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C. Tsai



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    P1.11 - Poster Session 1 - NSCLC Novel Therapies (ID 208)

    • Event: WCLC 2013
    • Type: Poster Session
    • Track: Medical Oncology
    • Presentations: 1
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      P1.11-035 - Outcomes of Afatinib-Based Regimens for Salvage Treatment of Advanced Stage Non-Small Cell Lung Cancer (NSCLC) Patients Who Had Been Heavily Pretreated (ID 2505)

      09:30 - 09:30  |  Author(s): C. Tsai

      • Abstract

      Background
      The therapeutic development for advanced stage NSCLC has improved in the past decade, but the poor treatment outcome still poses a major challenge. Investigators have combined conventional platinum-based chemotherapy with epidermal growth factor receptor-tyrosine kinase inhibitor (EGFR-TKI), in the hope of achieving greater therapeutic efficacy. However, current data show that the combination strategy has repeatedly failed to provide a better survival benefit, irrespective of the mutation status of the tumors. However, it might not be true for combination of EGFR-TKI with individual agents which exhibit a variety of anti-cancer actions. Afatinib, a novel irreversible ErbB-family blocker, has shown to provide efficacious effects for advanced stage NSCLC patients. From the Phase I data, afatinib in combination with chemotherapy or anti-EGFR therapy exhibited tumor inhibition response. We present retrospective clinical evidences of patients from Compassionate Usage Program. These patients are treated with continuation of afatinib in combination, alternately, with various chemotherapies or anti-EGFR therapy.

      Methods
      Between August 2012 to February 2013, 37 patients were enrolled for the program, 11 of these patients died of disease progression either received afatinib for less than 2 weeks or never started afatinib treatment, the remaining 26 patients were included in this analysis. Patient characteristics are median age was 67 (range 46-84), gender (male/female = 8/18), ECOG status (PS 1/2/3: 16/2/4), EGFR mutation status (exon 19 deletion = 10; L858R mutation = 6; exon 18 mutation = 1; wild type = 5; unknown = 5). All of these patients had been previously treated with either gefitinib or erlotinib with no disease progression for more than 6 months. The median TKI-free interval was 125 days (range 0-1,450 days); 8 patients had no TKI-free interval. All patients but 1 started the treatment of afatinib monotherapy (30 mg or 40 mg daily), and subsequently, either paclitaxel (60 mg/m2, day 1, 8, and 15, 4-week cycle), docetaxel (30 mg, day 1, and 8, 3-week cycle), or cetuximab (250mg/m2, every 2 weeks) was added. The combination was alternated or discontinued when patient had disease progression according to RECIST criteria version 1.1, intolerability or severe toxicity.

      Results
      Of the whole group of patients, 25 received afatinib monotherapy, 11 with 1 afatinib doublet (afatinib/cetuximab = 3; afatinib/paclitaxel = 6; afatinib/docetaxel = 2); 2 with 2 afatinib doublets (afatinib/cetuximab and afatinib/docetaxel = 1; afatinib/cetuximab and afatinib/docetaxel = 1) and 1 with 3 afatinib doublets (afatinib/cetuximab, afatinib/paclitaxel and afatinib/docetaxel). The median duration from administration of frontline systemic treatment to initiation of afatinib was 3 years (range 1 - 10 years). These patients had received 2 to 7 (median 5) lines of treatment before receiving afatinib-based treatment. The median time to treatment failure was 223 days (95% CI: 217, 249) and median overall survival was 288 days (6 events). The toxicities were mild and manageable. There was no correlation between the values of TKI-free interval and duration of afatinib monotherapy.

      Conclusion
      Integration of afatinib with various treatment agents based on different treatment rationales, the afatinib-based treatment may potentially extend treatment duration and patient survival.

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    P2.10 - Poster Session 2 - Chemotherapy (ID 207)

    • Event: WCLC 2013
    • Type: Poster Session
    • Track: Medical Oncology
    • Presentations: 1
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      P2.10-049 - Lung and Bone Metastasis Are Associated With Different Response and Disease Control Rate of First-line Therapy in Patients With Adenocarcinoma of Lung. (ID 3164)

      09:30 - 09:30  |  Author(s): C. Tsai

      • Abstract

      Background
      Bone and lung are frequent metastatic sites for adenocarcinoma of lung. Chemotherapy and tyrosine-kinase inhibitor (TKI) are standard first-line therapies for stage IV adenocarcinoma of lung according to the epidermal growth factor receptor (EGFR) mutation status. This study aimed at evaluating the relationship between bone, lung metastasis, with or without classic EGFR mutation, response rate and disease control rate of first-line chemotherapy and TKI therapy.

      Methods
      We retrospectively reviewed 206 patients who were diagnosed of adenocarcinoma of lung at our hospital. The patients’ bone and lung metastatic status at diagnosis, with or without classic EGFR mutation, response and disease control status of first-line chemotherapy and TKI therapy were collected for chi-square analysis.

