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Meta-Analysis
. 2014 Jun 30;2014(6):CD009266.
doi: 10.1002/14651858.CD009266.pub2.

Non-steroidal antiandrogen monotherapy compared with luteinising hormone-releasing hormone agonists or surgical castration monotherapy for advanced prostate cancer

Frank Kunath  1 , Henrik R Grobe, Gerta Rücker, Edith Motschall, Gerd Antes, Philipp Dahm, Bernd Wullich, Joerg J Meerpohl
Affiliations
Meta-Analysis

Non-steroidal antiandrogen monotherapy compared with luteinising hormone-releasing hormone agonists or surgical castration monotherapy for advanced prostate cancer

Frank Kunath et al. Cochrane Database Syst Rev. .

Abstract

Background: Non-steroidal antiandrogens and castration are the main therapy options for advanced stages of prostate cancer. However, debate regarding the value of these treatment options continues.

Objectives: To assess the effects of non-steroidal antiandrogen monotherapy compared with luteinising hormone-releasing hormone agonists or surgical castration monotherapy for treating advanced stages of prostate cancer.

Search methods: We searched the Cochrane Prostatic Diseases and Urologic Cancers Group Specialized Register (PROSTATE), the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, Web of Science with Conference Proceedings, three trial registries and abstracts from three major conferences to 23 December 2013, together with reference lists, and contacted selected experts in the field and manufacturers.

Selection criteria: We included randomised controlled trials comparing non-steroidal antiandrogen monotherapy with medical or surgical castration monotherapy for men in advanced stages of prostate cancer.

Data collection and analysis: One review author screened all titles and abstracts; only citations that were clearly irrelevant were excluded at this stage. Then, two review authors independently examined full-text reports, identified relevant studies, assessed the eligibility of studies for inclusion, assessed trial quality and extracted data. We contacted the study authors to request additional information. We used Review Manager 5 for data synthesis and used the fixed-effect model for heterogeneity less than 50%; we used the random-effects model for substantial or considerable heterogeneity.

Main results: Eleven studies involving 3060 randomly assigned participants were included in this review. The quality of evidence is hampered by risk of bias. Use of non-steroidal antiandrogens decreased overall survival (hazard ratio (HR) 1.24, 95% confidence interval (CI) 1.05 to 1.48, six studies, 2712 participants) and increased clinical progression (one year: risk ratio (RR) 1.25, 95% CI 1.08 to 1.45, five studies, 2067 participants; 70 weeks: RR 1.26, 95% CI 1.08 to 1.45, six studies, 2373 participants; two years: RR 1.14, 95% CI 1.04 to 1.25, three studies, 1336 participants), as well as treatment failure (one year: RR 1.19, 95% CI 1.02 to 1.38, four studies, 1539 participants; 70 weeks: RR 1.27, 95% CI 1.05 to 1.52, five studies, 1845 participants; two years: RR 1.14, 95% CI 1.05 to 1.24, two studies, 808 participants), compared with medical or surgical castration. The quality of evidence for overall survival, clinical progression and treatment failure was rated as moderate according to GRADE. Predefined subgroup analyses showed that use of non-steroidal antiandrogens, compared with castration, was less favourable for overall survival, clinical progression (at one year, 70 weeks, two years) and treatment failure (at one year, 70 weeks, two years) in men with metastatic disease. Use of non-steroidal antiandrogens also increased the risk for treatment discontinuation due to adverse events (RR 1.82, 95% CI 1.13 to 2.94, eight studies, 1559 participants), including events such as breast pain (RR 22.97, 95% CI 14.79 to 35.67, eight studies, 2670 participants), gynaecomastia (RR 8.43, 95% CI 3.19 to 22.28, nine studies, 2774 participants) and asthenia (RR 1.77, 95% CI 1.36 to 2.31, five studies, 2073 participants). The risk of other adverse events, such as hot flashes (RR 0.23, 95% CI 0.19 to 0.27, nine studies, 2774 participants), haemorrhage (RR 0.07, 95% CI 0.01 to 0.54, two studies, 546 participants), nocturia (RR 0.38, 95% CI 0.20 to 0.69, one study, 480 participants), fatigue (RR 0.52, 95% CI 0.31 to 0.88, one study, 51 participants), loss of sexual interest (RR 0.50, 95% CI 0.30 to 0.83, one study, 51 participants) and urinary frequency (RR 0.22, 95% CI 0.11 to 0.47, one study, 480 participants) was decreased when non-steroidal antiandrogens were used. The quality of evidence for breast pain, gynaecomastia and hot flashes was rated as moderate according to GRADE. The effects of non-steroidal antiandrogens on cancer-specific survival and biochemical progression remained unclear.

