Surrogate endpoints for prostate cancer-specific mortality after radiotherapy and androgen suppression therapy in men with localised or locally advanced prostate cancer: An analysis of two randomised trials

The Lancet Oncology

Volumn 13, Issue 2, 2012, Pages 189-195

  D'Amico, Anthony V ^a   Chen, Ming Hui ^b   de Castro, Mario ^b,c   Loffredo, Marian ^a   Lamb, David S ^d   Steigler, Allison ^e   Kantoff, Philip W ^a   Denham, James W ^f  

^a BRIGHAM AND WOMEN S HOSPITAL   (United States)

^b UNIVERSITY OF CONNECTICUT   (United States)

^c UNIVERSITY OF SÃO PAULO   (Brazil)

^d UNIVERSITY OF OTAGO   (New Zealand)

^e UNIVERSITY OF NEWCASTLE   (Australia)

^f NEWCASTLE MATER HOSPITAL   (Australia)

Author keywords

[No Author keywords available]

Indexed keywords

ANTIANDROGEN; GONADORELIN AGONIST; PROSTATE SPECIFIC ANTIGEN;

ADVANCED CANCER; ANDROGEN THERAPY; ARTICLE; CANCER MORTALITY; CANCER RADIOTHERAPY; CANCER RECURRENCE; CANCER SURVIVAL; CLINICAL ASSESSMENT; COHORT ANALYSIS; CONTROLLED STUDY; DISEASE MARKER; HUMAN; INTERMETHOD COMPARISON; MAJOR CLINICAL STUDY; MALE; PRIORITY JOURNAL; PROGNOSIS; PROSTATE CANCER; RISK FACTOR; SYSTEMATIC REVIEW; TREATMENT DURATION; TREATMENT RESPONSE;

AGED; ANDROGEN ANTAGONISTS; ANDROGENS; ANTINEOPLASTIC AGENTS, HORMONAL; AUSTRALIA; BIOLOGICAL MARKERS; COMBINED MODALITY THERAPY; HUMANS; MALE; META-ANALYSIS AS TOPIC; PROGNOSIS; PROSTATE-SPECIFIC ANTIGEN; PROSTATIC NEOPLASMS; RANDOMIZED CONTROLLED TRIALS AS TOPIC; SURVIVAL ANALYSIS; UNITED STATES;

EID: 84856423930     PISSN: 14702045     EISSN: 14745488     Source Type: Journal    
DOI: 10.1016/S1470-2045(11)70295-9     Document Type: Article

References (26)

