Browsing by Subject "bevacizumab"

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  • Taipale, Claudia; Laine, Ilkka; Tuuminen, Raimo (2019)
    Objective: To evaluate the functional and anatomical response after the switch from bevacizumab to aflibercept in treatment-resistant wet age-related macular degeneration (wAMD) using the treat-and-extend regimen protocol. Design: A retrospective single-center study. Participants: The registry consisted of 576 patients with wAMD. Of these, a total of 41 eyes of 37 patients met the study inclusion criteria with a minimum of three prior bevacizumab injections and at least 1-year follow-up after the switch to aflibercept injections for the treatment of wAMD. Methods: Central retinal thickness (CRT) and best-corrected visual acuity (BCVA) were recorded before and after bevacizumab loading phase, before the switch to aflibercept, after aflibercept loading phase, and after the last injection or at the study end point at a minimum of 1 year from the switch. Results: At the switch to aflibercept injections, the mean CRT was 361.1 +/- 117.7 mu m (mean +/- SD) and BCVA was 0.29 +/- 0.19 decimals. The switch to aflibercept resulted in mean CRT resolution by 59.9 +/- 80.2 mu m after the loading phase and by 61.3 +/- 102.9 mu m at the study end point. Anatomical response to aflibercept switch was found in 34 of 41 eyes (83%) after the loading phase, and in 32 of 41 eyes (78%)at the study end point. BCVA improvement was 0.08 +/- 0.13 decimals in 26 of 41 eyes (63%) after the loading phase, and 0.04 +/- 0.17 decimals in 17 of 41 eyes (41%) at the study end point. The mean treatment interval of aflibercept was 8.0 +/- 2.2 weeks at the study end point. Conclusion: Regardless of impressive anatomical outcomes of aflibercept switch, functional response was modest for most of the study eyes at long term.
  • Hyytiäinen, Aini (Helsingin yliopisto, 2021)
    Pään ja kaulan alueen syöpäpotilaiden ennuste on huono siitä huolimatta, että syöpähoidot ovat kehittyneet viime vuosina. Angiogeneesi, eli verisuonten uudismuodostus, on edellytys syövän kasvulle ja leviämiselle ja tämän takia useita angiogeeneesiä estäviä lääkkeitä on kehitetty syövän hoitoon. Tässä tutkimuksessa tehtiin systemaattinen kirjallisuuskatsaus, jossa kerättiin tiedot kliinisistä tutkimuksista, joissa käytettiin angiogeenesi-inhibiittoreita pään ja kaulan alueen syöpäpotilailla. Kirjallisuushaku tehtiin Ovid MEDLINE, Cochrane Library, Scopus sekä ClinicalTrials.gov tietokannoissa. Tutkimus rajattiin kolmeen kategoriaan angiogeneesiä estäviä lääkkeitä: bevacizumab, tyrosiinikinaasin estäjät sekä endostatin. Kirjallisuuskatsaukseen sisällytettiin 38 kliinistä tutkimusta, jotka olivat vaiheissa I, II tai III. Angiogeneesi-inhibiittoreita käytettiin tutkimuksissa yksinään sekä yhdistettynä sädehoitoon, kemoterapiaan, kohdennettuun syöpähoitoon tai immunoterapiaan. Tutkimuksissa esiintyi 12 erilaista angiogeneesi-inhibiittoria ja näistä bevacizumab oli yleisimmin tutkittu lääke. Bevacizumab osoittautui tehokkaaksi useissa eri kombinaatioissa, mutta siihen liittyi paljon haittavaikutuksia. Endostatin sekä lenvatinib olivat hyvin siedettyjä ja niiden teho oli lupaava. Useimmat kliiniset tutkimukset angiogeneesi-inhibiittoreista eivät osoittautuneet hyödyllisiksi pään ja kaulan alueen syöpäpotilaiden hoidossa ja lisäksi useisiin lääkkeisiin liitettiin paljon haittavaikutuksia. Jotkin tulokset olivat kuitenkin lupaavia, varsinkin yhdistelmähoitoina, joten lisätutkimukset angiogeeneesi-inhibiittoreista pään ja kaulan alueen syöpäpotilaiden hoidossa ovat perusteltuja.
