Intracoronary versus intravenous bolus abciximab application in patients with ST-elevation myocardial infarction undergoing primary percutaneous coronary intervention: 6-month effects on infarct size and left ventricular function

Background

Administration of abciximab during primary percutaneous coronary intervention (PCI) reduces major adverse cardiac events (MACE) in patients with ST-elevation myocardial infarction (STEMI). Intracoronary (IC) abciximab bolus application during PCI results in high local drug concentration, improved perfusion, reduction of infarct size, and less microvascular obstruction early after infarction. Aim of this study was to investigate whether the early benefits of an IC abciximab administration in STEMI patients undergoing PCI are sustained at 6?months.

Methods

We performed 6-month follow-up of 154 STEMI patients undergoing PCI, who were randomised to either IC (n?=?77) or intravenous (IV) (n?=?77) bolus abciximab administration with subsequent 12-h intravenous infusion. The primary endpoint was infarct size at 6-month follow-up as assessed by delayed enhancement magnetic resonance imaging. Clinical end points were MACEs within 6?months after infarction.

Results

The median infarct size after 6?months was significantly reduced in the IC abciximab group (16.7 vs. 24.1%, p?=?0.002). A significant recovery of LV function was only observed in the IC abciximab group (p?<?0.001), and IC abciximab group patients had significantly less adverse remodelling as compared to standard IV abciximab treatment (p?=?0.03). These beneficial effects also translated into a strong trend towards a reduced MACE rate in the IC abciximab group at 6-month follow-up (10 vs. 21%, p?=?0.07).

Conclusions

Intracoronary abciximab application in STEMI patients undergoing PCI is superior to standard IV treatment with respect to infarct size, recovery of LV function and reverse remodelling 6?months after infarction.     

Is intravascular ultrasound beneficial for percutaneous coronary intervention of bifurcation lesions? Evidence from a 4,314-patient registry

Background

Coronary bifurcations remain a challenging lesion subset for percutaneous coronary intervention (PCI). It is unclear whether intravascular ultrasound (IVUS) guidance can improve PCI results in bifurcations. We aimed to compare IVUS-guided PCI versus standard PCI in a large registry of patients undergoing PCI for bifurcations in the drug-eluting stent era.

Methods

A multicenter, retrospective study was conducted enrolling consecutive patients undergoing bifurcation PCI between January 2002 and December 2006 at 22 centers. The primary end-point was the long term rate of major adverse cardiac events [MACE, i.e. death, myocardial infarction or target lesion revascularization (TLR)].

Results

A total of 4,314 patients were included, 226 (5.2%) undergoing IVUS-guided PCI, and 4,088 (94.8%) standard PCI. Early (30-day) outcomes were similar in the two groups, with MACE in 1.3 versus 2.1%, respectively, death in 0.9 versus 1.0%, and stent thrombosis in 0 versus 0.6% (all p?>?0.05). After 24?±?15?months, unadjusted rates of MACE were 17.7 versus 16.4%, with death in 2.7 versus 4.9%, myocardial infarction in 4.4 versus 3.7%, TLR in 15.0 versus 12.3%, and stent thrombosis in 3.1 versus 2.7% (all p?>?0.05). Even at multivariable Cox proportional hazard analysis with propensity score adjustment, IVUS was not associated with any statistically significant impact on the risk of MACE, death, myocardial infarction, TLR (neither on the main branch nor on the side branch), or stent thrombosis (all p?>?0.05).

Conclusions

Despite a sound rationale to choose stent size, optimize stent expansion and guide kissing inflation, IVUS usage during PCI for coronary bifurcation lesions was not associated with significant clinical benefits in this large retrospective study.     

Influence of abciximab on evolution of left ventricular function in patients with non-ST-segment elevation acute coronary syndromes undergoing PCI after clopidogrel pretreatment: lessons from the ISAR-REACT 2 trial

Background

Abciximab reduced the combined endpoint of death, myocardial infarction (MI) and target vessel revascularization in patients with non-ST-segment elevation acute coronary syndromes (NSTE-ACS) undergoing percutaneous coronary intervention (PCI) with stent implantation after a 600-mg loading dose of clopidogrel. The aim of the present study was to investigate the impact of abciximab on the evolution of left ventricular ejection fraction (LVEF) in these patients.

