Incidence Of Rash Research Articles

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.

Chemotherapy and targeted therapy for advanced biliary tract cancers: an umbrella review

BackgroundMalignant tumors of the biliary system are characterized by a high degree of malignancy and strong invasiveness, and they are usually diagnosed at late stages with poor prognosis. For patients with advanced biliary tract cancer, chemotherapy and targeted therapy are two of the options available to improve prognosis and delay tumor progression. This study aimed to comprehensively evaluate the safety and effectiveness of various chemotherapy schemes for the treatment of advanced biliary tract cancer in published systematic reviews and meta-analyses (SRoMAs).MethodsAn umbrella review method was adopted, which aims to summarize the existing evidence from multiple studies around a research topic. SRoMAs up to April 9, 2022, were identified using PubMed, Web of Science, the Cochrane database, and manual screening. Eligible studies were screened according to inclusion and exclusion criteria. This study had been registered at PROSPERO (CRD42022324548). For each eligible study, we extracted the data of general characteristics and the main findings. The methodological quality of the included studies were assessed by the AMSTAR2 scale, and the quality of evidence was evaluated by the GRADE tools.ResultsA total of 1833 articles were searched; 14 unique articles with 94 outcomes were identified by eligibility criteria. The incidence of skin rash (RR = 18.11, 95% CI 5.13–63.91, GRADE: Moderate) and diarrhea (RR = 2.48, 95% CI 1.2–5.10, GRADE: Moderate) was higher in patients receiving gemcitabine-based chemotherapy plus targeted therapy than in patients receiving gemcitabine monotherapy. The number of patients receiving gemcitabine-based chemotherapy who developed leukopenia (OR = 7.17, 95% CI 1.43–36.08, GRADE: Moderate), anemia (OR = 7.04, 95% CI 2.59–19.12, GRADE: High), thrombocytopenia (RR = 2.45, 95% CI 1.39–4.32, GRADE: Moderate), and neutropenia (RR = 3.30, 95% CI 1.04–10.50, GRADE: Moderate) was significantly higher than that of patients who received gemcitabine-free regimens. In addition, patients receiving S-1 monotherapy had significantly better ORR (RR = 2.46, 95% CI 1.27–4.57, GRADE: Moderate) than patients receiving S-1 + gemcitabine. Patients receiving fluoropyrimidine-based chemotherapy had longer OS (HR = 0.83, 95% CI 0.7–0.99, GRADE: Moderate), higher DCR (0R = 5.18, 95% CI 3.3–10.23, GRADE: Moderate), and higher ORR (0R = 3.24, 95% CI 1.18–8.92, GRADE: Moderate) compared with patients who received 5-FU/LV monotherapy or supportive therapy. Surprisingly, we found evidence that gemcitabine-based chemotherapy did not improve postoperative patients’ OS (HR = 0.91, 95% CI 0.74–1.12, GRADE: Moderate) when compared with best supportive care.ConclusionsThis study comprehensively evaluated the safety and efficacy of chemotherapy or targeted therapy regimens for advanced biliary tract cancer and found 11 outcomes with “Moderate” or “High” levels; however, most of the outcomes were still at “low” or “very low” levels. More randomized controlled studies are needed in the future to further summarize high levels of evidence.

Advantage of achieving deep response following frontline daratumumab-VTd compared to VRd in transplant-eligible multiple myeloma: multicenter study.

The goal of induction therapy for multiple myeloma (MM) is to achieve adequate disease control. Current guidelines favor triplet (bortezomib-lenalidomide-dexamethasone; VRd) or quadruplet regimens (daratumumab, bortezomib-thalidomide-dexamethasone; D-VTd). In the absence of a direct comparison between two treatment regimens, we conducted this study to compare the outcomes and safety of VRd and D-VTd. Newly diagnosed MM patients aged ＞18 years who underwent induction therapy followed by autologous stem cell transplantation (ASCT) between November 2020 and December 2021 were identified. Finally, patients with VRd (N=37) and those with D-VTd (N=43) were enrolled. After induction, 10.8% of the VRd group showed stringent complete remission (sCR), 21.6% showed complete response (CR), 35.1% showed very good partial response (VGPR), and 32.4% showed partial response (PR). Of the D-VTd group, 9.3% showed sCR, 34.9% CR, 48.8% VGPR, and 4.2% PR (VGPR or better: 67.6% in VRd vs. 93% in D-VTd, P=0.004). After ASCT, 68.6% of the VRd group showed CR or sCR, while 90.5% of the D-VTd group showed CR or sCR (P=0.016). VRd was associated with an increased incidence of skin rash (P=0.044). Other than rashes, there were no significant differences in terms of adverse events between the two groups. Our study supports the use of a front-line quadruplet induction regimen containing a CD38 monoclonal antibody for transplant-eligible patients with newly diagnosed MM.

Titration as an effective strategy to reduce apalutamide induced skin rash: A multi-institutional real-world experience.

