Spiral CT Screens Raise Scientific, Economic Issues

WASHINGTON—The use of spiral CT scanning to screen for early lung cancers poses scientific, economic, and policy issues that the oncology community, advocacy groups, insurers, and government health agencies need to address quickly, an expert panel said at a day-long conference on reducing lung cancer mortality. The conference was sponsored by the Cancer Research Foundation of America and the Roy Castle Lung Cancer Foundation, Liverpool, England.

Interest in spiral CT scanning has exploded since a report last year that more than 80% of cancers found and staged in ELCAP, the Early Lung Cancer Action Program, were stage I.

“It’s routinely available now. You can’t walk more than six blocks in New York City and not find a radiologist who is prepared to do a spiral CT scan on you,” said John C. Ruckdeschel, MD, director and CEO, H. Lee Moffitt Cancer Center & Research Institute. “We have to fit into that reality quickly, take care of patients as they come in, get the criteria out for screening, and get guidelines published.”

Indeed, participants in the conference expressed urgent concerns that spiral CT scanning may be widely adopted before scientific studies are performed to show that it is truly valuable.

“Based on the numbers I have heard, more than 2,000 people a day are being screened right now, and that’s 10,000 a week,” Peggy McCarthy, of the Alliance for Lung Cancer Advocacy, Support & Education (ALCASE), said from the floor during the panel discussion.

Panelist Robert L. Comis, MD, director, Hahnemann University Clinical Trials Research Center, said that “you start to wonder how you are going to apply this information to 40 million former smokers. It’s a tremendous problem. It’s good that we had this meeting in Washington, because it’s the politicians and the people from the National Cancer Institute who have got to start thinking about these issues and their impact on society.”

Both Dr. Ruckdeschel and Donald S. Coffey, PhD, professor of urology, oncology, pharmacology and pathology, Johns Hopkins University, compared spiral CT screening today with the rapid, widespread acceptance of prostate-specific antigen (PSA) testing by community physicians, which has essentially precluded a large-scale, randomized test of PSA’s effectiveness.

Dr. Ruckdeschel, however, noted that not every effective medical advance has undergone full-scale clinical trials. “I’ve looked, but I can’t find a randomized clinical trial of penicillin,” he said. If spiral CT raised the detection rate of stage I lung cancer to 60%, he said, “that’s 80,000 people a year who have had their stage improved. You are not going to do any better in terms of changing this disease and making a truly substantial impact.”

Panel moderator James L. Mulshine, MD, head of NCI’s Intervention Section, noted that the mammography experience had shown that screening is not simply a test, “but a whole management process,” involving follow-up testing, biopsies, and the possibility of unnecessary biopsies. “It is important for those doing spiral CT scans to realize this,” he said.

Dr. Ruckdeschel agreed, but warned that community radiologists are not going to stop performing lung cancer screening to wait for guidelines or results of long-term trials. “I think it is foolish to say we can’t do anything until we have a 10-year randomized study.”

There was general agreement that a decade or more of clinical studies would not be feasible for spiral CT screening and a number of other techniques of the future that are likely to gain quick acceptance by patients and physicians.

“We need the finest science in the shortest amount of time so we can really have an impact on this awful disease,” said Martin Abeloff, MD, director, Johns Hopkins Oncology Center. “If we don’t scientifically get on top of this, we will lose opportunities to learn all that we need to know and fully understand the ramifications of screening.”

Said Robert A. Smith, PhD, director of cancer screening, American Cancer Society, “I think the days of the 15-year randomized trial have to be set behind us, unless there is no other way.” Nonetheless, he said, therapies and screening such as spiral CT scans must be validated. He suggested that more effort be put into developing and validating surrogate endpoints for use in clinical trials.

“Are there alternative ways to satisfy the policy questions in a way that everyone can collectively agree upon?” he asked. “Because if we don’t get organized, what we will have is a continuum of confidence, from some who are not confident until a full, standard trial is performed to another group that says, we’re confident and we’re offering this test.”

Dr. Smith agreed that it is vital to rapidly get in place an array of standards for lung cancer screening and follow-up, from training to resolving coverage issues. “It is one thing to say that screening can be shown to reduce mortality. It is another thing to say exactly how it should be done to ensure the greatest possible benefit with the fewest possible harms,” he said. “That is one of the very hard lessons we learned from mammography.”

Although the American Cancer Society does not now recommend lung cancer screening, “we say this is a reasonable decision that doctors and patients should make together,” Dr. Smith added.

Dr. Mulshine expressed concern about the ability of radiologists to do spiral CT screenings accurately in the absence of validated criteria for a positive scan.

A major issue remains how to get people into clinical studies rapidly. “Eighty-five percent of patients are unaware that this opportunity is available,” Dr. Comis said. “About 16% actually are aware, and, of those, a quarter participate.” Doctors drive participation, as a rule. “I think for something this important, one has to consider actually going out to the public and to primary care doctors to make them aware of these studies,” he said.

Dr. Comis noted that New Jersey and Maryland require insurers to pay the patient care costs of clinical trials, and that this might provide opportunities for rapidly implementing clinical trials of spiral CT screening. He was less sanguine about Medicare patients, despite President Clinton’s order to the Health Care Financing Administration (HCFA) that it pay the costs of routine patient care for those entering clinical trials.

“HCFA is really the big obstacle here,” Dr. Comis said. “We’ve made more progress with private insurers than anyone has made with HCFA.” Noting that several people in the room were involved in working out details of the payment plan with HCFA, he said that “without legislation on the federal level, HCFA probably will remain as recalcitrant as it has always been.”

Dr. Abeloff added, “The danger with the announcement from Medicare is that the world at large will think this has actually happened, and it really hasn’t. We’re in trouble because we are expected to get results for which there may not be the proper support. So I think the need for educating both the general public and physicians has to be one of the top priorities in this area.”

[Since these comments were made, HCFA has moved to implement the National Coverage Decision on clinical trials. It remains to be seen how effective this decision will be in providing the necessary coverage.]

A major factor in resolving the insurance issues will be whether spiral CT screening proves cost-effective. “At first blush, it appears to be so massively expensive that it can’t be cost-effective,” Dr. Comis said. “But it may be cost-effective if we can push the tumor size at diagnosis back to less than 1 cm.”