Demmy, T.L., Gu, L., Burkhalter, J.E., Toloza, E.M., D'Amico, T.A., Sutherland, S., . . . Cancer and Leukemia Group B. (2012). Optimal management of malignant pleural effusions (results of CALGB 30102). Journal of the National Comprehensive Cancer Network, 10(8), 975-982.

The objective of the study was to compare tunneled pleural catheter drainage (TCD) to bedside talc pleurodesis (TP) via chest catheter for efficacy in controlling symptomatic unilateral malignant pleural effusions (MPE).

Randomized patients received one of two methods (TP or TCD) for pleural drainage then were followed up for 60 days. For the TP procedure, a single dose of 4–5 g of sterile talc slurry in 100 mL of saline was infused into the pleural space with a chest catheter. Placement was confirmed on a chest x-ray. Talc was administered within 36 hours of tube placement. The tube remained clamped for two hours for talc distribution. When the chest drainage decreased to 150 mL/24 hours, pleurodesis was assumed and the tube was removed. TP was performed on an inpatient basis. For TCD, catheters were drained daily with drainage bottles. No more than 1,000 mL were drained at a time, other than during the initial drainage. A chest x-ray was taken within 36 hours of initial drainage and the patient, a caregiver, or a visiting nurse drained the catheter daily after that. The catheter was removed when the drainage volume was less than 30 mL each day over three consecutive days. TCD is generally an outpatient procedure.

• The sample was comprised of 57 patients aged 60–67 years.
• Of the 57 patients, 45%–55% were males and 39%–61% were females.
• Patients had a performance status of 0 to 2 with no active pleural infection, talc allergy, or other indications to talc use.
• Lung cancer (62%) and breast cancer (12%) were the most common malignancies.
• The study originally planned 530 total patients for 90% power to detect differences in efficacy between the two methods of pleural drainage.
• Trapped lung was not recommended for randomized therapy, as TCD may be a better therapy option.

The study was conducted in 21 comprehensive cancer centers—17 cases were conducted at one instution, and 1–7 cases were conducted at each of the other institutions.

• Patients were undergoing multiple phases of care.
• The study has clinical applicability for elder care and palliative care.

The study was a prospective, randomized phase III trial.

• Lung re-expansion was determined by the treating physician using serial chest x-rays.
• Condensed Memorial Symptom Assessment Scale form (specific elements: performance status, dyspnea scale, physical function, social life, and overall quality of life) measured quality of life and specific symptoms or functionality.

• No statistical differences in lung expansion were noted between the two treatment arms, but it improved from baseline in both cases.
• The odds ratio for TCD success was five times higher than TP, and patients with good expansion experienced better success (odds ratio, 5; 95% CI, 1–25; P = .053).
• Pleurodesis occurred in 86.2% of patients treated with TP, compared with 68.0% of those treated with TCD (P = .1883).
• Therapy-related complications were low but were higher in the TCD arm.
• Recurrent dyspnea was seen only in TP cases, and dyspnea was statistically better in patients treated with TCD (8.7 vs. 5.9; P = .036) even after adjusting for baseline dyspnea score, initial drainage, gender, inpatient status, and performance status at baseline.
• No relationship was seen between baseline dyspnea score and lung expansion at any of the three points; however, 30-day dyspnea-free exercise and all quality-of-life measures correlated significantly with lung expansion.

• TCD is preferred for patients with complicated effusions or when the lung may be trapped.
• Although TCD prolongs therapy, this added duration may maintain lung expansion and improve quality-of-life parameters.
• Lung expansion may be an unreliable indicator of the benefits of pleural drainage.
• TCDs in this study may more predictably relieve dyspnea.
• The study had to be closed early because patients had a strong preference for treatment (inpatient vs. outpatient) and refused randomization.

• The study had a small sample size of less than 100 patients.
• The study had a risk of bias because of no blinding and its sample characteristics.
• Accrual was far less than anticipated due to patient preferences interfering with patient consent to randomization.
• Refusals to participate may have influenced the final study population, as evidenced by lower-than-anticipated success of talc pleurodesis intervention.
• The study does not describe that “malignant effusion” was validated cyopathologically.

• TCD and TP are both common strategies to manage malignant pleural effusion.
• Similar lung expansion appears to be able to be achieved with both techniques in patients with uncomplicated pleural effusion, and the selection of method may be based upon patient preference.
• Nurses should ensure that patients are thoroughly informed of therapeutic options to make the best decision for their circumstances.
• In cases in which patients experience distress form dyspnea at baseline, they may experience better symptom relief with the TCD method of managing malignant pleural effusions.