Methods

The current study included 1,158 patients enrolled in the randomized, double-blind ISAR-REACT 2 (the Intracoronary Stenting and Antithrombotic Regimen: Rapid Early Action for Coronary Treatment) trial who had paired angiograms obtained at baseline and 6?C8?months after randomization. Of them, 586 patients received abciximab and 572 patients received placebo. The primary outcome analysis was LVEF at 6?C8-month follow-up.

Results

Baseline LVEF was comparable in patients assigned to abciximab or placebo (53.2?±?12.6 vs. 53.7?±?12.1%; P?=?0.393). At 6?C8-month follow-up angiography, there was no difference in LVEF between the abciximab and placebo groups (55.4?±?11.5 vs. 55.8?±?11.2%; P?=?0.743). Subgroup analysis of patients with elevated baseline troponin (>0.03???g/L) also revealed comparable LVEF at follow-up in both treatment groups (P?=?0.527). The multivariate analysis identified age, arterial hypertension, prior MI, prior coronary artery bypass graft surgery, baseline LVEF, MI at 30?days and repeat PCI as independent correlates of follow-up LVEF.

Conclusion

Although abciximab reduced the 30-day and 1-year incidence of major adverse cardiac events in patients with NSTE-ACS undergoing primary PCI after pre-treatment with a 600-mg loading dose of clopidogrel, the agent did not improve or impact on the evolution of LVEF over 6?C8?months of follow-up.     

Adverse effects of permanent atrial fibrillation on heart failure in patients with preserved left ventricular function and chronic right apical pacing for complete heart block

Background

The impact of atrial fibrillation (AF) on heart failure (HF) was evaluated in patients with preserved left ventricular (LV) function and long-term right ventricular (RV) pacing for complete heart block.

Methods

Clinical, echocardiographic, and laboratory parameters of HF were assessed in 35 patients with established AF who had undergone ablation of the atrioventricular node and pacemaker implantation (Group A) and 31 patients who received dual-chamber pacing for spontaneous complete heart block (Group B).

Results

During a follow-up period of 12.7?±?7.5?years, New York Heart Association (NYHA) functional class increased from 1.3?±?0.5 to 2.1?±?0.6 (p?p?p?p?=?0,21) in Group B. At the end of follow-up, markers of LV function were moderately depressed in Group A compared with those in Group B: NYHA class 2.1?±?0.6 versus 1.6?±?0.7, p?=?0.001; LVEF 53.0?±?8.2 versus 56.9?±?7.0?%, p?p?p?10?%, increasing NYHA class ≥1, and NT-proBNP levels >1,000?pg/ml.

Conclusions

Permanent AF was associated with adverse effects on LV function and symptoms of HF in patients with long-term RV pacing for complete heart block, and appears to play an important role in the development of HF in this specific patient cohort.     

Clinical correlates of endothelial function in chronic heart failure

Objective

There is a close link between heart failure and endothelial dysfunction. Brachial flow-mediated dilation (FMD) is a validated non-invasive measure of endothelial function. The aim of this study was to investigate the clinical correlates of FMD in patients with chronic heart failure (CHF).

Design, setting, patients

We evaluated 60 CHF outpatients (age 62?±?14?years; 49 males, NYHA class 2.2?±?0.7, left ventricular ejection fraction, LVEF, 33?±?8%) taking conventional medical therapy (ACE-inhibitors and/or ARBs 93%, beta-blockers 95%) and in stable clinical conditions.

Main outcome measures

The maximum recovery value of FMD was calculated as the ratio of the change in diameter (maximum-baseline) over the baseline value.

Results

As compared with patients with a higher FMD, those with FMD below the median value (4.3%) were more frequently affected by ischemic cardiopathy (50 vs. 23%; p?=?0.032) and diabetes mellitus (20 vs. 3%; p?=?0.044), had a higher NYHA class (2.5?±?0.5 vs. 1.9?±?0.7; p?<?0.001) and NT-proBNP (2,690?±?3,690 vs. 822?±?1,060; p?=?0.001), lower glomerular filtration rate estimated by Cockcroft-Gault (GFRCG: 63?±?28 vs. 78?±?25; p?=?0.001) and LVEF (29?±?8 vs. 37?±?9; p?=?0.001), as well as more frequently showing a restrictive pattern (40 vs. 7%; p?=?0.002). In a multivariate regression model (R ²?=?0.48; p?<?0.001), FMD remained associated only with the NYHA class (p?=?0.039) and diabetes mellitus (p?=?0.024).

