The choice between chemotherapy alone and chemotherapy plus consolidative radiotherapy (RT) for diffuse large B-cell lymphoma (DLBCL) remains controversial. We aimed to define factors affecting ...treatment selection and the resulting survival outcomes.
Using the National Cancer Data Base, we identified 59,255 patients with stages I and II DLBCL treated with multiagent chemotherapy alone or chemotherapy plus consolidative RT between 1998 and 2012. Univariable and multivariable analyses were performed to identify sociodemographic, treatment, and tumor characteristics predictive of overall survival (OS) and treatment use. Propensity-adjusted Cox proportional hazard ratios for survival were used to account for indication bias.
Of the 59,255 patients with DLBCL enrolled onto the study, 46% had stage II disease, 42% had extranodal disease, and 58% were more than 60 years of age. Only 39% received combined-modality therapy, and this proportion significantly declined from 47% in 2000 to 32% in 2012 (P < .001). Treatment selection was significantly influenced by race, comorbidity, insurance type, education quartile, facility type, age, stage, B symptoms, distance from treatment facility, and year of diagnosis. The median follow-up time was 60 months (interquartile range, 33 to 93). Estimated 5-year and 10-year OS rates were, respectively, 79% and 59% for all patients, 75% and 55% for patients receiving chemotherapy alone, and 82% and 64% for patients receiving combined-modality therapy (P < .001). Even after adjusting for immortal times and indication bias, combined-modality therapy was associated with better OS (HR, 0.66; 95% CI, 0.61 to 0.71; P < .001) than was chemotherapy alone.
Use of consolidative RT after multiagent chemotherapy in DLBCL is decreasing in the modern era. Selection of treatment strategy is affected by both classical prognostic features and socioeconomic factors. Abandonment of combined-modality therapy in favor of chemotherapy alone negatively affects patient survival.
To characterize long-term clinical outcomes of monotherapy selective laser trabeculoplasty (SLT) in Afro-Caribbean patients with open-angle glaucoma (OAG).
This was a post hoc analysis of nearly 8 ...years (median, 3.2; interquartile range, 2.1-7.1) of pooled data from the West Indies Glaucoma Laser Study and its preliminary study.
Setting: Three eye care practices in Saint Lucia and Dominica. Participants: Afro-Caribbean adults with mild-moderate OAG treated with ≤2 medications (61 in preliminary study, 72 in West Indies Glaucoma Laser Study). Intervention: Participants underwent medication washout, baseline intraocular pressure (IOP) determination, and bilateral 360-degree SLT. Participants were followed for up to 94 months. Repeat SLT was performed according to prespecified criteria. Main Outcome Measures: The primary outcome was mean IOP reduction from baseline. The secondary outcome was medication-free survival with SLT repeated as needed.
The pooled data set included 265 eyes of 133 Afro-Caribbean participants. The mean (standard deviation) baseline IOP was 21.2 (3.4) and 21.2 (3.9) mmHg in right and left eyes, respectively. Over 8 years, the mean IOP ranged from 12.8 to 15.7 mm Hg and from 13.1 to 15.8 mm Hg, respectively (P < .0001 for every comparison with baseline). The median medication-free survival time for initial SLT was 85.4 months in both eyes. The 94-month medication-free survival of SLT repeated as needed was 71.2% and 71.7%, respectively.
Monotherapy SLT, repeated as needed, safely provides significant IOP reductions in most Afro-Caribbean adults with primary OAG through nearly 8 years of follow-up and has significant potential to delay or prevent glaucoma-related vision loss in black patients in low-resource regions.
To characterize the 12-month intraocular pressure (IOP)-lowering efficacy of selective laser trabeculoplasty (SLT) as sole therapy for primary open-angle glaucoma (POAG) in an Afro-Caribbean ...population.
Stepped-wedge trial.
Subjects in St. Lucia and Dominica with established POAG were randomized to prompt washout of IOP-lowering medications followed by SLT, 3-month delay followed by washout and SLT, or 6-month delay followed by washout and SLT. Baseline IOP was obtained on 2 different days after washout. Bilateral 360-degree SLT was performed in 1 session. Posttreatment assessments took place 1 hour, 1 week, and 3, 6, 9, and 12 months post-SLT. The main outcome measure was SLT success (defined as IOP ≤ target IOP in both eyes) at 12 months. Target IOP was a 20% or greater reduction in IOP from postwashout baseline.
