A randomized, phase III, double-blind, placebo-controlled trial of intrapleural instillation of methylprednisolone acetate in the management of malignant pleural effusion.
OBJECTIVE
To determine if intrapleural administration of methylprednisolone acetate (MA) after therapeutic thoracentesis for symptomatic malignant pleural effusion improved time to repeat thoracentesis for symptom control, quality of life (QOL), and dyspnea.


METHODS
Double-blind, randomized, placebo-controlled trial.


METHODS
A tertiary care cancer treatment center in Edmonton, AB, Canada.


METHODS
Patients with symptomatic pleural effusions secondary to disseminated malignancy requiring therapeutic thoracentesis for symptom control.


METHODS
Sixty-seven patients underwent ultrasound-guided therapeutic thoracentesis for management of symptomatic malignant pleural effusion. Patients were randomly and blindly assigned to either 160 mg (8 mL) of MA or 8 mL of saline solution instilled into the pleural space. Patients were followed up for 6 weeks to determine the time to repeat therapeutic thoracentesis. All patients completed the Functional Assessment of Cancer Therapy-General (FACT-G) QOL questionnaire and a dyspnea visual analog scale (VAS) at baseline and again 2 weeks later.


RESULTS
Thirty-three patients received MA, and 34 patients received placebo; baseline characteristics for the two groups were similar, apart from a slightly higher use of concurrent systemic therapy in the placebo group. At 6 weeks follow-up, 50% of MA-treated patients required repeat thoracentesis compared to 56% of placebo-treated patients (not significant [NS]). The mean of the individual FACT-G change scores (2 weeks - baseline) was similar in the two groups (NS). VAS scores improved for both groups over the 2-week period, but the mean change scores (2 weeks - baseline) were not statistically different.


CONCLUSIONS
Despite previous case series describing benefit from intrapleural MA in malignant pleural effusion, this controlled study of intrapleural MA instillation did not delay reaccumulation of symptomatic pleural effusion compared to placebo, nor were differences in QOL or dyspnea observed.
North
Scott A
SA
Department of Oncology, University of Alberta, Edmonton, Canada. scottnor@cancerboard.ab.ca
Au
Heather-Jane
HJ
Halls
Steven B
SB
Tkachuk
Linda
L
Mackey
John R
JR
D000893:Anti-Inflammatory Agents / Q000008:administration & dosage*; D001943:Breast Neoplasms / Q000150:complications; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007322:Instillation, Drug; D008297:Male; D008775:Methylprednisolone / Q000008:administration & dosage* / Q000031:analogs & derivatives*; D000077555:Methylprednisolone Acetate; D008875:Middle Aged; D019152:Paracentesis / Q000379:methods*; D016066:Pleural Effusion, Malignant / Q000188:drug therapy* / Q000209:etiology; D011788:Quality of Life; D012008:Recurrence
D000893:Anti-Inflammatory Agents; D000077555:Methylprednisolone Acetate; D008775:Methylprednisolone