Symptom Burden in Extensive Disease Small Cell Lung Cancer (ED-SCLC): A prospective, observational study in U.S. community practices.

2018 ◽  
Vol 36 (30_suppl) ◽  
pp. 196-196
Author(s):  
Donald A. Richards ◽  
Maen A. Hussein ◽  
Steven L. McCune ◽  
Brian Kent Ulrich ◽  
Mark D. Danese ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Health Status ◽  
Observational Study ◽  
Repeated Measures ◽  
Prospective Observational Study ◽  
Symptom Burden ◽  
Patient Reported ◽  
Lung Cancer Symptom Scale ◽  
Line Of Therapy

196 Background: There is a paucity of data describing the effect of treatment on symptom burden and health status for patients with ED-SCLC receiving care in US community oncology centers. This study explores ED-SCLC patient-reported outcomes independently for either first-line (1L), second-line (2L) or third-line (3L) therapy. Methods: CA209-118 is a prospective observational study of adult patients with lung cancer, including patients with ED-SCLC, in 70 US community practices enrolled between 2014-2017. Participants completed the Lung Cancer Symptom Scale (LCSS) and Euro-QoL 5-D (EQ-5D) utility index and visual analog scale (VAS) at the start of 1L, 2L, or 3L treatment and at follow-up visits. The LCSS is summarized in 3 scales: LCSS total scale which ranges from 0 – 100, average symptom burden scale (ASBI) ranging from 0 – 100, and a three-item global scale (3-IGI) ranging from 0 – 300 (lower scores reflect reduced burden). The EQ-5D scale is a preference based measure of health status with higher scores reflecting better quality and ranges from 0 to 1.0 (index) or 0 – 100 (VAS). LCSS and EQ-5D values at 60 days were predicted in a repeated measures model for patients having a score at baseline and at least 1 follow-up. Results: The mean LCSS and EQ-5D scores at the start of each line of therapy and predicted 60 day change are presented in the table . 60-day improvement was observed only for appetite and cough in 1L. A slight declining trend was seen in 2L and 3L. Conclusions: Patients with ED-SCLC treated in the community reported a high symptom burden at the start of each line of therapy which did not diminish throughout 60 days of treatment. [Table: see text]

Patient-reported symptoms, functioning, and quality of life (QoL) in patients treated with cemiplimab monotherapy for first-line treatment of advanced NSCLC with PD-L1 ≥ 50%: Results from EMPOWER-Lung 1 study.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 9078-9078
Author(s):  
Mahmut Gumus ◽  
Chieh-I Chen ◽  
Cristina Ivanescu ◽  
Saadettin Kilickap ◽  
Igor Bondarenko ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Clinical Trial ◽  
Repeated Measures ◽  
Advanced Nsclc ◽  
Performance Status ◽  
Symptom Burden ◽  
Cancer Symptoms ◽  
Patient Reported ◽  
Lower Likelihood ◽  
Platinum Doublet

9078 Background: Cemiplimab, a PD-1 inhibitor, improved survival and progression-free survival vs platinum doublet chemotherapy (chemo) in patients (pts) with advanced NSCLC and PD-ligand(L)1 expression ≥50% in the EMPOWER-Lung 1 Phase 3 study (NCT03088540). Since pts with advanced NSCLC have a high symptom burden that adversely impacts QoL and functioning, these outcomes were evaluated as secondary endpoints in the clinical trial. Methods: Pts with advanced NSCLC with PD-L1 expression ≥50% and ECOG performance status ≤1 were randomized to IV cemiplimab 350 mg Q3W (n=356) or platinum doublet chemo (n=354). At baseline (BL) and day 1 of each treatment cycle (C) to C15, pts were administered the EORTC core questionnaire (QLQ-C30) and its lung cancer specific module (QLQ-LC13) to assess symptoms, functioning, and Global Health Status (GHS)/QoL. In the intent-to-treat population, mixed-effects repeated measures models were used to estimate least squares (LS) mean change from BL on all scales. Kaplan–Meier analysis estimated time to definitive deterioration, defined as worsening ≥10 points from BL observed at all subsequent time points or patient withdrawal after worsening; hazard ratios (HR) with 95% CIs estimated the likelihood of definitive deterioration. Results: BL scores showed moderate to high levels of functioning and low symptom burden. Cemiplimab-treated pts had lower likelihood of definitive deterioration vs chemo on key symptoms of dyspnea, cough, pain in chest, pain in other body parts, fatigue, nausea/vomiting, appetite loss, constipation, and diarrhea vs chemo (all P<.05). Treatment-related symptoms of peripheral neuropathy and alopecia had a lower likelihood of definitive deterioration with cemiplimab vs chemo (both P<.05). Cemiplimab resulted in significantly greater improvements vs chemo on all functioning scales and reduced the likelihood of definitive deterioration as indicated by HR <1 (Table). GHS/QoL improvements with cemiplimab at C2 were maintained to C15; LS mean change (SE) from BL across all timepoints was 7.1 (1.0) for cemiplimab vs 1.7 (1.2) for chemo ( P<.0001). Conclusions: In pts with advanced NSCLC and PD-L1 expression ≥50%, cemiplimab significantly improved GHS/QoL, functioning, and most symptoms vs chemo. Over 1 year of treatment, cemiplimab delayed worsening of key lung cancer symptoms and functioning. Clinical trial information: NCT03088540. [Table: see text]

