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Meta-Analysis
. 2006 Oct 18;2006(4):CD006019.
doi: 10.1002/14651858.CD006019.pub2.

Neo-adjuvant and adjuvant hormone therapy for localised and locally advanced prostate cancer

S Kumar  1 , M Shelley, C Harrison, B Coles, T J Wilt, M D Mason
Affiliations
Meta-Analysis

Neo-adjuvant and adjuvant hormone therapy for localised and locally advanced prostate cancer

S Kumar et al. Cochrane Database Syst Rev. .

Abstract

Background: Hormone therapy for early prostate cancer has demonstrated an improvement in clinical and pathological variables, but not always an improvement in overall survival. We performed a systematic review of both adjuvant and neo-adjuvant hormone therapy combined with surgery or radiotherapy in localised or locally advanced prostate cancer.

Objectives: The objective of this review was to undertake a systematic review and, if possible, a meta-analysis of neo-adjuvant and adjuvant hormone therapy in localised or locally advanced prostate cancer.

Search strategy: We searched MEDLINE (1966-2006), EMBASE, The Cochrane Library, Science Citation Index, LILACS, and SIGLE for relevant randomised trials. Handsearching of appropriate publications was also undertaken.

Selection criteria: Randomised or quasi-randomised controlled trials of patients with localised or locally advanced prostate cancer, that is, stages T1-T4, any N, M0, comparing neo-adjuvant or adjuvant hormonal deprivation in combination with primary therapy (radical radiotherapy or radical prostatectomy) versus primary therapy alone were included in this review.

Data collection and analysis: Data were extracted from eligible studies and assessed for quality, and included information on study design, participants, interventions, and outcomes. Comparable data were pooled together for meta-analysis with intention-to treat principle.

Main results: Men with prostate cancer have different clinical outcomes based on their risk (T1-T2, T3-T4, PSA levels and Gleason score). However, the majority of studies included in this review did not report results by risk groups; therefore, it was not possible to perform sub-group analysis. Neo-adjuvant hormonal therapy prior to prostatectomy did not improve overall survival (OR 1.11, 95% CI 0.67 to 1.85, P = 0.69). However, there was a significant reduction in the positive surgical margin rate (OR 0.34, 95% CI 0.27 to 0.42, P < 0.00001) and a significant improvement in other pathological variables such as lymph node involvement, pathological staging and organ confined rates. There was a borderline significant reduction of disease recurrence rates (OR 0.74, 95% CI 0.55 to 1.0, P = 0.05), in favour of treatment. The use of longer duration of neo-adjuvant hormones, that is either 6 or 8 months prior to prostatectomy, was associated with a significant reduction in positive surgical margins (OR 0.56, 95% CI 0.39 to 0.80, P = 0.002). In one study, neo-adjuvant hormones prior to radiotherapy significantly improved overall survival for Gleason 2 to 6 patients; although, in two studies, there was no improvement in disease-specific survival (OR 0.99, 95% CI 0.75 to 1.32, P = 0.97). However, there was a significant improvement in both clinical disease-free survival (OR 1.86, 95% CI 1.93 to 2.40, P < 0.00001) and biochemical disease-free survival (OR 1.93, 95% CI 1.45 to 2.56, P < 0.00001). Adjuvant androgen deprivation following prostatectomy did not significantly improve overall survival at 5 years (OR 1.50, 95% CI 0.79 to 2.85, P = 0.2); although one study reported a significant disease-specific survival advantage with adjuvant therapy (P = 0.001). In addition, there was a significant improvement in disease-free survival at both 5 years (OR 3.73, 95%CI 2.30 to 6.03, P < 0.00001) and 10 years (OR 2.06, 95% CI 1.34 to 3.15, P = 0.0009). Adjuvant therapy following radiotherapy resulted in a significant overall survival gain apparent at 5 (OR 1.46, 95% CI 1.17 to 1.83, P = 0.0009) and 10 years (OR 1.44, 95% CI 1.13 to 1.84, P = 0.003); although there was significant heterogeneity (P = 0.09 and P = 0.07, respectively). There was also a significant improvement in disease-specific survival (OR 2.10, 95% CI 1.53 to 2.88, P = 0.00001) and disease-free survival (OR 2.53, 95% CI 2.05 to 3.12, P < 0.00001) at 5 years.

