Treatment of patients with newly diagnosed metastatic hormone sensitive prostate cancer (mHSPC) in Belgium: a real world data analysis.

INTRODUCTION: Abiraterone acetate + prednisone (AAP) and docetaxel have proven their efficacy in the treatment of patients with newly diagnosed metastatic hormone-sensitive prostate cancer (mHSPC) in clinical trials. However, real-world data are scarce. The goal of this study is to evaluate real-world data on the efficacy and safety of these therapies in mHSPC patients. PATIENTS AND METHODS: Records of 93 patients from 21 different centres were retrospectively reviewed. Primary and secondary endpoints were radiographic and PSA progression-free survival (RPFS - PSA-PFS) and cancer specific and overall survival (CSS - OS), respectively. Adverse events (AEs) were evaluated according to the Common Terminology Criteria for Adverse Events version 5.0. Differences in oncological outcome and AEs were evaluated between three treatment groups: ADT only (N=26) - ADT + AAP (N=48) - ADT + docetaxel (N=19). Survival analysis was performed using Kaplan-Meier statistics. RESULTS: Median RPFS was 13 months (95% confidence interval [CI]: 9-17) for ADT only, 21 months (95% CI: 19-23) for ADT + AAP and 12 months (95% CI: 11-14) for ADT + docetaxel (p = 0.004). The 1-year PSA-PFS, CSS and OS were 73.5%, 90.7% and 88.7%, respectively, with no significant differences between the three groups. Adverse events of grade 3 or higher were not observed more frequently. CONCLUSION: Retrospective real-world data show a significantly longer RPFS for mHSPC patients treated with ADT + AAP compared to ADT only or ADT + docetaxel at short-term follow-up. This can aid in counselling of mHSPC patients in daily clinical practice.

A multicenter pilot study of a bronchial valve for the treatment of severe emphysema.

BACKGROUND: Chronic obstructive pulmonary disease (COPD) affects millions of people and has limited treatment options. Surgical treatments for severe COPD with emphysema are effective for highly selected patients. A minimally invasive method for treating emphysema could decrease morbidity and increase acceptance by patients. OBJECTIVE: To study the safety and effectiveness of the IBV(R) Valve for the treatment of severe emphysema. METHODS: A multicenter study treated 91 patients with severe obstruction, hyperinflation and upper lobe (UL)-predominant emphysema with 609 bronchial valves placed bilaterally into ULs. RESULTS: Valves were placed in desired airways with 99.7% technical success and no migration or erosion. There were no procedure-related deaths and 30-day morbidity and mortality were 5.5 and 1.1%, respectively. Pneumothorax was the most frequent serious device-related complication and primarily occurred when all segments of a lobe, especially the left UL, were occluded. Highly significant health-related quality of life (HRQL) improvement (-8.2 +/- 16.2, mean +/- SD change at 6 months) was observed. HRQL improvement was associated with a decreased volume (mean -294 +/- 427 ml, p = 0.007) in the treated lobes without visible atelectasis. FEV(1), exercise tests, and total lung volume were not changed but there was a proportional shift, a redirection of inspired volume to the untreated lobes. Combined with perfusion scan changes, this suggests that there is improved ventilation and perfusion matching in non-UL lung parenchyma. CONCLUSION: Bronchial valve treatment of emphysema has multiple mechanisms of action and acceptable safety, and significantly improves quality of life for the majority of patients.

Risk of bleeding in patients undergoing pulmonary procedures on antiplatelet or anticoagulants: A systematic review.

As many as 25% of all patients undergoing invasive pulmonary procedures are receiving at least one antiplatelet or anticoagulant agent. For those undergoing elective procedures, the decision-making process is uncomplicated and the procedure may be postponed until the antiplatelet or anticoagulant agent may be safely held. However, many invasive pulmonary procedures are semi-elective or emergent in nature in which case a risk-benefit calculation and discussion occur between the provider and patient or surrogate decision-maker. Therefore, it is critical for providers to have an awareness of the risk of bleeding complications with different pulmonary procedures on various antiplatelet and anticoagulant agents. This systematic review summarizes the bleeding complications associated with different pulmonary procedures in patients on various antiplatelet or anticoagulant agents in the literature and reveals a paucity of high-quality evidence across a wide spectrum of pulmonary procedures and antiplatelet or anticoagulant agents. The results of this review can help inform providers of the bleeding risk in these patients to aid in the shared decision-making process and risk vs benefit discussion.

