RESUMEN
PURPOSE: This paper reports a systematic review and meta-analysis protocol that will be used to evaluate the efficacy and safety of pembrolizumab, alone or combined with bevacizumab and other therapies, in adult women with cervical carcinoma from stage IB2 onwards. METHODS: The protocol follows PRISMA-P recommendations and was registered on PROSPERO (CRD42024531233). The search will be conducted without restrictions on language and year of publication in the following databases: Pubmed, Embase, Scopus, Web of Science, Cancerlit, The World Health Organization (WHO), International Clinical Trials Registry Platform (ICTRP) and Clinical Trials Registry Platform. Grey literature will be searched using the following sources: Clinicaltrials.gov, Google Scholar and Opengrey. Manual search will be carried out for the reference lists of eligible studies. The studies will be selected independently by two reviewers and all completed or ongoing randomized clinical trials that evaluated the efficacy and safety of pembrolizumab, used alone or combined with chemotherapy, radiotherapy, bevacizumab or surgery, in adult women diagnosed with cervical cancer, will be included. The data extraction will include population characteristics, type of treatment and main outcomes of studies. The methodological quality of the studies will be assessed using the Cochrane Risk of Bias 2.0. The certainty of the evidence will be rated using the Grading of Recommendations, Assessment, Development, and Evaluations (GRADE). CONCLUSIONS: The findings will be presented in narrative summary tables and a quantitative synthesis will be conducted using the 'meta' package of R software, version 4.3.1. This future systematic review may contribute with quality evidence for clinical decision-making on the use of pembrolizumab in women with cervical cancer.
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Anticuerpos Monoclonales Humanizados , Neoplasias del Cuello Uterino , Femenino , Humanos , Anticuerpos Monoclonales Humanizados/uso terapéutico , Anticuerpos Monoclonales Humanizados/efectos adversos , Antineoplásicos Inmunológicos/uso terapéutico , Antineoplásicos Inmunológicos/efectos adversos , Bevacizumab/uso terapéutico , Bevacizumab/efectos adversos , Metaanálisis como Asunto , Ensayos Clínicos Controlados Aleatorios como Asunto , Revisiones Sistemáticas como Asunto , Resultado del Tratamiento , Neoplasias del Cuello Uterino/tratamiento farmacológico , Neoplasias del Cuello Uterino/patologíaRESUMEN
OBJECTIVE: To assess the rate and risk factors for reactivation of retinopathy of prematurity (ROP) after intravitreal injection (IVI) of antivascular endothelial growth factor (VEGF) agents. STUDY DESIGN: Infants who received IVI therapy between 2017 and 2022 were enrolled and divided into 2 groups: those with and without ROP reactivation. Information on ROP variables and patient variables were analyzed using multivariable logistic regression. RESULTS: A total of 114 infants with 223 eyes were enrolled in the study. The ROP reactivation rate was 11.4% of infants (9.9% of eyes). The mean duration of reactivation was 84 ± 45 days. Among the 223 eyes treated with IVI, reactivation rates were 6% for bevacizumab, 13.9% for aflibercept, and 22.2% for ranibizumab. A multivariable regression model showed that ranibizumab was an independent risk factor (OR 11.4, P = .008) for reactivation. Other risk factors included infants with periventricular leukomalacia (OR 13.8, P = .003), patent ductus arteriosus ligation (OR 10.7, P = .032), and infants who still required invasive mechanical ventilation on the day of IVI therapy (OR 7.0, P = .018). CONCLUSIONS: All anti-VEGF agents carry a risk of ROP reactivation, with the risk being greater with ranibizumab 0.25 mg than with bevacizumab 0.625 mg. Reactivation of ROP should be assessed vigilantly, especially in those infants with increased risks. Future research to determine the optimal anti-VEGF selection and dosage in high-risk infants is warranted.
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Inhibidores de la Angiogénesis , Bevacizumab , Inyecciones Intravítreas , Ranibizumab , Receptores de Factores de Crecimiento Endotelial Vascular , Proteínas Recombinantes de Fusión , Retinopatía de la Prematuridad , Humanos , Retinopatía de la Prematuridad/tratamiento farmacológico , Inyecciones Intravítreas/efectos adversos , Masculino , Femenino , Inhibidores de la Angiogénesis/efectos adversos , Inhibidores de la Angiogénesis/administración & dosificación , Recién Nacido , Bevacizumab/efectos adversos , Bevacizumab/administración & dosificación , Bevacizumab/uso terapéutico , Factores de Riesgo , Ranibizumab/administración & dosificación , Ranibizumab/efectos adversos , Receptores de Factores de Crecimiento Endotelial Vascular/administración & dosificación , Proteínas Recombinantes de Fusión/administración & dosificación , Proteínas Recombinantes de Fusión/efectos adversos , Proteínas Recombinantes de Fusión/uso terapéutico , Factor A de Crecimiento Endotelial Vascular/antagonistas & inhibidores , Estudios Retrospectivos , Recurrencia , Recien Nacido Prematuro , LactanteRESUMEN
BACKGROUND Bevacizumab is an approved targeted therapy for metastatic cancer treatment. It can have adverse effects on multiple organs. Despite its low incidence, thrombotic microangiopathy (TMA) is the most severe complication. TMA has been associated with complement dysregulation, and treatment with eculizumab can be effective, despite the paucity of literature on eculizumab therapy for bevacizumab-associated TMA. To date, 10 cases have been reported, with less than half of them including a kidney biopsy. We present a new case of bevacizumab-associated TMA successfully treated with eculizumab, along with kidney biopsy records and an overview of mechanisms underlying TMA development in bevacizumab-treated patients. CASE REPORT A female patient diagnosed with metastatic breast cancer who was treated with bevacizumab in conjunction with chemotherapy was admitted to the hospital for acute kidney injury requiring hemodialysis, microangiopathic hemolytic anemia, and thrombocytopenia. TMA was diagnosed and was later confirmed by a kidney biopsy. Primary causes for TMA, such as ADAMTS13 deficiency and shiga toxin associated hemolytic-uremic syndrome, were ruled out, and the patient's condition was ultimately found to be triggered by exposure to bevacizumab. After discontinuing bevacizumab and receiving 4 weekly doses of eculizumab, kidney function and hematological parameters improved. CONCLUSIONS Bevacizumab-associated TMA can be reversed or attenuated in some patients with the use of eculizumab (inhibiting complement system overactivation), possibly reducing time to recovery, with fewer long-term sequelae. This additional case encourages future clinical trials to evaluate the safety and efficacy of eculizumab in cases of TMA associated with bevacizumab.