Authors' conclusions: Hormone therapy combined with either prostatectomy or radiotherapy is associated with significant clinical benefits in patients with local or locally advanced prostate cancer. Significant local control may be achieved when given prior to prostatectomy or radiotherapy, which may improve patient's quality of life. When given adjuvant to these primary therapies, hormone therapy, not only provides a method for local control, but there is also evidence for a significant survival advantage. However, hormone therapy is associated with significant side effects, such as hot flushes and gynaecomastia, as well as cost implications. The decision to use hormone therapy should, therefore, be taken at a local level, between the patient, clinician and policy maker, taking into account the clinical benefits, toxicity and cost. More research is needed to guide the choice, the duration, and the schedule of hormonal deprivation therapy, and the impact of long-term hormone therapy with regard to toxicity and the patient's quality of life.

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Conflict of interest statement

None.

Figures

1.1
1.1. Analysis
Comparison 1 Neo‐adjuvant hormone therapy and Prostatectomy Versus Prostatectomy alone, Outcome 1 Overall survival.
1.2
1.2. Analysis
Comparison 1 Neo‐adjuvant hormone therapy and Prostatectomy Versus Prostatectomy alone, Outcome 2 Disease‐free survival at 5 years (intention‐to‐treat analysis).
1.3
1.3. Analysis
Comparison 1 Neo‐adjuvant hormone therapy and Prostatectomy Versus Prostatectomy alone, Outcome 3 pT Staging: Organ Confined (Intention‐to‐treat Analysis).
1.4
1.4. Analysis
Comparison 1 Neo‐adjuvant hormone therapy and Prostatectomy Versus Prostatectomy alone, Outcome 4 pT Staging: Organ Confined (Case Analysis).
1.5
1.5. Analysis
Comparison 1 Neo‐adjuvant hormone therapy and Prostatectomy Versus Prostatectomy alone, Outcome 5 pT Staging: Downstaging (Intention‐to‐treat Analysis).
1.6
1.6. Analysis
Comparison 1 Neo‐adjuvant hormone therapy and Prostatectomy Versus Prostatectomy alone, Outcome 6 pT Staging: Downstaging (Case Analysis).
1.7
1.7. Analysis
Comparison 1 Neo‐adjuvant hormone therapy and Prostatectomy Versus Prostatectomy alone, Outcome 7 Positive Surgical Margin Status (Intention‐to‐treat Analysis).
1.8
1.8. Analysis
Comparison 1 Neo‐adjuvant hormone therapy and Prostatectomy Versus Prostatectomy alone, Outcome 8 Positive Surgical Margin Status (Case Analysis).
1.9
1.9. Analysis
Comparison 1 Neo‐adjuvant hormone therapy and Prostatectomy Versus Prostatectomy alone, Outcome 9 Seminal Vesicle Invasion Rate (Intention‐to‐treat Analysis).
1.10
1.10. Analysis
