Dataset Information

Quality of life in patients with malignant pleural effusion treated with an indwelling pleural catheter in an emerging country.

ABSTRACT:

Background

The use of Indwelling Pleural Catheter (IPC) in the care of patients with Malignant Pleural Effusion (MPE) is well established, however studies involving public health systems of low and middle-income countries are still lacking. This study aimed to determine the effect of IPC on the respiratory symptoms and Quality of Life (QoL) of patients with MPE in the setting of a Brazilian public health system.

Methods

From August 2015 to November 2019, patients with MPE underwent IPC placement and were prospectively followed. QoL and respiratory symptoms were assessed by the EORTC questionnaires (QLQ-30; LC13) and Visual Analogue Scale (VAS), respectively, at pre-treatment, 30 , and 60 days after IPC placement.

Results

56 patients were enrolled with 57 catheters inserted. The mean age was 63 (23‒88) years, of which 17 (30%) were men and 39 (70%) were women. Breast 24 (42%) and lung 21 (37%) were the main primary neoplasms. Cellulitis was the most common complication and all patients recovered with appropriate antimicrobial therapy. QoL did not change significantly over time, however, the VAS showed a significant improvement in dyspnea (+1.2: -0.5; p = 0.001).

Conclusion

IPC relieves respiratory symptoms without compromising the QoL, with a low complication rate. It represents a suitable option for patients with MPE and short LE in an emerging country.

SUBMITTER: Lauricella LL

PROVIDER: S-EPMC9214818 | biostudies-literature | 2022

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Quality of life in patients with malignant pleural effusion treated with an indwelling pleural catheter in an emerging country.

Lauricella Leticia Leone LL D'Ambrosio Paula Duarte PD Costa Priscila Berenice da PBD Augusto Marcia Cristina MC Pêgo-Fernandes Paulo Manuel PM Terra Ricardo Mingarini RM

Clinics (Sao Paulo, Brazil) 20220618

<h4>Background</h4>The use of Indwelling Pleural Catheter (IPC) in the care of patients with Malignant Pleural Effusion (MPE) is well established, however studies involving public health systems of low and middle-income countries are still lacking. This study aimed to determine the effect of IPC on the respiratory symptoms and Quality of Life (QoL) of patients with MPE in the setting of a Brazilian public health system.<h4>Methods</h4>From August 2015 to November 2019, patients with MPE underwen ...[more]

PMID: 35728443

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Project description:BackgroundSeveral studies have indicated that intrapleural infusion of bevacizumab is an effective treatment for non-small cell lung cancer (NSCLC) with malignant pleural effusion (MPE). However, the impact of bevacizumab administered through an indwelling pleural catheter (IPC) on the prognosis of these patients is unknown.MethodsConsecutive advanced NSCLC patients with symptomatic MPE receiving an IPC alone or bevacizumab through an IPC were identified in a tertiary hospital. The patient characteristics and clinical outcomes were collected.ResultsA total of 149 patients were included, and the median age was 60.3 years. Males and nonsmokers accounted for 48.3% and 65.8%, respectively. A total of 69.8% (104/149) of patients harbored actionable mutations, including 92 EGFR-activating mutations, 11 ALK fusions, and 1 ROS1 fusion. A total of 81.9% (122/149) of patients received IPC alone, and 18.1% (27/149) received bevacizumab through an IPC. The incidence of spontaneous pleurodesis during the first 6 months was greater in the bevacizumab-treated group than in the IPC-treated group in the subgroup with actionable mutations (64.3% vs. 46.9%, P = 0.28). The median overall survival (OS) in patients with actionable mutations treated with bevacizumab through an IPC was 42.2 months, which was significantly longer than the 26.7 months in patients who received an IPC alone (P = 0.045). However, the median OS did not differ between the two arms in the subgroup without actionable mutations (10.8 vs. 41.0 months, P = 0.24). No significant difference between the bevacizumab through an IPC group and the IPC group was detected in the number of participants who had adverse events, either in patients with actionable mutations (14.3% vs. 8.4%; P = 0.42) or in patients without actionable mutations (16.7% vs. 12.8%; P = 1.00).ConclusionsBevacizumab through an IPC resulted in a significantly improved prognosis for NSCLC patients with MPE and actionable mutations. However, patients without actionable mutations do not benefit from bevacizumab through IPC.

Project description:Malignant pleural effusion can complicate most cancers. It causes breathlessness and requires hospitalisation for invasive pleural drainages. Malignant effusions often herald advanced cancers and limited prognosis. Minimising time spent in hospital is of high priority to patients and their families. Various treatment strategies exist for the management of malignant effusions, though there is no consensus governing the best choice. Talc pleurodesis is the conventional management but requires hospitalisation (and substantial healthcare resources), can cause significant side effects, and has a suboptimal success rate. Indwelling pleural catheters (IPCs) allow ambulatory fluid drainage without hospitalisation, and are increasingly employed for management of malignant effusions. Previous studies have only investigated the length of hospital care immediately related to IPC insertion. Whether IPC management reduces time spent in hospital in the patients' remaining lifespan is unknown. A strategy of malignant effusion management that reduces hospital admission days will allow patients to spend more time outside hospital, reduce costs and save healthcare resources.The Australasian Malignant Pleural Effusion (AMPLE) trial is a multicentred, randomised trial designed to compare IPC with talc pleurodesis for the management of malignant pleural effusion. This study will randomise 146 adults with malignant pleural effusions (1:1) to IPC management or talc slurry pleurodesis. The primary end point is the total number of days spent in hospital (for any admissions) from treatment procedure to death or end of study follow-up. Secondary end points include hospital days specific to pleural effusion management, adverse events, self-reported symptom and quality-of-life scores.The Sir Charles Gairdner Group Human Research Ethics Committee has approved the study as have the ethics boards of all the participating hospitals. The trial results will be published in peer-reviewed journals and presented at scientific conferences.Australia New Zealand Clinical Trials Registry-ACTRN12611000567921; National Institutes of Health-NCT02045121.

