Incidence Of Rash Research Articles

Meta-Analysis of the Efficacy and Safety Evaluation of Vandetanib in the Treatment of Medullary Thyroid Cancer.

The aim of the work was to systematically evaluate the efficacy and safety of Vandetanib in the treatment of advanced medullary thyroid carcinoma (MTC). MeSH entries to search for randomized controlled trials and clinical research literature on the application of Vandetanib in the treatment of medullary thyroid cancer from PubMed, Chinese national knowledge infrastructure (CNKI), and Web of Science databases since their establishment until March 2023 were used. In terms of efficacy, the analysis results showed that Vandetanib had a significantly higher objective response rate compared to the control group using placebo (OR=2.13, 95% CI: 1.38, 3.29). In terms of side effects, Vandetanib significantly increases the incidence of hypertension, rash, and diarrhea, and has statistical significance (p+<+0.05). Vandetanib has a better therapeutic effect on MTC, but it also increases the incidence of hypertension, rash, and diarrhea. Attention should be paid to the relief of side effects when using it.

Incidence of Cutaneous Immune-Related Adverse Events and Outcomes in Immune Checkpoint Inhibitor-Containing Regimens: A Systematic Review and Meta-Analysis.

Immune checkpoint inhibitors (ICIs) are used to treat many cancers, and cutaneous immune-related adverse events (cirAEs) are among the most frequently encountered toxic effects. Understanding the incidence and prognostic associations of cirAEs is of importance as their uses in different settings, combinations, and tumor types expand. To evaluate the incidence of cirAEs and their association with outcome measures across a variety of ICI regimens and cancers, we performed a systematic review and meta-analysis of published trials of anti-programmed death-1/ligand-1 (PD-1/PD-L1) and anti-cytotoxic T lymphocyte antigen-4 (CTLA-4) ICIs, both alone and in combination with chemotherapy, antiangiogenic agents, or other ICIs in patients with melanoma, renal cell carcinoma, non-small cell lung cancer, and urothelial carcinoma. Key findings of our study include variable cirAE incidence among tumors and ICI regimens, positive association with increased cirAE incidence and response rate, as well as significant association between increased vitiligo incidence and overall survival. Across 174 studies, rash, pruritis, and vitiligo were the most reported cirAEs, with incidences of 16.7%, 18.0%, and 6.6%, respectively. Higher incidence of cirAEs was associated with ICI combination regimens and with CTLA-4-containing regimens, particularly with higher doses of ipilimumab, as compared to PD-1/L1 monotherapies. Outcome measures including response rate and progression-free survival were positively correlated with incidence of cirAEs. The response rate and incidence of pruritis, vitiligo, and rash were associated with expected rises in incidence of 0.17% (p = 0.0238), 0.40% (p = 0.0010), and 0.18% (p = 0.0413), respectively. Overall survival was positively correlated with the incidence of pruritis, vitiligo, and rash; this association was significant for vitiligo (p = 0.0483). Our analysis provides benchmark incidence rates for cirAEs and links cirAEs with favorable treatment outcomes at a study level across diverse solid tumors and multiple ICI regimens.

Effect of FOLFOX regimen combined with cetuximab treatment on the efficacy and tumor markers of advanced colon cancer patients.

To evaluate the efficacy of FOLFOX regimen combined with cetuximab in the treatment of advanced colon cancer. This retrospective study involved 60 patients with primary colon cancer who were treated in the PLA Navy Anqing Hospital from January 2022 to February 2023. According to their treatment regimen, the patients were divided into a treatment group that received FOLFOX4 combined with cetuximab (n=30), and a control group treated with cetuximab alone (n=30). The general data of the two groups were compared, and the short-term response rate was assessed by comparing the proportions of complete remission (CR), partial remission (PR), stable disease (SD) and progressive disease (PD) between the two groups. In addition, the progression free survival (PFS) and overall survival (OS) were compared between the two groups, along with the adverse reactions and changes in serum tumor marker (CEA and CA19-9) levels. The observation group showed a significantly higher short-term effective rate (CR+PR) compared to the control group (56.67% vs. 23.33%). The PFS and OS of the observation group were markedly longer compared to the control group. In terms of adverse reactions, the incidence of neutropenia, thrombocytopenia, nausea, vomiting, and diarrhea was similar between the two groups; however, the incidence of rash in the observation group was higher. After the treatment, the serum CEA and CA19-9 levels decreased markedly in both groups, and the observation group demonstrated obviously lower levels than the control group (P<0.001). Similarly, the decreases in VEGF-A and VEGFR2 levels in the observation group were more significant than those in the control group (all P<0.001). Despite inducing rash, which is controllable, the combined therapy of FOLFOX and cetuximab significantly improves short-term efficacy, reduces the levels of CEA, CA19-9, VEGF-A and VEGFR2, and extends the PFS and OS of patients, which can be served as an effective treatment strategy for advanced colon cancer.

