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Supplementary Information | The online version contains supplementary material available at 10.1007/s10549-023-07054-3. | PMC10460747 | ||
Keywords | Open Access funding provided by University of Helsinki including Helsinki University Central Hospital. | PMC10460747 | ||
Introduction | hormone receptor-positive breast cancer, cancer relapse [In postmenopausal women, cancers, breast cancer | CANCERS, RECURRENCE, BREAST CANCER RECURRENT, BREAST CANCER | Hormone receptor-positive [i.e., estrogen (ER) and/or progesterone (PR) receptor-positive] cancers account for 75 percent of all breast cancer cases. Adjuvant endocrine therapy blocks ER function or lowers estrogen levels, reduces the risk of recurrence, and improves survival among women with hormone receptor-positive ... | PMC10460747 |
Patients and methods | amenorrhea, Cancer | CANCER | This study was carried out at the Helsinki University Central Hospital Comprehensive Cancer Center from October 2015 to January 2017. Eligible patients were postmenopausal women with hormone receptor-positive early-stage breast cancer for whom adjuvant letrozole treatment was planned. Prior adjuvant chemotherapy was no... | PMC10460747 |
Quantification of estrogens by LC–MS/MS | SEPARATION | Serum E1 and E2 concentrations were analyzed by a LC–MS/MS: Agilent 1200 high-performance liquid chromatography (Agilent Technologies Inc., Santa Clara, CA, USA) coupled with an AB Sciex Triple Quad 5500 mass spectrometer controlled by Analyst Software 1.6.2 (AB Sciex, Concord, ON, Canada). Slight modifications of our ... | PMC10460747 | |
Assessments of health-related Quality of Life (QoL) and menopausal symptoms | Breast Cancer, nausea/vomiting, dyspnea, fatigue, diarrhea, pain, constipation, insomnia, Cancer | APPETITE LOSS, BREAST CANCER, CANCER | QoL data were obtained using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) and the EORTC Breast Cancer Module questionnaire (QLQ-BR23).The EORTC QLQ-C30 is composed of a global health status/QoL scale, five scales measuring physical, role, emoti... | PMC10460747 |
Statistical methods | REGRESSION | The data was analysed using SPSS statistic Version 28. Baseline demographics and characteristics of the patients were summarized using median and range, or mean and standard deviation. The association between baseline hormone levels, and between hormone levels and demographic characteristics (age, BMI, weight, waist ci... | PMC10460747 | |
Discussion | pain, muscle pain, breast cancer | SECONDARY, BREAST CANCER | The aim of the present study was to analyze the effects of letrozole on serum estradiol (E2) and estrone (E1) levels in postmenopausal breast cancer patients by using a highly sensitive and specific LC–MS/MS method. Quality of life and tolerability of the treatment were secondary outcome measures.AIs suppress plasma es... | PMC10460747 |
Conclusion | muscle pain | In conclusion, letrozole treatment caused complete suppression of both E2 and E1 when measured by our highly sensitive LC–MS/MS assay. A high pretreatment E2 level was associated with more frequent joint and muscle pain during letrozole treatment. Our commercial chemiluminescent immunoassay for serum E2 had no value in... | PMC10460747 | |
Acknowledgements | We are grateful to all participating patients, without whom it will be not have been possible to do this study. We also like to thank the Clinical Research Institute Helsinki University Hospital and Foundation for Promoting Laboratory Medicine for supporting this project. | PMC10460747 | ||
Funding | Open Access funding provided by University of Helsinki including Helsinki University Central Hospital. | PMC10460747 | ||
Data availability | Enquiries about data availability should be directed to the authors. | PMC10460747 | ||
Declarations | PMC10460747 | |||
Conflict of interest | The authors report no conflict of interest. The authors are responsible for the content and writing of the paper. | PMC10460747 | ||
