Category: Statistics

Breast Cancer Res Treat. 2024 Aug 17. doi: 10.1007/s10549-024-07461-0. Online ahead of print.

ABSTRACT

PURPOSE: One year of neratinib therapy is known to derive a significant invasive disease-free survival (iDFS) benefit in early-stage, hormone receptor-positive (HR +), HER2 + , node-positive breast cancer after trastuzumab-based adjuvant therapy. Limitations to neratinib use include significant gastrointestinal side effects, which often result in treatment discontinuation. In this study, we aimed to identify clinicopathologic features associated with adjuvant neratinib use and factors impacting treatment completion.

METHODS: We performed a retrospective review of patients with early-stage HR + HER2 + breast cancer who were prescribed neratinib from 2017 to 2023 at our institution. We used the electronic medical record to extract information on patient characteristics, clinical features, and treatment information. Patients were identified as high risk based on definitions adapted from the standard high-risk definition in HR + HER2- breast cancer combined with studies correlating high Ki67 or high tumor grade with lower recurrence-free survival. Statistical analysis was performed using two-sided T-tests and chi-square tests.

RESULTS: We identified 62 eligible patients of whom 55% completed 1 year of neratinib and 45% did not. Sixty percent (N = 37) of patients offered neratinib were considered high risk at diagnosis. The most common reason for neratinib discontinuation was inability to tolerate side effects (54%) followed by pill burden (18%). The most common side effect experienced by patients was diarrhea despite anti-diarrheal prophylaxis (56%), followed by rash (8%). Patients who received an up-titration of neratinib were more likely to complete the full course of neratinib when compared to those who did not (76% vs. 40.5% p = 0.013). The median starting dose of those who completed neratinib treatment was 140 vs. 240 mg in those who did not (p = 0.016). Neither group experienced a statistically significant greater likelihood of treatment holds or dose reductions. In terms of outcomes, 10 patients had progression of disease of whom 7 did not complete neratinib treatment (p = 0.169). Interestingly, those 7 patients developed metastatic disease and 57% (N = 4) had central nervous system metastases.

CONCLUSION: Patients are more likely to complete 1 year of adjuvant neratinib with dose up-titration. Dose reductions and interruptions did not affect neratinib adherence in our patient population. Seven patients (11%) in our study developed metastatic disease, all of whom did not complete adjuvant neratinib treatment.

PMID:39153126 | DOI:10.1007/s10549-024-07461-0

J Robot Surg. 2024 Aug 17;18(1):323. doi: 10.1007/s11701-024-02079-2.

ABSTRACT

The widespread acceptance of robotic surgery is extending to oral procedures. The demand for minimally invasive techniques is driving research into the cosmetic and oncologic benefits of robotic neck surgery. This study used propensity score matching to analyze the clinical course and postoperative outcomes of robot-assisted neck dissections for oncologic efficacy and surgical safety. Between May 2020 and April 2024, 200 OSCC patients underwent surgery and 42 were excluded. The cohort included 158 patients, 128 of whom underwent unilateral neck dissection and 30 of whom underwent bilateral neck dissection. Robotic-assisted neck dissection (RAND) was performed in 36 patients while conventional transcervical neck dissection (CTND) was performed in 122 patients. Data analysis included several factors, including lymph node retrieval and perioperative outcomes, with 1:1 propensity score matching to ensure fairness. Each of the 39 neck specimens with 36 patients was selected. The CTND group was 8 years older overall than the RAND group, but otherwise similar in terms of primary site and clinical stage. The RAND group had a 55-min longer operative time and 140 cc more hemovac drainage than the CTND group, but the hospital stay and intensive care unit duration were the same, and the number of lymph nodes retrieved was the same. Survival rates also showed no difference across all stages. This shows that RAND is in no way inferior to CTND in terms of perioperative or oncologic outcomes, and demonstrates the safety of robot-assisted surgery, even in patients who require flaps or in patients with advanced stages.

