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MeSH: receptory vaskulárního endoteliálního růstového faktoru-terapeutické užití

142 záznamů v BMČ Filtry

Článek

State-of-the art adjuvantní léčby renálního karcinomu
[State-of-the-art of adjuvant treatment of renal carcinoma]

Novák, Robert
Autor Novák, Robert Onkologicko-chirurgické oddělení LF MU a FN u sv. Anny, Brno
Katolická, Jana
Autor Autorita Onkologicko-chirurgické oddělení LF MU a FN u sv. Anny, Brno

Onkologická revue. 2024 ; 11 (2) : 133-139.

ISSN 2464-7195
Medvik
Zdroj

Lokalizovaný renální karcinom je spojen s rizikem rekurence po nefrektomii. Několik klinických modelů se snaží predikovat individuální riziko progrese onemocnění a mortality na základě klinických a patologických rysů. Systémová cílená antiangiogenní terapie, která se ukázala jako účinná u metastazujícího renálního karcinomu, neprokázala zlepšení celkového přežití v adjuvanci. Inhibitory imunitních kontrolních bodů vykazují signifikantní protinádorovou aktivitu a vedly k prodloužení přežití u metastazujícího renálního karcinomu, proto jsou předmětem zájmu v adjuvantní indikaci.1

Localized renal cell carcinoma has an associated risk of recurrence after nephrectomy. Several clinical risk models attempt to predict oncologic outcomes based on clinical and pathologic features. Systemic therapies targeting angiogenic pathways that are effective in metastatic renal cell carcinoma failed to show an improvement in overall survival in the adjuvant setting. Immune checkpoint inhibitors have shown significant antitumor activity with prolonged and durable responses in metastatic renal cell carcinoma, which led to an interest in evaluating these agents in the adjuvant setting.1

Článek

Intravitreal Aflibercept for Neovascular Age-Related Macular Degeneration Beyond One Year of Treatment: AZURE, a Randomized Trial of Treat-and-Extend vs. Fixed Dosing

Advances in therapy. 2024 ; 41 (3) : 1010-1024. [pub] 20240106

Adv Ther
ISSN 1865-8652
Medvik
Zdroj

INTRODUCTION: AZURE was a 76-week, randomized, open-label, parallel-group, phase IIIb noninferiority study comparing the efficacy and safety of intravitreal aflibercept (IVT-AFL) in a treat-and-extend (T&E) regimen with fixed dosing in patients with neovascular age-related macular degeneration (nAMD) previously receiving IVT-AFL for ≥ 1 year. METHODS: Patients were aged ≥ 51 years and had completed ≥ 1 year of IVT-AFL treatment prior to enrollment (IVT-AFL once per month [- 1 or + 2 weeks] for 3 months followed by IVT-AFL every 2 months [6-12 weeks]). Patients were randomly assigned (1:1) to receive IVT-AFL 2 mg in either a T&E (minimum treatment interval of 8 weeks with no upper limit, adjusted according to functional and anatomic outcomes, as assessed by the investigator; n = 168), or a fixed dosing regimen (treatment every 8 weeks [± 3 days]; n = 168). The primary endpoint was best-corrected visual acuity (BCVA) change from baseline to week (W) 52. The key secondary endpoint was the proportion of patients maintaining vision (< 15-letter loss) at W52. RESULTS: The full analysis set comprised 332 patients (T&E: n = 165; fixed dosing: n = 167). Mean BCVA change (baseline to W52) was - 0.3 ± 7.5 vs. - 0.5 ± 8.4 letters (T&E vs. fixed dosing; least-squares mean difference [95% CI]: 0.22 [- 1.51 to 1.96] letters; P < 0.0001 for noninferiority test [5-letter margin]). From baseline to W52, 95.2% (T&E) and 94.0% (fixed dosing) of patients maintained vision. Mean central subfield thickness change from baseline to W52 was - 24 ± 55 (T&E) and - 33 ± 47 (fixed dosing) μm. Last treatment interval to W76 was ≥ 12 weeks for 37.0% of T&E patients. No new safety signals were identified. CONCLUSION: IVT-AFL T&E can achieve similar functional and anatomic outcomes to fixed dosing every 8 weeks over 52 weeks in patients with nAMD who have completed ≥ 1 year of treatment, while reducing treatment burden. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02540954.

