AIMS: Abiraterone treatment requires regular drug intake under fasting conditions due to pronounced food effect, which may impact patient adherence. The aim of this prospective study was to evaluate adherence to abiraterone treatment in patients with prostate cancer. To achieve this aim, an abiraterone population pharmacokinetic model was developed and patients' adherence has been estimated by comparison of measured levels of abiraterone with population model-based simulations. METHODS: A total of 1469 abiraterone plasma levels from 83 healthy volunteers collected in a bioequivalence study were analysed using a nonlinear mixed-effects model. Monte Carlo simulation was used to describe the theoretical distribution of abiraterone pharmacokinetic profiles at a dose of 1000 mg once daily. Adherence of 36 prostate cancer patients treated with abiraterone was then evaluated by comparing the real abiraterone concentration measured in each patient during follow-up visit with the theoretical distribution of profiles based on simulations. Patients whose abiraterone levels were ˂5th or ˃95th percentile of the distribution of simulated profiles were considered to be non-adherent. RESULTS: Based on this evaluation, 13 patients (36%) have been classified as non-adherent. We observed significant association (P = .0361) between richness of the breakfast and rate of non-adherence. Adherent patients reported significantly better overall condition in self-assessments (P = .0384). A trend towards a higher occurrence of adverse effects in non-adherent patients was observed. CONCLUSIONS: We developed an abiraterone population pharmacokinetic model and proposed an advanced approach to medical adherence evaluation. Due to the need for administration under fasting conditions, abiraterone therapy is associated with a relatively high rate of non-adherence.

• MeSH
• adherence k farmakoterapii * statistika a číselné údaje   MeSH
• androsteny * farmakokinetika   aplikace a dávkování   terapeutické užití   MeSH
• biologické modely * MeSH
• dospělí MeSH
• interakce mezi potravou a léky MeSH
• lidé středního věku MeSH
• lidé MeSH
• metoda Monte Carlo MeSH
• nádory prostaty * farmakoterapie   MeSH
• omezení příjmu potravy MeSH
• prospektivní studie MeSH
• protinádorové látky farmakokinetika   aplikace a dávkování   MeSH
• senioři MeSH
• terapeutická ekvivalence MeSH
• Check Tag
• dospělí MeSH
• lidé středního věku MeSH
• lidé MeSH
• mužské pohlaví MeSH
• senioři MeSH
• Publikační typ
• časopisecké články MeSH

BACKGROUND: The PROpel study (NCT03732820) demonstrated a statistically significant progression-free survival benefit with olaparib plus abiraterone versus placebo plus abiraterone in the first-line metastatic castration-resistant prostate cancer (mCRPC) setting, irrespective of homologous recombination repair mutation status. OBJECTIVE: We report additional safety analyses from PROpel to increase clinical understanding of the adverse-event (AE) profiles of olaparib plus abiraterone versus placebo plus abiraterone. DESIGN, SETTING, AND PARTICIPANTS: A randomised (1:1), double-blind, placebo-controlled trial was conducted at 126 centres in 17 countries (October 2018-January 2020). Patients had mCRPC and no prior systemic mCRPC treatment. INTERVENTION: Olaparib (300 mg bid) or placebo with abiraterone (1000 mg od) plus prednisone/prednisolone (5 mg bid). OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: The data cut-off date was July 30, 2021. Safety was assessed by AE reporting (Common Terminology Criteria for Adverse Events v4.03) and analysed descriptively. RESULTS AND LIMITATIONS: The most common AEs (all grades) for olaparib plus abiraterone versus placebo plus abiraterone were anaemia (46.0% vs 16.4%), nausea (28.1% vs 12.6%), and fatigue (27.9% vs 18.9%). Grade ≥3 anaemia occurred in 15.1% versus 3.3% of patients in the olaparib plus abiraterone versus placebo plus abiraterone arm. The incidences of the most common AEs for olaparib plus abiraterone peaked early, within 2 mo, and were managed typically by dose modifications or standard medical practice. Overall, 13.8% versus 7.8% of patients discontinued treatment with olaparib plus abiraterone versus placebo plus abiraterone because of an AE; 3.8% versus 0.8% of patients discontinued because of anaemia. More venous thromboembolism events were observed in the olaparib plus abiraterone arm (any grade, 7.3%; grade ≥3, 6.8%) than in the placebo plus abiraterone arm (any grade, 3.3%; grade ≥3, 2.0%), most commonly pulmonary embolism (6.5% vs 1.8% for olaparib plus abiraterone vs placebo plus abiraterone). CONCLUSIONS: Olaparib plus abiraterone has a manageable and predictable safety profile. PATIENT SUMMARY: The PROpel trial showed that in patients who had not received any previous treatment for metastatic castration-resistant prostate cancer, olaparib combined with abiraterone was more effective in delaying progression of the disease than abiraterone alone. Most side effects caused by combining olaparib with abiraterone could be managed with supportive care methods, by pausing olaparib administration for a short period of time and/or by reducing the dose of olaparib.

