1911

Arthur I . Holleb, M D

In this article, the author provides a historical descrip- tion of the initiation of the Breast Cancer Detection Dem- onstration Project (BCDDP) and the subsequent develop- ment of screening guidelines for breast cancer by the American Cancer Society and other organizations. Cancer 1992; 69:1911-1912.

In the early 1970s Dr. Philip Strax visited me in the National Office of the American Cancer Society in New York and made a bold plea for a nationwide, free mam- mography breast cancer screening program, similar to what the American Cancer Society had done for cancer of the uterine cervix using the Pap test.

Based on the results of reduced mortality from breast cancer in the Health Insurance Plan (HIP) of Greater New York study of the 1960s the volunteers of the American Cancer Society agreed to provide funds for 12 Breast Cancer Detection Projects (BCDDP), three in each of the four administrative geographic areas of the American Cancer Society (east, south, midwest, and west). Each project would enroll 10,000 asymptomatic women 35 to 74 years of age for free annual screening that would include a clinical breast examination, the teaching of breast self-examination, bilateral thermogra- phy, and bilateral mammography. Each woman would then be followed for at least 5 years.

The purposes of the BCDDP were as follows: (1) to demonstrate whether hagnostic radiologists would be willing to participate in a large-scale project and share information; (2) to demonstrate whether women would voluntarily come in for screening and continue their annual examinations; (3) to demonstrate whether the volunteers of the American Cancer Society could help bring in enough women for screening and also serve each project to keep administrative costs as low as possi-

Presented at the American Cancer Society Workshop on Guide- lines and Screening for Breast Cancer, Pasadena, California, October

From the American Cancer Society, Larchmont, New York. Address for correspondence: Arthur I. Holleb, MD, Consultant,

Cancer Control, American Cancer Society, 3 Highridge Road, Larch- mont, NY 10538.

11-13, 1991.

Accepted for publication November 26, 1991.

ble; and (4) to demonstrate whether or not thermogra- phy and mammography could find very early breast cancer, a stage at which a high cure rate could be ex- pected in most cases.

As one can see, this was a “demonstration” project, not a ”controlled clinical trial.”

The HIP study showed an early benefit of screening in women beginning at 50 years of age, but the volun- teers of the American Cancer Society believed that the BCDDP should begin screening examinations at 35 years of age because more years of life might be saved.

Discussions were held with Dr. Frank J. Rauscher, at that time the Director of the National Cancer Insti- tute, and funds were made available to expand the total program from 12 to 27 demonstration projects examin- ing a total of 280,000 women. One project had 20,000 women enrolled rather than 10,000. The BCDDP was rapidly filled with women who were eager to partici- pate.

When the project entered its second year thermog- raphy was discontinued because it appeared unable to find cancer as early as mammography could.

Those were the halcyon days of the BCDDP. Then, suddenly, the critics descended on the Amen-

can Cancer Society and the National Cancer Institute. Critics generally fell into one or more of the following categories: (1) there was no proof that screening mam- mography had reduced mortality from breast cancer in women younger than 50 years of age; (2) mammogra- phy was finding breast ”cancers” that were really not cancer, or ”cancers” that would never become invasive; (3) unnecessary mastectomies were being performed; 4) the radiation exposure from mammography would pro- duce more breast cancers than mammography could find and, based on the concept of a linear dose-re- sponse relationship, there was no safe level of radiation exposure; (5) a good physical examination was better than a mammogram; and (6) the BCDDP was not a controlled clinical trial and should be stopped immedi- ately.

Consensus meetings were called at the National Cancer Institute and committees were appointed to re- view every minute facet of the BCDDP. The newspa-

1912 CANCER Supplement April 1, 2992, Volume 69, No. 7

pers produced devastating headlines. Television and radio stations carried confrontations between the sup- porters of breast cancer screening and the detractors.

As a matter of fact, one Chicago critic said on a nationwide morning television program that the Ameri- can Cancer Society had ”blood on its hands.”

I am sure that many of you recall those trying days. Credit must be given to the National Cancer Insti-

tute when it formed a Radiation Safety Medical Physics Committee. Tests of equipment resulted a reduction of radiation exposure during mammography. Radiation exposure is now at a level where even the most severe critic of mammography no longer expresses concern. Due credit must also be given to the persistence of diag- nostic radiologists, the manufacturers of mammogra- phy equipment, and changes in the film used for the examination.

When the turmoil began to subside and after the departure of some women from the BCDDP the proj- ects continued. The late Dr. Larry Baker provided the first report of 5-year end results of the BCDDP.’ Seid- man et a1.’ of the Epidemiology Department of the American Cancer Society added more detailed scientific evaluations. Dr. Robert Hutter served as Chairman of

the Society’s Cancer Prevention and Detection Com- mittee, and after many thorough and careful series of deliberations, developed the first set of guidelines that were the result of many expert opinion^.^ Dr. Gerald Dodd of the American College of Radiology held a num- ber of meetings with concerned organizations to try to achieve agreement and was eminently successful. Dr. Charles Smart of the National Cancer Institute also pursued a consensus among a variety of organizations and societies. Many others who are here today have contributed their talents and energies to the goal of bet- ter breast cancer control. Although concepts are not unanimously accepted there is remarkable agreement today compared with 20 years ago.

References

1. Baker LH. Breast Cancer Detection Demonstration Project: Five- year summary report. CA 1982; 32:194-225.

2. Seidman H, Gelb SK, Silverberg E et a/ . Survival experience in the Breast Cancer Detection Demonstration Project. CA 1987;

3. Mammography 1982: A statement of the American Cancer Soci- 37:258-290.

ety. CA 1982; 32:226-230.