OBJECTIVE:Biosimilars are helping to reduce the cost burden of treatment and widen patient access to therapies. This multicentre trial compared the efficacy, safety and immunogenicity of the biosimilar aflibercept FYB203 with reference aflibercept in patients with neovascular age-related macular degeneration (nAMD). METHODS AND ANALYSIS:Patients aged ≥50 years with newly diagnosed nAMD and a best-corrected visual acuity (BCVA) between 20/40 and 20/200 Snellen equivalent were randomised (1:1) to double-masked treatment with 2 mg FYB203 or EU-approved reference aflibercept by intravitreal injection every 4 weeks for three doses (baseline, weeks 4 and 8) then every 8 weeks up to week 48. The primary efficacy endpoint was the change from baseline in BCVA by Early Treatment Diabetic Retinopathy Study (ETDRS) letters at week 8 in the study eye. Therapeutic equivalence of FYB203 and reference aflibercept was demonstrated if, depending on the regulatory requirement with respect to the significance level, the two-sided 90.4% and 95.2% CIs were within the predefined equivalence interval of (-3.5 to 3.5) ETDRS letters. RESULTS:A total of 433 patients received treatment with FYB203 (n=215) or reference aflibercept (n=218). Mean improvement in BCVA from baseline to week 8 was 6.6 ETDRS letters with FYB203 and 5.6 ETDRS letters with reference aflibercept, with an estimated mean treatment difference of 1.0 and the two-sided 90.4% CI (-0.3 to 2.2) and 95.2% CI (-0.6 to 2.5) fully contained within the pre-defined equivalence margins, confirming therapeutic equivalence between FYB203 and reference aflibercept. Safety and immunogenicity profiles were similar between groups. CONCLUSION:Although conducted during the COVID-19 pandemic in a potentially vulnerable elderly population and affected by geopolitical disruption in Ukraine, mitigation measures minimised the overall impact of these events. FYB203 demonstrated therapeutic equivalence to reference aflibercept in patients with nAMD, supporting similar clinical performance across all approved indications. TRIAL REGISTRATION NUMBER:Clinicaltrials.gov: NCT04522167; EudraCT: 2019-003923-39.

Abstract Topic Benign Disease: Esophageal Surgery Background Esophageal reconstruction poses significant challenges, particularly when traditional methods are not viable. This study explores innovative applications of the internal mammary artery (IMA) in supercharged colon replacement for esophageal reconstruction. Methods Analyzing nearly 1,000 esophageal resections performed between 1995 and October 2024 in Surgical Department, University of Pecs. We highlight the use of microsurgical techniques in 49 cases, specifically employing 38 free jejunal grafts and 11 supercharged colon replacements. Results During 11 "supercharged" colon replacements, the internal mammary vessels were utilized as receiving vessels in 7 cases, comprising 2 delayed primary and 5 secondary reconstructions, with patients 42 years old in average. The procedures involved ileocolon replacement, and the internal mammary artery and vein were accessed through a previously unreported left intercostal approach with only minimal or without rib resection due to unsuitable cervical vessels. While one patient experienced an anastomotic failure leading to sepsis and another required graft removal due to thrombosis, five patients healed without complications and achieved a good swallowing function Conclusion The purpose of the study is to verify the advantages of supercharged colon grafts in complicated esophageal reconstructions, which, in addition to reducing reflux, provide safe blood supply and can be easily applied even in the case of the ileocolon replacement. Moreover, the implementation of the supercharge technique significantly mitigates risks associated with ischemia and delayed motility. This research underscores the necessity of interdisciplinary collaboration between general and plastic surgeons skilled in microsurgery to optimize esophageal reconstruction outcomes.Ultimately, supercharged ileocolon replacement emerges as a viable and effective alternative in complex surgical scenarios where conventional methods fail.