Článek

Efficacy and Safety of the Aflibercept Biosimilar SB15 in Neovascular Age-Related Macular Degeneration: A Phase 3 Randomized Clinical Trial

JAMA Ophthalmology. 2023 ; 141 (7) : 668-676. [pub] 2023Jul01

JAMA Ophthalmol
ISSN 2168-6173
Medvik
Zdroj

IMPORTANCE: Aflibercept biosimilars can expand available treatment options in retinal diseases and have the potential to improve patient access to safe and effective therapy. OBJECTIVE: To establish equivalence in efficacy and similarity in safety, pharmacokinetics, and immunogenicity of SB15 and reference aflibercept (AFL) in neovascular age-related macular degeneration (nAMD). DESIGN, SETTING, AND PARTICIPANTS: This was a randomized double-masked parallel group phase 3 trial conducted at 56 centers in 10 countries from June 2020 to March 2022, including follow-up through 56 weeks. Of 549 screened participants, 449 participants 50 years and older with treatment-naive nAMD were included and randomly assigned to SB15 (n = 224) or AFL (n = 225). Key exclusion criteria included considerable scarring, fibrosis, atrophy, and hemorrhage. This report includes results up to the end of the parallel group period at week 32. Of the 449 randomized participants, 438 (97.6%) completed week 32 follow-up. INTERVENTION: Participants were randomized 1:1 to receive 2 mg of SB15 or AFL every 4 weeks for the first 12 weeks (3 injections), followed by dosing every 8 weeks up to week 48, with final assessments at week 56. MAIN OUTCOMES AND MEASURES: The primary end point was the change in best-corrected visual acuity (BCVA) from baseline to week 8 with predefined equivalence margins of -3 letters to 3 letters. Other key end points were changes in BCVA and central subfield thickness up to week 32, safety, pharmacokinetics, and immunogenicity. RESULTS: The mean (SD) age among the 449 included participants was 74.0 (8.1) years, and 250 participants (55.7%) were female. Baseline demographic characteristics and most disease characteristics were comparable between treatment groups. The least squares mean change in BCVA from baseline to week 8 in the SB15 group was equivalent to that in the AFL group (6.7 letters vs 6.6 letters, respectively; difference, 0.1 letters; 95% CI, -1.3 to 1.4). Comparable efficacy between treatment groups was maintained up to week 32 (least squares mean change from baseline in BCVA: SB15, 7.6 letters vs AFL, 6.5 letters; least squares mean change from baseline in central subfield thickness: SB15, -110.4 μm vs AFL, -115.7 μm). No clinically relevant differences were observed in the incidence of treatment-emergent adverse events (TEAEs) (SB15, 107/224 [47.8%] vs AFL, 98/224 [43.8%]) and ocular TEAEs in the study eye (SB15, 41/224 [18.3%] vs AFL, 28/224 [12.5%]). The serum concentration profiles and cumulative incidences of overall antidrug antibody positive participants were comparable. CONCLUSIONS AND RELEVANCE: In this phase 3 randomized clinical trial, SB15 and AFL showed equivalent efficacy and comparable safety, pharmacokinetics, and immunogenicity in participants with nAMD. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04450329.

Článek

Vliv vstupní centrální retinální tloušťky na výsledek léčby diabetického makulárního edému afliberceptem - zkušenosti z běžné klinické praxe v České republice
[Effect of baseline central retinal thickness on the results of treatment of diabetic macular edema with aflibercept: real-life evidence in the Czech Republic]

Česká a slovenská oftalmologie. 2022 ; 78 (2) : 64-70.