Conclusions

This study demonstrates that a better functional status and absence of diabetes mellitus are associated to higher FMD regardless of the etiology of the cardiac disease.     

Cardiovascular magnetic resonance left ventricular strain in end-stage renal disease patients after kidney transplantation

Background

Cardiovascular disease is a significant cause of morbidity and mortality in patients with end-stage renal disease (ESRD) and kidney transplant (KT) patients. Compared with left ventricular (LV) ejection fraction (LVEF), LV strain has emerged as an important marker of LV function as it is less load dependent. We sought to evaluate changes in LV strain using cardiovascular magnetic resonance imaging (CMR) in ESRD patients who received KT, to determine whether KT may improve LV function.

Methods

We conducted a prospective multi-centre longitudinal study of 79 ESRD patients (40 on dialysis, 39 underwent KT). CMR was performed at baseline and at 12?months after KT.

Results

Among 79 participants (mean age 55 years; 30% women), KT patients had significant improvement in global circumferential strain (GCS) (p?=?0.007) and global radial strain (GRS) (p?=?0.003), but a decline in global longitudinal strain (GLS) over 12?months (p?=?0.026), while no significant change in any LV strain was observed in the ongoing dialysis group. For KT patients, the improvement in LV strain paralleled improvement in LVEF (57.4?±?6.4% at baseline, 60.6%?±?6.9% at 12?months; p?=?0.001). For entire cohort, over 12?months, change in LVEF was significantly correlated with change in GCS (Spearman’s r?=???0.42, p?<?0.001), GRS (Spearman’s r?=?0.64, p?<?0.001), and GLS (Spearman’s r?=???0.34, p?=?0.002). Improvements in GCS and GRS over 12?months were significantly correlated with reductions in LV end-diastolic volume index and LV end-systolic volume index (all p?<?0.05), but not with change in blood pressure (all p?>?0.10).

Conclusions

Compared with continuation of dialysis, KT was associated with significant improvements in LV strain metrics of GCS and GRS after 12?months, which did not correlate with blood pressure change. This supports the notion that KT has favorable effects on LV function beyond volume and blood pessure control. Larger studies with longer follow-up are needed to confirm these findings.

     

A systematic review and meta-analysis on the use of traditional Chinese medicine compound kushen injection for bone cancer pain

Purpose

Bone cancer pain presents a clinical challenge with limitations of current treatments. Compound kushen injection (CKI) is a well-known traditional Chinese medicine (TCM) formulation in treatment of patients with bone cancer pain. The objective of this study is to assess the efficacy and safety of CKI for bone cancer pain.

Methods

A systematic literature search was conducted in nine databases until December 2012 to identify randomized controlled trials (RCTs) of CKI versus current western therapies for bone cancer pain. The primary outcome was total pain relief rate. The secondary outcomes were the quality of life and adverse events at the end of treatment course. The methodological quality of RCTs was assessed independently using six-item criteria according to the Cochrane Collaboration, and the level of evidence was assessed by the GRADE approach. All data were analyzed using Review Manager 5.1.0.

Results

Seven RCTs with 521 patients from 2010 to 2012 were identified. Compared with radiotherapy or bisphosphonates, seven RCTs showed significant effects of CKI for improving pain relief in patients with bone cancer pain (n?=?521, risk ratio (RR)?=?1.25, 95 % CI (95 % confidence intervals (CI)), 1.13 to 1.38, p?<?0.0001)), three RCTs for improving Karnofsky scoring (KPS) increase rate (n?=?305, RR?=?1.62, 95 % CI, 1.32 to 1.99, p?<?0.00001), 1 RCT for increasing KPS scores (n?=?78, mean difference (MD)?=?10.43, 95 % CI 4.76 to 16.10, p?=?0.0003). 4 RCTs reported adverse effects in both the treatment and control groups. The patients treated with CKI achieved statistically significant reductions of incidences of leukopenia (n?=?276, RR?=?0.32, 95 % CI, 0.21 to 0.47, p?<?0.00001) and nausea (n?=?78, RR?=?0.15, 95 % CI, 0.06 to 0.34, p?<?0.00001). No severe adverse events were found and no treatment was stopped because of adverse events of CKI in the treatment groups. However, the studies were deemed to have a high risk of bias.