The negative predictive value of spiral computed tomography for the diagnosis of pulmonary embolism in patients with nondiagnostic ventilation-perfusion scans.

BACKGROUND: There is no noninvasive method to rule out pulmonary embolism when the clinical suspicion for pulmonary embolism is high. We did a prospective observational study to determine the negative predictive value of spiral computed tomography (CT) in this situation. METHODS: We performed spiral CT scans of the thorax in consecutive patients with high clinical suspicion of pulmonary embolism with intermediate or low probability ventilation-perfusion scans. Patients with negative or indeterminate spiral CT results had conventional angiography at the discretion of the attending physician. Only patients with positive spiral CT results or positive conventional angiograms were treated. All patients were observed for 6 months for evidence of venous thromboembolic disease. Clinical outcome without treatment or the results of conventional angiography were used as reference standards. False-negative results were defined as a negative spiral CT with a positive conventional angiogram or any diagnosis of venous thromboembolism within 6 months. RESULTS: Among the 103 patients who were studied, spiral CT scans were positive in 22 patients, indeterminate in 10 patients, and negative in 71 patients. Twenty-seven (26%) patients had pulmonary embolism by clinical outcome, including 3 of the 71 patients with negative spiral CT scans and 2 of the 10 patients with indeterminate scans. A negative spiral CT result had a likelihood ratio of 0.12 (95% confidence interval [CI]: 0.04 to 0.35) with a negative predictive value of 96% (95% CI: 88% to 99%). Using conventional angiography only as the reference standard, a negative spiral CT result had a likelihood ratio of 0.08 (95% CI: 0.02 to 0.31) and a negative predictive value of 93% (95% CI: 77% to 98%). CONCLUSIONS: Spiral CT has a high negative predictive value for pulmonary embolism and may replace conventional angiography in the workup of pulmonary embolism. Patients with indeterminate spiral CT results should be considered for conventional angiography.

Primary pulmonary melanoma: case report and literature review.

Primary pulmonary melanoma is a very rare disease, with only 19 cases previously reported in the English language literature. These cases suggest that melanoma can arise in the lung as a primary tumor, probably from residual melanoblasts. Primary pulmonary melanoma is frequently endobronchial and often manifests with symptoms of cough, hemoptysis, and lobar collapse. Aggressive surgical resection, irrespective of lymph node involvement, offers possible long-term survival in some patients. The diagnosis of primary pulmonary melanoma necessitates that both clinical and histologic criteria be fulfilled. Herein diagnostic criteria are proposed, and the diagnostic approach is discussed.

Acute sarcoid myositis with respiratory muscle involvement. Case report and review of the literature.

A 61-year-old woman with a history of sarcoidosis presented with acute sarcoid myositis affecting the respiratory muscles. The patient responded to prednisone therapy with improved pulmonary function test results and resolution of her symptoms. Acute myositis is a rare manifestation of sarcoidosis and should be treated with steroids.

Photodynamic therapy: a case series demonstrating its role in patients receiving mechanical ventilation.

Photodynamic therapy (PDT) has long been used to treat cancers within the tracheobronchial tree. There have been many reports about the use of PDT for the treatment of carcinoma in situ and for obstructive endobronchial lesions. PDT has not been previously reported in patients receiving mechanical ventilation. PDT offers the advantages of a relatively short duration of treatment, a low side effect profile, and relatively low risk when compared to Nd-YAG laser in patients receiving mechanical ventilation. We report the first successful use of PDT to wean patients from mechanical ventilation.

Outpatient pleurodesis of malignant pleural effusions using a small-bore pigtail catheter.

