ABSTRACT
Purpose: Chemotherapy-induced mucositis is a prevalent and burdensome toxicity among adolescent and young adults (AYAs) with cancer and impedes the delivery of optimal therapy. Its development is not well understood, but baseline stress and inflammation may be contributory factors. This pilot study evaluates stress and inflammation as risk factors for mucositis, identifies effect size estimates, and evaluates the feasibility of a prospective study to investigate mucositis development. Methods: Thirty AYAs receiving chemotherapy with substantial risk of mucositis completed baseline stress measures, and serum was collected for inflammatory biomarker analysis. Regression and mediation analyses determined the relationship between stress/inflammation and mucositis. Results: Stress appears to be a significant risk factor for incidence of mucositis (odds ratio 1.13, p = 0.125) and predicts total mucositis score (ß = 0.281, p = 0.023) as well as peak incidence (ß = 0.052, p = 0.018). Baseline levels of interleukin (IL)-1a and epidermal growth factor (EGF) predicted mucositis development, and EGF and IL-8 may mediate the relationship between stress and mucositis. Findings suggest that stress-induced inflammation exacerbates symptom development. Conclusion: Results from this pilot study inform mucositis symptom models, suggesting that psychosocial and physiologic factors are involved in development. Importantly, this pilot study provides initial effect size estimates, including magnitude and direction of relationships, that are essential to informing larger, more robustly powered studies. High enrollment, low attrition, and minimal missing data in this study suggest this model is feasible for research in this population. Importantly, this work is a first step in identifying new risk factors for mucositis and targets for nurse-led interventions to prevent toxicity development.
Subject(s)
Mucositis , Neoplasms , Stomatitis , Humans , Adolescent , Young Adult , Mucositis/complications , Stomatitis/chemically induced , Stomatitis/prevention & control , Pilot Projects , Epidermal Growth Factor/adverse effects , Prospective Studies , Neoplasms/complications , Neoplasms/therapy , Inflammation/complicationsABSTRACT
Gastric ulcer (GU) is a peptic disease with high morbidity and mortality rates affecting approximately 4% of the population throughout the world. Current therapies for GU are limited by the high relapse incidence and side effects. Therefore, novel effective antiulcer drugs are urgently needed. Ginsenosides have shown good anti-GU effects, and the major intestinal bacterial metabolite of ginsenosides, protopanaxatriol (PPT), is believed to be the active component. In this study, we evaluated the anti-GU effect of PPT in rats in an acetic acid-induced GU model. High (H-PPT) and medium (M-PPT) doses of PPT (20.0 and 10.0 mg/mg/day) significantly reduced the ulcer area and the ET-1, IL-6, EGF, SOD, MDA and TNF-α levels in serum were regulated by PPT in a dose-dependent manner. We also investigated the mechanisms of anti-GU activity of PPT based on metabolomics coupled with network pharmacology strategy. The result was that 16 biomarkers, 3 targets and 3 metabolomic pathways were identified as playing a vital role in the treatment of GU with PPT and were further validated by molecular docking. In this study, we have demonstrated that the integrated analysis of metabolomics and network pharmacology is an effective strategy for deciphering the complicated mechanisms of natural compounds.
Subject(s)
Ginsenosides , Stomach Ulcer , Rats , Animals , Stomach Ulcer/chemically induced , Stomach Ulcer/drug therapy , Stomach Ulcer/metabolism , Acetic Acid/toxicity , Ginsenosides/therapeutic use , Tumor Necrosis Factor-alpha , Molecular Docking Simulation , Interleukin-6/adverse effects , Epidermal Growth Factor/adverse effects , Network Pharmacology , Metabolomics , Biomarkers , Superoxide DismutaseSubject(s)
Cetuximab/adverse effects , Epidermal Growth Factor/adverse effects , ErbB Receptors/antagonists & inhibitors , Nevus, Pigmented/chemically induced , Skin Neoplasms/chemically induced , Antineoplastic Agents, Immunological/adverse effects , Colorectal Neoplasms/drug therapy , Humans , Male , Melanoma , Middle AgedABSTRACT
Although the lignan compound fargesin is a major ingredient in Shin-Yi, the roles of fargesin in carcinogenesis and cancer cell growth have not been elucidated. In this study, we observed that fargesin inhibited cell proliferation and transformation by suppression of epidermal growth factor (EGF)-stimulated G1/S-phase cell cycle transition in premalignant JB6 Cl41 and HaCaT cells. Unexpectedly, we found that signaling pathway analyses showed different regulation patterns in which fargesin inhibited phosphatidylinositol 3-kinase/AKT signaling without an alteration of or increase in mitogen activated protein kinase (MAPK) in JB6 Cl41 and HaCaT cells, while both signaling pathways were abrogated by fargesin treatment in colon cancer cells. We further found that fargesin-induced colony growth inhibition of colon cancer cells was mediated by suppression of the cyclin dependent kinase 2 (CDK2)/cyclin E signaling axis by upregulation of p21WAF1/Cip1, resulting in G1-phase cell cycle accumulation in a dose-dependent manner. Simultaneously, the suppression of CDK2/cyclin E and induction of p21WAF1/Cip1 were correlated with Rb phosphorylation and c-Myc suppression. Taken together, we conclude that fargesin-mediated c-Myc suppression inhibits EGF-induced cell transformation and colon cancer cell colony growth by the suppression of retinoblastoma (Rb)-E2F and CDK/cyclin signaling pathways, which are mainly regulated by MAPK and PKB signaling pathways.
