Total Response Rate Research Articles

Abstract OT2-18-01: Nab-paclitaxel followed by dose-dense epirubicin/cyclophosphamide in neoadjuvant chemotherapy for triple-negative breast cancer: an open-label, single-arm phase II study

Abstract Purpose: The anti-tumor activity of nab-paclitaxel followed by epirubicin/cyclophosphamide (EC) as neoadjuvant chemotherapy (NAC) in Asian patients remains unclear, particularly in the aggressive subtype triple-negative breast cancer (TNBC). This study aimed to evaluate the efficacy and safety of this NAC regimen in TNBC. Methods: In this Simon’s two-stage, phase II study, treatment-naïve patients with resectable unilateral primary invasive TNBC were enrolled. Eligible patients received nab-paclitaxel 125 mg/m2 weekly on day 1 for 12 weeks, followed by dose-dense EC (epirubicin 90 mg/m2; cyclophosphamide 600 mg/m2) on day 1 for four 2-week cycles. The primary endpoint was the total pathological complete response (tpCR, ypT0/is ypN0) rate. Secondary endpoints included breast pathological complete response (bpCR, ypT0/is) rate, objective response rate (ORR), the proportion of patients requiring breast-conserving surgery, and safety. Results: 55 eligible patients were enrolled and treated. After neoadjuvant therapy, tpCR and bpCR were respectively observed in 43.1% (95% CI, 29.3%-57.8%) and 49.0% (95% CI, 3)4.8%-63.4%) of 51 evaluable patients for pathological response evaluation. 44 had an ORR as their best response (80.0%; 95% CI, 67.0%-89.6%). No correlations between clinicopathological variables and pathological/clinical response were observed. Grade 3 or more AEs occurred in 63.6% of 55 patients. The most frequent AEs were alopecia. No treatment-related surgical delay or death occurred. Conclusions: Nab-paclitaxel followed by dose-dense EC as NAC demonstrates promising anti-tumor activity and acceptable tolerability for patients with TNBC. Citation Format: Yin Liu, Lei Fan, Zhi-Ming Shao, Zhong-Hua Wang. Nab-paclitaxel followed by dose-dense epirubicin/cyclophosphamide in neoadjuvant chemotherapy for triple-negative breast cancer: an open-label, single-arm phase II study [abstract]. In: Proceedings of the 2022 San Antonio Breast Cancer Symposium; 2022 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2023;83(5 Suppl):Abstract nr OT2-18-01.

Abstract P6-01-22: Age, Ki-67, Nodal pCR and overall survival following Neoadjuvant Chemotherapy for Node Positive ER+/Her2- Breast Cancer

