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S. Wang



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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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      P1.10-028 - A Phase II Trial of Erlotinib Versus Pemetrexed as Second-Line Therapy in Treating Patients With Advanced EGFR Wild-Type and EGFR FISH-Positive Lung Adenocarcinoma (ID 1501)

      09:30 - 09:30  |  Author(s): S. Wang

      • Abstract

      Background
      Both erlotinib and pemetrexed are second-line treatment options for patients with advanced non-small cell lung cancer. The value of erlotinib in the second-line setting in lung adenocarcinoma with EGFR wild-type and EGFR gene high polysomy or gene amplification remains unclear. Therefore, we undertook this study to investigate the efficacy and safety of erlotinib versus pemetrexed as second-line therapy in treating patients with advanced EGFR wild-type and EGFR FISH-positive (high polysomy or gene amplification) lung adenocarcinoma.

      Methods
      In this open-label, phase II study, EGFR mutation status was assessed by the amplification-refractory mutation system (ARMS) method and EGFR copy number was assessed by fluorescent in situ hybridization (FISH) method in patients with adenocarcinoma who had progressed during the first-line platinum-doublet. Only patients with EGFR wild-type and EGFR FISH-positive adenocarcinoma were randomly assigned (1:1) to receive erlotinib (250mg, per day, orally) or pemetrexed (500mg/m[2], day 1 of 21-day cycle, intravenously), until disease progression or death, unacceptable toxicity, or a request for discontinuation by the patient. The primary end point was progression-free survival.

      Results
      A total of 123 patients were enrolled (61 in the erlotinib arm and 62 in the pemetrexed arm). Median progression-free survival was 4.1 months (95% confidence interval [CI] 1.6-6.6) in the erlotinib group versus 3.9 months (95% CI 2.7-5.1) in the pemetrexed group, and the 6-month PFS was 45.1% and 38.8%, respectively. The difference in the progression-free survival between the erlotinib and pemetrexed group was not significant (hazard ratio [HR] 0.92; 95% CI 0.62-1.37; P=0.683). Objective response rate appeared to be higher among patients in the erlotinib arm compared with patients in the pemetrexed arm (19.7% vs 8.1%, P=0.062). Overall survival were similar between the two arms (P=0.970). Both regimens were well tolerated. The three most commonly reported adverse events were rash (54.1%) , fatigue (19.7%) and diarrhea (16.4%) in the erlotinib group, while they were fatigue (25.8%), nausea (24.2%) and anorexia (14.5%) in the pemetrexed group.

      Conclusion
      Treatment with erlotinib or pemetrexed demonstrated clinically equivalent efficacy and toxicity in the second-line setting for advanced EGFR wild-type and EGFR FISH-positive adenocarcinoma, although objective response rate appeared to be higher among patients in the erlotinib arm. Clinical trial information: NCT01565538.

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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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      P2.11-021 - Interim outcome analysis of phase II study of neoadjuvant bevacizumab plus pemetrexed and carboplatin in unresectable, locally advanced lung adenocarcinoma (ID 1756)

      09:30 - 09:30  |  Author(s): S. Wang

      • Abstract

      Background
      Locally advanced (III A-bulky N2, III B) lung cancer is often treated with chemotherapy with or without radiotherapy. The VEGF inhibitor bevacizumab has demonstrated clinical activity in advanced lung adenocarcinoma. To explore the role of bevacizumab in the neoadjuvant setting, we performed the phase II trial to assess the safety and efficacy of neoadjuvant bevacizumab plus pemetrexed and carboplatin followed by surgery in conventionally unresectable, locally advanced (III A-bulky N2, III B) lung adenocarcinoma. Here we report interim outcomes.

      Methods
      The single-center, single-arm, phase II study investigates neoadjuvant bevacizumab (7.5mg/kg) plus pemetrexed (500 mg/m[2]) and carboplatin (AUC=5) followed by surgery for patients with unresectable, locally advanced (III A-bulky N2, III B) lung adenocarcinoma. Four cycles of neoadjuvant therapy were planned and neoadjuvant therapy was administered on day 1 of every 21-day cycle. Patients’ resectability was assessed by a medical team (including thoracic surgeons, medical oncologists, and radiologists) and surgery was scheduled 3-4 weeks after last neoadjuvant therapy. Primary and secondary endpoints were resectability rate and perioperative complications.

      Results
      20 patients were enrolled. All patients received bevacizumab plus pemetrexed and carboplatin. Neoadjuvant-related toxicities included: epistaxis (5%), fatigue (30%), infusion reaction (5%), nausea (5%), diarrhea (10%), insomnia (5%), headache (5%); neutropenia (25%), anemia (10%), thrombocytopenia (5%). Grade 3 or above toxicities included fatigue (10%); neutropenia (5%), thrombocytopenia (5%). Complete response was observed in 1 patient, partial response in 8, stable disease in 10, and progressive disease in 1. After neoadjuvant therapy, 14 (70%) patients underwent surgery. Median time between last neoadjuvant therapy and surgery was 25 days (22-28). R0 resection was achieved in 10 patients. No patient died in the perioperative phase. Postoperative complications were manageable and included pneumonia (1 patient), atelectasis (1), subcutaneous emphysema (2), arrhythmia (1). No perioperative hemorrhage events, thromboembolic events and wound-healing problems were observed.

      Conclusion
      The treatment modality of neoadjuvant bevacizumab plus pemetrexed and carboplatin followed by surgery appears to be safe and feasible in patients with unresectable, locally advanced (III A-bulky N2, III B) lung adenocarcinoma. Clinical trial information: NCT01588704.

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    P3.07 - Poster Session 3 - Surgery (ID 193)

    • Event: WCLC 2013
    • Type: Poster Session
    • Track: Surgery
    • Presentations: 1
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      P3.07-026 - A non-interventional study on EGFR mutation status and clinical outcomes of Chinese patients with completely resected lung adenocarcinoma (ICAN study) (ID 2187)

      09:30 - 09:30  |  Author(s): S. Wang

      • Abstract

      Background
      ICAN study (NCT01106781) investigated EGFR mutation status, clinical outcomes and recurrent risk factors in Chinese lung adenocarcinoma (ADC) patients after complete resection. Here we report analysis results for the profile of surgery, adjuvant therapy and 2-year disease free survival (DFS) rate in the real-world practice.

      Methods
      Patients were aged ≥18 years, with histological diagnosed lung ADC, and received surgical complete resection. Tumor sample EGFR mutation status was determined according to clinical routine practice. All eligible patients would be followed up to collect the clinical information and the outcomes till 3 years after operation.

      Results
      Of 571 patients from 26 sites, 315 (55.2%) patients were EGFR mutation positive. The most common mutations were exon19 deletion and L858R mutation found in 140 (24.52%) and 132 (22.59%) patients respectively. There were 50.79% of patients who received adjuvant therapy, in which 45.37% received chemotherapy, 4.55% received radiotherapy and 1.93% received TKI therapy, respectively. The 2-year DFS rate was 68.83%. There was statistically significant difference of 2-year DFS among the patients with different postoperative pathologic stage (P <0.0001). There was no statistically significant difference of 2-year DFS among the patients with age, gender, smoking history and EGFR mutation status. Operation method and adjuvant therapy correlated significantly with 2-year DFS, but was not significant when adjusted for postoperative pathologic stage.

      Conclusion
      The overall EGFR mutation positive rate in operable Chinese ADC was 55.2%. 2-year DFS rate was 68.83%. Postoperative pathologic stage had a statistically significant association with 2-year DFS, while age, gender, smoking history and EGFR mutation status didn’t show statistically significant association.