. New concepts for the treatment of patients developed from 1955 to the mid-1960s included the combination of therapies with independent activity to increase response rates and the administration of therapy to patients in a disease-free (remission) state to prolong the disease-free state. Methodological developments related to clinical trials up to the mid-1960s included: a plan for phase II trials (Gehan); a generalization of the Wilcoxon test for the comparison of survival distributions with right-censored data (Gehan); a test of proportional hazards for survival distributions, which later became known as the Mantel-Haenszel test (Mantel), and an exponential regression model with an explanatory variable (Feigl and Zelen).
Child↗