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Y. Wang



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    MINI 31 - ALK (ID 158)

    • Event: WCLC 2015
    • Type: Mini Oral
    • Track: Treatment of Advanced Diseases - NSCLC
    • Presentations: 1
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      MINI31.07 - Cardiac Toxicity of Crizotinib Therapy in Advanced ALK-Rearranged Non-Small Cell Lung  Cancer (ID 2626)

      18:30 - 20:00  |  Author(s): Y. Wang

      • Abstract
      • Presentation
      • Slides

      Background:
      Crizotinib (XALKORI [TM], Pfizer) , a tyrosine kinase inhibitor targeting ALK, ROS1 and MET, is used for the therapy of advanced anaplastic lymphoma kinase (ALK)-rearranged non-small cell lung cancer (NSCLC). Cardiac toxicity is one of its adverse events which may interrupt the administration of crizotinib. Elevation of CK-MB has been reported but it remains to be determined whether the level of CK-MB can reflect cardiac toxicity of crizotinib therapy. We investigated the clinical manifestations and relevant frequency of heart-related side effects in 94 advanced ALK-rearranged NSCLC patients with treatment of crizotinib to share experiences of management of cardiac toxicity of crizotinib.

      Methods:
      A retrospective analysis was conducted to demonstrate the clinical manifestations as well as the corresponding frequency of cardiac toxicity in advanced ALK-rearranged NSCLC patients with treatment of crizotinib enrolled in our hospital in the past 4 years.

      Results:
      In the past 4 years, 95 advanced ALK-rearranged NSCLC patients were treated with crizotinib in our hospital, among which one patient dropped the treatment in 3 days due to grade 4 vomiting. In 94 eligible patients who continue the therapy more than one month, the heart-related side effects include QT interval prolongation (2/94), bradycardia (12/94), hypotension (3/94), aggravation of atrial fibrillation (1/94) and elevation of creatine kinase-MB(CK-MB) (59/94). Consequently, one of 2 patients with QT interval prolongation reduced dosage from 250 mg to 200mg twice daily for QT interval >500 ms on two electrocardiograms and then well tolerated. 12 patients with bradycardia presented asymptomatic and one patient with profound sinus bradycardia (heart rate [HR]≦45) continued crizotinib without dose reduction as she was asymptomatic and benefiting from continuous crizotinib treatment against the deadly disease. Patients with hypotension and aggravation of atrial fibrillation are tolerated and under close follow-up without dose reduction. Remarkably, we observed that majority of our patients (62.77%) experienced elevation of CK-MB and no correlation between age and CK-MB elevation (Pearson Correlation =-0.153,p=0.137).

      Conclusion:
      Cardiac toxicity is common during crizotinib treatment so that heart-related examinations, such as ECG as well as CK-MB, should be performed regularly especially for those with prior heart disease.

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    P3.01 - Poster Session/ Treatment of Advanced Diseases – NSCLC (ID 208)

    • Event: WCLC 2015
    • Type: Poster
    • Track: Treatment of Advanced Diseases - NSCLC
    • Presentations: 2
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      P3.01-039 - Patient Characteristics and Treatment Outcome of Advanced Non-Squamous NSCLC with over 6-Month Disease Control from Icotinib (ID 2806)

      09:30 - 17:00  |  Author(s): Y. Wang

      • Abstract
      • Slides

      Background:
      Epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI) has an established role in the treatment of advanced non-squamous non-small cell lung cancer (NSCLC). Icotinib is an EGFR-TKI with non-inferior efficacy but milder toxicities compared with gefitinib. Disease control for over 6 months suggests that the case is not primary resistant to the drug. The present study investigated the patient characteristics and treatment outcome of advanced non-squamous NSCLC with at least 6-month disease control from icotinib.

      Methods:
      Non-squamous NSCLC patients with disease control after 6-month icotinib treatment were enrolled and retrospectively analyzed. Clinical characteristics were collected from the medical records. Efficacy and outcome data were analyzed.

