RJ Reynolds
National Cancer Program. 1982 (820000) Director's Report and Annual Plan. Fy 1984-1988 (840000-880000).
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CHAPTER II
OVERVIEW OF THE NATIONAL CANCER PROGRAM
The National Cancer Program (NCP) was created by the National Cancer Act
of 1971. The latest amendments to that Act (Public Law 95-622, November 9,
1978) define the NCP as follows: .
Sec. 402. The National Cancer Program shall consist of
(1) an expanded, intensified, and coordinated cancer
research program encompassing the research programs
conducted and supported by the Institute and the related
research programs of the other research institutes and
including an expanded and intensified research program
for the prevention of cancer caused by occupational or
environmental exposure to carcinogens, and (2) the other
programs and activities of the Institute.
In addition to the NCP's focus on cancer prevention through environmental
and occupational studies, the Congress identified two other areas of emphasis.
These areas are (1) basic research programs, rather than targeted research
programs, funded primarily through contracts, and (2) education of health pro-
fessionals and the general public concerning both the factors that apparently
lead to a higher risk of cancer and ways to avoid them.
This chapter contains a review of the cancer-related activities of the
non-NCI agencies and organizations and the interagency, interorganizational,
and international mechanisms for the coordination of these activities. NCI
operations and programs will be discussed in depth in subsequent chapters.
NON-NCI ACTIVITIES
Information about non-NCI cancer-related activities was compiled from a
variety of sources, some of which provided more detail than others. Because
Of the difficulty in collecting accurate data, totals have been estimated
and are not exact amounts. Where necessary, 1981 funding figures were
strapolated.
Information about the cancer-related activities of other Institutes at
MY and other Federal agencies was obtained from the budget and planning
Ot(1tta or, in some cases, from program directors.
A primary source of information about cancer-related activities of the
ft*t! is the annual survey conducted by the National Public Health Program
*pORtins System. This system, initiated by the Association of State and
15
Territorial Health OfficiaLs, provides comprehensive and uniform national data
concerning the public health programs of the States.
Nonprofit groups represented in this report directly submitted descrip-
tions of their activities and associated funding.
Information about organized labor's cancer activities was obtained from
the Workers' Institute for Safety and Health, an arm of the Industrial Union
Department, American Federation of Labor-Congress of Industria]. Organizations
(AFL-CIO). There is no primary source of data for the varied components of
industry; therefore, the information reported came directly from the companies
cited. Information about professional organizations' involvement in cancer
was supplied by the various groups or extracted from general descriptions of
their activities.
Other Institutes of NIH
All of the other Institutes of NIH are engaged in cancer-related
activities costing an estimated $137.1 million in FY 1982.
The National Institute of Environmental Health Sciences (NIEHS) provided
the most support during the year for cancer-related research--over $58 million,
primarily for chemical carcinogenesis research. The NIEHS cancer-related
research activities deal with many types of toxicity. This research focuses
on the assessment of selected chemical substances for carcinogenic potential
and on the elucidation of mechanisms by which chemicals initiate, promote, or
inhibit carcinogenesis at the molecular level. Included are studies to
develop and validate in vivo and in vitro carcinogenesis test systems, cell
tissue and organ cultures and model systems for chemical carcinogenesis, and
test systems in submammalian species for detecting carcinogenicity as well as
mutagenicity. Efforts are under way to characterize biochemical and hormonal
markers for preneoplasia and neoplasia, the effects of carcinogens and other
chemicals on the enzyme system that activates and inactivates carcinogens, and
the binding of carcinogens to biological macromolecules such as DNA. Some of
these studies are associated with components of the National Toxicology
Program (NTP) conducted by the NIEHS.
The NTP consists of the relevant toxicology activities of NCI, NIEHS, the
National Center for Toxicological Research of the Food and Drug Administra-
tion, and the National Institute for Occupational Safety and Health of the
Centers*for Disease Control. The Program is funded by all of these agencies,
and its activities are planned and carried out as a coordinated effort under
the leadership of the Director of NIEHS, who serves as the NTP Program
Director.