PMID:39153111 | DOI:10.1007/s11701-024-02079-2

Int J Clin Oncol. 2024 Aug 17. doi: 10.1007/s10147-024-02597-x. Online ahead of print.

ABSTRACT

BACKGROUND: This retrospective observational study explored the therapeutic potential of combined androgen blockade (CAB) with bicalutamide (Bic-CAB) as an initial treatment for metastatic hormone-sensitive prostate cancer (mHSPC) in Japan.

METHODS: The electronic health records of 159 patients with mHSPC from three Japanese institutions who received initial treatment with Bic-CAB between 2007 and 2017 were analyzed. The time to prostate-specific antigen (PSA) progression, duration of Bic-CAB treatment, and overall survival (OS), with various definitions for PSA progression, were assessed. A multivariate Cox proportional hazards model was constructed using clinical parameters to predict time to the end of Bic-CAB treatment and OS.

RESULTS: The median observation period was 46.4 months, and the median age of patients at diagnosis was 71 years. A total of 46.5% patients experienced PSA progression with a median survival duration of 29 months (according to Prostate Cancer Clinical Trials Working Group 3 criteria), and 49.1% patients achieved a PSA nadir < 0.2 ng/mL in a median time of 4.7 months. When stratified by PSA nadir and PSA change, patients at low risk for disease progression with a small PSA change due to low initial PSA had a 5-year OS of 100% and a 10-year OS of 75%. The OS during the observation period was 72.9 months.

CONCLUSION: These findings highlight the potential effect of Bic-CAB in patients with mHSPC who were at low risk for disease progression. Initial treatment with Bic-CAB and adjusting treatment early based on PSA dynamics may be a reasonable treatment plan for these patients.

PMID:39153094 | DOI:10.1007/s10147-024-02597-x

Neuroradiology. 2024 Aug 17. doi: 10.1007/s00234-024-03450-8. Online ahead of print.

ABSTRACT

BACKGROUND: It is difficult to distinguish between tumor progression (TP) and treatment-related abnormalities (TRA) in treated glioblastoma patients via conventional MRI, but this distinction is crucial for treatment decision making. Glioblastoma is known to exhibit an invasive growth pattern along white matter architecture and vasculature. This study quantified lesion development patterns in treated glioblastoma lesions and their relation to white matter microstructure to distinguish TP from TRA.

MATERIALS AND METHODS: Glioblastoma patients with confirmed TP or TRA with T1-weighted contrast-enhanced and DTI MR scans from two posttreatment follow-up timepoints were reviewed. The contrast-enhancing regions were segmented, and the regions were coregistered to the DTI data. Lesion increase vectors were categorized into two groups: parallel (0-20 degrees) and perpendicular (70-90 degrees) to white matter. FA-values were also extracted. To test for a statistically significant difference between the TP and TRA groups, a Mann‒Whitney U test was performed.

RESULTS: Of 73 glioblastoma patients, fifteen were diagnosed with TRA, whereas 58 patients suffered TP. TP had a 25.8% (95% CI 24.1%-27.6%) increase in parallel lesions, and TRA had a 25.4% (95% CI 20.9%-29.9%) increase in parallel lesions. The perpendicular increase was 14.7% for TP (95% CI 13.0%-16.4%) and 18.0% (95% CI 13.5%-22.5%) for TRA. These results were not significantly different (p = 0.978). FA value for TP showed to be 0.248 (SD = 0.054) and for TRA it was 0.231 (SD = 0.075), showing no statistically significant difference (p = 0.121).

CONCLUSIONS: Based on our results, quantifying posttreatment contrast-enhancing lesion development directionality with DTI in glioblastoma patients does not appear to effectively distinguish between TP and TRA.

PMID:39153088 | DOI:10.1007/s00234-024-03450-8

Arch Dermatol Res. 2024 Aug 17;316(8):530. doi: 10.1007/s00403-024-03249-w.

