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J.Y. Hong



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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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      P1.10-037 - A retrospective comparison of adjuvant chemotherapeutic regimen for non-small cell lung cancer (NSCLC): Paclitaxel plus platinum versus Vinorelbine plus Cisplatin (ID 2176)

      09:30 - 09:30  |  Author(s): J.Y. Hong

      • Abstract

      Background
      Adjuvant vinorelbine/cisplatin (VC) has been demonstrated to increase overall survival in patients with AJCC 6th stage II/IIIA non-small cell lung cancer (NSCLC). Although adjuvant paclitaxel/carboplatin failed to demonstrate its efficacy in a study which enrolled only patients with AJCC 6th stage IB NSCLC, the exploratory analysis showed that patients with large tumor (≥ 4cm) got survival benefits from this regimen. We need to compare the clinical outcomes of these two regimens as adjuvant chemotherapy for NSCLC, since the previous prospective trials used different eligible stage criteria and AJCC stage system was recently updated.

      Methods
      We retrospectively analyzed patients with surgically completely resected NSCLC between December 2004 and December 2011. They received adjuvant chemotherapy using either paclitaxel/platinum (PP) or VC. Clinicopathological parameters, survivals including disease free survival (DFS) and overall survival (OS) and toxicity between two groups were compared. All tumor stages were updated based on the AJCC 7th edition.

      Results
      Of the 467 patients with surgically resected NSCLC, 236 received PP (paclitaxel/cisplatin, n=29; paclitaxel/carboplatin, n=206) and 231 patients got VC (n= 231). Two groups were well balanced with regard to demographics, histology, stage and type of surgery. Efficacy was comparable between two regimens: DFS (PP vs. VC: 65 vs. 55 months; p=0.42) and OS (73 vs 58 months; P=0.37). Regarding the adverse events, sensory neuropathy (41% vs. 11%), alopecia (19% vs. 4%), and myalgia (32% vs. 5%) are more frequent in the PP group, while anemia (71% vs. 87%), neutropenia (22% vs. 71%), fatigue (11% vs. 18%), anorexia (19% vs. 41%), and vomiting (9% vs. 19%) are more frequent in the VC group.

      Conclusion
      Although the adverse event profiles were different, the efficacy data in terms of DFS and OS were comparable between the two adjuvant regimens. Therefore, both regimens are appropriate as the adjuvant chemotherapy for NSCLC, and the selection can be done personally according to the expected profiles of adverse events.

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

    • Event: WCLC 2013
    • Type: Poster Session
    • Track: Medical Oncology
    • Presentations: 1
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      P2.11-030 - Is there any predictor for clinical outcome in EGFR mutant<br /> NSCLC patients treated with EGFR TKIs ? (ID 2202)

      09:30 - 09:30  |  Author(s): J.Y. Hong

      • Abstract

      Background
      Tyrosine kinase inhibitors (TKI) of the epidermal growth factor receptor (EGFR) have demonstrated dramatic response rate and prolonged progression-free survival (PFS) in advanced non-small cell lung cancer (NSCLC) patients with activating EGFR mutation. However, PFS and overall survival (OS) among those patients who were treated with EGFR TKIs are variable. In this study, we evaluated predictors of clinical outcome in EGFR mutant NSCLC patients treated with EGFR TKIs.

      Methods
      From January 2008 to December 2010, a total of 148 patients who had metastatic or recurrent NSCLC with activating EGFR mutation treated with either erlotinib or gefitinib as a first-line (n=10) and a second-line or more treatment (n=138) were retrospectively reviewed. The first analysis with a total 148 patients and subgroup analysis with patients who had received EGFR TKIs as second-line treatment (n=105) were undertaken to identify any difference in the clinical and molecular features among those patients who were treated with EGFR TKIs.

      Results
      Median follow-up duration was 21.9 months (range, 1.1-62.5) and median number of cycles was 7 (range, 1-44). The median PFS and OS for a total 148 patients were 10.6 months (95% CI, 9.0-12.2) and 21.8 months (95% CI, 18.5-25.1), respectively. The survival outcomes were similar between first-line and second-line or more line of treatment of EGFR TKIs (p=0.512 for PFS, p=0.699 for OS). A high number of metastasis sites (3-6 versus 1-2) was associated with shorter PFS and OS (median PFS 9.9 vs. 11.9 months, p=0.019; median OS 16.4 vs. 22.2 months, p=0.021, respectively) in univariate analysis, but not in multivariate analysis. According to the clinical and molecular markers by multivariate analysis, there were no significant differences in PFS. When PFS was dichotomized by median 11 months for 105 patients treated with EGFR TKIs as second-line therapy, no significant differences in any clinical or molecular features were found between longer PFS and shorter PFS groups.

      Conclusion
      Despite the heterogeneity in PFS among EGFR mutant patients treated with EGFR TKIs, no significant differences of clinical features were noted, suggesting more understanding of the variability of underlying biology should be needed.

