Statement of Claudia I. Henschke, M.D., Ph.D., Professor of Radiology,
Weill Medical College, Cornell University, New York, New York

Testimony Before the Subcommittee on Health
of the House Committee on Ways and Means

Hearing on Promoting Disease Management in Medicare

April 16, 2002

Each year, approximately 160,000 Americans die of lung cancer, that is more than 50 times the number of people who died in the attack of September 11, 2001.  The overall cure rate of lung cancer is dismal, somewhere around 10%.

About 85% of the lung cancers found by our 'usual' care are late-stage, and their cure is essentially zero.  None of the other major cancers (e.g., colon, breast and prostate) has such a poor outcome.

The prognosis of patients found with early stage lung cancer is much brighter.  It is well accepted that early stage (Stage I) non-small-cell lung cancer has a 5-year survival rate exceeding 70%.  Thus, the emphasis on early detection is compelling, with the probability of cure significantly increased.

Today's 'usual' care results in less than 15% of non-small-cell lung cancer being found in Stage I.  Chest x-ray screening alone resulted in less than 30% of cancers being found in this early stage.   Low-dose CT screening, on the other hand, finds about 80% in this early stage and this high percentage has been well documented by studies in the United States, Japan, and Europe (1-6). This diagnostic improvement of the CT is due to the many more detailed images it produces of the lungs (currently over 300/person) as compared to the single chest x-ray image.  The resulting dramatic shift in early stage cancers from 15% to over 80% suggests a concomitant improvement in the cure rate.  However, further follow-up is still needed of the currently on-going studies to confirm the exact amount of this improvement.

Analysis of Medicare cost data has shown that the cost associated with treatment of late stage lung cancer is at least twice the cost of treatment of early stage lung cancer.  Thus, there is also considerable financial incentive for early detection.  The charge of a low-dose screening CT scan currently set at $300 at our institution, although it may be as low as $200, although considerably more is charged in some settings.  The test is painless, the images are acquired in less than a single breath-hold, that is in less than 20 seconds and this equipment is already available in private practice offices, community hospitals as well as major medical centers throughout the country (7-9).  In my opinion, the most realistic scenario suggest that the cost is less than $3,000 per life-year saved, the worst-case is less than $40,000 per life-year saved.

Today, under 'usual' care, thoracic surgery is performed on many individuals with no cancer at all.  By following the recommended management plan for nodules either incidentally detected on chest x-ray or CT, many unnecessary biopsies and surgeries may be avoided by assessment of nodule growth on a subsequent CT scan one or several months later.  A rational lung cancer management plan of screening and standardized work-up in terms of actual nodule growth provides the benefit of early diagnosis and early treatment to over 80% of the individuals diagnosed with lung cancer as compared to that less than 15% as currently found and thus save lives now.

Current cost of care of the 170,000 annually diagnosed with lung cancer averages at least $50,000/case, totally more than $8.5 billion.  This does not include the work-up of many benign nodules, which often undergo surgery as well.  The majority of these dollars are spent on late-stage treatment, with a very poor outcome.

We are most concerned about the currently planned National Cancer Institute randomized trial (RCT) for assessment of CT screening for lung cancer.  It will be the most expensive screening trial ever planned (well over $300 million currently estimated) and it will take at least 10 years to complete.  It is, however, unlikely to provide an answer as it has the same design flaws that recently caused the firestorm about mammography screening (10).  Our published article pointed out fundamental flaws of the design and this article was widely endorsed (11-13).  Even the front-page article in the Los Angeles Times noted that our article in part caused the NCI to continue to endorse mammography.  It is simply not rational for NCI to embrace the design considerations when it comes to mammography yet ignore these same considerations when it comes to lung cancer.  It is an opportune time to intervene before the planned trial starts so as to avoid the misleading results that occurred with mammography.