197 Background: With increasing use of novel androgen receptor inhibitors to treat prostate cancer (PCa), better safety management has been spotlighted. Apalutamide (APA) is suggested for metastatic hormone-sensitive prostate cancer (mHSPC) and high-risk non-metastatic castrate-resistant prostate cancer (NM-CRPC). However, around 25% of patients will experience skin rash. This analysis aims to investigate whether dose titration might be effective to reduce the incidence of skin rash for apalutamide-treated patients. Methods: A retrospective analysis of 73 PCa patients received APA plus androgen deprivation therapy at 3 centers in Wenzhou, China by Aug 2022 was done. Titration was defined as starting APA from a low daily dose of 120mg or 180mg and gradually increase to 240mg. The study group was dose titration patients and compare group was patients received initial 240mg qd. 1 center used 1-week dose escalation (120mg qd in week 1, 180mg qd in week 2, 240mg qd in week 3 and after) strategy and the rest 2 centers used personalized plan (starting dose of 120 or 180mg qd, the physican decide when to increase the dose). Incidence of skin rash, Grade 3 skin rash, dose modification and termination were compared. We also compared the PSA response of two groups at 1,3 and 6 months. Results: 31 and 42 patients in study and control groups were enrolled. Median age was 75.36 years (56.0-90.0), with 1.67 m height (1.50-1.80) and 69.0 kg weight (47.5-92.0). 51% was mHSPC, 90% had Gleason score ≥ 8, 66% have a high tumor volume per CHAARTED. Incidence of skin rash was significantly lower in the study vs control (6.45% vs 26.19%, p=0.029). No patient in study vs 3 (7.5%) patients in control experienced Grade 3 rash. 2 (7.69%) and 9 (22.50%) patients in study and control had dose modification and 3 (7.5%) patients in control group terminated APA due to adverse events. PSA response was slightly lower in study group in month 1 (median PSA decline, study vs control, 85.80% vs 93.85%, p = 0.117) and was consistent in month 3 (95.17% vs 98.71, p=0.152) and month 6 (98.61% vs 99.19%, p=0.530). For selection of titration strategy, incidence of skin rash between 1-week strategy and personalized strategy was consistent (5.88% vs 7.14%, p=0.887). 1-week strategy has significantly better PSA decline at month 1 (median PSA decline, 1-week vs personalized 97.00% vs 75.54%, p=0.019) and performs slightly better in month 3 (99.29% vs 87.74%, p=0.087) vs personalized strategy, in which patients’ dose started to increase between week 2-8. Conclusions: Our results demonstrated that titration might be an effective strategy to reduce incidence of skin rash for PCa patients receiving apalutamide, with little interference to patient efficacy in PSA decline. For time frame to increase dose, 1-week plan might be a better selection. Future prospective studies are needed for validation.

The Influence Of Giving Coconut Oil On The Event Diaper Rash In Babies

Naturally processed ingredients that can be considered as an alternative topical therapy that can be used for skin care in babies who experience diaper rash and as a prevention of diaper rash are CO.The purpose of this study was to find the Effect of Coconut Oil Administration on the Incidence of Diaper Rash in Babies in the Work Area of the New Jumpandang Health Center.The research was conducted from January to April 2022 at the Jumpandang Baru Health Center. This research is an experimental study with the design of Two Group Posttest Only Design which aims to find the influence between independent variables and dependent variables. The population in this study was all babies who visited and were at the Jumpandang Baru Health Center as many as 30 people using purposive sampling techniques.The results showed that out of 30 respondents as a sample, it was divided into two groups with 15 people in the intervention group given coconut oil and 15 people in the control group who were not given.The results showed that of the 15 respondents who were sampled in the intervention group, after being given coconut oil, 4 people (37.5%) had diaper rash and 15 people were not given to 13 people who had diaper rash. The results showed that there was an effect of coconut oil administration on the incidence of diaper rash in babies with a value of ρ = 0.001&lt;from α = 0.05.It is necessary for the Puskesmas to plan counseling programs, especially regarding the provision of coconut oil and to midwives to further increase their attention to providing information about the importance of giving coconut oil with diaper rash to babies.

Effect of Medicine and Adverse Drug Reactions of Vonoprazan Fumarate Tablets in Patients with Reflux Esophagitis

To investigate the drug effects of vonoprazan fumarate tablets on reflux esophagitis and their adverse drug reactions is the objective of the study. A total of 102 patients with reflux esophagitis admitted to the Department of Gastroenterology of the Affiliated People’s Hospital of Ningbo University from June 2021 to November 2022 were selected and randomly grouped, with 51 cases in the observation group and 51 cases in the control group. The observation group received vonoprazan fumarate tablets and the control group received rabeprazole for 8 w. The drug effects of the two groups were analyzed, including the duration of symptom relief, changes in esophageal motility, the level of serum gastric hormone, the injury degree of esophageal mucosa and the level of inflammatory factors. Adverse drug reactions were analyzed in the two groups. After medication, the symptom remission time, changes in esophageal motility, serum gastric hormone level, esophageal mucosa injury degree and inflammatory factor level in observation group were better than those in control group (p<0.05). The total incidence of dizziness, rash, diarrhea and other adverse drug reactions in the observation group was 3.92 %, which was significantly lower than that in the control group (9.8 %, p<0.05). In conclusion, vonoprazan fumarate tablets has obvious effect on the treatment of reflux esophagitis with low adverse reactions, which is worthy of clinical promotion.