1. D'Amico AV, Chen M, Renshaw AA, Loffredo M, Kantoff PW Androgen suppression and radiation vs radiation alone for prostate cancer: a randomized trial. JAMA 2008, 299:289-295.
2. Denham JW, Steigler A, Lamb DS, et al. Short-term neoadjuvant androgen deprivation and radiotherapy for locally advanced prostate cancer: 10-year data from the TROG 96.01 randomised trial. Lancet Oncol 2011, 12:451-459.
3. D'Amico AV, Whittington R, Malkowicz SB, et al. Biochemical outcome after radical prostatectomy, external beam radiation therapy, or interstitial radiation therapy for clinically localized prostate cancer. JAMA 1998, 280:969-974.
4. Gleason DF Histologic grading and staging of prostatic carcinoma. Urologic pathology 1977, 171-187. Veterans Administration Cooperative Urological Research Group, Lea & Febiger, Philadelphia, PA. M. Tannenbaum (Ed.).
5. Beahrs OH, Henson DE, Hutter RVP American Joint Committee on Cancer: manual for staging cancer 1992, JP Lippincott, Philadelphia, PA. 4th edn.
6. Zelefsky MJ, Lyass O, Fuks Z, et al. Predictors of improved outcome for patients with localized prostate cancer treated with neoadjuvant androgen ablation therapy and three-dimensional conformal radiotherapy. J Clin Oncol 1998, 16:3380-3385.
7. Denham JW, Steigler A, Wilcox C, et al. Time to biochemical failure and prostate-specific antigen doubling time as surrogates for prostate cancer-specific mortality: evidence from the TROG 96.01 randomised controlled trial. Lancet Oncol 2008, 9:1058-1068.
8. D'Amico AV, Moul J, Carroll P, Sun L, Lubeck D, Chen M Surrogate marker for prostate cancer specific mortality following radical prostatectomy or radiation therapy. J Natl Cancer Inst 2003, 95:1376-1383.
9. Prentice RL Surrogate endpoints in clinical trials: definition and operational criteria. Stat Med 1989, 8:431-440.
10. Bolla M, de Reijke TM, van Tienhoven G, et al. Duration of androgen suppression in the treatment of prostate cancer. N Engl J Med 2009, 360:2516-2527.
11. Lamb DS, Denham JW, Joseph D, et al. A comparison of the prognostic value of early PSA test-based variables following external beam radiotherapy, with or without preceding androgen deprivation: analysis of data from the Trog96.01 randomized trial. Int J Radiat Oncol Biol Phys 2011, 79:385-391.
12. Benchikh El Fegoun A, Villers A, Moreau JL, Richaud P, Rebillard X, Beuzeboc P PSA and follow-up after treatment of prostate cancer. Prog Urol 2008, 18:137-144.
13. An introduction to categorical data analysis 2002, John Wiley & Sons, New York, NY. 2nd edn. A. Agresti (Ed.).
14. Nonparametric statistical methods 1999, 189-269. John Wiley & Sons, New York, NY. 2nd edn. M. Hollander, D.A. Wolfe (Eds.).
15. Fine JP, Gray RJ A proportional hazards model for the sub distribution of a competing risk. J Am Stat Assoc 1999, 94:496-509.
16. Li Z, Meredith MP, Hoseyni MS A method to assess the proportion of treatment effect explained by a surrogate endpoint. Stat Med 2001, 20:3175-3188.
17. Schemper M The relative importance of prognostic factors in studies of survival. Stat Med 1993, 12:2377-2382.
18. Gaynor JJ, Feuer EJ, Tan CC, et al. On the use of cause-specific failure and conditional failure probabilities: examples from clinical oncology data. J Am Stat Assoc 1993, 88:400-409.
19. Simultaneous inferences and other topics in regression analyses-1 in applied linear regression models 1983, 150-153. Irwin, Homewood, IL. J. Neter, W. Wassermann, M. Kutner (Eds.).
20. Payne H A summary of the STAMPEDE trial (assessed Aug 5, 2011). http://www.prostateuk.org/prostatenews/20080801_content2_trials_payne.pdf.
21. de Bono JS, Logothetis CJ, Molina A, et al. Abiraterone and increased survival in metastatic prostate cancer. N Engl J Med 2011, 364:1995-2005. for the COU-AA-301 Investigators.
22. Petrylak DP, Tangen CM, Hussain MH, et al. Docetaxel and estramustine compared with mitoxantrone and prednisone for advanced refractory prostate cancer. N Engl J Med 2004, 351:1513-1520.
23. Tannock IF, de Wit R, Berry WR, et al. Docetaxel plus prednisone or mitoxantrone plus prednisone for advanced prostate cancer. N Engl J Med 2004, 351:1502-1512. for the TAX 327 investigators.
24. Berger VW Does the Prentice criteria validate surrogate endpoints?. Stat Med 2004, 23:1571-1578.
25. Saylor PJ, Smith MR Metabolic complications of androgen deprivation therapy for prostate cancer. J Urol 2009, 181:1998-2006.
26. Dubray BM Does short term androgen depletion add to high dose radiotherapy (80 Gy) in localized intermediate-risk prostate cancer? Intermediary analysis of GETUG 14 randomized trial. Proc Am Soc Clin Oncol 2011, 29(suppl). abstr 4521.