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Z. Wang



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    MO02 - General Thoracic and Minimally Invasive Surgery (ID 99)

    • Event: WCLC 2013
    • Type: Mini Oral Abstract Session
    • Track: Surgery
    • Presentations: 1
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      MO02.11 - Video-Assisted Thoracic Surgery, Hybrid, versus Open Thoracotomy for Stage I Non-Small Cell Lung Cancer - A Propensity Score Analysis Based on a Multi-institutional Registry (ID 3034)

      11:20 - 11:25  |  Author(s): Z. Wang

      • Abstract
      • Presentation
      • Slides

      Background
      We conducted a multi-institutional study comparing VATS lobectomy to Hybrid, and conventional open lobectomy for unmatched and propensity score-matched patients with stage I NSCLC in an attempt to stratify any potential differences in perioperative outcomes and long-term survival outcomes among the three procedures in patients with stage I NSCLC on a homogeneous well-balanced large population from multi-institutions.

      Methods
      Between January 2001 and December 2008 in eight institutions from the People’s Republic of China, a total of 2485 patients with stage I NSCLC who underwent lobectomy via c-VATS, Hybrid, or open thoracotomy were entered into the current multi-institutional registry. One thousand and fifty-six patients (42.5%) underwent c-VATS lobectomy, 273 patients (11.0%) underwent Hybrid lobectomy, and 1156 patients (46.5%) underwent open lobectomy. Of the patients who attempted to undergo c-VATS lobectomy, 65 were converted to assisted-VATS and 49 patients were converted to open lobectomy.

      Results
      After propensity-matching, c-VATS, Hybrid, and open lobectomy patients were similar in regards to age, gender, histological type and pathological TNM staging. Median operative time was 156.16±17.08 min in open lobectomy group, higher than in c-VATS lobectomy group (145.39±13.1 min) and Hybrid lobectomy group (148.86±11.62) before matching (P<0.001), after matching, it was 154.5±16.89 min, 145.41±12.17 min, and 148.81±11.63 min in open, c-VATS, and Hybrid lobectomy group, respectively (P<0.001). Transfusion occurred in 4 (12.9%) patients in c-VATS group and 6 (19.4%) patients in Hybrid group, both of them lower than in open lobectomy group of 21 (67.7%) patients (P=0.003). However, after matching, there was no statistical difference among three groups, 5 (41.7%) patients, 1 (8.3%) patients, and 6 (50.0%) patients in open, c-VATS, and Hybrid group, respectively (P=0.112). After selecting the propensity-matched patients, the 5-year survival of 78%, 74% and 76% in patients who underwent c-VATS, Hybrid, and open lobectomy, respectively. The perioperative mortality rate was 1.1% for the open group, 1.0% for the Hybrid group, and 0.8% for the VATS group. Two prognostic factors were independently associated with improved survival outcome in multivariate analysis: age < 60 (p = 0.01) and smoking history (p = 0.012). When comparing the three propensity-matched populations, patients who underwent c-VATS lobectomy had similar long-term survival outcomes to patients who underwent Hybrid or conventional thoracotomy (p = 0.770).

      Conclusion
      The present multi-institutional study represents the largest dataset evaluating surgical outcomes of patients who underwent c-VATS or Hybrid for NSCLC. VATS lobectomy for NSCLC was not associated with inferior long-term survival compared to Hybrid or conventional thoracotomy.

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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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      P2.11-002 - A Prospective, Open-labeled, Randomized, Multicenter Phase II Study to Evaluate Efficacy and Safety of Erlotinib vs NP Chemotherapy as Adjuvant Therapy in Post Radical Operation stage IIIA NSCLC Patients With EGFR 19 or 21 Exon Mutation (EVAN, ML28280, NCT01683175) (ID 316)

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

      • Abstract

      Background
      Stage IIIA NSCLC represents a relatively heterogeneous group, which the relative roles of treatment modalities are not clearly defined. Adjuvant chemotherapy remains the most important treatment for stage IIIA NSCLC after radical operation, but the drug-related toxicities limit its use and benefits for patients. The tyrosine-kinase inhibitor might provide a promising treatment for NSCLC patients with EGFR19 or 21 exon mutation. In the OPTIMAL study comparing first-line erlotinib with carboplatin/gemcitabine in advanced NSCLC patients with EGFR activating mutations, the primary analysis showed significantly prolonged progressive free survival in erlotinib treatment in comparison to carboplatin/gemcitabine (p<0.0001). The aim of this study is to investigate the efficacy and safety of erlotinib in comparison to vinorelbin plus cisplatin (NP) chemotherapy as adjuvant therapy in post radical operation stage IIIA NSCLC patients with EGFR19 or 21 exon mutation to explore a new treatment strategy for this subset.

      Methods
      The study was designed as a prospective, open-labeled, randomized, multicenter phase II clinical trial. Patients aged between 18 and 75 with ECOG PS 0–1 IIIA NSCLC confirmed by histopathology or cytology after radical operation and with EGFR exon 19 deletion mutation or exon 21 L858R single base substitution were enrolled (n=94). Within 4 weeks post radical surgery, the enrolled patients would randomly allocated for adjuvant therapy, receiving either erlotinib (n=47) 150mg/day for 2 years or NP (n=47) chemotherapy (vinorelbine 25mg/m2 on day 1, 8 and cisplatinum 75mg/m2 on day 1 of a 3-week schedule ) for 4 cycles. Duration of trial recruitment is estimated to 18 months. Primary endpoint is 2-year disease free survival rate (DFSR). Secondary endpoints are disease free survival (DFS), 3-year and 5-year overall survival (OS), Quality of Life (QOL) and Safety. Biomarker profile will be the exploratory research. Patients after surgery and therapy will receive long-term follow-up including chest and abdominal CT scan every 3 months, brain MRI every 6 months and bone scan every 12 months for up to 2 years.

      Results
      Current recruitment: twenty-five patients have been enrolled since FPI in August, 2012.

      Conclusion
      Adjuvant erlotinib therapy in IIIA-N2 NSCLC with EGFR activating mutation is a promising strategy.