• MeSH
• androsteny * terapeutické užití   aplikace a dávkování   škodlivé účinky   MeSH
• dvojitá slepá metoda MeSH
• ftalaziny * terapeutické užití   škodlivé účinky   MeSH
• lidé středního věku MeSH
• lidé MeSH
• metastázy nádorů MeSH
• nádory prostaty rezistentní na kastraci * farmakoterapie   patologie   MeSH
• piperaziny * terapeutické užití   aplikace a dávkování   škodlivé účinky   MeSH
• protokoly protinádorové kombinované chemoterapie * terapeutické užití   MeSH
• senioři MeSH
• Check Tag
• lidé středního věku MeSH
• lidé MeSH
• mužské pohlaví MeSH
• senioři MeSH
• Publikační typ
• časopisecké články MeSH
• klinické zkoušky, fáze III MeSH
• multicentrická studie MeSH
• randomizované kontrolované studie MeSH

BACKGROUND: In the CARD study, cabazitaxel significantly improved radiographic progression-free survival and overall survival versus abiraterone or enzalutamide in patients with metastatic castration-resistant prostate cancer previously treated with docetaxel and the alternative androgen signalling-targeted inhibitor. Here, we report the quality-of-life outcomes from the CARD study. METHODS: CARD was a randomised, multicentre, open-label, phase 4 study involving 62 clinical sites across 13 European countries. Patients (aged ≥18 years, Eastern Cooperative Oncology Group (ECOG) performance status ≤2) with confirmed metastatic castration-resistant prostate cancer were randomly assigned (1:1) by means of an interactive voice-web response system to receive cabazitaxel (25 mg/m2 intravenously every 3 weeks, 10 mg daily prednisone, and granulocyte colony-stimulating factor) versus abiraterone (1000 mg orally once daily plus 5 mg prednisone twice daily) or enzalutamide (160 mg orally daily). Stratification factors were ECOG performance status, time to disease progression on the previous androgen signalling-targeted inhibitor, and timing of the previous androgen signalling-targeted inhibitor. The primary endpoint was radiographic progression-free survival; here, we present more detailed analyses of pain (assessed using item 3 on the Brief Pain Inventory-Short Form [BPI-SF]) and symptomatic skeletal events, alongside preplanned patient-reported outcomes, assessed using the Functional Assessment of Cancer Therapy-Prostate (FACT-P) questionnaire and the EuroQoL-5 dimensions, 5 level scale (EQ-5D-5L). Efficacy analyses were done in the intention-to-treat population. Pain response was analysed in the intention-to-treat population with baseline and at least one post-baseline assessment of BPI-SF item 3, and patient-reported outcomes (PROs) were analysed in the intention-to-treat population with baseline and at least one post-baseline assessment of either FACT-P or EQ-5D-5L (PRO population). Analyses of skeletal-related events were also done in the intention-to-treat population. The CARD study is registered with ClinicalTrials.gov, NCT02485691, and is no longer enrolling. FINDINGS: Between Nov 17, 2015, and Nov 28, 2018, of 303 patients screened, 255 were randomly assigned to cabazitaxel (n=129) or abiraterone or enzalutamide (n=126). Median follow-up was 9·2 months (IQR 5·6-13·1). Pain response was observed in 51 (46%) of 111 patients with cabazitaxel and 21 (19%) of 109 patients with abiraterone or enzalutamide (p<0·0001). Median time to pain progression was not estimable (NE; 95% CI NE-NE) with cabazitaxel and 8·5 months (4·9-NE) with abiraterone or enzalutamide (hazard ratio [HR] 0·55, 95% CI 0·32-0·97; log-rank p=0·035). Median time to symptomatic skeletal events was NE (95% CI 20·0-NE) with cabazitaxel and 16·7 months (10·8-NE) with abiraterone or enzalutamide (HR 0·59, 95% CI 0·35-1·01; log-rank p=0·050). Median time to FACT-P total score deterioration was 14·8 months (95% CI 6·3-NE) with cabazitaxel and 8·9 months (6·3-NE) with abiraterone or enzalutamide (HR 0·72, 95% CI 0·44-1·20; log-rank p=0·21). There was a significant treatment effect seen in changes from baseline in EQ-5D-5L utility index score in favour of cabazitaxel over abiraterone or enzalutamide (p=0·030) but no difference between treatment groups for change from baseline in EQ-5D-5L visual analogue scale (p=0·060). INTERPRETATION: Since cabazitaxel improved pain response, time to pain progression, time to symptomatic skeletal events, and EQ-5D-5L utility index, clinicians and patients with metastatic castration-resistant prostate cancer can be reassured that cabazitaxel will not reduce quality of life when compared with treatment with a second androgen signalling-targeted inhibitor. FUNDING: Sanofi.