However, despite numerous attempts for open discussion of the currently planned trial, or design alternatives that are less costly and more efficient, we have been ignored.  Such alternative designs allow for the assessment of the effectiveness of CT screening as part of the practice management plan; these designs provide the benefit of CT screening to all participants and allow for careful assessment of the improvement in the cure rate and associated costs. These alternative studies will yield more definitive answers in much less time than the traditional trial being contemplated.  It is also important to recognize that our group in New York has been doing lung cancer screening for over 10 years and we have found that the cost to perform the trial being contemplated by the NCI is at least 6 times the cost per patient as other alternatives.  In addition, it will take more than 10 years to have an answer, which will most likely be misleading.

We think this is a very important topic for the Committee and appreciate the opportunity to present.  A thoughtful approach to careful evaluation of the benefit and cost of CT screening now has the potential to save more lives than all of the treatments developed for cancer to date.  Such a benefit should not be delayed for years by a very expensive but probably inconclusive trial.  I suggest to this committee that the issue of cancer screening and how such screening is evaluated is the most important healthcare issue of our time.  With our rapidly changing technology, we need to make rapid and accurate decisions regarding the scientific application of these potential screening tests.  The prevailing methodology has overwhelming design flaws and an open scientific debate is essential.  Just looking at the confusion we have in regards to mammography where there have been no fewer than 7 large trials involving more than 500,000 women over 30 years makes this point abundantly clear.
 

References

1. Henschke CI, McCauley DI, Yankelevitz DF, Naidich DP, McGuinness G, Miettinen OS,  Libby D, Pasmantier M, Koizumi J, Altorki N, Smith JP.  Early Lung Cancer Action Project: Overall Design and Findings From Baseline Screening. The Lancet 1999; 354:99-105

2. Henschke CI, Naidich DP, Yankelevitz DF, McGuinness G, McCauley DI, Smith JP, Libby D, Pasmantier M, Koizumi J, Flieder D, Vazquez M, Altorki N, Miettinen OS.  Early Lung Cancer Action Project: Initial results of annual repeat screening. Cancer 2001;92:153-159

3. Kaneko M, Eguchi K, Ohmatsu H, Kakinuma R, Naruke T, Suemasu K, Moriyama N. Peripheral Lung Cancer: Screening and detection with low-dose spiral CT versus radiography. Radiology 1996;201:798-802

4. Sone S, Takahima S, Li F, Yang Z, et al. Mass screening for lung cancer with mobile spiral computed tomography scanner. Lancet 1998;351:1242-5

5. Sone S, Li F, Yang Z-G et al. Results of three-year mass screening programme for lung cancer using mobile low-dose spiral computed tomography scanner. British Journal of Cancer 2001;84:25-32

6. International Collaboration to Screen for Lung Cancer. Proceedings of the First, Second, Third, Fourth and Fifth International Conference on Screening for Lung Cancer.  New York, NY (Website: http://ICScreen.med.cornell.edu.)

7. Miettinen OS.  Screening for lung cancer: Can it be cost-effective?  Canadian Medical Association Journal. 2000;162:1431-6

8. Marshall D, Simpson KN, Earle CC, Chu CW. Economic decision analysis model of screening for lung cancer. European Journal of Cancer 2001;37:1759-67

9. Wisnivesky JP, Mushlin A, Kimmel M, Sicherman N, Henschke CI. Cost-effectiveness of baseline low-dose CT screening for lung cancer. Chest 2002. Accepted

10. Kimmel M, Gorlova OY, Henschke C. Randomized controlled trials for CT screening for lung cancer: The impact of protocol nonadherence. Submitted

11. Miettinen OS, Henschke CI, Pasmantier MW, Smith JP, Libby DM, Yankelevitz DF.  Mammographic screening: No reliable supporting evidence? Lancet 2002;359:404-5

12. Miettinen OS, Henschke CI, Pasmantier MW, Smith JP, Libby DM, Yankelevitz DF.  Mammographic screening: No reliable supporting evidence? www.Lancet.com Feb 2, 2002

13. Miettinen OS, Henschke CI. "Method appears appealing" but "analysis is flawed"! Lancet 2002;309:70613.ab