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Use of intravenous bisphosphonates in patients with breast, lung, or prostate cancer and metastases to bone: a 15-year study in two large US health systems.

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The purpose of this paper is to document the use of intravenous (IV) bisphosphonates for prevention of skeletal-related events (SREs) in patients with bone metastases (BM) due to breast cancer (BC), lung cancer (LC), or prostate cancer (PC).

METHODS: Using data from two large US health systems, we identified all patients aged ≥ 18 years with primary BC, LC, or PC and newly diagnosed BM between 1/1/1995 and 12/31/2009. Starting with the diagnosis of BM, we reviewed medical and administrative records for evidence of receipt of IV bisphosphonates (zoledronic acid or pamidronate) and occurrence of SREs. Initiation of IV bisphosphonates prior to occurrence of an SRE was designated "primary prophylaxis"; use following an SRE was designated "secondary prophylaxis".

RESULTS: We identified a total of 1,193 patients with newly diagnosed BM, including 400 with BC, 332 with LC, and 461 with PC. Use of IV bisphosphonates was substantially higher in BC (55.8 % of all patients) than in LC (14.8 %) or PC (20.2 %). Use of IV bisphosphonates was fairly evenly split between primary and secondary prophylaxis in BC (26.3 vs. 29.5 %, respectively) and PC (10.6 vs 9.5 %); in LC, however, primary prophylaxis was much less common than secondary prophylaxis (4.8 vs 9.9 %).

CONCLUSIONS: Almost one half of all patients with BM due to BC, and substantially more with LC and PC, do not receive IV bisphosphonates. Among patients receiving such therapy, treatment often is not initiated until after the occurrence of an SRE. Our study suggests that IV bisphosphonates may be substantially underutilized in patients with BM due to these common cancers.

Effect of chemotherapy on quality of life in patients with non-small cell lung cancer.

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This study was conducted to evaluate the extent to which quality of life (QoL) assessment has been incorporated into clinical trials of patients with advanced non-small cell lung cancer (NSCLC) receiving palliative chemotherapy.

PATIENTS AND METHODS: Phase III trials for patients with NSCLC treated with palliative chemotherapy were identified by a literature search of PubMed. All abstracts and relevant articles from August 1986 to October 2011 were reviewed. The primary focus was on (a) whether these articles had incorporated QoL as an endpoint, (c) what instruments were used to measure QoL and (c) impact of chemotherapy on QoL.

RESULTS: There were 3,780 items indexed under 'quality of life and lung cancer'. One hundred three studies were identified which measured QoL using validated QoL instruments. Fifty-five of these trials assessed the effects of palliative chemotherapy on QoL in patients with advanced NSCLC. The European Organisation for Research and Treatment of Cancer-Quality of Life Questionnaire was the most widely used questionnaire; other commonly used measurement scales used were the Functional Assessment of Cancer Therapy-Lung and the Lung Cancer Symptom Scale. The majority of studies showed that chemotherapy had a positive impact on QoL and disease-specific symptoms.

CONCLUSION: It is now widely accepted that QoL should be considered as a primary endpoint of treatment in patients with advanced lung cancer both in clinical practice and clinical trials to further define meaningful response. As the traditional outcome measures of survival and tumour response are poor in this population, QoL assessment may offer a more comprehensive approach to evaluating the relative risks and benefits associated with treatments.

Thrombolysis for pulmonary embolism and risk of all-cause mortality, major bleeding, and intracranial hemorrhage: a meta-analysis.

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thrombolysisIMPORTANCE: Thrombolytic therapy may be beneficial in the treatment of some patients with pulmonary embolism. To date, no analysis has had adequate statistical power to determine whether thrombolytic therapy is associated with improved survival, compared with conventional anticoagulation.

OBJECTIVE: To determine mortality benefits and bleeding risks associated with thrombolytic therapy compared with anticoagulation in acute pulmonary embolism, including the subset of hemodynamically stable patients with right ventricular dysfunction (intermediate-risk pulmonary embolism).
DATA SOURCES: PubMed, the Cochrane Library, EMBASE, EBSCO, Web of Science, and CINAHL databases from inception through April 10, 2014.
STUDY SELECTION: Eligible studies were randomized clinical trials comparing thrombolytic therapy vs anticoagulant therapy in pulmonary embolism patients. Sixteen trials comprising 211 individuals were identified. Eight trials comprising 1775 patients specified inclusion of patients with intermediate-risk pulmonary embolism.
DATA EXTRACTION AND SYNTHESIS: Two reviewers independently extracted trial-level data including number of patients, patient characteristics, duration of follow-up, and outcomes.