• MeSH
• androgeny genetika   MeSH
• androsteny aplikace a dávkování   škodlivé účinky   MeSH
• antagonisté androgenů aplikace a dávkování   škodlivé účinky   MeSH
• fenylthiohydantoin aplikace a dávkování   škodlivé účinky   analogy a deriváty   MeSH
• kvalita života MeSH
• lidé středního věku MeSH
• lidé MeSH
• metastázy nádorů MeSH
• nádory prostaty rezistentní na kastraci farmakoterapie   epidemiologie   patologie   MeSH
• přežití bez známek nemoci MeSH
• senioři MeSH
• taxoidy aplikace a dávkování   škodlivé účinky   MeSH
• výsledek terapie MeSH
• Check Tag
• lidé středního věku MeSH
• lidé MeSH
• mužské pohlaví MeSH
• senioři MeSH
• Publikační typ
• časopisecké články MeSH
• klinické zkoušky, fáze IV MeSH
• multicentrická studie MeSH
• práce podpořená grantem MeSH
• randomizované kontrolované studie MeSH

BACKGROUND: This systematic review and meta-analysis aimed to assess the prognostic value of sequential of abiraterone (ABI) and enzalutamide (ENZ) therapy in patients with castration-resistant prostate cancer (CRPC). METHODS: PUBMED, Web of Science, Cochrane Library, and Scopus databases were searched for articles published prior to December 2019 according to the Preferred Reporting Items for Systematic Review and Meta-analysis statement. Studies were deemed eligible if they compared overall survival (OS), combined progression-free survival (PFS), combined prostate specific antigen (PSA)-PFS, and PSA response rates in CRPC patients receiving sequential ABI/ENZ or vice versa. PSA response to both the first and second agents was defined as a >50% decrease in PSA achieved with each of these agents. Formal meta-analyses were performed for these outcomes. RESULTS: Ten studies with 1096 patients were eligible for the systematic review and eight studies with 643 patients for the meta-analysis. The ABI-to-ENZ sequence was significantly associated with better PFS (pooled hazard ratio (HR): 0.62, 95% confidential interval (CI): 0.49-0.78, P < 0.001), and PSA-PFS (pooled HR: 0.48, 95% CI: 0.38-0.61, P < 0.001) than the ENZ-to-ABI sequence. PSA response rates of both agents were significantly better with the ABI-to-ENZ sequence (risk ratio: 0.21, 95% CI: 0.09-0.47, P < 0.001). In contrast, treatment sequence was not significantly associated with OS (pooled HR: 0.77, 95% CI: 0.59-1.01, P = 0.055). CONCLUSIONS: ABI-to-ENZ sequential therapy in patients with CRPC was associated with better PFS, PSA-PFS, and PSA response rates. Regardless of sequencing, response to drug therapy was transient for both ABI and ENZ when either agent was used as a secondary therapy. Despite this, treatment sequencing is important to achieve the maximum possible benefit from available drugs in CRPC.