Efficacy and safety of Kanglaite plus EGFR-TKI in the treatment of advanced non-small cell lung cancer: A meta-analysis of 13 RCTs

Kanglaite (KLT) is a Chinese medicine antitumor drug independently developed in China, which has been widely used in the treatment of advanced non-small cell lung cancer (NSCLC). The purpose of this study was to systematically evaluate the efficacy and safety of KLT plus epidermal growth factor receptor-tyrosine kinase inhibitor (EGFR-TKI) in the treatment of advanced NSCLC. Up to September 1, 2022, the databases of PubMed, EMBASE, Cochrane Library, ClinicalTrials.gov, China National Knowledge Infrastructure, Chinese Biomedical Literature, China Science and Technology Journal, and Wanfang were searched, and the randomized controlled clinical trials (RCTs) of KLT plus EGFR-TKI in the treatment of advanced NSCLC were included. Two researchers independently screened the literature, extracted data, and evaluated the quality of the included literature. Revman5.4 software was used for meta-analysis. A total of 1057 patients were included in 13 RCTs. The results of meta-analysis showed that KLT plus EGFR-TKI could improve the objective response rate (ORR) (risk ratio (RR) confidence interval (CI) [RR = 1.54, 95% CI: 1.27-1.86, P < .00001]), the disease control rate (DCR) (RR = 1.23, 95% CI: 1.14-1.32, P < .00001), and quality of life (QOL) (RR = 1.79, 95% CI: 1.36-2.36, P < .0001) in patients with advanced NSCLC. The percentages of CD3+T cells (standardized mean difference [SMD = 2.37, 95% CI: 0.80-3.93, P = .003]), CD4+T cells (SMD = 1.39, 95% CI: 0.85-1.93, P < .00001), NK cells (SMD = 1.59, 95% CI: 0.88-2.30, P < .0001), and CD4+/CD8+ratio (SMD = 0.37, 95% CI: 0.19-0.55, P < .0001) were also increased. However, the results of subgroup analysis showed that in patients with EGFR mutation NSCLC, compared with EGFR-TKI alone, KLT plus EGFR-TKI did not significantly increase ORR and DCR (RR = 1.43, 95% CI: 0.88-2.32, P = .15; RR = 1.07, 95% CI: 0.96-1.20, P = .21). In terms of adverse events of drugs, the incidence of diarrhea, rash, anorexia, nausea and vomiting, liver and renal function damage of KLT plus EGFR-TKI was similar to that of EGFR-TKI alone (P > .05). KLT plus EGFR-TKI has some clinical benefits and good safety compared with EGFR-TKI alone in the treatment of advanced NSCLC. However, it seems that patients with EGFR mutations do not get significant clinical benefits, and more high-quality RCTs are needed to prove the efficacy of the combined regimen.

Edukasi Kesehatan Tentang Pengaruh Pemakaian Diapers Yang Menyebabkan Ruam Popok (Diaper Rash) Terhadap Ibu Di Klinik EvieTahun 2022

Diaper rash is a complaint of red spots on the genitals and buttocks of babies wearing diapers caused by skin rubbing against diapers (Dwi Maryanti, et al, 2011). Diaper rash often occurs in the area around a baby's buttocks due to the use of diapers that are rarely changed, are too tight, or are used for too long. Usually the rash is not dangerous, but it can cause pain and cause anxiety in the baby and parents. According to a report by the Journal of Pediatrics, there were 54% of babies aged 1 month who experienced diaper rash after using "disposable diapers", which were first made by Victor Miller in 1950 under the name pampers and are popular throughout the world. At first, mothers hoped that their babies would be comfortable and stay dry.but in the end the baby experiences diaper rush (diaper rash) and the incidence of diaper rash in babies who use disposable diapers increases to 61% Diaper rash in Indonesia is a skin problem in infants and children. Diaper rash, according to Dr. Siti Aisah Boediarjo, Sp. KK, is a skin disorder in the form of red, inflamed patches. Sometimes accompanied by hard, scaly skin, nodules, even blisters and blisters, which cause itching and burning in babies, approximately 50% of babies and children who wear diapers have experienced a diaper rush. The method of implementing this activity is: providing education or counseling to mothers who have children and still use diapers, distributing leaflets and explaining the use of diapers so that diaper rash does not occur. This activity begins with the preparation of proposals and activity administration and continues with an assessment of the situation. In August 2021 activities were carried out at the Evie Kec Babalan Clinic, Langkat Regency

Incidence of Cutaneous Adverse Events With Phosphoinositide 3-Kinase Inhibitors as Adjuvant Therapy in Patients With Cancer