Overall, 72 patients underwent SLT treatment. Mean IOP at enrollment was 15.4 ± 3.6 mm Hg in right eyes and 15.4 ± 3.6 mm Hg in left eyes, which rose to 21.0 ± 3.3 mm Hg and 20.9 ± 3.0 mm Hg, respectively, after washout. Mean IOP at 3, 6, 9, and 12 months ranged from 12.5 mm Hg to 14.5 mm Hg (29.7% to 39.5%; P < .0001 in each eye at each time point). The 12-month success rate was 78%. Transient photophobia and discomfort were common.
SLT monotherapy safely provides significant IOP reduction in Afro-Caribbean eyes with POAG. This treatment can play a significant role in preventing glaucoma vision loss and blindness in people of African descent living in resource-limited regions.
Summary Background On the basis of mixed results from previous trials, we assessed whether therapeutic hypothermia for 48–72 h with slow rewarming improved mortality in children after brain injury. ...Methods In this phase 3, multicenter, multinational, randomised controlled trial, we included patients with severe traumatic brain injury who were younger than 18 years and could be enrolled within 6 h of injury. We used a computer-generated randomisation sequence to randomly allocate patients (1:1; stratified by site and age <6 years, 6–15 years, 16–17 years) to either hypothermia (rapidly cooled to 32–33°C for 48–72 h, then rewarmed by 0·5–1·0°C every 12–24 h) or normothermia (maintained at 36·5–37·5°C). The primary outcome was mortality at 3 months, assessed by intention-to-treat analysis; secondary outcomes were global function at 3 months after injury using the Glasgow outcome scale (GOS) and the GOS-extended pediatrics, and the occurrence of serious adverse events. Investigators assessing outcomes were masked to treatment. This trial is registered with ClinicalTrials.gov , number NCT00222742. Findings The study was terminated early for futility after an interim data analysis on data for 77 patients (enrolled between Nov 1, 2007, and Feb 28, 2011): 39 in the hypothermia group and 38 in the normothermia group. We detected no between-group difference in mortality 3 months after injury (6 15% of 39 patients in the hypothermia group vs two 5% of 38 patients in the normothermia group; p=0·15). Poor outcomes did not differ between groups (in the hypothermia group, 16 42% patients had a poor outcome by GOS and 18 47% had a poor outcome by GOS-extended paediatrics; in the normothermia group, 16 42% patients had a poor outcome by GOS and 19 51% of 37 patients had a poor outcome by GOS-extended paediatrics). We recorded no between-group differences in the occurrence of adverse events or serious adverse events. Interpretation Hypothermia for 48 h with slow rewarming does not reduce mortality of improve global functional outcome after paediatric severe traumatic brain injury. Funding National Institute of Neurological Disorders and Stroke and National Institutes of Health.
Intraocular pressure (IOP) measurements obtained with the HOME2 rebound tonometer are interchangeable with measurements obtained using the office-based IC100 and IC200 rebound tonometers, making ...characterization of circadian IOP achievable with no inter-device sources of variability.
To evaluate test-retest reliability between intraocular pressure (IOP) measurements obtained with a home rebound tonometer operated by patients and those obtained with office rebound tonometers operated by experienced clinical staff.
Following training and practice with a home rebound tonometer (iCare HOME2) in a randomly selected eye, patients with established or suspected open-angle glaucoma underwent IOP measurement in the fellow eye as follows in randomized order: 3 good quality measurements with the iCare IC100 operated by experienced clinical staff, 3 good quality measurements with the iCare IC200 operated by experienced clinical staff, and 3 good quality measurements with the HOME2 operated by the subject. The Shrout-Fleisch intraclass correlation coefficient ICC (2,1) was the measure of reliability utilized based on the model using two-way random effects, absolute agreement, and single measurement.
Thirty eyes of 30 patients were evaluated. The Pearson correlation coefficient (r) for IOP measurements taken with the IC100 and HOME2 was 0.97, with the IC200 and HOME2 was 0.96, and with the IC100 and IC200 was 0.97. Test-retest reliability between HOME2 and IC100 (ICC 0.90), HOME2 and IC200 (ICC 0.92), and IC100 and IC200 (ICC 0.94) all reflected excellent test-retest reliability.