Abstract Background: The role of chemotherapy in node positive (N+) luminal breast cancer (BC) is often debated, given low total pathologic complete response (pCR) rates following neoadjuvant chemotherapy (NAC) and discrepancy in adjuvant chemotherapy benefit. A prior single institution study of cN+ luminal BC showed that pts age < 50 and tumor Ki-67 ≥ 20% had high nodal pCR (> 35%). This study’s goals were 1) to validate Ki-67 and age in relation to nodal pCR and 2) evaluate the prognostic impact of nodal pCR on overall survival (OS). Methods: We queried the National Cancer Database 2010-2019 for pts with cN+ ER+/HER2- BC treated with NAC and surgery. Breast pCR was defined as ypT0/ypTis and nodal pCR as ypN0/ypN0i+. Ki-67 was available in 2018 & 2019 only and was used to evaluate Ki-67 and nodal pCR. 2010-2018 data were used to evaluate nodal pCR and OS. OS was analyzed using multivariable Cox proportional hazards regression. Results: In 2018-2019, 4,801 pts were identified and 2,473 (51.5%) had Ki-67 available. Nodal pCR was 23.7% and was higher in pts < 50 years old (28.1% vs 21.1%) and in those with Ki67 ≥ 20% (28.4% vs 12.7%), both p < 0.001. Pts < 50 with Ki67 ≥ 20% had the highest nodal pCR at 31.7%, followed by age ≥ 50 with Ki67 ≥ 20% at 26.3%. With Ki67 < 20%, nodal pCR was 15.4% (in age < 50) and 11.3% (in age ≥ 50). From 2010-2018, we identified 20,084 cN+ ER+/HER2- BC pts treated with NAC. Total pCR was 7.4%, 14.3% had nodal pCR only, 3.8% had breast pCR only, and 74.5% had residual disease in breast and nodes. OS at 5 years was 79.1% and varied by NAC response: 90.8% with total pCR, 83.8% with nodal pCR only, 80.7% with breast pCR only, and 76.9% with residual disease in breast and nodes. Specifically nodal pCR (with or without breast pCR) was seen in 22.0% and was associated with 5-year OS rate of 86.4% compared to 77.1% without nodal pCR, p < 0.001. On multivariable analysis adjusted for other clinical and treatment factors, nodal pCR was associated with better OS (adjusted HR 0.56, 95% CI: 0.50-0.61, p < 0.001) in all ages combined and within both the age < 50 and age ≥ 50 subgroups (see Table). In a subgroup of pts approximating RxPonder entry criteria (defined as cT1-3, N1, Grade I or II, ER+/PR+), results were consistent with the overall cohort: nodal pCR varied by both age (17.5% in age < 50 and 13.6% in age ≥ 50, p < 0.001) and by Ki67 ≥ 20% vs < 20% (16.8% vs 7.9%, p < 0.001) and nodal pCR remained prognostic for OS with adjusted HR 0.63 (95% CI: 0.50-0.81, p < 0.001). Conclusion: In cN+ ER+/HER2- BC treated with NAC, nodal pCR is more common in pts< 50 and those with high Ki-67 and is highly prognostic for OS. These data strongly suggest that NAC chemotherapy benefit should not be evaluated using total pCR rates in isolation, but for N+ pts to also consider nodal response. Given that nodal pCR is highly prognostic for OS, future neoadjuvant strategies should consider nodal pCR as a potential intermediate biomarker for long term survival. Multivariable analysis of factors associated with overall survival, including the adjusted effect of nodal pCR Citation Format: Dan Moldoveanu, Matthew P. Goetz, Tanya L. Hoskin, Courtney N. Day, Judy C. Boughey. Age, Ki-67, Nodal pCR and overall survival following Neoadjuvant Chemotherapy for Node Positive ER+/Her2- Breast Cancer [abstract]. In: Proceedings of the 2022 San Antonio Breast Cancer Symposium; 2022 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2023;83(5 Suppl):Abstract nr P6-01-22.

Abstract P1-11-18: The efficacy and safety of trastuzumab and pertuzumab in combination with different chemotherapy regimens for neoadjuvant treatment of HER2-posotive breast cancer: a multi-center real-world study in China

Abstract Background: Dual HER2 targeted therapy with trastuzumab (H) and pertuzumab (P) has been approved as neoadjuvant therapy for patients with HER2-positive breast cancer in China in 2019 based on the results from NeoSphere and PEONY study. However, the real-world efficacy and safety data are currently lack of evidence in China. Therefore, this multi-center real-world study aims to retrospectively analyze the efficacy and safety of neoadjuvant trastuzumab and pertuzumab combined with different chemotherapy regimens of HER2-positive early breast cancer. Methods: Patients received trastuzumab and pertuzumab in combination with different chemotherapy regimens, including taxanes (T), cyclophosphamide (C), anthracyclines (A) were collected retrospectively from 12 centers. The primary endpoint was total pathological complete response (tpCR, ypT0/is ypN0) rate. Results: A total of 357 patients were enrolled, among which 204 (57.5%) recieved TCbHP, 92 (25.9%) recieved EC-THP, and 51 (14.4%) received THP as chemotherapy regimens. The median age was 48 years old (range, 22-76), 142 (39.8%) of patients were classified as hormone receptor (HR)-positive, and 215 (60.2%) were HR-negative. The overall tpCR rate was 58.5% (95%CI, 53.2%-63.7%). tpCR rate for HR-negative patients was significantly higher than HR-positive patients (65.6% vs. 47.9%, p=0.001) and there was not any statistical difference according to chemotherapy regimens (56.9% for TCbHP, 56.5% for EC-THP, and 66.7% for THP, p=0.445). The most common adverse events included anemia (40.1%), white blood cell count decreased (34.3%), ejection fraction decreased (19.5%), Alanine aminotransferase increased (18.9%), platelet count decreased (12.8%) and neutrophil count decreased (12.0%). There was not any toxicity leading to death. Conclusions: Multi-center real-world data show satisfactory tpCR rate and tolerable adverse events of trastuzumab and pertuzumab in combination with different chemotherapy regimens in China. Citation Format: Xiaowei Qi, Hong Hu, chen wenlin, xu yan, liu shu, fang yanman, Taolang Li, ming jia, zhou sihai, chai fan, liang yueyang, fan yuanming, Yi Zhang, Peng Tang, jiang jun, nie jianyun, Li Chen, Shushu Wang. The efficacy and safety of trastuzumab and pertuzumab in combination with different chemotherapy regimens for neoadjuvant treatment of HER2-posotive breast cancer: a multi-center real-world study in China [abstract]. In: Proceedings of the 2022 San Antonio Breast Cancer Symposium; 2022 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2023;83(5 Suppl):Abstract nr P1-11-18.