References | PMC10460747 | |||
ABSTRACT | CAP, lower respiratory tract, Pneumonia | PNEUMONIA, COMMUNITY-ACQUIRED PNEUMONIA | The authors declare no conflict of interest.Syndromic PCR-based analysis of lower respiratory tract (LRT) samples in patients with community-acquired pneumonia (CAP) improves the bacterial yield and time-to-results compared to culture-based methods. However, obtaining adequate sputum samples can be challenging and is f... | PMC10512787 |
KEYWORDS | PMC10512787 | |||
INTRODUCTION | CAP, deaths | COMMUNITY-ACQUIRED PNEUMONIA | Community-acquired pneumonia (CAP) is one of the leading causes of hospital admissions and deaths in the world (The introduction of syndromic molecular assays with broad panels targeting common respiratory tract pathogens improves the microbiological yield and time to results when analyzing specimens from the lower res... | PMC10512787 |
MATERIALS AND METHODS | PMC10512787 | |||
Patients and study design | We analyzed samples from prospectively enrolled CAP patients at Haukeland University Hospital, a tertiary care referral center in Bergen, Norway. The patients had been included in a randomized controlled trial (RCT) (CAPNOR, NCT04660084) or a following observational study on ED patients with suspected CAP, between Octo... | PMC10512787 | ||
Microbiological methods and sampling | Pneumonia | PNEUMONIA | Study nurses collected microbiological samples shortly after presentation to the ED. First, an OP sample was collected using an OP swab (Sigma VCM MW910PF) as part of routine hospital care (swabbing the OP back wall for approximately five seconds). Subsequently, an LRT sample was obtained from all patients (Both LRT sa... | PMC10512787 |
Statistical analysis | Descriptive statistics for continuous variables are reported as medians with interquartile range (IQR). Fisher’s exact test was used for analyzing categorical data, by use of contingency tables. A two-tailed | PMC10512787 | ||
RESULTS | PMC10512787 | |||
DISCUSSION | Pneumonia | FAP, PNEUMONIA | In this study, we evaluated the performance of a commercial rapid syndromic multiplex PCR panel on OP samples and high-quality LRT samples obtained from a well-characterized cohort of patients presenting to the ED with CAP. The PCR panel is validated for LRT samples, which can be difficult and time-consuming to obtain,... | PMC10512787 |
ETHICS APPROVAL | RECRUITMENT | The study is approved by the Regional Committee for Medical and Health Research Ethics in South East Norway (REK ID: 31935) and performed in accordance with the Declaration of Helsinki. Written informed consent was obtained from all participants or from their legal guardian/close relative at the time of recruitment. | PMC10512787 | |
SUPPLEMENTAL MATERIAL | The following material is available online at | PMC10512787 | ||
jcm.00505-23-s0001.pdf | Tables S1 and S2.Click here for additional data file.ASM does not own the copyrights to Supplemental Material that may be linked to, or accessed through, an article. The authors have granted ASM a non-exclusive, world-wide license to publish the Supplemental Material files. Please contact the corresponding author direc... | PMC10512787 | ||
REFERENCES | PMC10512787 | |||
Background | Erectile dysfunction, metabolic syndrome, MeTS | ERECTILE DYSFUNCTION, METABOLIC SYNDROME, PLAQUE PSORIASIS | Erectile dysfunction (ED) and metabolic syndrome (MeTS) are highly prevalent in chronic plaque psoriasis (CPP). | PMC10808673 |
Objective | OBESE | The aim of this lifestyle modification study is to explore the response of MeTS components and ED to a 12-week lifestyle modification program (low-calorie diet and moderate-intensity treadmill walking) in 60 obese men with CPP, mild and moderate ED, and MeTS. | PMC10808673 | |
The design, settings, participants, and intervention | OBESE, RECRUITMENT | In this lifestyle modification randomized study, a university-based hospital recruitment of 60 obese men with CPP, mild and moderate ED, and MeTS was randomly performed. Men were randomly assigned to the lifestyle modification group ( | PMC10808673 | |