Subject(s)
Benzodioxoles/pharmacology , Cell Transformation, Neoplastic/pathology , Colonic Neoplasms/metabolism , Colonic Neoplasms/pathology , Cyclin E/metabolism , Cyclin-Dependent Kinase 2/metabolism , Epidermal Growth Factor/adverse effects , Lignans/pharmacology , Signal Transduction , Cell Death/drug effects , Cell Differentiation/drug effects , Cell Line, Tumor , Cell Proliferation/drug effects , Cell Shape/drug effects , Cell Transformation, Neoplastic/drug effects , G1 Phase/drug effects , Humans , Phosphatidylinositol 3-Kinases/metabolism , Proto-Oncogene Proteins c-akt/metabolism , Proto-Oncogene Proteins c-myc/metabolism , Resting Phase, Cell Cycle/drug effects , Signal Transduction/drug effectsABSTRACT
To analyze the effects of sodium hyaluronate combined with recombinant human epidermal growth factor (rhEGF) eye drops in patients with dry eye. Totally 97 patients who suffered dry eye after cataract surgery in our hospital from March 2018 to June 2020 were selected and randomly assigned into control group (n=57, sodium hyaluronate eye drops) and intervention group (n=63, sodium hyaluronate combined with rhEGF eye drops). The clinical efficacy, Break Up Time (BUT), schirmer I test (SLt), fluorescent test (FL) and ocular surface disease index (OSDI), the scale of quality of life for disease with visual impairment (SQOL-DVI), interleukin-6 (IL-6), tumor necrosis factor (TNF-a) level of the two groups were compared. The intervention group yielded remarkably higher effective rate than the control group (p<0.05). Markedly higher BUT, SLt, SQOL-DVI scores and lower OSDI scores were witnessed among patients in the intervention group than the control group (p<0.05). The clinical effect of sodium hyaluronate combined with rhEGF eye drops in the treatment of dry eye is superior to sodium hyaluronate alone, in terms of enhancing the stability of tear film, accelerating corneal healing, inhibiting the level of inflammatory factors and improving patients' quality of life.
Subject(s)
Dry Eye Syndromes/drug therapy , Epidermal Growth Factor/administration & dosage , Hyaluronic Acid/administration & dosage , Administration, Ophthalmic , Adult , Aged , Cataract Extraction/adverse effects , China , Drug Combinations , Dry Eye Syndromes/diagnosis , Dry Eye Syndromes/etiology , Dry Eye Syndromes/physiopathology , Epidermal Growth Factor/adverse effects , Female , Humans , Hyaluronic Acid/adverse effects , Male , Middle Aged , Ophthalmic Solutions , Prospective Studies , Quality of Life , Recombinant Proteins/administration & dosage , Recovery of Function , Time Factors , Treatment OutcomeABSTRACT
Diabetic foot ulcer and its complications are becoming more and more serious problems threatening people's health. In the last decade, multiple growth factors and their combined applications have shown potentials in promoting the healing process of diabetic foot ulcers. The purpose of this study is to perform a meta-analysis of the efficacy and safety of topical recombinant human epidermal growth factor (rhEGF) on the treatment of diabetic foot ulcers. As of November 30, 2018, we had conducted a comprehensive review of PubMed, EMBASE, Cochrane Library databases, and Web of Science. Seven randomized controlled trials (RCTs) that involved 610 participants were included in this review. The pooled results showed that topical rhEGF could significantly promote the healing of diabetic foot ulcers (risk ratio [RR] 1.54, 95% confidence interval [CI] 1.30 to 1.83; I2 = 18%). Topical application of rhEGF could promote ulceration healing of diabetic feet of Wagner grade 1 or 2 significantly (RR, 1.61; 95% CI, 1.32 to 1.97; I2 = 0%), and intralesional injection of rhEGF appeared to promote the healing of more severe ulcers (RR, 2.06, 95%, CI 0.35 to 12.22; I2 = 50%). However, patients developed more shivering (RR, 4.67; 95% CI, 1.39 to 15.71; I2 = 0%), nauseas/vomiting (RR, 2.18; 95% CI, 0.72 to 6.55; I2 = 0%) in the group of intralesional injection of rhEGF compared with the control group, although these symptoms were not found with the topical application of rhEGF. No serious complications were found associated with topical rhEGF. Topical rhEGF treatment of diabetic foot ulcers has showed a broad application prospect, yet more relevant well-designed RCTs are needed in the future.