Clinical Efficacy of Spleen and Yin Prescription in the Treatment of Primary Sjogren Syndrome and Its Impact on Disease Activity

Objective: To study the clinical efficacy of primary Sjogren syndrome and the effect of disease activity. Methods: The 60 patients from January 2021 to January 2022 respectively, and divided into two groups according to random numbers, hydroxychloroquine sulfate, 30 patients, clinical effect combined with hydroxychloroquine sulfate, inflammatory index, complement levels, and immunoglobulins (ESR, RF, CRP, C3, C4, IgG, IgA, IgM), ESSDAI, ESSPRI, and adverse effects. Results: The total response rate of the two groups was 86.67% (26/30) and 73.33% (22/30), respectively, comparing with the treatment group (P <0.05). Comparison between groups found that no differences in CRP, C4, IgA, and IgM were significant (P>0.05). After treatment, peripheral ESR, RF, IgG decreased, complement C3 levels increased (P <0.05), the ESSDAI score and ESSPRI score of the two groups also decreased (P<0.05). On the Traditional Chinese medicine symptom integral, the treatment group had better results in improving dry mouth, dry throat, dry eyes, dry skin, five upset heat, and joint pain(P<0.05), and no adverse reactions were found in either group. Conclusion: The treatment group can effectively improve the clinical efficacy, reduce the level of inflammatory indicators and disease activity, and see no obvious adverse reactions, which can be effectively used in clinical practice.

Promoting the Use of Open Educational Resources by Librarians in University Libraries in Nigeria

The study examined the roles played by librarians in promoting the use of Open Educational Resources (OER) in their institutions in South-South and South-West geo-political zone of Nigeria. The descriptive survey design was adopted for the study. Data were collected using an online questionnaire and a total enumeration sampling technique was used. Data were analyzed with frequency counts and simple percentages, and Statistical Product and Service Solutions (SPSS) version 23 was used to generate the mean and standard deviation. A total of 200 librarians in university libraries were sent the online questionnaire and 83 librarians responded by filling out the questionnaire giving a total response rate of 42%. The 83 librarians who responded to the online questionnaire was used as the sample of the study. The questionnaire were validated by two experts in research methodology and educational technology. Cronbach Alpha was used to establish the reliability of the instrument, which yielded 0.86. The findings revealed that the librarians have a high level of awareness of the concept of OER and that the majority of librarians were actively involved in promoting the use of OER in their various institutions. Lastly, the study established that inconsistent power supply, lack of library sensitization on the use of OER, poor Internet connectivity, and lack of institutional support for the creation and use of OER were some of the significant challenges to the effective use of OER in universities in Nigeria. Based on the findings, the researchers recommended that academic libraries in Nigeria must meet global standards by promoting universal access to education through the use of OER among others.

Comparison of the efficacy and safety of leflunomide versus mycophenolate mofetil in treating IgG4-related disease: a retrospective cohort study.

Combination therapy of glucocorticoids (GCs) plus leflunomide (LEF) and GCs plus mycophenolate mofetil (MMF) was reported to have good efficacy and safety in the management of IgG4-RD. However, studies comparing the efficacy and safety of these two combination therapies were unavailable. Herein, this study aimed to compare the efficacy and safety of GCs plus LEF and GCs plus MMF in treating IgG4-RD. This study included 130 newly diagnosed IgG4-RD patients who received the therapy of GCs plus LEF (group I) and GCs plus MMF (group II). Clinical data at baseline and after treatment, treatment response, relapse rate, and adverse effects were recorded and analyzed. Patients in both groups responded well to the treatment in the 1st-month follow-up, and 100% of patients achieved treatment response. However, at the 6th and 12th-month follow-up, the total response rate of group II was higher than that in group I (75.6 vs. 53.7%, p = 0.038 and 85.4% vs. 61.0%, p = 0.013, respectively). In addition, the duration of disease remission in group II was longer than that in group I (9(6-9) vs. 6(6-6) months, p = 0.014). Moreover, more patients in group I had adverse effects compared with group II (36.6 vs. 7.3%, p < 0.01); andthe most common adverse events of LEF were rash (12.2%) and elevation of liver enzymes (9.8%). The combination therapy of GCs plus low-dose MMF had better efficacy and safety in the management of IgG4-RD compared with the therapy of GCs plus LEF.