This study aimed to evaluate the efficacy and safety of Eyluxvi, an aflibercept biosimilar, compared with reference Eylea in patients with neovascular age-related macular degeneration (nAMD). This phase 3, multicenter, randomized, double-masked, parallel-group study enrolled 431 patients at 79 sites across 12 countries. Patients were randomized 1:1 to receive intravitreal Eyluxvi or Eylea (2 mg) every 4 weeks through week 12, then every 8 weeks through week 48. The primary endpoint was change from baseline in best corrected visual acuity (BCVA) at week 8. The week 8 least-squares mean BCVA change was 5.771 letters with Eyluxvi vs 7.863 letters with Eylea (difference − 2.092 [95

Age-related macular degeneration (AMD) is among the leading causes of vision loss. Factors increasing the risk of AMD include aging, smoking, cardiovascular diseases and heritability. Although melanin pigment is known to protect retinal homeostasis, the link between pigmentation-related genes and AMD is unclear. We investigated associations between 26 variations in six pigmentation-related genes and wet AMD risk in a Finnish population, followed by replication in the United Kingdom (UK), Hungarian and Polish cohorts, totaling 775 patients and 959 controls. Associations of genetic components with smoking and body mass index (BMI) were tested in the Finnish and UK cohorts. The functionality of candidate variants in human retinal pigment epithelial (RPE) cells was evaluated using gene promoter analysis and gene silencing.Non-coding variants, rs1407995 in the dopachrome tautomerase (DCT) intron and rs3212351 in the melanocortin-1 receptor (MC1R) promoter, were associated with wet AMD in the Finnish cohort. The variant rs3212351 disrupts a binding site for transcription factor MITF and reduces MC1R expression in RPE cells. Unlike in the Finnish cohort, the data regarding the MC1R variant suggested a protective association in the Polish cohort. The incidence of AMD increased with age in all cohorts. Smoking increased AMD risk in the cohorts studied. Sex and BMI showed no associations.These findings suggest that variations in DCT and MC1R genes known to affect skin and eye pigmentation may also play a role in development of wet AMD. The observed population differences may be related to variable pigmentation traits.

Background:Patients suffering from upper gastrointestinal (UGI) cancers often present with malnutrition and frailty before undergoing major surgical procedures, which significantly elevates the risk of postoperative complications. Prehabilitation focuses on optimizing a patient's functional capacity before surgery to improve postoperative outcomes. Our goal was to synthesize the effects of prehabilitation on the postoperative outcomes of UGI cancer patients undergoing major surgical intervention using a systematic review and meta-analysis. Methods:A comprehensive systematic search was conducted across the PubMed, Embase, Cochrane, and Scopus databases to identify relevant randomized controlled trials (RCTs). Ten RCTs, encompassing data from 878 patients, were included in the analysis. Pooled risk ratios (RRs) were calculated for dichotomous variables (e.g., incidence of complications), and weighted mean differences were calculated for continuous variables using a random-effects model. Study quality was assessed using the RoB2 and GRADE approaches. Results:The meta-analysis showed a trend toward a lower incidence of minor postoperative complications (Clavien-Dindo Grade I-II) in the prehabilitation group. While the common effect model showed significance, the certainty of evidence remains low to very low for most outcomes, suggesting these results should be interpreted with caution. However, a significant reduction was found in Grade III complications when using a common effect model, although no significant differences were detected in Grade IV complications or mortality. Cardiovascular complications and hospital readmission rates also showed no significant disparity. Conclusion:The implementation of prehabilitation in UGI cancer patients is safe and shows a positive trend toward reducing minor postoperative complications, thereby enhancing patient comfort and potentially accelerating recovery time. While the certainty of evidence remains low, further high-quality RCTs with larger patient cohorts are warranted, especially to explore the role of multimodal prehabilitation.

