Author of

• 12853

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  P3.24 - Poster Session 3 - Supportive Care (ID 160)

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

  • 12892

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    P3.24-040 - Iodopovidone for pleurodesis in patients with malignant pleural effusion: a safe option (ID 2771)

    09:30 - 09:30  |  Author(s): R. Maia
    • Abstract

    Background
    Malignant pleural effusion (MPE) is a disabling condition in patients with metastatic disease. Pleurodesis is a well established treatment for recurrent MPE; however, the best sclerosing agent is still a matter of debate. Iodopovidone is described in the literature as a sclerosing agent easily obtained, easy to use, and inexpensive; nevertheless, its safety has not been systematically evaluated. The objective of this study was to analyze the occurrence of frequent (>5%) adverse events after pleurodesis using two different dosages of Iodopovidone in patients with MPE.

    Methods
    Randomized double blind clinical trial including patients with recurrent MPE eligible for pleurodesis. All patients were randomized into two groups; group 1 received 1% Iodopovidone and group 2 received 2% Iodopovidone. We sought adverse events systematically after pleurodesis through pain analog scale, dyspnea scale, oxygen saturation, heart frequency, arterial blood pressure, body temperature, visual acuity, EKG, chest x-ray and laboratory tests (CRP, hemogram, renal function, liver function and thyroid function). All adverse events were registered and classified according to the CTCAEV v3.0. We considered pleurodesis as failed when the patient underwent new pleural procedures. We compared groups as for adverse events, quality-of-life, and success using, chi-square or t-test, p<0.05 was considered significant.

    Results
    Fifty patients underwent pleurodesis over the study period, 45 females and 5 males with a mean age of 56,7 years. The etiology of MPE was breast cancer in 34 patients (68%), lung cancer in 6 patients (12%), and other neoplasms in 10 patients (20%). We found no difference in patient’s demographical data between groups. The most frequent adverse event was elevation of alkaline phosphatase, which occurred in 21 patients (42%), 6 in group 1 and 15 in group 2 (p = 0.03). Hyponatremia was the second most common adverse event, it occurred in 19 patients (38%), 5 in group 1 and 14 in group 2 (p= 0,02). In no patient did these laboratorial alterations require further care. The most frequent clinical adverse event was severe pain, it was observed in 5 patients (10%), 1 patients from group 1 and in 4 patients from group 2 (p=0.69). Hypotension occurred in one patient from each group (p=1). Two patients had postoperative empyema in group 2, and none in group 1 (p=0,35). Other adverse effects or complications commonly reported in the literature such as fever, renal or visual disorder were not found. Pleurodesis success rate was 92% in the Group 1 and 84% in Group 2 (p = 0.5).

    Conclusion
    Clinically relevant adverse events are not frequent after iodopovidone pleurodesis, being pain the most common. Apparently, the occurrence of laboratorial alterations is dose-dependent