Low-dose decitabine for refractory thrombocytopenia following allogeneic hematopoietic stem cell transplantation in children: A pilot study

Refractory thrombocytopenia is a critical complication following allogeneic hematopoietic stem cell transplantation (allo-HSCT), which is not sensitive to conventional treatment and often leads to lower overall survival and disease-free survival. Previous studies have showed the efficacy and safety of low-dose decitabine for adults' refractory prolonged isolated thrombocytopenia in hematologic malignancy after allo-HSCT. However, clinical data on pediatric patients or non-hematologic malignancies are lacking. Herein, we evaluated the safety and efficacy of low-dose decitabine in nine children with persistent thrombocytopenia after HSCT. Patients received decitabine at 3.5mg/m2, 5mg/m2 or 10mg/m2 respectively for three to five consecutive days according to underlying diseases and hyperplastic state of bone marrow. Six patients reached sustained platelets count more than 100×109/L, two patients achieved platelet transfusion independence. The total response rate was 88.8% (8/9). One patient died from severe infection because of persistent agranulocytosis longer than 3weeks. In conclusion, the present study supports the safety and efficacy of low-dose decitabine for treatment of refractory thrombocytopenia after allogeneic HSCT in children.

Developmental outcomes in children born to women with possible subclinical rubella exposures during pregnancy.

This study investigated outcomes of children born to women who seroconverted to rubella immune during pregnancy. In a prior 2012-2013 study of 296 women who were rubella nonimmune, 26 (8.8%) seroconverted to rubella immune during pregnancy. These same women and their now 8-9 years-old children were queried as to the children's developmental health. After removing exclusions and those lost to follow-up, the total response rate was 115/204 (56.4%). Three sets of twins in the nonimmune group increased the total to 118. The seroconversion group had more autism (12.5% vs. 3.9%, p = 0.19), ADHD (37.5% vs. 18.6%, p = 0.10), and any developmental disability (43.8% vs. 31.4%, p = 0.39) but none showed a statistical difference between the two groups. Compared to Autism and Developmental Disabilities Monitoring data, the seroconversion group had a greater prevalence of autism (odds ratio [OR] 6.07, p = 0.051, nonsignificant); and to data derived from the National Health Interview Survey, a nonsignificant higher odds of autism (OR 5.57, p = 0.060), higher odds of ADHD (OR 5.65, p = 0.0027) and of any developmental disability (OR 3.59, p = 0.014). The nonimmune group also demonstrated a statistically significant increase for both ADHD and any developmental disability, but not for autism.

P540 The opinions and needs of patients living with refractory ulcerative proctitis, and the health care professionals who care for them; A Delphi consensus survey

Abstract Background Refractory ulcerative proctitis presents a huge clinical challenge not only for the patients living with this chronic, progressive form of inflammatory bowel disease (IBD) but also for the professionals who care for them. Currently, there is limited research and evidence-based guidance on this condition, resulting in the large majority of patients living with the symptomatic burden of disease and reduced quality of life. The aim of this study was to establish a consensus on the thoughts and opinions surrounding refractory proctitis disease burden and management. Methods A three-round Delphi consensus survey was conducted among patients living with refractory proctitis and the healthcare experts with knowledge on this disease. A brainstorming stage which involved a focus group where the participants came up with an initial list of fourteen statements was completed. Following this, there were three rounds of Delphi surveys in which the participants were asked to rank the statements in order of importance alongside providing any additional comments or clarifications. Calculation of mean scores, analysis of comments and revision of statements was performed by the research team after each survey round. Statements meeting the pre-defined consensual mean score of at least 7 out of 10 were included in the final list of statements. Results In total, fourteen statements were suggested by the focus group at the initial creation stage. Based on these suggestions, the statements were presented to the participants and following completion of three Delphi survey rounds, all fourteen statements reached consensus following appropriate revision. The total response rate for the third Delphi round was 100% (21 out of 21 participants). Statements consider treatment options, areas for further research and clinical decision making factors. Conclusion This is the first study of its kind to provide a list of consensual statements on the opinions and needs of those living with refractory ulcerative proctitis. We established consensus on the thoughts and opinions surrounding refractory proctitis from both the experts who manage this disease and the patients living with it. These statements represent the first step towards providing more clinical research date and ultimately guidance aimed at this specific patient group.

