ES19.03 RCT's on Malignant Pleural Effusion Talc Pleurodesis Managment

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This talk will focus on 2 recently completed multicentre RCT's in talc pleurodesis for malignant pleural effusions; IPC plus trial (NEJM 2018) and the TAPPS trial (in submission). A summary of these 2 trials is below: IPC Plus - Methods: Over a period of 4 years, we recruited patients with malignant pleural effusion at 18 centers in the United Kingdom. After the insertion of an indwelling pleural catheter, patients underwent drainage regularly on an outpatient basis. If there was no evi- dence of substantial lung entrapment (nonexpandable lung, in which lung expansion and pleural apposition are not possible because of visceral fibrosis or bronchial ob- struction) at 10 days, patients were randomly assigned to receive either 4 g of talc slurry or placebo through the indwelling pleural catheter on an outpatient basis. Talc or placebo was administered on a single-blind basis. Follow-up lasted for 70 days. The primary outcome was successful pleurodesis at day 35 after randomization. Results: The target of 154 patients undergoing randomization was reached after 584 patients were approached. At day 35, a total of 30 of 69 patients (43%) in the talc group had successful pleurodesis, as compared with 16 of 70 (23%) in the placebo group (hazard ratio, 2.20; 95% confidence interval, 1.23 to 3.92; P=0.008). No significant be- tween-group differences in effusion size and complexity, number of inpatient days, mortality, or number of adverse events were identified. No significant excess of blockages of the indwelling pleural catheter was noted in the talc group. Conclusions: Among patients without substantial lung entrapment, the outpatient administration of talc through an indwelling pleural catheter for the treatment of malignant pleural effusion resulted in a significantly higher chance of pleurodesis at 35 days than an indwelling catheter alone, with no deleterious effects. (Funded by Becton Dickinson; EudraCT number, 2012-000599-40.) TAPPS - Methods We recruited patients with malignant pleural effusion from 17 United Kingdom hospitals over 5 years. On an open-label basis, patients were randomly assigned to receive either 4g talc poudrage at thoracoscopy under conscious sedation, or chest tube insertion under local anesthetic followed by 4g talc slurry. Follow-up lasted for six months. The primary outcome was pleurodesis failure rate three months after randomization, defined as the need for further pleural intervention during follow-up. Secondary outcomes including mortality and cost-effectiveness were also assessed. Results The target of 330 patients was reached after 583 were approached. At three months, pleurodesis failure rate was 36/161 (22%) with poudrage and 38/159 (24%) with slurry (adjusted odds ratio (OR) 0.91, 95% confidence interval (CI) 0.54-1.55, p=0.74). No statistically significant differences were noted in any secondary outcome. Numbers of adverse events were similar between groups. Using a standard threshold, poudrage had a 36% probability of being cost-effective. Conclusions In patients with malignant pleural effusion, there appears to be no additional clinical or cost-effectiveness benefit to choosing talc poudrage at physician-led thoracoscopy over talc slurry through chest tube. (Funded by the United Kingdom National Institute for Health Research). Pleural effusion, Talc pleurodesis, Malignant pleural effusion