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Púrpura Trombocitopénica Trombótica , Microangiopatías Trombóticas , Humanos , Femenino , Bevacizumab/efectos adversos , Anticuerpos Monoclonales Humanizados/efectos adversos , Microangiopatías Trombóticas/inducido químicamenteRESUMEN
A central retinal vein occlusion (CRVO) case in a patient developed with sudden blurred vision in some hemifield areas of his left eye, maintaining 20/20 vision 15-days after the COVID-19 vaccination. Initial retinal findings were venous dilation and tortuosity with dispersing dot hemorrhages. Fluorescein angiography (FA) and optical coherence tomography (OCT) confirmed a non-ischemic CRVO diagnosis, and a complete blood panel was requested with average results. An intravitreal steroid dose was applied. A decrease in best-corrected visual acuity (BCVA) (20/30) with more intraretinal hemorrhages was documented. An intravitreal dose of bevacizumab and oral apixaban were added with a final BCVA of 20/20 with decreased hemorrhages. There is no specific causal relationship between COVID-19 vaccines and CRVO. Without previous risk factors and positive treatment response, this case may correlate the first COVID-19 vaccine dose and the event.
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COVID-19 , Edema Macular , Oclusión de la Vena Retiniana , Inhibidores de la Angiogénesis/efectos adversos , Bevacizumab/efectos adversos , Vacunas contra la COVID-19 , Angiografía con Fluoresceína , Humanos , Inyecciones Intravítreas , Edema Macular/tratamiento farmacológico , ARN Mensajero , Oclusión de la Vena Retiniana/diagnóstico , Oclusión de la Vena Retiniana/tratamiento farmacológico , Oclusión de la Vena Retiniana/etiología , SARS-CoV-2 , Tomografía de Coherencia Óptica , Resultado del Tratamiento , Vacunación/efectos adversos , Agudeza VisualAsunto(s)
Adenocarcinoma/tratamiento farmacológico , Anafilaxia/prevención & control , Anticuerpos Monoclonales Humanizados/uso terapéutico , Antineoplásicos Inmunológicos/uso terapéutico , Bevacizumab/uso terapéutico , Desensibilización Inmunológica/métodos , Hipersensibilidad a las Drogas/terapia , Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos/prevención & control , Neoplasias Pulmonares/tratamiento farmacológico , Adenocarcinoma/complicaciones , Anafilaxia/etiología , Anticuerpos Monoclonales Humanizados/efectos adversos , Antineoplásicos Inmunológicos/efectos adversos , Bevacizumab/efectos adversos , Hipersensibilidad a las Drogas/complicaciones , Humanos , Neoplasias Pulmonares/complicaciones , Masculino , Persona de Mediana Edad , Índice de Severidad de la Enfermedad , Resultado del TratamientoRESUMEN
PURPOSE: We performed a cross-sectional study of neurocognitive function in non-brain cancer patients treated with long-term bevacizumab. METHODS/PATIENTS: From 2015 to 2017, we included patients with different types of cancer treated with bevacizumab with or without chemotherapy (BEV; N = 20) or only chemotherapy (ChT; N = 19) for at least 34 weeks, patients who received non-brain radiotherapy (RxT; N = 19), and healthy controls (HC; N = 19) were assessed once at week 34 of treatment (BEV and ChT) or at completion of radiotherapy. Neurocognition was evaluated with the Hopkins Verbal Learning Test-Revised (HVLT-R) total and delayed recall, the Trail Making Test A and B, and the Controlled Oral Word Association Test in the four groups. Non-parametric tests were used to assess differences between groups. RESULTS: The BEV, ChT, and RxT groups scored significantly lower than the HC group on all tests and especially on the HVLT-R total recall. In no case were the mean scores of the BEV group significantly lower than those of the ChT or RxT groups. CONCLUSIONS: Neurocognitive impairment was seen even in patients treated with local non-brain radiotherapy. Treatment with bevacizumab for a long period of time does not seem to worsen neurocognitive function to a greater extent than chemotherapy.
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Antineoplásicos Inmunológicos/uso terapéutico , Bevacizumab/uso terapéutico , Neoplasias/tratamiento farmacológico , Trastornos Neurocognitivos/diagnóstico , Antineoplásicos Inmunológicos/efectos adversos , Bevacizumab/efectos adversos , Estudios Transversales , Femenino , Humanos , Masculino , Persona de Mediana Edad , Neoplasias/radioterapia , Trastornos Neurocognitivos/etiología , Pruebas NeuropsicológicasRESUMEN
PURPOSE: We evaluated the addition of bevacizumab, a humanized monoclonal antibody that targets vascular endothelial growth factor, to platinum-based chemotherapy in recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN). PATIENTS AND METHODS: Patients with chemotherapy-naïve (or with prior platinum as part of multimodal therapy completed ≥ 4 months earlier) recurrent or metastatic SCCHN were randomly assigned to receive a platinum-based chemotherapy doublet with or without bevacizumab 15 mg/kg given intravenously every 3 weeks until disease progression. Chemotherapy could be discontinued after six cycles if a maximum response was achieved. RESULTS: The study randomly assigned 403 patients. Median overall survival (OS) was 12.6 months with bevacizumab plus chemotherapy (BC) and 11.0 months with chemotherapy alone (hazard ratio, 0.87; 95% CI, 0.70 to 1.09; P = .22). At 2, 3, and 4 years, the OS rates were 25.2% v 18.1%, 16.4% v 10.0%, and 11.8% v 6.4% for BC versus chemotherapy, respectively. In an analysis of 365 eligible patients who started treatment, the hazard ratio was 0.82 (95% CI, 0.65 to 1.04; P = .10), with a median OS of 14.2 months on BC v 11.1 months on chemotherapy. Median progression-free survival with BC was 6.0 months v 4.3 months with chemotherapy (P = .0014). Overall response rates were 35.5% with BC and 24.5% with chemotherapy (P = .016). There was increased toxicity, including a higher rate of treatment-related grade 3 to 5 bleeding events (6.7% v 0.5%; P < .001) and treatment-related deaths (9.3% v 3.5%; P = .022) with BC versus chemotherapy. CONCLUSION: The addition of bevacizumab to chemotherapy did not improve OS but improved the response rate and progression-free survival with increased toxicities. These results encourage biomarker-driven studies of angiogenesis inhibitors with better toxicity profiles in select patients with SCCHN.