Subject(s)
Diabetic Foot/drug therapy , Epidermal Growth Factor/administration & dosage , Wound Healing/drug effects , Administration, Cutaneous , Diabetic Foot/diagnosis , Epidermal Growth Factor/adverse effects , Humans , Randomized Controlled Trials as Topic , Recombinant Proteins/administration & dosage , Time Factors , Treatment OutcomeABSTRACT
Bladder cancer is the sixth most common cancer in the United States, and it exhibits an alarming 70% recurrence rate. Thus, the development of more efficient antibladder cancer approaches is a high priority. Accordingly, this work provides the basis for a transformative anticancer strategy that takes advantage of the unique characteristics of the bladder. Unlike mucin-shielded normal bladder cells, cancer cells are exposed to the bladder lumen and overexpress EGFR. Therefore, we used an EGF-conjugated anthrax toxin that after targeting EGFR was internalized and triggered apoptosis in exposed bladder cancer cells. This unique agent presented advantages over other EGF-based technologies and other toxin-derivatives. In contrast to known agents, this EGF-toxin conjugate promoted its own uptake via receptor microclustering even in the presence of Her2 and induced cell death with a LC50 < 1 nM. Furthermore, our data showed that exposures as short as ≈3 min were enough to commit human (T24), mouse (MB49) and canine (primary) bladder cancer cells to apoptosis. Exposure of tumor-free mice and dogs with the agent resulted in no toxicity. In addition, the EGF-toxin was able to eliminate cells from human patient tumor samples. Importantly, the administration of EGF-toxin to dogs with spontaneous bladder cancer, who had failed or were not eligible for other therapies, resulted in ~30% average tumor reduction after one treatment cycle. Because of its in vitro and in vivo high efficiency, fast action (reducing treatment time from hours to minutes) and safety, we propose that this EGF-anthrax toxin conjugate provides the basis for new, transformative approaches against bladder cancer.
Subject(s)
Antigens, Bacterial/administration & dosage , Antineoplastic Agents/administration & dosage , Bacterial Toxins/administration & dosage , Epidermal Growth Factor/administration & dosage , Immunotoxins/administration & dosage , Urinary Bladder Neoplasms/drug therapy , Administration, Intravesical , Animals , Antigens, Bacterial/adverse effects , Antineoplastic Agents/adverse effects , Apoptosis/drug effects , Bacterial Toxins/adverse effects , Cell Line, Tumor , Dogs , Drug Screening Assays, Antitumor , Epidermal Growth Factor/adverse effects , Female , Humans , Immunotoxins/adverse effects , Male , Mice , Primary Cell Culture , Receptor, ErbB-2/metabolism , Treatment Outcome , Urinary Bladder Neoplasms/pathology , Urinary Bladder Neoplasms/veterinaryABSTRACT
No disponible
Subject(s)
Humans , Epidermal Growth Factor/antagonists & inhibitors , Homeostasis/drug effects , ErbB Receptors/antagonists & inhibitors , Skin/drug effects , Epidermal Growth Factor/adverse effects , Epidermal Growth Factor/toxicity , Quality of LifeABSTRACT
2-Methoxy-5((3,4,5-trimethosyphenyl)seleninyl) phenol (SQ), a novel synthesized combretastatin A-4(CA-4) analogue, is identified as a microtubule inhibitor and has been shown to exert anticancer activity in breast cancer cells. Here, we found that SQ reversed epidermal growth factor (EGF)-induced motility and invasion in breast cancer cell lines by the in vitro Wound healing and Transwell assay. Further studies showed that SQ treatment resulted in inhibitory alteration of EGF-stimulated epithelial-to-mesenchymal transition (EMT) and MMP-2 activity. What is more, SQ significantly inhibited the EGF-induced mouse double minute 2- (MDM2) expression and transcription factor Twist1 expression. In addition, compared with the control cells, MDM2 overexpression up-regulated Twist1 expression and dramatically promoted cell migration and invasion, MDM2 under-expression also down-regulated Twist1 expression and suppressed cell motility and invasion. Taken together, our findings suggest that the inhibitory effects of SQ on migration and invasion were related to the suppression of MDM2 and Twist1 signal axis.
