Shortly after publication of the study, the National Research Council produced an NCI-sponsored report summarizing the growing evidence of a relationship between diet and cancer. During this period, NCI had increased its emphasis in cancer prevention with a particular focus on understanding the role of diet in cancer and identifying ways to reduce cancer incidence. It is worth stressing, however, that while many scientists believe that diet plays a role in cancer, there are uncertainties about the precise role of total calories, fiber, and other dietary factors. Not surprisingly, there also are divergent views among respected scientists about the best research approaches to address these uncertainties.

The accumulation of evidence regarding fat and cancer, and other evidence regarding the potentially protective effects of increased dietary fiber, led NCI to establish interim dietary guidelines suggesting that Americans consume no more than 30 percent of their calories from fat and that they increase their dietary fiber from approximately 10 grams per day to between 20 to 30 grams per day. These guidelines were prudent actions based on laboratory, animal, and epidemiologic studies. Recently the Department of Health and Human Services (DHHS) published nutritional guidelines carrying the same recommendations, and for the first time, the Department is now specifying the 30 percent figure for daily fat intake in its publications.

NCI's support of nutrition research and training is substantial, increasing from a total of $52.7 million in FY 1987 to $67.0 million in 1990 for all nutrition-related research. The figure may increase substantially if NCI, in cooperation with the National Heart, Lung, and Blood Institute, proceeds with a low-fat dietary intervention trial to reduce breast cancer, colorectal cancer and cardiovascular disease. The trial will last some ten years and cost over $100 million. The decision to move forward hinges on the results of an ongoing feasibility study to test the methods for dietary change among minority, less-educated, the poor, and the general populations. If the dietary change proves feasible, we would consider moving forward with a full-scale trial.

REDUCTION OF CANCER MORTALITY

Question. Do you still believe that NCI will attain its goal of a 50 percent reduction in cancer mortality by the year 2000? If so, please show in a detailed way how NCI intends to achieve that goal in less than nine years. If not, what reallocation of NCI resources do you purpose to attain this goal?

Answer. Our most recent mortality data is for 1988 and, for the period 1985-1988, we see little change in the overall mortality from cancer, but very significant changes in some cancers (recent data on lung cancer among males, colorectal cancer incidence and mortality, cancer mortality among those under age 65, and breast cancer mortality among those under age 50). However, there has been not been sufficient time to reflect the impact of changes since 1985 in smoking, nor the impact of increased screening for breast and cervical cancer, nor changes in diet. Therefore, in evaluating the progress toward achieving the

cancer control objectives, we must rely, at this point in time, on behavioral data.

-

In 1985, NCI established six cancer control objectives. Our purpose was to define those activities that based on current knowledge would lead to significant reductions in the morbidity and mortality from cancer. Recently these objectives have been incorporated into the Department of Health and Human Services prevention objectives known as "Healthy People/2000."

NCI's objectives call for significant smoking reduction to less than half the level of 1985, a decrease in dietary fat to 30 percent of calories, an increase in dietary fiber to between 20 to 30 grams per day, a substantial increase in breast and cervical cancer screening, and an increase in the use of state-of-the-art treatment. We estimated in our report that, with full achievement of these objectives, mortality could be reduced by 25 percent and by 50 percent if we increase the rate of progress in our development of new treatments.

In 1992, through the National Health Interview Survey conducted by the National Center for Health Statistics, under cosponsorship of the National Cancer Institute, we will obtain national estimates of smoking rates, dietary patterns, and screening behavior. From these figures we will be able to gain our most precise assessment of progress toward the Year 2000 goals. The most recent National Health Interview Survey that stressed cancer control was conducted in 1987.

In 1987 some 32 percent of males smoked as did 27 percent of females. These figures were down significantly from the 1965 figures of 52 percent for males, but down only 7 percent from the 1965 figure of 34 percent for females. State trends seem to indicate that the smoking figures are continuing to drop, and in 1992 we will be able to assess progress from a national sample. Turning to breast cancer screening, we believe there has been considerable progress since 1987. In 1987, only 36 percent of women over 40 had had a mammogram. From smaller surveys conducted in 1989 and 1990, we believe that figure to be at least 60 percent today. Although this is a considerable improvement, we need to determine whether breast cancer screening has become routine practice. It is only through periodic screening, rigorously adhered to, that we can hope to achieve the full potential of screening: a reduction in breast cancer mortality rate by 30 percent. Data from NCI's cancer database, the Surveillance, Epidemiology, and End Results Program, strongly suggests that screening for cervical cancer is continuing, and correspondingly, the cervical cancer mortality rates are continuing to decline. It is this same database that shows that lung cancer incidence rates for males appear to be on the decline.

We see other hopeful signs in the rates of colorectal cancer. After decades of an increase in colorectal cancer incidence, the rate appears to have peaked, the last several years showing a significant decline. While this does not confirm a new trend in colorectal cancer incidence, it does correlate with what we believe to be recent dietary patterns associated with the increased intake of fiber and a reduction in fat. The long term

trends in colorectal cancer mortality show a continuing decline, correlating with improvements in detection and in treatment.

To meet the Healthy People/2000 objectives, it is essential that we transfer the results of research as fully and as expeditiously as possible. Our task is to forge partnerships with other Federal agencies, and with the public and private sectors. To fully effect this transfer, NCI has developed a number of approaches keyed to particular risk factors, behaviors, and population groups, and all involving the broad public and private sectors who, working together, will help to achieve these objectives.

For instance, NCI has launched the America Stop Smoking Intervention Trial (ASSIST), a nationwide study to apply the results of a decade of smoking research in some 20 communities across the country. The effort has the potential to reach 50 million Americans and accelerate the smoking quit rates. Perhaps even more important, the program may be a model for programs aimed at the other components of cancer control.

