In last week’s issue of The New England Journal of Medicine, Rahul Bhatnagar, from the University of Bristol in the UK, and colleagues reported their data on the use of outpatient talc pleurodesis via an indwelling tunneled pleural catheter, also known as the IPC-Plus trial. Their group is to be congratulated on this trial, another prospective, randomized trial on questions related to the management of malignant pleural disease, offering great insight into how to deal with this horrible disease.
They successfully designed and performed a multicenter, single-blind, randomized trial, run in multiple institutions throughout the UK, looking at the impact of talc on pleurodesis rates in patients with expandable lung undergoing indwelling tunneled pleural catheter placement. Within their trial, those undergoing talc pleurodesis had a higher rate of successful pleurodesis at 35 days (primary endpoint) and at 70 days (secondary endpoint). Hazard ratios for both endpoints were greater than two, suggesting that those undergoing talc pleurodesis through an indwelling tunneled pleural catheter will experience twice the rate of pleurodesis as opposed to those not receiving talc. They also demonstrated that quality of life and symptoms scores were significantly better in the talc group, and they even report a trend towards improved survival within the talc group.
The strengths of this study include its blinded randomization, multicenter design involving numerous types of UK facilities, and its objective outcome of pleurodesis rates. The limitations include the rather short follow-up time of only 70 days, the inclusion of only patients with expandable lung, inclusion of less than one-fifth of the initially assessed patients, and the use of as-needed pleural drainage.
I suspect this study may lead to increased fervor for the use of talc in this population, something many of us have been shying away from in light of the need for hospitalization and reported adverse event rates associated with talc use. One of the biggest takeaways from this trial appears to be the demonstration of a fairly acceptable safety profile of outpatient talc administration via indwelling tunneled pleural catheters. Based on the adverse events reported in the trial, it appears that fears of catheter blockage, significant loculation, pain, and catheter malfunction are likely unfounded.
Unfortunately, the ultimate outcome for malignant pleural effusion trials has often been pleurodesis rate. I do applaud the authors for their trial design, including the inclusion of more “subjective” endpoints such as pain, dyspnea, and quality of life scores. Many have advocated for pleurodesis in this patient population, as the presence of having a catheter must be a burden and a risk, with not entirely clear data to support such a paternalistic claim. Ultimately, caring for this patient population must focus on palliation of symptoms, how one gets there may vary, but it must remain the ultimate focus for this oftentimes debilitating disease.