ImportanceThe phosphoinositide 3-kinase (PI3K) pathway is among the most frequently activated pathways in human cancers. As the use of PI3K inhibitors for cancer treatment grows, there is increasing need for understanding the cutaneous effects associated with these therapies.ObjectiveTo systematically review the published literature reporting incidence of cutaneous adverse events with PI3K inhibitors and to provide pooled incidence estimates using meta-analysis.Data SourcesThis systematic review and meta-analysis was conducted using the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) reporting guidelines. The literature search concerned entries through September 2021 in the following sources: PubMed, Cochrane registry, ClinicalTrials.gov, and evidence from the NHS UK and Trip medical database. To analyze PI3K inhibitors’ cutaneous adverse events incidence, only randomized clinical trials (RCTs) were considered. The search strategy used the following keywords: (prevalence OR incidence OR epidemiology) and (phosphoinositide 3 kinase inhibitors OR PI3K inhibitors). No language restriction was applied. Analysis was conducted on July 1, 2022.Study SelectionStudies included phase 2 and phase 3 RCTs that reported incidence of cutaneous adverse events associated with use of PI3K inhibitors.Data Extraction and MeasuresData extracted included sex, medication name and class, sample size, rash incidence, and grade. The bias risk was assessed by the Cochrane tool for risk of bias assessment in RCTs.Main Outcomes and MeasuresThe primary outcome was incidence of PI3K inhibitor cutaneous adverse events (with 95% CIs) among the overall population and among subgroups. Between-study heterogeneity was assessed using the I2 statistic.ResultsThe analysis found the incidence of PI3K inhibitor cutaneous events of any grade to be 29.30% in the intervention group, translating to a pooled odds ratio (OR) for incidence of cutaneous adverse events of any grades of 2.55 (95% CI, 1.74-3.75). Incidence of severe grade (grade ≥3) of rash in the intervention group was estimated to be 6.95%, yielding a pooled Peto OR of 4.64 (95% CI, 2.70-7.97). Subgroup analyses revealed that the incidence of severe cutaneous adverse events (grade ≥3) was higher with the use of Pan-class-1 PI3K inhibitors (OR, 6.67; 95% CI, 4.28-10.38) than isoform-selective PI3K inhibitors (OR, 6.37; 95% CI, 3.25-12.48).Conclusions and RelevanceThis systematic review and meta-analysis identified an overall incidence of PI3K inhibitor cutaneous adverse events of any grade to be 29.30% with a pooled OR of 2.55; (95% CI, 1.74-3.75). These findings clarify the risk of cutaneous adverse events associated with this important class of anticancer therapies.

The Relationship of the Use of Powder in the Genetalia Area of Babies Aged 0-9 Months to the Event of Diaper Rash at PMB Fadilah, Bulukagung Madura Village

Diaper rash or often called diaper rash is a bright red rash caused by irritation of the skin exposed to urine or feces that lasts a long time under a child's diaper. This study analyzed the relationship between the use of loose powder in the genital area of ​​infants aged 0-9 months to the incidence of diaper rash in PMB Fadilah, Bulukagung Village, Madura. Correlation research, cross sectional, population of 23 infants aged 0-9 months with diaper rash, 23 infants sampled, purposive sampling, observation data collection, checklist measuring instrument, chi square analysis, (0.05). The results of statistical analysis with the chi square test, the results obtained = 0.000 with a level of 0.05 which means = 0.000 &lt;0.05, so there is a relationship between the use of loose powder in the genital area of ​​infants aged 0-9 months to the incidence of diaper rash.

Efficacy and safety of EGFR‑TKIs plus Shenqi Fuzheng injection for non-small cell lung cancer patients with EGFR-sensitive mutations

PurposeThe aim of this retrospective study is to evaluate the impact on efficacy and safety between epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs) alone and in combination with Shenqi Fuzheng injection (SFI) in patients with advanced NSCLC harboring epidermal growth factor receptor (EGFR) activating mutations.MethodsRetrospectively, information of 88 patients receiving EGFR-TKIs as first-line targeted treatment or in combination with SFI in the Affiliated Drum Tower Hospital of Nanjing University Medical College and the Affiliated Cancer Hospital of Anhui University of Science and Technology was collected. The primary endpoint was to assess progression-free survival (PFS) and safety of EGFR-TKIs alone or in combination with SFI.ResultsBetween January 2016 and December 2019, a total of 88 patients were enrolled in this research, including 50 cases in the EGFR-TKIs single agent therapy group and 38 cases in the SFI combined with EGFR-TKIs targeted-therapy group. The median PFS (mPFS) of monotherapy group was 10.50 months (95%CI 9.81–11.19), and 14.30 months (95%CI 10.22–18.38) in the combination therapy group. Compared to the single EGFR-TKIs administration, combinational regimen with SFI exhibited a lower incidence of rash and diarrhea in patients and was even better tolerated.ConclusionsSFI combined with the first-generation EGFR-TKIs are more efficient, can prominently prolong the PFS and attenuate the adverse reactions in patients with advanced NSCLC with EGFR-sensitive mutations.