Comparison 1 Neo‐adjuvant hormone therapy and Prostatectomy Versus Prostatectomy alone, Outcome 10 Seminal Vesicle Invasion Rate (Case Analysis).
1.11
1.11. Analysis
Comparison 1 Neo‐adjuvant hormone therapy and Prostatectomy Versus Prostatectomy alone, Outcome 11 Positive Lymph Nodes (Intention‐to‐treat Analysis).
1.12
1.12. Analysis
Comparison 1 Neo‐adjuvant hormone therapy and Prostatectomy Versus Prostatectomy alone, Outcome 12 Positive Lymph Nodes (Case Analysis).
2.1
2.1. Analysis
Comparison 2 Short‐term versus Long‐term Neo‐adjuvant hormone therapy and prostatectomy, Outcome 1 Positive Surgical Margin Status (Case analysis only).
2.2
2.2. Analysis
Comparison 2 Short‐term versus Long‐term Neo‐adjuvant hormone therapy and prostatectomy, Outcome 2 pT Staging: Organ confined (Case analysis only).
3.1
3.1. Analysis
Comparison 3 Neo‐adjuvant hormone therapy and Radiotherapy Versus Radiotherapy alone, Outcome 1 Disease‐specific survival.
3.2
3.2. Analysis
Comparison 3 Neo‐adjuvant hormone therapy and Radiotherapy Versus Radiotherapy alone, Outcome 2 Biochemical disease‐free survival.
3.3
3.3. Analysis
Comparison 3 Neo‐adjuvant hormone therapy and Radiotherapy Versus Radiotherapy alone, Outcome 3 Clinical disease‐free survival.
4.1
4.1. Analysis
Comparison 4 Short‐term versus long‐term neo‐adjuvant hormone therapy Radiotherapy, Outcome 1 3 year biochemical disease‐free survival.
4.2
4.2. Analysis
Comparison 4 Short‐term versus long‐term neo‐adjuvant hormone therapy Radiotherapy, Outcome 2 5‐year biochemical disease free survival.
5.1
5.1. Analysis
Comparison 5 Adjuvant hormone therapy and Prostatectomy Versus Prostatectomy Alone, Outcome 1 Overall Survival: 5 Years.
5.2
5.2. Analysis
Comparison 5 Adjuvant hormone therapy and Prostatectomy Versus Prostatectomy Alone, Outcome 2 Overall Survival: 10 Years.
5.3
5.3. Analysis
Comparison 5 Adjuvant hormone therapy and Prostatectomy Versus Prostatectomy Alone, Outcome 3 Disease‐Free Survival: 5 Years.
5.4
5.4. Analysis
Comparison 5 Adjuvant hormone therapy and Prostatectomy Versus Prostatectomy Alone, Outcome 4 Disease‐Free Survival: 10 Years.
6.1
6.1. Analysis
Comparison 6 Adjuvant hormone therapy and Radiotherapy Versus Radiotherapy alone, Outcome 1 Overall Survival: 5 Years.
6.2
6.2. Analysis
Comparison 6 Adjuvant hormone therapy and Radiotherapy Versus Radiotherapy alone, Outcome 2 Overall Survival: 10 Years.
6.3
6.3. Analysis
Comparison 6 Adjuvant hormone therapy and Radiotherapy Versus Radiotherapy alone, Outcome 3 Disease‐Specific Survival: 5 Years.
6.4
6.4. Analysis
Comparison 6 Adjuvant hormone therapy and Radiotherapy Versus Radiotherapy alone, Outcome 4 Disease‐Free Survival: 10 Years.
See this image and copyright information in PMC

