Original Article

You have full text access to this OnlineOpen article

Hormone therapy adjuvant to external beam radiotherapy for locally advanced prostate carcinoma

A complication-adjusted number-needed-to-treat analysis

  1. Ashesh B. Jani M.D.,
  2. Johnny Kao M.D.,
  3. Samuel Hellman M.D.†,*

Article first published online: 20 OCT 2003

DOI: 10.1002/cncr.11804

Issue

Cancer

Cancer

Volume 98, Issue 11, pages 2351–2361, 1 December 2003

Additional Information

How to Cite

Jani, A. B., Kao, J. and Hellman, S. (2003), Hormone therapy adjuvant to external beam radiotherapy for locally advanced prostate carcinoma. Cancer, 98: 2351–2361. doi: 10.1002/cncr.11804

Author Information

  1. Department of Radiation and Cellular Oncology, University of Chicago, Chicago, Illinois

  1. †

    Fax: (773) 702-4347

*A.N. Pritzker Distinguished Service Professor, University of Chicago, Department of Radiation and Cellular Oncology, 5758 S. Maryland Ave., MC 9001, Chicago, IL 60637

Publication History

  1. Issue published online: 17 NOV 2003
  2. Article first published online: 20 OCT 2003
  3. Manuscript Accepted: 22 AUG 2003
  4. Manuscript Revised: 11 AUG 2003
  5. Manuscript Received: 10 JUN 2003

SEARCH

SEARCH BY CITATION

ARTICLE TOOLS

View Full Article (HTML) Get PDF (125K)

