Power of logrank test and Cox regression model in clinical trials with heterogeneous samples

Statistics in Medicine

Volumn 16, Issue 5, 1997, Pages 583-597

  Akazawa, Kouhei ^a   Nakamura, Tsuyoshi ^b   Palesch, Yuko ^c  

^a KYUSHU UNIVERSITY   (Japan)

^b NAGASAKI UNIVERSITY   (Japan)

^c MEDICAL UNIVERSITY OF SOUTH CAROLINA   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ADVANCED CANCER; ARTICLE; CANCER SURVIVAL; CLINICAL TRIAL; HUMAN; MAJOR CLINICAL STUDY; PROGNOSIS; REGRESSION ANALYSIS;

BIAS (EPIDEMIOLOGY); CLINICAL TRIALS; EFFECT MODIFIERS (EPIDEMIOLOGY); HUMANS; PROGNOSIS; PROPORTIONAL HAZARDS MODELS; REPRODUCIBILITY OF RESULTS; STOMACH NEOPLASMS; SURVIVAL ANALYSIS; TREATMENT OUTCOME;

EID: 0030937915     PISSN: 02776715     EISSN: None     Source Type: Journal    
DOI: 10.1002/(SICI)1097-0258(19970315)16:5<583::AID-SIM433>3.0.CO;2-Z     Document Type: Article

References (26)

1. Schumacher, M., Olshewski, M. and Schmoor, C. 'The impact of heterogeneity on the comparison of survival times', Statistics in Medicine, 6, 773-784 (1987).
2. Freedman, L. S. 'Tables of the number of patients required in clinical trials using the logrank test', Statistics in Medicine, 1, 121-130 (1982).
3. Schoenfeld, D. A. 'Sample-size formula for the proportional-hazards regression model', Biometrics, 39, 499-503 (1983).
4. Byar, D. 'Identification of prognostic factors', in Buyse, M. E., Staquet, M. J. and Sylvester, R. J. (eds), Cancer Clinical Trials - Methods and Practice, Oxford University Press, Oxford, 1984, pp. 423-443.
5. Altman, D. G. 'Comparability of randomized groups', The Statistician, 34, 125-136 (1985).
6. Senn, S. J. 'Covariate imbalance and random allocation in clinical trials', Statistics in Medicine, 8, 467-475 (1989).
7. Sather, H. N. 'The use of prognostic factors in clinical trials', Cancer, 58, 461-467 (1986).
8. Struthers, C. A. and Kalbfleisch, J. D. 'Misspecified proportional hazards model', Biometrika, 73, 363-369 (1986).
9. Moussa, M. A. 'Planning the size of survival time clinical trials with allowance for stratification', Statistics in Medicine, 7, 559-569 (1988).
10. Lagakos, S. W. and Schoenfeld, D. A. 'Properties of proportional-hazards score tests under misspecified regression models', Biometrics, 40, 1037-1048 (1984).
11. Lagakos, S. W. 'The loss in efficiency from misspecifying covariates in proportional hazards regression models', Biometrika, 75, 156-160 (1988).
12. Simon, R. 'Use of regression models: statistical aspects', in Buyse, M. E., Staquet, M. J. and Sylvester, R. J. (eds), Cancer Clinical Trials - Methods and Practice, Oxford University Press, Oxford, 1984, pp. 444-466.
13. Schmoor, C., Ulm, K. and Schumacher, M. 'Comparison of the Cox model and the regression tree procedure in analyzing a randomized clinical trial', Statistics in Medicine, 12, 2351-2366 (1993).
14. Cox, D. R. 'Regression models and life tables (with discussion)', Journal of the Royal Statistical Society, Series B, 34, 187-220 (1972).
15. Kalbfleisch, J. D. and Prentice, R. L. The Statistical Analysis of Failure Time Data, Wiley, New York, 1980.
16. Gail, M. H., Wieand, S. and Piantadosi, S. 'Biased estimates of treatment effects in randomized experiments with nonlinear regression and omitted covariates', Biometrika, 71, 431-444 (1984).
17. Chastang, C., Byar, D. and Piantadosi, S. 'A quantitative study of the bias in estimating the treatment effect caused by omitting a balanced covariate in survival models', Statistics in Medicine, 7, 1243-1255 (1988).
18. Inokuchi, K. (ed). Report of the Special Study Project 1 (in Japanese), Japanese Foundation for Multidisciplinary treatment of cancer, Tokyo, 1992, pp. 20-37.
19. Hattori, T., Nakajima, T., Nakazato, H., H., Tanabe, T., Kikuchi, K., Abe, O., Kondo, T., Taguchi, T., Komi, N., Sugimachi, K., Tominaga, S., Tsuru, S. and Inokuchi, K. 'Postoperative adjuvant immunochemotherapy with Mitomycin C, Tegafur, PSK and/or OK-432 for gastric cancer, with special reference to the change in stimulation index after gastrectomy', Japanese Journal of Surgery, 20, 127-136 (1990).
20. Japanese Research Society for Gastric Cancer. 'The general rules for the gastric cancer study in surgery and pathology', Japanese Journal of Surgery, 11, 127-139 (1981).
21. Hopkins, A. 'Survival analysis with covariates', in Dixon, W. J. (ed) BMDP Statistical Software Manual Vol. 2, University of California Press, Berkeley, 1990, pp. 769-806.
22. Nakamura, T. 'BMDP program for piecewise linear regression', Computer Methods and Programs in Biomedicine, 23, 53-55 (1986).
23. Nakazato, H., Koike, A., Saji, S., Ogawa, N. and Sakamoto, J. 'Efficacy of immunochemotherapy as adjuvant treatment after curative resection of gastric cancer', Lancet, 343, 1122-1126 (1994).
24. Uchida, A. and Hoshino, T. 'Patients with malignant disease, 1. Effect of immunotherapy with OK-432 on lymphocyte subpopulation and phytomitogen responsiveness in vitro', Cancer, 45, 476-483 (1980).
25. Maehara, Y., Moriguchi, S., Sakaguchi, Y., Emi, Y., Kohnoe, S., Tsujitani, S. and Sugimachi, K. 'Adjuvant chemotherapy enhances long-term survival of patients with advanced gastric cancer following curative resection', Journal of Surgical Oncology, 45, 169-172 (1990).
26. Cox, D. R. and Oakes, D. Analysis of Survival Data, Chapman and Hall, London, 1984.