Tag: statistics

J Clin Oncol. 2023 Sep 1;41(25):4065-4076. doi: 10.1200/JCO.22.02765.

ABSTRACT

PURPOSE: To evaluate the relative effect of percent maximal cytoreductive surgery and other prognostic variables on survival among cohorts of patients with advanced-stage ovarian carcinoma treated with platinum-based chemotherapy.

MATERIALS AND METHODS: Eighty-one cohorts of patients with stage III or IV ovarian carcinoma (6,885 patients) were identified from articles in MEDLINE (1989 through 1998). Linear regression models, with weighted correlation calculations, were used to assess the effects on log median survival time of the proportion of each cohort undergoing maximal cytoreduction, dose-intensity of the platinum compound administered, proportion of patients with stage IV disease, median age, and year of publication.

RESULTS: There was a statistically significant positive correlation between percent maximal cytoreduction and log median survival time, and this correlation remained significant after controlling for all other variables (P < .001). Each 10% increase in maximal cytoreduction was associated with a 5.5% increase in median survival time. When actuarial survival was estimated, cohorts with ≤ 25% maximal cytoreduction had a mean weighted median survival time of 22.7 months, whereas cohorts with more than 75% maximal cytoreduction had a mean weighted median survival time of 33.9 months-an increase of 50%. The relationship between platinum dose-intensity and log median survival time was not statistically significant.

CONCLUSION: During the platinum era, maximal cytoreduction was one of the most powerful determinants of cohort survival among patients with stage III or IV ovarian carcinoma. Consistent referral of patients with apparent advanced ovarian cancer to expert centers for primary surgery may be the best means currently available for improving overall survival.

PMID:37643543 | DOI:10.1200/JCO.22.02765

J Clin Oncol. 2023 Sep 1;41(25):4077-4083. doi: 10.1200/JCO.22.02766.

ABSTRACT

Purpose: In randomized trials the combination of cisplatin and paclitaxel was superior to cisplatin and cyclophosphamide in advanced-stage epithelial ovarian cancer. Although in nonrandomized trials, carboplatin and paclitaxel was a less toxic and highly active combination regimen, there remained concern regarding its efficacy in patients with small-volume, resected, stage III disease. Thus, we conducted a noninferiority trial of cisplatin and paclitaxel versus carboplatin and paclitaxel in this population.Patients and Methods: Patients with advanced ovarian cancer and no residual mass greater than 1.0 cm after surgery were randomly assigned to receive cisplatin 75 mg/m² plus a 24-hour infusion of paclitaxel 135 mg/m² (arm I), or carboplatin area under the curve 7.5 intravenously plus paclitaxel 175 mg/m² over 3 hours (arm II).Results: Seven hundred ninety-two eligible patients were enrolled onto the study. Prognostic factors were similar in the two treatment groups. Gastrointestinal, renal, and metabolic toxicity, as well as grade 4 leukopenia, were significantly more frequent in arm I. Grade 2 or greater thrombocytopenia was more common in arm II. Neurologic toxicity was similar in both regimens. Median progression-free survival and overall survival were 19.4 and 48.7 months, respectively, for arm I compared with 20.7 and 57.4 months, respectively, for arm II. The relative risk (RR) of progression for the carboplatin plus paclitaxel group was 0.88 (95% confidence interval [CI], 0.75 to 1.03) and the RR of death was 0.84 (95% CI, 0.70 to 1.02).Conclusion: In patients with advanced ovarian cancer, a chemotherapy regimen consisting of carboplatin plus paclitaxel results in less toxicity, is easier to administer, and is not inferior, when compared with cisplatin plus paclitaxel.

PMID:37643542 | DOI:10.1200/JCO.22.02766

Waste Manag. 2023 Aug 27;171:32-42. doi: 10.1016/j.wasman.2023.08.021. Online ahead of print.

ABSTRACT

Although there have been many research results on the chemical activation of fly ash (FA) as a supplementary cementitious material (SCM) in cementitious materials. However, there is a lack of research on the use of CO₂ foaming agent (sodium bicarbonate and potassium aluminum sulfate) to activate fly ash. In this experiment, the effects of CO₂ foaming agent, sodium bicarbonate, and potassium aluminum sulfate on the activity of FA mixed paste were investigated. The mechanism of FA activation by activator was revealed by selective acid dissolution, QXRD, BSE-EDS statistical analysis, and quantitative analysis of TGA. The results showed that the remaining fly ash amounts of MG, SBG, and PASG after 28 days were 17.5%, 25.9%, and 43.3% lower than those of the control group, respectively. In addition, potassium aluminium sulphate promoted hydration to generate more CH to activate the FA. Sodium bicarbonate promoted hydration and produces more CH to activate FA by generating nano-CaCO₃. The mixture of sodium bicarbonate and potassium aluminum sulfate took advantage of both nano-CaCO₃ and potassium aluminum sulfate to promote silicate hydration to provide CH. As a result, the two synergistically activate FA. The above results show that CO₂ foaming agents can be used not only as foaming agents to prepare lightweight materials, but also as chemical activators to activate solid waste. This will have a high practical application value.

