contemplation objectives: To determine if intrapleural administration of methylprednisolone acetate (MA) after therapeutic thoracentesis for symptomatic malignant pleural effusion improved time to repeat thoracentesis for symptom command quality of life (QOL).

contemplation objectives: To determine if intrapleural administration of methylprednisolone acetate (MA) after therapeutic thoracentesis for symptomatic malignant pleural effusion improved time to repeat thoracentesis for symptom command quality of life (QOL), and dyspnea.

Design: Double-blind, randomized, placebo-controlled trial.

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

Patient selection: Patients with symptomatic pleural effusions secondary to disseminated malignancy requiring therapeutic thoracentesis for symptom control

Interventions: 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 complet 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.

Measurements and results: Thirty-three patients received MA, and 34 patients received placebo; baseline characteristics for the brace groups were similar, apart from a slightly higher use of of equal authority systemic therapy in the placebo dispose 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 sum of two units groups (NS). VAS scores improved for the one and the other groups over the 2-week period, moreover the mean change scores (2 weeks--baseline) were not statistically different.

Conclusion: Despite previous ease series describing benefit from intrapleural MA in malignant pleural effusion, this controll studious mood of intrapleural MA instillation did not delay reaccumulation of symptomatic pleural effusion compared to placebo, nor were differences in QOL or dyspnea observ (CHEST 2003; 123:822-827)

fundamental note words: corticosteroids; intrapleural; malignancy pleural effusion; thoracentesis

Abbreviations: FACT-G = Functional Assessment of Cancer Therapy-General., HRQOL = health-related quality of life; LDH = lactate dehydrogenase; MA = methylprednisolone acetate; N = not significant; PWB = physical well-being; QOL = quality of life; VAS = visual analog scale

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Pleural effusion is belonging to all to many malignancies, including primary bronchogenic carcinoma, lymphoma, and metastatic disease from other primary sites as it is as ovary, breast, and stomach. When large compasss of fluid are present in the pleural space, patients commonly experience symptoms of shortness of breath, chest pain, cough and anxiety. These symptoms often reduce the quality of life (QOL) of patients with cancer.

Steroids have been shown to be effective in dealing with third-space fluid accumulations secondary to malignancy. rises of a phase II trial performed according to Mackey et al (1) using triamcinolone hexacetonide in the management of malignant ascites were positive in times of increasing the time interval between therapeutic paracenteses and improving health-related QOL (HRQOL) Bartal et al (2) performed a nonblinded, phase II trial exploring the character of methylprednisolone acetate (MA) instillations into the pleural space of patients requiring thoracentesis for malignant pleural effusion. Six of 10 patients showed symptomatic benefit, and 3 patients demonstrated finished resolution of their effusion. The conduct was tolerated well and could be performed forward an outpatient basis. To determine whether intrapleural corticosteroid instillation was effective in the management of malignant pleural effusions, we randomized patients in a double-blind, placebo-controlled fashion to receive either MA or placebo into the pleural space after thoracentesis.

MATERIALS AND METHODS

consideration Design

This was a randomized, double-blind studious mood of patients with symptomatic malignant pleural effusion comparing the intrapleural administration of MA, 160 mg v placebo after therapeutic thoracentesis. We carriageed this trial at the Cros Cancer Institute, Edmonton, AB, Canada between July 1998 and July 2001 The protocol and unison form were approved by the Alberta Cancer Board Research Ethics Board. All patients provided written informed acquiescence prior to enrollment. The primary objective of the consideration was to determine if instilling MA into the pleural space after therapeutic thoracentesis altered the mean time to reaccumulation of the effusion to the point that symptoms warranted another therapeutic drainage. Secondary objectives were to compare the HRQOL of patients of the couple study arms using the Functional Assessment of Cancer Therapy-General (FACT-G) QOL measurement instrument, and to assess ongoing dyspnea using a visual analog scale (VAS). Toxicity assessments were also performed.

Patient Population

All patients were required to have symptomatic pleural effusion in the appearance of disseminated malignancy, Eastern Cooperative Oncology form into groups performance status 0 to 3 life expectancy of at least 8 weeks, platelet enumerate > 50,000/[micro]L, neutrophil count > 1,000/[micro]L, and the ability to provide informed, written accord Patients could be enrolled at the disentanglement of their first symptomatic effusion or could be chronicleed at time of recurrence of an effusion. conjoined systemic and supportive therapies were allowed. Exclusion criteria included patients with uncontroll congestive heart failure, active systemic infection, history of tuberculosis, previous pleurodesis to the involved hemithorax, and systemic corticosteroids received within 2 weeks prior to enrollment Patients receiving any experimental put drugs into therapies and pregnant or nursing women were excluded

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