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PROGRESS BY TYPE OF CANCER

Question. Dr. Broder, for what types of cancer have we made the most progress?

Answer. Cancer mortality for all sites minus lung has declined three percent during the 16-year interval 1973-88. Annual cancer mortality rates (deaths per 100,000 persons, ageadjusted to the 1970 U.S. standard population) for the period 1973-1988 show that improvement is evident in the large reductions in the annual cancer mortality rates among persons under age 65. Between 1973 and 1988 the mortality rate for all cancers combined for persons under 65 decreased 4.3 percent. Annual cancer mortality rates, age-adjusted to the 1970 U.S. standard, for all cancers combined among persons 65 years and older increased 13 percent during the 15 year-period 1973 through 1987.

Mortality from cancers of the uterine corpus and cervix, urinary bladder, thyroid, and stomach has declined between 20 and 40 percent; reductions of 10 to 20 percent have occurred for oral cavity, colon and rectum, and breast cancer among women less than 50 years of age. Reductions of five to 10 percent have occurred in cancers of the ovary and larynx and in leukemia. Cancer in young adults has decreased greatly, for example testicular cancer and Hodgkin's disease have declined by more than 50 percent. However, other cancers have shown increases: lung cancer and melanoma are up over 30 percent, and increases of 10 to 20 percent occurred for multiple myeloma, non-Hodgkin's lymphoma, prostate, kidney and renal pelvis, esophagus, brain and nervous system, and liver and intrahepatic cancers. Breast cancer mortality for females 50 years and older increased five percent during the interval 1973 and 1988. Thus, there is good news and bad news in our progress against cancer, and we need to make sure we accelerate the pace of progress against the cancer suffered by the American people.

The following tables present data by site regarding progress in various types of cancers from 1973 to 1988.

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Percent changes for breast, cervix uteri, corpus uteri, and ovary are based only on female population.

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Percent changes for prostate and testis are based only on male population.

SEER 1973-88 Incidence Trend

Percent Change All

<65 65>

U.S. 1973-88
Mortality Trend

Percent Change
All <65 65>

SEER Survival (%)

1981-87 All <65 65

Site

48.3

Oral Cavity & Pharynx
Esophagus
Stomach
Colon/Rectum
Liver & Intrahep:

Liver
Pancreas
Larynx
Lung & Bronchus
Melanoma of Skin
Breast (females)
Cervix Uteri
Corpus Uteri & Uterus NOS
Ovary
Prostate Gland
Testis
Urinary Bladder
Kidney & Renal pelvis
Brain & Nervous System
Thyroid gland
Hodgkin's Disease
Non-Hodgkin's Lymphoma
Multiple Myeloma
Leukemia

-2.7

9.7
-20.5

3.7
23.5
17.2
-5.9

2.6
34.0
77.9
25.8
-37.0
-28.8
-1.4
58.0
32.7
12.3
28.4
22.7
11.2
- 10.7
56.9
10.3
- 10.8

-1.5

4.3
- 13.7
-2.2
18.8
15.5
- 14.8
-4.3
20.8
70.1
17.0
-35.3
-44.6
-9.1
74.3
36.5

8.3
22.7
10.1
10.9
-4.5
58.6

7.2
-9.1

-4.5
15.0
-24.1

7.0
27.8
18.7
: -0.2
12.8
47.4
101.2

41.8
-42.4

4.5
13.7
54.6
-49.8
14.8
34.9
62.1
12.3
-37.3
55.0
12.2
-12.4

- 17.6

12.1
-31.2
- 11.1
10.3
-2.8
-2.8
-6.5
36.1
31.0

1.8
-41.5
.22.2
-8.1
12.7
-60.7
-23.6
12.4
11.0
-22.4
-53.2
22.7
24.2
-6.8

-20.5

4.8
-29.7
- 15.8

6.5
-3.7
- 12.6
- 13.9
16.7
15.7
-4.7
-41.0
-37.2
-25.4

0.9
-61.9-
-32.3

2.6"
-8.1.
-25.7-
-54.7

1.7
10.6
- 16.9

- 14.6

19.2
-31.9
-8.9
12.7
-2.1
2.9
1.4
55.4
59.4
11.0
-42.4
- 12.1
15.7
14.2
-52.5
•21.1
21.1
59.4
- 20.7
-50.9
40.9
31.6
2.2

51.2 53.0
8.1

8.7
17.0 18.5
56.2 57.8
5.1

7.4
5.0 7.3
3.1 4.4
66.3 68.9
13.1 15.3
81.5 83.4
77.0

76.5
65.9 71.3
82.2 87.4
38.8 48.5
74.1
92.5 92.9
78.1 85.1
53.0 59.4
25.0 32.9
93.9 97.1
76.3 81.2
50.8 58.2
26.8 32.1
35.2 40.8

16.0
55.2
3.0
2.8
2.2
62.3
10.9
75.2
77.9
47.4
76.0
24.2
73.4
70.8
73.0
44.6

4.2
74.9
36.4
41.3
23.1
28.5

76.2

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Percent changes for breast, cervix uteri, corpus uteri, and ovary are based only on female population.

