Intermittent Versus Continuous Maximal Androgen Blockade in Metastatic (D2) Prostate Cancer Patients. A Randomized Trial

Mottet, N.; Goussard, Marion; Loulidi, Salim; Wolff, J. M.

doi:10.1016/s0022-5347(09)60659-5

Cited by 7 publications

(14 citation statements)

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“…The studies reporting survival data 13,17,18,21 showed no difference in overall and prostate cancer-specific survival between groups. However, those studies were underpowered and contained patients with both metastatic and nonmetastatic disease.…”

Section: Phase III Trialsmentioning

confidence: 94%

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Androgen Deprivation Therapy in Advanced Prostate Cancer: Is Intermittent Therapy the New Standard of Care?

Klotz

Toren

2012

Current Oncology

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Purpose: Intermittent androgen deprivation is increasingly used as an alternative to continuous life-long androgen deprivation therapy for men with advanced or recurrent prostate cancer. Recent Findings: Two recent phase III trials have clarified the benefits of intermittent therapy. The Canadian-led pr.7 trial in men with nonmetastatic disease and prostate-specific antigen recurrence after definitive local therapy showed that intermittent therapy resulted in survival equivalent to that with continuous therapy, with significant improvements in quality of life. Patients on intermittent therapy experienced improved bone health, fewer metabolic and hematologic disturbances, fewer hot flashes, and improved sexual function. In men with metastatic disease, the data are less clear. The long-awaited results of the Southwest Oncology Group 9346 trial, comparing intermittent with continuous therapy in metastatic disease, showed no difference in overall survival. Post hoc stratification analysis showed a worse outcome in patients with “minimal” metastatic disease, and no difference in those with widespread bone metastases. The significance of that observation is in dispute. The present review also addresses practical issues in the use of intermittent therapy, including patient selection, follow-up, and therapy cycling. Summary: The recent results of randomized clinical trials now establish that intermittent androgen deprivation therapy is an approach that should be considered the standard of care in most patients with nonmetastatic prostate cancer requiring hormonal therapy and in selected patients with metastatic disease. Key Points: (1) Level I evidence supports the oncologic equivalence of intermittent compared with continuous androgen blockade in men with biochemical failure. (2) Compared with continuous androgen deprivation, intermittent therapy demonstrates improved quality of life and fewer side effects. (3) Patient selection for intermittent therapy is important to maintain good oncologic results. (4) Monitoring of prostate-specific androgen response and duration of off-treatment intervals allow for stratification of patients by risk of progression.

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Section: Phase III Trialsmentioning

confidence: 94%

“…Some studies failed to show a qol benefit 17,18 . In the study by the South European Uroncological Group (seug), qol was similar between arms, although lower rates of hot flashes, gynecomastia, and headaches were seen in the intermittent arm 17 .…”

Section: Quality Of Lifementioning

confidence: 99%

Androgen Deprivation Therapy in Advanced Prostate Cancer: Is Intermittent Therapy the New Standard of Care?

Klotz

Toren

2012

Current Oncology

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“…However, a decrease in side‐effects as a result of the hormonal deprivation was reported in all cases during the off‐therapy period; hot flushes, an early androgen deprivation side‐effect, was statistically significant improved in the off‐treatment period 41 . Finally, no differences in QoL in IAD and CAD treatment groups have been observed in studies carried out by Mottet et al 39 . and Langenhuijsen et al 36 …”

Section: Resultsmentioning

confidence: 86%

Safety and tolerability of intermittent androgen deprivation therapy: A literature review

