scholarly journals Darolutamide and survival in nonmetastatic, castration-resistant prostate cancer: a patient perspective of the ARAMIS trial

2021 ◽  
pp. 1-9
Author(s):  
K Fizazi ◽  
Ian Blue ◽  
Joel T Nowak
Keyword(s):  
Prostate Cancer ◽  
Hormone Therapy ◽  
Bone Fractures ◽  
Oral Treatment ◽  
The Body ◽  
Castration Resistant Prostate Cancer ◽  
Plain Language ◽  
Clinical Trial Registration ◽  
Risk Of Death ◽  
Castration Resistant

This is a summary of a publication about the ARAMIS (Androgen Receptor Antagonizing Agent for Metastasis-free Survival) trial, which was published in the New England Journal of Medicine in September 2020. The trial was in adult participants with nonmetastatic, castration-resistant prostate cancer (nmCRPC) who received a trial treatment called darolutamide (brand name Nubeqa®). Darolutamide is currently available as an oral treatment for adults with nmCRPC. The ARAMIS trial looked at darolutamide taken by mouth in 1509 participants from 36 countries with nmCRPC (prostate cancer that has not spread to other parts of the body and no longer responds adequately to initial hormone therapy). The trial showed that darolutamide in addition to hormone therapy increased the length of time that the trial participants were still alive for and lowered the risk of death by 31% compared with placebo (sugar pill) and hormone therapy. The participants who received darolutamide and hormone therapy also had longer time to worsening pain, needing chemotherapy, and having cancer-related bone fractures or symptoms related to cancer-related bone fractures compared with those who received placebo and hormone therapy during the trial. In general, the percentage of participants who experienced medical problems (referred to as adverse events) was similar between those who received darolutamide and those who received placebo, in addition to hormone therapy. This summary also includes insights and perspectives from a participant who was in the ARAMIS trial and from a prostate cancer patient advocate. To read the full Plain Language Summary of this article, click on the View Article button above and download the PDF. Clinical Trial Registration: NCT02200614 ( ClinicalTrials.gov )

scholarly journals Treatment-Emergent Co-Morbidities and Survival in Patients With Metastatic Castration-Resistant Prostate Cancer Receiving Abiraterone or Enzalutamide

2021 ◽  
Vol 12 ◽  
Author(s):  
Yi-Ting Lin ◽  
Yen-Chun Huang ◽  
Chih-Kuan Liu ◽  
Tian-Shyug Lee ◽  
Mingchih Chen ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Overall Survival ◽  
Hormone Therapy ◽  
Cox Regression ◽  
Castration Resistant Prostate Cancer ◽  
Drug Induced ◽  
Cox Regression Analysis ◽  
Castration Resistant ◽  
Significant Difference ◽  
Taiwan National Health Insurance

Secondary hormone therapy, abiraterone and enzalutamide, has improved outcomes for metastatic castration-resistant prostate cancer (mCRPC) and prolonged patients’ lives significantly. Various studies have compared the cancer-related outcomes, adverse effects, and drug-induced comorbidities in patients with mCRPC who are treated with abiraterone or enzalutamide. However, few studies have explored associations between survival and comorbidities or comprehensive analyzed newly developed comorbidities during and after secondary hormone therapy. We attempted to clarify whether the Charlson comorbidity index (CCI) overall or itemized is predictive for overall survival, and we compared newly developed comorbidities between abiraterone and enzalutamide groups. We extracted data about expenses and comorbidities for patients who have mCRPC, received abiraterone and enzalutamide and met pre-examination operation criteria between September 2016 and December 2017 from the Taiwan National Health Insurance database. A total of 1153 patients with mCRPC who received abiraterone (n = 782) or enzalutamide (n = 371) with or without previous chemotherapy were included. We used the propensity score to match confounding factors, including age, pre-existing comorbidities, and precipitating factors for comorbidity (e.g., hypertension, hyperlipidemia), to eliminate selection bias in the comparison of newly developed comorbidities. Cox regression analysis was used for overall survival. We found that enzalutamide is superior to abiraterone with regard to overall survival. Our study revealed that there is no statistically significant difference in development of new comorbidities between abiraterone and enzalutamide group. Moreover, the CCI score, rather than any single item of the CCI, was a statistically significant predictor for overall survival.

scholarly journals Radiotherapy of Oligoprogressive Lesions in Castration-Resistant Prostate Cancer: Impact on Second-Generation Hormone Therapy