Results | Trends of significant improvements in all outcomes were documented in favor of the lifestyle modification group. All outcomes of the waitlist group did not show the same reported significant improvements of the lifestyle modification group. | PMC10808673 | ||
Conclusion | psoriasis-associated, weight loss, psoriasis | OBESE, PSORIASIS | A 12-week lifestyle modification program as a tool for weight loss in obese men with CPP is a good therapeutic method to improve psoriasis severity and psoriasis-associated ED and MeTS. | PMC10808673 |
Keywords | Open access funding provided by The Science, Technology & Innovation Funding Authority (STDF) in cooperation with The Egyptian Knowledge Bank (EKB). | PMC10808673 | ||
Introduction | chronic vascular inflammation, psoriasis, MeTS, MetS, LCD, CPP-associated cardiovascular comorbidities, erectile dysfunction | ENDOTHELIAL DYSFUNCTION, DYSFUNCTION, PSORIASIS, VASCULAR INSUFFICIENCY, ERECTILE DYSFUNCTION, CHRONIC INFLAMMATION, INFLAMMATORY SKIN DISEASE, PLAQUE PSORIASIS, ENDOTHELIAL DYSFUNCTION | The autoimmune-mediated inflammatory skin disease in 2 to 3% of the general adult population is chronic plaque psoriasis (CPP). In men, CPP is strongly associated with erectile dysfunction [The prevalence of CPP-associated MetS ranges from 20 to 50%. Compared with non-psoriatic age-matched control subjects, the risk of... | PMC10808673 |
Materials and methods | PMC10808673 | |||
Settings | MeTS | RECRUITMENT | The men diagnosed with CPP, ED, and MeTS were randomly recruited from Cairo University Hospitals. Recruitment of the subjects was conducted during the period between 16th October 2022 and 16th April 2023. | PMC10808673 |
Men’s inclusion criteria | MeTS, Psoriatic | RECRUITMENT | With ages ranging from 32 to 49 years old (because these age ranges were the available age ranges of CPP men who visited the recruitment settings during the recruitment period), this lifestyle modification trial included 60 mild-to-severe CPP married men with ED. The erectile function in psoriatic men was evaluated usi... | PMC10808673 |
Men’s exclusion criteria | autoimmune or neurological disorders, prostatic disorders, hypogonadism, lower limb arthritic disorders, mental disorders, hepato-renal or respiratory disorders, deformations, tumors, weight loss | HYPOGONADISM, TUMORS, VASCULAR DISORDERS | Men who received phototherapeutic interventions, weight loss prescriptions (diet, exercise, or drugs), biologic therapies, and pharmacological inhibitors of phosphodiesterase-type 5 (Is-PDET5) within the last 12 weeks were excluded. CPP men with autoimmune or neurological disorders, hypogonadism (low testosterone level... | PMC10808673 |
Randomization | MeTS, metabolic syndrome, psoriasis | METABOLIC SYNDROME, OBESE, ERECTILE DYSFUNCTION, PSORIASIS | The consented psoriatic men with MeTS and ED were divided by the simple randomization technique, a closed envelope technique conducted by a physiotherapy assistant who was unaware of the lifestyle changes that would be executed, into two 30-men groups. Men in the first group (lifestyle modification group, LMG) were tre... | PMC10808673 |
Lifestyle modification program | ’ basal metabolic rate | OBESE | Harris–Benedict equation—[(10 × weight of men in kilograms) + (6.25 × height of men in centimeters) − (5 × age of men in years) + 5]—was utilized to calculate participants’ basal metabolic rate (BMR) before involving them in the low-calorie-diet protocol. To start the low-calorie diet, the value of BMR was subtracted f... | PMC10808673 |
Main outcome (Arabic version of IIEFQ-5) | A hard copy of IIEFQ-5 was given to every psoriatic man to fill it before and after the 12-lifestyle-modification program. | PMC10808673 | ||