As a participant in the NTP, NIEHS has the responsibility for improving
the methodologies available to establish and assess the toxicity of chemical
agents. The NTP is responsible for providing scientific information for the
prevention of human disease that is related to chemical exposure. Cancer-
related research activities within this program are reported by the NIEHS for
the first time. In previous years, bioassay testing for chemical carcinogens
was an NCI activity; however, this activity and its funding have been
transferred to NIEHS as part of the NTP._
16
a
0
NIEHS research directed toward the assessment of environmental agents
includes: bioassays on suspected care-inogens; mutagen tests; studies of
ehort-ter° in vivo liver carcinogenesis models; epidemiological studies of
eancer morbidity and mortality, primarily in industrial cohorts; studies of
qoking as an interactive factor; in vivo research on genetic susceptibility
to cancer; time and dose/response studies of single and multiple carcinogens;
and research on natural and artificial food contaminants and on the potential
toxicity associated with food processing. NIEHS also supports research on the
mechanisms of cancer-related diseases through studies of body changes at the
olecular level; the biotransformation of chemically inactive components to
reactive intermediates; the cellular transformation caused by primary
carcinogens or reactive intermediates; the occurrence and mechanism of DNA
injury and repair; the enzyme induction effects of carcinogen metabolism; the
pathological effects of carcinogens on specific organ sites such as lung,
liver, and skin; and the interaction between exposures to chemicals and to
radiation.
The National Institute of Allergy and Infectious Diseases (NIAID)
provided over $27 million for cancer-related research, specifically for
research on the immune system and the relationship of viruses to tumors. The
continuing increase in funding is attributable to a widening perception by
many investigators of the importance of understanding the immune system's
basic mechanisms and its selective manipulation to enhance clearance by the
body of foreign material such as cancer cells. A second important area of
study was fundamental tumor virology, including the genetic transmission and
control of murine retrovirus infection in nature and the relation of this
group of viruses to spontaneous neoplastic disease, as well as studies of
herpesvirus type II and the papovaviruses. NIAID has supported pharmacolog-
ical studies of interferon as well as basic studies of its mechanism of
action. Antibodies are being produced against the new interferons, and
together with reagent standards, will be very useful in comparison studies.
The Division of Research Resources (DRR) sponsors many cancer-related
projects. Funds are provided by the Animal Resources Program for animal
research in the study of neoplasm development; immune mechanisms; and exposure
of animals to carcinogenic agents such as hormones, radiation, and toxic
chemicals. The Biotechnology Resources Program supports technology to manage
cancer patient data or tumor registries, to study the structure and function
of carcinogenic or anticarcinogenic agents, and to evaluate treatment and
diagnostic methods. Biomedical Research Support grants are used for studies
of the relationships between hormones, nutrition, or carcinogenic agents and
cancer; of various modes of therapy (chemotherapy, immunotherapy, radiation,
or surgery) and cancer remission; of cell structure and genetic control; and
of the effects of various diagnostic methods such as the use of markers,
antigens, and assays to detect tumors. In addition, these grants support
epidemiological studies and investigations of cancer health care options.
Clinical investigations into various modes of treatment and diagnosis are
funded through the General Clinical Research Centers, which also study the
relationships between cancer and nutrition, hormones, or heredity. DRR's
Minority Biomedical Support Program supports several basic research studies
involving carcinogens--toxicity testing, for example.
The National Institute of General Medical Sciences (NIGMS) supports
studies relevant to cancer research in such areas as: metabolism of
17
xenobiotica; nucleic acid biochemistry; mutagenesis and DNA repair; regulation
of transcription and translation; membrane and cell-surface recognition sites;
and cell differentiation, growth, and division.
In 1982, the National Heart, Lung, and Blood Institute (NHLBI) supported
research directed toward understanding the role of certain vasoactive mediators,
particularly protein substances, in tumor development. It is hoped that a
better understanding of such protease systems in tumor tissue could lead to
new chemotherapeutic approaches for treating malignancies.
Other studies supported by the NHLBI included the development and assess-
ment of radiopharmaceuticals to measure tumor turnover and the level of
estrogen receptors in breast carcinoma; investigations in animals to determine
whether changes in blood volume within a region treated by radiotherapy could
beused as early indicators of response to that therapy; smoking cessation
maintenance strategies to'assess abstinence rates; observations of vascular
and metabolic changes caused in tumors by certain treatments; basic research
on pulmonary cells exposed to Adriamycin; and the genetic role responsible for
an enzyme that appears to induce cell resistance to methotrexate.
The NHLBI and the NCI are funding a project to test the effect of aspirin
on the prevention of myocardial infarction in a population of healthy physi-
cians. The project also aims to determine the influence of every-other-day
doses of the bioequivalent of 30 mg of beta-carotene on cancer incidence by
giving this dose to half of the group that is taking aspirin.