2021 ◽  
Vol 12 (05) ◽  
pp. 302-310
Author(s):  
Kanta Ka ◽  
Papa Macoumba Gaye ◽  
Awa Sadikh Badiane ◽  
Ibrahima Thiam ◽  
Mouhamadou Bachir Ba ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Hormone Therapy ◽  
Second Generation ◽  
Castration Resistant Prostate Cancer ◽  
Castration Resistant

scholarly journals Apalutamide: a better option for the treatment of non-metastatic castration resistant prostatic carcinoma

2018 ◽  
Vol 7 (9) ◽  
pp. 1853 ◽  
Author(s):  
Raushan Kumar Ranjan ◽  
Akash Chandra
Keyword(s):  
Prostate Cancer ◽  
Specific Antigen ◽  
Digital Rectal Examination ◽  
The Body ◽  
Blood Levels ◽  
Gnrh Analogue ◽  
Castration Resistant Prostate Cancer ◽  
Reductase Inhibitors ◽  
Castration Resistant ◽  
Cancer Of The Prostate

Prostate cancer is cancer of the prostate, a gland in the male reproductive system. Most prostate cancers are slow growing; however, some grow relatively quickly. The cancer cells may spread from the prostate to other area of the body, particularly the bones and lymph nodes. Factors that increase the risk of prostate cancer include older age, a family history of the disease, and race. About 99% of cases occur in males over the age of 50. Clinical features include hematuria, dysuria (painful urination),nocturia(urination at night). Lower blood levels of vitami D may increase the risk of developing prostate cancer. Infection with the sexually transmitted diseases, chlamydia, gonorrhea, syphilis and prostatitis seem to increase risk of prostate cancer. Diagnosis can be confirmed by digital rectal examination (DRE) with prostate-specific antigen (PSA) blood test, cystoscopy, transrectal ultrasonography and biopsy (The removal of small pieces of the prostate for microscopic examination). Medicines like 5-alpha-reductase inhibitors (finasteride and dutasteride) reduce the overall risk of prostate cancer. Apalutamide, sold under the brand name Erleada, is a nonsteroidal antiandrogen (NSAA) medication which is used in the treatment of prostate cancer. It is specifically indicated for use in conjunction with castration in the treatment of non-metastatic castration-resistant prostate cancer (NM-CRPC). It is taken by mouth. Apalutamide was first described in 2007 and was approved for the treatment of prostate cancer in February 2018. Apalutamide is used in conjunction with castration, either via bilateral orchiectomy or gonadotropin-releasing hormone analogue (GnRH analogue) therapy, as a method of androgen deprivation therapy in the treatment of non-metastatic castration-resistant prostate cancer (NM-CRPC).

scholarly journals Tafamidis and quality of life in people with transthyretin amyloid cardiomyopathy in the study ATTR-ACT: A plain language summary

2021 ◽  
Author(s):  
Mazen Hanna ◽  
Thibaud Damy ◽  
Martha Grogan ◽  
Michelle Stewart ◽  
Balarama Gundapaneni ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Heart Failure ◽  
General Health ◽  
Oral Treatment ◽  
Plain Language ◽  
Clinical Trial Registration ◽  
Risk Of Death ◽  
The Usa ◽  
Amyloid Cardiomyopathy

This plain language summary describes the results of a study called ATTR-ACT, which was published in the American Journal of Cardiology. In ATTR-ACT, researchers looked at the effects of tafamidis treatment in people with transthyretin amyloid cardiomyopathy (called ATTR-CM for short). Tafamidis is currently available in the USA and other countries as an oral treatment for adults with ATTR-CM. In ATTR-ACT, 441 people with ATTR-CM from 13 different countries took either tafamidis or placebo by mouth for 30 months. First, researchers looked at the effects of tafamidis on the risk of death and hospitalization due to heart problems between the start and the end of the study; they found that these risks were about one-third lower with tafamidis compared with placebo. As described in this summary, researchers also looked at the effects of tafamidis on people’s heart failure symptoms, quality of life, and general health over the 30-month study. People who took part in ATTR-ACT rated these effects using questionnaires filled out before, during, and after the study. More people who took tafamidis saw improvement or no change in their heart failure symptoms and quality of life than people who took placebo. In addition, compared with people taking placebo, people taking tafamidis had less worsening of their general health during the study. These results show the benefits of tafamidis in reducing the declines in quality of life and health that often occur with this debilitating disease. To read the full Plain Language Summary of this article, click on the View Article button above and download the PDF. Clinical Trial Registration: NCT01994889 ( ClinicalTrials.gov )

scholarly journals Effectiveness of Vintage Hormone Therapy as Alternative Androgen Deprivation Therapy for Non-metastatic Castration-resistant Prostate Cancer