Subject(s)
Breast Neoplasms/drug therapy , Cell Movement/drug effects , Epidermal Growth Factor/adverse effects , Gene Expression Regulation, Neoplastic/drug effects , Organoselenium Compounds/pharmacology , Proto-Oncogene Proteins c-mdm2/antagonists & inhibitors , Apoptosis/drug effects , Breast Neoplasms/chemically induced , Breast Neoplasms/metabolism , Breast Neoplasms/pathology , Cell Adhesion/drug effects , Cell Proliferation/drug effects , Female , Humans , Neoplasm Invasiveness , Proto-Oncogene Proteins c-mdm2/metabolism , Tumor Cells, Cultured , Wound Healing/drug effectsABSTRACT
For 15 years, from 2001, we began to apply Heberprot-P®, an injectable Epidermal Growth Factor (0.75 µg) created in the Center of Biotechnology, in Havana, Cuba. More than 159,000 patients were treated around the world, from 25 countries, with, with only 9-11% high-level amputations. In this paper, we discuss our experience in the treatment of the most complex diabetic foot ulcers cases for the last 15 years.
Subject(s)
Diabetic Foot , Epidermal Growth Factor , Wound Healing/drug effects , Administration, Topical , Anti-Ulcer Agents/administration & dosage , Anti-Ulcer Agents/adverse effects , Cuba , Diabetic Foot/diagnosis , Diabetic Foot/therapy , Dose-Response Relationship, Drug , Drug Administration Schedule , Drug Monitoring/methods , Epidermal Growth Factor/administration & dosage , Epidermal Growth Factor/adverse effects , Humans , Injections, Intralesional , Recombinant Proteins , Treatment OutcomeABSTRACT
Adverse events (AEs) of epidermal growth factor inhibitors (EGFRi) influence well-being with a risk to dose modifications (DMs). Hereby, clinical benefit of treatment might be affected. This retrospective cohort study was set up to gain insight into the suitability and added value of a patient-reported outcome measurement tool (PROM), together with a stepwise intervention management plan for EGFRi-related AEs in daily practice. The primary objective was to gain insight into total treatment duration and DMs, and the secondary objective to gain insight into patient-reported symptoms and well-being as well as healthcare professional-reported AEs. Sixty-eight patients on cetuximab and 19 on panitumumab treatment were included for analysis; 69% had squamous cell carcinoma of head and neck (SCCHN) and 26% metastatic colorectal carcinoma. DMs due to AEs occurred in 39% of the patients and dose discontinuations in 22%. Especially anorexia, dysphagia, oral pain and skin changes led to a decreased well-being. In patients on EGFRi, application of PROMs together with a stepwise symptom management plan enhances early recognition of symptom burden, pro-active symptom management and effect evaluation of interventions performed whereby well-being recovers. Since only SCCHN patients discontinued treatment due to AEs, patient-centred care focused on radiotherapy-related AEs, creates opportunities for amelioration.
Subject(s)
Antibodies, Monoclonal/adverse effects , Antineoplastic Agents, Immunological/adverse effects , Carcinoma/drug therapy , Cetuximab/adverse effects , Colorectal Neoplasms/drug therapy , Epidermal Growth Factor/adverse effects , Head and Neck Neoplasms/drug therapy , Adult , Aged , Aged, 80 and over , Female , Humans , Male , Middle Aged , Panitumumab , Retrospective StudiesABSTRACT
Introducción: estudios previos han sugerido la relación del índice de masa corporal elevado con una mayor incidencia y un peor pronóstico del cáncer de mama.Objetivo: identificar la relación entre el índice de masa corporal en el momento del diagnóstico, y las características clinicopatológicas de pacientes con cáncer de mama de acuerdo con la presencia o no de menopausia. Métodos: estudio transversal y descriptivo de 47 mujeres, entre 36 y 84 años, con carcinoma ductal invasivo. Se midieron el peso y la estatura. Se calculó el índice de masa corporal para la clasificación de las pacientes en tres categorías: peso normal, sobrepeso y obesa. Se determinaron las características clinicopatológicas: tamaño del tumor, presencia de ganglios linfáticos metastásicos, etapa clínica, grado histológico y estado de los receptores de estrógeno, progesterona y receptor 2 para el factor de crecimiento epidérmico.Resultados: el índice de masa corporal varió en el rango de 18,54 a 44,92 kg/m2. No se observaron diferencias estadísticamente significativas entre los valores promedio globales de esta variable en las mujeres premenopáusicas y posmenopáusicas (26,76 kg/m2 ± 5,26 vs. 28,11 ± 5,61 kg/m2; p= 0,450), ni en el análisis realizado por categorías. La obesidad y el sobrepeso fueron asociados con un alto grado histológico, tanto en mujeres premenopáusicas (p= 0,038) como posmenopáusicas (p= 0,037). Adicionalmente, una asociación significativa entre el índice de masa corporal y el subtipo positivo al receptor de estrógenos o progesterona/receptor 2 para el factor de crecimiento epidérmico, se observó solo para las mujeres posmenopáusicas (p= 0,032). Conclusiones: estos resultados muestran que las mujeres obesas y con sobrepeso desarrollan fenotipos agresivos de cáncer de mama, independientemente de la presencia o no de menopausia. Además, entre las mujeres posmenopáusicas con índice de masa corporal elevado predominó el subtipo positivo al receptor de estró....(AU)
