Androgen-deprivation therapy and bone loss in prostate cancer patients: a clinical review

Bienz, Marc; Saad, Fred

doi:10.1038/bonekey.2015.85

Cited by 40 publications

(34 citation statements)

References 60 publications

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“…The magnitude of BMD reduction is similar to previous reports, in which reductions from baseline of between −2.6% and −4.1% were reported in patients who received ≤6 or >6 months of androgen‐deprivation therapy, respectively . Prevention and treatment of bone loss are therefore essential for patients receiving androgen‐deprivation therapy, such as TAK‐385 …”

Section: Discussionsupporting

confidence: 87%

Phase I trial of TAK‐385 in hormone treatment‐naïve Japanese patients with nonmetastatic prostate cancer

et al. 2019

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This open‐label, phase I dose‐finding study evaluated the gonadotropin‐releasing hormone antagonist, TAK‐385, in Japanese patients with nonmetastatic prostate cancer. In a two‐part design, patients received daily oral TAK‐385 at doses of 320 (loading, day 1)/80 (maintenance, day 2 and thereafter), 320/120, 320/160, or 360/120 mg for 28 days in a dose‐escalation phase (part A, n = 13), and at 320/80 or 320/120 mg for up to 96 weeks in a randomized expansion phase (part B, n = 30). Primary endpoint in both parts was safety, including dose‐limiting toxicity in part A. Secondary endpoints included pharmacokinetics, pharmacodynamics, and prostate‐specific antigen concentration. Ten (77%) patients in part A and all patients in part B experienced an adverse event; hot flush (part A, n = 4; part B, n = 15), viral upper respiratory tract infection (part A, n = 1; part B, n = 10), and diarrhea (part B, n = 8) were most frequent. No dose‐limiting toxicities were observed (part A). In 12 evaluable patients (part A), TAK‐385 was rapidly absorbed after a single loading dose; on day 28 (maintenance dose), median steady‐state Tmax was ~1‐2 hours and mean t1/2z was 67‐79 hours. All doses rapidly reduced testosterone concentrations to castration levels within 1 week. Durable reductions in prostate‐specific antigen of >90% from baseline were observed through 96 weeks. TAK‐385 appeared tolerable and resulted in sustained reductions in testosterone to castration levels at all doses. The lowest loading/maintenance dose required for a clinical effect was 320/80 mg. http://ClinicalTrials.gov: NCT02141659.

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Section: Discussionsupporting

confidence: 87%

Phase I trial of TAK‐385 in hormone treatment‐naïve Japanese patients with nonmetastatic prostate cancer

et al. 2019

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“…Accordingly, key observations on the impact of each class on BMD and fracture risk are indicated in table 6, primarily in accordance with the findings of Panday et al in their 2014 review on medication-induced osteoporosis [81]. Recent literature reviews specific to each drug class are also cited to provide the reader with a source of more detailed current information [82][83][84][85][86][87][88][89][90][91]. A focus on three commonly used classes -glucocorticoids, androgen deprivation therapy and aromatase inhibitors -serves to illustrate the potential benefits of strategies to prevent osteoporosis induced by medicines.…”

Section: Osteoporosis Induced By Medicinessupporting

confidence: 62%

Mind the (treatment) gap: a global perspective on current and future strategies for prevention of fragility fractures

et al. 2017

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-none for this submission. EVM -none for this submission. JAK and PJM have undertaken consultancy for governments, national osteoporosis societies, healthcare professional organisations and private sector companies relating to systematic approaches to fragility fracture care and prevention. JYR has no disclosures related to this work, and has received consultancy, lecture fees and grant support from Amgen, Analis, Asahi Kasei, Boehringer, Bristol Myers Squibb, Chiltern, Danone, Ebewee Pharma, Endocyte, Galapagos, GlaxoSmithKline, IBSAGenevrier, Lilly, Merck Sharp and Dohme, Merckle, Negma, Novartis, NovoNordisk, NPS, Nycomed-Takeda, Organon, Pfizer, PharmEvo, Radius Health, Roche, Rottapharm, Servier, Teijin, Teva, Theramex, Therabel, UCB, Will Pharma, Wyeth, Zodiac. NCWH has no disclosures related to this work, and has received consultancy, lecture fees and honoraria from Alliance for Better Bone Health, AMGEN, MSD, Eli Lilly, Servier, Shire, Consilient Healthcare and Internis Pharma. PJM serves as a consultant to the International Osteoporosis Foundation and received remuneration for his contribution to this manuscript. RR has received honoraria for participation in Advisory boards or speaker bureau fees from Danone, Labatec, Nestlé, and ObsEva. Introduction-This narrative review considers the key challenges facing healthcare professionals and policymakers responsible for providing care to populations in relation to bone health. These challenges broadly fall into 4 distinct themes: Europe PMC Funders Group

