scholarly journals Noninterventional studies of depot formulations of LHRH analogues for prostate cancer in routine clinical practice. The launch of an observational program to assess the use of Eligard 45 mg in Russia

2015 ◽  
Vol 11 (1) ◽  
pp. 68
Author(s):  
V. B. Matveev ◽  
A. S. Markova
Keyword(s):  
Prostate Cancer ◽  
Clinical Practice ◽  
Routine Clinical Practice ◽  
Lhrh Analogues ◽  
Observational Program

scholarly journals Criteria for indication and treatment modification in a cohort of patients with prostate cancer treated with hormone therapy

2018 ◽  
Vol 10 (12) ◽  
pp. 365-376 ◽  
Author(s):  
Thierry Lebret ◽  
Alain Ruffion ◽  
Igor Latorzeff ◽  
Marc Zerbib ◽  
Jean-Luc Moreau ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Clinical Practice ◽  
Hormone Therapy ◽  
Predictive Factors ◽  
Primary Endpoint ◽  
Locally Advanced ◽  
Local Treatment ◽  
Routine Clinical Practice ◽  
Gnrh Analogue ◽  
Treatment Modification

Background: No published studies have specifically assessed whether treatment modifications to androgen deprivation therapy (ADT) for prostate cancer (PCa) are frequently carried out in routine clinical practice. The current study was conducted to determine what proportion of patients who had initiated hormone therapy with a gonadotropin-releasing hormone (GnRH) analogue then had their treatment regimen modified during the first 24 months. Methods: A prospective, noninterventional study was carried out in routine clinical practice in France. Patients with locally advanced or metastatic PCa were followed up for 2 years after treatment initiation with a GnRH analogue. The primary endpoint was the proportion of patients with a modification to their initial hormone therapy. Results: In total, 1301 patients were enrolled into the study by 204 physicians, and the primary endpoint could be evaluated for 891 patients. The GnRH analogue treatment was initiated for metastatic PCa (24.2%), locally advanced PCa without planned local treatment (20.6%), locally advanced PCa in association with radiotherapy (31.6%), and biochemical recurrence after local treatment (21.4%). Hormonal treatment was modified in 43.8% (390/891) of patients during the 24-month follow-up period after GnRH analogue initiation. In 61.3% of cases (239/390), the type of modification involved a change of GnRH analogue formulation or switch to another GnRH analogue. A total of five significant predictive factors for GnRH analogue treatment modification were identified: metastatic stage; physician sector; physician speciality; presence or absence of urinary symptoms; and intermittent versus continuous ADT. Conclusions: This study shows that in 43.8% of the patients with advanced PCa, ADT is modified in the first 2 years after initiation in routine clinical practice. Predictive factors for alteration of ADT were metastatic stage and the choice of an intermittent schedule.

scholarly journals Luteinizing hormone-releasing hormone agonists for prostate cancer patients: routine clinical practice of Russian cancer urologists

2021 ◽  
Vol 17 (2) ◽  
pp. 83-92
Author(s):  
V. B. Matveev ◽  
B. Ya. Alekseev ◽  
B. Sh. Kamolov ◽  
A. S. Markova
Keyword(s):  
Prostate Cancer ◽  
Clinical Practice ◽  
Luteinizing Hormone ◽  
Testosterone Level ◽  
Routine Clinical Practice ◽  
Lhrh Agonist ◽  
Luteinizing Hormone Releasing Hormone ◽  
Lhrh Agonists ◽  
Hormone Sensitive ◽  
First Time

Background. Despite the recent amendments to the guidelines for the treatment of metastatic hormone-sensitive prostate cancer (PCa) implying standard use of luteinizing hormone-releasing hormone (LHRH) agonists in combination with chemotherapy or androgen inhibitors, androgen deprivation therapy (ADT) remains an essential component of treatment for advanced PCa. Testosterone target castration level of 20 ng/dL implies routine measurement of testosterone levels along with prostate-specific antigen (PSA) levels during ADT. It is particularly interesting to evaluate the frequency of achieving castration testosterone level in routine clinical practice. Objective: to assess the frequency of achieving castration testosterone level (20 ng/dL) and maintaining it after 6 months of therapy in patients with hormone-sensitive PCa receiving an LHRH agonist for the first time. Materials and methods. In 2019-2020, Russian Society of Cancer Urologists conducted a non-interventional prospective multicenter study (observational program) aimed to evaluate the efficacy of LHRH agonist (including buserelin, goserelin, leuprorelin or triptorelin) in routine clinical practice in Russia. This study involved 39 cancer urologists and 479 patients aged 18 years and older diagnosed with hormone-sensitive PCa, who started their ADT with LHRH agonists for the first time regardless of the disease stage and previous treatment. Patients received hormone therapy with an LHRH agonist for at least 6 months, visiting their doctor every 3 months (visit 1; visit 2: after 3 months; visit 3: after 6 months). Results. Patients received one of the following drugs: leuprorelin (3.75 mg; 7.5 mg; 22.5 mg; 45 mg; n = 225; 47,0 %), goserelin (3.6 mg; 10.8 mg; n = 132; 27.5 %), buserelin (3.75 mg; n = 67; 14.0 %), and triptorelin (3.75 mg; 11.25 mg; n = 55; 11.5 %). Of 479 patients, 186 (38.8 %) received combination treatment with bicalutamide, 12 (2.5 %) with fluta-mide, 54 (11.3 %) with zoledronic acid, and 11 (2.3 %) with denosumab. Among 146 patients with metastatic PCa, a combination of ADT plus docetaxel was administered to 30 participants (20.6 %), ADT plus abiraterone to 8 participants (5.5 %), and ADT plus enzalutamide to 2 participants (1.4 %). After 6 months of therapy, mean PSA level decreased by 94.2 % (from baseline 118.12 ng/mL to 6.87 ng/mL). Mean testosterone level was 19.0 ng/dL (range: 0.029-100 ng/dL). Among 430 patients, the targeted testosterone level <20 ng/dL was achieved in 257 individuals (59.8 %); the level of 20-50 ng/dL was achieved in 158 individuals (36.7 %); and fifteen patients (3.5 %) had their testosterone level >50 ng/dL. The incidence of adverse events was low; most of them were mild. Conclusion. Our findings suggest that not all patients achieve targeted testosterone level of <20 ng/dL, which corroborates the need for routine monitoring of testosterone levels during therapy to ensure its timely correction. We observed frequent administration of ADT with maximum androgen blockade. In patients with metastatic PCa, the use of standards for combination treatment with docetaxel and androgen inhibitors is limited.