Projects supported by the National Institute of Child Health and Human
Development (NICHD) comprise both basic and clinical research. The mechanisms
of normal and abnormal cell growth and differentiation are being investigated,
including studies of hormone synthesis and secretion of pituitary, ovarian,
and testicular tumors; experimental induction of neural tissue tumors using
ethylnitrosourea; and the effect of diethylatilbestrol on vaginal and cervical
cell development. Other basic research projects are concerned with the
genetic mechanisms of cell growth and differentiation. These include research
on gene control of chemical induction of carcinogenesis; the relationship
between a specific form of RNA processing and malignancy; the cytogenetics of
a cerebellar medulloblastoma; and the tumorigenic potential of rodent cells in
neoplastic cell transformation.
The NICHD clinical studies are concerned with both children and adults.
Among the pediatric studies are research'on acute and chronic leukemias and
the Wilms' tumor complex as well as research on the identification, epide-
miology, and prognosis of childhood brain tumors. Most of the adult studies
address the use of oral contraceptives. NICHD supports a number of investi-
gations to determine the relative risks of developing malignant melanomas,
pituitary adenomas, or reproductive system tumors resulting from use of oral
contraceptives. Other research examines progesterone and estrogen receptor
assays in the management of breast carcinoma.
Research into the diagnosis, biology, metabolism, and treatment of brain
tumors is a primary program of the National Institute of Neurological and
Communicative Disorders and Stroke (NINCDS). Primary and secondary tumors of
the central and peripheral nervous system are of major concern. Specific
project areas involve the use of poI!'tron emission tomography (PETT) as a
m
18
qoninvasive means to analyze tumor metabolism. Whereas computer-assisted
tomography (CT) scanning delineates awatomical variation caused by a brain
tumor, the NINCDS PETT program is evaluating the metabolic activity within
tumor, as well as normal brain tissue, and is attempting to determine varia-
tions. In addition, a new, higher-resolution positron scanner (the Neuro-
PET"1') has been developed at the NINCDS and is now being used to study intra-
cerebral tumors. The Neuro-PETT scanner is a step closer to in vivo
utoradiography.
Scientists are producing monoclonal antibodies with high specific
sctivity. These antibodies, designed to recognize and differentiate tumor
from normal brain, can then be used for the study of the early development of
tumors and will analyze the biochemistry of antigens causing antibody reac-
tions. Monoclonal antibodies have been developed against neuroblastoma, and
patients with this tumor can now be studied in greater detail. Using the
athymic nude mouse, investigators are analyzing the predictive potential of
direct subcutaneous transplants of human brain tumor.
In vitro chemotherapy sensitivity studies and clinical treatment regimens
using nitrosoureas are being carried out. Collaborative research into the
metabolic products of nitrosourea therapy and the efficacy of azidiridinyl-
benzoquinone (AZQ) and CBDCA, a platinum derivative, is under way. Intra-
arterial therapy is also being explored.
As heterogeneity becomes a major concern in the events of neoplastic
disease, efforts are directed toward basic biochemical research, cell
kinetics, mechanisms of drug sensitivity and resistance, and the possibilities
of biological modification as well as toward the control mechanisms related to
tumor growth.
Other research at the NINCDS is directed toward developing both diag-
nostic and serologic tests that can quantify and determine the severity and
the rate of progression of nervous system disease secondary to cellular
damage. Radiopotentiating agents may be able to increase the efficacy of
irradiation in the treatment of tumors and are therefore being carefully
studied. Additional studies include the use of ultrasonic brain imaging;
quantitative CT scan analysis of architecture, water, and tissue concen-
trations associated with hydrocephalus and intracranial pressure resulting
from tumor; experimental models of intracerebral tumors; and blood-brain
barrier pharmacodynamics of therapeutic agents. To examine the effectiveness
of using a glucose derivative in diagnosis, patient data are being correlated
with tissue culture data.
The National Eye Institute (NEI) supports research on the diagnosis,
treatment, and biology of ocular tumors. Currently, the Institute is funding
studies in genetics, immunology, animal models, and drug-delivery devices.
Scientists are seeking to determine whether the enzyme esterase D may be a
genetic marker for human retinoblastoma. Tumor cell lines from human retino-
blastoma cells will be cultured and assayed. Since many cases of retino-
blastoma are hereditary, family relationships are being investigated, with
implications for family counseling and prenatal diagnosis.
The goal of several NEI-supported projects concerned with immunologic
mechanisms is to determine the antigens responsible for triggering the host's
19
immunologic response in choroidal melanoma and retinoblastoma. In other
studies, diagnostic methods, such as in vitro immunologic responses to tumor
associated antigens, are tested for their ability to differentiate patients
with ocular melanoma and those with benign and metastatic simulating lesione.