Efficacy and safety of camrelizumab-based comprehensive treatment for non-small cell lung cancer: a systematic review and meta-analysis.

Many studies show that camrelizumab combination therapy can significantly improve progression-free survival (PFS) and overall survival (OS) in non-small cell lung cancer (NSCLC). However, the time of camrelizumab to market is short, and there is no systematic evaluation of camrelizumab-based comprehensive treatment of NSCLC. To systematically evaluate the efficacy and safety of camrelizumab in comprehensively treating NSCLC. A systematic review and meta-analysis. Databases, including PubMed, Web of Science, Embase, and Cochrane, were searched by computer before August 2023 based on Preferred Reporting Items for Systematic Review and Meta-Analysis (PRISMA) guidelines, and reports on the efficacy and safety of camrelizumab-based treatment for NSCLC were collected, and RevMan 5.4 software was employed for meta-analysis finally. Totally, 5 RCTs, 2 cohort studies, and 12 single-arm studies were included. The meta-analysis results revealed that, compared with the treatment without camrelizumab, the camrelizumab-based combination treatment considerably extended the OS (hazard ratio (HR) = 0.60, 95% confidence interval (CI): (0.44-0.82), p < 0.01), PFS (HR = 0.42, 95% CI: (0.28-0.63), p < 0.01), and event-free survival (EFS) (HR = 0.55, 95% CI: (0.44-0.68), p < 0.01). The median objective response rate in single-arm studies was 41% (95% CI: 28%-53%), and the disease control rate was 84% (95% CI: 78%-89%). Furthermore, in terms of the occurrence of grades 3-5 adverse events, the incidence of neutropenia was lower in the camrelizumab combination group than in the control group, while the incidence of leukopenia and rash was higher than in the combination group, and no significant difference was revealed in the incidence of other adverse events. Among single-arm studies, the incidence of grades 3-5 adverse events did not exceed 10%. Treatment combined with camrelizumab can effectively prolong OS, PFS, and EFS in NSCLC patients with good safety, camrelizumab combined with chemotherapy is an effective treatment option for NSCLC patients.

Insights into Mefenamic Acid-Induced Allergic Reactions: A Comprehensive Clinical and Research Review

This study investigates the incidence of Drug Rash with Eosinophilia and Systemic Symptoms (DRESS) syndrome associated with the over-the-counter non-steroidal anti-inflammatory drug (NSAID) mefenamic acid. Approximately 10% of individuals exposed to mefenamic acid experience DRESS syndrome, a severe and potentially fatal allergic reaction characterized by fever, skin rash, lymphadenopathy, hematological abnormalities, and internal organ involvement. Leukocytosis with eosinophilia (90%) and mononucleosis (40%) has been linked to certain cases, emphasizing the diversity of clinical presentations. The causative medication must be promptly discontinued upon identification of DRESS syndrome, with documented evidence indicating improved prognosis with early drug removal. Despite the severity of these reactions, the study sheds light on the alarming accessibility of mefenamic acid and other banned medications in developing nations, particularly exemplified by the Indian Pharmacopoeia Commission’s alert on mefenamic acid issued on December 7, 2023. The lack of effective law enforcement and medical awareness poses significant challenges, allowing banned drugs, including Nimesulide and Rofecoxib, to persist in the market despite being banned by the USFDA. This research underscores the critical need for global collaboration to address regulatory gaps, enhance medical awareness, and enforce stringent measures to restrict the availability of harmful medications in developing nations. Urgent attention to these issues is imperative to safeguard public health and ensure the effective implementation of drug regulations on a global scale.

