Phase III intergroup study of talc poudrage vs talc slurry sclerosis for malignant pleural effusion

被引:394
作者
Dresler, CM
Olak, J
Herndon, JE
Richards, WG
Scalzetti, E
Fleishman, SB
Kernstine, KH
Demmy, T
Jablons, DM
Kohman, L
Daniel, TM
Haasler, GB
Sugarbaker, DJ
机构
[1] Int Agcy Res Canc, Tobacco Unit, F-69372 Lyon, France
[2] Lutheran Gen Hosp, Canc Care Ctr, Park Ridge, IL 60068 USA
[3] Canc Ctr Biostat, Durham, NC USA
[4] Brigham & Womens Hosp, Boston, MA 02115 USA
[5] SUNY Upstate Med Univ, Dept Radiol, Syracuse, NY USA
[6] Beth Israel Deaconess Med Ctr, Canc Support Serv, Continuum Canc Ctr New York, New York, NY 10003 USA
[7] St Lukes Roosevelt, Canc Support Serv, Continuum Canc Ctr New York, New York, NY USA
[8] Univ Iowa, Dept Surg, Iowa City, IA USA
[9] Roswell Pk Canc Inst, Buffalo, NY 14263 USA
[10] Univ Calif San Francisco, Dept Surg, Mt Zion Med Ctr, San Francisco, CA 94143 USA
[11] Univ Virginia Hlth Syst, Dept Surg, Charlottesville, VA USA
[12] Med Coll Wisconsin, Milwaukee, WI 53226 USA
关键词
insufflation; malignant pleural effusion; slurry; talc;
D O I
10.1378/chest.127.3.909
中图分类号
R4 [临床医学];
学科分类号
1002 ; 100602 ;
摘要
Study objective: To demonstrate the efficacy, safety, and appropriate mode of instillation of tale 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 bad 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 tale need further exploration.
引用
收藏
页码:909 / 915
页数:7
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