Virtual Library

Start Your Search

Dennis Wigle



Author of

  • +

    P2.04 - Immuno-oncology (ID 167)

    • Event: WCLC 2019
    • Type: Poster Viewing in the Exhibit Hall
    • Track: Immuno-oncology
    • Presentations: 1
    • Moderators:
    • Coordinates: 9/09/2019, 10:15 - 18:15, Exhibit Hall
    • +

      P2.04-89 - Neoadjuvant Pembrolizumab in Early Stage Non-Small Cell Lung Cancer (NSCLC): Toxicity, Efficacy, and Surgical Outcomes (ID 1941)

      10:15 - 18:15  |  Author(s): Dennis Wigle

      • Abstract

      Background

      Pembrolizumab is a programmed death receptor-1 masking antibody approved for advanced NSCLC in program death receptor ligand-1 high tumors, and in chemotherapy combinations. This trial studies the effect of neoadjuvant pembrolizumab on surgical tolerability (primary endpoint), tumor response, side effects, and immune biomarkers in blood and tumor.

      Method

      Baseline PET/CT, brain imaging, histologic diagnosis NSCLC, and surgical consultation were required for eligibility. Patients with stage T > 3 cm and N0, N1, or resectable N2 NSCLC received neoadjuvant pembrolizumab 200 mg every 21 days 2 cycles prior to pre-operative chest CT scan followed by standard surgery. Adjuvant chemotherapy was strongly encouraged but not required. After completion of standard chemotherapy, 4 cycles of adjuvant pembrolizumab 200 mg every 21 days was offered. Blood for immune profiling of circulating immune cells was collected at baseline, after cycle 2 pembrolizumab, after surgery, and after adjuvant pembrolizumab. Excess tumor was disaggregated for tumor infiltrating lymphocytes, regulatory immune cells, and tumor cells, and viably stored for later analysis. We report clinical outcomes of tumor response and surgical outcomes.

      Result

      Study activated 31/1/2017, last enrollment 6/2/2019, and last surgery 19/3/2019. 35 patients signed consent and 30 received at least 1 dose pembrolizumab: 2 withdrew consent, 3 screen failed. Characteristics of 30 treated patients (%): male 16 (53), adenocarcinoma 10 (33), squamous 17 (57), other histology 3 (10), and stages 1B 8 (27), IIA 8 (27), IIB 6 (20), IIIA 8 (27). Planned surgery completed for 25/30 (83%). Reasons for not undergoing surgery: distant metastatic disease (1 brain metastases, 2 pleural metastases), 1 would not tolerate required pneumonectomy, 1 N3 nodal disease. Surgeries performed: video-assisted thoracic surgery (VATS) lobectomy 12, thoracotomy lobectomy 9, VATS pneumonectomy 2, thoracotomy pneumonectomy 1, and VATS bilobectomy and chest wall resection 1. All surgery was performed within range 38-77 days (median 48 days) after cycle 1 day 1 pembrolizumab. Data will be presented for toxicities neoadjuvant pembrolizumab, surgical outcomes, and neoadjuvant pembrolizumab RECIST responses, and pathologic responses. Some major pathologic responses (< 10% viable tumor) and at least 2 pathologic CRs were observed.

      Conclusion

      Two doses of neoadjuvant pembrolizumab was tolerable and produced major or complete pathologic responses in some tumors. Neoadjuvant pembrolizumab is tolerable and is an ideal platform to investigate mechanisms of immune resistance and sensitivity in early stage NSCLC.