Introduction: previous studies have suggested the relationship of the high body mass index with higher incidence and bad prognosis of the breast cancer.Objective: to determine the relationship between the body mass index at the time of diagnosis of cancer, and the clinical-pathological characteristics of menopausal or non-menopausal breast cancer patients.Methods: descriptive and cross-sectional study of 47 women aged 36 to 84 years, with invasive duct carcinoma. Their weight and height were taken. Body mass index calculation served to classify the patients into 3 categories: normoweighed, overweighed and obese. The studied clinical-pathological characteristics were size of tumor, presence of metastatic lymph nodes, clinical staging, histological grade and state of estrogen receptor, progesterone receptor and 2 receptor for the epidermal growth factor. Results: the body mass index changed from 18.54 to 44.92 kg/m2. There were no statistically significant differences among the average overall values of this variable either in premenopausal and postmenopausal women ((26.76 kg/m2 ± 5.26 vs. 28.11 ± 5.61 kg/m2; p= 0.450) or in the analysis by categories. Obesity and overweight were associated to high histological grade both in premenopausal (p= 0.035) and postmenopausal women (p= 0.037). Additionally, a significant association was found between the body mass index and the estrogen or progesterone receptor /receptor 2-positive subtype (for the epidermal growth factor) in postmenopausal women (p= 0.032). Conclusions: these results show that obese and overweighed women may develop aggressive breast cancer phenotypes regardless of menopause. Moreover, the estrogen or progesterone receptor/receptor 2-positive subtype for the epidermal growth factor prevailed in postmenopausal women with high body mass index. Further studies should be conducted to... (AU)
Subject(s)
Humans , Female , Adult , Aged , Body Mass Index , Breast Neoplasms/diagnosis , Breast Neoplasms/epidemiology , Obesity/prevention & control , Epidermal Growth Factor/adverse effects , Premenopause , Postmenopause , Epidemiology, Descriptive , Cross-Sectional StudiesABSTRACT
Introducción: estudios previos han sugerido la relación del índice de masa corporal elevado con una mayor incidencia y un peor pronóstico del cáncer de mama. Objetivo: identificar la relación entre el índice de masa corporal en el momento del diagnóstico, y las características clinicopatológicas de pacientes con cáncer de mama de acuerdo con la presencia o no de menopausia. Métodos: estudio transversal y descriptivo de 47 mujeres, entre 36 y 84 años, con carcinoma ductal invasivo. Se midieron el peso y la estatura. Se calculó el índice de masa corporal para la clasificación de las pacientes en tres categorías: peso normal, sobrepeso y obesa. Se determinaron las características clinicopatológicas: tamaño del tumor, presencia de ganglios linfáticos metastásicos, etapa clínica, grado histológico y estado de los receptores de estrógeno, progesterona y receptor 2 para el factor de crecimiento epidérmico. Resultados: el índice de masa corporal varió en el rango de 18,54 a 44,92 kg/m2. No se observaron diferencias estadísticamente significativas entre los valores promedio globales de esta variable en las mujeres premenopáusicas y posmenopáusicas (26,76 kg/m2 ± 5,26 vs. 28,11 ± 5,61 kg/m2; p= 0,450), ni en el análisis realizado por categorías. La obesidad y el sobrepeso fueron asociados con un alto grado histológico, tanto en mujeres premenopáusicas (p= 0,038) como posmenopáusicas (p= 0,037). Adicionalmente, una asociación significativa entre el índice de masa corporal y el subtipo positivo al receptor de estrógenos o progesterona/receptor 2 para el factor de crecimiento epidérmico, se observó solo para las mujeres posmenopáusicas (p= 0,032). Conclusiones: estos resultados muestran que las mujeres obesas y con sobrepeso desarrollan fenotipos agresivos de cáncer de mama, independientemente de la presencia o no de menopausia. Además, entre las mujeres posmenopáusicas con índice de masa corporal elevado predominó el subtipo positivo al receptor de estrógenos o progesterona/receptor 2 para el factor de crecimiento epidérmico. Estudios futuros deberán realizarse para comprender los factores relevantes del hospedero y del tumor, para la prevención y el manejo clínico de las pacientes obesas con cáncer de mama(AU)