PD-L1 expression guidance on sintilimab versus pembrolizumab with or without platinum-doublet chemotherapy in untreated patients with advanced non-small cell lung cancer (CTONG1901): A phase 2, randomized, controlled trial

No direct comparison has been performed between different programmed cell death-1 (PD-1) inhibitors for first-line treatment in patients with advanced non-small cell lung cancer (NSCLC). The feasibility of using PD-L1-expression-guided immunotherapy remains unknown. In this open-label, phase 2 study (NCT04252365), patients with advanced NSCLC without EGFR or ALK alterations were randomized (1:1) to receive sintilimab or pembrolizumab monotherapy (PD-L1 expression ≥ 50%), or sintilimab or pembrolizumab plus platinum-based chemotherapy (PD-L1 expression < 50%). The sample size was calculated by optimal two-stage design. The primary endpoint was the objective response rate (ORR). The study included 71 patients (sintilimab arms, n = 35; pembrolizumab arms, n = 36) and met its primary endpoint, with a confirmed ORR of 51.4% (18/35) in the sintilimab arms. The confirmed ORR (95% confidence interval) was 46.2% (19.2%, 74.9%) and 42.9% (17.7%, 71.1%) for patients treated with sintilimab and pembrolizumab monotherapy; and 54.5% (32.2%, 75.6%) and 45.4% (24.4%, 67.8%) for those treated with sintilimab- and pembrolizumab-based combination therapies. The median progression-free survival was 6.9 versus 8.1 months for all sintilimab-treated versus all pembrolizumab-treated patients, respectively, in which it was 7.6 versus 11.0 months in monotherapy and 7.4 versus 7.1 months in combination therapies. The median overall survival was 14.9 versus 21.3 months for all sintilimab-treated versus all pembrolizumab-treated patients, respectively, in which it was 14.9 versus 22.6 months in monotherapy and 14.7 versus 17.3 months in combination therapies. Treatment-related adverse events were consistent with safety outcomes of monotherapy and combination therapy in previous phase III studies. However, the incidence of rash was higher with sintilimab than pembrolizumab monotherapy. This is the first prospective phase 2 study to directly compare two anti-PD-1 antibodies as first-line treatment in advanced NSCLC. Sintilimab was efficacious and well-tolerated irrespective of PD-L1 expression level in patients with advanced NSCLC and had similar efficacy and safety to pembrolizumab.

Association of Geriatric Nutritional Risk Index With Immune Checkpoint Inhibitor Treatment Duration and Adverse Events in Lung Cancer.

Compared to conventional cytotoxic anticancer agent-based therapy, treatment with immune checkpoint inhibitors (ICI) significantly prolongs overall survival. The Geriatric Nutritional Risk Index (GNRI) has been used as a new prognostic indicator in cancer. As nutritional status is associated with prognosis and indicates treatment response, we investigated the effect of the pretreatment GNRI on the (1) occurrence of ICI-induced immune-related adverse events (ir-AE) and (2) association with time to treatment failure (TTF) in ICI monotherapy for lung cancer. In this study, 127 patients with lung cancer who were treated with ICI monotherapy were retrospectively enrolled. Based on a cutoff value of 92 for the GNRI, we investigated intergroup differences in the occurrence of adverse events and their association with TTF in the High-GNRI (≥92) and Low-GNRI (<92) groups. For intergroup comparisons, we used the Student's t-test, Welch's t-test, Fisher's direct probability test, and Mann-Whitney's U-test, and factors with p<0.05 in the intergroup comparison were extracted as explanatory variables. Based on the pretreatment GNRI, the median TTF was 5.1 months (95%CI=2.4-7.9 months) in the High-GNRI group and 2.3 months (95%CI=1.6-3.1 months) in the Low-GNRI group, with the High-GNRI group having a significantly longer TTF (p<0.01). The incidence of skin rash (p=0.0129) and pruritus (p<0.01) was significantly higher in the High-GNRI group. Pretreatment GNRI influences the continuation of ICI monotherapy. The High-GNRI group demonstrated a significantly higher frequency of skin lesions, which may have influenced the prolongation of TTF.

Third-line Treatment for Metastatic Triple-negative Breast Cancer: A Systematic Review and Network Meta-analysis.

Metastatic triple-negative breast cancer (mTNBC) is an invasive histologic subtype with a poor prognosis and rapid progression. Currently, there is no standard therapy for the third-line treatment of mTNBC. In this study, we conducted a network meta-analysis to compare regimens and determine treatment outcomes. We performed a systematic search of PubMed, EMBASE, the Cochrane Central Register of Controlled Bases, and the minutes of major conferences. Progression-free survival, overall survival, and objective response rate were analyzed through network meta-analysis using the R software (R Core Team). The efficacy of the treatment regimens was compared using hazard ratios, odds ratios, and 95% CIs. We evaluated 15 randomized controlled trials involving 6,010 patients. Compared with the physician's choice treatment, sacituzumab govitecan showed significant advantages in progression-free survival and overall survival, with hazard ratio values of 0.41 (95% CI: 0.32-0.52) and 0.48 (95% CI, 0.39-0.60). In terms of objective response rate, sacituzumab govitecan is the best-performing therapy (odds ratio: 10.82; 95% CI: 5.58-20.97). Adverse events among grades 3 to 5 adverse reactions, the incidence of neutropenia and leukopenia in each regimen was higher, whereas the incidence of fever, headache, hypertension, and rash was lower. Compared with the treatment of the physician's choice, sacituzumab govitecan appears more efficacious and is the preferred third-line treatment for mTNBC.