      Results
      Fifty-five (26.7%) patients had bone metastasis and 82 (39.8%) patients had lung metastasis. 107 (51.9%) patients had classic EGFR mutation. There was no significant difference between bone, lung metastatic status and with or without classic EGFR mutation (p=0.65 for bone, p=0.46 for lung). For the patients without classic EGFR mutation and received first-line chemotherapy, 33(57.9%) patients were without response (13, 20 patients were without, with bone metastasis, respectively), 24(42.1%) patients were with response (21, 3 patients were without, with bone metastasis, respectively), p<0.01; 21(36.8%) patients were not controlled (9, 12 patients were without, with bone metastasis, respectively),36 (63.2%) patients were controlled (25, 11 patients were without, with bone metastasis, respectively), p=0.048. For the patients with classic EGFR mutation and received first-line chemotherapy, 27(60%) patients were without response (14, 13 patients were without, with bone metastasis, respectively), 18(40%) patients were with response (16, 2 patients were without, with bone metastasis, respectively), p=0.01; 10(22.2%) patients were not controlled (4, 6 patients were without, with bone metastasis, respectively), 35(77.8%) patients were controlled (26, 9 patients were without, with bone metastasis, respectively), p=0.043. There were no significant difference between response status of TKI and lung metastatic status (p=0.469), control status of TKI and lung metastatic status(p=0.855), response status of TKI and bone metastatic status(p=0.673), control status of TKI and bone metastatic status(p=0.58), response status of chemotherapy and bone metastatic status(p=0.533), control status of chemotherapy and bone metastatic status(p=0.777) in patients without classic EGFR mutation. For patients with classic EGFR mutation, there were also no significant difference between response status of TKI and lung metastatic status(p=0.077), control status of TKI and lung metastatic status(p=0.332), response status of TKI and bone metastatic status(p=0.76), control status of TKI and bone metastatic status(p=0.05), response status of chemotherapy and bone metastatic status (p=0.143), except for control status of chemotherapy and bone metastatic status(p=0.017).

      Conclusion
      For patients with adenocarcinoma of lung, bone metastasis is associated with decreased disease control rate in those with classic EGFR mutation and received first-line chemotherapy, and lung metastasis is associated with decreased response and disease control rate in those received first-line TKI therapy no matter of with or without classic EGFR mutation.

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    P2.11 - Poster Session 2 - NSCLC Novel Therapies (ID 209)

    • Event: WCLC 2013
    • Type: Poster Session
    • Track: Medical Oncology
    • Presentations: 2
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      P2.11-028 - Erlotinib salvage therapy in pulmonary adenocarcinoma patients who had disease progressed after previous EGFR-TKI treatment and platinum-based chemotherapies (ID 2110)

      09:30 - 09:30  |  Author(s): C. Tsai

      • Abstract

      Background
      Erlotinib is an EGFR tyrosine kinase inhibitor with promising efficacy in treating lung adenocarcinoma. However, after the failure of two lines of EGFR-TKI and chemotherapy, the remaining treatment choices are few. The purpose of this study is to demonstrate the efficacy of erlotinib as ≥ third-line treatment in this kind of patients.

      Methods
      We retrospectively reviewed the chart records of our stage IV pulmonary adenocarcinoma patients who were diagnosed and treated in our hospital between July 2004 and June 2013. Clinical data, type of response to the treatment, time to disease progression, the duration between starting erlotinib treatment and end of first line EGFR-TKI treatment, and overall survival time were collected.

      Results
      Seventy-four patients were enrolled and they all had been treated with EGFR-TKI, either as a first-line therapy or following platinum-based chemotherapy. Thirty-nine patients had response to initial EGFR-TKI treatment and thirty-five of them did not. The median progression free survival (PFS) of front-line EGFR-TKI is 8.2 months. All received erlotinib as salvage treatment after they had disease progressed to both chemotherapy and front-line EGFR-TKI. The median PFS of erlotnib as salvage treatment for patients with and without response to front-line EGFR-TKI are 5.1 months and 4.9 months (p=0.768), respectively. Detailed data of subgroup analysis regarding EGFR mutation status and clinical characteristics will be presented in the meeting.

      Conclusion
      In pulmonary adenocarcinoma patients who were heavily treated, erlotinib is still a choice whether or not the patient was responsive to previous EGFR-TKI.

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      P2.11-036 - Association Between Tumor EGFR Mutation and primary tumor location in Patients with Adenocarcinoma of the Lungs (ID 2547)

      09:30 - 09:30  |  Author(s): C. Tsai

      • Abstract

      Background
      Lung cancer is the leading cause of cancer death in the world, and the non-small cell lung cancer accounts for more than 80% of the lung cancer. Among patients with non-small cell lung cancer, tumor epidermal growth factor receptor (EGFR) activating mutations were mostly found in patients with adenocarcinoma and were associated with a better prognosis than EGFR wild-type tumors. The relationship between EGFR activating mutations and their primary tumor location in the lungs was not reported before.

      Methods
      We retrospectively reviewed the data of our pulmonary adenocarcinoma patients who had received complete staging and received tumor EGFR mutation analysis. The association between EGFR mutation status, patients smoking status, patient’s gender and primary tumor location were analyzed.

      Results
      205 cases were reviewed. There are 126 patients with tumor EGFR mutations, including 115 patients with classic EGFR mutations (exon 19 deletions or L858R), and 79 patients were without EGFR mutation. There are statistically significant association between tumor EGFR mutations and primary tumor location in right upper lobe (P=0.007); especially in RB1 segment (P=0.018), and primary tumor location of exon 19 deletions occurred more frequently in right upper lobe (P<0.001). There were no significant associations between patients smoking status and primary tumor location(P=0.659), nor was patients gender and primary tumor location (P=0.473).

      Conclusion
      There are statistically significant association between EGFR mutation and primary tumor location in right upper lobe of patients with adenocarcinoma of the lungs.