Introduction: previous studies have suggested the relationship of the high body mass index with higher incidence and bad prognosis of the breast cancer. Objective: to determine the relationship between the body mass index at the time of diagnosis of cancer, and the clinical-pathological characteristics of menopausal or non-menopausal breast cancer patients. Methods: descriptive and cross-sectional study of 47 women aged 36 to 84 years, with invasive duct carcinoma. Their weight and height were taken. Body mass index calculation served to classify the patients into 3 categories: normoweighed, overweighed and obese. The studied clinical-pathological characteristics were size of tumor, presence of metastatic lymph nodes, clinical staging, histological grade and state of estrogen receptor, progesterone receptor and 2 receptor for the epidermal growth factor. Results: the body mass index changed from 18.54 to 44.92 kg/m2. There were no statistically significant differences among the average overall values of this variable either in premenopausal and postmenopausal women ((26.76 kg/m2 ± 5.26 vs. 28.11 ± 5.61 kg/m2; p= 0.450) or in the analysis by categories. Obesity and overweight were associated to high histological grade both in premenopausal (p= 0.035) and postmenopausal women (p= 0.037). Additionally, a significant association was found between the body mass index and the estrogen or progesterone receptor /receptor 2-positive subtype (for the epidermal growth factor) in postmenopausal women (p= 0.032). Conclusions: these results show that obese and overweighed women may develop aggressive breast cancer phenotypes regardless of menopause. Moreover, the estrogen or progesterone receptor/receptor 2-positive subtype for the epidermal growth factor prevailed in postmenopausal women with high body mass index. Further studies should be conducted to better understand the relevant factors in the host and the tumor for the prevention and the clinical management of obese patients with breast cancer(AU)
Subject(s)
Humans , Female , Adult , Middle Aged , Aged , Body Mass Index , Breast Neoplasms/diagnosis , Epidermal Growth Factor/adverse effects , Obesity/prevention & control , Breast Neoplasms/epidemiology , Epidemiology, Descriptive , Postmenopause/metabolism , Premenopause , Serial Cross-Sectional StudiesSubject(s)
Epidermal Growth Factor/administration & dosage , Epidermal Growth Factor/adverse effects , Hair Follicle/drug effects , Hair Follicle/growth & development , Wound Healing/drug effects , Wounds and Injuries/drug therapy , Administration, Topical , Adult , Female , Humans , Treatment OutcomeABSTRACT
OBJECTIVE: To evaluate the efficacy, tolerability, and safety of a novel wound dressing containing epidermal growth factor (EGF) in a collagen-gel matrix on hard-to-heal venous leg ulcers. PATIENTS AND METHODS: The authors included 33 hard-to-heal venous leg ulcers found on 31 patients. The EGF-containing dressing was applied 3 times while best practice conservative wound treatment was continued. Patients were followed up with after 1, 2, and 3 months to evaluate (a) the wound size, (b) the ease of application and dissolution of the dressing, and (c) the wound dressing by means of a scale ranging from 1 to 5 (1 = best, 5 = worst). RESULTS: The protocol was completed by 25 of 31 patients. The reasons for discontinuation were wound infection, pain, and lost to follow-up (n = 2 each, respectively). After 3 months, the average wound surface was significantly reduced (from 33.69 cm to 18.94 cm, P = .023). On a scale from 0 to 100, the wound dressing was evaluated as very easy to apply and highly dissolvable (mean value of 97.14 and 98.11, respectively; 100 = very easy to apply or 100% dissolution). The dressing was generally well tolerated and scored a mean overall rating of 2.16 by healthcare specialists and 2.40 by patients. CONCLUSION: The authors' results demonstrate that the novel EGF-containing wound dressing was generally well tolerated and safe. Combined with the significant wound surface reduction, it can be regarded as an adequate novel treatment option for patients with hard-to-heal venous leg ulcers.
