Phase III Intergroup Study of Talc Poudrage vs Talc Slurry Sclerosis for Malignant Pleural Effusion

Abstract

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. HHS Public Access Author Manuscript Author ManuscriptAuthor Manuscript 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...

Efficacy of pleurodesis for malignant pleural effusions in breast cancer patients

“…Talc has been reported as safe and efficacious for pleurodesis [15][16][17][18][19][20][21][22][23]. A Cochrane review reported that pleurodesis with talc provided the highest relative chance of MPE nonrecurrence when compared with bleomycin, tetracycline, mustine or chest-tube drainage alone [24].…”

Nonintubated Videothoracoscopic Operations in Thoracic Oncology

“…These figures appear to be remarkably higher that those observed after bedside instillation of talc [68,70] or other agents [63,79]. We have evaluated comparatively the results obtained in a large series of patients with malignant pleural effusion, who were treated by either standard videothoracoscopy or NITOS.…”

“…Reported success rates for videothoracoscopic talc pleurodesis range from 84% to 95% [66][67][68][69][70][71][72]. These figures appear to be remarkably higher that those observed after bedside instillation of talc [68,70] or other agents [63,79].…”

Management of Pleural Effusion by Combining Talc Poudrage and Indwelling Pleural Catheter: A Retrospective Single Center Study

“…The current standard treatment strategy for malignant pleural effusion (MPE) is talc pleurodesis, a procedure that has been implemented more than 80 years ago [2]. Today, talc pleurodesis is a safe procedure and talc is known to be the most successful pleurodesis agent with a success rate of more than 70% [3][4][5]. A major disadvantage of the procedure is however the need of chest tube(s) and the therefore long hospital stay up to seven days until they can be removed [6].…”