Authors' conclusions: Currently available evidence suggests that use of non-steroidal antiandrogen monotherapy compared with medical or surgical castration monotherapy for advanced prostate cancer is less effective in terms of overall survival, clinical progression, treatment failure and treatment discontinuation due to adverse events. Evidence quality was rated as moderate according to GRADE. Further research is likely to have an important impact on results for patients with advanced but non-metastatic prostate cancer treated with non-steroidal antiandrogen monotherapy. However, we believe that research is likely not necessary on non-steroidal antiandrogen monotherapy for men with metastatic prostate cancer. Only high-quality, randomised controlled trials with long-term follow-up should be conducted. If further research is planned to investigate biochemical progression, studies with standardised follow-up schedules using measurements of prostate-specific antigen based on current guidelines should be conducted.

PubMed Disclaimer

Conflict of interest statement

This review was supported by a Ferdinand Eisenberger grant of the Deutsche Gesellschaft für Urologie (German Society of Urology; grant ID KuF1/FE‐10).

Figures

1
1
Study flow diagram (searched 26 February 2013; updated 23 December 2013).
2
2
Funnel plot: Outcome: 1.1 Overall survival, 1.1.1 Total.
3
3
Risk of bias summary: review authors' judgements about each risk of bias item for each included study.
1.1
1.1. Analysis
Comparison 1 Non‐steroidal antiandrogen monotherapy versus LHRH agonists or surgical castration monotherapy, Outcome 1 Overall survival.
1.2
1.2. Analysis
Comparison 1 Non‐steroidal antiandrogen monotherapy versus LHRH agonists or surgical castration monotherapy, Outcome 2 Cancer‐specific mortality.
1.3
1.3. Analysis
Comparison 1 Non‐steroidal antiandrogen monotherapy versus LHRH agonists or surgical castration monotherapy, Outcome 3 Treatment discontinuation due to adverse events.
1.4
1.4. Analysis
Comparison 1 Non‐steroidal antiandrogen monotherapy versus LHRH agonists or surgical castration monotherapy, Outcome 4 Clinical progression.
1.5
1.5. Analysis
Comparison 1 Non‐steroidal antiandrogen monotherapy versus LHRH agonists or surgical castration monotherapy, Outcome 5 Clinical progression (with imputed event numbers).
1.6
1.6. Analysis
Comparison 1 Non‐steroidal antiandrogen monotherapy versus LHRH agonists or surgical castration monotherapy, Outcome 6 Biochemical progression.
1.7
1.7. Analysis
Comparison 1 Non‐steroidal antiandrogen monotherapy versus LHRH agonists or surgical castration monotherapy, Outcome 7 Biochemical progression (with imputed event numbers).
1.8
1.8. Analysis
Comparison 1 Non‐steroidal antiandrogen monotherapy versus LHRH agonists or surgical castration monotherapy, Outcome 8 Treatment failure.
1.9
1.9. Analysis
Comparison 1 Non‐steroidal antiandrogen monotherapy versus LHRH agonists or surgical castration monotherapy, Outcome 9 Treatment failure (with imputed event numbers).
1.10
1.10. Analysis
Comparison 1 Non‐steroidal antiandrogen monotherapy versus LHRH agonists or surgical castration monotherapy, Outcome 10 Breast pain.
1.11
1.11. Analysis
Comparison 1 Non‐steroidal antiandrogen monotherapy versus LHRH agonists or surgical castration monotherapy, Outcome 11 Pelvic pain.