NLRP12-associated autoinflammatory disease in Chinese adult patients: a single-centre study

BackgroundNLRP12-associated autoinflammatory disease (NLRP12-AID) is an autosomal dominant autoinflammatory disorder caused by variants of NLRP12 gene. We aimed to report a cohort of Chinese adult patients with NLRP12-AID and summarised...

Clinical Study on the Efficacy and Safety of Peg Rhg CSF for Autologous Hematopoietic Stem Cell Mobilization in Lymphoma and Multiple Myeloma：a Randomized Controlled, Multicenter Clinical Study

Introduction: PEG rhG CSF has been widely used in the prevention and treatment of bone marrow suppression after chemotherapy for a variety of tumors, but whether it can be used for lymphoma and Multiple myeloma autologous hematopoietic stem cell mobilization has no relevant clinical evidence. Therefore we carried out this randomized controlled, multicenter clinical study to evaluate the efficiency and safety of PEG-rhG-CSF in the mobilization of autologous hematopoietic stem cells for lymphoma and Multiple myeloma. Methods:This experiment selected an appropriate mobilization based on the patient's willingness and physical condition of the subjects. Chemotherapy mobilized patients underwent bone marrow mobilization when white blood cells reached their lowest point and began to rebound. The experimental group received a fixed dose of 12mg of polyethylene glycol recombinant human granulocyte stimulating factor injection (PEG-rhG-CSF) for mobilization; the control group received recombinant human granulocyte stimulating factor (rhG-CSF) 5-10μg/kg daily. Collect blood and bone marrow samples from patients daily and test white blood cells and CD34+cells every day. Record CD34+cells proportion until its qantity reached 2×10 6 proportion. The interval from mobilization to collection, the time for hematopoietic reconstruction after transplantation, and complications were also collected. Results : A total of 60 patients were included in this study, including 31 in the experimental group and 29 in the control group. There were no statistically significant differences in gender, age, disease classification, and pre harvest CD34+levels between the two groups of patients. The CD34+cells collected from both the experimental and control groups reached ≥ 2.0×10 6/kg and there was no statistically significant difference (Figure 1). There was no statistical difference between the experimental group and the control group in terms of CD34+cell collection frequency, CD34+cell count, interval from mobilization to collection time, neutrophil reconstruction time, and platelet reconstruction time. In terms of related side effects there was no statistically significant difference in the incidence of rash, fever, infection, and diarrhea between the two groups of patients. The incidence of bone pain in all patients was 15% (9/60), with 8 cases being mild and only 1 case being moderate. There was no significant statistical difference in the incidence of bone pain between the experimental group and the control group (Table 1). Conclusion : PEG-rhG-CSF is safe and effective for autologous hematopoietic stem cell mobilization in lymphoma and Multiple myeloma, and its efficacy is consistent with that of rhG CSF. However, the subcutaneous injection of rhG CSF is less frequent, which is easier for patients to accept. [Key words] PEG rhG CSF; matopoietic stem cell mobilization;ymphoma and Multiple myeloma; inical study

Pembrolizumab and Enzalutamide in Patients with Abiraterone Acetate–Pretreated Metastatic Castration-Resistant Prostate Cancer: Cohort C of the Phase 1b/2 KEYNOTE-365 Study