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Antineoplásicos Inmunológicos/administración & dosificación , Protocolos de Quimioterapia Combinada Antineoplásica/administración & dosificación , Bevacizumab/administración & dosificación , Neoplasias de Cabeza y Cuello/tratamiento farmacológico , Recurrencia Local de Neoplasia , Carcinoma de Células Escamosas de Cabeza y Cuello/tratamiento farmacológico , Anciano , Antineoplásicos Inmunológicos/efectos adversos , Protocolos de Quimioterapia Combinada Antineoplásica/efectos adversos , Bevacizumab/efectos adversos , Progresión de la Enfermedad , Esquema de Medicación , Femenino , Neoplasias de Cabeza y Cuello/mortalidad , Neoplasias de Cabeza y Cuello/patología , Humanos , Masculino , Supervivencia sin Progresión , Carcinoma de Células Escamosas de Cabeza y Cuello/mortalidad , Carcinoma de Células Escamosas de Cabeza y Cuello/secundario , Factores de Tiempo , Estados UnidosRESUMEN
PURPOSE: Patients with recurrent glioblastoma (rGBM) have a poor prognosis, with survival ranging from 25 to 40 weeks. Antiangiogenic agents are widely used, showing a variable response. In this study, we explored the efficacy of carmustine plus bevacizumab (BCNU/Bev) for treating rGBM. METHODS/PATIENTS: In this study, we assessed 59 adult patients with histologically confirmed rGBM who were treated with BCNU/Bev as second-line regimen. The response rate (RR), progression-free survival (PFS) and overall survival (OS) were evaluated according to their molecular expression profile, including CD133 mRNA expression, MGMT methylation (pMGMT), PDGFR amplification, YKL40 mRNA expression, IDH1/2 condition, p53 and EGFRvIII mutation status. RESULTS: Median follow-up was 18.6 months, overall RR to the combination was 56.3%, and median PFS was 9.0 months (95% CI 8.0-9.9). OS from time of diagnosis was 21.0 months (95% CI 13.2-28.7) and from starting BCNU/Bev it was 10.7 months (95% CI 9.5-11.8). IDH1/2 mutations were found in 30.5% of the patients, pMGMT in 55.9% and high CD133 mRNA expression in 57.6%. Factors which positively affected PFS included performance status (p = 0.015), IDH+ (p = 0.05), CD133 mRNA expression (p = 0.009) and pMGMT+ (p = 0.007). OS was positively affected by pMGMT+ (p = 0.05). Meanwhile, YKL40 negatively affected PFS (p = 0.01) and OS (p = 0.0001). Grade ≥ 3 toxicities included hypertension (22%) and fatigue (12%). CONCLUSIONS: BCNU/Bev is a safe and tolerable treatment for rGBM. Patients with MGMT+/IDH+ derive the greatest benefit from the treatment combination in the second-line setting. Nonetheless, high YKL40 expression discourages the use of antiangiogenic therapy.
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Inhibidores de la Angiogénesis/uso terapéutico , Bevacizumab/uso terapéutico , Neoplasias Encefálicas/tratamiento farmacológico , Carmustina/uso terapéutico , Glioblastoma/tratamiento farmacológico , Recurrencia Local de Neoplasia/tratamiento farmacológico , Antígeno AC133/genética , Antígeno AC133/metabolismo , Adulto , Anciano , Inhibidores de la Angiogénesis/efectos adversos , Antineoplásicos/efectos adversos , Antineoplásicos/uso terapéutico , Bevacizumab/efectos adversos , Neoplasias Encefálicas/irrigación sanguínea , Neoplasias Encefálicas/genética , Neoplasias Encefálicas/mortalidad , Carmustina/efectos adversos , Proteína 1 Similar a Quitinasa-3/genética , Colombia , Metilasas de Modificación del ADN/metabolismo , Enzimas Reparadoras del ADN/metabolismo , Esquema de Medicación , Femenino , Genes erbB-1 , Genes p53 , Glioblastoma/irrigación sanguínea , Glioblastoma/genética , Glioblastoma/mortalidad , Humanos , Isocitrato Deshidrogenasa/genética , Masculino , Metilación , Persona de Mediana Edad , Mutación , Recurrencia Local de Neoplasia/irrigación sanguínea , Recurrencia Local de Neoplasia/genética , Recurrencia Local de Neoplasia/mortalidad , Supervivencia sin Progresión , ARN Mensajero/metabolismo , Receptores del Factor de Crecimiento Derivado de Plaquetas/genética , Análisis de Supervivencia , Proteínas Supresoras de Tumor/metabolismo , Adulto JovenRESUMEN
OBJECTIVE: To investigate the question of whether salvage therapy with the programmed cell death protein 1 (PD-1)-blocking antibodies nivolumab or pembrolizumab with or without bevacizumab offers clinical or survival benefit in patients with recurrent high-grade gliomas (HGGs). METHODS: This was a single-institution retrospective observational study in 31 adult patients who received pembrolizumab (Keytruda) or nivolumab (Opdivo) with or without concurrent bevacizumab for recurrent high-grade glioma. RESULTS: Median progression-free survival (mPFS) from first anti-PD-1 dose was 3.2 months (95% confidence interval [CI] 2.2-4.2), and there was no difference in patients receiving nivolumab (mPFS 3.8 months, 95% CI 1.7-5.8) compared to patients receiving pembrolizumab (mPFS 2.3 months, 95% CI 1.7-2.8, log rank 3.1, p = 0.08). There was also no difference in mPFS if patients had previously received bevacizumab (mPFS 3.2 months, 95% CI 2-4.3) or were bevacizumab naive (mPFS 3.7, 95% CI 0-7.9, log rank 1.3, p = 0.3). The median survival from date of first anti-PD-1 dose was 6.6 months (95% CI 4.2-9.1). CONCLUSION: Salvage therapy with nivolumab or pembrolizumab with or without bevacizumab does not confer a survival benefit in this heavily pretreated unselected patient population. Until the results of the currently ongoing clinical trials become available, the use of PD-1-blocking antibodies should be considered in selected individuals only. CLASSIFICATION OF EVIDENCE: This retrospective observational study provides Class IV evidence that for patients with recurrent HGGs, salvage therapy with nivolumab or pembrolizumab does not significantly improve survival.