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    P3.11 - Poster Session 3 - NSCLC Novel Therapies (ID 211)

    • Event: WCLC 2013
    • Type: Poster Session
    • Track: Medical Oncology
    • Presentations: 2
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      P3.11-035 - An Open Label Compassionate Use Programme of BIBW 2992/afatinib in Advanced Non-Small Cell Lung Cancer Patients Pre-treated with Erlotinib or Gefitinib in Korea (ID 3028)

      09:30 - 09:30  |  Author(s): J.Y. Hong

      • Abstract

      Background
      Afatinib is a potent and selective, irreversible ErbB family blocker. Previous phase 3 trial demonstrated that afatinib prolonged progression-free survival compared with placebo in patients with advanced lung adenocarcinoma who progressed after 12 weeks of treatment with reversible EGFR tyrosine-kinase inhibitors (TKIs). The purpose of this Open Label Compassionate Use Programme is to provide afatinib to patients with advanced NSCLC with previous treatment failure on erlotinib or gefinitib and for whom no other approved treatment is available.

      Methods
      who have failed at least one line of platinum-based cytotoxic chemotherapy and following at least 6 months on erlotinib or gefinitib were eligible. Thestarting dose of afatinib was 50mg daily.

      Results
      Between Aug 2011 and Dec 2012, 107 patients were treated with afatinib. Most patients were females (60.7%) and never-smokers (69.2%) with a median age of 57 years. Of the 95 patients who had prior EGFR mutation results, 82 (86.3%) were positive. With afatinib treatment 25 (23.4%) of 107 patients had a partial response. Median progression-free survival was 4.6 months (95% CI 4.1-5.1). The most common adverse events were diarrhea (97 [90.7%] patients; 22 [20.6%] were grade 3) and rash or acne (72 [67.3%] patients; 11 [10.3%] were grade 3). No drug-related death was found. Sixty-four (59.8%) patients needed a dose reduction because of an adverse event.

      Conclusion
      Our results suggested that afatinib could be a feasible option to patients with advanced lung adenocarcinoma who have progressed after clinical benefit on previous EGFR TKIs.

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      P3.11-036 - Comparison of Clinical Outcome between Gefitinib and Erlotinib treatment in patients with non-small cell lung cancer harboring an epidermal growth factor receptor exon 19 or exon 21 mutations (ID 2599)

      09:30 - 09:30  |  Author(s): J.Y. Hong

      • Abstract

      Background
      Gefitinib and Erlotinib are oral small-molecule kinase inhibitors that inhibit signaling via EGFR and both agents showed dramatic response rate and prolonged PFS in patients harboring activating EGFR mutation. We investigated the clinical outcomes between gefitinib- and erlotinib-treated patients with recurrent or metastatic non-small cell lung cancer (NSCLC) harboring EGFR mutations.

      Methods
      A total 375 patients with recurrent or metastatic stage IIIB/IV NSCLC who had either an exon 19 deletion or L858R mutation on exon 21 and received gefitinib(n=228) or erlotinib(n=147) therapy between August 2007 and December 2011 were retrospectively reviewed. By using a matched-pair case-control study design, 121 pairs of gefitinib-treated and erlotinib-treated patients were matched according to sex, smoking history, ECOG performance status, and types of EGFR mutation.

      Results
      The median age of all patients was 58 years(range, 30-84) and more than half of patients were never smokers(63.6%). Most patients had adenocarcinoma (98.3%) and good ECOG performance status (0, 1) (90.9%). The median number of cycles in TKI treatment was 12.7 in gefitinib group and 10.8 in erlotinib group. Of 242 patients, 64(26.4%) received an EGFR TKI as first line therapy. The overall response rates and disease control rates in the gefitinib-treated and erlotinib-treated groups were 85.5% versus 79.8 % (p=.375) and 94.0% versus 89.1%, respectively (p=.242). There was no statistically significant difference noted with regard to OS (median, 22.1 vs 25.2; p=.546) and PFS (median, 12.5 vs 9.9; p=.114) between the gefitinib-treated and erlotinib-treated groups. For a subgroup which patients were treated with TKI as first line therapy, the overall response rates were higher than those of patients who had progressed on prior chemotherapy (90.3% vs 79.9%; p=.063). However, there was no significant differences in PFS (median, 13.1 vs 10.1; p=.082) between subjects with first line TKI therapy and more than second line treatment. Regarding safety and dose adjustment of EGFR TKIs, patients with erlotinib more frequently had G3/4 toxicity than ones with gefitinib and required dose reduction(18.1% vs 1.65%).

      Conclusion
      Both gefitinib and erlotinib showed similar effective activity in selected population of NSCLC that harbored an EGFR mutation and further studies are needed to evaluate the efficacy of EGFR TKI as first line treatment.