The National Cancer Advisory Board last week recommended that NCI advise women between ages of 40 and 49 to have screening mammograms every one to two years if they are at average risk for breast cancer.

Women who are at higher than average risk for breast cancer should seek medical advice about beginning mammography before age 40 and about the screening frequency when they are in their forties, the NCAB said. For women over 50, NCI should recommend mammograms every one to two years, the board said.

The NCAB said women at “higher risk” include those who:

  • had breast cancer or have been diagnosed with breast disease that may predispose to cancer;
  • had two or more breast biopsies for benign disease;
  • carry identified genetic alterations that may make them more susceptible to breast cancer;
  • have multiple family members affected with breast cancer;
  • have 75 percent or more dense breast tissue on previous mammograms that made mammography reading difficult;
  • had a first birth after the age of 30.

Women without these risk factors are considered at average risk, the board said. Health insurers should pay for mammography for higher risk women at any age, and for all women beginning at 40, the board said.

“The board concluded that there is enough evidence to support a woman’s decision to begin screening in her forties,” said NCAB Chairman Barbara Rimer, director of cancer prevention, detection and control research, Duke Comprehensive Cancer Center.

NCI Director Richard Klausner accepted the NCAB recommendations March 27. “We hope that these new recommendations will help clarify what has been a confusing issue for women in their forties,” Klausner said. The new recommendation replaces a 1993 NCI statement.

To demonstrate consensus on what has been a divisive issue, NCI and the American Cancer Society released a joint statement saying the two organizations agreed that screening women in their forties is “beneficial and supportable with current scientific evidence.”

“Both organizations recognize the importance of basing their guidance on currently available scientific evidence that shows a benefit of screening with mammography for women in their 40s,” the statement said.

NCI and ACS said they would work together “to provide clear guidance to women concerning the risk of developing breast cancer and the value and limitations of screening mammography.”

Clinton: “Clear, Consistent Guidance”

In a White House press briefing following the NCAB announcement, President Clinton praised the recommendations and commended Rimer, Klausner, and the board for their work.

“These recommendations, based on the latest and best medical evidence, give clear, consistent guidance to women in our national fight against breast cancer,” Clinton said. “Breast cancer is the most commonly diagnosed cancer among women. It affects one in eight women in their lifetimes, and has touched the families of nearly every American, including my own.”

Clinton said the Administration would take action to bring Medicare, Medicaid and federal employee health plans in line with the new recommendations:

  • The Administration’s proposed budget for Medicare would include funds to cover annual screening mammography beginning at age 40 for Medicare recipients.
  • HHS Secretary Donna Shalala will send a letter to state Medicaid directors urging them to cover annual mammograms beginning at 40. The federal government would pay matching funds if states cover the exam.
  • Clinton directed the Office of Personnel Management to require all federal health benefit plans to comply with the NCAB recommendation, beginning next year.
  • The Administration will launch “a major public education campaign to make sure every woman and every health care professional in America” is aware of the new recommendations, Clinton said.

“One of the biggest fears that women have about breast cancer is the fear of not knowing what to do or when to do it,” Shalala said at the White House briefing. “But today, years of confusion have been replaced by a clear, consistent scientific recommendation for women between the ages of 40 and 49.

“We can now tell all women over 40: Talk to your doctor because regular mammography can save your life,” Shalala said.

“All of us should be very proud of the fact that mortality rates for breast cancer are falling, not nearly enough, but they are finally going down in this country—and all of us should be proud that with this announcement today, we have replaced confusion with clarity, and moved another step closer to the day when our grandchildren will have to turn to the history books to learn about a disease called breast cancer,” Shalala said.

Members of Congress also praised the NCAB statement for providing specific recommendations.

“This recommendation clears confusion and gives women confidence that early detection saves lives, and that the benefits of mammography outweigh the risks,” Sen. Connie Mack (R-FL) said in a statement.

“The United States’ premier cancer research institute finally is clarifying its message, and this will save the lives of thousands of women in our country,” said Sen. Kay Bailey Hutchison (R-TX).

Sen. Arlen Specter (R-PA), who had held four hearings of the Senate Labor, HHS and Education Appropriations Subcommittee on the screening controversy, praised the recommendations, but said it took too long.

Specter held hearings in Washington, Philadelphia, Pittsburgh and Hershey, PA, following the release of the NIH consensus panel report last January.

Specter criticized the report and pressured NCI to make recommendations quickly.

“I am pleased that the record is now corrected that mammograms are warranted for women in their forties,” Specter said in a statement. “I’m still perplexed about why it took so long to set the record straight.

“The Appropriations Subcommittee will be inquiring about this delay at a future hearing,” he said.

Agreement As Well As Uncertainty

The NCAB’s ability to reach agreement shows that a consensus is emerging about mammographic screening, Rimer said. “When we talk about the benefit, the NIH consensus conference, the ACS statement and our statement are all within two percentage points in talking about the reduction in mortality,” she said. “There is a great deal of agreement here.

“We hope women will talk to their doctors and come up with a schedule that best fits their needs,” Rimer said.

By combining data from seven randomized trials, there is a 17 percent reduction in breast cancer mortality for women 40-49 invited for screening, the NCAB said in a three-page statement.

“To many, but not all experts, this is statistically significant,” the NCAB statement said. “This level of mortality reduction appears impressive, but is actually difficult to detect with a high level of certainty because the seven mammography studies different with regard to study design and implementation, age composition of participants and other factors.