Célkitűzés: A legjobb korrigált látóélesség (BCVA) és a centrális retinavastagsága (CRT) közötti összefüggés vizsgálata nedves típusú makuladegeneráció miatt antivaszkuláris endothelialis növekedési faktor (VEGF) terápiában részesülő szemekben. Betegek és módszerek: Retrospektív, esetszéria tanulmányunkban 37 nedves típusú makuladegenerációval egyszemes kezelésben részesülő beteg 37 szeméről készült spectral-domain optikai koherencia tomográfia (SD-OCT) felvétel CRT értékeit hasonlítottuk össze az azonos időben vizsgált BCVA-értékekkel. Az összes BCVA-érték ugyanazon olvastató által került meghatározásra. Összehasonlítottuk az anti-VEGF- (aflibercept) kezelés előtti, a kezelés 12. hónapjában mért CRT- és BCVA-értékeket. A kezelés alatt a két paraméterben bekövetkező változás összefüggését Pearson-korrelációval elemeztük. Eredmények: A kezelés megkezdése előtt mért 467,8 (±20,3) μm-ről a 12. hónapra 321,4 (±11,3) μm-re csökkent az átlag CRT. A kiinduláshoz képest a BCVA átlagos értéke 56,8 (±1,7) betűről 63,8 (±2,2) betűre emelkedett a 12. hónapra. A vizsgálat kezdetén alacsony korrelációt mértünk a BCVA- és a CRT-értékek között (r=–0,379). 12 hónapos kezelést követően nem volt kimutatható korreláció a CRT és a BCVA között (r=–0,082), illetve a 12. hónapban nem találtunk összefüggést a BCVA és a CRT kiindulási értékhez viszonyított változásai között (r=0,307). Következtetések: A kiinduláskor mért alacsony korreláció a CRT és a BCVA között a kezelés 12. hónapjában és a két időpont közötti változásban nem volt kimutatható, amiből arra következtethetünk, hogy a látóélesség alakulása komplexebb folyamatok együttese. A klinikai tapasztalatokkal összhangban a látásfunkciót nem kizárólag a CRT változása határozza meg.

The aim of this study was to analyse data from a clinical database using a novel visual acuity parameter to determine whether anti-VEGF molecules that target multiple domains involved in neovascularisation are more likely to achieve good visual acuity than agents that solely inhibit VEGF. This retrospective study analysed data from patients treated with anti-VEGF injections between 2015 and 2023. We set an ETDRS score threshold of 70 (equivalent to 20/40 Snellen acuity) to calculate ‘time in range’ (TIR). TIR is defined as ‘time spent with best-corrected visual acuity (BCVA) better than 20/40’ and can highlight significant variations in the time individuals spend above the threshold during their AMD treatment. Over nine years, 30,209 aflibercept and 10,876 ranibizumab injections were administered to 6043 patients. Patients received an average of 6.8 injections. The mean BCVA at the first injection was 57.00 ± 16.15 ETDRS letters for ranibizumab patients and 58.75 ± 15.82 for aflibercept patients, with a statistically significant difference (p < 0.001). Both groups showed significant improvement in visual acuity at follow-up (aflibercept: 60.21 ± 15.53; ranibizumab: 59.43 ± 15.81; both p < 0.001). The mean time between the two consecutive injections, including both the initial loading phase and the subsequent maintenance phase, was 67.22 ± 34.08 days for ranibizumab and 72.15 ± 31.00 days for aflibercept; the difference was statistically significant (p < 0.001). After controlling for the effect of initial BCVA and time between injections, patients who received aflibercept had a significantly higher average TIR (60.90 ± 36.27 days vs. 56.55 ± 38.78 days, p < 0.001), and significantly more likely to achieve >70 letters at the next visit (OR: 1.10; 95% CI: 1.05–1.15; p < 0.001) compared to patients receiving ranibizumab. Aflibercept treatment improves the likelihood of maintaining good BCVA by 10% compared to ranibizumab in patients receiving intravitreal anti-VEGF treatment for nAMD. Furthermore, the beneficial effects of aflibercept treatment are observed with less frequent dosing. Our results suggest that using anti-VEGF compounds that target multiple domains provides a detectable advantage in treating age-related macular degeneration, particularly when these agents have a longer duration of action.