ABSTRACT

Patients’ experience accessing dermatologic care is understudied. The purpose of this cross-sectional study was to examine current wait times for new patients to receive dermatological care in NYC. Websites at 58 accredited private and public hospitals in the five boroughs of NYC were reviewed to identify dermatology practices. Office telephone numbers listed on each website were called to collect information pertaining to whether the physician was accepting new patients, type of insurance accepted (public, private, both, or none), and the number of days until a new patient could be seen for an appointment. Data pertaining to the time kept on hold and availability of web-based booking were also collected. Mean waiting time for an appointment was 50 days [standard deviation, SD 66] – nearly 2 months, but the distribution was considerably skewed. The median waiting time was 19.5 days [Interquartile range, IQR 4-60]. The time kept on hold to make the appointment was negligible at about 1 min (63 s, SD = 77) but could take up to ~ 7 min. Two-thirds of dermatologists accepted private, Medicare, and Medicaid insurance (n = 228, 66%); a small number accepted only private insurance (n = 12, 4%) or no insurance at all (n = 16, 5%). The median waiting time for an appointment for the 228 providers that accepted Medicaid was 30.5 days (IQR = 5.0-73.25) while for providers who did not accept Medicaid (n = 116) the median wait time for an appointment was 13.0 days (IQR = 3.0-38.0). Just over half (56%) of the dermatologists allowed for appointments to be booked on their website (n = 193). This research highlights the necessity of incorporating new strategies into routine dermatology appointments in order to increase treatment availability and decrease healthcare inequality.

PMID:39153084 | DOI:10.1007/s00403-024-03249-w

Rheumatol Int. 2024 Aug 17. doi: 10.1007/s00296-024-05690-6. Online ahead of print.

ABSTRACT

Systemic lupus erythematosus (SLE) is a chronic autoimmune disease that affects women of childbearing age and has been reported to cause sexual dysfunction in women. Although there are articles on sexual function in women with SLE, the number of articles is small, and the factors affecting sexual function in women with SLE are controversial. Based on this, this study aimed to investigate the prevalence of sexual dysfunction in Chinese female SLE patients and to explore the factors that influence it. The study design was a cross-sectional study conducted from December 2023 to April 2024 in the Department of Rheumatology and Immunology of a tertiary hospital in Hefei, Anhui Province. A total of 293 female patients diagnosed with SLE were enrolled using face-to-face questionnaires and online questionnaires. The questionnaire consisted of four parts: general information questionnaire, fatigue severity scale (FSS), depression-anxiety-stress scale (DASS-21), and female sexual functioning index (FSFI) scale. A total of 173 (59.04%) patients had sexual dysfunction, including 251 (85.67%) with decreased libido and 186 (63.46%) with difficulty in sexual arousal. There was a correlation between the patients’ total FSFI scores and age (p = 0.028), marital satisfaction (p < 0.001), own education level (p = 0.008), partner’s education level (p = 0.003), place of residence (p = 0.039), monthly household income (p < 0.001), family financial satisfaction(p < 0.001), menstrual status (p = 0.003), hormone use (p = 0.021),immunosuppressant use (p = 0.042), disease activity (p = 0.016), FSS score (p < 0.001), stress score (p < 0.001), anxiety score (p < 0.001) and depression score (p < 0.001)were correlated. The results of stepwise regression analysis showed that marital satisfaction (b = 2.011, t = 3.797, p < 0.001), monthly household income (b = 0.854, t = 2.316, p = 0.021), menstrual status (b = 1.218, t = 2.350, p = 0.019), fatigue scale score (b = – 0.069, t = – 2.302, p = 0.022), and depression score (b = – 0.117, t = – 2.910, p = 0.004) were the influencing factors of FSFI total score, and the difference was statistically significant. The incidence of sexual dysfunction in Chinese female SLE patients is high, and medical personnel should pay more attention to patients’ sexual problems, to provide theoretical and practical bases for further prevention, treatment, and care of sexual dysfunction in female SLE patients.

