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G. Jiang



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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)

      10:30 - 12:00  |  Author(s): G. Jiang

      • 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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    P1.09 - Poster Session 1 - Combined Modality (ID 212)

    • Event: WCLC 2013
    • Type: Poster Session
    • Track: Combined Modality
    • Presentations: 1
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      P1.09-016 - A single arm, multi-center, phase II study of intercalated erlotinib with gemcitabine/cisplatin as neoadjuvant treatment in stage IIIA non-small cell lung cancer (CTONG 1101, NCT01297101): preliminary result (ID 2041)

      09:30 - 16:30  |  Author(s): G. Jiang

      • Abstract

      Background
      The optimal treatment for stage IIIA non-small cell lung cancer (NSCLC) disease is not well established with only 15% of 5-year survival rate, probably due toalready micro-metastatic lesion at the diagnosis. Thus, neoadjuvant therapy might be a good choice for IIIA NSCLC patients. The treatment modality of EGFR (TKI) intercalated with chemotherapy has been demonstrated to significantly improve objective response rate (ORR), progression free survival(PFS) and overall survival (OS) in advanced NSCLC patients with or without activating EGFR mutations. The objective of this study is to assess the efficacy and safety profile of intercalated erlotinib with gemcitabine/cisplatin as neoadjuvant treatment in stage IIIA NSCLC.

      Methods
      This is a single arm, multi-center, clinical phase II trial. Patients with untreated stage IIIA bulky N2 NSCLC and ECOG PS 0/1 were enrolled to received up to 2 cycles of gemcitabine 1,000 mg/m[2] on days 1 and 8 and cisplatin 75 mg/m[2] on day 1 or carboplatin AUC=5 d1, followed by oral erlotinib (150 mg, once a day) on days 15 to 28 as neoadjuvant therapy. A repeat computed tomography (CT) scan evaluated the response after induction therapy and eligible patients would undergo surgical resection. The primary endpoint was ORR, and secondary endpoints included pCR, resection rate, DFS (disease free survival) and OS , safety, QoL and biomarker analyses. Subgroup analysis of ORR by EGFR mutation status was also performed

      Results
      Between March 2011 and December 2012, a total of 39 patients were enrolled in the study, in which 36 patients (92.3% ITT population) have completed 2-cycle neoadjuvant treatment. According to Response Evaluation Criteria in Solid Tumors (RECIST) criteria, 18 patients achieved partial response (PR) (ORR=46.2%) and 18 patients achieved stable disease (SD) (DCR=92.3%); 22(56.4%) patients underwent resection with 18 R0 (46.2%), 2 R1(5.1%),1 R2(2.6%),1 NE(2.6%). Fifteen patients have had EGFR mutation test, with 7 EGFR mutation and 8 EGFR wild type. ORR in patients with EGFR mutations and wild type was 85.7%(6/7) vs. 50%(4/8), respectively. Common toxicities included myelosuppression (38.5%), rash (28.2%), neutropenia (5.1%), alanine transaminase (ALT) elevation(5.1%), diarrhea(5.1%) , fatigue(2.6%) and alopecia(2.7%) . Five (12.8%) patients suffered from CTCAE ≥3. No CTCAE ≥4 complications were recorded perioperatively.

      Conclusion
      Two cycles of intercalated administered gemcitabine/cisplatin with erlotinib as an induction treatment is a feasible and efficacious approach for stage IIIA NSCLC, which provides evidence for the further investigation.