In Vivo ◽  
2021 ◽  
Vol 35 (2) ◽  
pp. 1247-1252
Author(s):  
HIROAKI IWAMOTO ◽  
HIROSHI KANO ◽  
TAKAFUMI SHIMADA ◽  
RENATO NAITO ◽  
TOMOYUKI MAKINO ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Hormone Therapy ◽  
Androgen Deprivation Therapy ◽  
Androgen Deprivation ◽  
Castration Resistant Prostate Cancer ◽  
Castration Resistant

Effects of abiraterone acetate and enzalutamide on muscle and adipose mass in men with metastatic castration-resistant prostate cancer (mCRPC).

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. 5088-5088
Author(s):  
Ecaterina Ileana ◽  
Sami Antoun ◽  
Laurence Albiges ◽  
Christophe Massard ◽  
Mario Di Palma ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Body Composition ◽  
Adipose Tissue ◽  
Lumbar Vertebra ◽  
Abiraterone Acetate ◽  
The Body ◽  
Castration Resistant Prostate Cancer ◽  
Castration Resistant ◽  
Significant Difference ◽  
Composition Changes

5088 Background: Abiraterone acetate (AA) and enzalutamide (MDV3100), two androgen receptor-directed compounds, have been shown to improve survival for patients with metastatic castration-resistant prostate cancer (mCRPC) progressing after Docetaxel.. Since these drugs might be used at an early-stage in the future, and skeletal muscle (SM) and adipose tissue (AT) are known to be prognosis parameters, the aim of this study was to evaluate the body composition changes in patients with mCRPC treated with AA and MDV3100. Methods: Patients included in AFFIRM (n=62 treated with MDV3100 and placebo n=28) and COU-AA-301 (n=24 treated with AA+Prednisone (P)10mg/day and placebo+P n= 13) trials at the Institute Gustave Roussy were included in the analysis. Cross-sectional areas (cm2) of visceral adipose tissue (VAT), subcutaneous adipose tissue (SAT) and SM were assessed by computed tomography imaging at 3rd lumbar vertebra and were indexed for height (cm2/m2) with Slice-O-Matic software V4.3 at baseline, 3, 6 and 12 months of treatment. The data from patients treated with AA or MDV3100 were compared to placebo-patients and tissues changes were compared to baseline. We used the validated sarcopenic definitions as SM index less than 52.4 (cm2/m2). Results: For all cohort, median age was 69 years (range: 48-83), median weight was 79 kg (range: 47-150) and median BMI was 25.9 kg/m2(range: 18-46). At inclusion, 74 patients (58%) were overweight or obese (BMI>24.9 kg/m2), and only 2 patients were underweight (BMI<18.5kg/m2). 97 patients (81%) were sarcopenic, and 56 (75%) of overweight or obese patients were sarcopenic. Over 3 months, the patients from the entire cohort lost muscle mass (mean change: 4.5±7.5% (» 0.7 kg of muscle)) (P=0.01) . A non significant loss of SAT -4.6±19.2% and a non significant increase of VAT (+10.7±50.3% ) were observed. A similar pattern was observed at 6 months. There was no significant difference between body composition changes in treated groups and placebo. Conclusions: Sarcopenia is highly prevalent in patients with advanced CRPC. Unexpectedly, no difference in body composition changes was observed between patients treated with MDV3100 or AA and placebo.

Identification of a predictive factor of metastatic castration-resistant prostate cancer patients’ response to alternative antiandrogen therapy with flutamide.