P030 Assessing dietetic interventions in inflammatory bowel disease patients

Abstract Background Nutrition can play a role in the management of inflammatory bowel disease (IBD) as well as general nutritional status, however there are many types of dietetic interventions depending on the circumstances. We decided to survey some of the nutrition interventions that IBD patients may be provided with to obtain a general picture of how helpful this is to patients, as well as the effectiveness of having a specific IBD dietetic post. Methods The inclusion criteria were patients with a diagnosis of IBD, reviewed by the IBD dietitian and patients had to be under the IBD team at Whipps Cross Hospital. Patients were asked if they consented to providing their email address for the anonymous survey link to be sent to. The survey was then emailed to 50 IBD patients. Nine questions were asked on the survey and an internet survey provider was used. Results The total response rate was 32% to the survey. The mean age was about 40 years old. 40% of patients were male with the remainder being female. 58% of the patients had Crohn’s disease with the remainder having UC. 100% of patients felt the dietitian involved them in decision making. The results of the following dietetic interventions are only where applicable to patients: 100% of patients rated nutrition support care (including exclusive enteral nutrition for Crohn’s disease) as excellent or good. 100% of patients rated specific IBD dietary advice as excellent or good. 100% of patients rated functional symptoms or irritable bowel syndrome advice as excellent or good. 100% of patients rated artificial nutrition advice as good. 81% of patients felt advice improved symptoms and nutritional state with 13% being unsure. 81% of patients felt advice improved quality of life with 13% being unsure. 81% of patients felt cultural, lifestyle and language needs were considered with 13% being unsure. 100% of patients felt having access to a dietitian was helpful. Conclusion All patients felt that the specific types of dietary care provided were excellent or good, with the majority of patients responding that advice improved symptoms, improved quality of life and that cultural and lifestyle needs were taken into account. All patients found it supportive to have a dietitian as part of the IBD multidisciplinary team. It would be useful in the future to further assess these types of dietetic care, such as exclusive enteral nutrition for Crohn’s disease. These findings support the best practice guidelines for having a dietetic post as part of the IBD team.

The diabetes epidemic in Malta

Aim: The small European Mediterranean island state of Malta is a highly prevalent type 2 diabetes (T2DM) country. Over recent decades drastic environmental, cultural and ethnic changes occurred and it was considered timely to undergo a cross-sectional survey to establish up-to-date prevalence of T2DM, its socio-geographical distribution and ultimately estimating the economic burden of T2DM. Methods: A health examination survey was conducted (2014-16) including a representative sample of the adult population stratified by 18-70 years, gender and locality (n=3,947; males n=1,997 male). The survey consisted of a socio-demographic questionnaire, various health examination measurements and blood samples for fasting blood glucose (FBG). Prevalence for T2DM (depending on medical history, medication and FBG &gt;7mmol/L) were calculated for the general population as well as for each of the districts making up the Maltese Islands. The economic burden of T2DM for 2017 and projected burden for 2045 were calculated using secondary sources and by incorporating 2% compound interest per annum respectively. Results: A total response rate of 47.15% was obtained, with a mean age of 48 years for males and 46 years for females. Out of the total adjusted population (n=3,947, male n=1,998), the prevalence of T2DM was of 10.31%, with 6.31% already known to have T2DM while 4% were newly diagnosed. Females were diagnosed with T2DM at an earlier age than the males. No significant geographical T2DM prevalence differences were established. The total annual diabetes health care expenditure was approximately €107,316,517.82 for 2017, while the projected expenditure for 2045 was estimated at €244,136,040. Conclusion: Malta is a country with a high prevalence of diabetes. The females were observed to be at an earlier risk of developing undiagnosed diabetes compared to males. Although geographical location did not appear to have significant effect on T2DM distribution, this disease contributes to a high economic burden. The expected exponential increase in diabetes prevalence is subsequently expected to affect negatively the healthcare expenditure. This puts forward the recommendation for development of early screening programmes as part of preventive action strategies.

Office-Based Photodynamic Therapy Using Locally Applied 5-aminolevulinic Acid and 635 nm Laser for Laryngeal Leukoplakia.