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Antineoplásicos/farmacología , Neoplasias Encefálicas/tratamiento farmacológico , Glioma/tratamiento farmacológico , Recurrencia Local de Neoplasia/tratamiento farmacológico , Receptor de Muerte Celular Programada 1/antagonistas & inhibidores , Adulto , Anciano , Anciano de 80 o más Años , Anticuerpos Monoclonales Humanizados/efectos adversos , Anticuerpos Monoclonales Humanizados/uso terapéutico , Antineoplásicos/efectos adversos , Bevacizumab/efectos adversos , Bevacizumab/uso terapéutico , Neoplasias Encefálicas/metabolismo , Neoplasias Encefálicas/mortalidad , Femenino , Glioma/metabolismo , Glioma/mortalidad , Humanos , Masculino , Persona de Mediana Edad , Recurrencia Local de Neoplasia/metabolismo , Recurrencia Local de Neoplasia/mortalidad , Nivolumab/efectos adversos , Nivolumab/uso terapéutico , Receptor de Muerte Celular Programada 1/metabolismo , Estudios Retrospectivos , Terapia Recuperativa , Análisis de Supervivencia , Resultado del Tratamiento , Adulto JovenRESUMEN
BACKGROUND: BEVZ92 is a proposed biosimilar to bevacizumab. The two molecules have similar physicochemical and functional properties in in-vitro and preclinical studies. In this clinical study, we compared the pharmacokinetic profile, efficacy, safety, and immunogenicity of BEVZ92 with reference bevacizumab as a first-line treatment in patients with metastatic colorectal cancer. METHODS: We did a randomised, open-label trial at 15 centres in Argentina, Brazil, India, Spain, and Ukraine. Eligible patients were aged 18 years or older, had metastatic colorectal cancer with at least one measurable non-irradiated lesion for which first-line chemotherapy was indicated and Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less, had not received previous treatment for advanced disease, and whose bone marrow, hepatic, renal, and coagulation markers were all within normal ranges. Patients were randomly assigned (1:1) to either BEVZ92 or reference bevacizumab (5 mg/kg on day 1 of each cycle every 2 weeks) in combination with fluorouracil, leucovorin, and oxaliplatin (FOLFOX) or fluorouracil, leucovorin, and irinotecan (FOLFIRI). Randomisation was done via a web service based on a stochastic minimisation algorithm and was stratified by chemotherapy regimen (FOLFOX vs FOLFIRI), previous adjuvant therapy (yes vs no), ECOG performance status (0-1 vs 2), and study site. The primary endpoint was the area under the concentration-versus-time curve after a single infusion (AUC0-336h) and at steady state (AUCss)-ie, at cycle 7-in the assessable population, which comprised all treated patients for whom serum concentration measurements were available during the first seven cycles. Bioequivalence was established if the 90% CIs for the ratio of BEVZ92 to reference bevacizumab of the geometric means for AUC0-336h and AUCss were within the acceptance interval of 80-125%. Secondary endpoints included objective response, clinical benefit, and progression-free survival in the intention-to-treat population and immunogenicity and safety profiles in all treated patients. This trial is registered with ClinicalTrials.gov, number NCT02069704, and is closed to new participants, with follow-up completed. FINDINGS: 142 patients were randomly assigned, 71 to the BEVZ92 group and 71 to the reference bevacizumab group. Two participants assigned to BEVZ92 did not receive treatment (one withdrew consent, the other had a serious intestinal obstruction before starting treatment); therefore, the treated population comprised 69 patients in the BEVZ92 group and 71 in the reference bevacizumab group. The geometric mean ratio of AUC0-336h in the BEVZ92 versus the control group was 99·4% (90% CI 90·5-109·0) and of AUCss was 100·0% (90·2-112·0). Objective response (35 [49%] of 71 vs 40 [56%] of 71), clinical benefit (62 [87%] vs 65 [92%]), and progression-free survival (median 10·8 months [95% CI 7·4-11·5] vs 11·1 months [95% CI 8·0-12·8]) were similar in the BEVZ92 and reference bevacizumab groups. No relevant differences were noted between the safety profiles of the two study treatments. Neutropenia was the most common grade 3 or 4 adverse event reported in the BEVZ92 (14 [20%] of 69 patients) and reference bevacizumab (19 [27%] of 71 patients) groups. Serious adverse events occurred in 19 (28%) patients in the BEVZ92 group and 21 (30%) in the reference bevacizumab group. Two patients died because of bevacizumab-related serious adverse events: a sudden death in the BEVZ92 group and a serious large intestinal perforation in the reference bevacizumab group. The occurrence of anti-drug antibodies was low and similar in both treatment groups (two patients in the BEVZ92 group and one in the reference bevacizumab group). INTERPRETATION: Our results suggest that BEVZ92 and reference bevacizumab are pharmacokinetically bioequivalent and have no appreciable differences in efficacy, immunogenicity, and safety profiles as first-line treatment in combination with FOLFOX or FOLFIRI in patients with metastatic colorectal cancer. FUNDING: mAbxience Research SL.
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Antineoplásicos Inmunológicos/uso terapéutico , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapéutico , Bevacizumab/uso terapéutico , Biosimilares Farmacéuticos/uso terapéutico , Camptotecina/análogos & derivados , Neoplasias Colorrectales/tratamiento farmacológico , Adulto , Anciano , Anticuerpos/sangre , Antineoplásicos Inmunológicos/efectos adversos , Antineoplásicos Inmunológicos/inmunología , Área Bajo la Curva , Bevacizumab/efectos adversos , Bevacizumab/inmunología , Bevacizumab/farmacocinética , Biosimilares Farmacéuticos/efectos adversos , Biosimilares Farmacéuticos/farmacocinética , Camptotecina/uso terapéutico , Neoplasias Colorrectales/patología , Femenino , Fluorouracilo/uso terapéutico , Humanos , Análisis de Intención de Tratar , Leucovorina/uso terapéutico , Masculino , Persona de Mediana Edad , Metástasis de la Neoplasia , Compuestos Organoplatinos/uso terapéutico , Supervivencia sin Progresión , Equivalencia TerapéuticaRESUMEN
OBJECTIVE: The current study aimed to investigate the clinical efficacy of paclitaxel combined with avastin for non-small cell lung cancer (NSCLC) patients diagnosed with malignant pleural effusion (MPE). METHOD: Total of 33 patients diagnosed with NSCLC as well as malignant pleural effusion were included. All of them received paclitaxel (175 mg/m2) and avastin (5 mg/kg). Clinical efficacy was evaluated using the total response rate, overall survival, progression-free survival and changes in MPE volume. Adverse events and rates of toxicities were examined as well. RESULTS: The total response rate reached 77% while the overall survival and the median progression-free survival were respectively 22.2 months and 8.4 months. Toxicities of grade 3-4 consisted of neutropenia in 57% of patients, anemia in 17% of them, febrile neutropenia in 11%, as well as anorexia in 7%. No treatment-correlated deaths were found. CONCLUSION: Paclitaxel combined with avastin decreased MPE volume and increased survival rate of NSCLC patients via inhibiting vascular endothelial growth factor expression.