Risk of cutaneous adverse events in cancer patients treated with phosphatidylinositol-3-kinase inhibitors: A systematic review and meta-analysis of randomized controlled trials.

Cutaneous adverse effects (AEs) are common following the phosphoinositide-3-kinase (PI3K) inhibitors treatment. We aim to estimate the incidence and risk of PI3K inhibitor-related cutaneous AEs. The protocol was submitted to the PROSPERO registry. We searched ClinicalTrials.gov and international databases up to July 29, 2022. Meta-analysis was conducted by using risk ratios (RRs) with 95% confidence intervals (CIs). Fourteen randomized controlled trials (RCTs) comprising 3877 patients were analyzed in this study. Compared with control arms, PI3K inhibitors showed a significant increase in the risk of all-grade rash, high-grade rash, and serious rash events (RR 2.29, 95% CI 1.58-3.31, p < 0.00001; RR 9.34, 95% CI 4.21-20.69, p < 0.00001; RR 5.11, 95% CI 2.11-12.36, p=0.0003). The overall incidences of all-grade rash and high-grade rash were 26.2% (592/2257) and 4.4% (66/1487). Subgroup analyses of all-grade rash according to cancer types and PI3K inhibitor assignations identified the significant associations. PI3K inhibitors also significantly increased the risk of pruritus and dry skin (RR 1.63, 95% CI 1.14-2.33, p=0.007; RR 3.34, 95% CI 2.30-4.85, p < 0.00001), with incidences of 13.4% (284/2115) and 9.8% (141/1436) in the treatment group. There is a significantly increased risk of some cutaneous AEs in patients using PI3K inhibitors. Advance intervention is recommended in case of severe and life-threatening events. Further research is required to investigate the risk factors and pathogenesis.

Outcome of Post-resection Intravesical BCG and Mitomycin C Therapy on Non-muscle Invasive High- Grade Transitional Cell Carcinoma of Urinary Bladder

Objective: This study aimed to compare the outcome of postoperative intravesical BCG and Mitomycin C therapy on non-muscle invasive high grade superficial bladder tumor. Methods: This prospective quasi experimental study was carried out among the patients with non-muscle invasive high grade transitional cell carcinoma (TCC) of urinary bladder, who underwent complete transurethral resection of bladder tumor of primary tumor attended at the urology department of DMCH, during March 2017 to August 2019. After pre-operative evaluation and counselling, 70 patients with histologically documented high grade superficial bladder tumor were included and divided in two groups. We instilled intravesical BCG in one group and Mitomycin C (MMC) therapy in other group. The patients were followed up at 3rd ,6th , 9th , 12th and 18th month. Results: The mean age of BCG group was 55.8 years while 60.2years in MMC group with majority between 45 to 65 years (&gt;80%). Sex distribution in both groups were almost equal (p=0.062). There were equal number of TaG3 and T1G3 disease in each group (p=0.809). Local adverse reactions were significant in BCG group (p= 0.016), among them UTI, between two groups, was statistically significant (p=0.039). Incidence of hematuria (p=0.324), voiding frequency (p=0.163) and local rash (P=0.642) had no statistically significant difference. The incidence of post-instillation systemic adverse reactions between two groups were statistically significant (p=0.034). Fever (p=0.028) was significant among them. Intavesical BCG was significantly more effective than MMC in terms of disease recurrence (p=0.047) and progression (p=0.008). Conclusions: We analysed the efficacy and safety of intravesical BCG and MMC in two groups, showing that BCG was more effective in terms of disease recurrence and progression but local and systemic side effects were higher in BCG group. Bangladesh J. Urol. 2021; 24(1): 62-71

Study on Application of RVD Regimen Sequential Auto-HSCT in the Treatment of Multiple Myeloma Evaluated by Propensity Score Matching

To investigate the application effect of sequential autologous hematopoietic stem cell transplantation (Auto-HSCT) with lenalidomide, bortezomib and dexamethasone (RVD) in the treatment of multiple myeloma (MM) evaluated by propensity score matching. The clinical data of 49 MM patients treated with RVD scheme and followed-up for 36 months in the hospital from January 2015 to January 2021 were retrospectively analyzed and included in the control group, the clinical data of 54 MM patients who received RVD scheme and sequential Auto-HSCT scheme and completed 36 months of follow-up in the hospital during the same period were collected and included in the observation group. PSM method (1∶1, caliper value=0.01) was used to match the control group with the observation group based on baseline data and laboratory indexes, covariate equilibrium samples were obtained between groups (40 cases in each group). The clinical efficacy of patients in the two groups after 18 weeks of treatment was compared; the incidence of toxic and side effects during treatment of patients in the two groups was compared; the survival of patients in the two groups was compared after 36 months of follow-up. The ORR and DCR in the observation group were higher than those in the control group, the difference was statistically significant (P<0.05). Compared the incidence of fatigue, rash, thrombocytopenia, anemia and nausea of patients in the two groups, there was no statistical significant difference (P>0.05). After 36 months of follow-up (no loss during follow-up), 4 cases died from illness in the observation group, with a survival rate of 90% and an average survival time of 35.61 (95% CI: 35541-35.685) months, 10 cases died from illness in the control group, with a survival rate of 75% and an average survival time of 34.70 (95% CI: 34.559-34.832) months, the survival rate of the observation group was higher than that of the control group, the difference was statistically significant (P<0.05). Sequential Auto-HSCT with RVD regimen in the treatment of MM can improve the short-term efficacy and increase the survival rate of patients, which will not increase toxic and side effects and has high safety.