Photodynamic therapy (PDT) is a minimally invasive method with strong tissue selectivity and nonthermal effects. We aim to investigate the efficacy of an in-office method utilizing PDT with local application of 5-aminolevulinic acid (ALA) and 635 nm diode laser for treating laryngeal leukoplakia. Retrospective cohort study. Outpatient clinic-tertiary medical center. This study reviewed 32 patients with laryngeal leukoplakia, including 11 recurrent cases after surgery. All the procedures were performed in an office setting under topical anesthesia. Fifteen percent ALA solution was locally applied to the lesion through a flexible laryngoscope. Light illumination was performed using a 635 nm diode laser through a 400 μm optic fiber. The power density was 165 mW/cm2 to reach 100 J/cm2 . Results of laryngostroboscopy and voice evaluation during follow-up were collected. The mean follow-up was 7.91 ± 4.83 (3-18) months. Thirty-nine procedures were performed, including 1 session for 27 patients, 2 sessions for 3 patients, and 3 sessions for 2 patients. The total response rate was 96.875% (31/32), including complete responses in 26 (81.25%) patients, partial responses in 5 patients (15.625%), and no response in 1 patient (3.125%). It appeared that PDT selectively eliminated the leukoplakia without affecting lamina propria and the surrounding normal mucosa remained unharmed. Scores of Voice Handicap Index-10, jitter, shimmer, and harmonic-to-noise ratio were significantly improved after PDT. Office-based PDT is an effective, repeatable, and practical method for treating laryngeal leukoplakia. Local application of ALA is sufficient to achieve photodynamic reactions. PDT could eliminate laryngeal leukoplakia selectively while protecting the normal laryngeal structure.

Neoadjuvant chemotherapy with weekly cisplatin and paclitaxel followed by chemoradiation for locally advanced cervical cancer

BackgroundCurrently, the standard treatment for locally advanced cervical cancer is concurrent chemoradiation (CCRT). Forty percent of patients present with disease recurrence. This study aims to investigate the feasibility, safety and efficacy of neoadjuvant chemotherapy (NACT) with weekly cisplatin and paclitaxel (TP) followed by CCRT.MethodsWe are conducting a phase III trial comparing the efficacy and side effects of patients with cervical cancer (FIGO 2018 stage IIB to IVA) who were assigned to four cycles of NACT with cisplatin (40 mg/m2) and paclitaxel (60 mg/m2) weekly followed by CCRT or CCRT alone. In this report, we studied the medium-term effect of 50 patients enrolled in the NACT + CCRT arm. The primary endpoints were the response rate post-NACT and 12 weeks post-CCRT evaluated by MR/CT based on RECIST v 1.1. The secondary endpoints were 3-year OS (overall survival) and PFS (progression-free survival) measured by the Kaplan–Meier method.ResultsAmong 50 patients enrolled in the NACT + CCRT arm, the complete and partial response rates were 10.4% and 68.8%, post-NACT. Twelve weeks after treatment completion, the complete response rate was 72.0%, whereas the total response rate (complete and partial response) was 90.0%. After a median follow-up of 28 months, the 3-year OS rate was 83.9%, and the 3-year PFS rate was 73.6%. NACT response was related to superior PFS and OS compared with NACT nonresponse (P < 0.01). Late AEs were exiguous, while early AEs mainly included myelosuppression and gastrointestinal AEs.ConclusionsThis study showed a good response rate achieved by dose-dense weekly cisplatin and paclitaxel followed by standard CCRT. The treatment regimen is feasible, as evidenced by the acceptable toxicity of NACT and by the high compliance with radiotherapy.Trial registrationProtocol version number and date.Chinese clinical trial registry, ChiCTR1900025327; http://www.chictr.org.cn. Registered 24 August 2019. Retrospectively registered, medresman.org.cn/ChiCTR1900025326.The date recruitment began 01–01-2019.

Efficacy and safety of warm acupuncture combined with Western medicine for sciatica: A protocol for systematic review and meta-analysis

There are more and more clinical studies on the efficacy of warm acupuncture in treating sciatica, but the systematic review of the efficacy of warm acupuncture is still lacking. The objective of this study was to evaluate the efficacy and safety of warm acupuncture combined with conventional Western medicine in the treatment of sciatica. The review was registered in the PROSPERO database (CRD42022379486) and was conducted according to the Preferred Reporting Items for Systematic reviews and Meta-Analyses guidelines. The following databases will be used to search the existing literature (from inception to January 2023): Web of Science, Embase, Cochrane Library, PubMed, Cumulative Index to Nursing and Allied Health Literature, Wanfang, Allied and Complementary Medicine Database, China Knowledge Network, and SPORT-Discus. Included studies are considered eligible if they met the population, intervention, comparator, outcomes, and study design criteria as follows: Population: patients with newly diagnosed sciatica; Intervention: warm acupuncture combined with conventional Western medicine; Comparator: Western medicine alone; Outcomes: total response rate, pain score and pain threshold, adverse events and recurrence rate. Study design: randomized controlled trials or non-randomized cohort studies. Review Manager (RevMan) V.5.3 will be used to perform statistical analyses and to generate forest plots. The review will add to the existing literature by showing compelling evidence and improved guidance in clinic settings.