Docetaxel in older patients for metastatic prostate cancer.

2019 ◽  
Vol 37 (7_suppl) ◽  
pp. 187-187 ◽  
Author(s):  
Frances May Mark ◽  
Adam Pollard ◽  
Alastair H Thomson
Keyword(s):  
Prostate Cancer ◽  
Overall Survival ◽  
Clinical Practice ◽  
Metastatic Prostate Cancer ◽  
Age Groups ◽  
Response Rates ◽  
Routine Clinical Practice ◽  
Age Group ◽  
Psa Response ◽  
Castrate Resistant

187 Background: Docetaxel use has led to a significant prolongation in overall survival in metastatic prostate cancer (MPC). There is however limited information on treatment tolerance and outcomes in patients 80 years old and over in routine clinical practice. With the ever aging population it is becoming more important to assess outcomes in this age group. Methods: Patients diagnosed with MPC and treated with docetaxel from 2006 to 2016 were identified and their records retrospectively reviewed via electronic clinical and prescribing systems in a single centre in the UK. Data was assessed for prostate specific antigen (PSA) response, number of cycles and dosing of docetaxel and castrate resistant overall survival (OS). Results: 209 consecutive patients with MPC receiving docetaxel were reviewed. Three patient groups were identified; younger than 75 years old (n = 150, 37 early (as part of initial therapy) docetaxel), 75-79 years (n = 40, 2 early docetaxel) and 80 years or over (n = 19, no early docetaxel). When comparing mean OS excluding early docetaxel treatment, respective mean survival times for each of the three age groups, younger to older were 1001, 1045 and 1294 days, with between class difference being insignificant. The PSA response rates to docetaxel excluding first line use were compared between the age groups and did not show a significant difference at 39% in the youngest group, 38% in the intermediate age group and 42% for the oldest patients. There was a trend that the older the patient, the more likely docetaxel was the final systemic treatment given at 42% (80 years or over), 32% (75-79 years) and 23% (younger than 75 years). The 80 years or over group received fewer docetaxel cycles (3.8, p = 0.006) and less dose per course (226mg/m2, p = 0.004) than the group less than 75 years (5.8 cycles, 409mg/m2) and 75-79 years (5.1 cycles, 341mg/m2). Conclusions: In this group of patients, in routine clinical practice, the 80 years and over age group received fewer cycles of docetaxel in MPC and less dose per course, but nevertheless achieved similar PSA response rates and castrate resistant OS. Given these results, docetaxel should be considered as a treatment option in suitable patients of 80 years and over.

scholarly journals IMPROVE observational program: safety and effectiveness of biphasic insulin aspart 30 in routine clinical practice. Overview of starting characteristics of the Russian patient cohort

2009 ◽  
Vol 12 (4) ◽  
pp. 93-97
Author(s):  
Marina Vladimirovna Shestakova ◽  
Akill Ballan
Keyword(s):  
Clinical Practice ◽  
Glycemic Control ◽  
Hba1c Level ◽  
Routine Clinical Practice ◽  
Poor Glycemic Control ◽  
Patient Cohort ◽  
Antidiabetic Treatment ◽  
Starting Characteristics ◽  
Observational Program ◽  
Russian Patient

AIM: To analyse starting characteristics of the Russian patient cohort included in the IMPROVE observational program with reference to its demographiccomposition and clinical features of the disease in patients allocated to different groups depending on previous treatment, reason for prescribing DiAsp 30 (NovoMix 30) therapy, and its initial dosage regime. METHODS:The analysis covered the cohort of Russian patients included in the IMPROVE global program, an open non-randomizedobservational multicentre study of safety and effectiveness of insulin DiAsp for patients with DM2 during 26 weeks of routine clinical practice. In thepreceding period, the patients (n=4869) received either oral hypoglycemic agents (OHAs) (n=2430) or insulin +/- OHAs (n=2343); the controlgroup was comprised of 95 patients given no previous antidiabetic treatment. RESULTS: Most patients had inadequate glycemic control prior to DiAsp therapy with the mean HbA1c level of 9,2%. Those given no previous antidiabetictreatment showed the highest HbA1c level (9,9%) and higher frequency of microvascular vs macrovascular complications (91 and 51% respectively).Patients that used the largest amount of antidiabetic agents developed the highest number of complications; this situation reflects therelationship between poor glycemic control and the risk of complications. CONCLUSIONS: The Russian patient cohort is one of the three largest ones in the IMPROVE? global program. They reside in different geographic regions,have different history of antidiabetic treatment and far-from-normal HbA1c levels as a result of altogether poor glycemic control in Russian patientswith DM2. The cohort at large exhibits a suboptimal HbA1c level even though the majority of the patient have an access to antidiabetic therapy. Mostphysicians participating in the study refer to improved glycemic control in their DM2 patients (lowered HbA1c, fasting and postprandial glucose levels)as the main reason for the initiation of therapy with DiAsp 30 (NovoMix 30).

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