Conclusion

This systematic review showed positive but weak evidence of CKI for bone cancer pain because of the poor methodological quality and the small quantity of the included trials. Future rigorously designed RCTs are required.     

Prevalence, predictors, and prognostic impact of fatigue among Brazilian outpatients with advanced cancers

Purposes

The purposes of this study are to evaluate the impact of cancer-related fatigue (CRF) on quality of life (QoL), and to identify its clinical predictors. In addition, the authors investigated the prognostic impact of CRF and its relationship with the inflammatory marker C-reactive protein.

Method

Data regarding patient characteristics, symptom scores, and QoL indices were collected at the initial evaluation. At the same time, blood samples were collected in order to evaluate some laboratorial markers. Patients were followed by telephone interviews every 15 days until death. CRF was defined as ≥66.67 points on EORTC QLQ-C30 fatigue subscale.

Results

The examined patients had a median age of 61 years (range, 21–86 years) and 50.7 % were male. Median Karnofsky performance score (KPS) was 75.5 (SD, 15.1). The prevalence of CRF was 25 % (55 out of 221). Overall, patients with CRF presented higher symptom burden and also worst QoL scores. The following variables were independently associated with CRF: nausea (OR 1.22, p?=?0.009), dyspnea (OR 1.33, p?=?0.002), KPS (OR 0.96, p?=?0.009), body mass index (OR 0.93, p?=?0.046), and C-reactive protein (OR 1.08, p?=?0.004). The median overall survival (OS) was lower in CRF patients (p?<?0.0001). Only KPS (HR?=?0.96, p?<?0.001) and C-reactive protein (HR?=?1.07, p?<?0.001) were independent prognostic factors for OS.

Conclusions

Advanced cancer patients (ACP) with CRF had a higher burden of symptoms and impaired QoL. Our findings support the hypothesis that chronic inflammatory state (CIS) could play a role in the pathogenesis of fatigue in ACP. Moreover, CIS seems to have greater prognostic impact than the associated fatigue.     

The impact of radiotherapy on quality of life for cancer patients: a longitudinal study

Purpose

The aim of this study was to assess for changes in quality of life (QOL) among cancer patients who undergo radiotherapy (RT) and to identify factors that influence QOL in this group.

Materials and methods

Three hundred sixty-seven cancer patients who received curative RT were investigated using the EORTC QLQ-C30 questionnaire at the start of RT, end of RT, and 1 and 6 months post-RT.

Results

The patients were 49 % women, 51 % men, and median age at diagnosis was 57 years (range, 16–86 years). Compared to pre-RT, at the end of RT, the global health status score (p?<?0.001), nausea/vomiting (p?<?0.001), and apetite loss scores (p?<?0.001) were significantly poorer. Compared to the end of RT, at 1 and 6 months post-RT, global health status, all functional, and all symptom scores were significantly improved (p?<?0.001). Patient sex influenced scores for pain (p?=?0.036), appetite loss (p?=?0.027), and financial difficulty (p?=?0.003). Performance status influenced scores for global health status (p?=?0.006), physical functioning (p?<?0.001), cognitive functioning (p?=?0.001), and role functioning (p?=?0.021). Comorbidity influenced fatigue score (p?<?0.001). Cancer stage influenced scores for physical functioning (p?=?0.001), role functioning (p?=?0.010), and fatigue (p?<?0.001). Treatment modality (chemoRT vs. RT alone) influenced scores for physical functioning (p?=?0.016), fatigue (p?<?0.001), nausea/vomiting (p?=?0.009), and appetite loss (p?<?0.001); and RT field influenced scores for nausea/vomiting (p?=?0.001), appetite loss (p?=?0.003), and diarrhea (p?=?0.037). Radiotherapy dose functioning (p?<?0.001), cognitive functioning (p?<?0.001), social functioning (p?<?0.001), fatigue (p?<?0.001), and pain (<60 vs ≥60 Gy) had an effect on scores for physical functioning (p?<?0.001), role functioning (p?<?0.001), emotional (p?<?0.001), insomnia (p?<?0.001), constipation (p?<?0.001).

Conclusion

While RT negatively affects cancer patients’ QOL, restoration tends to be rapid and patients report significant improvement by 1 month post-RT. Various patient- and disease-specific factors and RT modality affect QOL in this patient group. We advocate measuring cancer patients’ QOL regularly as part of routine patient management.     