• MeSH
• androsteny aplikace a dávkování   MeSH
• antagonisté androgenů aplikace a dávkování   MeSH
• benzamidy aplikace a dávkování   MeSH
• fenylthiohydantoin aplikace a dávkování   MeSH
• kalikreiny krev   MeSH
• klinické zkoušky, fáze II jako téma MeSH
• lidé MeSH
• míra přežití MeSH
• nádory prostaty rezistentní na kastraci krev   farmakoterapie   patologie   MeSH
• nitrily aplikace a dávkování   MeSH
• progrese nemoci MeSH
• prostatický specifický antigen krev   MeSH
• randomizované kontrolované studie jako téma MeSH
• rozvrh dávkování léků MeSH
• výsledek terapie MeSH
• Check Tag
• lidé MeSH
• mužské pohlaví MeSH
• Publikační typ
• časopisecké články MeSH
• metaanalýza MeSH
• systematický přehled MeSH

Metody hormonální antikoncepce představují významný nástroj v realizaci plánovaného rodičovství. Ač byla primární konstrukce hormonální antikoncepce založena na kombinaci estrogenní a progestagenní komponenty, nejvýznamnější složkou přípravků hormonální antikoncepce je právě molekula progestinu zodpovědná za antigonadotropní účinek vedoucí k inhibici ovulace, zvýšení viskozity cervikálního hlenu a desynchronizaci endometria. Kombinace progestinů s estrogeny doposud zlepšovala profil krvácení, u rizikových uživatelek však zvyšovala riziko kardiovaskulárních komplikací, zejména hluboké žilní trombózy a plicní embolie. Vývoj čistě progestagenních kontraceptiv je veden s cílem eliminovat tato kardiovaskulární rizika. Nový preparát hormonální antikoncepce založený na samotné perorální aplikaci drospirenonu v denní dávce 4 mg aplikované v modelu 24 aktivních tablet + 4 dny hormon-free interval vykazuje antikoncepční efektivitu a profil krvácení shodný s přípravky kombinované hormonální antikoncepce i vysoký bezpečnostní profil, neboť riziko hluboké žilní trombózy a plicní embolie podle recentních klinických studií nezvyšuje. Jeví se jako velmi efektivní alternativa přípravků kombinovaných vhodná pro široké spektrum uživatelek.

Methods of hormonal contraception are an important tool in the implementation of family planning. Although the primary design of hormonal contraceptives was based on a combination of estrogenic and progestogenic components, the most important component of hormonal contraceptives is the progestin molecule responsible for the anti-gonadotropic effect leading to ovulation inhibition, increased cervical mucus viscosity and endometrial desynchronization. The combination of progestins with estrogens has improved the bleeding profile, but it has increased the risk of cardiovascular complications, particularly deep venous thrombosis and pulmonary embolism, in patients at specific risk. The development of purely progestogenic contraceptives is being conducted to eliminate these cardiovascular risks. A new hormonal contraceptive based on oral drospirenone alone at a daily dose of 4 mg administered in a 24-active tablet + 4 days hormone-free interval shows contraceptive efficacy and bleeding profile consistent with combined hormonal contraceptives and high safety profile as the risk of deep vein thrombosis and pulmonary embolism does not increase according to recent clinical studies. It appears to be a very effective alternative to combination products suitable for a wide range of users.

• Klíčová slova
• drospirenon, komplikace hormonální antikoncepce, profil krvácení,
• MeSH
• androsteny aplikace a dávkování   farmakologie   terapeutické užití   MeSH
• hodnocení léčiv MeSH
• hormonální antikoncepce * MeSH
• krvácení MeSH
• lidé MeSH
• progestiny aplikace a dávkování   farmakologie   terapeutické užití   MeSH
• Check Tag
• lidé MeSH
• ženské pohlaví MeSH