Background/Aim: Enhanced recovery after surgery (ERAS) protocol is adopted in clinical practice worldwide, but a lack of evidence for measurable benefits after upper gastrointestinal (GI) surgeries can be detected especially regarding early oral feeding. Patients and Methods: A propensity score-matching study was conducted at the Department of Surgery of the University of P & eacute;cs between January 2020 and December 2023. The study included patients who underwent upper GI cancer surgery and were treated according to an early oral feeding protocol (EOF). Investigational and control groups were analyzed and compared from prospectively collected datasets. Results: We enrolled 72 patients, 36 in the EOF group, and 36 case- matched patients in the traditional late oral feeding (LOF) group. Oral feeding in the EOF group started on an average of 1.94 days postoperatively, while in the LOF group, it began on an average of 5.72 days postoperatively. EOF could reduce the average length of hospital stay. Statistically significant decreases were observed in the EOF group concerning the time until the first bowel movements, and the length of postoperative intravenous fluid therapy. No significant differences were detected regarding mortality, anastomosis insufficiency, inflammation and stricture or seroma formation. Conclusion: Early oral nutritional support positively impacts the recovery of patients following upper GI surgery without increasing mortality or anastomosis insufficiency rates compared to traditional protocols. Significant improvements were observed in quality of life indicators for patients in the early oral feeding group. This approach aligns with ERAS goals and suggests a valuable strategy for postoperative care in upper GI cancer surgeries.

PURPOSE:To evaluate the clinical efficacy, safety, and immunogenicity of biosimilar ABP 938 compared with the aflibercept reference product (RP) in adults with neovascular (wet) age-related macular degeneration (nAMD). DESIGN:A randomized, double-masked, active-controlled, multiregional clinical study. PARTICIPANTS:A total of 579 patients with active treatment-naïve choroidal neovascularization secondary to nAMD were randomized. METHODS:Evaluable patients (N = 576) received 2 mg of ABP 938 (n = 288) or aflibercept RP (n = 288) by intravitreal injection every 4 weeks for the first 3 doses, then every 8 weeks through week 48. At week 16, the ABP 938 group continued on ABP 938 (n = 273), whereas the aflibercept RP group was rerandomized to continue on aflibercept RP (n = 136) or transition to ABP 938 (n = 134). MAIN OUTCOME MEASURES:The primary efficacy end point was the least squares (LS) mean difference in change in best-corrected visual acuity (BCVA), measured by ETDRS letter score, from baseline to week 8. Secondary efficacy end points, safety, and immunogenicity were analyzed descriptively. In a substudy of patients, serum drug concentration profiles were assessed. RESULTS:Demographic and baseline characteristics and exposure to treatment were similar between groups. Among initially randomized patients, the LS mean difference in change from baseline in BCVA at week 8 between ABP 938 and aflibercept RP was 0.1, with a 2-sided 95% confidence interval (CI: -1.3, 1.5) and 90% CI (-1.1, 1.3) falling within prespecified similarity margins (-3.9, 3.9, and -3, 3, respectively); thus, the primary clinical efficacy end point was met. Secondary efficacy end points (parallel-arm and posttransition) were overall similar between groups. No clinically meaningful differences were observed in the incidence of ocular and nonocular adverse events or events of interest. A low and similar incidence of binding antidrug antibodies was observed in all groups. The substudy confirmed low systemic exposure of free drug concentrations of ABP 938 and aflibercept RP. CONCLUSIONS:This study supports the conclusion of no clinically meaningful differences in efficacy, safety, and immunogenicity between ABP 938 and aflibercept RP in patients with nAMD. Additionally, transitioning from aflibercept RP to APB 938 at week 16 resulted in comparable efficacy, safety, and immunogenicity between treatment groups. FINANCIAL DISCLOSURE(S):Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.

A 24-week phase 3 analysis previously demonstrated equivalent efficacy and comparable tolerability between candidate biosimilar CT-P42 and reference aflibercept in participants with diabetic macular edema. Here, we report long-term outcomes through week 52. This was a randomized, double-masked, active-controlled, phase 3 international trial, conducted at 83 study centers across Czech Republic, Estonia, Germany, Hungary, India, Latvia, Lithuania, Poland, Republic of Korea, Russia, Slovakia, Spain, and Ukraine. Adults (aged ≥ 18 years) diagnosed with type 1 or 2 diabetes mellitus, with diabetic macular edema involving the center of the macula, were randomized (1:1) to receive CT-P42 or reference aflibercept (2 mg in 0.05 mL) by intravitreal injection every 4 weeks (five doses), then every 8 weeks (four doses), over a 52-week study period. Study data were collected from July 2021 to April 2023. Efficacy, safety, and immunogenicity of CT-P42 compared with reference aflibercept were evaluated until week 52. Overall, 306 participants (CT-P42, 153; reference aflibercept, 153) completed the study through week 52. The primary efficacy endpoint of mean change from baseline in best corrected visual acuity through week 8 was reported previously. Improvements in best corrected visual acuity were maintained throughout and were similar between CT-P42 and reference aflibercept, with mean (standard deviation) change from baseline at week 52 of 12.1 (8.9) versus 11.1 (9.9) letters, respectively. Changes from baseline in central subfield thickness and other secondary efficacy endpoints as well as safety endpoints, including treatment-emergent adverse events and immunogenicity, were comparable between groups through week 52. Results through week 52 support the therapeutic equivalence between CT-P42 and reference aflibercept by demonstrating comparable long-term efficacy, safety, and immunogenicity. ClinicalTrials.gov identifier: NCT04739306.