Lung water assessment by lung ultrasonography in intensive care: a pilot study

Objective

To investigate the accuracy of lung ultrasonography (LUS) in the quantification of lung water in critically ill patients by using quantitative computed tomography (CT) as the gold standard for the determination of lung weight.

Methods

Twenty consecutive patients admitted to an intensive care unit who underwent chest CT as a step in their clinical management were evaluated within 4?h by LUS. Lung weight, lung volume, and physical lung density were calculated from the CT scans using ad hoc software. Semiquantitative ultrasound assessment of lung water was performed by determining the ultrasound B-line score, defined as the total number of B-lines detectable in an anterolateral LUS examination.

Results

Good correlations were found between the B-line score and lung weight (r?=?0.75, p?<?0.05) and density (r?=?0.82, p?<?0.01), that only marginally increased when the lung density of the first 10?mm of subpleural lung tissue was evaluated (r?=?0.83, p?<?0.01). Moreover, values of subpleural lung density were not significantly different from values of the whole lung density (0.34?±?0.11 vs. 0.37?±?0.16?g/ml, p?=?ns). Very good correlations were found between the B-line score and both the weight (r?=?0.85, p?<?0.01) and the density (r?=?0.88, p?<?0.01) of the upper lobes. The weight of the lower lobes was not correlated with the B-line score (r?=?0.14, p?=?ns).

Conclusions

Lung ultrasound B-lines are correlated with lung weight and density determined by CT. LUS may provide a reliable, simple and radiation-free lung densitometry in the intensive care setting.     

Determinants of quality of life in advanced cancer patients with bone metastases undergoing palliative radiation treatment

Purpose

Assessment of health-related quality of life (HRQOL) is critical to effective delivery of palliative care in patients with advanced cancer. The current study analyzes relationships between baseline social determinants of health and medical factors, and self-reported HRQOL in patients with bone metastases receiving palliative radiotherapy.

Methods and materials

Advanced cancer patients referred for radiotherapy treatment of bone metastases completed the EORTC QLQ-C30 questionnaire in multiple outpatient clinics internationally. Demographics and social determinants were collected as baseline information. Univariate and Bonferroni-adjusted multivariate linear regression analyses were used to detect significant correlations between baseline determinants and different HRQOL domains.

Results

Karnofsky Performance Status (KPS) was correlated with better physical (p?=?0.0002), role (p?<?0.0001), emotional (p?<?0.0001), and social (p?<?0.0001) functioning, and global health scores (p?=?0.0015) and predicted lower symptom scores for fatigue (p?<?0.0001), pain (p?<?0.0001), appetite loss (p?<?0.0001), and constipation (p?<?0.0001). Increased age was predictive of better social functioning (p?<?0.0001) and less insomnia (p?=?0.0036), higher education correlated with better global health status (p?=?0.0043), and patients who were employed or retired had improved physical functioning (p?=?0.0004 and p?=?0.0030, respectively) and less financial challenges compared to patients who were unemployed (p?=?0.0005).

Conclusions

Baseline KPS had the greatest influence on EORTC QLQ-C30 domain scores. Age, education level, and employment status had significant impacts, although on fewer domains. Further studies that investigate baseline determinants are worthwhile to clarify relationships in order to care for patients more effectively at the end of life.     

Predictors of anxiety and depression in people with colorectal cancer

Background

People living with colorectal cancer are at risk of anxiety and depression. We investigated what factors were most highly associated with these.

Methods

Four hundred and ninety-six people with colorectal cancer completed the Hospital Anxiety and Depression Scale (HADS). Data on functioning, symptoms, illness perceptions and social difficulties were collected by questionnaire. Case-note-identified disease, treatment and co-morbidity data were recorded. Multiple logistic regression identified factors independently predictive of anxiety and depression caseness.

Results

Self-reported history of anxiety/depression predicted anxiety but not depression caseness. Depression caseness predicted anxiety caseness (p?=?0.043), as did poorer self-reported cognitive functioning (p?=?0.001), dyspnoea (p?=?0.015) or diarrhoea (p?=?0.021), reporting a high negative life and emotional impact (p?<?0.001) and having difficulties with finance (p?=?0.007). Having neo-adjuvant radiotherapy increased the odds of depression caseness (p?=?0.007), as did poorer physical (p?=?0.007), cognitive (p?<?0.001) and social (p?<?0.001) functioning, having constipation (p?=?0.011), reporting a high negative life and emotional impact (p?<?0.001), having difficulties with personal care (p?=?0.022) and communicating with others (p?=?0.014).