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Inhibidores de la Angiogénesis/uso terapéutico , Antineoplásicos Fitogénicos/uso terapéutico , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapéutico , Bevacizumab/uso terapéutico , Carcinoma de Pulmón de Células no Pequeñas/tratamiento farmacológico , Neoplasias Pulmonares/tratamiento farmacológico , Paclitaxel/uso terapéutico , Adulto , Anciano , Inhibidores de la Angiogénesis/efectos adversos , Antineoplásicos Fitogénicos/efectos adversos , Protocolos de Quimioterapia Combinada Antineoplásica/efectos adversos , Bevacizumab/efectos adversos , Supervivencia sin Enfermedad , Femenino , Humanos , Masculino , Persona de Mediana Edad , Paclitaxel/efectos adversos , Derrame Pleural Maligno/tratamiento farmacológico , Calidad de Vida , Seguridad , Análisis de Supervivencia , Resultado del TratamientoRESUMEN
Summary Objective: The current study aimed to investigate the clinical efficacy of paclitaxel combined with avastin for non-small cell lung cancer (NSCLC) patients diagnosed with malignant pleural effusion (MPE). Method: Total of 33 patients diagnosed with NSCLC as well as malignant pleural effusion were included. All of them received paclitaxel (175 mg/m2) and avastin (5 mg/kg). Clinical efficacy was evaluated using the total response rate, overall survival, progression-free survival and changes in MPE volume. Adverse events and rates of toxicities were examined as well. Results: The total response rate reached 77% while the overall survival and the median progression-free survival were respectively 22.2 months and 8.4 months. Toxicities of grade 3-4 consisted of neutropenia in 57% of patients, anemia in 17% of them, febrile neutropenia in 11%, as well as anorexia in 7%. No treatment-correlated deaths were found. Conclusion: Paclitaxel combined with avastin decreased MPE volume and increased survival rate of NSCLC patients via inhibiting vascular endothelial growth factor expression.
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Humanos , Masculino , Femenino , Adulto , Anciano , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapéutico , Paclitaxel/uso terapéutico , Carcinoma de Pulmón de Células no Pequeñas/tratamiento farmacológico , Inhibidores de la Angiogénesis/uso terapéutico , Bevacizumab/uso terapéutico , Neoplasias Pulmonares/tratamiento farmacológico , Antineoplásicos Fitogénicos/uso terapéutico , Calidad de Vida , Seguridad , Protocolos de Quimioterapia Combinada Antineoplásica/efectos adversos , Análisis de Supervivencia , Derrame Pleural Maligno/tratamiento farmacológico , Resultado del Tratamiento , Paclitaxel/efectos adversos , Supervivencia sin Enfermedad , Inhibidores de la Angiogénesis/efectos adversos , Bevacizumab/efectos adversos , Persona de Mediana Edad , Antineoplásicos Fitogénicos/efectos adversosRESUMEN
INTRODUCCIÓN: El presente dictamen expone la evaluación del uso de aflibercept para el tratamiento de la vasculopatía coroidea polipoidal (VCP) refractaria a antiangiogénicos (bevacizumab o ranibizumab). La vasculopatía coroidea polipoidal (VCP) es una afección vascular de la coroides que se caracteriza por el desarrollo de dilataciones aneurismáticas, en forma de pólipos, de los vasos de la coroides. Además, se acompaña de formación anómala de vasos sanguíneos en forma ramificada. El diagnóstico se basa en el hallazgo de dilataciones polipoideas en la angiografía con indocianina verde. Los pólipos coroideos y la neovascularización pueden conducir a episodios recurrentes de desprendimiento de retina con exudados, desprendimiento epitelial con pigmento hemorrágico y hemorragia subretiniana. Inicialmente el tratamiento del VCP consistía en la terapia fotodinámica (PDT, por sus siglas en inglés photodynamic therapy) con verteporfina. Posteriormente, este fue reemplazado por los agentes anti receptor del factor de crecimiento endotelial vascular (anti-VEGF, por sus siglas en inglés vascular endotelial growth factor), como bevacizumab, ranibizumab y aflibercept, en el tratamiento de primera línea en pacientes con VCP. La extensión de su uso en esta población fue a partir de los resultados de ensayos clínicos aleatorizados (ECA) en la degeneración macular asociada a la edad (DMAE), pero que no distinguieron a los pacientes con VCP a pesar de que los efectos de la terapia anti-VEGF para la VCP puede diferir de aquellos con DMAE. TECNOLOGÍAS SANITARIA DE INTERÉS: AFLIBERCEPT: La solución de aflibercept para inyección (Eylea ®, Bayer Pharma) es una proteína de fusión consistente en la porción Fc de la inmunoglobulina IgG humana y de derivados de péptidos del receptor de factor de crecimiento endotelial vascular (VEGF). Esta proteína soluble se une a todas las formas de VEGF-A, VEGF-B y el factor de crecimiento placentario, previniendo que estos factores estimulen el crecimiento de los nuevos y frágiles vasos sanguíneos asociados con la degeneración macular asociado con la edad (FDA 2011). METODOLOGÍA: Se realizó una búsqueda de la literatura con respecto a la eficacia y perfil toxico del uso de aflibercept para el tratamiento de la vasculopatía coroidea polipoidal refractaria a antiangiogénicos (bevacizumab o ranibizumab). Esta búsqueda se efectuó en los meta-buscadores: Translating Research into Practice (TRIPDATABASE), National Library of Medicine (Pubmed-Medline) y Health Systems Evidence. Adicionalmente, se amplió la búsqueda revisando la evidencia generada por grupos internacionales que realizan revisiones sistemáticas (RS), evaluación de tecnologías sanitarias (ETS) y guías de práctica clínica (GPC), tales como, la Cochrane Group, the National Institute for Health and Care Excellence (NICE), the Agency for Health care Research and Quality (AHRQ), the Canadian Agency for Drugs and Technologies in Health (CADTH) y the Scottish Medicines Consortium (SMC). Esta búsqueda se completó ingresando a la página web www.clinicaltrials.gov, para así poder identificar ensayos clínicos en elaboración o que no hayan sido publicados aún, y así disminuir el riesgo de sesgo de publicación. RESULTADOS: La búsqueda de la literatura científica no identificó ningún ensayo clínico aleatorizado en la población de interés. En su lugar solo se identificaron escasos estudios de series de casos, que representan el nivel más bajo de evidencia. Pero que, además, presentaron importantes limitaciones metodológicas que disminuyen en gran medida la confianza en sus resultados. Los problemas metodológicos se relacionaron con problemas en la definición de los pacientes, los análisis estadísticos, el reporte de los resultados, un periodo corto de seguimiento y muestras pequeñas. La definición de ser refractario al tratamiento con anti-VEGF estaba ausente o no era uniforme entre los estudios. Cada estudio incluyó entre 10 y 30 ojos, un número muy limitado y con alto riesgo de errores tipo I y II. Los autores realizaron múltiples comparaciones sin implementar ningún ajuste. Los resultados se reportaron de manera incompleta sin agregar información de los valores de varianza o valores de significancia. En algunos estudios que incluyeron tanto a pacientes con VCP y DMAE, los resultados no se presentaron de manera diferenciada por diagnóstico. Respecto a los resultados reportados, no había consistencia en los desenlaces evaluados ni en las escalas con las que fueron medidas o los presentaron de manera cualitativa sin definiciones claras. Tampoco hubo uniformidad en el tratamiento con aflibercept. Así, el número de dosis de carga y de mantenimiento fueron inconsistentes, además, de que el tiempo