The test-retest reliability of IOP measurements taken by patients using the iCare HOME2 self-tonometer compared with IOP measurements taken by trained operators using the iCare IC100 and IC200 tonometers was uniformly excellent (ICCs all ≥0.9). These findings indicate that these three devices should be considered interchangeable for the clinical assessment of circadian IOP.
Studies examining temporal trends in cervical brachytherapy use are conflicting and examined different health insurance populations. This study examined brachytherapy utilization over time by health ...insurance type and whether reported declines in brachytherapy have reversed.
The National Cancer Database (NCDB) was queried for patients with FIGO IIB-IVA cervical cancer treated with definitive chemoradiotherapy between 2004 and 2014, identifying 17,442 patients. Brachytherapy utilization over time and by insurance type and other sociodemographic factors were compared using binary logistic regression. A sensitivity analysis was done in a sub-cohort of patients using the boost modality variable in the NCDB.
Brachytherapy utilization declined during 2008–10 (52.6%) compared to 2004–2007 (54.4%; odds ratio OR 0.93, 95% confidence interval CI 0.86–1.01) and declines were disproportionately larger for patients with government insurance (49.4% vs 52.3%, respectively) than privately-insured patients (57.6% vs 58.9%, respectively). However, rates of brachytherapy use subsequently recovered during 2011–14 in all insurance groups (58.0%, OR 1.24, 95% CI 1.16–1.34) and was especially improved for Medicaid (OR 1.44, 95% CI 1.26–1.65) and uninsured patients (OR 1.28, 95% CI 1.03–1.57). Sensitivity analysis using the boost modality variable confirmed these trends.
In patients with FIGO IIB-IVA cervical cancer treated with definitive chemoradiotherapy from 2004 to 2014, brachytherapy utilization declined during the late 2000s and disproportionately affected patients with government insurance, but subsequently recovered in the early 2010s. Since government insurance covers vulnerable patient populations at-risk for future declines in brachytherapy use, proposed alternative payment models should incentivize cervical brachytherapy to solidify gains in brachytherapy utilization.
•Use of cervical brachytherapy (BT) declined in the late 2000s and disproportionately affected government-insured patients.•However, trends reversed in the early 2010s such that patients of all insurance types had increased BT use.•Awareness of declining BT use raised by researchers and the Affordable Care Act may have facilitated this improvement.•Proposed alternative payment models should incentivize cervical BT to encourage and solidify these gains.
To characterize changes in endothelial cell density and morphology following phacoemulsification combined with either excisional goniotomy with the Kahook Dual Blade (KDB-phaco) or first-generation ...iStent trabecular microbypass implantation (iStent-phaco).
A single clinical practice.
Twenty-one adult subjects from one center with visually significant cataract and mild-moderate open-angle glaucoma underwent KDB-phaco or iStent-phaco in one eye and the alternate procedure in the fellow eye as part of a prospective, multicenter, randomized trial. Specular microscopy and pachymetry were performed before and 6-29 months after surgery. Parameters analyzed included change from baseline of endothelial cell density (ECD), the coefficient of variation (CV), the percent of hexagonal cells (%HEX), and central corneal thickness (CCT).
Baseline ECD, CV, %HEX, and CCT were similar between groups. A mean (standard deviation) of 18.2 (5.8) months postoperatively (range 12.5-28.7 months), the change from baseline in ECD was -90 ± 226 cells/mm
(-3.4%) in KDB-phaco eyes (p=0.083) and -239 ± 247 cells/mm
(-9.0%) in iStent-phaco eyes (p<0.001); the change in iStent-phaco eyes was significantly greater than in KDB-phaco eyes (p=0.013). The magnitude of Endothelial Cell Loss (ECL) was not correlated with length of postoperative follow-up time in either group. No significant differences in change from baseline in CV, %HEX, or CCT were noted with the exception of a decrease in %HEX in iStent-phaco eyes (p=0.017). No eyes manifested corneal edema, decompensation, or other cornea-related complications.
Both KDB-phaco and iStent-phaco are associated with postoperative ECL, with iStent-phaco producing significantly greater ECL than KDB-phaco. The clinical significance of these findings is unclear, and future studies are warranted to more robustly characterize long-term effects of glaucoma surgical procedures-with and without permanent implants-on ECD and corneal health and to develop evidence-based guidelines for the pre- and post-operative evaluation of corneal health in eyes undergoing glaucoma surgery.
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