Subject(s)
Bandages, Hydrocolloid , Collagen/therapeutic use , Epidermal Growth Factor/therapeutic use , Varicose Ulcer/therapy , Wound Healing , Adult , Aged , Aged, 80 and over , Bandages, Hydrocolloid/adverse effects , Collagen/adverse effects , Epidermal Growth Factor/adverse effects , Female , Humans , Male , Middle Aged , Treatment OutcomeABSTRACT
Acne is one of the most common adverse events associated with the use of anticancer agents, such as epidermal growth factor receptor (EGFR) inhibitors. Based on data from several previous reports, we predicted that topical application of EGF could improve acne vulgaris. To evaluate the clinical efficacy and safety of topical recombinant human EGF (rhEGF) cream for the treatment of facial acne vulgaris. Twenty Korean adults with mild to moderate acne vulgaris applied topical rhEGF cream on one half of the face and a vehicle cream on the other half twice daily for six weeks. Clinical assessments were conducted at baseline, two, four, and six weeks. Two assessment methods were applied: inflammatory and non-inflammatory acne lesion counts and acne severity score by investigator's global assessment. Skin sebum output level and hydration level were also measured at each visit. All volunteers completed the study. At the final visit, inflammatory acne lesions were reduced by 33.5% on the rhEGF-applied side. Non-inflammatory acne lesions also decreased by 25.4%, whereas the lesions on the control side increased. The majority of patients demonstrated improvement on the side of the face where rhEGF cream was applied. Sebum output decreased on the rhEGF side, and skin hydration level increased on both sides. No severe side effects were observed during the study. Topical rhEGF seems to be an effective and safe adjuvant treatment option for mild to moderate acne vulgaris.
Subject(s)
Acne Vulgaris/drug therapy , Dermatologic Agents/administration & dosage , Epidermal Growth Factor/administration & dosage , Administration, Cutaneous , Adult , Dermatologic Agents/adverse effects , Double-Blind Method , Epidermal Growth Factor/adverse effects , Female , Humans , Male , Recombinant Proteins/administration & dosage , Recombinant Proteins/adverse effects , Severity of Illness Index , Skin Cream/administration & dosage , Skin Cream/adverse effects , Young AdultABSTRACT
BACKGROUND: After several exploratory and confirmatory clinical trials, the intralesional administration of human recombinant epidermal growth factor (hrEGF) has been approved for the treatment of advanced diabetic foot ulcers (DFU). The aim of this work was to evaluate the effectiveness and safety of this procedure in medical practice. METHODS: A prospective, post-marketing active pharmacosurveillance was conducted in 41 hospitals and 19 primary care polyclinics. Patients with DFU received hrEGF, 25 or 75 µg, intralesionally 3 times per week until complete granulation of the ulcer or 8 weeks maximum, adjuvant to standard wound care. Outcomes measured were complete granulation, amputations, and adverse events (AE) during treatment; complete lesion re-epithelization and relapses in follow-up (median: 1.2; maximum 4.2 years). RESULTS: The study included 1788 patients with 1835 DFU (81% Wagner's grades 3 or 4; 43% ischemic) treated from May 2007 to April 2010. Complete granulation was observed in 76% of the ulcers in 5 weeks (median). Ulcer non-ischemic etiology (OR: 3.6; 95% CI: 2.8-4.7) and age (1.02; 1.01-1.03, for each younger year) were the main variables with influence on this outcome. During treatment, 220 (12%) amputations (171 major) were required in 214 patients, mostly in ischemic or Wagner's grade 3 to 5 ulcers. Re-epithelization was documented in 61% of the 1659 followed-up cases; 5% relapsed per year. AE (4171) were reported in 47% of the subjects. Mild or moderate local pain and burning sensation, shivering and chills, were 87% of the events. Serious events, not related to treatment, occurred in 1.7% of the patients. CONCLUSIONS: The favorable benefit/risk balance, confirms the beneficial clinical profile of intralesional hrEGF in the treatment of DFUs.
Subject(s)
Diabetic Foot/drug therapy , Epidermal Growth Factor/therapeutic use , Product Surveillance, Postmarketing , Wound Healing/drug effects , Adult , Aged , Aged, 80 and over , Amputation, Surgical/statistics & numerical data , Diabetic Foot/epidemiology , Diabetic Foot/surgery , Dose-Response Relationship, Drug , Epidermal Growth Factor/administration & dosage , Epidermal Growth Factor/adverse effects , Female , Granulation Tissue/drug effects , Humans , Injections, Intralesional , Male , Middle Aged , Prospective Studies , Treatment Outcome , Young AdultABSTRACT
PURPOSE: The Functional Assessment of Cancer Therapy-Epidermal Growth Factor Receptor Inhibitor 18 (FACT-EGFRI-18) is a patient-reported outcomes questionnaire developed to assess the effect of EGFRI on patients. The FACT-EGFR-18 was translated into Dutch and evaluated in order to document that the translation adequately captures the concepts of the original English-language version of the questionnaire and is readily understood by subjects in the target population. METHOD: Translation of the FACT-EGFRI-18 from English to Dutch was accomplished by employing the Functional Assessment of Chronic Illness Therapy (FACIT) multilingual translation methodology. Ten native-speaking residents of the target country who reported EGFRI associated dermatological adverse events (dAEs) were asked to review the translation of the harmonized FACT-EGFRI-18. RESULTS: Participants generally found the Dutch FACT-EGFRI-18 easy to understand and complete. In addition, the translation retained the original meaning of the FACT-EGFRI-18 items and instructions. Based on the results of the cognitive debriefing interviews, no changes to improve clarity and comprehension of translations were identified. CONCLUSIONS: The Dutch FACT-EGFRI-18 demonstrates content validity and linguistic validity, and was found conceptually equivalent to its English source, thus confirming linguistic validation. The results suggest that the Dutch FACT-EGFRI-18 can be applied to measure dAE related health related quality of life in Dutch-speaking patients undergoing EGFRI therapy. Formal validation of the Dutch FACT-EGFRI-18 is ongoing.
