Research Spotlight

Health-related quality of life of postmenopausal women with hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced breast cancer treated with ribociclib + letrozole: results from MONALEESA-2.

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PURPOSE: Evaluate patient-reported outcomes (PROs) for postmenopausal women with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer treated with first-line ribociclib plus letrozole. METHODS: In the phase III MONALEESA-2 study (NCT01958021), 668 patients were randomized 1:1 to ribociclib (600 mg/day; 3-weeks-on/1-week-off) plus letrozole (2.5 mg/day) or placebo plus letrozole. PROs were assessed using the European Organisation for Research and Treatment of Cancer core quality-of-life (EORTC QLQ-C30) and breast cancer-specific (EORTC QLQ-BR23) questionnaires. Changes from baseline and time to deterioration in health-related quality of life (HRQoL) were analyzed using linear mixed-effect and stratified Cox regression models, respectively. Exploratory analysis of area-under-the-curve for change from baseline in pain score (AUC-pain) was performed. RESULTS: On-treatment HRQoL scores were consistently maintained from baseline and were similar between arms. A clinically meaningful (> 5 points) reduction in pain score was observed as early as Week 8 and was maintained up to Cycle 15 in the ribociclib arm. A statistically significant increase in mean AUC-pain was also observed in the ribociclib arm. Scores for all other EORTC QLQ-C30 and EORTC QLQ-BR23 domains were maintained from baseline and were similar between arms. CONCLUSIONS: HRQoL was consistently maintained from baseline in postmenopausal women with HR+, HER2- advanced breast cancer receiving ribociclib plus letrozole and was similar to that observed in the placebo plus letrozole arm. Together with the improved clinical efficacy and manageable safety profile, these PRO results provide additional support for the benefit of ribociclib plus letrozole in this patient population.

Tajti, P., D. Karmpaliotis, K. Alaswad, F. A. Jaffer, R. W. Yeh, M. Patel, E. Mahmud, J. W. Choi, M. N. Burke, A. H. Doing, P. Dattilo, C. Toma, A. J. C. Smith, B. Uretsky, E. Holper, R. M. Wyman, D. E. Kandzari, S. Garcia, O. Krestyaninov, D. Khelimskii, M. Koutouzis, I. Tsiafoutis, J. W. Moses, N. J. Lembo, M. Parikh, A. J. Kirtane, Z. A. Ali, D. Doshi, B. V. Rangan, I. Ungi, S. Banerjee and E. S. Brilakis (2018). “The Hybrid Approach to Chronic Total Occlusion Percutaneous Coronary Intervention: Update From the PROGRESS CTO Registry.” JACC Cardiovasc Interv 11(14): 1325-1335.

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OBJECTIVES: The aim of this study was to determine the techniques and outcomes of hybrid chronic total occlusion (CTO) percutaneous coronary intervention (PCI) in a diverse group of patients and operators on 2 continents. BACKGROUND: CTO PCI has been evolving with constant improvement of equipment and techniques. METHODS: Contemporary outcomes of CTO PCI were examined by analyzing the clinical, angiographic, and procedural characteristics of 3,122 CTO interventions performed in 3,055 patients at 20 centers in the United States, Europe, and Russia. RESULTS: The mean age was 65 +/- 10 years, and 85% of the patients were men, with high prevalence of diabetes (43%), prior myocardial infarction (46%), prior coronary artery bypass graft surgery (33%), and prior PCI (65%). The CTO target vessels were the right coronary artery (55%), left anterior descending coronary artery (24%), and left circumflex coronary artery (20%). The mean J-CTO (Multicenter Chronic Total Occlusion Registry of Japan) and PROGRESS CTO (Prospective Global Registry for the Study of Chronic Total Occlusion Intervention) scores were 2.4 +/- 1.3 and 1.3 +/- 1.0, respectively. The overall technical and procedural success rate was 87% and 85%, respectively, and the rate of in-hospital major complications was 3.0%. The final successful crossing strategy was antegrade wire escalation in 52.0%, retrograde in 27.1%, and antegrade dissection re-entry in 20.9%; >1 crossing strategy was required in 40.9%. Median contrast volume, air kerma radiation dose, and procedure and fluoroscopy time were 270 ml (interquartile range: 200 to 360 ml), 2.9 Gy (interquartile range: 1.7 to 4.7 Gy), 123 min (interquartile range: 81 to 188 min) and 47 min (interquartile range: 29 to 77 min), respectively. CONCLUSIONS: CTO PCI is currently being performed with high success and acceptable complication rates among various experienced centers in the United States, Europe, and Russia. (Prospective Global Registry for the Study of Chronic Total Occlusion Intervention [PROGRESS CTO]; NCT02061436).

Strober, B., J. Crowley, R. G. Langley, K. Gordon, A. Menter, C. Leonardi, D. Arikan and W. C. Valdecantos (2018). “Systematic review of the real-world evidence of adalimumab safety in psoriasis registries.” J Eur Acad Dermatol Venereol Aug 1. [Epub ahead of print].