Conclusion

Levels of anxiety caseness were similar to those of non-clinical samples, but depression caseness was higher, particularly in those who had received neo-adjuvant radiotherapy. Most factors associated with possible or probable depression may be modified with appropriate intervention.     

Long-term follow-up after coronary stenting with the sirolimus-eluting stent in clinical practice: results from the prospective multi-center German Cypher Stent Registry

Aims

To obtain long-term follow-up data of the sirolimus-eluting coronary stent (SES) and to determine factors associated with clinical events and target vessel revascularization (TVR).

Methods and results

Between 2002 and 2005, 5,946 patients were treated with at least one SES. A follow-up after a median of 4.1?years was obtained in 5,247 patients (88.2?%). During the follow-up, death occurred in 9.2?% of patients, nonfatal myocardial infarction in 5.9?%, nonfatal stroke in 2.2?% and MACCE (death/myocardial infarction/stroke) in 16.3?%. Any TVR was performed in 20.3?%. Independent predictors of MACCE were: older age (p?p?p?p?p?=?0.0002), three-vessel disease (p?=?0.0012), reduced left ventricular function (p?=?0.0048), target vessel?=?bypass graft (p?=?0.0122), indication for treatment?=?ACS (p?=?0.0181) and PCI before implantation (p?=?0.0308). Independent predictors of TVR were target vessel?=?coronary bypass (<0.0001), two- or three-vessel disease (p?p?p?=?0.0012) and older age being a protective factor (p?=?0.0187).

Conclusions

Long-term follow-up of the SES in clinical practice showed clinical event rates that were comparable to randomized trials with a MACCE rate of 16.3?% and TVR rate of 20.3?%.     

Mottling score predicts survival in septic shock

Background

Experimental and clinical studies have identified a crucial role of microcirculation impairment in severe infections. We hypothesized that mottling, a sign of microcirculation alterations, was correlated to survival during septic shock.

Methods

We conducted a prospective observational study in a tertiary teaching hospital. All consecutive patients with septic shock were included during a 7-month period. After initial resuscitation, we recorded hemodynamic parameters and analyzed their predictive value on mortality. The mottling score (from 0 to 5), based on mottling area extension from the knees to the periphery, was very reproducible, with an excellent agreement between independent observers [kappa?=?0.87, 95% CI (0.72?C0.97)].

Results

Sixty patients were included. The SOFA score was 11.5 (8.5?C14.5), SAPS II was 59 (45?C71) and the 14-day mortality rate 45% [95% CI (33?C58)]. Six?hours after inclusion, oliguria [OR 10.8 95% CI (2.9, 52.8), p?=?0.001], arterial lactate level [<1.5 OR 1; between 1.5 and 3 OR 3.8 (0.7?C29.5); >3 OR 9.6 (2.1?C70.6), p?=?0.01] and mottling score [score 0?C1 OR 1; score 2?C3 OR 16, 95% CI (4?C81); score 4?C5 OR 74, 95% CI (11?C1,568), p?<?0.0001] were strongly associated with 14-day mortality, whereas the mean arterial pressure, central venous pressure and cardiac index were not. The higher the mottling score was, the earlier death occurred (p?<?0.0001). Patients whose mottling score decreased during the resuscitation period had a better prognosis (14-day mortality 77 vs. 12%, p?=?0.0005).

Conclusion

The mottling score is reproducible and easy to evaluate at the bedside. The mottling score as well as its variation during resuscitation is a strong predictor of 14-day survival in patients with septic shock.     

Quality of life outcomes in patients with chronic myeloid leukemia treated with tyrosine kinase inhibitors: a controlled comparison

Purpose

Tyrosine kinase inhibitors (TKIs) are now standard treatment for chronic myeloid leukemia (CML). While TKIs have less toxicity than previous treatments, they have side effects that can impact quality of life (QOL).

Methods

This study compared CML patients taking a TKI for an average of 4.01 years (range 0.50–9.79 years) to age- and gender-matched controls with no history of cancer on measures of symptom burden, depression, fatigue, sleep, and health-related QOL.