  • Hyytiäinen, Aini; Wahbi, Wafa; Väyrynen, Otto; Saarilahti, Kauko; Karihtala, Peeter; Salo, Tuula; Al-Samadi, Ahmed (2021)
    Background Head and neck squamous cell carcinoma (HNSCC) carries poor survival outcomes despite recent progress in cancer treatment in general. Angiogenesis is crucial for tumour survival and progression. Therefore, several agents targeting the pathways that mediate angiogenesis have been developed. We conducted a systematic review to summarise the current clinical trial data examining angiogenesis inhibitors in HNSCC. Methods We carried out a literature search on three angiogenesis inhibitor categories-bevacizumab, tyrosine kinase inhibitors and endostatin-from Ovid MEDLINE, Cochrane Library, Scopus and ClinicalTrials.gov database. Results Here, we analysed 38 clinical trials, total of 1670 patients, investigating 12 angiogenesis inhibitors. All trials were in phase I or II, except one study in phase III on bevacizumab. Angiogenesis inhibitors were used as mono- and combination therapies together with radio-, chemo-, targeted- or immunotherapy. Among 12 angiogenesis inhibitors, bevacizumab was the most studied drug, included in 13 trials. Although bevacizumab appeared effective in various combinations, it associated with high toxicity levels. Endostatin and lenvatinib were well-tolerated and their anticancer effects appeared promising. Conclusions Most studies did not show benefit of angiogenesis inhibitors in HNSCC treatment. Additionally, angiogenesis inhibitors were associated with considerable toxicity. However, some results appear encouraging, suggesting that further investigations of angiogenesis inhibitors, particularly in combination therapies, for HNSCC patients are warranted. Systematic Review Registration PROSPERO (https://www.crd.york.ac.uk/prospero/), identifier CRD42020157144.
  • Andre, T.; Vernerey, D.; Im, S. A.; Bodoky, G.; Buzzoni, R.; Reingold, S.; Rivera, F.; McKendrick, J.; Scheithauer, W.; Ravit, G.; Fountzilas, G.; Yong, W. P.; Isaacs, R.; Österlund, P.; Liang, J. T.; Creemers, G. J.; Rakez, M.; Van Cutsem, E.; Cunningham, D.; Tabernero, J.; de Gramont, A. (2020)
    Background: The bevacizumab-Avastin (R) adjuVANT (AVANT) study did not meet its primary end point of improving disease-free survival (DFS) with the addition of bevacizumab to oxaliplatin-based chemotherapy in stage III colon cancer (CC). We report here the long-term survival results (S-AVANT). Patients and methods: Patients with curatively resected stage III CC were randomly assigned to FOLFOX4, FOLFOX4-bevacizumab, or XELOX-bevacizumab. Results: A total of 2867 patients were randomized: FOLFOX4: n = 955, FOLFOX4-bevacizumab: n = 960, XELOX-bevacizumab: n = 952. With a median of 6.73 years follow-up (interquartile range 5.51-10.54), 672 patients died, of whom 198 (20.7%), 250 (26.0%), and 224 (23.5%) were in the FOLFOX4, FOLFOX4-bevacizumab, and XELOX-bevacizumab arms, respectively. The 10-year overall survival (OS) rates were 74.6%, 67.2%, and 69.9%, (P = 0.003) and 5-year disease-free survival (DFS) rates were 73.2%, 68.5%, and 71.0% (P = 0.174), respectively. OS and DFS hazard ratios were 1.29 [95% confidence interval (CI) 1.07-1.55; P = 0.008] and 1.16 (95% CI 0.99-1.37; P = 0.063) for FOLFOX4-bevacizumab versus FOLFOX4 and 1.15 (95% CI 0.95-1.39; P = 0.147) and 1.1 (95% CI 0.93 -1.29; P = 0.269) for XELOX-bevacizumab versus FOLFOX4, respectively. CC-related deaths (n = 542) occurred in 157 (79.3%) patients receiving FOLFOX4, 205 (82.0%) receiving FOLFOX4-bevacizumab, and 180 (80.4%) receiving XELOX-bevacizumab (P = 0.764), while non-CC-related deaths occurred in 41 (20.7%), 45 (18.0%), and 44 (19.6%) patients, respectively. Cardiovascular-related and sudden deaths during treatment or follow-up were reported in 13 (6.6%), 17 (6.8%), and 14 (6.3%) patients, in the FOLFOX4, FOLFOX4-bevacizuamb, and XELOX-bevacizumab arms, respectively (P = 0.789). Treatment arm, sex, age, histological differentiation, performance status, T/N stages, and localization of primary tumor were independent prognostic factors of OS in stage III. Conclusions: S-AVANT confirms the initial AVANT report. No benefit of the bevacizumab addition to FOLFOX4 adjuvant therapy in patients with stage III CC was observed in terms of DFS with a negative effect in OS, without increase in non-CC related deaths.