BackgroundLimited responses have been observed in patients treated with enzalutamide after disease progression on abiraterone for metastatic castration-resistant prostate cancer (mCRPC), but androgen receptor signaling impacts T-cell function. ObjectiveTo evaluate the efficacy and safety of pembrolizumab plus enzalutamide in mCRPC. Design, setting, and participantsPatients in cohort C of the phase 1b/2 KEYNOTE-365 study, who received ≥4 wk of treatment with abiraterone acetate in the prechemotherapy mCRPC state and experienced treatment failure or became drug-intolerant, were included. InterventionPembrolizumab 200 mg intravenously every 3 wk plus enzalutamide 160 mg orally once daily. Outcome measurements and statistical analysisThe primary endpoints were safety, the confirmed prostate-specific antigen (PSA) response rate, and the objective response rate (ORR) according to Response Evaluation Criteria in Solid Tumors version 1.1 on blinded independent central review (BICR). Secondary endpoints included radiographic progression-free survival (rPFS) on BICR and overall survival (OS). Results and limitationsA total of 102 patients received pembrolizumab plus enzalutamide. Median follow-up was 51 mo (interquartile range 37–56). The confirmed PSA response rate was 24% (95% confidence interval [CI] 16–33%). The confirmed ORR was 11% (95% CI 2.9–25%; 4/38 patients; two complete responses). Median rPFS was 6.0 mo (95% CI 4.1–6.3). Median OS was 20 mo (95% CI 17–24). Treatment-related adverse events (TRAEs) occurred in 94 patients (92%); grade 3–5 TRAEs occurred in 44 patients (43%). The incidence of treatment-related rash was higher with combination therapy than expected from the safety profile of each drug. One patient (1.0%) died of a TRAE (cause unknown). Study limitations include the single-arm design. ConclusionsPembrolizumab plus enzalutamide had limited antitumor activity in patients who received prior abiraterone treatment without previous chemotherapy for mCRPC, with a safety profile consistent with the individual profiles of each agent. Patient summaryPembrolizumab plus enzalutamide showed limited antitumor activity and manageable safety in patients with metastatic castration-resistant prostate cancer.The KEYNOTE-365 trial is registered on ClinicalTrials.gov as NCT02861573.

Feasibility of apalutamide combined with androgen deprivation therapy and short-course low-dose prednisone in treating metastatic hormone-sensitive prostate cancer: a pilot randomized controlled trial.

The role of prednisone in the prevention of androgen receptor antagonist-related rash and treatment for metastatic hormone-sensitive prostate cancer (mHSPC) is unclear. This pilot trial (ChiCTR2200060388) aimed to investigate the feasibility of apalutamide combined with androgen deprivation therapy (ADT) and short-course low-dose prednisone in the treatment of mHSPC. All patients received apalutamide and ADT and were randomly divided into two groups based on the administration of oral prednisone or not (control group). The primary endpoint was the incidence of rash. The secondary endpoint included the proportions of patients with a decline in PSA ≥50% from baseline, PSA ≥90% from baseline, and decreased to PSA ≤0.2 ng/mL. Between June 2021 and March 2022, a total of 83 patients were enrolled (41 in the prednisone group and 42 in the control group). During the 6-month follow-up, the incidence of rash was significantly lower in the prednisone group compared with the control group (17.1% vs. 38.1%, P=0.049). There were no significant differences in the incidence of other adverse events, the number of patients who required dose adjustment (reduction, interruption, or discontinuation) of apalutamide due to rash, the number of patients with prostate-specific antigen (PSA) decreased by ≥50%, the number of patients with PSA decrease ≥90%, and the number of patients with PSA ≤0.2 ng/mL between the two groups. All patients with diabetes had stable glycemic control with no glucose-related adverse events. In patients with mHSPC, the addition of short-course low-dose prednisolone to apalutamide plus ADT can reduce the incidence of rash without risk of other adverse events.

Cutaneous manifestations, viral load, and prognosis among hospitalised patients with COVID-19: a cohort study.

Various cutaneous manifestations have been reported as symptoms of coronavirus disease 2019 (COVID-19), which may facilitate early clinical diagnosis and management. This study explored the incidence of cutaneous manifestations among hospitalised patients with COVID-19 and investigated its relationships with viral load, co-morbidities, and outcomes. This retrospective study included adult patients admitted to a tertiary hospital for COVID-19 from July to September 2020. Clinical information, co-morbidities, viral load (cycle threshold [Ct] value), and outcomes were analysed. In total, 219 patients with confirmed COVID-19 were included. Twenty patients presented with new onset of rash. The incidence of new rash was 9.1% (95% confidence interval=6.25%-14.4%). The most common manifestations were maculopapular exanthem (n=6, 42.9%, median Ct value: 24.8), followed by livedo reticularis (n=4, 28.6%, median Ct value: 21.3), varicella-like lesions (n=2, 14.3%, median Ct value: 19.3), urticaria (n=1, 7.1%, median Ct value: 14.4), and acral chilblain and petechiae (n=1, 7.1%, median Ct value: 33.1). The median Ct values for patients with and without rash were 22.9 and 24.1, respectively (P=0.58). There were no significant differences in mortality or hospital stay between patients with and without rash. Patients with rash were more likely to display fever on admission (P<0.01). Regardless of cutaneous manifestations, patients with older age, hypertension, and chronic kidney disease stage ≥3 had significantly higher viral load and mortality (P<0.05). This study revealed no associations between cutaneous manifestation and viral load or clinical outcomes. Older patients with multiple co-morbidities have risks of high viral load and mortality; they should be closely monitored.