BACKGROUND: The efficacy and safety of cabazitaxel, as compared with an androgen-signaling-targeted inhibitor (abiraterone or enzalutamide), in patients with metastatic castration-resistant prostate cancer who were previously treated with docetaxel and had progression within 12 months while receiving the alternative inhibitor (abiraterone or enzalutamide) are unclear. METHODS: We randomly assigned, in a 1:1 ratio, patients who had previously received docetaxel and an androgen-signaling-targeted inhibitor (abiraterone or enzalutamide) to receive cabazitaxel (at a dose of 25 mg per square meter of body-surface area intravenously every 3 weeks, plus prednisone daily and granulocyte colony-stimulating factor) or the other androgen-signaling-targeted inhibitor (either 1000 mg of abiraterone plus prednisone daily or 160 mg of enzalutamide daily). The primary end point was imaging-based progression-free survival. Secondary end points of survival, response, and safety were assessed. RESULTS: A total of 255 patients underwent randomization. After a median follow-up of 9.2 months, imaging-based progression or death was reported in 95 of 129 patients (73.6%) in the cabazitaxel group, as compared with 101 of 126 patients (80.2%) in the group that received an androgen-signaling-targeted inhibitor (hazard ratio, 0.54; 95% confidence interval [CI], 0.40 to 0.73; P<0.001). The median imaging-based progression-free survival was 8.0 months with cabazitaxel and 3.7 months with the androgen-signaling-targeted inhibitor. The median overall survival was 13.6 months with cabazitaxel and 11.0 months with the androgen-signaling-targeted inhibitor (hazard ratio for death, 0.64; 95% CI, 0.46 to 0.89; P = 0.008). The median progression-free survival was 4.4 months with cabazitaxel and 2.7 months with an androgen-signaling-targeted inhibitor (hazard ratio for progression or death, 0.52; 95% CI, 0.40 to 0.68; P<0.001), a prostate-specific antigen response occurred in 35.7% and 13.5% of the patients, respectively (P<0.001), and tumor response was noted in 36.5% and 11.5% (P = 0.004). Adverse events of grade 3 or higher occurred in 56.3% of patients receiving cabazitaxel and in 52.4% of those receiving an androgen-signaling-targeted inhibitor. No new safety signals were observed. CONCLUSIONS: Cabazitaxel significantly improved a number of clinical outcomes, as compared with the androgen-signaling-targeted inhibitor (abiraterone or enzalutamide), in patients with metastatic castration-resistant prostate cancer who had been previously treated with docetaxel and the alternative androgen-signaling-targeted agent (abiraterone or enzalutamide). (Funded by Sanofi; CARD ClinicalTrials.gov number, NCT02485691.).

• MeSH
• androsteny aplikace a dávkování   škodlivé účinky   MeSH
• antagonisté androgenů aplikace a dávkování   škodlivé účinky   MeSH
• doba přežití bez progrese choroby MeSH
• fenylthiohydantoin aplikace a dávkování   škodlivé účinky   analogy a deriváty   MeSH
• intravenózní infuze MeSH
• Kaplanův-Meierův odhad MeSH
• lidé středního věku MeSH
• lidé MeSH
• nádory prostaty rezistentní na kastraci farmakoterapie   mortalita   MeSH
• prednison aplikace a dávkování   MeSH
• protokoly protinádorové kombinované chemoterapie škodlivé účinky   terapeutické užití   MeSH
• senioři nad 80 let MeSH
• senioři MeSH
• taxoidy aplikace a dávkování   škodlivé účinky   MeSH
• Check Tag
• lidé středního věku MeSH
• lidé MeSH
• mužské pohlaví MeSH
• senioři nad 80 let MeSH
• senioři MeSH
• Publikační typ
• časopisecké články MeSH
• multicentrická studie MeSH
• práce podpořená grantem MeSH
• randomizované kontrolované studie MeSH
• srovnávací studie MeSH

