A small sample study of the STEPP approach to assessing treatment-covariate interactions in survival data

Statistics in Medicine

Volumn 28, Issue 8, 2009, Pages 1255-1268

  Bonetti, Marco ^a   Zahrieh, David ^b   Cole, Bernard F ^c   Gelber, Richard D ^b,d  

^a BOCCONI UNIVERSITY   (Italy)

^b DANA FARBER CANCER INSTITUTE   (United States)

^c University of Vermont   (United States)

^d HARVARD SCHOOL OF PUBLIC HEALTH   (United States)

Author keywords

Clinical trials; Permutation based inference; Survival analysis; Treatment covariate interaction

Indexed keywords

ARTICLE; COVARIANCE; POPULATION RESEARCH; SAMPLE SIZE; SIMULATION; STATISTICAL ANALYSIS; STATISTICAL DISTRIBUTION; STATISTICAL SIGNIFICANCE; SUBPOPULATION TREATMENT EFFECT PATTERN PLOT; SURVIVAL; THERAPY EFFECT; TREATMENT OUTCOME; CLINICAL TRIAL; HUMAN; METHODOLOGY; STATISTICAL MODEL;

CLINICAL TRIALS AS TOPIC; HUMANS; MODELS, STATISTICAL; SURVIVAL ANALYSIS; TREATMENT OUTCOME;

EID: 65649108011     PISSN: 02776715     EISSN: 10970258     Source Type: Journal    
DOI: 10.1002/sim.3524     Document Type: Article

References (11)

1. Bonetti M, Gelber RD. A graphical method to assess treatment-covariate interactions using the Cox model on subsets of the data. Statistics in Medicine 2000; 19:2595-2609.
2. Bonetti M, Gelber RD. Patterns of treatment effects in subsets of patients in clinical trials. Biostatistics 2004; 5(3):465-481.
3. Colleoni M, Li S, Gelber RD, Coates AS, Castiglione-Gertsch M, Price KN, Lindtner J, Rudenstam C-M, Crivellari D, Collins J, Pagani O, Simoncini E, Thürlimann B, Murray E, Forbes J, Eržen D, Holmberg SB, Veronesi A, Goldhirsch A for the International Breast Cancer Study Group. Timing of CMF chemotherapy in combination with tamoxifen in postmenopausal women with breast cancer: role of endocrine responsiveness of the tumor. Annals of Oncology 2005; 16:716-725.
4. Colleoni M, Litman HJ, Castiglione-Gertsch M, Sauerbrei W, Gelber RD, Bonetti M, Coates AS, Schumacher M, Bastert G, Rudenstam C-M, Schmoor C, Lindtner J, Collins J, Thürlimann B, Holmberg S, Crivellari D, Beyerle C, Neumann RLA, Goldhirsch A for the International Breast Cancer Study Group and the German Breast Cancer Study Group. Duration of adjuvant chemotherapy for breast cancer: a joint analysis of two randomised trials investigating 3 versus 6 courses of CMF (cyclophosphomide, methotrexate, and 5-fluorouracil). British Journal of Cancer 2002; 86:1705-1714.
5. Crivellari D, Price K, Gelber RD, Castiglione-Gertsch M, Rudenstam C-M, Lindtner J, Fey MF, Senn HJ, Coates AS, Collins J, Goldhirsch A for the IBCSG. Adjuvant endocrine therapy compared with no systemic therapy for elderly women with early breast cancer: 21-year results of International Breast Cancer Study Group trial iv. Journal of Clinical Oncology 2003; 21:4517-4523.
6. International Breast Cancer Study Group. Endocrine responsiveness and tailoring adjuvant therapy for postmenopausal lymph node negative breast cancer: a randomized trial. Journal of the National Cancer Institute 2002; 94:1054-1065.
7. International Breast Cancer Study Group. Adjuvant chemotherapy followed by goserelin versus either modality alone for premenopausal lymph node negative breast cancer: a randomized trial. Journal of the National Cancer Institute 2003; 95:1833-1846.
8. Potthoff RF, Peterson BL, George SL. Detecting treatment-by-centre interaction in multi-centre clinical trials. Statistics in Medicine 2001; 20:193-213.
9. Pesarin F. Multivariate Permutation Tests with Applications in Biostatistics. Wiley: Chichester, 2001.
10. Keaney KM, Wei LJ. Interim analyses based on median survival times. Biometrika 1994; 81:279-286.
11. Wang R, Lagakos SW, Ware JH, Hunter DJ, Drazen JM. Statistics in medicine - reporting of subgroup analyses in clinical trials. New England Journal of Medicine 2007; 357:2189-2194.