REFERENCES

  • 1
    Gronberg H. Prostate cancer epidemiology. Lancet. 2003; 361: 859–864.
  • 2
    Jani AB, Hellman S. Early prostate cancer: clinical decision-making. Lancet. 2003; 361: 1048–1053.
  • 3
    Huggins C. Endocrine-induced regression of cancers. Science. 1967; 156: 1050–1054.
  • 4
    Prostate Cancer Trialists' Collaborative Group. Maximum androgen blockade in advanced prostate cancer: an overview of 22 randomised trials with 3283 deaths in 5710 patients. Lancet. 1995; 346: 265–269.
  • 5
    Prostate Cancer Trialists' Collaborative Group. Maximum androgen blockade in advanced prostate cancer: an overview of the randomised trials. Lancet. 2000; 355: 1491–1498.
  • 6
    Klein EA, Kupelian PA, Dreicer R, et al. Locally advanced prostate cancer. Curr Treat Options Oncol. 2001; 2: 403–411.
  • 7
    Pilepich MV, Krall JM, Al-Sarraf M, et al. Androgen deprivation with radiation therapy compared with radiation therapy alone for locally advanced prostate carcinoma: a randomized comparative trial of the Radiation Therapy Oncology Group. Urology. 1995; 45: 616–623.
  • 8
    Laverdiere J, Gomez JL, Cusan L, et al. Beneficial effect of combination hormonal therapy administered prior and following external beam radiation therapy in localized prostate cancer. Int J Radiat Oncol Biol Phys. 1997; 37: 247–252.
  • 9
    Hanks GE, Lu JD, Machtay M, et al. RTOG Protocol 92-02: a Phase III trial of the use of long term total androgen suppression following neoadjuvant hormonal cytoreduction and radiotherapy in locally advanced carcinoma of the prostate. Int J Radiat Oncol Biol Phys. 2000; 48(3 Suppl ): 112.
  • 10
    Pilepich MV, Winter K, John MJ, et al. Phase III Radiation Therapy Oncology Group (RTOG) Trial 86-10 of androgen deprivation adjuvant to definitive radiotherapy in locally advanced carcinoma of the prostate. Int J Radiat Oncol Biol Phys. 2001; 50: 1243–1252.
  • 11
    Lawton CA, Winter K, Murray K, et al. Updated results of the Phase III Radiation Therapy Oncology Group (RTOG) Trial 85-31 evaluating the potential benefit of androgen suppression following standard radiation therapy for unfavorable prognosis carcinoma of the prostate. Int J Radiat Oncol Biol Phys. 2001; 49: 937–946.
  • 12
    Bolla M, Collette L, Blank L, et al. Long-term results with immediate androgen suppression and external irradiation in patients with locally advanced prostate cancer (an EORTC study): a Phase III randomised trial. Lancet. 2002; 360: 103–106.
  • 13
    The Medical Research Council Prostate Cancer Working Party Investigators Group. Immediate versus deferred treatment for advanced prostatic cancer: initial results of the Medical Research Council Trial. Br J Urol. 1997; 79: 235–246.
  • 14
    Fellows GJ, Clark PB, Beynon LL, et al. Treatment of advanced localized prostatic cancer by orchiectomy, radiotherapy, or combined treatment. Br J Urol. 1992; 70: 304–309.
  • 15
    Stege R. Potential side-effects of endocrine treatment of long duration in prostate cancer. Prostate Suppl. 2000; 10: 38–42.
    Direct Link:
  • 16
    Albertsen PC, Aaronson NK, Muller MJ, et al. Health-related quality of life among patients with metastatic prostate cancer. Urology. 1997; 49: 207–216.
  • 17
    da Silva FC, Reis E, Costa T, et al. Quality of life in patients with prostatic cancer: a feasibility study. Cancer. 1993; 71(3 Suppl ): 1138–1142.
    Direct Link:
  • 18
    Klotz L. Hormone therapy for patients with prostate carcinoma. Cancer. 2000; 88(12 Suppl ): 3009–3014.
    Direct Link:
  • 19
    Schroder FH. Endocrine treatment of prostate cancer—recent developments and the future. Part 1: maximal androgen blockade, early vs delayed endocrine treatment and side-effects. BJU Int. 1999; 83: 161–170.
    Direct Link:
  • 20
    Stone P, Hardy J, Huddart R, et al. Fatigue in patients with prostate cancer receiving hormone therapy. Eur J Cancer. 2000; 36: 1134–1141.
  • 21
    Kouriefs C, Georgiou M, Ravi R. Hot flushes and prostate cancer: pathogenesis and treatment. BJU Int. 2002; 89: 379–383.
    Direct Link:
  • 22
    Moinpour CM, Savage MJ, Troxel A, et al. Quality of life in advanced prostate cancer: results of a randomized therapeutic trial. J Natl Cancer Inst. 1998; 90: 1537–1544.
  • 23
    Samson DJ, Seidenfeld J, Schmitt B, et al. Systematic review and meta-analysis of monotherapy compared with combined androgen blockade for patients with advanced prostate carcinoma. Cancer. 2002; 95: 361–376.
    Direct Link:
  • 24
    Laupacis A, Sackett DL, Roberts RS. An assessment of clinically useful measures of the consequences of treatment. N Engl J Med. 1988; 318: 1728–1733.
  • 25
    Cook RJ, Sackett DL. The number needed to treat: a clinically useful measure of treatment effect. BMJ. 1995; 310: 452–454.
  • 26
    Cordell DL. Number needed to treat (NNT). Ann Emerg Med. 1999; 33: 433–436.
  • 27
    Labbe KA, Detsky AS, O'Rourke K. Meta-analysis in clinical research. Ann Intern Med. 1987; 107: 224–233.
  • 28
    Abdalla I, Basu A, Hellman S. An evidence-based analysis of the management of localized prostate cancer. Cancer J. 2002; 8: 40–46.
  • 29
    Jani AB, Basu A, Heimann R, Hellman S. Sentinel node versus axillary node dissection for early stage breast cancer: a comparison using a utility-adjusted NNT (number needed to treat) analysis. Cancer. 2003; 97: 359–366.
    Direct Link:
  • 30
    Jani AB, Myrianthopoulos L, Vijayakumar S. The number needed to treat (NNT) and its applications in radiation therapy. Cancer Invest. In press.
  • 31
    Shipley WU, Lu JD, Pilepich MV, et al. Effect of a short course of neoadjuvant hormonal therapy on the response to subsequent androgen suppression in prostate cancer patients with relapse after radiotherapy: a secondary analysis of the randomized protocol RTOG 86-10. Int J Radiat Oncol Biol Phys. 2002; 54: 1302–1310.
  • 32
    Cancer and Leukemia Group B. Phase II trial of androgen suppression for 6 months combined with external beam radiotherapy (EBRT) with a brachytherapy (BT) boost for patients with intermediate risk prostate cancer. (CALGB 99809). Available from URL: http://www.calgb.org [accessed 8 August 2003].
