Lung cancer mortality in the Mayo Lung Project: impact of extended follow-up.

BACKGROUND The Mayo Lung Project (MLP) was a randomized, controlled clinical trial of lung cancer screening that was conducted in 9211 male smokers between 1971 and 1983. The intervention arm was offered chest x-ray and sputum cytology every 4 months for 6 years; the usual-care arm was advised at trial entry to receive the same tests annually. No lung cancer mortality benefit was evident at the end of the study. We have extended follow-up through 1996. METHODS A National Death Index-PLUS search was used to assign vital status and date and cause of death for 6523 participants with unknown information. The median survival for lung cancer patients diagnosed before July 1, 1983, was calculated by use of Kaplan-Meier estimates. Survival curves were compared with the log-rank test. RESULTS The median follow-up time was 20.5 years. Lung cancer mortality was 4.4 (95% confidence interval [CI] = 3.9-4.9) deaths per 1000 person-years in the intervention arm and 3.9 (95% CI = 3.5-4.4) in the usual-care arm (two-sided P: for difference =.09). For participants diagnosed with lung cancer before July 1, 1983, survival was better in the intervention arm (two-sided P: =.0039). The median survival for patients with resected early-stage disease was 16.0 years in the intervention arm versus 5.0 years in the usual-care arm. CONCLUSIONS Extended follow-up of MLP participants did not reveal a lung cancer mortality reduction for the intervention arm. Similar mortality but better survival for individuals in the intervention arm indicates that some lesions with limited clinical relevance may have been identified in the intervention arm.

[1]  W F Taylor,et al.  Early lung cancer detection: results of the initial (prevalence) radiologic and cytologic screening in the Mayo Clinic study. , 2015, The American review of respiratory disease.

[2]  P. Prorok,et al.  Reanalysis of the Mayo Lung Project data: the impact of confounding and effect modification , 1999, Journal of medical screening.

[3]  G. Friedman,et al.  Screening in chronic disease , 2004, Cancer Causes & Control.

[4]  T. Visakorpi,et al.  Low biological aggressiveness of screen-detected lung cancers may indicate over-diagnosis. , 1996, International journal of cancer.

[5]  P. Prorok,et al.  Concepts and problems in the evaluation of screening programs. , 1981, Journal of chronic diseases.

[6]  B. Achinstein,et al.  Journal of the National Cancer Institute, Vol. 29, 1962: Action of bacterial polysaccharide on tumors. II. Damage of sarcoma 37 by serum of mice treated with Serratia marcescens polysaccharide, and induced tolerance. , 2009, Nutrition reviews.

[7]  D. Schoenfeld,et al.  Sample-size formula for the proportional-hazards regression model. , 1983, Biometrics.

[8]  H. Hansen,et al.  Lung cancer. , 1990, Cancer chemotherapy and biological response modifiers.

[9]  T. Visakorpi,et al.  Low biological aggressiveness of screen‐detected lung cancers may indicate over‐diagnosis , 1996 .

[10]  T. Naruke,et al.  Survival for clinical stage I lung cancer not surgically treated. Comparison between screen‐detected and symptom‐detected cases , 1992, Cancer.

[11]  V. Ernster,et al.  Increases in ductal carcinoma in situ (DCIS) of the breast in relation to mammography: a dilemma. , 1997, Journal of the National Cancer Institute. Monographs.

[12]  M Kimmel,et al.  Screening for lung cancer: The Mayo lung project revisited , 1993, Cancer.

[13]  J. Lawless Statistical Models and Methods for Lifetime Data , 2002 .

[14]  G. Rhoads The Epidemiologic Necropsy , 1987 .

[15]  P. Prorok,et al.  Issues in the mortality analysis of randomized controlled trials of cancer screening. , 1994, Controlled clinical trials.

[16]  E. Bergstralh,et al.  Screening for lung cancer. A critique of the mayo lung project , 1991, Cancer.

[17]  R. Fontana,et al.  Screening for Lung Cancer: A Progress Report on the Mayo Lung Project , 1981 .

[18]  C. Wells,et al.  The 'epidemiologic necropsy'. Unexpected detections, demographic selections, and changing rates of lung cancer. , 1987, JAMA.

[19]  O. Miettinen,et al.  Early Lung Cancer Action Project: overall design and findings from baseline screening , 1999, The Lancet.

[20]  Screening for lung cancer. , 2000, Chest surgery clinics of North America.

[21]  L. Ayvazian Lung Cancer: Current Status and Prospects for the Future , 1987 .

[22]  J. Mandel,et al.  Screening in Chronic Disease , 1985 .

[23]  A. Morrison,et al.  Basic issues in population screening for cancer. , 1980, Journal of the National Cancer Institute.

[24]  D. Wolpaw Early detection in lung cancer. Case finding and screening. , 1996, The Medical clinics of North America.

[25]  P. Prorok Epidemiologic Approach for Cancer Screening: Problems in Design and Analysis of Trials , 1992, The American journal of pediatric hematology/oncology.

[26]  G. Bepler,et al.  Screening for lung cancer. , 2000, The New England journal of medicine.

[27]  D. Sugarbaker,et al.  Screening for Lung Cancer: Another Look; A Different View , 1997 .

[28]  S. Ciatto,et al.  Overdiagnosis of prostate carcinoma by screening: an estimate based on the results of the Florence Screening Pilot Study. , 1998, Annals of oncology : official journal of the European Society for Medical Oncology.

[29]  W F Taylor,et al.  Lung cancer screening: the Mayo program. , 1986, Journal of occupational medicine. : official publication of the Industrial Medical Association.