STUDY OBJECTIVE: Patients with symptomatic malignant pleural effusion are usually treated with large-bore chest tube placement and pleurodesis requiring > or = 3 days of hospitalization. We sought to demonstrate the feasibility of ambulatory drainage and sclerosis using a small-bore pigtail catheter in patients with malignant pleural effusions. We reasoned that this approach would improve symptoms and quality of life at a reduced cost. METHODS: A 14F pigtail catheter was percutaneously inserted into the pleural space and connected to a closed gravity-drainage bag system. The patients were instructed in the use of the drainage system and discharged to return for sclerosis with 4 g of talc after the drainage was < 100 mL/24 h. Patients were graded for dyspnea and performances status using the Eastern Cooperative Oncology Group score (ECOG) and baseline and transitional dyspnea index score (BDI-TDI) before tube placement and again at 30 days. Radiographic response was graded as total response, partial response, or failure. Telephone follow-up was initiated when the patient could not return for evaluation. RESULTS: Ten ambulatory women, ages 41 to 79 years, were enrolled. The chest tube was left in place from 1 to 10 days, draining a mean of 2,956 mL (1,685 to 6,050 mL). Only two patients were unable to undergo sclerosis owing to catheter dislodgment and minimal drainage. Six reported symptomatic improvement at 30 days confirmed by TDI and ECOG scores in four of six. One with a prior history of a lobectomy was found to have a chylous pleural effusion and experienced a hydropneumothorax, for which sclerosis was unsuccessful. One died in hospital on day 26 after sclerosis despite radiographic resolution. Of the four patients who had improved dyspnea and functional status by TDI and EGOG scores, radiographic response was complete in three and partial in one. Two of the six were not able to return for follow-up because of weakness but reported improvement by telephone inquiry. CONCLUSION: Ambulatory sclerosis of malignant effusion using a small-bore catheter is a feasible alternative to inpatient sclerosis with a large-bore chest tube, especially in patients with strong preferences for outpatient care.

Failure of dithiothreitol and pronase to reveal a false-positive cryptococcal antigen determination in cerebrospinal fluid.

A patient with squamous cell carcinoma of the lung and a serum rheumatoid factor (RF) of 1:1,280 had a positive cerebrospinal fluid (CSF) latex agglutination test (LAT) for cryptococcal antigen, in culture-negative, India-ink-negative CSF. Pretreatment of the sample of CSF with 2-mercaptoethanol (2-ME) ablated the antigen titer and established the presence of a false-positive LAT, whereas CSF pretreated with dithiothreitol (DTT) and pronase continued to yield a false-positive result. The differing ability of pronase, DTT, and 2-ME to eliminate interfering substances from CSF has not been previously described. Moreover, because RF is unlikely to cross the blood-brain barrier, the authors postulated that malignant disease was responsible for the patient's false-positive LAT in CSF. Hence, the authors report the case to emphasize that false-positive LAT results in CSF are unlikely to be produced by RF and to underscore the benefit of using enzymatic and sulfhydryl-reducing agents when the validity of the initial test results are in doubt. Such a procedure will optimize the chances of accurately identifying false-positive LAT results in CSF.

Independent lung ventilation.

Situations in which independent lung ventilation may be of use include massive hemoptysis, pulmonary alveolar proteinosis, risk of interbronchial aspiration, unilateral lung injury, single lung transplant, and BPF. Any decision to attempt independent lung ventilation should take into consideration the many technical difficulties associated with the procedure. They include difficulties in the placement of DLTs and monitoring tube position, the risk of tube displacement, and the risk of airway trauma. The clinician also must consider the costs in terms of available manpower and resources. Maintaining a patient on independent lung ventilation requires highly skilled nursing care, specialized monitoring devices, and readily available FOB. Even with these limitations, independent lung ventilation may be of use in certain clinical situations when standard methods have failed.

Photodynamic therapy in lung cancer.

Photodynamic therapy (PDT) involves the use of photosensitizing agents that are selectively retained within tumor cells. The agents remain inactive until exposed to light of the proper wavelength. When activated by light, these compounds generate toxic oxygen radicals that result in tumor necrosis. In lung cancer, PDT can be used for both carcinoma in situ and for the treatment of unresectable disease with endobronchial obstruction. For patients with advanced disease, careful patient selection and integration of PDT with other interventional techniques are critical. Limited data suggest that PDT is comparable in efficacy to neodymium-yttrium-aluminum garnet (Nd-YAG) laser therapy, and some evidence indicates that it may be superior in terms of duration of response. For PDT to be used effectively, it should be integrated into a multimodality approach with chemotherapy and radiation. The optimal sequencing of these treatment modalities remains an area for further investigation.

Conservative bladder management in advanced multiple sclerosis.

Anticholinergics and intermittent catheterization are the cornerstones of bladder management in early multiple sclerosis (MS). In advanced MS however, bladder management is based more on tradition than on evidence. Nurses seem to deal with catheter problems and chronic incontinence. Despite the abundant use of indwelling catheters, there is a lack for guidelines on catheter-induced problems. The psychosexual and social impact of bladder problems in advanced MS is often neglected. The international multidisciplinary special interest group on sexual, urological and bowel dysfunction in MS (SUBDIMS) as a special interest group of the Rehabilitation in Multiple Sclerosis (RIMS) was confronted with a high variability in practice and a lack of guidelines. A literature review was prepared during three multidisciplinary expert meetings. This review will be the basis of further initiatives to improve the urological treatment of patients with advanced MS.