Secondary outcomes | ’s head, neck, upper/low limbs, and trunk, psoriasis | PSORIASIS | Besides BMI, MeTS components of all psoriatic men were tested. The components included men’s BP (systolic and diastolic pressures were assessed with a manual sphygmomanometer), WC (evaluated via in elastic tape at men’s umbilicus level), SFBG (assessed with a glucose blood meter after overnight fasting), and overnight ... | PMC10808673 |
Blinding | MeTS | SECONDARY | Assessors of the primary outcome (IIEFQ-5) or secondary outcomes (BMI, MeTS components, and PASI) were not informed of the details of the 12-week lifestyle modification program introduced to the examined 60 CPP men with MeTS and ED. | PMC10808673 |
G*power sample size | OBESE | Sixteen obese men with CPP, MeTS, and ED were the pilot test that was used to extract the needed sample size calculation at a power of 80%. The effect size of IIEFQ-5 ( | PMC10808673 | |
Statistical analysis (SPSS 18) | SECONDARY | The Smirnov test—used to examine the distribution of primary outcome (IIEFQ-5) or secondary outcomes (BMI, MeTS components, and PASI)—confirmed the normal distribution of CPP men’s primary and secondary outcomes, so ANOVA test (repeated measure) was used to assess the statistical changes within and between groups, resp... | PMC10808673 | |
Discussion | MeTS.The exercise-induced decrease, overactivity of the sympathetic nervous system, psoriasis, MeTS, overweight, diabetic, hypertensive, penile erection, diabetes | DIABETES, OBESE, PATHOGENESIS, PSORIASIS | This is the first lifestyle modification study that reported an improvement in ED, MeTS components, and PASI after a 12-week randomized-controlled program of exercise and diet restriction in men with CPP, ED, and MeTS.The exercise-induced decrease in psoriatic severity may be in part due to a decrease in obesity-associ... | PMC10808673 |
Limitations | psoriasis-associated, MeTS, psoriasis | PSORIASIS | Comparing the effect of different types of calorie restriction diets on psoriasis severity and psoriasis-associated ED and MeTS is the main limitation of this study. The two authors invite researchers of CPP to cover this limitation in future studies. | PMC10808673 |
Authors’ contributions | OBESE | Ismail AMA and Hamed DE contributed equally in all parts of this lifestyle modification study conducted on 60 obese men with CPP, MeTS, and ED. Both authors authorize the responsibility of the content of this lifestyle modification study. | PMC10808673 | |
Funding | Open access funding provided by The Science, Technology & Innovation Funding Authority (STDF) in cooperation with The Egyptian Knowledge Bank (EKB). | PMC10808673 | ||
Data availability | Data (age, WC, BMI, IIEFQ-5, PASI, BP, STG, SFBG, and SHDL) will be available on request. | PMC10808673 | ||
Declarations | PMC10808673 | |||
Ethics approval | MeTS | All ethical issues concerned with Helsinki recommendations, institutional approval, and men’s consent were followed by the two authors. This single-blinded lifestyle-modification approach in CPP men with MeTS and ED received local institutional approval (P.T.REC/012/004117). | PMC10808673 | |
Consent to participate | MeTS | All CPP men with MeTS and ED consented. | PMC10808673 | |
Consent for publication | This is not applicable. | PMC10808673 | ||
Conflict of interests | The authors declare no competing interests. | PMC10808673 | ||
References | PMC10808673 | |||
Research Design and Methods | PMC9983122 | |||
Design | This post hoc subgroup analysis of a single-center open-label randomized controlled trial included 13 participants undergoing total or partial pancreatic surgery at the University Hospital Bern (6 in the FCL group, 7 in the UC group). Details can be found in the original publication.All participants provided written in... | PMC9983122 | ||
Procedures | RS, UC | The SC FCL system consisted of an Android smartphone, running the Cambridge adaptive model predictive control algorithm (version 0.3.71; HX variant) on the CamAPS HX mobile application (CamDiab Ltd., Cambridge, UK), an SC real-time continuous glucose monitoring (CGM) sensor (Dexcom G6; Dexcom, San Diego, CA), and the S... | PMC9983122 | |