ISSN 1211-9059
Medvik
Zdroj

Cíle: Prezentovat roční výsledky léčby afliberceptem u pacientů s diabetickým makulárním edémem (DME) a porovnat léčebnou odezvu u nemocných s rozdílnou vstupní centrální retinální tloušťkou (CRT). Materiál a metody: Jedná se o multicentrickou, retrospektivní, observační studii série případů. Pacienti s DME byli léčeni ve fixním režimu (5x injekcí s odstupem 1 měsíce a poté injekce ve 2měsíčních intervalech). Doba sledování byla 12 měsíců. Byl zhodnocen vývoj nejlepší korigované zrakové ostrosti (NKZO) a CRT. Měření byla prováděna před zahájením léčby a dále v období po 4, 6, 8, 10 a 12 měsících. Výsledky: Terapeuticky naivní skupina se skládala z 82 očí 79 pacientů. Celkový soubor pacientů byl rozdělen na 3 skupiny podle vstupních hodnot CRT. První skupinu tvořilo 28 očí se vstupní CRT < 450 μm (34,1 %), do druhé skupiny bylo zařazeno 25 očí s CRT v rozmezí 450–550 μm (30,5 %) a třetí skupina se skládala z 29 očí se vstupní CRT > 550 μm (35,4 %). Průměrná vstupní NKZO a SO byla v první skupině 66 ±7,1 písmen ETDRS optotypů, poté 70 ±7 písmen, 69,6 ±7,3 písmen a 71,3 ±7 písmen na kontrole po 4, 8 a 12 měsících. Průměrná vstupní hodnota CRT a SO byla v první skupině 379 ±48,6 μm, poté 337,1 ±76,5 μm, 320,2 ±74,1 μm a 315,1 ±62,2 μm po 4, 8 a 12 měsících. Průměrná vstupní NKZO a SO ve druhé skupině byla 64,1 ±9,7 písmen ETDRS, poté 66,9 ±10 písmen, 70 ±9,9 písmen a 70,5 ±11,5 písmen po 4, 8 a 12 měsících. Průměrná vstupní hodnota CRT a SO ve druhé skupině byla 497,4 ±76,4 μm a poté 376,5 ±106,1 μm, 360,8 ±70 μm a 351,3 ±91,3 μm ve 4, 8 a 12 měsících. V třetí skupině byla průměrná vstupní hodnota NKZO a SO 59,7 ±10,4 písmen ETDRS a poté 65 ±10,6 písmen, 64,8 ±9,6 písmen a 67 ±10 písmen po 4, 8 a 12 měsících. Průměrná vstupní hodnota CRT a SO ve třetí skupině byla 639,4 ±79,6 μm a poté 396,7 ±147,1 μm, 416,9 ±139,8 μm a 368,5 ±109,9 μm ve 4, 8 a 12 měsících. Všechny tyto změny byly statisticky významné (p < 0,05). Závěr: Léčba afliberceptem ve fixním režimu u nemocných s DME v prvním roce léčby vede ke statisticky významnému zlepšení NKZO a poklesu CRT. Pacienti s větší vstupní CRT, která byla doprovázena horší vstupní NKZO, prokázali nejlepší anatomické a funkční výsledky roční léčby afliberceptem.

