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K. Yanagihara



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    P1.10 - Poster Session 1 - Chemotherapy (ID 204)

    • Event: WCLC 2013
    • Type: Poster Session
    • Track: Medical Oncology
    • Presentations: 1
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      P1.10-001 - Phase II study of Bevacizumab and Erlotinib in patients with non-Squamous non-small lung cancer that is refractory or relapsed after 1-2 previous Treatment (BEST study) (ID 124)

      09:30 - 09:30  |  Author(s): K. Yanagihara

      • Abstract

      Background
      We report the interim-analysis result of the BEST trial, which examines efficacy and safety of second- or third-line chemotherapy with erlotinib (E) and bevacizumab (B) for the Japanese patients (pts) with non-squamous, non-small cell lung cancer.

      Methods
      E was administered initially at 150 mg/day orally and B was administered at a dose of 15 mg/kg on the first day of each 3-week cycle. The primary endpoint was objective response rate (RR). The secondary endpoints included overall survival (OS), progression-free survival (PFS), disease control rate (DCR) and incidence of adverse events. This trial was planned to accrue 80 pts based on a two-stage design employing a binomial distribution with an alternative hypothesis response rate of 35% and a null hypothesis threshold response rate of 20%. A subset analysis according to EGFR mutation status was planned (Trials. 2011; 12: 120).

      Results
      Total of 28 pts enrolled in 2 years from November, 2010. One patient was excluded due to thrombosis in lower limb and 27 pts (15 men and 12 women) with a median age of 67 (43-82) were analyzed; 18 pts had a PS of 0; all had adenocarcinoma; 11 pts had EGFR mutation; 1 patient had stage IIIB, 23 pts had stage IV and 3 pts had recurrences after surgery; 21 pts received as second-line and 6 pts received as third-line chemotherapy. RR was 18.5% (p=1.00; one-sided); DCR was 77.8%. Median PFS was 5.6 months (m); OS data were not yet mature (median follow-up time was 11.9 m). Grade 3/4 non-hematologic toxicities were mainly acne (11.1%) and hypertension (11.1%). The subset analysis according to EGFR showed significantly higher RR (p=0.02) and better PFS (p=0.03) in mutant group than in wild group. RR in mutant group was compared with 20% null hypothesis using the same binomial test (p=0.056).

      Conclusion
      Combination therapy of B and E had mild adverse effects but did not increase anti-cancer effect.

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    P2.24 - Poster Session 2 - Supportive Care (ID 157)

    • Event: WCLC 2013
    • Type: Poster Session
    • Track: Supportive Care
    • Presentations: 1
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      P2.24-011 - Left Ventricular Thormbosis due to Chemotherapy using Bevacizumab for Lung Cancer. (ID 887)

      09:30 - 09:30  |  Author(s): K. Yanagihara

      • Abstract

      Background
      Thoromboembolism has been reported as one of side effects of bevacizumab (BEV). An occurrence frequency of venous thoromboembolism caused by BEV is 0.2%. Specifically, it increases to approximately 4% within 1 to 3 months soon after chemotherapy. However, a ventricular thormbosis caused by BEV has almost never reported as far. We report a case of a ventricular thormbosis that occurred during chemotherapy using BEV for the lung cancer.

      Methods
      (case) 55 year-old, Japanese woman, who suffered myocardial infarction at 27 year-old and had a history of smoking (B.I.:350), complained of left.hemiplegia for brain tumor at first. After surgical treatment for brain tumor, she was diagnosed as lung adenocarcinaoma, cT1aN3M1b stage IV and was referred to our hospital. The first line pemetrexed(500 mg/m2) / carboplatin (AUC 6) /BEV (15 mg/kg) chemotherapy for two cycles every 3 weeks was performed. A partial response was found in the initial computed tomography (CT) evaluation, whereas the examination showed a thrombus of 26 × 25 mm in diameter in the left ventricle. D-dimer is 2.0 μg / mL at this point (D-dimer before treatment is 1.5 μg / mL). The anticoagulation therapy by using heparin continuous infusion and sequential oral agent therapy of warfarin and aspirin reduced the thrombus to 11 × 22 mm in diameter.

      Results
      (Discussion) Thromboembolism is clinically diagnosed by clinical findings, ultrasonography, contrast CT, and D-dimer. D-dimer is a simple indicator even for asymptomatic thrombus formation and has been reported to be valid for the evaluation of thrombus formation. In this case, D-dimer value was almost conserved through this event. We cannot be undeniable the relation the chemotherapy including BEV and left ventricular thrombosis. Also, since there is no evaluation of left ventricular function before chemotherapy treatment, it can not be denied the possibility of thrombus formation by reduced left ventricular function.

      Conclusion
      (conclusion) We have experienced a case that developed ventricular thrombosis during chemotherapy for lung cancer. It is believed to be evaluated, such as ultrasonography before using BEV in the case passing a long period of time after myocardial infarction.