Author of

• 12592

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  P3.10 - Poster Session 3 - Chemotherapy (ID 210)

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

  • 12599

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    P3.10-007 - Avastin® for advanced or recurrent non-squamous non-small cell lung cancer: A nested case control study exploring risk factors for hemoptysis in Japan (ID 782)

    09:30 - 09:30  |  Author(s): M. Endo
    • Abstract

    Background
    A nested case control (NCC) study was conducted to assess the incidence of hemoptysis (Grade 2 cases that used an injectable hemostatic or Grade 3+ cases) and to explore risk factors for hemoptysis in patients receiving Avastin[®] (bevacizumab) in real-life-practice in Japan.

    Methods
    From November 2009 to August 2011 patients intending to use bevacizumab were pre-enrolled, and we calculated incidence of hemoptysis in the 6774 patients actually receiving bevacizumab. Excluding one patient of unspecified age, we selected a control group from the 6773 patients by matching each patient who developed hemoptysis (cases) to four patients who did not (controls) by sex and age. We selected 92 controls for the 23 cases and performed conditional logistic regression analysis of a total 113 patients (23 cases and 90 controls) to investigate risk factors for hemoptysis. A third party including radiologists performed blind assessment of imaging characteristics for the 104 patients with evaluable baseline computerized tomography images.

    Results
    In the 6774 patients receiving bevacizumab, incidence of hemoptysis was 0.33%. To perform conditional logistic regression analysis of the 113 patients in the case control study, we included the following factors in the model: smoking history, stage (7th ed.), PS (baseline), present metastasis, previous lung disease, concurrent lung disease, previous thoracic radiotherapy, concomitant drugs (anticoagulant, aspirin preparation, non-steroidal anti-inflammatory drug, antiplatelet drug), concomitant thoracic radiotherapy, treatment line, macrovascular (arterial) invasion, and central airway tumor exposure extending to segmental bronchus. Analysis using the stepwise method identified presence of previous thoracic radiotherapy (odds ratio [OR], 2.76; 95% confidence interval [CI], 0.61–12.43), concomitant thoracic radiotherapy (OR, 6.19; 95% CI, 0.63–60.47), and central airway tumor exposure extending to segmental bronchus (OR, 5.29; 95% CI, 1.22–22.89).

    Conclusion
    At 0.33%, the incidence of hemoptysis in this study was low, and three risk factors were identified. Because this was a case control study in patients receiving Avastin, these risks cannot necessarily be attributed to Avastin treatment, and further study of safety risks is needed.