PMID:37643482 | DOI:10.1016/j.wasman.2023.08.021

Elife. 2023 Aug 10;12:e85024. doi: 10.7554/eLife.85024.

ABSTRACT

BACKGROUND: This study seeks to understand how and for whom COVID-19 disrupted cancer care to understand the potential for cancer health disparities across the cancer prevention and control continuum.

METHODS: In this cross-sectional study, participants age 30+residing in an 82-county region in Missouri and Illinois completed an online survey from June-August 2020. Descriptive statistics were calculated for all variables separately and by care disruption status. Logistic regression modeling was conducted to determine the correlates of care disruption.

RESULTS: Participants (N=680) reported 21% to 57% of cancer screening or treatment appointments were canceled/postponed from March 2020 through the end of 2020. Approximately 34% of residents stated they would need to know if their doctor’s office is taking the appropriate COVID-related safety precautions to return to care. Higher education (OR = 1.26, 95% CI:1.11-1.43), identifying as female (OR = 1.60, 95% CI:1.12-2.30), experiencing more discrimination in healthcare settings (OR = 1.40, 95% CI:1.13-1.72), and having scheduled a telehealth appointment (OR = 1.51, 95% CI:1.07-2.15) were associated with higher odds of care disruption. Factors associated with care disruption were not consistent across races. Higher odds of care disruption for White residents were associated with higher education, female identity, older age, and having scheduled a telehealth appointment, while higher odds of care disruption for Black residents were associated only with higher education.

CONCLUSIONS: This study provides an understanding of the factors associated with cancer care disruption and what patients need to return to care. Results may inform outreach and engagement strategies to reduce delayed cancer screenings and encourage returning to cancer care.

FUNDING: This study was supported by the National Cancer Institute’s Administrative Supplements for P30 Cancer Center Support Grants (P30CA091842-18S2 and P30CA091842-19S4). Kia L. Davis, Lisa Klesges, Sarah Humble, and Bettina Drake were supported by the National Cancer Institute’s P50CA244431 and Kia L. Davis was also supported by the Breast Cancer Research Foundation. Callie Walsh-Bailey was supported by NIMHD T37 MD014218. The content does not necessarily represent the official view of these funding agencies and is solely the responsibility of the authors.

PMID:37643471 | DOI:10.7554/eLife.85024

Med Phys. 2023 Aug 29. doi: 10.1002/mp.16668. Online ahead of print.

ABSTRACT

BACKGROUND: Multiple approaches are under development for delivering temporary intensity modulated brachytherapy (IMBT) using partially shielded applicators wherein the delivered dose distributions are sensitive to spatial uncertainties in both the applicator position and shield orientation, rather than only applicator position as with conventional high-dose-rate brachytherapy (HDR-BT). Sensitivity analyses to spatial uncertainties have been reported as components of publications on these emerging technologies, however, a generalized framework for the rigorous determination of the spatial uncertainty tolerances of dose-volume parameters is needed.

PURPOSE: To derive and present the population percentile allowance (PPA) method, a generalized mathematical and statistical framework to evaluate the tolerance of temporary IMBT approaches to spatial uncertainties in applicator position and shield orientation.

METHODS: A mathematical formalism describing geometric applicator position and shield orientation shifts was derived that supports straight and curved applicators and applies to serial and helical rotating shield brachytherapy (RSBT) and direction modulated brachytherapy (DMBT). The PPA method entails defining the percentage of a patient population receiving a given therapy that is, allowed to receive dose-volume errors in the target volume and specified organs at risk of a defined percentage or less, then determining what combinations of applicator position and shield orientation systematic errors would be expected to produce that outcome in the population. The PPA method was applied to the use case of multi-shield helical ¹⁶⁹ Yb-based RSBT for cervical cancer, with 45° and 180° shield emission angles. A total of 37 cervical cancer patients were considered in the population, with average (± 1 standard deviation) HR-CTV volumes of 79 cm³ ± 37 cm³ and optimized baseline treatment plans (no spatial uncertainties applied) created for each patient to meet dose-volume requirements of 85 Gy_EQD2 (equivalent uniform dose in 2 Gy fraction), with D_2cc tolerance doses of 90 Gy_EQD2 , 75 Gy_EQD2 , and 75 Gy_EQD2 for bladder, rectum, and sigmoid colon, respectively.

