Chest
Volume 127, Issue 3, March 2005, Pages 909-915
Journal home page for Chest

Clinical Investigations: Pleura
Phase III Intergroup Study of Talc Poudrage vs Talc Slurry Sclerosis for Malignant Pleural Effusion

https://doi.org/10.1378/chest.127.3.909Get rights and content

Study objective

To demonstrate the efficacy, safety, and appropriate mode of instillation of talc for sclerosis in treatment of malignant pleural effusions (MPEs)

Design

A prospective, randomized trial was designed to compare thoracoscopy with talc insufflation (TTI) to thoracostomy and talc slurry (TS) for patients with documented MPE

Measurements

The primary end point was 30-day freedom from radiographic MPE recurrence among surviving patients whose lungs initially re-expanded ≥ 90%. Morbidity, mortality, and quality of life were also assessed

Results

Of 501 patients registered, those eligible were randomized to TTI (n = 242) or TS (n = 240). Patient demographics and primary malignancies were similar between study arms. Overall, there was no difference between study arms in the percentage of patients with successful 30-day outcomes (TTI, 78%; TS, 71%). However, the subgroup of patients with primary lung or breast cancer had higher success with TTI than with TS (82% vs 67%). Common morbidity included fever, dyspnea, and pain. Treatment-related mortality occurred in nine TTI patients and seven TS patients. Respiratory complications were more common following TTI than TS (14% vs 6%). Respiratory failure was observed in 4% of TS patients and 8% of TTI patients, accounting for five toxic deaths and six toxic deaths, respectively. Quality-of-life measurement demonstrated less fatigue with TTI than TS. Patient ratings of comfort and safety were also higher for TTI, but there were no differences on perceived value or convenience of the procedures

Conclusions

Both methods of talc delivery are similar in efficacy; TTI may be better for patients with either a lung or breast primary. The etiology and incidence of respiratory complications from talc need further exploration

Section snippets

Materials and Methods

This was an intergroup cooperative trial led by the CALGB and monitored semiannually by its Data and Safety Monitoring Board, with participation by the Radiation Therapy Oncology Group, the Eastern Cooperative Oncology Group (ECOG), and the North Central Cooperative Oncology Group, encompassing both private and teaching hospitals. Credentialing of participating surgeons was required. Institutional review board approval and written informed patient consent were obtained.

Patients were identified

Results

Between January 1995 and September 1999, 501 patients were randomized (TS, n = 250; TTI, n = 251). Nineteen patients were excluded: 13 were ineligible and 6 withdrew consent. Thus, 240 TS and 242 TTI patients remained for outcome analysis. Patient demographics (Table 1) and distribution of underlying malignancies (Table 2) were similar between study arms.

The criterion of > 90% lung re-expansion was met by 163 of 240 TS patients (68%) and 177 of 242 TTI patients (73%) [p = 0.231]. Among these,

Discussion

The current finding of no difference in the ability of talc, whether insufflated or placed as slurry, to prevent recurrence of MPE at 30 days is not surprising. An equivalence design was used because there was no a priori reason to expect that efficacy would differ between the study arms. Although there is considerable variability in reported “success” rates among published studies, a review15 of MPE studies published through 1994 reveals identical overall success rates of 91% for slurry (n =

References (39)

Cited by (451)

  • An unusual case of explosive pleuritis without mediastinal shift

    2022, American Journal of the Medical Sciences
View all citing articles on Scopus

This work was supported by the National Cancer Institute (2 U01 CA65170)

View full text