MAIN OUTCOMES AND MEASURES: The primary outcomes were all-cause mortality and major bleeding. Secondary outcomes were risk of recurrent embolism and intracranial hemorrhage (ICH). Peto odds ratio (OR) estimates and associated 95% CIs were calculated using a fixed-effects model.

RESULTS: Use of thrombolytics was associated with lower all-cause mortality (OR, 0.53; 95% CI, 0.32-0.88; 2.17% [23/1061] vs 3.89% [41/1054] with anticoagulants; number needed to treat [NNT] = 59) and greater risks of major bleeding (OR, 2.73; 95% CI, 1.91-3.91; 9.24% [98/1061] vs 3.42% [36/1054]; number needed to harm [NNH] = 18) and ICH (OR, 4.63; 95% CI, 1.78-12.04; 1.46% [15/1024] vs 0.19% [2/1019]; NNH = 78). Major bleeding was not significantly increased in patients 65 years and younger (OR, 1.25; 95% CI, 0.50-3.14). Thrombolysis was associated with a lower risk of recurrent pulmonary embolism (OR, 0.40; 95% CI, 0.22-0.74; 1.17% [12/1024] vs 3.04% [31/1019]; NNT = 54). In intermediate-risk pulmonary embolism trials, thrombolysis was associated with lower mortality (OR, 0.48; 95% CI, 0.25-0.92) and more major bleeding events (OR, 3.19; 95% CI, 2.07-4.92).

CONCLUSIONS AND RELEVANCE: Among patients with pulmonary embolism, including those who were hemodynamically stable with right ventricular dysfunction, thrombolytic therapy was associated with lower rates of all-cause mortality and increased risks of major bleeding and ICH. However, findings may not apply to patients with pulmonary embolism who are hemodynamically stable without right ventricular dysfunction.

Pathogenesis of idiopathic pulmonary fibrosis and its clinical implications.

Idiopathic pulmonary fibrosis (IPF) is the most common and lethal form of idiopathic interstitial pneumonia. The disease is thought to arise following an aberrant reparative response to recurrent alveolar epithelial cell injury leading to progressive loss of function.

The median survival time is 3-5 years from diagnosis. Cigarette smoking, exposure to organic and inorganic dust and genetic factors have been shown to increase the risk of disease, although the cause of IPF remains elusive and its pathogenesis incompletely understood. In the last decade, several clinical trials evaluating novel therapies for IPF have been conducted but the results have been mostly disappointing. Conversely, compounds that target anti-fibrotic and growth factor pathways have been proven effective in slowing functional decline and disease progression.

These promising results notwithstanding, truly effective therapeutic strategies will likely require combinations of drugs in order to target the multitude of pathways involved in disease pathogenesis.

Pneumonia, thrombosis and vascular disease.

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An enhanced risk of cardiovascular mortality has been observed after pneumonia. Epidemiological studies have shown that respiratory tract infections are associated with an increased risk of thrombotic-related vascular disease such as myocardial infarction, ischemic stroke and venous thrombosis.

Myocardial infarction and stroke have been detected essentially in the early phase of the disease, i.e. within 48 hours from hospital admission, with an incidence ranging from as low as 1% to as high as 11%. Age, previous cardiovascular events and high pneumonia severity index were independent predictors of myocardial infarction; clinical predictors of stroke were not identified. Deep venous thrombosis and pulmonary embolism may also occur after pneumonia but incidence and clinical predictors must be defined. Biological plausibility of such association may be deduced by experimental and clinical studies, showing that lung infection is complicated by platelet aggregation and clotting system activation, as documented by up-regulation of Tissue Factor and down-regulation of activated Protein C. The effect of antithrombotic drugs have been examined in experimental and clinical studies but results are still inconclusive.

Thrombotic-related vascular disease such as myocardial infarction, stroke and venous thrombosis may complicate the clinical course of pneumonia and worsen its prognosis. Further definition of predictors may help to identify patients at higher risk of artery and venous thrombosis.

Patients with pneumonia could benefit from antithrombotic strategy including anticoagulants and/or antiplatelet drugs but this should be tested in randomized clinical studies. This article is protected by copyright. All rights reserved.

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