de tratamiento fue corto (entre 3 y 6 meses) y solo un estudio presentó sus resultados a los 12 meses. CONCLUSIONES: La vasculopatía coroidea polipoidal (VCP) es una afección vascular de la coroides que se caracteriza por el desarrollo de dilataciones aneurismáticas, en forma de pólipos, de los vasos de la coroides. Aunque se considera a la VCP como un subtipo de la DMAE, existen controversias acerca de si la VCP forma parte del espectro de presentación de la DMAE. Existen varias marcas distintivas en la patología entre ambas, además de diferencias en el curso clínico, respuesta a los tratamientos, incluso algunos estudios proponen diferentes factores de riesgo genéticos. El reemplazo del uso del PDT por el de los agentes anti-VEGF intra-vítreo en pacientes con VCP como tratamiento de primera línea se derivó de los resultados de los ECA en pacientes con DMAE. Pero estos estudios no distinguieron entre los fenotipos de DMAE, y los efectos de la terapia anti-VEGF para la VCP, que puede diferir de aquellos con DMAE. La información disponible del uso de aflibercept en pacientes con VCP y respuesta inadecuada al tratamiento previo con anti-VEGF proviene de unos escasos estudios de series de casos, en un número limitado de pacientes y por un corto periodo de seguimiento. Estos estudios padecen de limitaciones metodológicas importantes relacionados con la definición de los pacientes, el número de pacientes incluidos, los análisis estadísticos, el reporte de resultados y el tiempo de seguimiento. El nivel de evidencia respecto a los efectos de aflibercept en pacientes con VCP refractarios a un agente anti-VEGF es muy bajo. Pero, además se suman limitaciones metodológicas de los estudios que afectan en gran medida su validez y confiabilidad. Asimismo, está comprometida la validez externa debido a las muestras pequeñas de los pacientes incluidos. No es posible evaluar el perfil de toxicidad de aflibercept en la población de interés del este dictamen. Los estudios de series de casos no reportaron los eventos adversos, o lo hicieron de manera incompleta, situación que no permite saber cuál es el perfil de toxicidad de aflibercept en los pacientes con VCP y uso previo de anti-VEGF. Con la información disponible, la incertidumbre es alta respecto a la potencial eficacia de aflibercept en el tratamiento de segunda línea en pacientes con VCP. Asimismo, la ausencia de datos de toxicidad oculares y sistémicos, no permite evaluar la relación beneficio/riesgo de este medicamento. El Instituto de Evaluación de Tecnologías en Salud e Investigación IETSI no aprueba el uso de aflibercept para el tratamiento de la vasculopatía coroidea polipoidal refractario a anti-angiogénicos (bevacizumab o ranibizumab).
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Humanos , Inmunoglobulina G/uso terapéutico , Enfermedad Cerebrovascular de los Ganglios Basales/tratamiento farmacológico , Receptores de Factores de Crecimiento Endotelial Vascular/uso terapéutico , Bevacizumab/efectos adversos , Ranibizumab/efectos adversos , Evaluación de la Tecnología Biomédica , Análisis Costo-EficienciaRESUMEN
LESSONS LEARNED: Accrual to renal cell carcinoma trials remains a challenge despite the lack of prolonged response to the available treatments.The observation of three responses among the 30 patients with median progression-free survival and overall survival of 8.3 and 15 months, respectively, indicates the combination has some activity, but it is not sufficient for further development. BACKGROUND: Treatment of metastatic renal cell carcinoma (mRCC) remains suboptimal. Preclinical data have previously shown that ixabepilone, a microtubule-stabilizing agent approved for the treatment of breast cancer, is active in taxane-sensitive and -resistant cells. In this single-arm phase II trial, we investigated a combination of ixabepilone plus bevacizumab in patients with refractory mRCC. METHODS: We enrolled 30 patients with histologically confirmed mRCC, clear cell subtype, who had not been previously treated with ixabepilone or bevacizumab but had received at least one prior U.S. Food and Drug Administration (FDA)-approved treatment for renal cell carcinoma (RCC). The treatment regimen consisted of 6 mg/m2 ixabepilone per day for 5 days and 15 mg/kg bevacizumab every 21 days. After 6 cycles, the treatment interval could be extended to every 28 days. The primary endpoint was the objective response rate according to the Response Evaluation Criteria in Solid Tumors (RECIST). Secondary endpoints were progression-free survival (PFS), overall survival (OS), and the toxicity of the combination. RESULTS: The median number of prior therapies was two (range per patient one to five). Patients received a median of 8 cycles of ixabepilone plus bevacizumab (range 2-54). The median follow-up was 36.4 months (range 23.5-96.5). Nineteen patients (63.3%) had stable disease as a best response. Three patients (10%) had a partial response. The median PFS was 8.3 months (95% confidence interval [CI], 4.9-10.6) and the median OS was 15.0 months (95% CI, 11.3-28.8). The total number of cycle for safety evaluation was 289. Grade 3/4 adverse events (>5% incidence) included lymphopenia (16.7%), hypertension (6.7%), and leukopenia (6.7%). CONCLUSION: The combination of ixabepilone and bevacizumab was well tolerated, with modest activity in second - or later-line mRCC, but it is not recommended as a therapy without further clinical development. Alternative combinations with these agents could be explored in future studies.
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Protocolos de Quimioterapia Combinada Antineoplásica/administración & dosificación , Bevacizumab/administración & dosificación , Carcinoma de Células Renales/tratamiento farmacológico , Epotilonas/administración & dosificación , Adulto , Anciano , Protocolos de Quimioterapia Combinada Antineoplásica/efectos adversos , Bevacizumab/efectos adversos , Hidrocarburos Aromáticos con Puentes/efectos adversos , Carcinoma de Células Renales/patología , Supervivencia sin Enfermedad , Epotilonas/efectos adversos , Femenino , Humanos , Persona de Mediana Edad , Estadificación de Neoplasias , Taxoides/efectos adversosRESUMEN
PURPOSE:: To analyze the effects of injections of intravitreal triamcinolone acetonide (IVTA) and intravitreal bevacizumab (IVB) on the incidence rates of anterior segment neovascularization (ASN) and neovascular glaucoma (NVG) in patients with macular edema secondary to central retinal vein occlusion (CRVO). METHODS:: In this prospective, randomized, double-masked, sham-controlled study, 35 patients with macular edema following CRVO were randomized to intravitreal bevacizumab, intravitreal triamcinolone acetonide, or sham injections during the first 6 months of the study. The primary outcome was the incidence rate of ASN at month 6. The secondary outcomes were the mean changes from baseline in best-corrected visual acuity (BCVA) and central foveal thickness (CFT) on optical coherence tomography over time to month 12. RESULTS:: ASN developed in 8 (22.86%) eyes, including 5 (62.50%) eyes in the sham group and 3 (37.50%) eyes in the IVTA group, during 12 months of fol low-up (p=0.009). BCVA differed significantly (p<0.05) among the groups only at month 1. CFT did not differ significantly (p<0.05) among the groups over 12 months. NVG required surgery and developed in one eye despite laser treatment. CONCLUSION:: Early treatment with intravitreal antivascular endothelial growth factor therapy decreases the rates of ASN and NVG after CRVO.
