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N. Li



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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): N. Li

      • 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.