Author of

• 11001

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  P1.24 - Poster Session 1 - Clinical Care (ID 146)

  • Event: WCLC 2013
  • Type: Poster Session
  • Track: Supportive Care
  • Presentations: 1
  • Moderators:
  • Coordinates: 10/28/2013, 09:30 - 16:30, Exhibit Hall, Ground Level

  • 11029

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    P1.24-028 - Chemical pleurodesis using mistletoe extraction (ABNOVAviscumⓇ Injection) for malignant pleural effusion (ID 2056)

    09:30 - 09:30  |  Author(s): Y.J. Lee
    • Abstract

    Background
    Malignant pleural effusion is common in patients with advanced cancer. Several treatment modalities for malignant pleural effusion have known and of those, chemical pleurodesis can be considered for malignant effusion that do not respond to chemotherapy, radiotherapy, or therapeutic thoracentesis. However, which agent is more effective and safe in chemical pleurodesis is not yet clear.

    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 ABNOVAviscum[Ⓡ] Injection (Abnoba GmbH. Germany). Reference of other agents in chemical pleurodesis was investigated to compare efficacy and safety, and decide statistical sample size. Of patients who needed pleurodesis for malignant pleural effusion, the patients who had full expansion of lung within 24 hours after pleural drainage, expected life span more than 2 months, and Karnofsky performance scale of more than 50 were enrolled. Efficacy was evaluated by the amount of pleural effusion in chest x ray taken four weeks after pleurodesis (WHO guidelines of response – complete response; few effusion, partial response; lesser than 50% of initial pleural effusion, no response, or not evaluable), and changes of clinical symptoms and karnofsky performance scale. Safety was evaluated by serious adverse event (SAE) and changes of kidney and liver function (AST, ALT, BUN, or creatinine) after pleurodesis. A follow-up period was 4 weeks after last pleurodesis.

    Results
    A total of 68 patients were enrolled which 7 of them dropped out. Median age of patients was 60 years old [range, 34-80]. The number of male and female was 23 and 38, respectively. 49(80.3%) had complete response, 11(18.0%) had partial response, and one patient had no response. Mean response rate of reference for other agents in chemical pleurodesis was 64%. The mean karnofsky performance scale before the pleurodesis was 79.5 and the mean karnofsky performance scale on fourth week after pleurodesis was 81.9. SAE definitely related to ABNOVAviscum[Ⓡ] Injection was presented in two cases; dyspepsia and generalized muscle weakness. Both of these cases were recovered before the end of this study. SAE probably related to ABNOVAviscum[Ⓡ] Injection was seven cases; dyspepsia, fever (3), constipation, vomiting, and fatigue. These seven cases were recovered before the end of this study as well. No other toxicity related to ABNOVAviscum[Ⓡ] Injection was presented in laboratory findings such as AST, ALT, BUN, or creatinine during a follow-up period.

    Conclusion
    This study suggests that chemical pleurodesis using ABNOVAviscum[Ⓡ] Injection for malignant pleural effusion might be an effective and safe modality.