“The currently observed beneficial effect of mammography might increase, decrease or disappear over time,” the statement said. “There may be unexpected late beneficial or harmful effects of screening mammography that cannot be detected presently.”

Rimer said the board’s statement about uncertainty was an important point in the document.

“The reason the mammography issue has been so difficult to resolve is because the data are so complex and the evidence is not transparent,” Rimer said. “Well-trained, well-intentioned scientists have come to different conclusions because they hold different standards of evidence.

“As the recommendations read, we caution that although we accept that there is about a 17 percent reduction in mortality, that difference is hard to detect with a high level of certainty,” Rimer said. “Like it or not, this uncertainty is a fact of life.”

Rimer said that after the NCAB meeting last February, she was not sure the board to reach a consensus. That is why she said at the time that the board would limit its recommendations to educational materials about screening (The Cancer Letter, Feb. 28).

“I admit that at that time I was extremely cautious and conservative, having watched the impact of this issue on groups of people in the past,” Rimer said. “I did not want to promise something that we could not deliver.

“I was convinced that the least we could do was come up with a set of educational recommendations,” Rimer said. “I wasn’t sure if people could put aside their own perspectives enough to come up with a unified statement.”

17-1 In Favor Of Statement

The NCAB made its recommendations after a subcommittee of the board developed a proposed statement. After suggesting some changes, the board voted, on a mail ballot, 17-1 in favor of the statement.

The dissenting vote was cast by Kay Dickersin, associate professor of epidemiology and preventive medicine, University of Maryland School of Medicine, and co-chairman of the Research Task Force of the National Breast Cancer Coalition.

Dickersin could not be reached for comment.

Rimer said her comments about the uncertainty of the data were made in part to convey Dickersin’s viewpoint. “Different people look at the evidence and come to different conclusions,” Rimer said. “Dr. Dickersin is an excellent epidemiologist and breast cancer survivor herself who looked at the evidence and felt that the evidence did not justify a recommendation for women in their forties.”

Recommendations Replace 1993 Statement

The NCAB recommendations replace the Institute’s 1993 “Summary of Scientific Fact” that said randomized clinical trials of screening mammograms had not shown a statistically significant reduction in breast cancer mortality for women under age 50, Klausner said.

The 1993 statement had replaced a 1988 guideline developed in conjunction with ACS and other health organizations that recommended screening every one to two years for women in their forties and fifties.

“Since that time, more evidence from clinical trials accrued, leading us at NCI about a year ago to begin a process to re-evaluate our recommendations,” Klausner said at a press conference last week.

The NIH Consensus Development Conference on Breast Cancer Screening for Women 40-49, held last January at NCI’s request, provided a public forum for the presentation of the new data, Klausner said.

The consensus panel concluded the evidence was insufficient to make a recommendation for all women in their forties to receive mammographic screening. Two panel members disagreed with the majority, and in a minority opinion, said evidence supported the recommendation that women in their forties should get regular screening (The Cancer Letter, March 28).

The implication that NCI sought the NCAB recommendations after failing to get a positive endorsement for screening from the consensus panel is not true, Klausner said. NCI had asked the NCAB last year to use the consensus panel’s review of the data to make recommendations to the Institute, he said.

“We decided at that time that the Presidentially-appointed NCAB, representing the wide constituency of the NCI, propose recommendations for the Institute on this important issue,” Klausner said. “We used [the consensus conference] process both for the [consensus panel’s] report and to bring together experts in all different aspects of mammography to present updated data, in order to allow the NCAB to provide the advice and recommendations from this Institution.

“We never intended that [the consensus panel’s] recommendations would automatically [represent NCI],” Klausner said.

Klausner said it is appropriate for NCI to make recommendations about oncology issues.

“We are being asked to make a recommendation based upon the evidence, as we are asked to recommend about many things—treatment strategies, interventions,” Klausner said. “We are asked to make a recommendation to be used by women and physicians to make decisions. In the end, it’s their decision.”

Rimer said the NCAB statement is a “recommendation” rather than a “guideline,” because the board wanted to encourage women, with the help of their physicians, to determine their personal risk for developing breast cancer and take an individualized approach to screening.

“We are making a recommendation about the screening interval,” Rimer said. “We expect women can come to their own conclusions. They have been doing that all along.

“Mammography hasn’t stopped because organizations have been giving different messages about this,” Rimer said.

The recommendations may change as new data emerge, Rimer said.

“The recommendations we have made are not brought forth as tablets etched in stone, but are dynamic, living and evolving,” she said. “As the science base continues to grow and evolve, NCI will share new information and adjust the advice when appropriate.”

Proposed Database, Data Monitoring Board

The NCAB also recommended that NCI take the following actions:

  • Develop, in partnership with other professional and advocacy organizations, innovative methods of educating women, physicians and other providers regarding the benefits and limitations of mammography as well as the risk factors for breast cancer.
  • Create a uniform database that will encourage all investigators conducting large-scale randomized screening studies for women ages 40-49 to provide primary data from combined analyses.
  • Convene an independent Mammography Data Monitoring Board to review on an ongoing basis the data from randomized mammography trials and to report regularly to the NCAB and the public on the progress of the trials.

The NCAB statement is available via Internet though at http://cancernet.nci.nih.gov, or by phone from the Cancer Information Service, 800/4-CANCER. Document lists are available by fax by calling 301-402-5874 from a fax machine, or by email to cancernet@icicc.nci.nih.gov with the word “help” in the body of the message.