scholarly journals Long-Term Follow-Up of Accelerated Transepithelial Corneal Crosslinking for Post-LASIK Ectasia: A Pilot Prospective Observational Study

2021 ◽  
Vol 9 ◽  
Author(s):  
Mi Tian ◽  
Xiaoyu Zhang ◽  
Weijun Jian ◽  
Ling Sun ◽  
Yang Shen ◽  
...  
Keyword(s):  
Observational Study ◽  
Repeated Measures ◽  
Prospective Observational Study ◽  
Statistical Significance ◽  
Corneal Thickness ◽  
Corneal Crosslinking ◽  
Epithelial Thickness ◽  
Long Term Follow Up

Background: Keratectasia after corneal refractive surgery is a rare but serious postoperative complication, and reports on accelerated transepithelial corneal crosslinking (ATE-CXL)-based treatment of patients with post-laser-assisted in situ keratomileusis (LASIK) ectasia are limited. Therefore, this study evaluated the long-term efficacy and safety of ATE-CXL for progressive post-LASIK ectasia.Methods: This prospective observational study was conducted at the Eye and ENT Hospital, Fudan University, Shanghai, China, and 25 eyes from 25 patients with post-LASIK ectasia undergoing ATE-CXL were examined. Clinical examinations were conducted preoperatively and postoperatively to assess parameters such as manifest refraction, corrected distance visual acuity (CDVA), endothelial cell density; keratometry, corneal thickness, posterior elevation and topometric indices were measured using Pentacam; sectoral pachymetry and epithelial thickness were evaluated using optical coherence tomography. A paired t-test, Wilcoxon rank-sum test, Kruskal-Wallis test, and repeated measures analysis of variance were used for statistical analysis.Results: Participants were examined for an average of 46 months. No severe complications occurred during or after ATE-CXL. CDVA improved from 0.25 ± 0.31 preoperatively to 0.15 ± 0.17 postoperatively (p = 0.011). Maximum keratometry decreased from 55.20 ± 8.33 D to 54.40 ± 7.98 D, with no statistical significance (p = 0.074), and the central corneal thickness increased from 414.92 ± 40.96 μm to 420.28 ± 44.78 μm (p = 0.047) at the final follow-up. Posterior elevation, pachymetry, and epithelial thickness remained stable (p &gt; 0.05) throughout the follow-up. No significant differences were noted in topometric indices, except the central keratoconus index, which decreased significantly (p &lt; 0.001) at the final follow-up.Conclusion: Improvements in CDVA and stabilization in corneal keratometry and posterior elevation after ATE-CXL were noted at the 46-months follow-up, demonstrating that ATE-CXL is a safe and effective treatment for progressive post-LASIK ectasia.

scholarly journals Fluoroscopically-Guided Cervical Zygapophyseal Therapeutic Joint Injections May Reduce the Need for Radiofrequency Neurotomy

2018 ◽  
Vol 1 (21;1) ◽  
pp. E661-E665
Author(s):  
Christopher Huston
Keyword(s):  
Observational Study ◽  
Neck Pain ◽  
Prospective Observational Study ◽  
Facet Joint ◽  
Zygapophyseal Joint ◽  
Radiofrequency Neurotomy ◽  
Case Series Study ◽  
Patient Reported ◽  
Joint Injections