Subject(s)
Epidermal Growth Factor/antagonists & inhibitors , Neoplasms/drug therapy , Neoplasms/psychology , Quality of Life , Surveys and Questionnaires , Translating , Aged , Comprehension , Drug Eruptions/diagnosis , Drug Eruptions/etiology , Drug-Related Side Effects and Adverse Reactions , England , Epidermal Growth Factor/adverse effects , Epidermal Growth Factor/therapeutic use , Female , Humans , Linguistics/methods , Male , Middle Aged , Netherlands , Risk Assessment , Self Report , Treatment OutcomeABSTRACT
Oral mucositis (OM) is one of the most common and debilitating complications in patients undergoing intensive chemotherapy followed by hematopoietic stem cell transplantation (HSCT). The aim of this study was to evaluate the efficacy and safety of recombinant human epidermal growth factor (rhEGF) oral spray for OM induced by intensive chemotherapy followed by HSCT. Patients were randomly assigned to either the rhEGF group or placebo group. The severity of OM and self-reported quality of life (QOL) were assessed daily. A total of 58 patients were analyzed. Baseline characteristics were similar between the two groups. The incidence of NCI grade ≥ 2 OM was higher in the rhEGF group (78.6% vs. 50%, P = 0.0496). However, the duration of OM in patients with NCI grade ≥ 2 tended to be shorter in the rhEGF group (8.5 days vs. 14.5 days, P = 0.262). The QOL analysis in patients with World Health Organization (WHO) grade ≥ 3 OM showed that rhEGF significantly reduced limitations in swallowing (P = 0.039) and drinking (P = 0.042). The duration of hospitalization (P = 0.047), administration of total parenteral nutrition (P = 0.012), and the usage of opioid analgesics (P = 0.018) were significantly shorter in the rhEGF group with WHO grade ≥ 3 OM. Adverse events were mild and similar between the two groups. In conclusion, this analysis showed that rhEGF did not reduce the incidence of NCI grade ≥ 2 OM. However, the patients with WHO grade ≥ 3 OM in the rhEGF group showed better results compared to the placebo group for several secondary endpoints.
Subject(s)
Epidermal Growth Factor/therapeutic use , Hematologic Neoplasms/therapy , Hematopoietic Stem Cell Transplantation , Stomatitis/drug therapy , Transplantation Conditioning/adverse effects , Adolescent , Adult , Analgesics, Opioid/administration & dosage , Analgesics, Opioid/therapeutic use , Deglutition Disorders/etiology , Deglutition Disorders/prevention & control , Double-Blind Method , Epidermal Growth Factor/administration & dosage , Epidermal Growth Factor/adverse effects , Female , Humans , Length of Stay , Male , Middle Aged , Oral Sprays , Parenteral Nutrition , Quality of Life , Recombinant Proteins/administration & dosage , Recombinant Proteins/adverse effects , Recombinant Proteins/therapeutic use , Severity of Illness Index , Stomatitis/chemically induced , Stomatitis/physiopathology , Stomatitis/prevention & control , Young AdultABSTRACT
A three month, open-label, single center study was conducted to determine whether a uniquely derived serum containing barley bioengineered, human-like epidermal growth factor protein could improve visible signs of photodamage and aging in facial skin. Twenty-nine females, aged 39 to 75 years, with mild to severe, fine and course rhytids, photodamage, and pigmentation were enrolled. Subjects then applied the treatment serum per the prescribed protocol twice-daily for 3 months, in addition to the use of a basic sunscreen and facial cleanser. In-person clinical evaluations and subject self-assessment questionnaires were administered at each follow up visit. In addition, clinical photography was completed at baseline, and each subsequent visit. Clinical evaluations showed statistically significant improvement in the appearance of fine lines and rhytids, skin texture, pore size, and various dyschromatic conditions apparent within the first month of use, and continuing improvement trends for the duration of the study. The treatment serum was well tolerated with minimal treatment-related complications reported throughout. Efficacy of this novel serum and treatment protocol resulted in meaningful improvements in photodamage and visible signs of aging.