Anaphylaxis as the only presenting symptom of COVID 19

Most children with SARS-CoV-2 infection are asymptomatic or exhibit only mild symptoms. A varied incidence of cutaneous rashes has been described in different studies.A recent review of the cutaneous manifestations in patients with COVID-19 highlighted that urticarial rash is common at the onset of the disease but very rare cases found to have associated anaphylaxis. With this report, we are describing a 10-year-old child who presented to a tertiary care hospital in Jordan with anaphylaxis as the only presenting symptom of COVID-19.

Poison ivy (Toxicodendron radicans) leaf shape variability: Why plant avoidance‐by‐identification recommendations likely do not substantially reduce poison ivy rash incidence

Societal Impact StatementAvoidance of poison ivy plants is currently the primary approach to prevent the estimated 30–50 million annual poison ivy skin rash cases. The “leaves of three let it be” mnemonic device lacks specificity to differentiate poison ivy from other three‐leaflet native plants. This report demonstrated that poison ivy leaves show marked total leaf shape variability that likely confounds accurate poison ivy plant identification, and significantly undermines a poison ivy avoidance strategy for mitigating poison ivy rash cases. Therefore, there is an ongoing need to develop prophylactic medical procedures to prevent poison ivy rash that do not depend on human poison ivy plant identification.Summary Urushiol is the natural product produced by poison ivy (Toxicodendron radicans) that is responsible for millions of cases of delayed contact allergenic dermatitis in North America each year. Avoidance of poison ivy plant material is the clinically recommended strategy for preventing urushiol‐induced dermatitis symptoms. However, poison ivy leaf shape is anecdotally notoriously variable, thereby confounding accurate poison ivy identification. This study focused on quantitative analyses of poison ivy and a common poison ivy look‐alike (American hog peanut) leaf shape variability in North America to empirically validate the high degree of poison ivy leaf shape plasticity. Poison ivy and American hog peanut iNaturalist.org records were scored for seven attributes of compound leaf shape that were combined to produce a total leaf complexity score. Both the mean and the distribution of poison ivy total leaf complexity scores were significantly greater than that of American hog peanut. Non‐metric multidimensional scaling analyses corroborated a high degree of poison ivy leaf shape variability relative to American hog peanut. A poison ivy accession producing frequent palmate penta‐leaflet compound leaves was evaluated using linear regression modeling. Poison ivy total leaf complexity was exceedingly variable across a given latitude or longitude. With that said, there was a small but significant trend of poison ivy total leaf complexity increasing from east to west. Palmate penta‐leaflet formation was significantly correlated with a stochastic leaflet deep‐lobing developmental process in one unusual poison ivy accession. The empirically‐validated poison ivy leaf shape hypervariability described in this report likely confounds accurate poison ivy identification, thereby likely resulting in many accidental urushiol‐induced clinical allergenic dermatitis cases each year.

A meta-analysis for the efficacy and safety of icotinib combined with radiotherapy in treating brain metastases of non-small cell lung cancer.

Currently, the therapies for brain metastases of non-small cell lung cancer (NSCLC) mainly include whole brain radiotherapy and icotinib. For exploring the efficacy and safety of radiotherapy and icotinib, a meta-analysis was performed based on a series of data. A systematic search was performed on PubMed, Web of Science, Cochrane Library, China National Knowledge Infrastructure and Wanfang Database. The search time was set from the database establishment to December, 2022. All randomized controlled trials evaluating the efficacy and safety of whole brain radiotherapy alone or in combination with icotinib for whole brain metastases of NSCLC were included in our meta-analysis. Clinical outcomes and adverse reactions were analyzed using Stata17.0 software. Finally, 10 clinical studies were enrolled in this meta-analysis, including 717 patients. Briefly, compared with radiotherapy alone, icotinib combined with radiotherapy increased response rate [relative ratio (RR) = 1.240; 95% confidence interval (CI) (1.141, 1.348); P < .001] and disease control rate (RR = 1.240, 95% CI [1.141,1.348], P < .001). Besides, according to the outcomes of adverse reaction assessment exhibited, there were no significant differences between the 2 group patients in the incidence of rash (RR = 1.536, 95% CI [0.694, 3.402], P = .290), adverse reaction in gastrointestinal tract (RR = 1.060, 95% CI [0.792, 1.419], P = 1.419), hepatic injury (RR = 1.541, 95% CI [0.798,2.975], P = .198) and leukopenia (RR = 1.182, 95% CI [0.787, 1.777], P = .421). However, the patients receiving combination treatment showed much longer progression free survival than those receiving radiotherapy alone (standardized mean difference = 1.559; 95% CI [0.699, 2.419]; P < .001). Icotinib combined with radiotherapy can significantly short-term and long-term efficacy of NSCLC patients with brain metastases but not increase adverse reactions.