1.12
1.12. Analysis
Comparison 1 Non‐steroidal antiandrogen monotherapy versus LHRH agonists or surgical castration monotherapy, Outcome 12 Bone pain.
1.13
1.13. Analysis
Comparison 1 Non‐steroidal antiandrogen monotherapy versus LHRH agonists or surgical castration monotherapy, Outcome 13 Back pain.
1.14
1.14. Analysis
Comparison 1 Non‐steroidal antiandrogen monotherapy versus LHRH agonists or surgical castration monotherapy, Outcome 14 Headache.
1.15
1.15. Analysis
Comparison 1 Non‐steroidal antiandrogen monotherapy versus LHRH agonists or surgical castration monotherapy, Outcome 15 Abdominal pain.
1.16
1.16. Analysis
Comparison 1 Non‐steroidal antiandrogen monotherapy versus LHRH agonists or surgical castration monotherapy, Outcome 16 General pain.
1.17
1.17. Analysis
Comparison 1 Non‐steroidal antiandrogen monotherapy versus LHRH agonists or surgical castration monotherapy, Outcome 17 Gynaecomastia.
1.18
1.18. Analysis
Comparison 1 Non‐steroidal antiandrogen monotherapy versus LHRH agonists or surgical castration monotherapy, Outcome 18 Constipation.
1.19
1.19. Analysis
Comparison 1 Non‐steroidal antiandrogen monotherapy versus LHRH agonists or surgical castration monotherapy, Outcome 19 Diarrhoea.
1.20
1.20. Analysis
Comparison 1 Non‐steroidal antiandrogen monotherapy versus LHRH agonists or surgical castration monotherapy, Outcome 20 Vomiting.
1.21
1.21. Analysis
Comparison 1 Non‐steroidal antiandrogen monotherapy versus LHRH agonists or surgical castration monotherapy, Outcome 21 Hypertension.
1.22
1.22. Analysis
Comparison 1 Non‐steroidal antiandrogen monotherapy versus LHRH agonists or surgical castration monotherapy, Outcome 22 Loss of sexual interest.
1.23
1.23. Analysis
Comparison 1 Non‐steroidal antiandrogen monotherapy versus LHRH agonists or surgical castration monotherapy, Outcome 23 Asthenia.
1.24
1.24. Analysis
Comparison 1 Non‐steroidal antiandrogen monotherapy versus LHRH agonists or surgical castration monotherapy, Outcome 24 Insomnia.
1.25
1.25. Analysis
Comparison 1 Non‐steroidal antiandrogen monotherapy versus LHRH agonists or surgical castration monotherapy, Outcome 25 Hot flashes.
1.26
1.26. Analysis
Comparison 1 Non‐steroidal antiandrogen monotherapy versus LHRH agonists or surgical castration monotherapy, Outcome 26 Night sweats.
1.27
1.27. Analysis
Comparison 1 Non‐steroidal antiandrogen monotherapy versus LHRH agonists or surgical castration monotherapy, Outcome 27 Anaemia.
1.28
1.28. Analysis
Comparison 1 Non‐steroidal antiandrogen monotherapy versus LHRH agonists or surgical castration monotherapy, Outcome 28 Hepatic enzyme increase.
1.29
1.29. Analysis
Comparison 1 Non‐steroidal antiandrogen monotherapy versus LHRH agonists or surgical castration monotherapy, Outcome 29 Rash.
1.30
1.30. Analysis
Comparison 1 Non‐steroidal antiandrogen monotherapy versus LHRH agonists or surgical castration monotherapy, Outcome 30 Pruritus.
1.31
1.31. Analysis
Comparison 1 Non‐steroidal antiandrogen monotherapy versus LHRH agonists or surgical castration monotherapy, Outcome 31 Dyspnoea.
1.32
1.32. Analysis
Comparison 1 Non‐steroidal antiandrogen monotherapy versus LHRH agonists or surgical castration monotherapy, Outcome 32 Infection.
1.33
1.33. Analysis