The 'right' not to know.

There is a common view in medical ethics that the patient's right to be informed entails, as well, a correlative right not to be informed, i.e., to waive one's right to information. This paper argues, from a consideration of the concept of autonomy as the foundation for rights, that there can be no such 'right' to refuse relevant information, and that the claims for such a right are inconsistent with both deontological and utilitarian ethics. Further, the right to be informed is shown to be a mandatory right (though not a welfare right); persons are thus seen to have both a right and a duty to be informed. Finally, the consequences of this view are addressed: since the way in which we conceptualize our problems tends to determine the actions we take to resolve them, it is important properly to conceptualize patients' requests not to be informed. There may be many reasons for acting in accord with such a request, but it is a mistake to conceptualize one's act as 'respecting a right possessed by persons'.

KIE: The author rejects, as inconsistent with ethical theory, the view that a patient's right to be informed entails a correlative right to waive this right. He argues that informed consent is a mandatory right of an autonomous agent which carries with it the obligation to be exercised. Ost concludes that a physician who withholds information out of compassion is acting humanely, but that a humanistic value orientation requires that the physician do what he can to help the patient make autonomous decisions.

Non-calcium environmental sensitivity of intracellular Indo-1.

Several mechanisms might account for the difference between spectra of Indo-1 measured on intracellular and on extracellular dye. Experiments to discriminate between various possibilities used quantitative analyses of intracellular and extracellular Indo-1 spectra. Intracellular calcium-free dye showed a 20-nm blue shift, when compared with the extracellular case. However, the calcium-bound spectrum was unaffected by the intracellular milieu. This eliminated the possibility that the spectral shift was due to calcium-independent unhydrolyzed dye. The spectral shift was reversible and was seen in resting cells as well as calcium-depleted cells. Since the apparent dissociation constant for calcium was not detectably different inside the cell, the possibility of competitive binding to another divalent cation, such as Zn2+, was eliminated as the principle source of the spectral shift. The shift appears to be due to a noncompetitive solvent effect on the emission of the calcium-free dye that is absent in the calcium-bound form.

Assessment of a bronchoscopy simulator.

The study objective was to validate a flexible bronchoscopy simulator by determining if it could differentiate between expert and novice bronchoscopists. A subsequent evaluation phase was then done to determine whether use of the simulator would improve the rate of bronchoscopy skill acquisition for new pulmonary fellows. A multicenter prospective cohort study was performed using a bronchoscopy simulator. Three cohorts were evaluated based on the number of bronchoscopies previously performed: "experts" (> 500, n = 9), "intermediates" (25 to 500, n = 8), and "novices" (none, n = 11). Each participant performed two simulated cases with performance measures being recorded by the simulator. Performance measures that distinguished between groups were then used to evaluate the learning curve for new fellows training on the simulator. A randomized-controlled trial was then conducted comparing the quality of bronchoscopy performance for new pulmonary fellows who were trained either with conventional methods or with the simulator. Expert bronchoscopists performed better on the simulator than intermediates who performed better than novices in terms of procedure time, percentage of segments visualized, time in red-out, and wall collisions. Training of new fellows demonstrated that after performing 20 bronchoscopic simulations, the skill level acquired with the simulator significantly improved in terms of speed, percentage of segments visualized, time in red-out, and collisions. Fellows trained on the simulator performed better than fellows trained using conventional methods during their first actual bronchoscopies as assessed by procedure time (815 versus 1,168 s, p = 0.001), a bronchoscopy nurse's subjective quality assessment score (7.7 +/- 0.3 versus 3.7 +/- 2.5, p = 0.05), and by a quantitative bronchoscopy quality score (percentage of segments correctly identified/procedure time, 0.119 +/- 0.015 versus 0.046 +/- 034, p = 0.03). In conclusion, the bronchoscopy simulator was able to accurately assess bronchoscopy experience level. Training new fellows on the bronchoscopy simulator leads to more rapid acquisition of bronchoscopy expertise compared with conventional training methods. This technology has the potential to facilitate bronchoscopy training and to improve objective evaluations of bronchoscopy skills.