Background: There is a paucity of literature studying therapeutic intraarticular zygapophyseal (commonly referred to as facet) joint injections in the atraumatic patient population. As a result of this, intraarticular injections have been dismissed as a possible treatment for cervical zygapophyseal joint-mediated pain. Radiofrequency neurotomy (RFN) is currently the accepted treatment for facet joint neck pain. Objective: This prospective observational study investigated injection response in an atraumatic population to determine treatment viability and whether injections reduce the need for RFN in neck pain patients. Study Design: Observational case series study. Setting: This study took place in the outpatient clinic of a private practice. Methods: The double-block paradigm (DBP) was used to determine if symptoms were zygapophyseal joint-mediated. Lidocaine and bupivacaine diagnostic injections were used. Participants passing the DBP underwent fluoroscopically-guided cervical zygapophyseal joint injections (betamethasone and 1% lidocaine) and 1 year of follow-up. Outcomes were a Verbal Numeric Scale score (VNS) > 2, 50% decrease in VNS, patient-reported improvement, and opioid use at the 1-year follow-up. Results: One hundred and eighteen patients were enrolled; 51 passed the DBP. These 51 patients underwent injections. Forty-four patients (59 joints) were surveyed 1 year later with 7 follow-up losses. Thirty-four of 59 joints showed ≥ 2-point VNS reductions or ≥ 50% overall symptomatic improvement after 1 year. Twenty-four of 44 ceased narcotics use. Limitations: The limitations of this research included the lack of randomization and blinding, smaller sample size, and reliance on subjective reporting from the participants both immediately after the procedures and at follow-up. As this was a prospective observational study, there is the possibility of unintended bias by both patients as well as the authors. Conclusion: Cervical zygapophyseal joint injections may reduce the need for RFN; additional studies are required. Key words: Neck pain, facet joint, cervical zygapophyseal joint injections, radiofrequency neurotomy

scholarly journals Patient-Reported Outcomes After Complex Adult Spinal Deformity Surgery: 5-Year Results of the Scoli-Risk-1 Study

2021 ◽  
pp. 219256822098827
Author(s):  
Scott L. Zuckerman ◽  
Meghan Cerpa ◽  
Lawrence G. Lenke ◽  
Christopher I. Shaffrey ◽  
Leah Y. Carreon ◽  
...  
Keyword(s):  
Repeated Measures ◽  
Adult Spinal Deformity ◽  
Corrective Osteotomy ◽  
Leg Pain ◽  
Major Surgery ◽  
Mean Values ◽  
Self Image ◽  
Patient Reported ◽  
Spinal Deformity Surgery

Study Design: Prospective cohort. Objective: To prospectively evaluate PROs up to 5-years after complex ASD surgery. Methods: The Scoli-RISK-1 study enrolled 272 ASD patients undergoing surgery from 15 centers. Inclusion criteria was Cobb angle of >80°, corrective osteotomy for congenital or revision deformity, and/or 3-column osteotomy. The following PROs were measured prospectively at intervals up to 5-years postoperative: ODI, SF36-PCS/MCS, SRS-22, NRS back/leg. Among patients with 5-year follow-up, comparisons were made from both baseline and 2-years postoperative to 5-years postoperative. PROs were analyzed using mixed models for repeated measures. Results: Seventy-seven patients (28.3%) had 5-year follow-up data. Comparing baseline to 5-year data among these 77 patients, significant improvement was seen in all PROs: ODI (45.2 vs. 29.3, P < 0.001), SF36-PCS (31.5 vs. 38.8, P < 0.001), SF36-MCS (44.9 vs. 49.1, P = 0.009), SRS-22-total (2.78 vs. 3.61, P < 0.001), NRS-back pain (5.70 vs. 2.95, P < 0.001) and NRS leg pain (3.64 vs. 2.62, P = 0.017). In the 2 to 5-year follow-up period, no significant changes were seen in any PROs. The percentage of patients achieving MCID from baseline to 5-years were: ODI (62.0%) and the SRS-22r domains of function (70.4%), pain (63.0%), mental health (37.5%), self-image (60.3%), and total (60.3%). Surprisingly, mean values ( P > 0.05) and proportion achieving MCID did not differ significantly in patients with major surgery-related complications compared to those without. Conclusions: After complex ASD surgery, significant improvement in PROs were seen at 5-years postoperative in ODI, SF36-PCS/MCS, SRS-22r, and NRS-back/leg pain. No significant changes in PROs occurred during the 2 to 5-year postoperative period. Those with major surgery-related complications had similar PROs and proportion of patients achieving MCID as those without these complications.

scholarly journals Safety of High-Dose Dabigatran in Elderly and Younger Patients with a Low Bleeding Risk: A Prospective Observational Study