Recombinant human thrombopoietin (rhTPO) of different dosing regimens for refractory/relapsed primary immune thrombocytopenia: a multicenter, randomized controlled trial and pharmacokinetics study

Recombinant human TPO (rhTPO) is effective for refractory/relapsed primary immune thrombocytopenia (ITP), but optimal dosing regimen remains elusive. In this multicenter, randomized, controlled trial, a total of 282 adult ITP patients (mean age 47.3 years; 82 men) with a platelet count ≤30 × 109/L or >30 × 109/L with active bleeding randomly received a once daily (QD) subcutaneous injection of 7500 U (n = 64) or 15000 U rhTPO for 14 injections, or 15000 U or 30000 U rhTPO once every other day (QOD) for 7 injections. The primary outcomes included change from baseline in platelet count and total response rate (TRR) on day 14. On day 14, the median increase of platelet count from baseline was the highest in the 15000-U QD group (167.5 × 109/L, interquartile range [IQR] 23.0–295.0 × 109/L), followed by the 30000-U QOD group (57.5 × 109/L, IQR 9.0–190.0 × 109/L) (ANCOVA P < .001; P = .266 with baseline count as a covariate). The TRR on day 14 was also the highest in the 15000-U QD group (63.2%), followed by the 30000-U QOD group (59.7%). The rate of grade 3 and above adverse events did not differ among the four groups. There were no new safety concerns. All 4 regimens are safe and well-tolerated. The 30000-U QOD regimen is practically indistinguishable in efficacy to the 15000-U QD regimen.

Antibiotic prescribing pattern among dental interns for common dental conditions: A self-reported questionnaire-based survey

Aim: The aim of this study was to investigate about the antibiotic prescribing pattern of dental interns for various dental conditions. Materials and Methods: A survey was carried out with the help of a self-administered questionnaire in a central government-based dental institute. Sixty dental interns were asked to fill out the questionnaire sent electronically, which inquired about their current practice of prescribing antibiotics and their awareness about the use of antibiotic in common dental conditions. Results: The total response rate was 85%. The most prescribed antibiotic was amoxicillin (84.83%), followed by a combination of amoxicillin and clavulanic acid (56.9%). The most common dental condition for which the dental interns prescribed antibiotics was acute periapical abscess (90.2%), followed by periodontal abscess (76.5%). Conclusion: Dental practitioners prescribe antibiotics on a daily basis and its unchecked usage could lead to the development of antimicrobial resistance. The current survey highlights the need for dental professionals to audit their existing antimicrobial prescription practice and keep updating them according to the latest guidelines. In the dental practice, antibiotics should only be used as an adjunct to a dental interventional procedure, and never as a substitute for it.

The curative effect of fallopian tube interventional recanalization and ethiodode oil

Objective: To analyze the efficacy of fallopian tube interventional recanalization and ethiodized oil in treating fallopian tube obstruction. Methods: 84 patients were selected from August 2020 to August 2021. Patients were randomly divided into control group and observation group, with 42 patients in each group. The control group was treated by conventional uterine laparoscopic combined surgery, and the observation group adopted the method of tubal interventional recanalization combined with ethiodized oil. To compare the treatment effect of the two groups, the serum inflammatory factor levels before and after the treatment, and the postoperative recovery. Results: In terms of treatment effect, the total response rate was 95.24% higher than 71.43% in the control group, and P &lt;0.05. In terms of serum inflammatory factor levels, there was no significant difference between the two groups before treatment, with P&gt; 0.05; and IL-6 (64.02±12.52)ng/L, TNF-α (21.03±2.20) ng/L, respectively, lower than the control group (72.35±16.39) ng/L, (28.35±2.34)ng/L,P&lt;0.05. In terms of postoperative recovery, the observation group had a postoperative pain score (2.02±0.41) Break up and get out of bed activity time (16.31±2.82) h, length of stay (2.31±0.82) d, lower than the control group (4.56±1.42) component, (24.42±5.47)h, (4.42±0.47) d, P&lt;0.05. Conclusion: In the treatment of fallopian tube obstruction, the treatment method of fallopian tube interventional recanalization combined with ethylene iodized oil can improve the overall treatment efficiency, reduce the inflammation, improve the postoperative recovery, and the curative effect is more ideal.