BACKGROUND: Patients with metastatic castration-resistant prostate cancer and homologous recombination repair (HRR) mutations have a better response to treatment with the poly(ADP-ribose) polymerase inhibitor olaparib than patients without HRR mutations. Preclinical data suggest synergy between olaparib and androgen pathway inhibitors. We aimed to assess the efficacy of olaparib plus the androgen pathway inhibitor abiraterone in patients with metastatic castration-resistant prostate cancer regardless of HRR mutation status. METHODS: We carried out this double-blind, randomised, placebo-controlled phase 2 trial at 41 urological oncology sites in 11 countries across Europe and North America. Eligible male patients were aged 18 years or older with metastatic castration-resistant prostate cancer who had previously received docetaxel and were candidates for abiraterone treatment. Patients were excluded if they had received more than two previous lines of chemotherapy, or had previous exposure to second-generation antihormonal drugs. Patients were randomly assigned (1:1) using an interactive voice or web response system, without stratification, to receive oral olaparib 300 mg twice daily or placebo. All patients received oral abiraterone 1000 mg once daily and prednisone or prednisolone 5 mg twice daily. Patients and investigators were masked to treatment allocation. The primary endpoint was investigator-assessed radiographic progression-free survival (rPFS; based on Response Evaluation Criteria in Solid Tumors version 1.1 and Prostate Cancer Clinical Trials Working Group 2 criteria). Efficacy analyses were done in the intention-to-treat population, which included all randomly assigned patients, and safety analyses included all patients who received at least one dose of olaparib or placebo. This trial is registered with ClinicalTrials.gov, number NCT01972217, and is no longer recruiting patients. FINDINGS: Between Nov 25, 2014, and July 14, 2015, 171 patients were assessed for eligibility. Of those, 142 patients were randomly assigned to receive olaparib and abiraterone (n=71) or placebo and abiraterone (n=71). The clinical cutoff date for the final analysis was Sept 22, 2017. Median rPFS was 13·8 months (95% CI 10·8-20·4) with olaparib and abiraterone and 8·2 months (5·5-9·7) with placebo and abiraterone (hazard ratio [HR] 0·65, 95% CI 0·44-0·97, p=0·034). The most common grade 1-2 adverse events were nausea (26 [37%] patients in the olaparib group vs 13 [18%] patients in the placebo group), constipation (18 [25%] vs eight [11%]), and back pain (17 [24%] vs 13 [18%]). 38 (54%) of 71 patients in the olaparib and abiraterone group and 20 (28%) of 71 patients in the placebo and abiraterone group had grade 3 or worse adverse events, including anaemia (in 15 [21%] of 71 patients vs none of 71), pneumonia (four [6%] vs three [4%]), and myocardial infarction (four [6%] vs none). Serious adverse events were reported by 24 (34%) of 71 patients receiving olaparib and abiraterone (seven of which were related to treatment) and 13 (18%) of 71 patients receiving placebo and abiraterone (one of which was related to treatment). One treatment-related death (pneumonitis) occurred in the olaparib and abiraterone group. INTERPRETATION: Olaparib in combination with abiraterone provided clinical efficacy benefit for patients with metastatic castration-resistant prostate cancer compared with abiraterone alone. More serious adverse events were observed in patients who received olaparib and abiraterone than abiraterone alone. Our data suggest that the combination of olaparib and abiraterone might provide an additional clinical benefit to a broad population of patients with metastatic castration-resistant prostate cancer. FUNDING: AstraZeneca.

• MeSH
• androsteny aplikace a dávkování   MeSH
• dvojitá slepá metoda MeSH
• ftalaziny aplikace a dávkování   MeSH
• hodnocení rizik MeSH
• Kaplanův-Meierův odhad MeSH
• lidé středního věku MeSH
• lidé MeSH
• míra přežití MeSH
• nádory prostaty rezistentní na kastraci farmakoterapie   mortalita   patologie   MeSH
• piperaziny aplikace a dávkování   MeSH
• přežití bez známek nemoci MeSH
• prognóza MeSH
• proporcionální rizikové modely MeSH
• protokoly protinádorové kombinované chemoterapie terapeutické užití   MeSH
• rozvrh dávkování léků MeSH
• senioři MeSH
• věkové faktory MeSH
• výsledek terapie MeSH
• vztah mezi dávkou a účinkem léčiva MeSH
• Check Tag
• lidé středního věku MeSH
• lidé MeSH
• mužské pohlaví MeSH
• senioři MeSH
• Publikační typ
• časopisecké články MeSH
• klinické zkoušky, fáze II MeSH
• multicentrická studie MeSH
• práce podpořená grantem MeSH
• randomizované kontrolované studie MeSH

Cíl: Enzalutamid a abirateron představují novou možnost terapie metastatického kastračně rezistentního karcinomu prostaty (metastatic castration-resistant prostate cancer – mCRPC). Cílem předkládané práce je retrospektivní analýza klinických zkušeností, léčebných výsledků a vzájemné porovnání obou preparátů u pacientů s mCRPC, kteří byli předléčeni chemoterapií v rámci našeho onkologického centra. Pacienti a metody: Bylo hodnoceno celkem 32 pacientů s mCRPC. Všichni pacienti byli předléčení minimálně jednou linií chemoterapie. Enzalutamidem bylo léčeno 23 pacientů, devět pacientů bylo léčeno abirateronem. Hodnotili jsme celkové přežití i přežití bez známek progrese. Výsledky: Při mediánu sledování 6,5 měsíce jsme u pacientů léčených enzalutamidem pozorovali celkem 10 progresí onemocnění (43,47 %). Celkem zemřelo osm pacientů k datu hodnocení (34,78 %). U pacientů léčených abirateronem jsme pozorovali celkem pět progresí onemocnění (55,56 %), jeden pacient zemřel (11,11 %). V rámci hodnocení celkového přežití nebyl prokázán statisticky významný rozdíl mezi skupinou pacientů léčených enzalutamidem a skupinou pacientů léčených abirateronem (HR 0,2362, 95% CI 0,0295– 1,8942; p = 0,102). V rámci hodnocení přežití bez známek progrese nebyl prokázán statisticky významný rozdíl mezi skupinou pacientů léčených enzalutamidem a skupinou pacientů léčených abirateronem (HR 0,9853, 95% CI 0,2934– 3,308; p = 0,939). Závěr: Naše retrospektivní studie prokázala podobnou účinnost enzalutamidu a abirateronu u pacientů s mCRPC, kteří byli předléčení chemoterapií.