Together with the Centers for Disease Control and the Food and Drug Administration, we have developed a National Plan for Breast and Cervical Cancer Screening aimed at achieving the breast and cervix cancer control objectives. Representatives from state and local government, academe, and a variety of public and private sector agencies participated in two national meetings held to assist in development of the plan.

Directing cancer prevention and control efforts at those who suffer most or disproportionately from cancer is a cornerstone of the program. The National Black Leadership Initiative on Cancer (NBLIC) was established by the National Cancer Advisory Board and NCI in late 1987 and is a continuing activity. The purpose of this health education initiative is to solicit the assistance of Black Americans who are leaders in the business, civic, religious, and lay communities to develop coalitions to promote NCI's cancer prevention and control goals and to stimulate the involvement of the Black American community in this effort. Among the NBLIC's priorities are the promotion of smoking cessation, diet modification, and early detection, screening and treatment. Given the success of the NBLIC, NCI is using this established format to develop similar initiatives for both the Hispanic and Appalachian populations.

These are but a few examples of NCI's initiatives aimed at the full application of our knowledge. If the Nation were to quit smoking tomorrow, fully adopt the breast and cervical cancer screening guidelines, reduce fat in the diet to 30 percent of calories, increase fiber as recommended, and fully apply all of our existing knowledge regarding treatment, we believe that we would see, by the end of this decade, a significant reduction in cancer mortality. Although we cannot achieve the needed public and health profession behavior changes overnight (it has taken some 25 years to reduce the prevalence of smoking among males from 52 percent to 32 percent), we believe the Nation can reduce its cancer mortality.

It is essential to note, as well, the role of the NCI's research program in reducing the toll of cancer. It is only through the joint pursuit of basic and applied research, along with etiology and epidemiology, prevention and treatment research, and research training that we will conquer this disease. The results of this program have been startling in our new knowledge of the most fundamental processes of the cancer cell, and in their integration into new cancer treatments, new detection methods, and cancer prevention research. Cancer prevention, which once seemed

impossible, is now a realistic goal of our research program.

NCI remains committed to our cancer control objectives and is confident both of their achievement and the concomitant reduction in cancer mortality.

CANCER PREVENTION

Question. Please provide a line item budget with full abstracts for current and proposed NCI funding in the following

Answer. NCI supports primary prevention activities which encompass a variety of research areas. Activities in the areas of diet and nutrition, lifestyle and environmental carcinogenesis are highlighted below. Funding for primary prevention efforts is as

Evidence continues to accumulate from epidemiologic and experimental studies that nutritional factors contribute to a significant portion of cancers in humans. Animal studies, which are used to investigate mechanisms of action, consistently indicate that diet and nutrition have significant impact on tumor risk in the promotion and progression of carcinogenesis. Human evidence for the role of dietary and nutritional factors comes from large international variations of cancer incidence, from studies of migrants, and from case-control and cohort studies.

NCI's diet and nutrition program conducts research in nutritional and molecular regulation, prevention-related epidemiology, clinical trials and nutrition studies. The program identifies and validates cancer-preventive dietary patterns; and, through the information dissemination channels of the NCI, encourages changes to the dietary patterns of the American public.

Research in diet and nutrition comprise four distinct areas: etiologic and epidemiologic studies; clinical nutrition studies;

clinical trials; and expansion of the knowledge base on diet and cancer. These four areas of study are interrelated and together provide for a comprehensive research program on diet, nutrition and cancer. Examples of diet and nutrition studies are described below:

Breast cancer mortality rates among women in China and Japan are about one-fifth those of white American women. When Asian women migrate to the United States, however, their rates of breast cancer rise over several generations to those prevailing among Caucasian women. The rising trend is suspected to be related to the gradual adoption of a Western diet, which is high in fat, calories, meat, and dairy products. This hypothesis is being tested in a population-based case-control study of breast cancer among Asian-American women living in the United States. Extensive information on diet, physical activity, growth, and body size will be evaluated to assess the role of nutrition in childhood, adolescence, and adult life.

Breast cancer incidence rates in the United States have been increasing at a rate of 1-2 percent per year for the past 20 years, mainly among postmenopausal women. However, in the past few years, the increase has been 3-4 percent and predominantly among premenopausal women. Several possible explanations for this increase are being investigated in a case-control study of premenopausal breast cancer initiated this year. Information is being collected on diet, alcohol consumption patterns and body size at various times in life. Anthropometry and biochemical measurements are being used in both breast cancer studies to complement the dietary information.

Endometrial and ovarian cancer, like breast cancer, are highly correlated with dietary fat in international comparisons. However, few careful studies of these cancers have been conducted to disentangle the effects of obesity, total calories, fat, saturated fat, and low fruit and vegetable consumption. Obesity, patterns of weight gain as an adult, body fat distribution, dietary patterns and fat cell biochemistry will be correlated with hormone levels and endometrial cancer risk in another NCI study. In an ovarian cancer study, the interaction of diet, genetics, reproductive factors and hormone use will be investigated. These studies will be important in understanding the origins of breast and genital cancers, and therefore the means to prevent them.

Efforts are underway to study the role of nutrition for tumors that occur in excess among Black Americans. Specifically, prostate, pancreatic, and esophageal cancers and multiple myeloma are being investigated in a large multicenter case-control study. Emphasis is being placed on whether dietary factors can explain, at least partially, the higher rates of these cancers among Black American.

While tobacco smoking remains the major cause of lung cancer, evidence is accumulating that other environmental and host factors influence the risk. Several studies of lung cancer have demonstrated a protective effect associated with the intake of fresh fruits and vegetables. Whatever the mechanism, the current evidence is sufficiently strong and well-documented to warrant