Update of

References

References to studies included in this review

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Schulman 2000 {published data only}
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References to studies excluded from this review

Ahlgren 1999 {published data only}
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Ahlgren 2000a {published data only}
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Asbell 1996 {published data only}
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Aus 1994 {published data only}
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Bono 2001 {published data only}
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Bullock 2002 {published data only}
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Chang 2000 {published data only}
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De Leval 2002 {published data only}
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Debruyne 2000 {published data only}
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Fellows 1992 {published data only}
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Galalae 2004 {published data only}
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Goldenberg 1996 {published data only}
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Granfors 1998 {published data only}
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Hanks 2003 {published data only}
    1. Hanks GE, Pajak TF, Porter A, Grignon D, Brereton H, Venkatesan V, Horwitz EM, Lawton C, Rosenthal SA, Sandler HM, Shipley WU. Phase III trial of long‐term adjuvant androgen deprivation after neoadjuvant hormonal cytoreduction and radiotherapy in locally advanced carcinoma of the prostate: the Radiation Therapy Oncology Group Protocol 92‐02. Journal of Clinical Oncology 2003;21(21):3972‐8. - PubMed
Homma 1999 {published data only}
    1. Homma Y, Akaza H, Okada K, Yokoyama M, Moriyama N, Usami M, Hirao Y, Tsushima T, Sakamoto A, Ohashi Y, Aso Y. Early results of radical prostatectomy and adjuvant endocrine therapy for prostate cancer with or without preoperative androgen deprivation. The Prostate Cancer Study Group. International Journal of Urology 1999;6(5):229‐37; discussion 238‐9. - PubMed
Homma 2004 {published data only}
    1. Homma Y, Akaza H, Okada K, Yokoyama M, Usami M, Hirao Y, Tsushima T, Sakamoto A, Ohashi Y, Aso Y, Prostate Cancer Study G. Endocrine therapy with or without radical prostatectomy for T1b‐T3N0M0 prostate cancer. International Journal of Urology 2004;11(4):218‐24. [0919‐8172] - PubMed
Horwitz 2001 {published data only}
    1. Horwitz EM, Winter K, Hanks GE, Lawton CA, Russell AH, Machtay M. Subset analysis of RTOG 85‐31 and 86‐10 indicates an advantage for long‐term vs. short‐term adjuvant hormones for patients with locally advanced nonmetastatic prostate cancer treated with radiation therapy. International Journal of Radiation Oncology, Biology, Physics 2001;49(4):947‐56. - PubMed
Hugosson 1996 {published data only}
    1. Hugosson J, Abrahamsson PA, Ahlgren G, Aus G, Lundberg S, Schelin S, Schain M, Pedersen K. The risk of malignancy in the surgical margin at radical prostatectomy reduced almost three‐fold in patients given neo‐adjuvant hormone treatment. European Urology 1996;29:413‐9. - PubMed
Isaka 1994 {published data only}
    1. Isaka S, Shimazaki J, Akimoto S, Okada K, Yoshida O, Arai Y, Usami M, Kotake T, Tobisu K, Kakizoe T, et al. A prospective randomized trial for treating stages B2 and C prostate cancer: radical surgery or irradiation with neoadjuvant endocrine therapy. Japanese Journal of Clinical Oncology 1994;24(4):218‐23. - PubMed
Iversen 2002 {published data only}
    1. Iversen P, Tammela TLJ, Vaage S, Lukkarinen O, Lodding P, Bull‐Njaa T, Viitanen J, Hoisaeter P, Lundmo P, Rasmussen F, Johansson JE, Persson BE, Carroll K. A randomised comparison of bicalutamide ('Casodex') 150 mg versus placebo as immediate therapy either alone or as adjuvant to standard care for early non‐metastatic prostate cancer first report from the Scandinavian Prostatic Cancer Group Study no. 6. European Urology 2002;42(3):204‐11. - PubMed
Iversen 2004a {published data only}
    1. Iversen P, Johansson JE, Lodding P, Lukkarinen O, Lundmo P, Klarskov P, Tammela TLJ, Tasdemir I, Morris T, Carroll K. Bicalutamide (150 mg) versus placebo as immediate therapy alone or as adjuvant to therapy with curative intent for early nonmetastatic prostate cancer: 5.3‐Year median followup from the Scandinavian Prostate Cancer Group Study Number 6. Journal of Urology 2004;172(5 pt 1):1871‐6. - PubMed
Iversen 2004b {published data only}