2016 ◽  
Vol 34 (2_suppl) ◽  
pp. 321-321
Author(s):  
Masato Yasui ◽  
Shuko Yoneyama ◽  
Koichi Uemura ◽  
Takashi Kawahara ◽  
Yusuke Hattori ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Risk Factors ◽  
Hormone Therapy ◽  
Predictive Factors ◽  
Hormonal Therapy ◽  
Bone Scan ◽  
Second Line ◽  
Castration Resistant Prostate Cancer ◽  
Castration Resistant ◽  
N Stage

321 Background: Recently, new androgen pathway inhibitors, abiraterone and enzalutamide, are demonstrated to improve overall survival for metastatic castration-resistant prostate cancer (mCRPC). In Japan, alternative antiandrogen (AA) as second-line hormonal therapy for mCRPC that relapses after initial hormone therapy have been commonly used before new androgen pathway inhibitors. In this study, we attempted to identify the predictive factors for efficacy of AA as second-line hormone therapy. Methods: We identified consecutive 65 mCRPC patients treated with AA as second-line hormonal therapy. All patients were treated with maximum androgen blockade (MAB) initially and evaluated antiandrogen withdrawal syndrome after relapse. We analyzed the correlations between progression-free survival (PFS) of AA and clinicopathological characteristics, including patients’ age, initial PSA levels, PSA levels at flutamide induction, Gleason scores, T stage, N stage, extent of disease (EOD) classifications on bone scan, and the previous duration of prostate cancer sensitivity to MAB. Results: The median duration of prostate cancer sensitivity to MAB was 11.3 months (range: 1.5-53.0 months). In multivariate analysis, four significant risk factors for poor PFS were identified; initial PSA levels ( > 263 ng/mL vs ≤ 263; HR 0.53, p = 0.038), N stage (1 vs 0; HR 3.00, p = 0.001), EOD classifications (3-4 vs 1-2; HR 2.50, p = 0.007), and the previous duration of prostate cancer sensitivity to MAB ( < 12 months vs ≥ 12; HR 2.16, p = 0.026). We stratified the patients into two cohorts with low risk (0-2 risk factor present) and high risk (3-4 risk factors present). We found a significant difference in PFS among risk groups (median PFS 7.3 months vs 1.5, p < 0.000). Conclusions: Initial PSA, N stage, EOD classifications on bone scan, and the previous duration of prostate cancer sensitivity to MAB were the significant predictive factors for efficacy of AA as second-line hormone therapy in patients with mCRPC. These findings might support that decision-making of when to start the new AR pathway inhibitors.

Incidence of skeletal-related events in men with castration-resistant prostate cancer.

2018 ◽  
Vol 36 (34_suppl) ◽  
pp. 188-188
Author(s):  
Alison Tse Kawai ◽  
David Martinez ◽  
Catherine W. Saltus ◽  
Zdravko Vassilev ◽  
Montse Soriano-Gabarro ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Real World ◽  
Castration Resistant Prostate Cancer ◽  
Castration Resistance ◽  
Cohort Entry ◽  
Risk Of Death ◽  
Castration Resistant ◽  
Increased Risk ◽  
Before And After ◽  
Skeletal Related Events

188 Background: Skeletal-related events (SREs) are common in men with bone metastases and have negative consequences for patients with castration-resistant prostate cancer (CRPC), including pain, reduced quality of life, and increased risk of death. Published data on background rates of SREs in men with CPRC in real-world practice are sparse. Methods: We included men aged ≥ 65 years in the SEER-Medicare database with a prostate cancer diagnosis in 2000-2011 if they had no prior malignancy, had surgical or medical castration, and met protocol-defined criteria for castration resistance. Castration resistance was inferred from subsequent treatment with any of these systemic therapies: abiraterone, cabazitaxel, docetaxel, enzalutamide, mitoxantrone, or sipuleucel-T. The first occurrence of an SRE was identified in Medicare claims using diagnosis or procedure codes for fracture, bone surgery, radiation therapy, or spinal cord compression. We estimated incidence rates (IRs) of SREs in all eligible person-time and stratified by person-time before and after any use of the following bone-targeted agents (BTAs): alendronate, denosumab, ibandronate, pamidronate, risedronate, or zoledronic acid. Results: Of 2,234 men with CRPC (84% white, mean age 76.6 years), 896 (40%) had an SRE during follow-up, with 74% occurring within a year after cohort entry. Overall, the IR of SREs was 3.78 (95% CI, 3.53-4.03) per 100 person-months. The IR of SREs before any BTA use was 4.16 (95% CI, 3.71-4.65) per 100 person-months, and after any use was 3.60 (95% CI, 3.32-3.91) per 100 person-months. Conclusions: In this large cohort of elderly men with CRPC in a real-world setting in the U.S., SREs were common, with most occurring within a year after cohort entry. Although a direct causal interpretation of the difference in rates before and after BTA use is not possible (since confounding by indication and other factors cannot be excluded), further analysis may address at least some potential confounders.

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