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%).Correspondence to: Carolyn Dresler, MD, MPA, Head, Tobacco Unit, International Agency for Research on Cancer, Lyon, France; Carolyn_dresler@ksg03.harvard.edu.
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Author ManuscriptRespiratory 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. Since that time, a significant number of single institution reports have been published, primarily using thorascopically insufflated talc. However, a growing number of authors have advocated talc slurry via a percutaneously placed chest tube as a simpler and equally effective method for control of MPE with minimal short-term morbidity. However, several reports 10,11 of serious respiratory complications with talc have also been published.
Conclusions-BothThe objectives of the current trial Cooperative Groups Cancer and Leukemia Group B (CALGB) 9334 compare tube thoracostomy with talc slurry (TS) to surgical thoracoscopy with talc insufflation (TTI), and assesses their efficacy at 30 days, in addition to the safety and associated quality of life in a randomized multicenter trial. Portions of this work have been presented in abstract form. 12
Materials and MethodsThis 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 surgeon...