Results

Compared to controls (n?=?62), CML patients (n?=?62) taking a TKI (imatinib 55 %, nilotinib 31 %, and dasatinib 14 %) reported significantly worse fatigue severity (p?<?.001), fatigue interference (p?<?.001), depression (p?=?.007), symptom burden (p?<?.001), and physical QOL (p?<?.001). TKI patients were also more likely meet established cutoffs for clinically meaningful fatigue (p values?<?.001) and depression (p?=?.004). There were no differences in mental QOL or sleep (p values?>?.010). Regarding specific symptoms, TKI patients were more likely to report nausea, diarrhea, itching, skin changes, swelling of arms or legs, and not looking like themselves (p values?<?.001).

Conclusions

These data suggest the need for interventions to address QOL in CML patients taking TKIs.     

Changes in nutritional status, body composition, quality of life, and physical activity levels of cancer patients undergoing autologous peripheral blood stem cell transplantation

Purpose

This pilot exploratory study aimed to describe the changes in nutritional status, body composition, quality of life (QoL), and physical activity levels (PAL) of cancer patients undergoing high-dose conditioning and autologous peripheral blood stem cell transplantation (PBSCT) at pre-admission, hospital discharge, and at 100 days post-transplantation, and to examine if changes in these parameters are interrelated.

Methods

Twenty-four patients (56.2?±?12.9 years; 7 females, 17 males) were recruited from an Australian transplant center. Assessment was prospectively conducted at pre-admission, hospital discharge, and 100 days post-transplantation using the scored patient-generated subjective global assessment, air displacement plethysmography, EORTC QLQ-C30 (version 3), and the international physical activity questionnaire.

Results

At discharge, nutritional status deteriorated (patient-generated subjective global assessment (PG-SGA) median, +8.0; interquartile range, 6.0–13.0; p?<?0.001) and the number of malnourished patients increased (n?=?8/23; p?=?0.023). Patients experienced significant loss of lean body mass (LBM; ?2.2 kg, CI 95 % ?3.0, ?1.4; p?<?0.001), and decrease in QoL (?10.6, CI 95 % ?24.1, 2.9; p?=?0.117); the proportion of patients with high PAL decreased (p?=?0.012). By 100 days post-transplantation, all patients were well-nourished; however, LBM remained lower ?1.0 kg (CI 95 % ?1.9, ?0.1; p?=?0.028). Change in nutritional status (PG-SGA score) was associated with weight (r?=??0.46; p?=?0.039) and fat mass (r?=??0.57; p?=?0.013). Change in QoL was associated with nutritional reservoir (i.e., fat; r?=?0.54; p?=?0.024); QoL was consistently higher for patients with high PAL.

Conclusions

High-dose conditioning and autologous PBSCT is associated with deterioration in nutritional status, QoL and PAL, with LBM remaining below baseline levels at 100 days post-transplantation. A nutrition and exercise intervention program post-hospital discharge may be beneficial for these patients.     

Efficacy and safety of a high loading dose of clopidogrel administered prehospitally to improve primary percutaneous coronary intervention in acute myocardial infarction: the randomized CIPAMI trial

Objectives

To compare a loading dose of 600?mg clopidogrel given in the prehospital phase versus clopidogrel administered only after the diagnostic angiogram in patients with STEMI scheduled for primary PCI.

Background

The optimal time and dose for the initiation of clopidogrel therapy in patients with STEMI scheduled for primary PCI has not been studied in prospective randomized trials.

Methods

The primary efficacy endpoint was the TIMI 2/3 patency of the infarct-related artery in the diagnostic angiography immediately prior to PCI.

Results

We randomized 337 patients to prehospital (n?=?166) loading dose versus standard therapy (n?=?171). The time interval between initiation of clopidogrel therapy and diagnostic angiography was 47?min. TIMI 2/3 patency before PCI was not different between the groups (49.3 vs. 45.1%, P?=?0.5). We observed a trend towards a reduction of the combined endpoint death, re-infarction, and urgent target vessel revascularization in the prehospital-treated patients (3.0 vs. 7.0%, P?=?0.09), this difference was significant if patients were classified as treated (4/161 vs. 13/174; 2.5 vs. 7.5%, P?P?=?0.8).