Transarterial chemoembolization with insertion of radioactive seeds for hepatocellular carcinoma.

For patients diagnosed with hepatocellular carcinoma (HCC) not eligible for surgical tumor resection, transarterial chemoembolization (TACE) is commonly employed as a therapeutic strategy. After TACE is complete, a variety of other therapeutic approaches can be employed to improve patient overall survival (OS) and progression-free survival (PFS). This study was developed with the goal of comparing the relative clinical efficacy and long-term outcomes observed in HCC patients who underwent combination TACE and radioactive seed insertion (RSI) treatment to those of patients who only underwent TACE treatment. This retrospective analysis included a total of 80 patients with HCC who underwent treatment via TACE with (n = 39) or without (n = 41) RSI. Treatment responses and long-term outcomes in these two groups were compared with one another. The baseline characteristics of both groups were comparable. None of the patients experienced adverse complications related to treatment. Individuals in the combination treatment group experienced complete response (59.0% vs. 22.0%, p = 0.001) and total response (92.3% vs. 58.5%, p = 0.001) rates that were significantly better than those of patients that underwent TACE alone. Combination treatment was also associated with significant prolongation of patient PFS (13 vs. 7 months, p = 0.019) and OS (23 vs. 15 months, p = 0.005), with Cox regression analyses identifying combination treatment as a predictor of prolonged PFS and OS. These data suggest that a combination of TACE and RSI can contribute to significant improvements in HCC patient therapeutic response rates, OS, and PFS relative to TACE alone.

Meta-analysis of Simotang Oral Liquid in treatment of functional dyspepsia in adults

This study was conducted to evaluate the efficacy and safety of Simotang Oral Liquid in the treatment of functional dyspepsia in adults. &quot;Simotang Oral Liquid&quot; &quot;Simotang&quot; &quot;Si Mo Tang&quot; &quot;Si Mo Tang Oral Liquid&quot; were used for retrieval of the relevant papers from CNKI, Wanfang, VIP, SinoMed, PubMed, Cochrane Library, Springer Link, and Web of Science from database inception to June 2021. Randomized controlled trial(RCT) of Simotang Oral Liquid in the treatment of functional dyspepsia in adults was screened out for Meta-analysis which was conducted in RevMan 5.3. A total of 16 RCTs were included. Meta-analysis showed that compared with the control group, Simotang Oral Liquid increased the total response rate and lowered the traditional Chinese medicine syndrome scores, serum cholecystokinin(CCK), serum nitric oxide(NO), and incidence of adverse reactions. However, the serum substance P(SP) had no statistical difference between the two groups. Simotang Oral Liquid is effective and safe in the treatment of functional dyspepsia in adults. However, this study has evidence and limitations, so the conclusions need to be further verified by large sample and multicenter clinical studies.

Effect of Paternalistic Leadership on Employee Creativity and Organizational Citizenship Behavior

Purpose: The overall objective of the study was to investigate the relationship between paternalistic leadership, Trust, employee creativity, and organizational citizenship behavior. Based on the review, the present study examines and tries to fill the gaps that have yet to be tended to in previous literature. This research is comparatively and possibly a novel thought from a Pakistani perspective and especially in Government and Semi Government related organizations since it expects to develop and test an integrative model. Design/Methodology/Approach: The unit of analysis for the study is individuals employed in the selected organizations of Pakistan. The sample size of the study was determined at 188 and the total response rate of the data collection is 85%. A sample size of 188 was faced as a restraint. The sampling technique is convenience based and data collection is cross-sectional. The study has its originality as an integrative model formulated with the combination of these variables that have not been tested earlier specifically in government and semi-government related organizations i.e. OGDCL &amp; PTCL. Findings: Results of the study indicate that paternalistic leadership is having a significant relationship with both the dependent variables i.e. Employee Creativity and Organization Citizenship Behavior. The employee reported that such leadership traits allow them to come up with creative performance and with citizenship behavior. Moreover, trust is also mediating the proposed relationship between paternalistic leadership, employee creativity, and organizational citizenship behavior. The sample size was faced as a limitation. Practical Implications: However, the organizations should encourage leaders to ensure the formulation and implementation of the employee concerning policies and procedures which will resultantly assist in exhibiting citizenship behavior. The study has significance for policymakers, managers, supervisors, and employees at all levels.