The Effectiveness of Giving Olive Oil Against the Occurrence of Diaper Rash in Infants Aged 0 to 12 Months

Babies are not used to the problems that will attack their body condition, especially problems that can occur on the skin. All babies have very sensitive skin in the first month of life. The condition of the skin in babies which is relatively thinner makes babies more susceptible to infection, irritation and allergies. Objective: To determine the effectiveness of giving olive oil to the incidence of diaper rash in infants aged 0 to 12 months. Method: quasy experimental with one group pretest posttest design. The population in this study were infants aged 0 to 12 months who experienced diaper rash in the working area of the Moti Health Center, Gantarang Keke District, Bantaeng Regency, totaling 20 people. The sampling technique uses total sampling. the research time was 1 month, namely June 1-30 2021. Meanwhile, the treatment was carried out for 3-7 days with a frequency of 3 times a day. Data analysis used the Wilcoxon test. Results: the mean diaper rash pre test was 1.45 with a standard deviation of 0.51 and the diaper rash post test was 0.45 with a standard deviation of 0.68. The median for pre diaper rash was 1.45 and post diaper rash was 0.38. Meanwhile, the table also shows that the value of p = 0.001 &lt;0.05, which means that olive oil is effective for diaper rash. Conclusion: the Wilcoxon test shows a p value of 0.000 &lt;0.05, so it can be concluded that olive oil is effective in reducing the incidence of diaper rash in infants aged 0 to 12 months

Efficacy and safety of flurbiprofen cataplasms versus loxoprofen sodium cataplasms in knee osteoarthritis: a randomized controlled trial.

Clinical trial evidence is limited to identify better topical Non-steroidal anti-inflammatory drugs (NSAIDs) for treating knee osteoarthritis (OA). We aimed to compare the clinical efficacy and safety of flurbiprofen cataplasms (FPC) with loxoprofen sodium cataplasms (LSC) in treating patients with knee OA. This is an open-label, non-inferiority randomized controlled trial conducted at Peking University Shougang Hospital. Overall, 250 patients with knee OA admitted from October 2021 to April 2022 were randomly assigned to FPC and LSC treatment groups in a 1:1 ratio. Both medications were administered to patients for 28 days. The primary outcome was the change of pain measured by visual analog scale (VAS) score from baseline to day 28 (range, 0-10 points; higher score indicates worse pain; non-inferiority margin: 1 point; superiority margin: 0 point). There were four secondary outcomes, including the extent of pain relief, the change trends of VAS scores, joint function scores measured by the Western Ontario and McMaster University Osteoarthritis Index (WOMAC), and adverse events. Among 250 randomized patients (age, 62.8 ± 10.5 years; 61.4% [153/249] women), 234 (93.6%) finally completed the trial. In the intention-to-treat analysis, the decline of the VAS score for the 24-h most intense pain in the FPC group was non-inferior, and also superior to that in the LSC group (differences and 95% confidence interval, 0.414 (0.147-0.681); P <0.001 for non-inferiority; P = 0.001 for superiority). Similar results were observed of the VAS scores for the current pain and pain during exercise. WOMAC scores were also lower in the FPC group at week 4 (12.50 [8.00-22.50] vs. 16.00 [11.00-27.00], P = 0.010), mainly driven by the dimension of daily activity difficulty. In addition, the FPC group experienced a significantly lower incidence of adverse events (5.6% [7/124] vs. 33.6% [42/125], P <0.001), including irritation, rash and pain of the skin, and sticky hair uncovering pain. This study suggested compelling evidence that FPC is superior to LSC for treating patients with knee OA in pain relief, joint function improvement, and safety profile. ChiCTR.org.cn, ChiCTR2100054822.