RESULTS: For the PPA requirement that 90% of cervical cancer patients receiving multi-shield helical RSBT could have a maximum dose-volume uncertainty of 10% for high-risk clinical target volume (HR-CTV) D₉₀ (minimum dose to hottest 90%) and bladder, rectum, and sigmoid colon D_2cc (minimum dose to hottest 2 cm³ ), the tolerance systematic applicator position and shield orientation uncertainties were approximately ± 1.0 mm and ± 4.25°, respectively. For ± 1.5 mm and ± 5° systematic applicator position and shield orientation tolerances, 90% of the patients considered would have a maximum dose-volume uncertainty of 12.8% or less.

CONCLUSION: The PPA method was formalized to determine the temporary IMBT spatial uncertainty tolerances that would be expected to result in an allowed percentage of a population of patients receiving relative dose-volume errors above a defined percentage. Multi-shield, helical ¹⁶⁹ Yb-based RSBT for cervical cancer was evaluated and tolerances determined, which, if applied on each treatment fraction, would represent an extreme situation. The PPA method is applicable to a variety of temporary IMBT approaches and can be used to rigorously determine the design parameters for the delivery systems such as mechanical driver motor accuracy, shield angle backlash, applicator rotation, and applicator fixation stability.

PMID:37643427 | DOI:10.1002/mp.16668

Menopause. 2023 Aug 29. doi: 10.1097/GME.0000000000002249. Online ahead of print.

ABSTRACT

OBJECTIVE: Adverse childhood experiences (ACEs) are reported in more than half of the women in the United States and have been shown to negatively impact the menopause experience. The objective of this study was to evaluate the association between ACEs and age at natural menopause.

METHODS: This is a cross-sectional study conducted among participants of the Data Registry on the Experiences of Aging, Menopause, and Sexuality (DREAMS). The registry included women who were seen for consultations in the women’s health clinic at Mayo Clinic, Rochester, between May 2015 and December 2016. Only postmenopausal women were included in this analysis. Childhood adversity was assessed with the validated ACE questionnaire. Age at natural menopause was self-reported. The association between ACEs and age at menopause was evaluated using a multivariable linear regression model adjusting for multiple confounders.

RESULTS: A total of 350 women were evaluated. The mean age was 59.2 years, and a majority were White (92.9%), married/partnered (82%), and educated (91.2% with at least some college education). Women with a history of at least four ACEs were estimated to reach natural menopause 1.3 years sooner than women with no ACE in multivariable analysis, but the results were not statistically significant (95% confidence interval, -3.2 to 0.6; P = 0.18).

CONCLUSIONS: Although stressful life experiences such as ACEs may negatively influence health for midlife women, this study did not find an association with the age at natural menopause.

PMID:37643394 | DOI:10.1097/GME.0000000000002249

JCO Oncol Pract. 2023 Aug 29:OP2300185. doi: 10.1200/OP.23.00185. Online ahead of print.

ABSTRACT

PURPOSE: The onset of the COVID-19 pandemic created major disruptions in the conduct of cancer clinical trials. In response, regulators and sponsors allowed modifications to traditional trial processes to enable clinical research and care to continue. We systematically evaluated how these mitigation strategies affected data quality and overall trial conduct.

METHODS: This study used surveys and live interviews. Forty-one major industry and National Cancer Institute Network groups (sponsors) overseeing anticancer treatment trials open in the United States from January 2015 to May 2022 were invited to participate. Descriptive statistics were used for survey data summaries. Key themes from interviews were identified.

RESULTS: Twenty sponsors (48.8%; 15 industry and five Network groups) completed the survey; 11/20 (55.0%) participated in interviews. Sponsors predominantly (n = 12; 60.0%) reported large (≥11 trials) portfolios of phase II and/or phase III trials. The proportion of sponsors reporting a moderate (9) or substantial (8) increase in protocol deviations in the initial pandemic wave versus the pre-pandemic period was 89.5% (17/19); the proportion reporting a substantial increased dropped from 42.1% (n = 8/19) in the initial wave to 15.8% (n = 3/19) thereafter. The most commonly adopted mitigation strategies were remote distribution of oral anticancer therapies (70.0%), remote adverse event monitoring (65.0%), and remote consenting (65.0%). Most respondents (15/18; 83.3%) reported that the pandemic had minimal (n = 14) or no impact (n = 1) on overall data integrity.