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“…Despite the benefits of bisphosphonates with respect to skeletal-related events and bone pain, 49 , 50 the effect of bisphosphonates on survival in men with hormone-sensitive prostate cancer is less clear. In men with M1 disease, although based only on three trials, these results represent 87% of men who were randomly assigned to treatment groups and suggest a small potential survival benefit.…”

Section: Discussionmentioning

confidence: 99%

Addition of docetaxel or bisphosphonates to standard of care in men with localised or metastatic, hormone-sensitive prostate cancer: a systematic review and meta-analyses of aggregate data

Vale

Burdett

Rydzewska

et al. 2016

The Lancet Oncology

376

228

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SummaryBackgroundResults from large randomised controlled trials combining docetaxel or bisphosphonates with standard of care in hormone-sensitive prostate cancer have emerged. In order to investigate the effects of these therapies and to respond to emerging evidence, we aimed to systematically review all relevant trials using a framework for adaptive meta-analysis.MethodsFor this systematic review and meta-analysis, we searched MEDLINE, Embase, LILACS, and the Cochrane Central Register of Controlled Trials, trial registers, conference proceedings, review articles, and reference lists of trial publications for all relevant randomised controlled trials (published, unpublished, and ongoing) comparing either standard of care with or without docetaxel or standard of care with or without bisphosphonates for men with high-risk localised or metastatic hormone-sensitive prostate cancer. For each trial, we extracted hazard ratios (HRs) of the effects of docetaxel or bisphosphonates on survival (time from randomisation until death from any cause) and failure-free survival (time from randomisation to biochemical or clinical failure or death from any cause) from published trial reports or presentations or obtained them directly from trial investigators. HRs were combined using the fixed-effect model (Mantel-Haenzsel).FindingsWe identified five eligible randomised controlled trials of docetaxel in men with metastatic (M1) disease. Results from three (CHAARTED, GETUG-15, STAMPEDE) of these trials (2992 [93%] of 3206 men randomised) showed that the addition of docetaxel to standard of care improved survival. The HR of 0·77 (95% CI 0·68–0·87; p<0·0001) translates to an absolute improvement in 4-year survival of 9% (95% CI 5–14). Docetaxel in addition to standard of care also improved failure-free survival, with the HR of 0·64 (0·58–0·70; p<0·0001) translating into a reduction in absolute 4-year failure rates of 16% (95% CI 12–19). We identified 11 trials of docetaxel for men with locally advanced disease (M0). Survival results from three (GETUG-12, RTOG 0521, STAMPEDE) of these trials (2121 [53%] of 3978 men) showed no evidence of a benefit from the addition of docetaxel (HR 0·87 [95% CI 0·69–1·09]; p=0·218), whereas failure-free survival data from four (GETUG-12, RTOG 0521, STAMPEDE, TAX 3501) of these trials (2348 [59%] of 3978 men) showed that docetaxel improved failure-free survival (0·70 [0·61–0·81]; p<0·0001), which translates into a reduced absolute 4-year failure rate of 8% (5–10). We identified seven eligible randomised controlled trials of bisphosphonates for men with M1 disease. Survival results from three of these trials (2740 [88%] of 3109 men) showed that addition of bisphosphonates improved survival (0·88 [0·79–0·98]; p=0·025), which translates to 5% (1–8) absolute improvement, but this result was influenced by the positive result of one trial of sodium clodronate, and we found no evidence of a benefit from the addition of zoledronic acid (0·94 [0·83–1·07]; p=0·323), which translates to an absolute improvement in ...

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Androgen-deprivation therapy and bone loss in prostate cancer patients: a clinical review

Cited by 40 publications

References 60 publications

Phase I trial of TAK‐385 in hormone treatment‐naïve Japanese patients with nonmetastatic prostate cancer

Phase I trial of TAK‐385 in hormone treatment‐naïve Japanese patients with nonmetastatic prostate cancer

Mind the (treatment) gap: a global perspective on current and future strategies for prevention of fragility fractures

Addition of docetaxel or bisphosphonates to standard of care in men with localised or metastatic, hormone-sensitive prostate cancer: a systematic review and meta-analyses of aggregate data

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