      Results:
      A total of 87 patients were enrolled onto this study in which 56 were female, 18 with brain metastasis, and 32 patients harbored known EGFR mutation. For the overall population, 42(48.3%) patients achieved partial response. Response rate were 65.6%(21/32)and 38.2%(21/55)in patients with EGFR mutation and those with unknown mutation status, respectively(P=0.014). Patients with brain metastasis appeared to have lower response rate (26.7% vs 56.9%, p=0.033).The median progression-free survival (PFS) after 6 months’ icotinib treatment was 9.7 months (95% CI 4.1-15.4 months) for the overall population, and 5.0 months (95% CI 0.6-3.9 months) and 12.9 months (95% CI 3.4-6.2 months) for those with and without brain metastasis, respectively. Median progression-free survival in patients with PR or SD showed no statistically significant difference (15.5 months vs 9.3 months, P=0.477).

      Conclusion:
      The present study provided evidence from a relatively large single institutional study of icotinib in clinical practice. Patients with disease control for over 6 months showed similar clinical features to those with EGFR mutation. Those patients will have prolonged clinical benefits with continuous icotinib therapy after 6 months, regardless of PR or SD. Brain metastasis is a potential unfavorable predictive factor for PFS for those patients

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      P3.01-061 - A Prognostic Model for Platinum-Doublet Regimens as Second-Line Chemotherapy in Advanced Non-Small-Cell Lung Cancer (NSCLC) Patients (ID 1228)

      09:30 - 17:00  |  Author(s): Y. Wang

      • Abstract
      • Slides

      Background:
      Poor prognosis of advanced non-small-cell lung cancer (NSCLC) patients and the promising therapeutic effect of platinum urge the oncologists to evaluate the role of platinum-doublet as second-line chemotherapy and establish the definition of platinum sensitivity in NSCLC.

      Methods:
      We retrospectively analyzed 364 advanced NSCLC patients who received platinum-doublet regimens as second-line chemotherapy after platinum-based first-line treatment. Patients were divided into four groups by their time-to-progression (TTP) after first-line chemotherapy: 0-3, 4-6, 7-12, and >12months group, respectively. Treatment efficacy of patients’ overall survival (OS), progression-free survival (PFS) and response rate (RR), as well as treatment-related toxicity, were compared among the four groups. A prognosis score system was established by Cox proportional hazard model.

      Results:
      All patients had Eastern Cooperative Oncology Group performance status (ECOG PS) of 0-1. As part of the platinum-doublet regimen,145(39.8%) patients received taxol, 81(22.3%) received gemcitabine, 99(27.2%) received pemetrexed, 32(8.8%) received vinorelbine, 4(1.1%) received etoposide, and 3(0.8%) received irinotecan. The most frequent grade 3/4 toxicity was neutropenia (20.1%) and nausea/vomiting (3.3%).The median follow-up time was 11.0 months. Patients with TTP> 12 months had significant longer survival than the rest of the group after second-line platinum-rechallenge (HR, 0.809; 95% CI: 0.703-0.931;P=0.003).Prognostic score (TAF score) was calculated by adding 1 point each for any of the following: TTP>12 months, age≤60 years, and female, all of which were independent prognostic factors for patient survival (P=0.015, P=0.002, P=0.012, respectively). Median OS were equal to 25.0, 16.0 and 11.0 months for best (2-3 points), intermediate (1 point) and worst (0 point) category, respectively (P<0.0001, Figure 1). Figure 1 Kaplan–Meier curves of overall survival according to patients’ TAF Score. After second-line platinum-based chemotherapy, patients with a TAF Score of 2-3 had significant better survival than those scored 0 or 1 (P<0.0001). Figure 1



      Conclusion:
      A TAF score of 2 or 3 points indicates a good prognosis if advanced NSCLC patients received platinum-rechallenge after disease progression.

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