To compare the efficacy and safety of the proposed aflibercept biosimilar SCD411 and reference aflibercept in patients with neovascular age-related macular degeneration, this randomized, double-masked, parallel-group, multicenter study was conducted in 14 countries from 13 August 2020 to 8 September 2022. Patients with neovascular age-related macular degeneration. With subfoveal, juxtafoveal, or extrafoveal choroidal neovascularization were aged 50 years or older. Intravitreal injection of SCD411 or aflibercept (2.0 mg) were administered every 4 weeks for the first three injections and every 8 weeks until week 48. The primary efficacy endpoint was the change in best-corrected visual acuity from baseline to week 8 with an adjusted equivalence margin of ± 3.0 letters. Patients were randomly assigned to receive either SCD411 (n = 288) or reference aflibercept (n = 288). A total of 566 participants (98.3%) completed week 8 of the study. The least-squares mean difference of change in best-corrected visual acuity from baseline to week 8 (SCD411—aflibercept) was − 0.4 letters (90% confidence interval = − 1.6 to 0.9). The incidence of ocular (69 of 287 [24.0%] vs. 71 of 286 [24.8%]) and serious ocular (5 of 287 [1.7%] vs. 3 of 286 [1.0%]) treatment-emergent adverse effects were similar between the SCD411 and aflibercept groups. Immunogenicity analysis revealed a low incidence of neutralizing antibody formation in both groups. In conclusion, SCD411 has equivalent efficacy compared with reference aflibercept in patients with neovascular age-related macular degeneration and has a comparable safety profile. The results support the potential use of SCD411 for the treatment of neovascular age-related macular degeneration.

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. 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. 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

BACKGROUND Neoadjuvant therapy is an essential modality for reducing the clinical stage of esophageal cancer; however, the superiority of neoadjuvant chemotherapy (nCT) or neoadjuvant chemoradiotherapy (nCRT) is unclear. Therefore, a discussion of these two modalities is necessary. AIM To investigate the benefits and complications of neoadjuvant modalities. METHODS To address this concern, predefined criteria were established using the PICO protocol. Two independent authors performed comprehensive searches using predetermined keywords. Statistical analyses were performed to identify significant differences between groups. Potential publication bias was visualized using funnel plots. The quality of the data was evaluated using the Risk of Bias Tool 2 (RoB2) and the GRADE approach. RESULTS Ten articles, including 1928 patients, were included for the analysis. Significant difference was detected in pathological complete response (pCR) [P < 0.001; odds ratio (OR): 0.27; 95%CI: 0.16-0.46], 30-d mortality (P = 0.015; OR: 0.4; 95%CI: 0.22-0.71) favoring the nCRT, and renal failure (P = 0.039; OR: 1.04; 95%CI: 0.66-1.64) favoring the nCT. No significant differences were observed in terms of survival, local or distal recurrence, or other clinical or surgical complications. The result of RoB2 was moderate, and that of the GRADE approach was low or very low in almost all cases. CONCLUSION Although nCRT may have a higher pCR rate, it does not translate to greater long-term survival. Moreover, nCRT is associated with higher 30-d mortality, although the specific cause for postoperative complications could not be identified. In the case of nCT, toxic side effects are suspected, which can reduce the quality of life. Given the quality of available studies, further randomized trials are required.