  • Laine, Ilkka; Lindholm, Juha-Matti; Ylinen, Petteri; Tuuminen, Raimo (2017)
    Purpose: To compare the short-term effects of three monthly intravitreal bevacizumab (IVB) injections to single dexamethasone (DEX) implantation in treatment-naive patients with cystoid macular edema (CME) secondary to branch (BRVO) and central retinal vein occlusion (CRVO). Design: A retrospective single-center study. Subjects: A total of 135 eyes of 135 patients with BRVO (n=83) and CRVO (n=52). Methods: Changes in clinical parameters were recorded before treatment and at the first and third month after commencement of IVB (n=121) and DEX (n=14). Main outcome measures: Central retinal thickness (CRT), intraocular pressure (IOP), and best-corrected visual acuity (BCVA). Results: The baseline parameters were comparable between IVB and DEX groups. After the first month, CRT decreased by 131.3 +/- 42.9 mu m in IVB and by 266.9 +/- 48.3 mu m in DEX (mean +/- SEM; p=0.047). IOP change was -0.29 +/- 0.39 mmHg in IVB and +3.70 +/- 2.34 mmHg in DEX (p=0.005). IOP elevation to. 25 mmHg and. 5 mmHg from the baseline was observed in two of the DEX- and in none of the IVB-treated eyes (p=0.010). After the third month, no differences regarding CRT and IOP were observed between the treatment modalities. Moreover, BCVA gain was comparable between IVB (0.37 +/- 0.05 logarithm of minimum angle of resolution [logMAR] units) and DEX (0.33 +/- 0.30 logMAR units) groups. Conclusion: DEX was associated with faster resolution of CME, but had greater probability for short-term IOP elevation when compared to IVB. After the third month, treatments were comparably effective. Anatomical outcomes and adverse drug reactions of IVB versus DEX should be considered case specifically in patients having CME secondary to BRVO/CRVO.
  • Rantala, Silja (Helsingin yliopisto, 2020)
    Tutkielman tavoitteena on selvittää silmän suonikalvon uudissuonten kasvustoa estävien lääkkeiden (anti-vascular endothelial growth factor, VEGF) vaikutusta näöntarkkuuteen ja verkkokalvon paksuuteen silmänpohjan kosteaa ikärappeumaa (neovascular age-related macular degeneration, nAMD) sairastavilla henkilöillä 6-8 vuoden seurannan aikana. Lisäksi selvitetään VEGF-lääkeinjektioiden vaikutusta näöntarkkuuteen ja verkkokalvon paksuuteen eri potilasryhmillä, jotka on jaoteltu käytettävän lääkityksen mukaan. Erityisesti halutaan tietää, onko aflibersepti bevasitsumabia parempi säilyttämään näöntarkkuus. Tutkielman potilasaineisto on analysoitu retrospektiivisesti. Tutkimusaineisto koostuu 48:sta potilasjärjestelmästä järjestyksessä valitusta potilaasta, joilla on todettu nAMD, ja jotka ovat olleet seurannassa vähintään 6 vuotta. Potilaita hoidettiin lasiaiseen annetuin lääkeinjektioin keskimäärin 1-2 kuukauden välein niin kauan kun potilaalla oli nAMD:n merkkejä. Lääkeaineina käytettiin bevasitsumabia (Avastin®; Roche Pharma AG), afliberseptia (Eylea®; Bayer AG) ja ranibitsumabia (Lucentis®; Novartis Pharma GmbH). Afliberseptilla hoidettiin niitä potilaita, joiden hoidoksi bevasitsumabi ei tehonnut. Näöntarkkuus mitattiin ETDRS-taulun avulla ja verkkokalvon paksuus sekä verkkokalvon alaisen nesteen määrä mitattiin Optical Coherence Tomography (OCT) -laitteella (Heidelberg Spectralis). Näöntarkkuus aleni kaikilla potilailla seurantajakson aikana 0,02 Snellen desimaalilukua (+0.07 logMAR). Verkkokalvon paksuus aleni keskimäärin 167μm. Lääkkeenvaihtoryhmän potilailla pelkällä bevasitsumabilla näöntarkkuus parani 0,03 Snellen desimaalia (-0,02 logMAR). Verkkokalvon paksuus aleni 58μm. Afliberseptilla näöntarkkuus aleni lääkkeenvaihdosta seurantajakson loppuarvoon 0,04 Snellen desimaalia (+0,08 logMAR). Verkkokalvon paksuus aleni 144 μm. Tulosten perusteella verkkokalvon paksuuden alenema afliberseptilla ei selkeästi heijastunut näöntarkkuuden paranemisena.
  • Rimpelä, Anna-Kaisa; Kiiski, Iiro; Deng, Feng; Kidron, Heidi; Urtti, Arto (2019)
    Biologicals are important ocular drugs that are be delivered using monthly and bimonthly intravitreal injections to treat retinal diseases, such as age-related macular degeneration. Long acting delivery systems are needed for prolongation of their dosing interval. Intravitreal biologicals are eliminated from the eye via the aqueous humor outflow. Thus, the anterior and posterior segments are exposed to the drug. We utilized a kinetic simulation model to estimate protein drug concentrations in the vitreous and aqueous humor after bolus injection and controlled release administration to the vitreous. The simulations predicted accurately the experimental levels of 5 biologicals in the vitreous and aqueous humor. The good match between the simulations and experimental data demonstrated almost complete anterior segment bioavailability, and major dose sparing with ocular controlled release systems. Overall, the model is a useful tool in the design of intraocular delivery of biologicals.