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Inhibidores de la Angiogénesis/administración & dosificación , Antiinflamatorios/administración & dosificación , Bevacizumab/administración & dosificación , Edema Macular/tratamiento farmacológico , Neovascularización Patológica/epidemiología , Triamcinolona Acetonida/administración & dosificación , Adulto , Anciano , Anciano de 80 o más Años , Inhibidores de la Angiogénesis/efectos adversos , Segmento Anterior del Ojo/irrigación sanguínea , Antiinflamatorios/efectos adversos , Bevacizumab/efectos adversos , Método Doble Ciego , Femenino , Estudios de Seguimiento , Fóvea Central/fisiopatología , Glaucoma Neovascular/tratamiento farmacológico , Humanos , Incidencia , Inyecciones Intravítreas , Edema Macular/etiología , Masculino , Persona de Mediana Edad , Neovascularización Patológica/etiología , Estudios Prospectivos , Oclusión de la Arteria Retiniana/complicaciones , Oclusión de la Arteria Retiniana/tratamiento farmacológico , Resultado del Tratamiento , Triamcinolona Acetonida/efectos adversos , Agudeza VisualRESUMEN
ABSTRACT Purpose: To analyze the effects of injections of intravitreal triamcinolone acetonide (IVTA) and intravitreal bevacizumab (IVB) on the incidence rates of anterior segment neovascularization (ASN) and neovascular glaucoma (NVG) in patients with macular edema secondary to central retinal vein occlusion (CRVO). Methods: In this prospective, randomized, double-masked, sham-controlled study, 35 patients with macular edema following CRVO were randomized to intravitreal bevacizumab, intravitreal triamcinolone acetonide, or sham injections during the first 6 months of the study. The primary outcome was the incidence rate of ASN at month 6. The secondary outcomes were the mean changes from baseline in best-corrected visual acuity (BCVA) and central foveal thickness (CFT) on optical coherence tomography over time to month 12. Results: ASN developed in 8 (22.86%) eyes, including 5 (62.50%) eyes in the sham group and 3 (37.50%) eyes in the IVTA group, during 12 months of fol low-up (p=0.009). BCVA differed significantly (p<0.05) among the groups only at month 1. CFT did not differ significantly (p<0.05) among the groups over 12 months. NVG required surgery and developed in one eye despite laser treatment. Conclusion: Early treatment with intravitreal antivascular endothelial growth factor therapy decreases the rates of ASN and NVG after CRVO.
RESUMO Objetivo: Analisar as taxas de incidência de neovascularização do segmento anterior (NSA) e de glaucoma neovascular (GNV), em pacientes com edema macular secundário a oclusão de veia central da retina (OVCR), em tratamento com injeções intravítreas de triamcinolona (IVTA) ou bevacizumab (IVB). Métodos: Neste estudo prospectivo, randomizado, duplo mascarado e sham controlado, 35 pacientes com edema macular secundário a OVCR foram randomizados para IVB, IVTA ou para o grupo controle (sham), durante os 6 primeiros meses do estudo. O desfecho primário foi a taxa de incidência de NSA no mês 6. Os desfechos secundários foram alterações médias da acuidade visual corrigida (BCVA) e espessura foveal central (EFC) ao exame de tomografia de coerência óptica, até o mês 12. Resultados: NSA ocorreu em oito (22,86%) olhos, cinco (62,50%) olhos no grupo sham e três (37,50%) olhos no grupo tratado com injeções intravítreas de Triamcinolona, Não houve nenhum caso com NSA no grupo tratado com bevacizumab durante 12 meses de acompanhamento (p=0,009). A BCVA apresentou diferença estatisticamente significante (p<0,05) entre os grupos, somente no mês 1. A EFC não apresentou diferenças estatisticamente significantes (p<0,05) entre os grupos ao longo dos 12 meses. GNV ocorreu em um olho apesar do tratamento com laser e este paciente necessitou de intervenção cirúrgica. Conclusão: O tratamento precoce com injeções intravítreas de Anti VEGF podem diminuir as taxas de neovascularização do segmento anterior e glaucoma neovascular após oclusão de veia central da retina.
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Humanos , Masculino , Femenino , Adulto , Persona de Mediana Edad , Anciano , Anciano de 80 o más Años , Triamcinolona Acetonida/administración & dosificación , Edema Macular/tratamiento farmacológico , Inhibidores de la Angiogénesis/administración & dosificación , Bevacizumab/administración & dosificación , Antiinflamatorios/administración & dosificación , Neovascularización Patológica/epidemiología , Oclusión de la Arteria Retiniana/complicaciones , Agudeza Visual , Glaucoma Neovascular/tratamiento farmacológico , Edema Macular/etiología , Método Doble Ciego , Incidencia , Estudios Prospectivos , Estudios de Seguimiento , Inhibidores de la Angiogénesis/efectos adversos , Inyecciones Intravítreas , Bevacizumab/efectos adversos , Fóvea Central/fisiopatología , Segmento Anterior del Ojo/irrigación sanguínea , Antiinflamatorios/efectos adversos , Neovascularización Patológica/etiologíaRESUMEN
BACKGROUND: Retinopathy of prematurity (ROP) is an eye disease caused by an alteration in retinal vasculogenesis that may lead to partial or complete vision loss with a harmful impact in terms of neurodevelopment. The purpose of the present study was to determine the neurodevelopment in patients with type i retinopathy of prematurity treated with intravitreal bevacizumab. MATERIAL AND METHODS: Case series. The inclusion criteria were: patients with type I ROP treated with a dose of 0.625mg/0.025ml of intravitreal bevacizumab. Demographic data and comorbidities were documented. Neurodevelopment was evaluated with the screening test of the Bayley Scale of Infant Development (BSID) in all patients between 11 and 28 weeks of age. RESULTS: Seven patients were included in the study. Four patients showed normal neurodevelopment according to the overall scores of the BSID scale. The distribution of high risk for neurodevelopmental delay in the different areas evaluated were as follows: 3 patients presented it in the cognitive area, one in the receptive communication area, one in the expressive area, one in the fine motor skills and 3 patients in the gross motor skills area. CONCLUSIONS: In these case series, the majority of patients treated with intravitreal bevacizumab for ROP showed normal neurodevelopment scores.
