Comparison of treatment effects measured by the hazard ratio and by the ratio of restricted mean survival times in oncology randomized controlled trials

Journal of Clinical Oncology

Volumn 34, Issue 15, 2016, Pages 1813-1819

  Trinquart, Ludovic ^a,b,c,d   Jacot, Justine ^a   Conner, Sarah C ^a   Porcher, Raphaël ^a,b  

^a HÔTEL DIEU   (France)

^b UNIVERSITÉ PARIS DESCARTES   (France)

^c ASSISTANCE PUBLIQUE HÔPITAUX DE PARIS   (France)

^d Cochrane France ^*  (France)

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; BREAST CANCER; DIGESTIVE SYSTEM CANCER; ENDOCRINE TUMOR; FEMALE GENITAL TRACT CANCER; HAZARD RATIO; HEAD AND NECK CANCER; HEMATOLOGIC MALIGNANCY; HUMAN; LUNG CANCER; NEUROENDOCRINE TUMOR; ONCOLOGY; OUTCOME ASSESSMENT; OVERALL SURVIVAL; PATIENT CODING; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL (TOPIC); RESTRICTED MEAN SURVIVAL TIME; SCIENTIFIC LITERATURE; SKIN CANCER; SURVIVAL TIME; SYSTEMATIC REVIEW; UROGENITAL TRACT CANCER; COMPARATIVE STUDY; MORTALITY; NEOPLASMS;

HUMANS; NEOPLASMS; RANDOMIZED CONTROLLED TRIALS AS TOPIC;

EID: 84969507001     PISSN: 0732183X     EISSN: 15277755     Source Type: Journal    
DOI: 10.1200/JCO.2015.64.2488     Document Type: Article

References (36)

