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STATEMENT OF DR. SAMUEL BRODER

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This year, the twentieth since the National Cancer Act was passed, has been marked by high scientific achievement for the National Cancer Program. Research on gene therapies is progressing, resulting in new ways of intervening against cancer. Studies assessing the cancer risk posed by nuclear facilities have been conducted. New drugs to treat cancer patients have been developed and new prevention strategies using vitamin derivatives have proven effective. A high level of sophistication in recombinant DNA technology has been achieved and much of the biotechnology industry in the United States has emerged from basic science investigations in these areas. One measure of the success of the National Cancer Act is that there are over six million cancer survivors in the United States today. Despite these and many other successes, the priority placed on cancer research by the National Cancer Act is as needed today as it was in 1971 when the National Cancer Program was founded. There will be over a million new cases of cancer and a half million people will die of cancer in the United States this year. Many Americans who could benefit from the findings of this research do not currently have access to state-of-the-art prevention, early diagnosis and

treatment.

The National Cancer Institute also has an important role in AIDS research and works closely with the National Institute of Allergy and Infectious Diseases and other Federal agencies. NCI scientists have made vital contributions using basic biomedical research to study the pathogenesis and natural history of Human Immunodeficiency Virus (HIV) infection, AIDS drug development, and vaccine development. The NCI intramural program is one of the most important centers in the world for developing new therapies for children with AIDS. A new challenge is now on the horizon: as people with AIDS are surviving longer, the incidence of AIDS-related cancers is increasing, and NCI is working to meet this challenge.

Cancer is the second leading cause of death among women in the United States, with more than 150,000 women expected to die of lung, breast, and colon cancers and cancers of the reproductive tract in 1991. Women participate in every phase of NCI research and NCI strives for proportional representation of women in all clinical trials. Research on cancers that affect the survival of women is an exceedingly high NCI priority.

Major progress has been made in reducing deaths from childhood cancers--a

reduction of 36 percent between 1973 and 1987. Almost two-thirds of children with cancer now survive to the 5-year "cure" point. There also has been important progress in preventing or treating many common cancers in adults as well, particularly in people under age 65 where, for instance, the death rate for colorectal cancer has fallen by approximately 15 percent in the last 20 years. The death rate for ovarian cancer has fallen by approximately 25 percent, about the same for stomach cancer, by 30 percent for bladder cancer, and by nearly 40 percent for cancer of the cervix.

There has been less progress in reducing the death rate from the common solid tumors in patients aged 65 and over. There are disproportionate rates of cancer mortality in some minority groups as well as in poor and underserved groups. Ironically, as technology for prevention, diagnosis and treatment improves, the groups without access to the technology appear to suffer even more. In recognition of this, NCI has begun and will continue in 1992 to develop new research and outreach programs to reach women, minority group members, older individuals and other underserved groups.

The NCI cancer centers provide a resource within their geographic area for interdisciplinary cancer research and for state-of-the-art diagnosis, treatment, rehabilitation, prevention and control of cancer. In 1992, the comprehensive cancer centers will continue to emphasize community service and outreach activities. In addition, the centers are emerging as a potent national resource for study of and state-of-the-art treatment for the rapidly increasing number of AIDS-related cancers as well.

NCI's ability to transfer technology effectively rests on programs such as the cancer centers, the Clinical Cooperative Groups and the Community Clinical Oncology Program (CCOP). The CCOP is a network of community cancer specialists, primary care physicians, and other health care professionals who conduct both clinical treatment research and cancer prevention and control research studies in the areas of early detection and screening, chemoprevention, smoking, patient management, continuing care, and rehabilitation. The current program involves over 300 hospitals and 2,100 physicians. Approximately 5,000 patients per year are entered onto treatment clinical trials through the CCOP alone, which represents about one-third of the annual Phase III accrual to NCI-approved randomized clinical trials.

New treatments continue to be developed. NCI scientists and colleagues from the National Heart, Lung and Blood Institute have conducted a number of

gene treatment studies. Last year, gene transfer research successfully traced the activity of reinfused genes. Last September, a related study introduced gene therapy for an extremely rare, inherited immune system disorder caused by the absence of the enzyme adenosine deaminase (ADA). The first patient, a 4year old girl, has received monthly transfusions of gene-corrected white blood cells, and preliminary results suggest that her immune function has improved. We are now at the point of inserting genes for specific tumor-fighting substances such as tumor necrosis factor into patients' genes. The first two patients were treated on January 29, 1991.

