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Quality-adjusted survival following treatment of malignant pleural effusions with indwelling pleural catheters.

ABSTRACT: Malignant pleural effusions (MPEs) are a frequent cause of dyspnea in patients with cancer. Although indwelling pleural catheters (IPCs) have been used since 1997, there are no studies of quality-adjusted survival following IPC placement.With a standardized algorithm, this prospective observational cohort study of patients with MPE treated with IPCs assessed global health-related quality of life using the SF-6D to calculate utilities. Quality-adjusted life days (QALDs) were calculated by integrating utilities over time.A total of 266 patients were enrolled. Median quality-adjusted survival was 95.1 QALDs. Dyspnea improved significantly following IPC placement (P < .001), but utility increased only modestly. Patients who had chemotherapy or radiation after IPC placement (P < .001) and those who were more short of breath at baseline (P = .005) had greater improvements in utility. In a competing risk model, the 1-year cumulative incidence of events was death with IPC in place, 35.7%; IPC removal due to decreased drainage, 51.9%; and IPC removal due to complications, 7.3%. Recurrent MPE requiring repeat intervention occurred in 14% of patients whose IPC was removed. Recurrence was more common when IPC removal was due to complications (P = .04) or malfunction (P < .001) rather than to decreased drainage.IPC placement has significant beneficial effects in selected patient populations. The determinants of quality-adjusted survival in patients with MPE are complex. Although dyspnea is one of them, receiving treatment after IPC placement is also important. Future research should use patient-centered outcomes in addition to time-to-event analysis.ClinicalTrials.gov; No.: NCT01117740; URL: www.clinicaltrials.gov.

SUBMITTER: Ost DE

PROVIDER: S-EPMC4694176 | biostudies-literature | 2014 Jun

REPOSITORIES: biostudies-literature

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Quality-adjusted survival following treatment of malignant pleural effusions with indwelling pleural catheters.

Ost David E DE Jimenez Carlos A CA Lei Xiudong X Cantor Scott B SB Grosu Horiana B HB Lazarus Donald R DR Faiz Saadia A SA Bashoura Lara L Shannon Vickie R VR Balachandran Dave D Noor Lailla L Hashmi Yousra B YB Casal Roberto F RF Morice Rodolfo C RC Eapen George A GA

Chest 20140601 6

<h4>Background</h4>Malignant pleural effusions (MPEs) are a frequent cause of dyspnea in patients with cancer. Although indwelling pleural catheters (IPCs) have been used since 1997, there are no studies of quality-adjusted survival following IPC placement.<h4>Methods</h4>With a standardized algorithm, this prospective observational cohort study of patients with MPE treated with IPCs assessed global health-related quality of life using the SF-6D to calculate utilities. Quality-adjusted life days ...[more]

PMID: 24480929

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Project description:BackgroundMalignant pleural effusion (MPE) is a debilitating condition as it commonly causes disabling breathlessness and impairs quality of life (QoL). Indwelling pleural catheter (IPC) offers an effective alternative for the management of MPE. However, IPC-related infections remain a significant concern and there are currently no long-term strategies for their prevention. The Australasian Malignant PLeural Effusion (AMPLE)-4 trial is a multicentre randomised trial that evaluates the use of topical mupirocin prophylaxis (vs no mupirocin) to reduce catheter-related infections in patients with MPE treated with an IPC.MethodsA pragmatic, multi-centre, open-labelled, randomised trial. Eligible patients with MPE and an IPC will be randomised 1:1 to either regular topical mupirocin prophylaxis or no mupirocin (standard care). For the interventional arm, topical mupirocin will be applied around the IPC exit-site after each drainage, at least twice weekly. Weekly follow-up via phone calls or in person will be conducted for up to 6 months. The primary outcome is the percentage of patients who develop an IPC-related (pleural, skin, or tract) infection between the time of catheter insertion and end of follow-up period. Secondary outcomes include analyses of infection (types and episodes), hospitalisation days, health economics, adverse events, and survival. Subject to interim analyses, the trial will recruit up to 418 participants.DiscussionResults from this trial will determine the efficacy of mupirocin prophylaxis in patients who require IPC for MPE. It will provide data on infection rates, microbiology, and potentially infection pathways associated with IPC-related infections.Ethics and disseminationSir Charles Gairdner and Osborne Park Health Care Group Human Research Ethics Committee has approved the study (RGS0000005920). Results will be published in peer-reviewed journals and presented at scientific conferences.Trial registrationAustralia New Zealand Clinical Trial Registry ACTRN12623000253606. Registered on 9 March 2023.

Project description:RationalePlacement of an indwelling pleural catheter is an established modality for symptom relief and pleurodesis in the treatment of malignant pleural effusion. Concerns remain regarding possible infectious complications, risk of hemorrhage, and the rate of pleurodesis with the use of pleural catheters in the treatment of hematologic malignancies.ObjectivesThe goals of our study were: (1) to evaluate the safety and cumulative incidence of pleurodesis with indwelling pleural catheters for patients with hematologic malignancies, and (2) to evaluate overall survival of this cohort of patients with pleural effusions.MethodsWe performed a retrospective review of 172 patients with a hematologic malignancy who underwent placement of an indwelling pleural catheter between September 1997 and August 2011 at the University of Texas MD Anderson Cancer Center in Houston, Texas. A competing risk model analysis was used for complications and pleurodesis. Analysis was based on each patient's first intrapleural catheter.ResultsThere were 172 patients with lymphoma (58%), acute (16%) or chronic leukemia (16%), or multiple myeloma (10%). The effusions were characterized as malignant (85.5%), infectious (4.1%), volume overload (4.7%), or therapy-related (4.7%). Chylothorax was found in 20.1%. Pleural biopsies were obtained from 13 patients. The cumulative incidence of all complications was 13.6%, and the cumulative incidence of all significant catheter-related complications was 9.5%. The incidence of empyema was 2.9%, and major bleeding (requiring transfusion or intervention) was 1.7%. Thirty-day procedure-associated mortality was 0.6%. The cumulative incidence of pleurodesis at 180 days was 50%, with a median time to pleurodesis of 81 days for the entire cohort.ConclusionsIndwelling pleural catheters appear to be safe for patients with hematologic malignancies. Complications and the cumulative incidence of pleurodesis are comparable to those reported for patients with solid organ malignancies.

Dataset Information

Quality-adjusted survival following treatment of malignant pleural effusions with indwelling pleural catheters.

Publications

Quality-adjusted survival following treatment of malignant pleural effusions with indwelling pleural catheters.

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