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• W1956749841 abstract "Research papers addressing relevant and complex clinical problems are rare to find. It is therefore no mean feat that the present issue of Respirology contains two original research papers focused on pleurodesis for malignant pleural effusion. Both papers evaluate iodopovidone as a pleurodesis agent: Andrade Neto and co-workers1 report a retrospective analysis of iodopovidone efficacy in clinical practice whereas Guo and co-workers2 performed an animal-based prospective study comparing the efficacy of iodopovidone with that of doxycycline. In combination these papers are complementary and warrant a critical appraisal of the current state of clinical research in malignant pleural effusion. Symptomatic pleural effusions are not infrequently seen in clinical practice. This problem will occur in almost all patients with mesothelioma, in 50% of patients with breast cancer, in 25% of patients with lung cancer and in a minority of patients with numerous other malignancies.3 Some effusions do not become symptomatic, and some can be ameliorated with chemo- or radiotherapy aimed at the underlying disease. Most patients, however, will require a palliative local intervention to remove fluid and prevent its re-accumulation. Ideally, this process will permanently alleviate shortness of breath, cough and pain associated with the presence of tumour and fluid in the pleural space. A therapeutic thoracentesis is an essential initial intervention. Symptomatic relief upon fluid drainage and complete expansion of the atelectatic lung identify good candidates for some form of pleurodesis, particularly in patients with a reasonable life expectancy. The most frequently used method consists of intercostal catheter placement, drainage of pleural fluid and instillation of a sclerosing agent, but there is poor consensus regarding the best modality of chest catheter pleurodesis.4 Talc is the most commonly used chemical pleurodesis agent today and also the most successful,5 albeit there is only limited data that compare talc with other agents such as bleomycin or tetracycline. The research methodologies used in the few available comparative studies are so heterogeneous that useful comparisons are difficult.6 Talc as a pleurodesis agent has a tainted safety record. Talc as a mined mineral contains variable particle sizes. Preparations containing small talc particles have been linked to adverse events associated with the presence of talc particles in the systemic circulation, causing systemic inflammatory reactions with severe hypoxemia and acute respiratory failure. This has led to considerable controversy and efforts to regulate talc preparations similar to any other biologically active substance (as opposed to a medical device).7 There is not only a need to identify the ideal pleurodesis agents, but also to standardize and optimize research tools to evaluate pleurodesis success in malignant effusions. To this end it is worthwhile scrutinizing the methodology utilized in the papers presented in this issue, and how they attempt to create preclinical and clinical evidence for the evaluation of the incumbent pleurodesis agent iodopovidone. The paper by Guo and co-workers2 is an exemplary preclinical study which demonstrates on a proven rabbit model that the desired outcome of pleurodesis can be achieved without prohibitive toxicity with a range of dosages applicable to humans. The hard end point of histologically identified pleural fibrosis is used to investigate a dose–response relationship, to measure the potency of the agent against a positive control and to elegantly provide evidence about the mode of action. The study by Andrade Neto and co-workers1 is a retrospective study of iodopovidone as a pleurodesis agent in humans with malignant pleural effusion. It is clear that the choice of end point must be different in humans because harvesting tissue to obtain histological evidence of pleural symphysis would be inappropriate in humans. It is often overlooked that the next best surrogate outcomes such as lung function testing or radiological improvement are of limited value for evaluating a palliative procedure. What makes pleurodesis a successful clinical intervention is not entirely clear, but complete lung expansion after pleurodesis has been shown not to correlate with quality of life, the preservation of which is the main goal of palliation.8 The main end point used by Andrade Neto and co-workers1 was pragmatic and entirely clinical. If a patient did not need a repeat ipsilateral pleural intervention following chest tube pleurodesis, the outcome was regarded as successful. From the patient's perspective, this represents the desired outcome which validates the end point as clinically relevant. While this choice of main outcome is commendable and may be adopted for such trials in general, it is clear that studies of pleurodesis agents in humans should be done in prospective fashion. A prospective design is superior in addressing safety concerns and standardizing clinical end points. It is unfortunate that iodopovidone as a pleurodesis agent has been anecdotally linked to serious adverse events, a record not unlike to talc. Ocular toxicity was reported in three cases where iodopovidone was used, albeit in much higher dosage than in the study by Andrade Neto and co-workers.1, 9 Only meticulous prospective recording of adverse events, coupled with serial blood sampling to exclude the presence of the pleurodesis agent in the systemic circulation in at least a subset of patients could be considered vigorous enough to restore the safety record of iodopovidone as a pleurodesis agent. Such clinical studies require a considerable amount of funding, expertise, planning and also sufficient patient numbers. Continuing research into pleurodesis for malignant pleural effusion therefore calls for the establishment of multicentre collaborative pleural research networks that operate according to standard protocols. Only such collaborations can provide scientifically sound prospective studies within a reasonable time frame and advance the field towards a universally acceptable and safe procedure for pleurodesis in malignant pleural effusions." @default.
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• W1956749841 date "2010-01-01" @default.
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• W1956749841 title "Iodopovidone as a pleurodesis agent: Setting standards for clinical pleural research" @default.
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• W1956749841 doi "https://doi.org/10.1111/j.1440-1843.2009.01654.x" @default.
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