8

Percent changes for prostate and testis are based only on male population. TAXOL

Question. Dr Broder, we have been hearing a lot about a new drug called TAXOL that is effective in treating ovarian cancer. Can you tell us more about this promising new therapy?

Answer. Taxol is a new plant derived antineoplastic agent isolated from the western yew, taxus brevifolia. It is a complex alkaloid ester which has unusual interactions with mammalian tubulin. Taxol markedly enhances all aspects of tubulin polymerization including initiation and elongation, and the microtubules formed are more stable to depolymerization. Currently, the only source of taxol is from the bark of the western yew tree and because of low yield on isolation, large numbers of trees must be harvested. For this reason, drug supply is limited. As I noted earlier when we discussed taxol as a treatment for ovarian cancer, several approaches have been taken to relieve this situation, including identification of new sources of yew trees, identification of renewable species of taxus, and the development of semi-synthetic techniques. In order to increase drug supply, a Cooperative Research and Development Agreement (CRADA) for the production of taxol has been established between the NCI and Bristol-Myers Squibb.

Over the past year, clinical trials have demonstrated that taxol has significant activity against recurrent ovarian cancer and has promising activity in recurrent breast cancer in 25 previously treated patients (a total of 48 percent complete plus partial remissions) and non-small lung cancers. At present, the NCI has active Phase I and II studies of taxol in ovarian, gastric, breast, non-small lung cancer, cervical, colon, and prostate cancers. Because of this response rate, the Medicine Branch in NCI's intramural program is planning an up-front regimen in ovarian cancer with taxol, cisplatin, cyclophosphamide and GCSF a colony stimulating factor. The Gynecologic Oncology Cooperative Group, a member of the NCI Clinical Trial Program, has already started an up-front study with taxol in suboptimally debulked ovarian cancer. In this study, patients are randomized to receive either cyclophosphamide/cisplatin or taxol/cisplatin; 66 patients have been entered with a goal of 120-180. The NCI also plans a confirmatory trial in breast cancer that will be starting in the next several months at Memorial Sloan Kettering. Additionally, a combination trial of taxol, adriamycin, and GM-CSF in metastatic breast cancer is slated to start soon in the Medicine Branch, NCI. Taxol represents a major advance in chemotherapy. However, obtaining adequate supplies of this drug will remain a formidable problem.

QUESTIONS SUBMITTTED BY SENATOR DALE BUMPERS

PROGRAM PROJECT GRANTS

Question. Program project grants are particularly important because they provide an opportunity to integrate basic and clinical research teams. I understand that NCI may be considering breaking up Pols and encouraging PO1-supported investigators to apply upon renewal for individual investigator awards. This would result in a greater number of total awards.

Aren't pols particularly important in translating laboratory findings into clinical applications?

Answer. By supporting related basic and clinical research projects within a single poi, program project grants provide a useful framework to encourage collaboration between basic and clinical researchers. When used in this way, they provide new opportunities to facilitate translation of basic laboratory findings to clinical application. The NCI will continue to support with enthusiasm Pols which promote these collaborative efforts.

It is important to note that pols are not the only vehicle for moving basic research findings quickly into clinical applications. Several other NCI mechanisms such as the clinical Cooperative Groups and Cancer Centers are valuable and necessary to this effort. Within the Cancer Prevention and Control Program, many community outreach efforts have been developed which permit the translation of basic and clinical research findings into a community setting; the Community Clinical Oncology Program, through over 50 awards, is one of the most notable.

The revolution in biomedical research over the past few years has made it possible to move basic research findings from the laboratory to the bedside. Developing innovative ways to facilitate such a movement is one of the challenges facing the NCI. Program projects are among the weapons in the armamentarium which assist in this effort.

Question. How can NCI defend dismantling the P01 mechanism to play a numbers game?

Answer. The NCI is not reviewing the option to disaggregate Program Projects (Pols) solely to meet a requirement to support a specific number of competing grants. We are making a programmatic evaluation to assure that research projects being supported within a P0l are part of a cohesive entity that is the most effective way to conduct the research. Each Program Project, on the average, supports the equivalent of five to seven independent investigatorinitiated grants. There may be instances in which an individual project does not require the synergism provided by a Pol and would be as effective if supported as an independent research grant (R01) rather than as a sub-project within a pol. NCI would recommend that in such cases projects become independent ROI grants during their competitive cycles.

TRAINING OF PHYSICIAN SCIENTISTS

Question. NIH and the scientific community are well aware of the shortage of well-trained physician scientists. Despite this recognition, the number of awards from the NCI Research Career Program training mechanisms particularly attractive to physicians has not increased over the past decade. The By-Pass budget calls for a doubling of these awards over the next two years. How will the President's budget proposal affect this goal?

Answer. The NCI Research Career Program is the primary way in which medical doctors who have developed clinical skills can receive the training necessary to pursue effective research

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