The high incidence and risk factors of levetiracetam and lacosamide-related skin rashes in glioma patients

ObjectiveAntiseizure drug (ASD)-induced skin rash remains the main side effect of seizure management in patients with glioma. New generations of ASDs, such as levetiracetam (LEV) and lacosamide (LCM) are associated with less frequent skin rashes than conventional ASDs. However, there are few reports regarding the incidence of skin rashes by LEV and LCM in patients with glioma. Therefore, the aim of this study was to investigate the incidence and risk factors of LEV- and LCM-associated skin rashes in patients with glioma. MethodsWe compared the incidence of ASD-associated skin rash between 353 patients with glioma and 125 patients with meningioma, who received LEV or LCM and underwent surgery between 2017 and 2019 at our institution. Furthermore, to evaluate the association between potential risk factors and ASD-associated skin rashes, univariate and multivariate analyses were performed. ResultsThe incidence of ASD-associated skin rash in patients with glioma was higher (11 %) than in those with meningiomas (1.6 %). The multivariate regression analysis showed that adjuvant treatment with radiotherapy (p = 0.023) and a history of drug allergy (p = 0.023) were significant risk factors for ASD-associated skin rash. The rate of ASD-related skin rashes in patients with glioma was also higher than the previously reported rates of 1–3 % in patients with epilepsy. ConclusionOur results indicate that adjuvant treatment with radiotherapy and a history of drug allergy correlated with a high incidence of ASD-related skin rashes in patients with glioma who receive LEV and LCM. Patients with these two factors should be carefully checked for skin rashes.

Abstract CT025: BT8009-100 phase I/II study of novel bi-cyclic peptide and MMAE conjugate BT8009 in patients with advanced malignancies associated with nectin-4 expression

Abstract BT8009 is a Bicycle® Toxin Conjugate (BTC™), a novel class of chemically synthesized molecules, comprising a bicyclic peptide targeting Nectin-4 tumor antigen, linked to cytotoxin (monomethyl auristatin E [MMAE]) via a valine-citrulline (val-cit) cleavable linker. Due to their small size, BTCs represent a unique therapeutic class, combining the pharmacology normally associated with a biologic with the pharmacokinetic properties of a small molecule. Here, we describe the preliminary monotherapy dose escalation results of the ongoing multicenter Phase I/II clinical trial (NCT04561362) that assesses the safety and tolerability of BT8009 administration in patients with advanced solid tumors associated with Nectin-4 expression, not exposed to enfortumab vedotin. Patients were treated until disease progression or intolerable toxicity, with tumor assessments for response per RECIST taken every two months. Nectin-4 expression levels were measured in tumor tissue. Thirty-four patients were initiated on weekly BT8009 (7 patients at 2.5 mg/m2, 20 patients at 5.0 mg/m2, and 4 patients at 7.5 mg/m2) or biweekly BT8009 (3 patient at 7.5 mg/m2). Baseline demographics were 62% patients were male, 44% and 56% were ECOG 0 and ECOG 1, respectively, median age was 65.5 years. BT8009 exhibits linear pharmacokinetics. The most common treatment-related adverse events were nausea (14 patients, 41%; ≥ G3 1 patient, 3%), fatigue (13 patients, 38%; ≥ G3 2 patients, 6%), anorexia (11 patients, 32%; ≥ G3 0 patients), constipation (10 patients, 29%; ≥ G3 1 patient, 3%) and anemia (10 patients, 29%; ≥ G3 3 patients, 9%). To date, BT8009 had low incidences of ocular disorders (3%), hyperglycemia (6%), neuropathy (6%), and rash (18%). There was 1 dose-limiting toxicity (G3 asthenia) reported at the 7.5 mg/m2 weekly dose level. Six patients (18%) experienced an SAE, with only 1 related SAE (vomiting). Treatment-emergent AEs resulting in treatment discontinuation, dose interruption, or reductions were observed in 2 patients (6%), 11 patients (32%), and 5 patients (15%), respectively. Preliminary confirmed responses observed in patients with urothelial carcinoma (UC) enrolled in the 5 mg/m2 cohort show 4/8 patients with a complete response (CR) or partial response (PR), including 1/8 patients with a CR and 3/8 patients with a PR, and 2/8 patients (25%) with stable disease (SD), reflecting a 50% overall response rate and a 75% disease control rate in UC patients for this cohort. BT8009 exhibits a promising preliminary tolerability profile and preliminary antitumor activity. The molecule will continue to be explored in the current dose-escalation/dose-expansion study of BT8009 monotherapy and in combination with nivolumab. Citation Format: Meredith McKean, Capucine Baldini, Loic Verlingue, Bernard Doger, Gerald Falchook, Antoine Italiano, Julia Lostes, Oscar Reig, Roshawn Watson, Sebastien Hazard, Dominic Smethurst, Giulia Fulci, Hongmei Xu, Phil Jeffery, Kevin Lee, Irene Braña, Sophie Cousin, Elisa Fontana, Hendrik-Tobias Arkenau. BT8009-100 phase I/II study of novel bi-cyclic peptide and MMAE conjugate BT8009 in patients with advanced malignancies associated with nectin-4 expression [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2022; 2022 Apr 8-13. Philadelphia (PA): AACR; Cancer Res 2022;82(12_Suppl):Abstract nr CT025.