PMID:39153077 | DOI:10.1007/s00296-024-05690-6

Int Urogynecol J. 2024 Aug 17. doi: 10.1007/s00192-024-05889-y. Online ahead of print.

ABSTRACT

INTRODUCTION AND HYPOTHESIS: Condition-specific sexual questionnaires are important patient-reported outcome measures. The aim of this study was to translate and validate the Pelvic Organ Prolapse/Incontinence Sexual Questionnaire-International Urogynecology Association Revised (PISQ-IR) into Brazilian Portuguese and to clinically validate it in a Brazilian Portuguese-speaking population.

METHODS: Translation and validation of the PISQ-IR was performed according to the International Urogynecological Association-recommended process and guidelines. For external validity, PISQ-IR subscales were compared with the clinical measures, Pelvic Organ Prolapse Quantification system (POP-Q) stage, pelvic floor muscle tone, and Oxford Grading Scale (Pearson correlations). Descriptive statistics, internal consistency (Cronbach’s alpha coefficient), and test-retest reliability (interclass correlation coefficient) were calculated for all PISQ-IR subscales.

RESULTS: A total of 120 sexually active and 106 not sexually active women were enrolled in the study between March 2015 and July 2019. Internal consistency was acceptable, with Cronbach’s alpha values 0.60-0.80, except for the sexual arousal and orgasm, sexual arousal and partner-related issues, sexual arousal and condition-specific issues, global rating of sexual quality and condition impact subscales. PISQ-IR demonstrated good reliability (α > 0.6, CIC = 0.996). The agreement for each individual questionnaire item also individually presented substantial agreement between the assessments (κ 0.61-0.8). There was a correlation between PISQ-IR and POP, mixed, stress and fecal incontinence diagnosis and a positive correlation with pelvic floor muscle function according to the Oxford Scale in sexually active women. For sexually inactive women there was a correlation between PISQ-IR and mixed urinary symptoms.

CONCLUSIONS: The Brazilian Portuguese version of PISQ-IR is a reliable and valid tool that can be easily used for the identification and assessment of sexual function in Brazilian Portuguese-speaking women with pelvic floor disorders.

PMID:39153070 | DOI:10.1007/s00192-024-05889-y

Environ Sci Pollut Res Int. 2024 Aug 17. doi: 10.1007/s11356-024-34713-9. Online ahead of print.

ABSTRACT

Twenty-two eco-friendly, novel Schiff bases were synthesized from 2,4,5-trichloro aniline and characterized by using FT-IR, ¹H NMR, and ¹³C NMR techniques. Fungicidal activity against pathogenic fungi Sclerotium rolfsii and Rhizoctonia bataticola and insecticidal activity against the stored grain insect pest Callosobruchus maculatus of the test compounds were evaluated under control condition. All of the investigated compounds, according to the study, exhibited moderate to good antifungal and insecticidal activities. The best antifungal activity against both pathogenic fungi was demonstrated by C15 and C16 whose ED₅₀ values were recorded 11.4 and 10.4 μg/mL against R. bataticola and 10.6 and 11.9 μg/mL against S. rolfsii, respectively. They were further screened in for disease suppression against both pathogenic fungi under pot condition through different methods of applications in green gram (Vigna radiata L.) crop. The compounds C10 and C18 had the highest insecticidal activity, with LD₅₀ values of 0.024 and 0.042 percentages, respectively. Stepwise regression analysis using root mean square error (RMSE) and correlation coefficient (R) method used to validate the quantitative structure activity relationship (QSAR) of synthesized compounds in addition to their fungicidal and insecticidal actions. To the best of our knowledge, this investigation on the 22 new Schiff bases as possible agrochemicals is the first one that has been fully reported.