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Long-term safety of adalimumab in psoriasis clinical studies has been established. The objective of this research was to review real-world evidence of adalimumab safety from registries of adult patients with psoriasis treated in clinical practise. Databases (BIOSIS Previews, Current Contents Search, Derwent Drug File, Embase, Embase Alert, EMCare, MEDLINE, SciSearch) were searched for psoriasis registries with adalimumab safety data. Eligible papers were English language manuscripts (conference abstracts excluded) from psoriasis registries presenting safety data for adult patients with psoriasis receiving adalimumab. The incidence and rate (events/100 patient-years [PY]) of adverse events (AEs), serious AEs (SAEs), and AEs of special interest are reported. Abstracts of 425 publications were screened, and 401 publications excluded (208 conference abstracts; 193 papers). Remaining manuscripts were fully screened; 14 were excluded (no adalimumab data, n=10; no safety data, n=2; no on-treatment data, n=1; not English, n=1), and 10 selected. Overall rates of AEs (4273 [22.2/100PY]) and SAEs (827 [4.3/100PY]) were reported in the ESPRIT registry (N=6059). Rates of infections (7.7-14.7/100PY) and serious infections (<0.6-2.0/100PY) were reported in 4 studies. Cardiovascular-related events were reported in 3 studies:

Rini, B. I., T. E. Hutson, R. A. Figlin, M. J. Lechuga, O. Valota, L. Serfass, B. Rosbrook and R. J. Motzer (2018). “Sunitinib in Patients With Metastatic Renal Cell Carcinoma: Clinical Outcome According to International Metastatic Renal Cell Carcinoma Database Consortium Risk Group.” Clin Genitourin Cancer 16(4): 298-304.

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BACKGROUND: Sunitinib malate, a targeted tyrosine kinase inhibitor, is standard of care for metastatic renal cell carcinoma (mRCC) and serves as the active comparator in several ongoing mRCC clinical trials. In this analysis we report benchmarks for clinical outcomes on the basis of International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) risk groups for patients treated with sunitinib for mRCC in a first-line setting. MATERIALS AND METHODS: A retrospective analysis was performed on data from sunitinib-treated patients (n = 375) in the pivotal phase III trial of sunitinib versus interferon-alpha as first-line treatment for mRCC. Objective response rates (ORRs) were determined from independently reviewed radiologic assessments. The Kaplan-Meier method was used to estimate median progression-free survival (PFS) and median overall survival (OS) according to patient risk group. RESULTS: Median PFS (95% confidence interval [CI]) was 14.1 (13.4-17.1), 10.7 (10.5-12.5), 2.4 (1.1-4.7), and 10.6 (8.1-10.9) months in sunitinib-treated patients in the IMDC favorable (n = 134), intermediate (n = 205), poor (n = 34), and intermediate + poor (n = 239) risk groups, respectively. Median OS (95% CI) was 23.0 (19.8-27.8), 5.1 (4.3-9.9), and 20.3 (16.8-23.0) months in sunitinib-treated patients in IMDC intermediate, poor, and intermediate + poor risk groups, respectively, and was not reached in the favorable risk group (>50% of patients were alive at data cutoff). ORRs (95% CI) was 53.0% (44.2%-61.7%), 33.7% (27.2%-40.6%), 11.8% (3.3%-27.5%), and 30.5% (24.8%-36.8%) in sunitinib-treated patients in IMDC favorable, intermediate, poor, and intermediate + poor risk groups, respectively. CONCLUSION: Results of this retrospective analysis show differences in patient outcomes for PFS, OS, and ORR on the basis of IMDC prognostic risk group assignment for patients with mRCC.

Reynolds, M., S. Driver, M. Bennett, S. Patel, E. Rainey and A. M. Warren (2018). “Examining the relationship between obesity and mental health outcomes among individuals admitted to a level I trauma centre.” Clin Obes Jul 31. [Epub ahead of print].

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The increased incidence of obesity in the general population translates into clinicians caring for an increased number of trauma patients with obesity. Previous research has documented the unique anatomical and physiological challenges that clinicians face when caring for trauma patients with obesity; however, little is known about psychological challenges that trauma patients with obesity may also experience in the months following injury. The aim of this study is to determine the relationship between obesity and (i) mental health, (ii) demographic and injury-related variables and (iii) quality-of-life outcomes among trauma patients between hospitalization and 3-months post-injury. This is a prospective, longitudinal study conducted between March 2012 and May 2014 at a single, level I trauma centre in the southwest United States. Inclusion criteria for this convenience sample consisted of patients who were admitted to the trauma or orthopaedic trauma service >/=24 h, medically stable, spoke English or Spanish and >/=18 years of age. In total, 455 eligible patients were consented and enrolled; 343 (70.87%) completed 3-month follow-up. The objective of this study is to investigate the relationship between obesity and mental health among trauma patients in the months following injury. Demographic and injury-related data were also collected; patients’ height and weight were used to determine body mass index. Health outcomes were assessed during initial hospitalization and at 3-month follow-up and included depression, post-traumatic stress symptoms, pain and return to work. Prior to data collection, it was hypothesized that obesity would have a negative effect on mental health outcomes among patients 3 months post-injury. The final sample consisted of 343 participants; average age was 46.4 +/- 17.3 years; majority male (n = 213, 63%) and Caucasian (n = 231, 69%). Patients with obesity had higher odds of screening positive for depression (odds ratio [OR] = 2.36, P = 0.02) and overweight patients had lower odds of returning to work (OR = 0.31, P = 0.01) 3 months post-injury compared to patients of normal weight (65% vs. 40%). No other significant differences were found. Results of the current study are novel in that they identify psychological challenges that overweight and trauma patients with obesity may experience. These results demonstrate the need for mental health professionals to be involved in follow-up care to extending in the months following injury.