    1. Iversen P, Wirth MP, See WA, McLeod DG, Klimberg I, Gleason D, Chodak G, Montie J, Tyrrell C, Wallace DM, Delaere KP, Lundmo P, Tammela TL, Johansson JE, Morris T, Carroll K. Is the efficacy of hormonal therapy affected by lymph node status? data from the bicalutamide (Casodex) Early Prostate Cancer program. Urology 2004;63(5):928‐33. [1527‐9995] - PubMed
Jani 2003 {published data only}
    1. Jani AB, Kao J, Hellman S. Hormone therapy adjuvant to external beam radiotherapy for locally advanced prostate carcinoma: a complication‐adjusted number‐needed‐to‐treat analysis. Cancer 2003;98(11):2351‐61. - PubMed
Klotz 1999 {published data only}
    1. Klotz LH, Goldenberg SL, Jewett M, et al. CUOG randomised trial of neo‐adjuvant androgen ablation before radical prostatectomy: 36 month post treatment PSA results. Urology 1999;53:757. - PubMed
Klotz 2000 {published data only}
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Labrie 1993a {published data only}
    1. Labrie F, Dupont A, Cusan L, Gomez J, Diamond P, Koutsilieris M, Suburu R, Fradet Y, Lemay M, Tetu B, Emond J, Candas B. Downstaging of localized prostate cancer by neoadjuvant therapy with flutamide and lupron: The first controlled and randomized trial. Clinical and Investigative Medicine. Medecine Clinique et Experimentale 1993;16(6):499‐509. - PubMed
Labrie 1993b {published data only}
    1. Labrie F, Belanger A, Simard J, Labrie C, Dupont A. Combination therapy for prostate cancer. Endocrine and biologic basis of its choice as new standard first‐line therapy. Cancer 1993;71(3 Suppl):1059‐67. [0008‐543X] - PubMed
Labrie 1994 {published data only}
    1. Labrie F, Cusan L, Gomez JL, Diamond P, Suburu R, Lemay M, Tetu B, Fradet Y, Candas B. Down‐staging of early stage prostate cancer before radical prostatectomy: The first randomized trial of neoadjuvant combination therapy with flutamide and a luteinizing hormone‐releasing hormone agonist. Urology 1994;44(6 Suppl):29‐37.
Labrie 1995 {published data only}
    1. Labrie F, Cusan L, Gomez JL, Diamond P, Suburu R, Lemay MT, tu B, Fradet Y, Candas B. Downstaging by combination therapy with flutamide and an LHRH agonist before radical prostatectomy. Cancer Surveys 1995;23:149‐56. [MEDLINE: ] - PubMed
Lawton 1997 {published data only}
    1. Lawton CA, Winter K, Byhardt R, Sause WT, Hanks GE, Russell AH, Rotman M, Porter A, McGowan DG, DelRowe JD, Pilepich MV. Androgen suppression plus radiation versus radiation alone for patients with D1 (pN+) adenocarcinoma of the prostate (results based on a national prospective randomized trial, RTOG 85‐31). International Journal of Radiation Oncology, Biology, Physics 1997;38(5):931‐9. - PubMed
Lawton 2001 {published data only}
    1. Lawton CA, Winter K, Murray K, Machtay M, Mesic JB, Hanks GE, Coughlin CT, Pilepich MV. 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. International Journal of Radiation, Oncology, Biology, Physics 2001;49(4):937‐46. - PubMed
Lawton 2005 {published data only}
    1. Lawton CA, Winter K, Grignon D, Pilepich MV. Androgen suppression plus radiation versus radiation alone for patients with stage D1/pathologic node‐positive adenocarcinoma of the prostate: updated results based on national prospective randomized trial Radiation Therapy Oncology Group 85‐31. Journal of Clinical Oncology 2005;23(4):800‐7. [0732‐183X] - PubMed
Lee 2002 {published data only}
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Matveev 1993 {published data only}
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Mazzucchelli 2001 {published data only}
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Montironi 1999 {published data only}
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Pilepich 1989 {published data only}
    1. Pilepich MV, Krall JM, John MJ, Rubin P, Porter AT, Marcial VA, Martz KL. Hormonal cytoreduction in locally advanced carcinoma of the prostate treated with definitive radiotherapy: Preliminary results of RTOG 83‐07. International Journal of Radiation Oncology, Biology, Physics 1989;16(3):813‐7. - PubMed
Pilepich 1993 {published data only}
    1. Pilepich MV. Phase III trial of hormone cytoreduction in conjunction with definative radiotherapy in loacally advanced prostate carcinoma: the emerging role of PSA in the assessment of outcome. abstract no: 193. International Journal of Radiation Oncology, Biology, Physics 1993;27(S1):246.
Pilepich 1995a {published data only}
    1. Pilepich MV, Buzydlowski JW, John MJ, Rubin P, McGowan DG, Marcial VA. Phase II trial of hormonal cytoreduction with megestrol and diethylstilbestrol in conjunction with radiotherapy for carcinoma of the prostate: Outcome results of RTOG 83‐07. International Journal of Radiation Oncology, Biology, Physics 1995;32(1):175‐80. - PubMed
Pilepich 1995b {published data only}
