PURPOSE: Malignant pleural effusion (MPE) is common in patients with advanced cancer. Chemical pleurodesis can be considered for MPE that do not respond to chemotherapy, radiotherapy, or therapeutic thoracentesis. However, it is not yet clear which agent is more effective and safer in chemical pleurodesis. METHODS: This study was designed as a single arm, multicenter, and open-label phase III clinical trial to evaluate efficacy and safety of chemical pleurodesis using mistletoe extraction (ABNOVAviscum(®) Injection). References of other agents in chemical pleurodesis were investigated to compare efficacy and safety. Efficacy was evaluated by followed up chest X-ray and changes of clinical symptoms and Karnofsky performance scale. Safety was evaluated by serious adverse event (SAE) and changes of laboratory findings. A follow-up period was 4 weeks after last pleurodesis. RESULTS: Of 62 patients, 49 (79.0%) had complete response, 11 (17.7%) had partial response, and two had no response. Mean response rate was significantly different in this study comparing with reference response rate which was 64% (p <0.0001). There were two SAEs, but all were recovered without sequelas. CONCLUSION: The results of this study suggest that mistletoe extraction (ABNOVAviscum(®) Injection) could be an effective and safe agent of chemical pleurodesis in patients with MPE.
PURPOSE:Malignant pleural effusion (MPE) is common in patients with advanced cancer. Chemical pleurodesis can be considered for MPE that do not respond to chemotherapy, radiotherapy, or therapeutic thoracentesis. However, it is not yet clear which agent is more effective and safer in chemical pleurodesis. METHODS: This study was designed as a single arm, multicenter, and open-label phase III clinical trial to evaluate efficacy and safety of chemical pleurodesis using mistletoe extraction (ABNOVAviscum(®) Injection). References of other agents in chemical pleurodesis were investigated to compare efficacy and safety. Efficacy was evaluated by followed up chest X-ray and changes of clinical symptoms and Karnofsky performance scale. Safety was evaluated by serious adverse event (SAE) and changes of laboratory findings. A follow-up period was 4 weeks after last pleurodesis. RESULTS: Of 62 patients, 49 (79.0%) had complete response, 11 (17.7%) had partial response, and two had no response. Mean response rate was significantly different in this study comparing with reference response rate which was 64% (p <0.0001). There were two SAEs, but all were recovered without sequelas. CONCLUSION: The results of this study suggest that mistletoe extraction (ABNOVAviscum(®) Injection) could be an effective and safe agent of chemical pleurodesis in patients with MPE.