WASHINGTONThe 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.
Its routinely available now. You cant 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 thats 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.
Its a tremendous problem. Its good that we had this
meeting in Washington, because its 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 PSAs effectiveness.
Dr. Ruckdeschel, however, noted that not every effective medical
advance has undergone full-scale clinical trials. Ive
looked, but I cant 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, thats 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
Panel moderator James L. Mulshine, MD, head of NCIs
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 cant do anything until we have a 10-year
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
dont 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 dont 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,
were confident and were 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,
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 Clintons 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.
Weve 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 hasnt. Were 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 cant 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.