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Pilepich 1997 {published data only}
    1. Pilepich MV, Caplan R, Byhardt RW, et al. Phase III trial of androgen suppression using goserelin in unfavourable prognosis carcinoma of the prostate treated with definitive radiotherapy: report of RTOG protocol 85 ‐31. Journal of Clinical Oncology 1997;15:1013‐21. - PubMed
Prezioso 1999 {published data only}
    1. Prezioso D, Lotti T, Montironi R, Polito M. Role of neoadjuvant treatment in clinically confined prostate cancer. Takeda NHT Italian Group. European Urology 1999;35(Suppl 1):17‐21; discussion 22. - PubMed
Rabbani 1998a {published data only}
    1. Rabbani F, Goldenberg SL, Klotz LH. Predictors of pathological stage before neoadjuvant androgen withdrawal therapy and radical prostatectomy. The Canadian Urologic Oncology Group. [see comment]. Journal of Urology 1998;159(3):925‐8. - PubMed
Rabbani 1998b {published data only}
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Schmidt 1993 {published data only}
    1. Schmidt JD, Gibbons RP, Murphy GP, Bartolucci A. Adjuvant therapy for localized prostate cancer. Cancer 1993;71(3 Suppl):1005‐13. [MEDLINE: ] - PubMed
Schmidt 1996a {published data only}
    1. Schmidt JD, Gibbons RP, Murphy GP, Bartolucci A. Adjuvant therapy for clinical localized prostate cancer treated with surgery or irradiation. European Urology 1996;29(4):425‐33. - PubMed
Schmidt 1996b {published data only}
    1. Schmidt JD, Gibbons RP, Murphy GP, Bartolucci A. Evaluation of adjuvant estramustine phosphate, cyclophosphamide, and observation only for node‐positive patients following radical prostatectomy and definitive irradiation. Investigators of the National Prostate Cancer Project. Prostate 1996;28(1):51‐7. - PubMed
See 2002 {published data only}
    1. See WA, Wirth MP, McLeod DG, Iversen P, Klimberg I, Gleason D, Chodak G, Montie J, Tyrrell C, Wallace DMA, Delaere KPJ, Vaage S, Tammela TLJ, Lukkarinen O, Persson BE, Carroll K, Kolvenbag G. Bicalutamide as immediate therapy either alone or as adjuvant to standard care of patients with localized or locally advanced prostate cancer: First analysis of the early prostate cancer program. Journal of Urology 2002;168(2):429‐35. - PubMed
See 2003 {published data only}
    1. See W, Iveresen P, Wirth M, McLeod D, Garside L, Morris T. Immediate treatment with bicalutamide 150mg as adjuvant therapy significantly reduces the risk of PSA progression in early prostate cancer. European Urology 2003;44:512‐8. - PubMed
Shipley 2002 {published data only}
    1. Shipley WU, Lu JD, Pilepich MV, Heydon K, Roach IM, Wolkov HB, Sause WT, Rubin P, Lawton CA, Machtay M. 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. International Journal of Radiation Oncology, Biology, Physics 2002;54(5):1302‐10. - PubMed
Solomon 1993 {published data only}
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Soloway 1995 {published data only}
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Vaillancourt 1996 {published data only}
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Van Poppel 1992 {published data only}
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Van Poppel 1995 {published data only}
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Van Poppel 2001 {published data only}
    1. Poppel H. Neoadjuvant hormone therapy and radical prostatectomy: The jury is still out. European Urology 2001;39(Suppl 1):10‐14. - PubMed
Wirth 2004b {published data only}
    1. Wirth MP, See WA, McLeod DG, Iversen P, Morris T, Carroll K, Casodex Early Prostate Cancer Trialists G. Bicalutamide 150 mg in addition to standard care in patients with localized or locally advanced prostate cancer: results from the second analysis of the early prostate cancer program at median followup of 5.4 years. Journal of Urology 2004;172(5 Pt 1):1865‐70. [0022‐5347] - PubMed
Witjes 1997 {published data only}
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Yamanaka 2005 {published data only}
    1. Yamanaka H, Ito K, Naito S, Tsukamoto T, Usami M, Fujimoto H, Matsuoka N, Fukui I, Harada M, Ohashi Y, Kotake T, Kakizoe T. Effectiveness of adjuvant intermittent endocrine therapy following neoadjuvant endocrine therapy and external beam radiation therapy in men with locally advanced prostate cancer. Prostate 2005;63(1):56‐64. [0270‐4137] - PubMed
Zagars 1999 {published data only}
    1. Zagars GK, Pollack A, Smith LG. Conventional external‐beam radiation therapy alone or with androgen ablation for clinical stage III (T3, NX/N0, M0) adenocarcinoma of the prostate. International Journal of Radiation Oncology, Biology, Physics 1999;44(4):809‐19. - PubMed
Zurlo 2002 {published data only}
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