Outcomes | Outcomes of this subgroup analysis were the level of glucose control (% time spent with CGM values in predefined ranges and mean glucose concentration) and glucose variability (defined as standard deviation [SD] and coefficient of variation of sensor glucose). We further assessed insulin doses in the UC group and inves... | PMC9983122 | ||
Statistical analysis | Aggregated period-specific summary measures (overall, perioperative, and postoperative periods) were calculated and are presented by treatment. Outcomes were compared between treatments using unpaired Welch's | PMC9983122 | ||
Discussion | hypoglycemia, UC | STILL, POSTOPERATIVE COMPLICATIONS, TYPE 1 DIABETES, HYPOGLYCEMIA, COMPLICATIONS | In this exploratory post hoc analysis, we compared the perioperative glycemic efficacy and insulin requirements of SC FCL insulin delivery with UC insulin therapy in patients undergoing pancreatic surgery. We observed that FCL substantially improved glycemic control by increasing time spent in the glycemic target range... | PMC9983122 |
Supplementary Material | PMC9983122 | |||
Supplemental data | PMC9983122 | |||
Supplemental data | PMC9983122 | |||
Acknowledgments | Diabetes | DIABETES | We are grateful to all study participants for their contribution, time, and support. We acknowledge administrative support from Laura Goetschi and data management support from Markus Huber, University Hospital Bern. We thank R. Dragulin, D. Studer, A. Goerg, M. Somasundaram, and study nurses (all University Hospital Be... | PMC9983122 |
Authors' Contributions | D.H. and L.B. | G.K. contributed to writing—original draft (equal), formal analysis (support), and writing—review and editing (equal). J.R. was involved in data curation (equal) and writing—review and editing (equal). D.S. carried out data curation (equal) and writing—review and editing (equal). C.C. contributed to writing—review and ... | PMC9983122 | |
Author Disclosure Statement | hypoglycemia, Diabetes | HYPOGLYCEMIA, DIABETES | M.E.W. reports receiving license fees from B. Braun, patents related to closed-loop, and being a consultant at CamDiab Ltd. R.H. reports receiving speaker honoraria from Eli Lilly, Dexcom, and Novo Nordisk; receiving license fees from B. Braun and Medtronic; declares consulting fees from Abbott Diabetes Care; patent is... | PMC9983122 |
Funding Information | The study was funded by the Swiss Helmut Horten Foundation and the Swiss Foundation of Anaesthesiology and Intensive Care. Dexcom provided product support (CGM equipment). Company representatives had no role in study design, data collection, data analysis, data interpretation, or writing of the report. | PMC9983122 | ||
Supplementary Material | PMC9983122 | |||
References | PMC9983122 | |||
Subject terms | T cell lymphopenia, death, SARS-CoV-2 infection | SYNDROME, SARS-COV-2 INFECTION, CYTOKINE RELEASE SYNDROME, SECONDARY | The clinical course of COVID-19 may show severe presentation, potentially involving dynamic cytokine storms and T cell lymphopenia, which are leading causes of death in patients with SARS-CoV-2 infection. Plasma exchange therapy (PLEX) effectively removes pro-inflammatory factors, modulating and restoring innate and ad... | PMC9812351 |
Introduction | infection, death, tumor necrosis | VIRUS, TUMOR NECROSIS, DISEASE, CYTOKINE RELEASE SYNDROME, INFECTION, ACUTE RESPIRATORY FAILURE, CORONAVIRUS, SEVERE ACUTE RESPIRATORY SYNDROME, MULTI-ORGAN FAILURE | Since December 2019, health workers and governments around the world have been fighting a virus that changed our lives. COVID-19 is an infection caused by the severe acute respiratory syndrome coronavirus type 2 (SARS-CoV-2)Coronavirus disease is characterized by a wide spectrum of manifestations, ranging from asymptom... | PMC9812351 |