Kawasaki disease like presentation of Multisystem inflammatory syndrome in children - A Case report

A new COVID-19 related clinical syndrome in children called Multisystem inflammatory syndrome in children (MISC) has been reported, with significant inflammation and similarities to Kawasaki disease (KD) with concurrent SARS-CoV-2 in Europe and in USA since 7 April 2020. On 25th April, concerns were initially raised in the United Kingdom regarding a cluster of children of various ages, presenting with a Multisystem inflammatory state who required intensive care, and who all displayed "overlapping features of toxic shock syndrome and atypical Kawasaki disease with blood parameters consistent with severe COVID 19 in children. Clinical presentations were variable, with significant gastrointestinal (GI) symptoms, cardiac disease, mild or absent respiratory symptoms, and variable incidence of rash, red eyes, oral mucous membrane changes. Later on this was diagnosed as part of a post covid Multisystem inflammatory disease (MISC). We report one patient admitted in Civil hospital, Ahmedabad with high grade fever for more than three days along with manifestations of multisystem disease involving cardiovascular system with myocarditis,and gastrointestinal system in form hepatitis, widespread blanchable rashes and respiratory distress due to pleural effusion.The clinical features had similarly to features of Kawasaki disease. Patients also had raised inflammatory markers in form of increased CRP, ESR, PT, APTT. Covid IgG antibody was found positive and patient was treated as per MISC protocol with steroid, IVIG and aspirin together with proper supportive management in form of oxygen through High flow nasal cannula and ionotropes for shock. Multiple theories on pathogenesis have been suggested in form of Antibody dependent enhancement precipitating kawasaki like illness due to cytokine storm provoked by type 1 and 3 interferon. Role of STING (Stimulator of interferon gamma) pathway has been found to be involved in MISC. With proper treatment as per protocol it is possible to successfully discharge patients with MISC admitted in decompensated states. Keywords: MISC, Kawasaki, steroids, PIMS-TS, blanchable rashes, COVID 19 antibody

P-90 First-line anti-EGFR agents (panitumumab or cetuximab) plus chemotherapy in patients with metastatic colorectal cancer: Onco-colon Turkey study subgroup analysis

The guidelines support the use of the epidermal growth factor receptor (EGFR) inhibitors panitumumab or cetuximab for the treatment of metastatic colorectal cancer (mCRC) on significant clinical benefits in patients with wild-type RAS. We assessed the efficacy and toxicity of panitumumab versus cetuximab in Onco-Colon Turkey registry patients. Patients with wild-type RAS mCRC treated with fluorouracil-oxaliplatin- and irinotecan-based chemotherapies in first-line setting were evaluated to either panitumumab or cetuximab including combinations. The efficacy of cetuximab vs panitumumab on overall survival (OS) and progression-free survival (PFS) and safety profile when combined with chemotherapy regimen was compared retrospectively. From January 2016 to March 2019, 1065 patients were recorded in Onco-Colon Turkey Registry, and 316 (47.4%) and 351(52.6%) patients were received the panitumumab and cetuximab as anti-EGFR treatment in first-line setting, respectively. The panitumumab was used more commonly with a combination regimen containing oxaliplatin (74.9%), while the cetuximab was used more in contingency with a combination regimen containing irinotecan (50.4%) (p=0.000). The median PFS was 11.6 months in the panitumumab arm and 11.0 months in the cetuximab arm, (p=0.270), and median OS was 26.5 and 27.6 months (p = 0.726), respectively. The overall response rate was 58.4% in panitumumab arm and 51.4% in cetuximab arm (p=0.138). The incidence of acneiform rash and thrombocytopenia was higher in the panitumumab arm (p=0.011 and 0.045) and the incidence of nausea/vomiting was higher in the cetuximab arm (p=0.013). Our findings show that panitumumab is similar to cetuximab and that these agents provide equal progression-free and overall survival benefit in this population of patients with wild-type RAS. Both agents had toxicity profiles that were to be expected.

Efficacy and Side Effects of Irinotecan Combined with Nedaplatin versus Paclitaxel Combined with Cisplatin in Neoadjuvant Chemotherapy for Locally Advanced Cervical Cancer and Tumor Marker Analysis: Based on a Retrospective Analysis.