Comparison 1 Non‐steroidal antiandrogen monotherapy versus LHRH agonists or surgical castration monotherapy, Outcome 33 Pharyngitis.
1.34
1.34. Analysis
Comparison 1 Non‐steroidal antiandrogen monotherapy versus LHRH agonists or surgical castration monotherapy, Outcome 34 Arthritis.
1.35
1.35. Analysis
Comparison 1 Non‐steroidal antiandrogen monotherapy versus LHRH agonists or surgical castration monotherapy, Outcome 35 Sinusitis.
1.36
1.36. Analysis
Comparison 1 Non‐steroidal antiandrogen monotherapy versus LHRH agonists or surgical castration monotherapy, Outcome 36 Urinary tract infection.
1.37
1.37. Analysis
Comparison 1 Non‐steroidal antiandrogen monotherapy versus LHRH agonists or surgical castration monotherapy, Outcome 37 Dizziness.
1.38
1.38. Analysis
Comparison 1 Non‐steroidal antiandrogen monotherapy versus LHRH agonists or surgical castration monotherapy, Outcome 38 Haemorrhage.
1.39
1.39. Analysis
Comparison 1 Non‐steroidal antiandrogen monotherapy versus LHRH agonists or surgical castration monotherapy, Outcome 39 Haematuria.
1.40
1.40. Analysis
Comparison 1 Non‐steroidal antiandrogen monotherapy versus LHRH agonists or surgical castration monotherapy, Outcome 40 Nocturia.
1.41
1.41. Analysis
Comparison 1 Non‐steroidal antiandrogen monotherapy versus LHRH agonists or surgical castration monotherapy, Outcome 41 Urinary frequency.
1.42
1.42. Analysis
Comparison 1 Non‐steroidal antiandrogen monotherapy versus LHRH agonists or surgical castration monotherapy, Outcome 42 Urinary retention.
1.43
1.43. Analysis
Comparison 1 Non‐steroidal antiandrogen monotherapy versus LHRH agonists or surgical castration monotherapy, Outcome 43 Peripheral oedema.
1.44
1.44. Analysis
Comparison 1 Non‐steroidal antiandrogen monotherapy versus LHRH agonists or surgical castration monotherapy, Outcome 44 Anorexia.
1.45
1.45. Analysis
Comparison 1 Non‐steroidal antiandrogen monotherapy versus LHRH agonists or surgical castration monotherapy, Outcome 45 Loss of sexual function.
1.46
1.46. Analysis
Comparison 1 Non‐steroidal antiandrogen monotherapy versus LHRH agonists or surgical castration monotherapy, Outcome 46 Arthralgia.
1.47
1.47. Analysis
Comparison 1 Non‐steroidal antiandrogen monotherapy versus LHRH agonists or surgical castration monotherapy, Outcome 47 Gastralgia.
1.48
1.48. Analysis
Comparison 1 Non‐steroidal antiandrogen monotherapy versus LHRH agonists or surgical castration monotherapy, Outcome 48 Nausea.
1.49
1.49. Analysis
Comparison 1 Non‐steroidal antiandrogen monotherapy versus LHRH agonists or surgical castration monotherapy, Outcome 49 Fatigue.
1.50
1.50. Analysis
Comparison 1 Non‐steroidal antiandrogen monotherapy versus LHRH agonists or surgical castration monotherapy, Outcome 50 Dry skin.
1.51
1.51. Analysis
Comparison 1 Non‐steroidal antiandrogen monotherapy versus LHRH agonists or surgical castration monotherapy, Outcome 51 Aggravation reaction.
1.52
1.52. Analysis
Comparison 1 Non‐steroidal antiandrogen monotherapy versus LHRH agonists or surgical castration monotherapy, Outcome 52 Serious adverse events.
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Update of

  • doi: 10.1002/14651858.CD009266

References

References to studies included in this review

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Akaza 1993 {published data only}
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