1. Wilson MK, Collyar D, Chingos DT, et al: Outcomes and endpoints in cancer trials: Bridging the divide. Lancet Oncol 16:e43-e52, 2015
2. Wilson MK, Karakasis K, Oza AM: Outcomes and endpoints in trials of cancer treatment: The past, present, and future. Lancet Oncol 16:e32-e42, 2015
3. Blagoev KB, Wilkerson J, Fojo T: Hazard ratios in cancer clinical trials-a primer. Nat Rev Clin Oncol 9: 178-183, 2012
4. Case LD, Kimmick G, Paskett ED, et al: Interpreting measures of treatment effect in cancer clinical trials. Oncologist 7:181-187, 2002
5. Prentice RL, Pettinger M, Anderson GL: Statistical issues arising in the Women's Health Initiative. Biometrics 61:899-911, 2005; discussion 911-941
6. Hernán MA: The hazards of hazard ratios. Epidemiology 21:13-15, 2010
7. Irwin JO: The standard error of an estimate of expectation of life, with special reference to expectation of tumourless life in experiments with mice. J Hyg (Lond) 47:188-189, 1949
8. Karrison TG: Use of Irwin's restricted mean as an index for comparing survival in different treatment groups-interpretation and power considerations. Control Clin Trials 18:151-167, 1997
9. Royston P, Parmar MK: The use of restricted mean survival time to estimate the treatment effect in randomized clinical trialswhen the proportional hazards assumption is in doubt. Stat Med 30:2409-2421, 2011
10. Royston P, Parmar MK: Restricted mean survival time: An alternative to the hazard ratio for the design and analysis of randomized trials with a time-toevent outcome.BMCMedResMethodol 13:152, 2013
11. Uno H, Claggett B, Tian L, et al: Moving beyond the hazard ratio in quantifying the betweengroup difference in survival analysis. J Clin Oncol 32: 2380-2385, 2014
12. ISIWeb of Knowledge: 2013 journal citation reports science edition. http://admin-apps.webofknowledge.com/JCR/JCR
13. Guyot P, Ades AE, OuwensMJ, et al: Enhanced secondary analysis of survival data: Reconstructing the data from published Kaplan-Meier survival curves. BMC Med Res Methodol 12:9, 2012
14. Bormann I: DigitizeIt. http://www.digitizeit.de/
15. Grambsch PM, Therneau TM: Proportional hazards tests and diagnostics based on weighted residuals. Biometrika 81:515-526, 1994
16. Pepe MS, Fleming T: Weighted Kaplan-Meier statistics: A class of distance tests for censored survival data. Biometrics 45:497-507, 1989
17. Uno H: Vignette for survRM2 package: Comparing two survival curves using the restricted mean survival time. https://cran.r-project.org/web/packages/survRM2/vignettes/survRM2-vignette3-1.pdf
18. Efron B: Better bootstrap confidence intervals. J Am Stat Assoc 82:171-185, 1987
19. DerSimonian R, Laird N: Meta-analysis in clinical trials. Control Clin Trials 7:177-188, 1986
20. Higgins JP, Thompson SG: Quantifying heterogeneity in a meta-analysis. Stat Med 21:1539-1558, 2002
21. R Core Team: R: A Language and Environment for Statistical Computing. Vienna, Austria, R Foundation for Statistical Computing, 2014
22. Schnipper LE, Davidson NE, Wollins DS, et al; American Society of Clinical Oncology: American Society of Clinical Oncology statement: A conceptual framework to assess the value of cancer treatment options. J Clin Oncol 33:2563-2577, 2015
23. Buyx AM, Friedrich DR, Schöne-Seifert B: Ethics and effectiveness: Rationing healthcare by thresholds of minimum effectiveness. BMJ 342:d54, 2011
24. Struthers CA, Kalbfleisch JD: Misspecified proportional hazard models. Biometrika 73:363-369, 1986
25. Uno H, Wittes J, Fu H, et al: Alternatives to hazard ratios for comparing the efficacy or safety of therapies in noninferiority studies. Ann Intern Med 163:127-134, 2015
26. Zhao L, Tian L, Uno H, et al: Utilizing the integrated difference of two survival functions to quantify the treatment contrast for designing, monitoring, and analyzing a comparative clinical study. Clin Trials 9:570-577, 2012
27. Seruga B, Pond GR, Hertz PC, et al: Comparison of absolute benefits of anticancer therapies determined by snapshot and area methods. Ann Oncol 23:2977-2982, 2012
28. Seruga B, Hertz PC, Wang L, et al: Absolute benefits of medical therapies in phase III clinical trials for breast and colorectal cancer. Ann Oncol 21: 1411-1418, 2010
29. Cortés J, González JA, Campbell MJ, et al: A hazard ratio was estimated by a ratio of median survival times, but with considerable uncertainty. J Clin Epidemiol 67:1172-1177, 2014
30. Andersen PK, Hansen MG, Klein JP: Regression analysis of restricted mean survival time based on pseudo-observations. Lifetime Data Anal 10: 335-350, 2004
31. Tian L, Zhao L, Wei LJ: Predicting the restricted mean event time with the subject's baseline covariates in survival analysis. Biostatistics 15:222-233, 2014
32. Royston P, Parmar MK: Flexible parametric proportional-hazards and proportional-odds models for censored survival data, with application to prognostic modelling and estimation of treatment effects. Stat Med 21:2175-2197, 2002
33. Zhao L, Claggett B, Tian L, et al: On the restricted mean survival time curve in survival analysis. Biometrics 10.1111/biom.12384 [epub ahead of print on August 24, 2015]
34. Boutron I, Altman DG, Hopewell S, et al: Impact of spin in the abstracts of articles reporting results of randomized controlled trials in the field of cancer: The SPIIN randomized controlled trial. J Clin Oncol 32:4120-4126, 2014
35. Deeks J, Higgins J, Altman D: Analysing data and undertaking meta-analyses, in Higgins JPT, Green S (eds): Cochrane Handbook for Systematic Reviews of Interventions Version 5.1.0. http://handbook.cochrane.org/
36. Wei Y, Royston P, Tierney JF, et al: Metaanalysis of time-to-event outcomes from randomized trials using restricted mean survival time: Application to individual participant data. Stat Med 34:2881-2898, 2015