CONCLUSION: Despite nearly all sponsors observing a temporary increase in protocol deviations, most reported the pandemic had minimal/no impact on overall data integrity. The COVID-19 pandemic accelerated an emerging trend toward greater flexibility in trial conduct, with potential benefits of reduced burden on trial participants and sites and improved patient access to research.

PMID:37643386 | DOI:10.1200/OP.23.00185

J Clin Oncol. 2023 Aug 29:JCO2300529. doi: 10.1200/JCO.23.00529. Online ahead of print.

ABSTRACT

PURPOSE: Platinum-based doublets with concurrent and maintenance bevacizumab are standard therapy for ovarian cancer (OC) relapsing after a platinum-free interval (PFI) >6 months. Immunotherapy may be synergistic with bevacizumab and chemotherapy.

PATIENTS AND METHODS: ATALANTE/ENGOT-ov29 (ClinicalTrials.gov identifier: NCT02891824), a placebo-controlled double-blinded randomized phase III trial, enrolled patients with recurrent epithelial OC, one to two previous chemotherapy lines, and PFI >6 months. Eligible patients were randomly assigned 2:1 to atezolizumab (1,200 mg once every 3 weeks or equivalent) or placebo for up to 24 months, combined with bevacizumab and six cycles of chemotherapy doublet, stratified by PFI, PD-L1 status, and chemotherapy regimen. Coprimary end points were investigator-assessed progression-free survival (PFS) in the intention-to-treat (ITT) and PD-L1-positive populations (alpha .025 for each population).

RESULTS: Between September 2016 and October 2019, 614 patients were randomly assigned: 410 to atezolizumab and 204 to placebo. Only 38% had PD-L1-positive tumors. After 3 years’ median follow-up, the PFS difference between atezolizumab and placebo did not reach statistical significance in the ITT (hazard ratio [HR], 0.83; 95% CI, 0.69 to 0.99; P = .041; median 13.5 v 11.3 months, respectively) or PD-L1-positive (HR, 0.86; 95% CI, 0.63 to 1.16; P = .30; median 15.2 v 13.1 months, respectively) populations. The immature overall survival (OS) HR was 0.81 (95% CI, 0.65 to 1.01; median 35.5 v 30.6 months with atezolizumab v placebo, respectively). Global health-related quality of life did not differ between treatment arms. Grade ≥3 adverse events (AEs) occurred in 88% of atezolizumab-treated and 87% of placebo-treated patients; grade ≥3 AEs typical of immunotherapy were more common with atezolizumab (13% v 8%, respectively).

CONCLUSION: ATALANTE/ENGOT-ov29 did not meet its coprimary PFS objectives in the ITT or PD-L1-positive populations. OS follow-up continues. Further research on biopsy samples is warranted to decipher the immunologic landscape of late-relapsing OC.

PMID:37643382 | DOI:10.1200/JCO.23.00529

Pediatr Emerg Care. 2023 Aug 30. doi: 10.1097/PEC.0000000000003036. Online ahead of print.

ABSTRACT

OBJECTIVES: Severe pancreatitis often requires intensive care; therefore, early detection is important. This study aimed to evaluate the possible predictors of pancreatitis severity in children. Furthermore, we evaluated the prevalence of pancreatitis recurrence and related factors.

METHODS: We retrospectively analyzed the medical records of patients aged younger than 18 years who were diagnosed with acute pancreatitis between January 2017 and June 2022. Acute pancreatitis was diagnosed and classified based on the revised Atlanta criteria.

RESULTS: A total of 64 patients were enrolled, and severe pancreatitis was observed in 10 (15.6%) patients. Patients with severe pancreatitis were younger and had higher C-reactive protein levels than those with mild pancreatitis. The areas under the receiver operating characteristic curves of C-reactive protein levels at admission and 48 hours after diagnosis were 0.612 (95% confidence interval, 0.379-0.844) and 0.873 (95% confidence interval, 0.537-0.983), respectively. Fourteen patients (21.9%) experienced further episodes of recurrent pancreatitis. Patients with recurrent pancreatitis were older (13.7 vs 11.4 years, P = 0.022) and prominently boys (85.7 vs 52%, P = 0.022) compared with those without recurrence. Obesity was observed in 4 (0.6%) patients, which was confirmed in all recurrence groups and was statistically significant.

CONCLUSIONS: This study demonstrated the feasibility of C-reactive protein in the early risk assessment of patients with acute pancreatitis and highlighted the potential risk of recurrence in patients with obesity.

PMID:37643350 | DOI:10.1097/PEC.0000000000003036