2012

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Androgen deprivation therapy is commonly used in men with advanced prostate cancer; however, it is associated with many short‐ and long‐term side‐effects. Intermittent androgen deprivation therapy was first suggested as an alternative regimen in the early 1990s and is now part of treatment guidelines as a result of its ability to reduce adverse events associated with continuous androgen deprivation therapy without decreasing its efficacy. Although many publications evaluated intermittent androgen deprivation therapy's efficacy, the safety and tolerability information of this regimen is relatively limited. The goal of this literature review was to analyze clinical trials that have reported safety and tolerability data in prostate cancer patients treated with intermittent androgen deprivation therapy, as well as assessing quality of life outcomes. A literature search was carried out using biomedical and pharmaceutical databases for published information comparing intermittent androgen deprivation therapy with continuous androgen deprivation therapy. A total of 13 randomized and non‐randomized studies were selected and reviewed based on their relevance to the safety, tolerability and quality of life of intermittent androgen deprivation therapy. Benefits for intermittent androgen deprivation therapy were observed for the short‐term side‐effects (hot flushes and sexual functions) mainly during the off‐treatment phase, whereas the data for the long‐term side‐effects were not as conclusive. Quality of life evaluations are more in support of intermittent androgen deprivation therapy. Although there are some safety, tolerability and quality of life benefits associated with intermittent androgen deprivation therapy, the overall evidence is still limited.

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“…Supporting the rationale for IAD, preclinical studies have shown that castration‐resistant status is associated with adaptive stem‐cell survival mechanisms activated by androgen deprivation [11], and IAD restores androgen sensitivity and delays the time to progression to castration resistance [12,13]. A meta‐analysis of phase II trials involving 1446 patients with prostate cancer has shown that 39% of time was spent off treatment after a median of two IAD cycles [14], while a similar analysis of a phase III trial revealed that patients spent 49% of time off therapy after 15 cycles of IAD [15]. Therefore, IAD also has the potential to offer cost savings vs CAD (assuming outcomes are similar/better) by reducing medication use and the management costs associated with the side effects of continuous therapy [16].…”

Section: Use Of Iad To Improve Tolerability Of Adtmentioning

confidence: 99%

Improving the management of patients with prostate cancer receiving long‐term androgen deprivation therapy

2012

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3In many patients with prostate cancer, androgen deprivation therapy (ADT) is administered over prolonged periods of time. The benefi ts of long-term ADT in patients with advanced disease are well established and, more recently, studies have shown that long-term adjuvant ADT used in combination with radiotherapy improves survival in patients with earlier stages of disease. Nevertheless, clinicians should remain aware of the potential long-term side effects of ADT and the strategies that can be used to manage or prevent long-term complications.One such strategy is intermittent androgen deprivation (IAD), in which patients receive cycles of ADT, the duration of which is usually determined by PSA levels. Accumulating data indicate that this approach improves the tolerability of ADT (particularly sexual dysfunction) and patients ' quality of life, without compromising clinical outcomes (progression and survival). Indeed, the latest European Association of Urology guidelines state that IAD should no longer be considered investigational. Nevertheless, some questions remain unanswered, including: who are the most suitable patients for IAD and what are the optimal PSA levels for stopping and restarting treatment?Osteoporosis (and the resultant increased risk of fractures) is a well-recognized complication of long-term ADT. Bone mineral density should be measured before and during long-term ADT and patients advised to make appropriate lifestyle changes to help preserve bone health. Pharmacological intervention is also an option. Denosumab (an NF-κ B ligand inhibitor) signifi cantly reduces ADT-induced bone loss and the risk of fractures in patients with non-metastatic disease. In those whose disease has metastasized, zoledronate and denosumab are licensed to prevent skeletal-related events and a large randomized study has shown that denosumab is more effective than zoledronate in this setting. KEYWORDSintermittent androgen deprivation therapy , tolerability , quality of life , bone mineral density , skeletal-related events , denosumab

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Intermittent Versus Continuous Maximal Androgen Blockade in Metastatic (D2) Prostate Cancer Patients. A Randomized Trial

Cited by 7 publications

References 0 publications

Androgen Deprivation Therapy in Advanced Prostate Cancer: Is Intermittent Therapy the New Standard of Care?

Androgen Deprivation Therapy in Advanced Prostate Cancer: Is Intermittent Therapy the New Standard of Care?

Safety and tolerability of intermittent androgen deprivation therapy: A literature review

Improving the management of patients with prostate cancer receiving long‐term androgen deprivation therapy

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