The introduction of robot-assisted minimally invasive esophageal surgery (RAMIE) represents a significant advancement in minimally invasive surgery. The robot system typically includes a high-resolution 3D camera and specially maneuverable instruments that are controlled by the surgeon from a console. By reducing the trauma caused by the intervention, this method allows for faster recovery compared to traditional open surgeries. Furthermore, the increased range of motion provided by the robot instruments enables more precise manipulations in the area of the esophagus and surrounding tissues, thereby improving the effectiveness of tumor resections and reconstructions. The results of clinical trials are promising: there is a decrease in postoperative pain, a lower risk of complications, and a shorter hospital stay, while the oncological outcomes are at least equivalent to open surgeries. As technology advances, robot-assisted esophageal surgery is expected to spread more widely, providing better patient care and surgical outcomes for both benign and malignant esophageal diseases.

Bevezetés: A malignus megbetegedésekben szenvedő páciensek prehabilitációjának és rehabilitációjának kiemelkedően fontos eleme a tápláltság és a fizikai állapot felmérése és nyomon követése. Az ERAS- (Enhanced Recovery After Surgery) protokoll fontos része a posztoperatív korai, szájon keresztüli táplálás megkezdése. Az e táplálási metódusnak a felső gastrointestinalis traktus műtétei utáni alkalmazására vonatkozó adatok hiányosak. Célkitűzés: Annak igazolására, hogy a korai, szájon át történő táplálás nem jelent hátrányt ebben a betegcsoportban, a Pécsi Tudományegyetem Sebészeti Klinikáján a 2020 februárja és 2022 júliusa között ilyen módon táplált betegek adatait vetettük össze egy becsült részvételi valószínűség szerinti párosítási tanulmány során, a klasszikus módon kezelt betegek adataival. Módszer: Vizsgálatunkba olyan betegeket vontunk be, akik felső gastrointestinalis daganat miatti műtéten estek át, melynek során nyelőcsővel képzett anastomosis került kialakításra (teljes gastrectomiák és nyelőcső-resecciók). A tanulmány 50 beteget foglalt magában: 25 beteget a korai oralis táplálási csoportba, míg 25 beteget a hagyományos oralis táplálásban részesülő csoportba soroltunk. Eredmények: Az oralis táplálás átlagosan a korai táplálási csoportban a műtét utáni 2,09. napon, míg a késői táplálási csoportban az 5,52. napon kezdődött. A korai csoportban a posztoperatív kórházi tartózkodási idő átlagosan 8,875 nap volt, szemben a késői csoportban jegyzett 12,161 napos átlaggal (p<0,05). Ugyanakkor nem volt kimutatható különbség a mortalitási rátában, illetve az anastomosissal összefüggő szövődmények előfordulásában. Megbeszélés: Megállapítható, hogy a korai, szájon keresztüli táplálási csoportban statisztikailag szignifikáns csökkenés mutatható ki a bélműködés megindulásáig eltelt időben, a kórházi tartózkodási időt tekintve és a posztoperatív parenteralis táplálás időtartamában. Következtetés: Elmondható, hogy a korai, szájon keresztüli táplálás alkalmazása a felső gastrointestinalis traktus műtétei után is biztonságos. Orv Hetil. 2024; 165(1): 24–29.