Tumor models of melanoma in the nude mouse are being studied to ascertain
the usefulness of radiotherapy in addition to enucleation. In one project,
polymers and ocular devices are being developed in the form of hydrogel
contact inserts for use in sustained delivery of anticancer agents to the eye,
Such devices, implanted in the vitreous, would allow continuous release of
drugs directly to the tumor site.
Researchers are investigating the possible role of viruses in the
development of intraocular tumors, as determined by ultrastructural and
biochemical studies. In another study, feline virus is injected in cats to
produce a model of melanoma. This animal model could prove useful in testing
new diagnostic and therapeutic techniques that could be adapted for use with
human tumors.
Using established cell lines, researchers have recently made progress in
understanding the biology of retinoblastoma cells. Investigators in two
research laboratories have demonstrated the presence of cellular retinol and
retinoic acid-binding proteins on retinoblastoma cells grown in vitro. The
studies should prove useful in determining the cell of origin of retino-
blastoma and should provide clues to the therapeutic management of the
disease.
To investigate the long-debated question of whether it is better to treat
tumors in the eye or to remove the eye, NEI-supported researchers are studying
the natural course of untreated uveal melanoma and are trying to evaluate the
effects of two types of enucleation in such cases in animal models. Among
future needs in eye tumor research are studies of the epidemiology, natural
history, optimal therapy, and classification of malignant cell types. Efforts
to develop animal models of choroidal melanoma are considered of high
priority.
The National Institute of Dental Research (NIDR) is supporting research
on the role of herpes simplex virus in the transformation of oral tissue, both
with and without cocarcinogens. Moreover, the human serum of patients with
oral squamous cell carcinomas is being examined for various classes of immune
globulins against herpesviruses. Other research projects are investigating
whether there is an increased incidence of cancer associated with human allo-
grafts and are studying the role of regional lymph nodes in oral cancer. The
role of low-dose x-irradiation in carcinogenesis, both with and without
chemical carcinogens, is the subject of another study supported by the NIDR.
The Institute's research program addresses factors associated with hyperplasia
and normal differentiation, and keratinization of oral mucosa.
The National Institute of Arthritis, Diabetes, and Digestive and Kidney
Diseases (NIADDK) is currently funding a wide variety of projects related to
cancer research. Research includes investigations of the regulation of
hormone responsiveness of normal, malignant, and otherwise diseased liver
cells; the metabolism and biosynthesis of gastrin and its role in the regula-
tion of gene expression of islet cell tumors through an understanding of the
mechanisms surrounding uncontrolled cell growth as it occurs in malignancies;
__..:.
20
ccoplications of malignant neoplasms such as acute renal failure and thyroid
disorders; attempts to determine the mechanism of bone marrow damage caused by
myalotoxins; and the cellular kinetiSi..and growth characteristics of human
spidermal cells from normal individuals and from those with various benign
end malignant skin diseases in order to establish a model for chemotherapy.
,rne NIADDK also supports research to improve the therapy of patients with
~alignant and aggressive bone tumors through the use of bone and osteo-
~tticulerUch o as a the . gastrointestinalnl endocrinefe and o muscu~loakeletalan
,yStems, s
,ystems, and basic research on the way cells grow and change will continue
to be funded.
The National Institute on Aging (NIA) funds research related to aging and
cancer in a broad range of disciplines such as immunology, cell biology,
tenetics, biochemistry, nutrition, pharmacology, and endocrinology. The
jnstitute supports the development of research resources, which include
standardized cell lines and aged animals for research on aging and cancer.
NIA research projects include: changes in sex hormone production in aging men
and women and the effects on target organs, changes in biochemical regulatory
echanisms during aging, the effects of aging and declining immune response on
tumor formation, cessation of proliferation in normal human fibroblast-like
cells in vitro, genetic and epigenetic control of senescence and death at the
cellular level, the interrelationship between aging and carcinogenesis, and
changes in the immune system with age. There is also an ongoing study of the
epidemiology of cancer related to aging.
The National Library of Medicine (NLM) provides to some 2,000 worldwide
institutions access to its numerous on-line data bases and data files, of
which three--CANCERLIT (Cancer Literature), CANCERPROJ (Cancer Projects),
and CLINPROT (Clinical Protocols)--pertain specifically to the cancer field.
These make up a component of the International Cancer Research Data Bank,
specifically, the CANCERLINE System, which is a computer-based information
system that links cancer information stored at the NLM in Bethesda, Maryland,
with terminals throughout the world. Other pertinent on-line files and
data bases include MEDLINE, HEALTH, TOXLINE, CHEMLINE, Toxicology Data
Bank, and the Registry of Toxic Effects of Chemical Substances. In addi-
tion to its on-line activities, the NLM acquires, catalogs, and indexes
biomedical literature, including cancer-related materials, for its extensive
collection.