  • 33
    Riegelman R, Schroth WS. Adjusting the number needed to treat: incorporating adjustments for the utility and timing of benefits and harms. Med Decis Making. 1993; 13: 247–252.
  • 34
    Schulzer M, Mancini GB. ‘Unqualified success’ and ‘unmitigated failure’: number-needed-to-treat-related concepts for assessing treatment efficacy in the presence of treatment-induced adverse events. Int J Epidemiol. 1996; 25: 704–712.
  • 35
    GreeneFL, PageDL, FlemingID, et al., editors. Prostate. In: GreeneFL, PageDL, FlemingID, et al., editors. AJCC cancer staging manual, 6th edition. New York: Springer-Verlag, 2002: 309–316.
  • 36
    National Center for Biotechnology Information. PubMed [database online]. Available from URL: http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed [accessed 8 August 2003].
  • 37
    Lawton CA, Won M, Pilepich MV, et al. Long-term treatment sequelae following external beam irradiation for adenocarcinoma of the prostate: analysis of RTOG studies 7506 and 7706. Int J Radiat Oncol Biol Phys. 1991; 21: 935–939.
  • 38
    Pilepich MV, Asbell SO, Krall JM, et al. Correlation of radiotherapeutic parameters and treatment related morbidity analysis of RTOG Study 77-06. Int J Radiat Oncol Biol Phys. 1987; 13: 1007–1012.
  • 39
    Shipley WU, Zietman AL, Hanks GE, et al. Treatment related sequelae following external beam radiation for prostate cancer: a review with an update in patients with Stages T1 and T2 tumor. J Urol. 1994; 152: 1799–1805.
  • 40
    Whitmore WF. The natural history of prostate cancer. Cancer. 1973; 32: 1104–1112.
    Direct Link:
  • 41
    Borre M, Nerstrom B, Overgaard J. The natural history of prostate carcinoma based on a Danish population treated with no intent to cure. Cancer. 1997; 80: 917–928.
    Direct Link:
  • 42
    Sartor O. Endpoints in prostate cancer clinical trials. Urology. 2002; 60 (Suppl 3A): 101–108.
  • 43
    Pound CR, Partin AW, Eisenberger MA, et al. Natural history of progression after PSA elevation following radical prostatectomy. JAMA. 1999; 281: 1591–1597.
  • 44
    Horwitz EM, Vicini FA, Ziaja EL, et al. The correlation between the ASTRO Consensus Panel definition of biochemical failure and clinical outcome for patients with prostate cancer treated with external beam irradiation. Int J Radiat Oncol Biol Phys. 1998; 41: 267–272.
  • 45
    Zietman AL, Dallow KC, McManus PA, et al. Time to second prostate-specific antigen failure is a surrogate endpoint for prostate cancer death in a prospective trial of therapy for localized disease. Urology. 1996; 47: 236–239.
  • 46
    Grossfeld GD, Li YP, Lubeck DP, et al. Patterns of failure after primary local therapy for prostate cancer and rationale for secondary therapy. Urology. 2002; 60(3 Suppl 1 ): 57–62.
  • 47
    Thurman SA, Ramakrishna NR, DeWeese TL. Radiation therapy for the treatment of locally advanced and metastatic prostate cancer. Hematol Oncol Clin North Am. 2001; 15: 423–443.
  • 48
    Zelefsky MJ, Harrison A. Neoadjuvant androgen ablation prior to radiotherapy for prostate cancer: reducing the potential morbidity of therapy. Urology. 1997; 49(3A Suppl ): 38–45.
  • 49
    Yang FE, Chen GT, Ray P, et al. The potential for normal tissue dose reduction with neoadjuvant hormonal therapy in conformal treatment planning for Stage C prostate cancer. Int J Radiat Oncol Biol Phys. 1995; 33: 1009–1017.
  • 50
    Roach M III, DeSilvio M, Lawton C, et al. Phase III trial comparing whole-pelvic versus prostate-only radiotherapy and neoadjuvant versus adjuvant combined androgen suppression: Radiation Therapy Oncology Group 9413. J Clin Oncol. 2003; 21: 1904–1911.
  • 51
    D'Amico AV, Schultz D, Loffredo M, et al. Biochemical outcome following external beam radiation therapy with or without androgen suppression therapy for clinically localized prostate cancer. JAMA. 2000; 284: 1280–1283.
  • 52
    Jani AB, Basu A, Abdalla I, et al. The impact of hormone therapy when combined with external beam radiotherapy for early-stage, intermediate- or high-risk prostate cancer. Am J Clin Oncol. 2003; 26: 382–385.
  • 53
    Radiation Therapy Oncology Group. A Phase III trial of the study of endocrine therapy used as a cytoreductive and cytostatic agent prior to radiation therapy in good prognosis locally confined adenocarcinoma of the prostate. (RTOG 94-08 protocol). Available from URL: http://www.rtog.org [accessed 8 August 2003].
  • 54
    Sinclair JC, Cook RJ, Guyatt GH, et al. When should an effective treatment be used? Derivation of the threshold number needed to treat and the minimum event rate for treatment. J Clin Epidemiol. 2001; 54: 253–262.
  • 55
    Walter SD, Irwig L. Estimating the number needed to treat (NNT) index when the data are subject to error. Stat Med. 2001; 20: 893–906.
    Direct Link:
  • 56
    Wu LA, Kottke TE. Number needed to treat: caveat emptor. J Clin Epidemiol. 2001; 54: 111–116.
  • 57
    Scolieri MJ, Altman A, Resnick MI. Neoadjuvant hormonal ablative therapy before radical prostatectomy: a review. Is it indicated? J Urol. 2000; 164: 1465–1472.
  • 58
    Jani A, Vogelzang NJ. Re: Neoadjuvant hormonal ablative therapy before radical prostatectomy: a review. Is it indicated? J Urol. 2001; 166: 631–632.
  • 59
    Garnick MB, Fair WR. First international conference on neoadjuvant hormonal therapy of prostate cancer: overview consensus statement. Urology. 1997; 49(3A Suppl ): 1–4.
  • 60
    Messing EM, Manola J, Sarosdy M, et al. Immediate hormonal therapy compared with observation after radical prostatectomy and pelvic lymphadenectomy in men with node-positive prostate cancer. N Engl J Med. 1999; 341: 1781–1788.
  • 61
    Jani AB, Roeske JC, Rash C. Intensity modulated radiotherapy (IMRT) for prostate cancer. Clin Prostate Cancer. In press.
  • 62
    Feldstein ML. Quality-of-life-adjusted survival for comparing cancer treatments. A commentary on TWiST and Q-TWiST. Cancer. 1991; 67(3 Suppl ): 851–854.
    Direct Link:
View Full Article (HTML) Get PDF (125K)