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: 3
  • Moderators:
  • Coordinates: 10/30/2013, 09:30 - 16:30, Exhibit Hall, Ground Level

  • 12606

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    P3.10-014 - Efficacy and Safety of docetaxel plus oxaliplatin as a first-line chemotherapy in patients with advanced or metastatic Non-small-cell Lung Cancer (ID 1285)

    09:30 - 09:30  |  Author(s): B. Lee
    • Abstract

    Background
    Platinum doublets are standard first-line treatment of stage IV non-small-cell lung cancer (NSCLC) without targetable driver mutations such as EGFR or ALK. Oxaliplatin is known to be more potent than cisplatin, requiring fewer DNA adducts to provide equivalent cytotoxicity. The objective of this study is to evaluate the efficacy and safety of oxaliplatin combined with docetaxel as a first line treatment of stage IV NSCLC.

    Methods
    This is prospective, single-center, phase II trial. Patients with chemotherapy-naive NSCLC received docetaxel 60mg/㎡ (day 1) and oxaliplatin 70mg/㎡ (day 2) every 3 weeks for up to 6 cycles. The primary endpoint was objective response rate (ORR) and the secondary endpoints were progression-free survival (PFS), overall survival (OS) and safety. Treatment response was evaluated according to RECIST version 1.1.

    Results
    Thirty three patients were enrolled and response evaluation is available in 30 patients at the present time. There were 10 partial responses, 16 stable diseases. ORR was 33.3% and disease control rate was 86.7%. Median PFS was 127 days (95% confidence interval, 59~195) and median OS was 394 days (95% confidence interval, 264~524). Grade 3-4 toxicities occurred in 45% of patients, and the most common hematologic toxicity was neutropenia. There were two cases of hyperglycemia and sepsis.

    Conclusion
    This study suggests that the combination of oxaliplatin and docetaxel is effective in patients with NSCLC, with reasonable toxicities. (ClinicalTrials.gov Identifier: NCT01243775)

  • 12623

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    P3.10-031 - Comparative Study Between Belotecan/Cisplatin and Etoposide/Cisplatin (COMBAT) in Patients with Previously Untreated, Extensive Stage Small Cell Lung Cancer (ID 1896)

    09:30 - 09:30  |  Author(s): B. Lee
    • Abstract

    Background
    Belotecan (camtobell™) is a topoisomerase I inhibitor, and effective in small cell lung cancer (SCLC). The objective of this study is to compare the efficacy and safety of belotecan+cisplatin (BP) and etoposide+cisplatin (EP) in first line setting.

    Methods
    This is a multicenter, randomized, prospective controlled trial to prove non-inferiority of BP compared to standard EP regimen. The primary endpoint is overall response rate (ORR), and secondary endpoints are toxicity, overall survival (OS) and progression-free survival (PFS). BP was administrated by belotecan 0.5 mg/㎡ for 4 days combined with cisplatin 60 mg/㎡ only for first day. Treatment response was evaluated according to version 1.0 of Response Evaluation Criteria in Solid Tumors.

    Results
    A total of 147 (BP: 71, EP: 76) patients were randomly assigned and received study drug at least once. In BP arm, there were 1 complete response, 41 partial responses (PR), 17 stable diseases (SD), and there were 35 PR and 28 SD in EP arm. Non-inferiority of BP compared to the EP arm was confirmed by the ORR (BP: 59.2%, EP: 46.1%, 90% confidence interval -0.3 to 26.5, meeting the predefined non-inferiority criterion). Median OS (BP: 360, EP: 305 days, p=0.21) and PFS (BP: 190, EP: 172 days, p=0.37) were not significantly different. The mean relative dose intensity was significantly different (BP: 0.79, EP: 0.86, p<0.01). The frequency of grade ≥ 3 anemia (BP: 34.3%, EP: 13.0%, p<0.01) and thrombocytopenia (BP: 54.3%, EP: 16.9%, p=<0.01) were higher in BP arm.

    Conclusion
    In extensive stage SCLC, ORR of BP was not inferior to EP and there was no difference of survival. But anemia and thrombocytopenia were more frequent in BP arm. (ClinicalTrials.gov number, NCT00826644)

  • 12630

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    P3.10-038 - The efficacy and safety of Pemetrexed after the failure of gefitinib in patients with adenocarcinoma with EGFR mutation. (ID 2206)

    09:30 - 09:30  |  Author(s): B. Lee
    • Abstract

    Background
    Patients with epidermal growth factor receptor(EGFR) mutation positive adenocarcinoma exhibited marked response to gefitinib. In most cases, the patients showed disease progression after EGFR-tyrosine kinase inhibitor treatment. We evaluated the efficacy and safety of pemetrexed after the failure of gefitinib in patients with adenocarcinoma with EGFR mutation.

    Methods
    Patients harvoring EGFR-mutant stage IV adenocarcinoma that progressed during gefitinb were administered pemetrexed after discontinuing of gefitinib treatment. We retrospectively analysed the efficacy of pemetrexed monotherapy.

    Results
    Retrospectively, we analysed the 41 patients in this study. All patients were treated with gefitinib as the first line and treated as the 2[nd] line with pemetrexed monotherapy. The median number of treatment cycles was 3.15±2.1 cycles. Overall response rate was 2.6% (95% confidence interval, 0%-7.9%) and disease control rate was 23.7% (95% confidence interval, 10.5%-39.4%). Grade 3/4 hematological toxicities were neutropenia (5.2%), leucopenia (5.2%), anemia (5.3%), and thrombocytopenia (2.6%). Grade 4 non-hematological toxicities and chemotherapy related death were not observed.

    Conclusion
    Pemetrexed shows unfavorable result to patients with acquired drug resistance after EGFR-tyrosine kinase inhibitor treatment. We will have to study the efficacy of pemetrexed after EGFR-TKI treatment prospectively.