Methods | lymphopenia, bleeding, NLV, hypofibrinogenemia | ACUTE RESPIRATORY DISTRESS SYNDROME, BLEEDING, LUNG, SARS-COV-2 INFECTION, CYTOKINE RELEASE SYNDROME, LYMPHOPENIA, HYPOFIBRINOGENEMIA, BLOOD, OPACITIES | Study design. Our trial was designed to evaluate the impact of plasmapheresis therapy in the outcome of severe COVID-19 and cytokine release syndrome at one medical center in Mexico City. The study was designed and performed according to ethical guidelines of the 1975 Declaration of Helsinki, and approved by the Local ... | PMC9812351 |
Ethics approval and consent to participate | The study was designed and performed according to ethical guidelines of the 1975 Declaration of Helsinki, and approved by the Local Committees of Research, Ethics in Research and Biosafety of the Centro Médico Nacional ‘20 de Noviembre’ ISSSTE, Mexico City (Protocol ID No. 09-136.2021). All participants provided writte... | PMC9812351 | ||
Discussion | bleeding, pneumonia, inflammation, ARDS, lymphopenia, empyema | BLEEDING, PNEUMONIA, SARS-COV-2 INFECTION, INFLAMMATORY RESPONSE, ADVERSE EVENTS, INFLAMMATION, CYTOKINE RELEASE SYNDROME, INFECTIONS, DISORDERS, LYMPHOPENIA, SECONDARY, SYNDROME, EMPYEMA, ARDS, PULMONARY FAILURE | In our study, plasmapheresis (PLEX) showed to improve survival from patients with severe COVID-19, as compared with control group. Consistently, several case-series have reported a reduction of 28-days mortality associated with PLEX, which ranges between 10% and 28% in patients with SARS-Cov2, ARDS and cytokine release... | PMC9812351 |
Conclusion | ADVERSE EVENTS | PLEX therapy provided significant benefits of pro-inflammatory clearance and reduction of 60-days mortality in selected patients with COVID-19, without significant adverse events. These results are relevant to better characterize the effect of PLEX in patients with COVID-19; which may contribute to establish more speci... | PMC9812351 | |
Acknowledgements | The authors acknowledge all the medical team and Nephrology residents who participated in the application of PLEX therapy. | PMC9812351 | ||
Author contributions | J.H.-A. | G.F.-G. and M.A.-S. conceived the design and experiments. V.G.-M., J.H.-A., M.V.-B., E.T.-R., D.M.-T., M.L.-M., J.H.C.-C., J.O.-V., D.T.-M., S.C.-M., M.E.-S., S.M.-L. and L.M.-L. collected data and analyzed the results. P.M.-T. and J.A.S.-C. critically revised the manuscript. All authors reviewed the manuscript. All th... | PMC9812351 | |
Data availability | The datasets generated and analyzed during the current study are not publicly available due to privacy policies of the hospital and patients information; but are available from the corresponding author on reasonable request. | PMC9812351 | ||
Competing interests | The authors declare that they have no competing interests. | PMC9812351 | ||
References | PMC9812351 | |||
Supplementary Information | toxicity | SOLID TUMORS | To determine the maximum tolerated dose (MTD) and recommended dose (RD) of orally-administered bendamustine in Japanese patients with advanced solid tumors. The optimal dosing schedule, safety, pharmacokinetics, and preliminary antitumor effects were also evaluated. A multicenter, open-label trial with a standard 3 + 3... | PMC10030450 |
Keywords | PMC10030450 | |||
Introduction | SCLC, cancers, cancer, malignant tumors, toxic alkylating, tumors | CANCERS, SCLC, CANCER, SOLID TUMORS, MALIGNANT TUMORS, SMALL CELL LUNG CANCER, TUMORS, METASTATIC BREAST CANCER | Drug therapies for malignant tumors include chemotherapy, hormone therapy, and molecular-targeted therapy, and a combination of these therapies has been used in clinical settings. Chemotherapy has long been used to treat cancer and remains the backbone of systemic treatment in most cancers. Bendamustine hydrochloride (... | PMC10030450 |
Materials and methods | PMC10030450 | |||
Study design | toxicity, diarrhea, anemia, nausea, vomiting | ADVERSE EVENTS, MAY, ANEMIA | This study (NCT03604679) was conducted from May 16, 2018 to May 12, 2020 in Japan as a two-center, open-label, standard 3 + 3 dose escalation study, according to Good Clinical Practice, the Declaration of Helsinki, and other applicable regulations. A 3-week treatment period was considered as one cycle, and the maximum ... | PMC10030450 |