Aim: Enzalutamide and abiraterone represent new therapeutical options in the treatment of metastatic castration-resistant prostate cancer (mCRPC). The aim of the presented study was retrospective analysis of clinical experience and efficacy of enzalutamide or abiraterone in the postchemo indication in patients with mCRPC. Patients and Methods: A total of 32 mCRPC patients were evaluated. All patients received one or more lines of chemotherapy. Twenty-three patients were treated by enzalutamide, nine patients were treated by abiraterone. We defined two parameters: over all survival and progression-free survival. Results: The median follow-up was 6.5 months. A total of 10 patients treated by enzalutamide progressed (43.47%) and eight patients died (34.78%). A total of five patients treated by abiraterone progressed (55.56%) and one patient died (11.11%). We did not observe any statistical difference in over all survival (HR 0.2362, 95% CI 0.0295– 1.8942; p = 0.102) and in progression-free survival (HR 0.9853, 95% CI 0.2934– 3.308; p = 0.939) between enzalutamide and abirateron. Conclusion: Our retrospective study demonstrated similar efficacy of enzalutamide and abiraterone in mCRPC patients previously treated by chemotherapy. Key words: prostate cancer – enzalutamide – abiraterone – over­all survival – progression-free survival – toxicity – metastases The authors declare they have no potential conflicts of interest concerning drugs, products, or services used in the study. The Editorial Board declares that the manuscript met the ICMJE recommendation for biomedical papers. Submitted: 11. 11. 2015 Accepted: 11. 1. 2016

• Klíčová slova
• hematologická toxicita,
• MeSH
• analýza přežití MeSH
• androsteny * aplikace a dávkování   škodlivé účinky   MeSH
• fenylthiohydantoin * analogy a deriváty   aplikace a dávkování   škodlivé účinky   MeSH
• Kaplanův-Meierův odhad MeSH
• krevní nemoci chemicky indukované   MeSH
• lidé středního věku MeSH
• lidé MeSH
• metastázy nádorů terapie   MeSH
• nádory prostaty rezistentní na kastraci * farmakoterapie   mortalita   MeSH
• nežádoucí účinky léčiv MeSH
• prednison terapeutické užití   MeSH
• přežití bez známek nemoci MeSH
• progrese nemoci MeSH
• retrospektivní studie MeSH
• senioři nad 80 let MeSH
• senioři MeSH
• Check Tag
• lidé středního věku MeSH
• lidé MeSH
• mužské pohlaví MeSH
• senioři nad 80 let MeSH
• senioři MeSH
• Publikační typ
• srovnávací studie MeSH

• MeSH
• analýza přežití MeSH
• androsteny * aplikace a dávkování   terapeutické užití   MeSH
• lidé MeSH
• nádory prostaty rezistentní na kastraci * farmakoterapie   MeSH
• retrospektivní studie MeSH
• taxoidy * aplikace a dávkování   terapeutické užití   MeSH
• výsledek terapie MeSH
• Check Tag
• lidé MeSH
• mužské pohlaví MeSH

• MeSH
• androsteny aplikace a dávkování   MeSH
• antagonisté mineralokortikoidních receptorů aplikace a dávkování   MeSH
• antikoncepce * trendy   MeSH
• estradiol analogy a deriváty   aplikace a dávkování   MeSH
• generika MeSH
• konjugované estrogeny (USP) terapeutické užití   MeSH
• kontraceptiva orální hormonální * aplikace a dávkování   škodlivé účinky   MeSH
• kontraceptiva orální kombinovaná * aplikace a dávkování   škodlivé účinky   MeSH
• lidé MeSH
• progestiny aplikace a dávkování   MeSH
• Check Tag
• lidé MeSH
• ženské pohlaví MeSH