Aim: Presentation of the 1-year results of aflibercept treatment in patients suffering from diabetic macular edema (DME) and comparison of the response to treatment of patients with different baseline central retinal thickness (CRT). Methods: This was a multicentre, retrospective observational study of a series of cases. Patients with DME were treated in a fixed regimen (5 injections at 1-monthly intervals and then injections at 2-monthly intervals). The period of follow-up was 12 months. The development of best corrected visual acuity (BCVA) and CRT was evaluated. Measurements were performed prior to the commencement of treatment and then after 4, 6, 8, 10, and 12 months. Results: The therapeutically naive group consisted of 82 eyes of 79 patients. The total cohort of patients was divided into 3 groups according to the baseline values of CRT. The first group was composed of 28 eyes with baseline CRT < 450 μm (34.1%), the second included 25 eyes with CRT in the range of 450–550 μm (30.5%), and the third group consisted of 29 eyes with baseline CRT > 550 μm (35.4%). The average baseline BCVA and SD in the first group was 66 ±7.1 letters ETDRS optotypes, and then 70 ±7 letters, 69.6 ±7.3 letters, and 71.3 ±7 letters at the follow-ups after 4, 8, and 12 months. The average baseline value of CRT and SD in the first group was 379 ±48.6 μm, and then 337.1 ±76.5 μm, 320.2 ±74.1 μm, and 315.1 ±62.2 μm after 4, 8, and 12 months. The average baseline BCVA and SD in the second group was 64.1 ±9.7 ETDRS letters, and then 66.9 ±10 letters, 70 ±9.9 letters, and 70.5 ±11.5 letters after 4, 8, and 12 months. The average baseline value of CRT and SD in the second group was 497.4 ±76.4 μm, and then 376.5 ±106.1 μm, 360.8 ±70 μm, and 351.3 ±91.3 μm after 4, 8, and 12 months. In the third group, the average baseline value of BCVA and SD was 59.7 ±10.4 ETDRS letters, and then 65 ±10.6 letters, 64.8 ±9.6 letters, and 67 ±10 letters after 4, 8, and 12 months. The average baseline value of CRT and SD in the third group was 639.4 ±79.6 μm, and then 396.7 ±147.1 μm, 416.9 ±139.8 μm, and 368.5 ±109.9 μm after 4, 8, and 12 months. All these changes were statistically significant (p < 0.05). Conclusion: Aflibercept treatment in a fixed regimen in patients suffering from DME results in a statistically significant improvement in BCVA and a decrease in CRT in the first year of treatment. Patients with a higher baseline CRT showed the best anatomical and functional results of the 1-year treatment with aflibercept.

Klíčová slova
aflibercept, diabetický makulární edém,
MeSH
komplikace diabetu MeSH
lidé MeSH
makulární edém * terapie MeSH
receptory vaskulárního endoteliálního růstového faktoru terapeutické užití MeSH
retrospektivní studie MeSH
Check Tag
lidé MeSH

Článek

Renální karcinom a možnosti jeho léčby v našich podmínkách

Novák, Robert
Autor Novák, Robert Onkologicko-chirurgické oddělení FN u sv. Anny v Brně

Profi medicína. 2022 ; 7 (16) : 13-16.

ISSN 2571-2527
Medvik
Zdroj

Článek

Two-year results of a combined regimen of aflibercept treatment in three types of choroidal neovascular membrane in the wet form of age-related macular degeneration: Real-life evidence in the Czech Republic

European journal of ophthalmology. 2021 ; 31 (5) : 2488-2495. [pub] 20201116

Eur J Ophthalmol
ISSN 1724-6016
Medvik
Zdroj

AIM: To present the results of a 2-year therapy with aflibercept in real-life practice in a mixed regimen in patients with a neovascular form of age-related macular degeneration (nAMD) and to evaluate the treatment response of various types of choroidal neovascular membranes (CNV) - occult (Type 1), classic (Type 2) and minimally classic (Type 4). METHODS: This was a multicentric, prospective, observational study of a series of cases. Patients diagnosed with the wet form of AMD were treated in a fixed regimen (3 injections at intervals of 1 month and then injections at 8-week intervals) in the first year, and in a pro re nata regimen (PRN) in the second year. The period of investigation was 24 months. The development of the best corrected visual acuity (BCVA) was evaluated by means of ETDRS optotypes (Early Treatment Diabetic Retinopathy Study) and the central retinal thickness (CRT). Measurements were performed prior to the commencement of therapy and then after 4, 8, 12, 16, 20 and 24 months. RESULTS: The therapeutically naïve group consisted of 135 eyes of 135 patients. Sixty-one eyes suffered from CNV of the 1st type, 50 eyes from CNV of the 2nd type and 24 eyes from CNV of the 4th type. The average baseline of BCVA ± SD in Type 1 CNV was 56.1 ± 10.8 letters of ETDRS, and then, respectively, 62.2 ± 12.9 letters, 62.8 ± 15.1 letters and 59.4 ± 13.2 letters after 4, 12 and 24 months. The average baseline value of CRT ± SD for Type 1 CNV was 442.4 ± 194.9 µm, and then 302.5 ± 144.4 µm, 277.7 ± 106.5 µm and 327.6 ± 138.6 µm at months 4, 12 and 24. The average baseline value of BCVA ± SD in Type 2 CNV was 55.6 ± 9.9 letters of ETDRS, and then 62.5 ± 11.1 letters, 62.5 ± 14.2 letters and 60.6 ± 15.1 letters after 4, 12 and 24 months. The average baseline value of CRT ± SD in Type 2 CNV was 446.8 ± 159.1 µm, and then 327.4 ± 127.0 µm, 316.7 ± 139.1 µm and 352.5 ± 132.4 µm at 4, 12 and 24 months. In Type 4 CNV, the average baseline value of BCVA ± SD was 56.7 ± 9.0 letters of ETDRS, and then 59.1 ± 10.6 letters, 59.2 ± 12.6 letters and 58 ± 8.8 letters after 4, 12 and 24 months. The average baseline value of CRT ± SD in Type 4 CNV was 492.1 ± 187.0 µm, and then 333.3 ± 137.5 µm, 326.7 ± 122.4 µm and 328.4 ± 132 µm at months 4, 12 and 24. All these changes were statistically significant (p < 0.05). CONCLUSION: Therapy with aflibercept in a mixed regimen in patients with the wet form of AMD during the investigation resulted in a statistically significant improvement in BCVA and decrease in CRT in both the occult and classic type of CNV. Both the functional and anatomical response to therapy was worse in the minimally classic type (Type 4) of CNV. SUMMARY DECLARATION: Patients suffering from the neovascular form of age-related macular degeneration were treated with aflibercept in a mixed regimen (fixed in the first year and PRN in the second year). After 24 months of examination, a significant improvement of both morphological and functional results was observed in three types of choroidal neovascular membrane.