NCI-supported scientists are continuing to unravel the genetic mysteries of the cancer cell and as a result, important new theories of how cancer evolves from the normal cell are emerging. About 10 years ago it was discovered that a gene, located at the 13q14 position (on chromosome 13), was missing in familial retinoblastoma, a rare childhood cancer of the eye. The protein produced by the gene at 13q14 is called RB. The normal RB gene appears to play a role in the suppression of cancer. Abnormalities in the RB gene and the RB protein have been found in acute lymphocytic leukemia, osteosarcomas and in many of the common "adult" tumors such as lung and

breast.

Abnormalities in another suppressor gene, p53, have been detected in colorectal cancer and other common malignancies, including lung and breast

cancers.

The Li-Fraumeni syndrome is characterized by multiple tumors and is inherited within families. NCI-supported scientists have recently pinpointed

tumors.

an inherited mutation of p53 as the responsible factor for these multiple Finding this critical gene may allow counseling of individuals with this inherited syndrome, and increase the understanding of the mechanisms that result in the transformation of a normal cell into a malignant cell.

NCI has an active drug development program for cancer and AIDS. NCI's high capacity drug screen examines synthetic compounds and natural products for activities against many human tumor cell lines and retroviruses such as HIV. A large number of the cancer drugs available today have been developed through the support of the National Cancer Program. Currently, there is great interest in the compound taxol as it can kill ovarian and breast cancer cells. Unfortunately, taxol is extracted from the bark of yew trees and stripping the bark kills the tree. However, so that clinical tests can go forward, NCI is making production of taxol from alternative renewable sources a priority. The

development of taxol and clinical investigations of taxol in combination with

other drugs will continue in 1992.

Studies in

Prevention is the most effective way to eliminate a disease. chemoprevention point the way to the day when people at high risk for cancer or those with premalignant conditions will be protected from getting cancer by adding a vitamin supplement, a micronutrient or other chemopreventive agent to their diets. Recently, findings from chemoprevention studies have shown that vitamin A-related compounds can prevent oral cancers and second primary head and neck tumors.

A new prevention clinical trial will employ tamoxifen, an anti-estrogen agent, as a breast cancer prevention agent. Tamoxifen has the potential to reduce the incidence of breast cancer by some 30 to 50 percent among postmenopausal women.

NCI is planning a two to three year study to determine the feasibility of conducting a full randomized dietary intervention trial to assess the impact of a low fat diet on the prevention of cancer and cardiovascular disease among women. A broad cross-section of women will be recruited to the feasibility trial with special attention to women from poor and underserved minority groups whose cancer mortality statistics are particularly high.

Tobacco use remains the single most deadly contributor to cancer mortality rates. NCI supports several large-scale smoking cessation studies: the Community Intervention Trial for Smoking Cessation (COMMIT) and the American Stop Smoking Intervention Study (ASSIST).

There is an intense effort to develop vaccines and vaccine-like approaches to the prevention of cancer. Vaccination is a classical tool to prevent diseases caused by a virus, and since a number of cancers are linked to a virus, vaccination is a promising strategy. For instance, Epstein-Barr

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virus and related viruses are detected in Burkitt's and other B cell lymphomas, oral hairy leukoplakia, nasopharyngeal carcinoma, and AIDS-related lymphomas. Vaccination is already preventing infection by the hepatitis B virus, a risk factor for the development of liver cancer. NCI-supported researchers have reported significant regressions of non-virus-caused malignant melanoma tumors using a vaccine-like approach to increase the patient's immune response.

NCI has pioneered the rapid communication about advances in clinical research. NCI disseminates important new clinical research results via

professional journals, PDQ, clinical announcements, press conferences, and consensus development conferences. The latest information about cancer treatment and clinical trials is available via the NCI's Cancer Information Service. Over 500,000 patients, families and doctors received information via the CIS toll-free 1-800-4-CANCER telephone number. NCI also reaches the public in novel ways, for instance, adding cancer education messages to rental videos of popular films. Last year, to extend information services abroad, NCI installed a state-of-the-art system using a compact disk technology (CDROM) product at demonstration sites in three cancer research institutes in Eastern Europe. In 1992, an additional 15 systems will be installed in developing countries. A number of NCI publications also are being provided free of charge to key medical libraries and academic institutions in Poland, Hungary, and the Soviet Union.

In conclusion, we have accrued understanding of the basic biology of cancer, which in turn is pointing to effective prevention, diagnostic and

treatment strategies.

fulfill that goal.

We must continue our progress and NCI stands ready to

Mr. Chairman, the FY 1992 budget request for the National Cancer Institute is $1,810,230,000. I will be happy to answer any questions.

BIOGRAPHICAL SKETCH OF DR. SAMUEL BRODER

PERSONAL: b. February 24, 1945; US citizenship

Married, two children

EDUCATION:

University of Michigan, Ann Arbor, MI

1966 B.S.

College of Literature, Science and the Arts (high honors)

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National Cancer Institute, National Institutes of Health, Bethesda, MD

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