Patients | idiopathic or drug-induced pneumonitis, pneumonitis, emphysema, pain | PNEUMONITIS, PULMONARY FIBROSIS, INTERSTITIAL PNEUMONIA, BONE LESIONS, SOLID TUMORS, CENTRAL NERVOUS SYSTEM METASTASES, EMPHYSEMA, HEPATIC METASTASIS, ONCOLOGY | Patients aged ≥ 20 years diagnosed with advanced solid tumors and resistant to standard therapy or no standard therapy and met the selection criteria were included in the study. The main inclusion criteria were:1) patients with an Eastern Clinical Oncology Group performance status of 0–1; 2) preserved organ and bone ma... | PMC10030450 |
Study drug | An LFHC formulation (orally-administered bendamustine) containing 10 or 30 mg of bendamustine (as a free base) in one capsule was administered once daily in the fasted state (fasting for 2 h before administration and 1 h after administration). The individual nominal dose at each level was calculated using the body surf... | PMC10030450 | ||
Study evaluation | Tumors, PD, tumor, SD | DISEASE, SECONDARY, TUMORS, TUMOR | The primary endpoint was the identification of DLT in cycle 1 and the number of patients with DLT. The MTD, RD, and recommended dosing schedules were estimated based on the primary endpoints. The secondary endpoints were safety, PK, and efficacy. Efficacy was assessed as complete response (CR), partial response (PR), s... | PMC10030450 |
Pharmacokinetics | BLOOD | Blood samples were collected at 8 time points: immediately before administration and 0.5, 1, 1.5, 2, 4, 6, and 8 h after administration. Plasma concentrations of unchanged bendamustine were determined using liquid chromatography-tandem mass spectrometry. The individual PK parameters, maximum concentration (C | PMC10030450 | |
Safety | ADVERSE DRUG REACTIONS | At each observation time point, AEs were evaluated based on factors, such as subjective and objective symptoms, vital signs, laboratory tests, and general condition and graded using the NCI CTCAE (version 4.03). A causal relationship with bendamustine was assessed, and AEs, wherein a causal relationship could not be ru... | PMC10030450 | |
Statistical analysis | Continuous variables were summarized using the number of patients, mean, and standard deviation. Categorical variables were summarized using frequencies and percentages. PFS was estimated using the Kaplan–Meier method. All analyses were performed using SAS version 9.4. | PMC10030450 | ||
Results | PMC10030450 | |||
Dose-limiting toxicity and maximum tolerated dose | None of the patients at 25 mg/mDLT occurred in one of three patients at 37.5 mg/m | PMC10030450 | ||
Efficacy | As the best overall response, no patients were assessed as having CR; however, PR was observed in two patients at 75 mg/mCT imaging in patients who experienced partial response. Findings for each patient (swimmer plot). *The colors in the bar chart indicate dose reductions of bendamustine | PMC10030450 | ||
Pharmacokinetics | PK parameters were calculated for all 18 patients who received orally-administered bendamustine. The CMean concentration–time profiles of bendamustine in plasma | PMC10030450 | ||
Discussion | tBendamustine-based, death, thymic carcinoma, prostatic small cell carcinoma | DRUG INTERACTIONS, SOLID TUMORS | After administering bendamustine orally to 18 patients with advanced solid tumors, FN (n = 1) and a decrease in platelet count (n = 2) were observed as DLT; however, no AEs led to death or discontinuation of orally-administered bendamustine. PR was obtained in one patient each with prostatic small cell carcinoma and th... | PMC10030450 |
Acknowledgements | The authors express their gratitude to the patients and their families who participated in this study. The authors are grateful to Accerise, Inc. for supporting the preparation of this manuscript. | PMC10030450 |
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