The Division of Computer Research and Technology (DCRT) supports several
cancer-related projects. DCRT has designed a computer system that is aiding
the Laboratory of Viral Carcinogenesis, NCI, in trying to find characteristics
of serum samples that can be used to predict cancer. The system manages all
the data needed for efficient inventory control, test results feedback, and
statistical analysis related to the study.
DCRT is aiding the Radiation Oncology Branch, NCI, in providing the best
methods of planning automated radiotherapy treatment by finding improved ways
of isolating diseased areas in computerized tomography images.
Also, the Division is collaborating with researchers at the NCI and
elsewhere in studies of the analysis of coupled transport and biochemical
kinetics and of mathematical modeling of binding equilibria.
21
S02y9 ~582
The NIH Clinical Center provides several specialized programs. The
Rehabilitation Department offers vocational and psychological counseling to
cancer patients and provides therapy to patients who have had amputations a
axillary dissections. This Department also conducts programs in pain managa.
ment; surveil.lance of functional cognitive speech and language status in
patients receiving radiation treatment and chemotherapy; and the development
of outcome measurements to assess the impact of cancer on physical, psycho-
logical, and vocational/educational activities. The Audiology Department
monitors patients receiving chemotherapy for hearing-related side effects,
and the Blood Bank conducts research relevant to breast cancer and leukemia.
The Clinical Center currently administers an NCI contract for HLA typing and
plans to establish an in-house capability in the Blood Bank Department. The
Nuclear Medicine Department makes positron emission tomography available to
researchers and has plans to acquire nuclear magnetic resonance imaging
technology.
Funding levels for cancer-related activities of the various Institutes o
NIH are presented in Table II-1.
Other Federal Agencies
Federal agencies other than the National Cancer Institute and the
National Institutes of Health conduct cancer-related activities such as
etiology, cell biology, epidemiology, and therapy.
The Department of Health and Human Services (DHHS), which includes the
National Institutes of Health, supports cancer-related,activities through the
Alcohol, Drug Abuse, and Mental Health Administration (ADAMHA); the Centers
for Disease Control (CDC); the Food and Drug Administration (FDA); the Health
Resources Administration (HRA); the Office on Smoking and Health (OSH); and
the National Center for Health Statistics (NCHS).
ADAMHA consists of three Inst'itutes, each of which supports cancer-
related activities. The National Institute on Drug Abuse (NIDA) is testing
new, potentially less addictive analgesics on cancer patients and is also
clinically evaluating naltrexone, a narcotic antagonist, for possible carcin-
ogenicity. The National Institute on Alcohol Abuse and Alcoholism (NIAAA)
supports epidemiological studies in alcohol-related cancers as well as research
into possible mechanisms of the development of alcohol-induced cancers and
methods for their prevention and/or early detection. Research projects sup-
ported by the National Institute of Mental Health (NIMH) include scudies of
the behavioral control of the pain and nausea experienced as side effects of
cancer chemotherapy and hyperthermia, the effects of stress and personality on
the development of serious illnesses such as cancer, the behavioral effects of
brain tumors, and the influence of prevention-oriented messages on health
attitudes and behavior. The NIMH also currently supports two cancer-related
clinical studies, one concerning the effects of treatment to the central
nervous system on the intellectual functioning of leukemic children, and the
other on the adaptati.on of children and adults to research hospitalization.
In addition, basic science research projects are in progress.
Three major components of the Centers for Disease Control (CDC) involve
cancer-related work: the Center for Environmental Health (CEH), the Center
22
Table II-1.
Funding of Cancer-nated Activities by Other
Institutes of NIH (FY 1982)
Division of Research Resources $ 17,987
National Eye Institute 2,500
National Heart, Lung, and Blood Institute 3,956
National Institute of Allergy and Infectious Diseases 27,777
I _. ^^°I :nctautP ^f Arthritis, D:abetec, and Digestive ai .~
fVjillVl~a~ ~ I ec
o vba.ua.~. w L,/JO
Kidney Diseases
National Institute of Child Health and Human Development 2,564
National Institute of Dental Research 530
National Institute of Environmental Health Sciences* 58,600
National Institute of General Medical Sciences 10,900
National Institute of Neurological and Communicative Disorders 2,441
and Stroke
National Institute on Aging 3,236
National Library of Medicine 2,500
Total
$135,747
(Note: The Division of Computer Research and Technology and the Clinical Center are funded by all of
the NIH Institutes.)
'Includes funds transferred from NCI for the National Toxicology Program.
23
