Single-Therapy Androgen Suppression in Men with Advanced Prostate Cancer

Seidenfeld, Jerome; Samson, David J; Hasselblad, Vic; Aronson, Naomi; Albertsen, Peter C.; Bennett, Charles L.; Wilt, Timothy J

doi:10.7326/0003-4819-132-7-200004040-00009

Cited by 426 publications

(271 citation statements)

References 46 publications

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“…On the basis of the NMA, together with a paper 12 and poster 13 which do not include one of the comparators (triptorelin), the company assumed that the efficacy and safety profiles of the LHRH agonist comparators were equivalent. The ERG considered the assumption that the LHRH agonists: goserelin; leuprorelin and triptorelin are clinically equivalent to be unproven and therefore inappropriate.…”

Section: Critique Of Clinical Evidence and Interpretationmentioning

confidence: 99%

Degarelix for Treating Advanced Hormone-Dependent Prostate Cancer: An Evidence Review Group Perspective of a NICE Single Technology Appraisal

et al. 2016

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As part of its Single Technology Appraisal Process, the National Institute for Health and Care Excellence (NICE) invited the manufacturer of degarelix (Ferring Pharmaceuticals) to submit evidence for the clinical and costeffectiveness of degarelix for the treatment of advanced hormone-dependent prostate cancer. The School of Health and Related Research Technology Appraisal Group at the University of Sheffield was commissioned to act as the independent Evidence Review Group (ERG). The ERG produced a critical review of the evidence contained within the company's submission to NICE. The evidence, which included a randomised controlled trial (RCT) of degarelix versus leuprorelin, found that degarelix was non-inferior to leuprorelin for reduction of testosterone levels and that degarelix achieved a more rapid suppression of prostate-specific antigen levels and subsequently decreased incidences of testosterone flare associated with LHRH agonists. However, protection against testosterone flare for the comparators in the clinical trials was not employed in line with UK clinical practice.Further claims surrounding overall survival, cardiovascular adverse events and clinical equivalence of the comparator drugs from six RCTs of degarelix should be regarded with caution due to flaws and inconsistencies in the pooling of trial data to draw conclusions. The cost-effectiveness evidence included a de novo economic model. Based on the ERG's preferred base case, the deterministic ICER for degarelix versus 3-monthly triptorelin was £14,798 per QALY gained. Additional scenario analyses undertaken by the ERG resulted in ICERs for degarelix versus 3-monthly triptorelin ranging from £17,067 to £35,589 per QALY gained. Subgroup analyses undertaken using the Appraisal Committee's preferred assumptions suggested that degarelix was not costeffective for the subgroup with metastatic disease but could be cost-effective for the subgroup with spinal metastases. The company submitted further evidence to NICE following an initial negative Appraisal Committee decision. Further analyses from the Decision Support Unit found that that whilst there was some evidence that degarelix could be cost-effective for a small subgroup of people with spinal cord compression (SCC), there were insufficient data on the potential size of this subgroup and the rate of SCC in order to estimate an ICER based on the evidence submitted by the company and a separately commissioned systematic review. NICE recommended degarelix as an option for treating advanced hormone-dependent prostate cancer in people with spinal metastases, only if the commissioner can achieve at least the same discounted drug cost as that available to the NHS in June 2016. Key points for decision makers Degarelix is non-inferior to leuprorelin in reducing testosterone to castrate level in those with all stages of prostate cancer requiring androgen deprivation therapy.  Based on the assumptions used in the Evidence Review Group's (ERG) exploratory analyses, the incremental cost effective...

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Section: Critique Of Clinical Evidence and Interpretationmentioning

confidence: 99%

Degarelix for Treating Advanced Hormone-Dependent Prostate Cancer: An Evidence Review Group Perspective of a NICE Single Technology Appraisal

et al. 2016

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“…The effects of pure anti-androgen treatment have been compared to those of medical or surgical castration in randomized trials in men with metastatic prostate cancer. Although these drugs seem to be better tolerated, they are inferior therapies in terms of overall and progression-free survival 33,34 .…”

Section: Boxmentioning

confidence: 99%

A history of prostate cancer treatment

2002

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The increased incidence of prostate cancer has led to remarkable changes in diagnosis and treatment over the past century. What were the first ways in which prostate cancer was treated, and how did these evolve into the variety of therapeutic strategies from which patients have to choose today?In 1853, J. Adams, a surgeon at The London Hospital, described the first case of prostate cancer, which he discovered by histological examination 1 . Adams noted in his report that this condition was "a very rare disease". Remarkably, 150 years later, prostate cancer has become a significant health problem. In the United States, it is the most commonly diagnosed cancer in men, with 180,000 new cases and about 31,000 deaths occurring annually 2 . This dramatic increase in the number of prostate cancer cases can be attributed to several causes. First, prostate cancer was not differentiated from other types of urinary obstruction until the early 1900s. Second, the incidence of prostate cancer increases more rapidly with age than any other cancer type 2 . The number of cases has risen as the average life expectancy has increased over the past century. Third, the increased incidence seems to be, in some way, related to the 'Western' lifestyle: the incidence of clinical prostate cancer is significantly lower in Asian populations, compared with Western populations 3 , and it

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“…Cyproterone, a steroid compound, was the first anti-androgen, but it was soon discovered that the drug binds AR both in the prostate and in the hypothalamus and pituitary, thereby inhibiting the negative feedback mechanism and ultimately leading to LH release and increased testosterone levels (55). To circumvent this problem and to reduce discomforting, sexual side effects caused by surgical or medical castration, drug companies developed non-steroidal anti-androgens, including flutamide and bicalutamide, but randomized trials have demonstrated that these drugs are not as effective as castration or LHRH inhibitors (60). Clinical trials have also been performed to assess the effectiveness of combining treatments, for example using a LHRH agonist with a non-steroidal anti-androgen, but meta-analyses have shown that such an approach confers only modest to no benefit versus therapy with a single drug (61,62).…”

Section: Androgen Deprivation Therapy For Advanced and Metastatic Dismentioning

confidence: 99%

Pathogenetic Influences of Human Herpesvirus 8 (HHV-8) in Prostate Cancer Progression

Mygatt¹

2012

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The mechanisms that give rise to androgen-independent prostate cancer (AIPC) are incompletely understood, resulting in a lack of treatment options for this fatal form of the disease. It is believed that most cases of AIPC are the result of constitutive activation of the androgen receptor (AR) pathway, leading us to hypothesize that chronic, prostatic infection could promote cancer progression as a result of pathogen virulence factors activating cell signaling pathways known to induce AR signaling. We found that human

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Single-Therapy Androgen Suppression in Men with Advanced Prostate Cancer

Abstract: Survival after therapy with an LHRH agonist was equivalent to that after orchiectomy. No evidence shows a difference in effectiveness among the LHRH agonists. Survival rates may be somewhat lower if a nonsteroidal antiandrogen is used as monotherapy.

Cited by 426 publications

References 46 publications

Degarelix for Treating Advanced Hormone-Dependent Prostate Cancer: An Evidence Review Group Perspective of a NICE Single Technology Appraisal

Degarelix for Treating Advanced Hormone-Dependent Prostate Cancer: An Evidence Review Group Perspective of a NICE Single Technology Appraisal

A history of prostate cancer treatment

Pathogenetic Influences of Human Herpesvirus 8 (HHV-8) in Prostate Cancer Progression

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