OBJECTIVE:To demonstrate the therapeutic similarity of CT-P42 compared with reference aflibercept (Eylea) in adult patients with diabetic macular edema (DME). DESIGN:Randomized, active-controlled, double-masked, phase III clinical trial PARTICIPANTS: Patients with a diagnosis of either type 1 or 2 diabetes mellitus with DME involving the center of the macula. METHODS:Patients were randomized (1:1) to receive either CT-P42 or reference aflibercept (2 mg/0.05 ml) by intravitreal injection every 4 weeks (5 doses), then every 8 weeks (4 doses), in the main study period. Results up to week 24 are reported herein. MAIN OUTCOME MEASURES:The primary end point was mean change from baseline at week 8 in best-corrected visual acuity (BCVA) using the ETDRS chart. Equivalence between CT-P42 and reference aflibercept was to be concluded if the 2-sided 95% confidence interval (CI) (global assumptions) and 2-sided 90% CI (United States Food and Drug Administration [FDA] assumptions) for the treatment difference fell entirely within the equivalence margin of ±3 letters, as assessed in the full analysis set. RESULTS:Overall, 348 patients were randomized (CT-P42: 173; reference aflibercept: 175). Best-corrected visual acuity improved from baseline to week 8 in both groups, with a least squares mean (standard error) improvement of 9.43 (0.798) and 8.85 (0.775) letters in the CT-P42 and reference aflibercept groups, respectively. The estimated between-group treatment difference was 0.58 letters, with the CIs within the predefined equivalence margin of ±3 letters (95% CI, -0.73 to 1.88 [global]; 90% CI, -0.52 to 1.67 [FDA]). Through week 24, other efficacy results for the 2 groups, in terms of change in BCVA and retinal central subfield thickness, as well as ETDRS Diabetic Retinopathy Severity Scale score, supported therapeutic similarity. Pharmacokinetics, usability, safety (including the proportions of patients experiencing ≥1 treatment-emergent adverse event [CT-P42: 50.3%; reference aflibercept: 53.7%]), and immunogenicity were also comparable between groups. CONCLUSIONS:This study in patients with DME demonstrated equivalence between CT-P42 and reference aflibercept (2 mg/0.05 ml) in terms of efficacy, with similar pharmacokinetic, usability, safety, and immunogenicity profiles. FINANCIAL DISCLOSURE(S):Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.

Introduction: Assessing the nutritional and physical status of patients with malignant diseases, is an essential element in their prehabilitation and rehabilitation. Initiating early oral feeding is an important part of the Enhanced Recovery After Surgery (ERAS) protocol. However, there is a lack of data regarding the application of this feeding method after upper gastrointestinal tract surgeries. Objective: To demonstrate that early oral feeding has no disadvantages in this patient population, we compared the data of patients treated by early oral feeding method between January 2020 and July 2022 at the Department of Surgery, University of Pécs, through a propensity score-matching study, with data of patients treated by the traditional method. Method: In our study, we included patients who underwent surgery due to upper gastrointestinal tumors with an esophageal anastomosis (total gastrectomies and esophageal resections). The study included 50 patients, 25 patients in the early oral feeding group and 25 patients in the traditional oral feeding group, with similar characteristics. Results: Oral feeding in the early group was started 2.09 days, while in the traditional group 5.52 days after surgery on an average. The average length of hospital stay was 8.875 days in the early oral feeding group, compared to 12.161 days in the traditional oral feeding group (p<0.05). However, no significant differences were observed in the mortality rate and anastomosis-related complications. Discussion: We found that the early oral feeding group had a statistically significant reduction in the time until the return of bowel movements, the length of hospital stay, and the duration of postoperative parenteral nutrition. Conclusion: It can be concluded that the application of early oral feeding is safe and feasible after upper gastrointestinal tract surgeries Orv Hetil. 2024; 165(1): 24–29.

Objective: The topic of this meta-analysis is the comparison of gastric conduit esophageal reconstructions with or without pyloroplasty. Background: Surgical procedures, especially minimal invasive esophagectomy (MIE) can be a curative treatment in the early stages of esophageal cancer. Previously, intraoperative pyloroplasty was routinely performed, but nowadays it became debated again in the light of minimally invasive esophagectomy. Methods: A comprehensive search was performed in multiple databases to identify randomized controlled trials investigating the topic. Two independent authors performed the selection based on predefined criteria. Statistical analysis was performed to assess any significant difference, then the bias and quality of the data were estimated. Results: Nine relevant RCTs consisting of 529 patients with esophageal cancer were identified. No significance was found in mortality [odds ratio (OR): 0.85; p = 0.642], anastomosis leakage (OR: 0.57; p = 0.254), respiratory morbidity (OR: 0.51; p = 0.214) and vomiting (OR: 0.74; p = 0.520), however the results about gastric emptying time (GET) were controversial (weighted mean difference (WMD): -67.71; p = 0.009, OR: 2.75; p = 0.072). Significant heterogeneity was not detected except for GET. Trial sequential analyses (TSA) show that a certain conclusion would require more data except in the binary variables of GET. Conclusion: We conclude that the pyloric drainage procedure is not routinely necessary, but further well-designed studies would be needed, especially in Europe.