PMID:39153063 | DOI:10.1007/s11356-024-34713-9

Dysphagia. 2024 Aug 17. doi: 10.1007/s00455-024-10738-7. Online ahead of print.

ABSTRACT

Multiple bolus trials are administered during clinical and research swallowing assessments to comprehensively capture an individual’s swallowing function. Despite valuable information obtained from these boluses, it remains common practice to use a single bolus (e.g., the worst score) to describe the degree of dysfunction. Researchers also often collapse continuous or ordinal swallowing measures into categories, potentially exacerbating information loss. These practices may adversely affect statistical power to detect and estimate smaller, yet potentially meaningful, treatment effects. This study sought to examine the impact of aggregating and categorizing penetration-aspiration scale (PAS) scores on statistical power and effect size estimates. We used a Monte Carlo approach to simulate three hypothetical within-subject treatment studies in Parkinson’s disease and head and neck cancer across a range of data characteristics (e.g., sample size, number of bolus trials, variability). Different statistical models (aggregated or multilevel) as well as various PAS reduction approaches (i.e., types of categorizations) were performed to examine their impact on power and the accuracy of effect size estimates. Across all scenarios, multilevel models demonstrated higher statistical power to detect group-level longitudinal change and more accurate estimates compared to aggregated (worst score) models. Categorizing PAS scores also reduced power and biased effect size estimates compared to an ordinal approach, though this depended on the type of categorization and baseline PAS distribution. Multilevel models should be considered as a more robust approach for the statistical analysis of multiple boluses administered in standardized swallowing protocols due to its high sensitivity and accuracy to compare group-level changes in swallowing function. Importantly, this finding appears to be consistent across patient populations with distinct pathophysiology (i.e., PD and HNC) and patterns of airway invasion. The decision to categorize a continuous or ordinal outcome should be grounded in the clinical or research question with recognition that scale reduction may negatively affect the quality of statistical inferences in certain scenarios.

PMID:39153045 | DOI:10.1007/s00455-024-10738-7

J Neurooncol. 2024 Aug 17. doi: 10.1007/s11060-024-04738-8. Online ahead of print.

ABSTRACT

PURPOSE: Stereotactic Radiosurgery (SRS) is the primary treatment for patients with limited numbers of small brain metastases. Head fixation is usually performed with framed-based (FB) fixation; however, mask-based (MB) fixation has emerged as a less invasive alternative. A comparative meta-analysis between both approaches has not been performed.

METHODS: Databases were searched until August 28th, 2023, to identify studies comparing MB and FB SRS in the treatment of brain metastases. Our outcomes of interest included local tumor control (LTC), radiation necrosis (RN), mortality, and treatment time (TT). Mean difference (MD), risk ratio (RR), and hazard ratio (HR) were used for statistical comparisons.

RESULTS: From 295 articles initially identified, six studies (1 clinical trial) involving 509 patients were included. LTC revealed comparable RR at 6-months (RR = 0.95[95%CI = 0.89-1.01], p = 0.12) and a marginal benefit in FB SRS at 1-year (RR = 0.87[95%CI = 0.78-0.96], p = 0.005). However, in oligometastases exclusively treated with single-fraction SRS, LTC was similar among groups (RR = 0.92 [95%CI = 0.89-1.0], p = 0.30). Similarly, in patients with oligometastases treated with single-fraction SRS, RN (HR = 1.69; 95%CI = 0.72-3.97, p = 0.22), TT (MD = -29.64; 95%CI = -80.38-21.10, p = 0.25), and mortality were similar among groups (RR = 0.62; 95%CI = 0.22-1.76, p = 0.37).

CONCLUSION: Our findings suggest that FB and MB SRS, particularly oligometastases treated with single-fraction, are comparable in terms of LTC, RN, TT, and mortality. Further research is essential to draw definitive conclusions.

PMID:39153030 | DOI:10.1007/s11060-024-04738-8