Cardiology ◽  
2021 ◽  
pp. 1-5
Author(s):  
Aharon Erez ◽  
Gregory Golovchiner ◽  
Robert Klempfner ◽  
Ehud Kadmon ◽  
Gustavo Ruben Goldenberg ◽  
...  
Keyword(s):  
Observational Study ◽  
Elderly Patients ◽  
Prospective Observational Study ◽  
Bleeding Risk ◽  
The Elderly ◽  
High Dose ◽  
World Population ◽  
Younger Patients ◽  
End Point

<b><i>Introduction:</i></b> In patients with atrial fibrillation (AF) at risk for stroke, dabigatran 150 mg twice a day (DE150) is superior to warfarin for stroke prevention. However, there is paucity of data with respect to bleeding risk at this dose in elderly patients (≥75 years). We aimed to evaluate the safety of DE150 in comparison to warfarin in a real-world population with AF and low bleeding risk (HAS-BLED score ≤2). <b><i>Methods:</i></b> In this prospective observational study, 754 consecutive patients with AF and HAS-BLED score ≤2 were included. We compared outcome of elderly patients (age ≥75 tears) to younger patients (age &#x3c;75 years). The primary end point was the combined incidence of all-cause mortality, stroke, systemic emboli, and major bleeding event during a mean follow-up of 1 year. <b><i>Results:</i></b> There were 230 (30%) elderly patients, 151 patients were treated with warfarin, and 79 were treated with DE150. Fifty-two patients experienced the primary endpoint during the 1-year follow-up. Among the elderly, at 1-year of follow-up, the cumulative event rate of the combined endpoint in the DE150 and warfarin was 8.9 and 15.9% respectively (<i>p</i> = 0.14). After adjustment for age and gender, patients who were treated with DE150 had a nonsignificant difference in the risk for the combined end point as patients treated with warfarin both among the elderly and among the younger population (HR 0.58, 95% C.I = 0.25–1.39 and HR = 1.12, 95% C.I 0.62–2.00, respectively [<i>p</i> for age-group-by-treatment interaction = 0.83). <b><i>Conclusions:</i></b> Our results suggest that Dabigatran 150 mg twice a day can be safely used among elderly AF patients with low bleeding risk.

scholarly journals What are the barriers to the completion of a home-based rehabilitation programme for patients awaiting surgery for lung cancer: a prospective observational study

BMJ Open ◽  
2021 ◽  
Vol 11 (2) ◽  
pp. e041907
Author(s):  
Heloise Catho ◽  
Sebastien Guigard ◽  
Anne-Claire Toffart ◽  
Gil Frey ◽  
Thibaut Chollier ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Observational Study ◽  
Prospective Observational Study ◽  
Living Alone ◽  
Chronic Obstructive ◽  
Obstructive Pulmonary Disease ◽  
Factors Associated ◽  
Home Based ◽  
Registration Number

ObjectivesHome-based rehabilitation programmes (H-RPs) could facilitate the implementation of pulmonary rehabilitation prior to resection for non-small cell lung cancer (NSCLC), but their feasibility has not been evaluated. The aim of this study was to identify determinants of non-completion of an H-RP and the factors associated with medical events occurring 30 days after hospital discharge.DesignA prospective observational study.InterventionAll patients with confirmed or suspected NSCLC were enrolled in a four-component H-RP prior to surgery: (i) smoking cessation, (ii) nutritional support, (iii) physiotherapy (at least one session/week) and (iv) home cycle-ergometry (at least three times/week).OutcomesThe H-RP was defined as ‘completed’ if the four components were performed before surgery.ResultsOut of 50 patients included, 42 underwent surgery (80% men; median age: 69 (IQR 25%–75%; 60–74) years; 64% Chronic Obstructive Pulmonary Disease (COPD); 29% type 2 diabetes). Twenty patients (48%) completed 100% of the programme. The median (IQR) duration of the H-RP was 32 (19; 46) days. Multivariate analysis showed polypharmacy (n=24) OR=12.2 (95% CI 2.0 to 74.2), living alone (n=8) (single vs couple) OR=21.5 (95% CI 1.4 to >100) and a long delay before starting the H-RP (n=18) OR=6.24 (95% CI 1.1 to 36.6) were independently associated with a risk of non-completion. In univariate analyses, factors associated with medical events at 30 days were H-RP non-completion, diabetes, polypharmacy, social precariousness and female sex.ConclusionFacing multiple comorbidities, living alone and a long delay before starting the rehabilitation increase the risk of not completing preoperative H-RP.Trial registration numberNCT03530059.

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