Objective A case-control study was adopted to investigate the efficacy and side effects of irinotecan combined with nedaplatin (NP) versus paclitaxel combined with cisplatin for locally advanced cervical cancer (CC) neoadjuvant chemotherapy (NACT) and to analyze the changes in tumor marker levels. Methods A total of 96 patients with locally advanced CC who were treated from October 2019 to October 2021 were enrolled in our hospital as the research subjects, and their clinical data were collected for retrospective analysis and grouped according to their treatment regimens. Among them, 53 patients received paclitaxel combined with cisplatin as the control group, and the other 43 patients received irinotecan combined with NP as the observation group. The clinical effectiveness of neoadjuvant chemotherapy and alterations in tumor markers (CEA, AFP, CA125, and SCCA) were compared between the two groups. The incidence of common chemotherapy side effects was observed and compared between the two groups, including nausea and vomiting, abdominal pain and diarrhea, liver function impairment, bone marrow suppression, transient hyperglycemia, rash, ECG abnormalities, peripheral neurotoxicity, and muscle aches and pains. Results The clinical efficiency of neoadjuvant chemotherapy was 97.67% in the observation group and 81.13% in the control group, with no statistically significant difference between the groups (P > 0.05). There was no significant difference in CEA, AFP, and CA125 between the two groups before and after chemotherapy, but the decrease of SCCA before and after chemotherapy was statistically significant. There was no significant difference in the incidence of liver function damage, myelosuppression, abnormal ECG, and rash between the two groups (P > 0.05). There are statistically significant differences in the incidence of nausea and vomiting, transient hyperglycemia, peripheral neurotoxicity, and muscle aches between the observation and control groups (P < 0.05). The incidence of nausea and vomiting, transient hyperglycemia, peripheral neurotoxicity, and muscle aches was higher in the control group than in the observation group, with statistically significant differences (P < 0.05). The difference in the incidence of diarrhea and abdominal pain between the observation group and the control group was statistically significant (P < 0.05), and the incidence of diarrhea and abdominal pain in the observation group was higher than that in the control group. Conclusion Irinotecan in combination with nedaplatin can be an effective neoadjuvant chemotherapy regimen for advanced localized cervical cancer, particularly in patients with combined diabetes.

Efficacy and safety of pembrolizumab in Chinese patients with recurrent/unresectable/metastatic head and neck squamous cell carcinoma.

e18001 Background: The efficacy and safety of Pembrolizumab in recurrent /unresectable/metastatic head and neck squamous cell carcinoma have been well documented in KEYNOTE-048 and other studies, and the effectiveness of different areas’ population have been shown in related studies. However, there is no native data based on the Chinese population. The purpose of this study was to investigate the efficacy and safety of Pembrolizumab in the treatment of R/U/M head and neck squamous cell carcinoma in Chinese population. Methods: We reviewed patients data from the department of Oral &amp; Maxillofacial Surgery, the Affiliated Hospital of Qingdao University. The patients with R/U/M head and neck squamous cell carcinoma were treated with or without combined chemotherapy / targeted therapy according to their PD-L1 expression status (CPS). Pembrolizumab was infused intravenously with 200mg every 3 weeks for a maximum of 35 cycles. The primary endpoint was Objective Response Rate(ORR). The secondary endpoints were Quality of Life, Safety and Progression Free Survival(PFS). Results: A total of 23 eligible patients with R/U/M head and neck squamous cell carcinoma were included from February 2021 to February 2022, including 18 males (78.26%) and 5 females (21.74%) with a median age of 68 years. The primary sites were oral cavity in 16 cases (69.56%), oropharynx in 4 cases (17.39%), hypopharynx in 1 case (4.35%), and larynx in 2 cases (8.70%). P16 status was positive in 4 cases (17.39%), negative in 12 cases (52.17%), and unknown in 7 cases (30.43%). The expression status of PD-L1 in all patients was known. Patients with CPS ≥ 20 were treated with Pembrolizumab monotherapy and patients with CPS &lt; 20 were treated with Pembrolizumab combined with chemotherapy / targeting therapy, of which 22 (95.65%) were treated with first-line therapy and 1 (4.35%) were treated with second-line therapy. The median follow-up period was 6 months. 15 patients were assessed as remission (as of February 2022), of which 4 (17.39%) showed CR, 11 (47.83%) showed PR, 7 (30.43%) showed SD, and 1 (4.35%) showed PD. ORR was 65.22%, DCR was 95.65%. After 4 cycles of treatment, 14 patients (60.87%) achieved tumor remission and control, and the functional status score (KPS) increased from 65 to 85. The incidences of thyroid dysfunction, skin rash, fatigue, neutropenia and immune pneumonia were 2 (8.70%), 3 (13.04%), 2 (8.70%), 1 (4.35%) and 1(4.35%), respectively. Conclusions: This retrospective data have shown excellent efficacy and safety of pembrolizumab in the Chinese population of R/U/M head and neck squamous cell carcinoma, and provide data support for follow-up related research.Due to the short follow-up time, most of the patients have not yet reached PFS, and follow-up will continue.