PURPOSE: To evaluate if the addition of intrapleural doxycycline via a PleurX® catheter improves the success of pleurodesis compared to PleurX® catheter alone in the treatment of malignant pleural effusions.
METHODS: This is a randomized, prospective, double-blinded, placebo-controlled single-center clinical trial. Patients are assigned to receive either PleurX® catheter plus placebo (50 cc saline) or PleurX® plus intrapleural injection of 500mg Doxycycline (in 50 cc saline) at the time of catheter insertion. The injection of either placebo or doxycycline is performed after the evacuation of the pleural effusion. The primary endpoints to the study are successful pleurodesis with removal of the catheter or death.
RESULTS: To date, a total of 20 patients met inclusion criteria. Of the 17 that agreed to enroll in the study, 3 were excluded. The primary malignancies were 5 lung cancer, 3 adenocarcinoma with unknown primary, 2 breast cancer, 1 colon cancer, 1 parotid gland cancer, 2 lymphoma/leukemia. 10/14 (79%) have already reached one of the study's primary endpoints. 7/10 (70%) received intrapleural doxycycline, with 3/7 (43%) achieving pleurodesis and having the PleurX® removed with an average length of catheter duration of 33 days, and 4/7 (57%) died prior to achieving pleurodesis with an average length of duration of 19.25 days. 3/10 (30%) received placebo, with 2/3 (67%) achieving pleurodesis and having the PleurX® removed with an average length of duration of 25 days, and 1/3 (33%) died prior to achieving pleurodesis with a length of duration of 151 days.
CONCLUSION: Preliminary results of this study suggest that there may be no advantage to using intrapleural doxycycline after insertion of the PleurX® catheter. However, a larger number of patients will be needed and are still being enrolled.
CLINICAL IMPLICATIONS: The use of intrapleural sclerosing agents in the management of malignant effusions has been well studied. However, there are no randomized-controlled studies looking at their use with the PleurX® catheter and whether it improves pleurodesis rates.
DISCLOSURE: Christopher Wyckoff, No Financial Disclosure Information; No Product/Research Disclosure Information