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Inhibidores de la Angiogénesis/uso terapéutico , Bevacizumab/uso terapéutico , Trastornos del Neurodesarrollo/etiología , Retinopatía de la Prematuridad/tratamiento farmacológico , Adulto , Inhibidores de la Angiogénesis/administración & dosificación , Inhibidores de la Angiogénesis/efectos adversos , Bevacizumab/administración & dosificación , Bevacizumab/efectos adversos , Cesárea , Femenino , Estudios de Seguimiento , Edad Gestacional , Humanos , Hiperbilirrubinemia/complicaciones , Recién Nacido de Bajo Peso , Recién Nacido , Recien Nacido Prematuro , Recién Nacido de muy Bajo Peso , Inyecciones Intravítreas , Masculino , Edad Materna , Trastornos del Neurodesarrollo/inducido químicamente , Trastornos del Neurodesarrollo/epidemiología , Trastornos del Neurodesarrollo/prevención & control , Embarazo , Complicaciones del Embarazo/epidemiología , Retinopatía de la Prematuridad/complicaciones , Resultado del Tratamiento , Adulto JovenRESUMEN
PURPOSE: To evaluate choroidal thickness (CT) using spectral domain optical coherence tomography (SD-OCT) imaging at baseline and 6 months after intravitreal anti-vascular endothelial growth factor (anti-VEGF) treatment in patients with diabetic macular edema (DME). METHODS: A retrospective chart review was performed to identify patients with DME who underwent intravitreal injection of anti-VEGF (bevacizumab or ranibizumab) in a pro re nata (PRN) regimen. Subfoveal choroidal thickness was compared between values obtained at baseline and at 6-month follow-up visits. RESULTS: Thirty-nine eyes (15 females, 24 males) from 39 patients were enrolled (mean age, 62.43 ± 8.7 years; range, 44-79 years). Twenty-three and 16 eyes were treated with ranibizumab and bevacizumab respectively. The mean number of anti-VEGF injections was 2.28 ± 1.27 (range, 1-5). Mean nasal, subfoveal, and temporal choroidal thickness (CT) measurements at baseline were 234.10 ± 8.63 µm, 246.89 ± 8.94 µm, and 238.12 ± 8.20 µm, respectively, and those at 6 months post-treatment were 210.46 ± 8.00 µm, 215.66 ± 8.29 µm, and 212.43 ± 8.14 µm, respectively. Significant differences in CT were observed between baseline and the 6-month follow-up at all measured points (p=0.0327). CONCLUSIONS: Over a 6-month period, the use of intravitreal anti-VEGF was associated with significant thinning of the choroid in patients with DME. The clinical significance of a thinner choroid in DME is currently unknown; however, it may contribute to long-term adverse effects on choroidal and retinal function, representing an area requiring future investigation.
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Bevacizumab/administración & dosificación , Coroides/efectos de los fármacos , Coroides/patología , Retinopatía Diabética/tratamiento farmacológico , Edema Macular/tratamiento farmacológico , Ranibizumab/administración & dosificación , Factor A de Crecimiento Endotelial Vascular/antagonistas & inhibidores , Adulto , Anciano , Análisis de Varianza , Inhibidores de la Angiogénesis/administración & dosificación , Bevacizumab/efectos adversos , Femenino , Humanos , Inyecciones Intravítreas/métodos , Masculino , Persona de Mediana Edad , Ranibizumab/efectos adversos , Reproducibilidad de los Resultados , Estudios Retrospectivos , Factores de Tiempo , Tomografía de Coherencia Óptica , Resultado del TratamientoRESUMEN
ABSTRACT Purpose: To evaluate choroidal thickness (CT) using spectral domain optical coherence tomography (SD-OCT) imaging at baseline and 6 months after intravitreal anti-vascular endothelial growth factor (anti-VEGF) treatment in patients with diabetic macular edema (DME). Methods: A retrospective chart review was performed to identify patients with DME who underwent intravitreal injection of anti-VEGF (bevacizumab or ranibizumab) in a pro re nata (PRN) regimen. Subfoveal choroidal thickness was compared between values obtained at baseline and at 6-month follow-up visits. Results: Thirty-nine eyes (15 females, 24 males) from 39 patients were enrolled (mean age, 62.43 ± 8.7 years; range, 44-79 years). Twenty-three and 16 eyes were treated with ranibizumab and bevacizumab respectively. The mean number of anti-VEGF injections was 2.28 ± 1.27 (range, 1-5). Mean nasal, subfoveal, and temporal choroidal thickness (CT) measurements at baseline were 234.10 ± 8.63 µm, 246.89 ± 8.94 µm, and 238.12 ± 8.20 µm, respectively, and those at 6 months post-treatment were 210.46 ± 8.00 µm, 215.66 ± 8.29 µm, and 212.43 ± 8.14 µm, respectively. Significant differences in CT were observed between baseline and the 6-month follow-up at all measured points (p=0.0327). Conclusions: Over a 6-month period, the use of intravitreal anti-VEGF was associated with significant thinning of the choroid in patients with DME. The clinical significance of a thinner choroid in DME is currently unknown; however, it may contribute to long-term adverse effects on choroidal and retinal function, representing an area requiring future investigation.
RESUMO Objetivos: Avaliar a espessura de coroide pré-tratamento e após 6 meses da injeção intravítrea de anti-fator de crescimento vascular endotelial (anti-VEGF) em pacientes com edema macular diabético (EMD), utilizando a tomografia de coerência óptica de domínio espectral (SD-OCT). Métodos: Análise retrospectiva, com revisão de prontuários, foi realizada para identificação de pacientes submetidos a tratamento com injeções intravítreas de anti-VEGF, no regime pro re nata, para tratamento de EMD. As medidas da espessura de coroide pré-tratamento foi comparada com as medidas após acompanhamento de 6 meses. Resultados: Trinta e nove olhos de 39 pacientes (15 femininos, 24 masculinos) foram incluídos, com idade média de 62,43 ± 8,7 anos (variando de 44-79 anos). Trinta e três olhos foram tratados com ranibizumab e 18 com bevacizumab. O número médio de injeções de anti-VEGF foi 2,28 ± 1,27 (variando de 1-5). A medida média pré-tratamento da espessura de coroide nasal, subfoveal e temporal foi 234,10 ± 8,63 µm, 246,89 ± 8,94 µm e 238,12± 8,20 µm, respectivamente. Após acompanhamento de 6 meses as medidas médias da espessura de coroide foram 210,46 ± 8,00 µm, 215,66 ± 8,29 µm e 212,43 ± 8,14 µm. A diferença entre as medidas médias pré e pós tratamento foi estatisticamente significante (p=0,0327) em todos os pontos medidos. Conclusão: Após um período de 6 meses, o uso de injeções intravítreas de anti-VEGF foi associado com diminuição significante da espessura de coroide nos pacientes com EMD. O significado clínico de uma coroide mais fina nos pacientes com EMD é desconhecido mas pode causar eventos adversos a longo prazo para função da coroide e retina, representando uma área para futura investigações.