Conclusions

Early inhibition of the platelet ADP-receptor with a high loading dose of 600?mg clopidogrel given in the prehospital phase in patients with STEMI scheduled for primary PCI is safe, did not increase pre-PCI patency of the infarct vessel, but was associated with a trend towards a reduction in clinical events.     

Parental sleep experiences on the pediatric oncology ward

Purpose

Parents of pediatric oncology patients are encouraged to sleep on the ward with their child to provide additional care throughout the night. The purpose of this study was to provide the first prevalence estimates of self-reported sleep quantity and quality among parents accommodated on the pediatric oncology ward, compared to parents of age-matched controls.

Methods

Parents of children receiving in-patient cancer treatment and parents of healthy, age-matched children completed a self-report questionnaire, including validated measures of parental sleep and psychological distress, demographic, and clinical characteristics.

Results

In total, 114 parents participated (52 parents of children with cancer; 62 control parents; over all response rate 70 %). Parents on the pediatric oncology ward reported sleeping 5.7 h (SD?=?1.8) on average, in comparison to control parents who reported sleeping 7.0 h at home (SD?=?1.4; t?=?4.3, p?<?0.001). Parents reported waking an average of 4.6 times (SD?=?0.3) per night on the ward, compared to control parents who reported 2.0 (SD?=?0.2) nighttime awakenings (t?=?7.69, p?<?0.001). Parents of children with cancer were significantly more likely to report that they had slept “badly” (67.3 versus 21.0 %; χ²?=?21.9, p?<?0.001). Significant predictors of sleep duration included anxiety (p?=?0.013) and caffeine consumption (p?=?0.017). Parents who slept on the ward attributed poor sleep to feelings of anxiety, environmental noise, and child-related factors.

Conclusions

Parents who sleep on the pediatric oncology ward experience poor sleep outcomes, including inadequate duration and frequent interruptions. The detrimental effects of sleep deprivation on parents' ability to cope during this challenging time require further investigation and intervention.     

Fatigue in advanced cancer patients attending an outpatient palliative radiotherapy clinic as screened by the Edmonton Symptom Assessment System

Introduction

Advanced cancer patients present with a variety of physical and psychological symptoms. Fatigue is one such symptom which reduces overall quality of life and is difficult to manage. The purpose of this study was to report the presence, severity, and correlating factors of fatigue in advanced cancer patients attending an outpatient palliative radiotherapy clinic.

Materials/methods

Patients referred to the Rapid Response Radiotherapy Program between January 1999 and October 2009 completed the Edmonton Symptom Assessment System (ESAS) prior to consultation. Demographic information including age, Karnofsky Performance Status (KPS), gender, and primary cancer sites were collected. Ordinal logistic regression analysis was conducted to determine relationships between demographic information, other ESAS items, and levels of fatigue. Multivariate ordinal logistic regression analysis was used to determine the most significant predictors of fatigue. A p value of <0.05 was considered statistically significant.

Results

A total of 1,397 patients completed the ESAS prior to consultation. Median age was 68?years (range, 21–95), median KPS was 60 (range, 10–100), and slightly more males completed the ESAS (53.0%). Common primary cancers were of the lung (35.8%), breast (20.7%), and prostate (17.7%). Only 179 (12.8%) patients reported no fatigue; the majority of patients reported moderate (31.8%) or severe (34.4%) fatigue. A low KPS (p?<?0.0001), being female (p?=?0.0056), or being referred for bone metastases (p?=?0.0185) significantly correlated with higher levels of fatigue. Patients with a genitourinary primary cancer (p?=?0.0078) and/or referred for malignant spinal cord compression (p?=?0.0004) reported less fatigue. All other ESAS items were significantly related to fatigue. The most significant predictors of fatigue were pain (p?<?0.0001, odds ratio (OR)?=?1.07), nausea (p?=?0.0010, OR?=?1.10), depression (p?<?0.0001, OR?=?1.10), drowsiness (p?<?0.0001, OR?=?1.33), dyspnea (p?=?0.0003, OR?=?1.08), and overall well-being (p?<?0.0001, OR?=?1.19).

Conclusion

Moderate fatigue was reported in over 66% of our advanced cancer patients prior to radiotherapy. Since radiotherapy inherently causes fatigue, proactive and multidisciplinary management is required for these patients. Similar rates of fatigue severity, in lengthier, fatigue-specific tools, suggest that the ESAS may be a good tool for screening the advanced cancer population.