MeSH
inhibitory angiogeneze terapeutické užití MeSH
injekce intravitreální MeSH
lidé MeSH
prospektivní studie MeSH
ranibizumab terapeutické užití MeSH
receptory vaskulárního endoteliálního růstového faktoru terapeutické užití MeSH
rekombinantní fúzní proteiny terapeutické užití MeSH
vlhká makulární degenerace * diagnóza farmakoterapie MeSH
výsledek terapie MeSH
zraková ostrost MeSH
Check Tag
lidé MeSH
Publikační typ
časopisecké články MeSH
multicentrická studie MeSH
pozorovací studie MeSH
Geografické názvy
Česká republika MeSH

Článek

Věkem podmíněná makulární degenerace
[Age-related macular degeneration]

Stěpanov, Alexandr
Autor Autorita ORCID Oční klinika LF UK a FN Hradec Králové

Geriatrie a gerontologie. 2021 ; 10 (2) : 87-91.

ISSN 1805-4684
Medvik
Zdroj

Věkem podmíněná makulární degenerace (VPMD) je ve vyspělých zemích nejčastější příčinou ztráty zraku lidí starších 65 let. U většiny pacientů lze zaznamenat „suchou“ formu VPMD, která pozvolna progreduje. Přibližně u 10 % pacientů se vyvíjí rychle postupující „vlhká“ forma VPMD, jejíž hlavní známkou je přítomnost choroidální nevaskulární membrány. VPMD vzniká na základě spojení genetických faktorů a životního stylu pacienta. Léčbou volby vlhké formy VPMD jsou intravitreální antiVEGF preparáty, v případě suché formy VPMD volíme antioxidanty, preparáty s obsahem luteinu a hemorheoferézu. Zásadním předpokladem úspěšné léčby je včasná diagnostika, a zejména včasné zahájení terapie.

Age-related macular degeneration (AMD) is the most common cause of vision loss in people over the age of 65 in developed countries. In most patients, a „dry“ form of AMD is noted, which gradually progresses. Choroidal nonvascular membrane is the main sign of „wet“ form of AMD which is present in 10 % of patients approximately. AMD develops as a result of an interaction between genetic and lifestyle factors of patients. The treatment of the choice of the wet form of AMD is intravitreal anti-VEGF injections, in the case of the dry form of AMD we can choose antioxidants, preparations with lutein and haemorheopheresis. An essential prerequisite for successful treatment is early diagnosis and especially early initiation of the treatment.