Project description:IntroductionMalignant pleural effusions (MPEs) are common. MPE causes significant breathlessness and impairs quality of life. Indwelling pleural catheters (IPC) allow ambulatory drainage and reduce hospital days and re-intervention rates when compared to standard talc slurry pleurodesis. Daily drainage accelerates pleurodesis, and talc instillation via the IPC has been proven feasible and safe. Surgical pleurodesis via video-assisted thoracoscopic surgery (VATS) is considered a one-off intervention for MPE and is often recommended to patients who are fit for surgery. The AMPLE-3 trial is the first randomised trial to compare IPC (±talc pleurodesis) and VATS pleurodesis in those who are fit for surgery.Methods and analysisA multi-centre, open-labelled randomised trial of patients with symptomatic MPE, expected survival of ≥ 6 months and good performance status randomised 1:1 to either IPC or VATS pleurodesis. Participant randomisation will be minimised for (i) cancer type (mesothelioma vs non-mesothelioma); (ii) previous pleurodesis (vs not); and (iii) trapped lung, if known (vs not). Primary outcome is the need for further ipsilateral pleural interventions over 12 months or until death, if sooner. Secondary outcomes include days in hospital, quality of life (QoL) measures, physical activity levels, safety profile, health economics, adverse events, and survival. The trial will recruit 158 participants who will be followed up for 12 months.Ethics and disseminationSir Charles Gairdner and Osborne Park Health Care Group (HREC) has approved the study (reference: RGS356). Results will be published in peer-reviewed journals and presented at scientific meetings.DiscussionBoth IPC and VATS are commonly used procedures for MPE. The AMPLE-3 trial will provide data to help define the merits and shortcomings of these procedures and inform future clinical care algorithms.Trial registrationAustralia New Zealand Clinical Trial Registry ACTRN12618001013257 . Registered on 18 June 2018.Protocol versionVersion 3.00/4.02.19.

Project description:ImportanceIndwelling pleural catheter and talc pleurodesis are established treatments for malignant pleural effusions among patients with poor prognosis.ObjectiveTo determine whether indwelling pleural catheters are more effective than talc pleurodesis in reducing total hospitalization days in the remaining lifespan of patients with malignant pleural effusion.Design, setting, and participantsThis open-label, randomized clinical trial included participants recruited from 9 centers in Australia, New Zealand, Singapore, and Hong Kong between July 2012 and October 2014; they were followed up for 12 months (study end date: October 16, 2015). Patients (n = 146) with symptomatic malignant pleural effusion who had not undergone indwelling pleural catheter or pleurodesis treatment were included.InterventionsParticipants were randomized (1:1) to indwelling pleural catheter (n = 74) or talc pleurodesis (n = 72), minimized by malignancy (mesothelioma vs others) and trapped lung (vs not), and stratified by region (Australia vs Asia).Main outcomes and measuresThe primary end point was the total number of days spent in hospital from procedure to death or to 12 months. Secondary outcomes included further pleural interventions, patient-reported breathlessness, quality-of-life measures, and adverse events.ResultsAmong the 146 patients who were randomized (median age, 70.5 years; 56.2% male), 2 withdrew before receiving the randomized intervention and were excluded. The indwelling pleural catheter group spent significantly fewer days in hospital than the pleurodesis group (median, 10.0 [interquartile range [IQR], 3-17] vs 12.0 [IQR, 7-21] days; P = .03; Hodges-Lehmann estimate of difference, 2.92 days; 95% CI, 0.43-5.84). The reduction was mainly in effusion-related hospitalization days (median, 1.0 [IQR, 1-3] day with the indwelling pleural catheter vs 4.0 (IQR, 3-6) days with pleurodesis; P < .001; Hodges-Lehmann estimate, 2.06 days; 95% CI, 1.53-2.58). Fewer patients randomized to indwelling pleural catheter required further ipsilateral invasive pleural drainages (4.1% vs 22.5%; difference, 18.4%; 95% CI, 7.7%-29.2%). There were no significant differences in improvements in breathlessness or quality of life offered by indwelling pleural catheter or talc pleurodesis. Adverse events were seen in 22 patients in the indwelling pleural catheter group (30 events) and 13 patients in the pleurodesis group (18 events).Conclusions and relevanceAmong patients with malignant pleural effusion, treatment with an indwelling pleural catheter vs talc pleurodesis resulted in fewer hospitalization days from treatment to death, but the magnitude of the difference is of uncertain clinical importance. These findings may help inform patient choice of management for pleural effusion.Trial registrationanzctr.org.au Identifier: ACTRN12611000567921.

Dataset Information

Quality of life in patients with malignant pleural effusion treated with an indwelling pleural catheter in an emerging country.

Background

Methods

Results

Conclusion

Publications

Quality of life in patients with malignant pleural effusion treated with an indwelling pleural catheter in an emerging country.

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