FDA analysis of toxicity profiles of oral TKIs recently approved for non-small cell lung cancer based on receipt of prior immune checkpoint inhibitor therapy.

9119 Background: Immune checkpoint inhibitors (ICIs) targeting PD-(L)1 are standard front-line therapy for advanced non-small cell lung cancer (NSCLC). Molecularly targeted tyrosine kinase inhibitors (TKIs) are standard of care for subsets of oncogene-driven NSCLC. Published literature suggests the possibility of increased toxicity in patients who receive ICIs followed by EGFR or ALK TKI treatment. However, the toxicity profile in patients who receive ICIs followed by TKIs with other genomic targets has not been well described. Methods: Marketing applications for TKIs in patients with NSCLC submitted to the Office of Oncologic Diseases between Jan 2019 to Dec 2022 were reviewed. Datasets were analyzed for demographics, treatment-emergent adverse events (TEAE), and prior anti-cancer therapies for TKI-treated patients in the primary efficacy population. Drug classes for which &lt; 5% of patients received prior ICI were excluded. Grade 3-4 TEAE, serious adverse events (SAE), discontinuation TEAE and TEAE of interest (hepatotoxicity, rash, and interstitial lung disease [ILD]) were summarized. Results: 9 applications were identified and 2 were excluded. The remaining applications involved TKIs targeting EGFR exon 20 insertion, KRAS G12C, MET exon 14 skipping, and RET fusion alterations. Analyses included 867 patients; 61% received prior ICI therapy. Patient characteristics and results of analyses are presented in the table. In our pooled analysis, the incidence of Grade 3-4 AEs, SAEs, and hepatotoxicity were slightly higher in the prior ICI group, while the incidence of discontinuation TEAE, ILD, and rash were similar between groups. Analysis for hepatotoxicity was limited to reported AEs (did not include analysis of laboratory data). Review of toxicity data across individual drug classes did not show major differences compared to the overall results. Conclusions: Our analysis of safety data for newer TKIs with varied genomic targets does not appear to show excessive toxicity in patients with NSCLC who received prior ICI compared to those who did not. In future clinical trials evaluating TKIs in this population, inclusion of patients who have received prior ICI therapy should be considered when appropriate. [Table: see text]

A retrospective study on the incidence, management and risk factors of skin rash in patients with advanced prostate cancer in Japan

BackgroundWorldwide, prostate cancer (PC) is the second most diagnosed cancer and the fifth leading cause of cancer death in men. Hormonal therapies, commonly used for PC, are associated with a range of treatment-emergent adverse events (TEAEs). The population from Japan seems to be at higher risk of developing TEAEs of skin rash compared to the overall global population. This study was conducted to get a better insight into the incidence, management, and risk factors for skin rash during active treatment for advanced PC in Japan.MethodsA retrospective cohort of PC patients was identified and subsequently categorized, into non-metastatic and metastatic castration-resistant prostate cancer patients (nmCRPC and mCRPC), and metastatic castration-naïve prostate cancer patients (mCNPC). The analysis was based on a dataset from the Medical Data Vision (MDV) database. Descriptive statistics were determined, and a multivariate Cox proportional hazards model was used to the associated risk factors for the onset of rash.ResultsOverall, 1,738 nmCRPC patients, 630 mCRPC patients, and 454 mCNPC patients were included in this analysis. The median age was 78 years old and similar across the three cohorts. The skin rash incidence was 19.97% for nmCRPC cohort, 28.89% for mCRPC cohort, and 28.85% for mCNPC cohort. The median duration of skin rash ranged from 29 to 42 days. Statistically significant risk factors for developing skin rash included a history of allergy or hypersensitivity (all cohorts), increased age (nmCRPC and mCRPC), a body mass index (BMI) of < 18.5 (nmCRPC and mCRPC), and a PSA level higher than the median (nmCRPC). Skin rash was commonly managed with systemic and topical corticosteroids which ranged from 41.76% to 67.03% for all cohorts. Antihistamines were infrequently used.ConclusionThis study provides a better understanding of the real-world incidence, onset, duration, management and risk factors of skin rash in patients on active PC treatment in Japan. It was observed that approximately 20–30% of PC patients experience skin rash. Development of skin rash was associated with previous allergy or hypersensitivity, BMI of < 18.5, increased age and higher PSA levels, and was usually treated with corticosteroids.