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J. He



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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): J. He

      • 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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    MO05 - Prognostic and Predictive Biomarkers II (ID 95)

    • Event: WCLC 2013
    • Type: Mini Oral Abstract Session
    • Track: Medical Oncology
    • Presentations: 1
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      MO05.07 - Nomogram combining clinicopathologic factors and molecular markers for predicting survival in patients with resected non-small cell lung cancer (ID 3317)

      16:55 - 17:00  |  Author(s): J. He

      • Abstract
      • Presentation
      • Slides

      Background
      Nomogram is a recognized method for individually predicting prognosis of cancer patients through combining various significant prognostic factors. Although the prognostic value of molecular biomarkers has been well studied, previous published nomograms are basically built based on only clinical factors. We sought to combine the clinicopathologic variables with the molecular markers to develop a more precise nomogram for predicting survival for early stage NSCLC patient who underwent surgery.

      Methods
      Based on data from the China Clinical Trials Consortium (CCTC) that included 1038 patients with resected NSCLC for whom the 14-gene molecular assay (BAG1, BRCA1, CDC6, CDK2AP1, ERBB3, FUT3, iL11, LCK, RND3, SH3BGR, WNT3A with ESD, TBP and YAP as internal reference) was tested, we conducted multivariate stepwise Cox regression analyses to identify significant factors which were then integrated to establish the nomogram. Nomogram based on clinicopathologic variables only (c-nomogram) or both clinical and molecular factors (cm-nomogram) were established respectively. Eighty percents of randomly sampled data were used to build the nomogram while the remaining data were used to validate it. The predictive accuracy and discriminative ability of the nomogram was determined by concordance index (C-index). Risk group stratification within a certain stage was proposed for the nomograms.

      Results
      We identified 15 independent prognostic factors, including 7 clinicopathologic variables (age, sex, histology, differentiation, tumor location, T and N stage) and 8 genes (with only CDK2AP1, FUT3, iL11, BAG1, CDC6, and RND3 were selected), then incorporated them to build the nomogram (Figure 1). The calibration curves for probability of 1, 3, 5-year overall survival (OS) showed good concordance between prediction by nomograms and actual observation in the validation set. The C-index of the cm-nomogram was statistically higher than that of the 7[th] edition TNM stage for predicting survival (0.72 vs 0.66, P=0.02) whereas the c-nomgram did not show superior performance than TNM stage system (0.69 vs 0.66, P=0.463). The stratification into three risk groups according to cm-nomogram allows significant distinction between Kaplan-Meier curves in each TNM stage respectively (P<0.01 for all stages, Figure 2).Figure 1

      Conclusion
      We developed a novel and validated nomogram that combines clinicopathologic factors and molecular markers, which provided more accurate predictions for OS of resected NSCLC patients compared with the TNM staging system and nomogram considering only clinical variables. This prognostic model lent support to clinicians and patients in decision making. In addition, it indicated that it is feasible and essential to incorporate molecular markers when building a nomogram to obtain more accurate prediction.

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    MO06 - NSCLC - Chemotherapy I (ID 108)

    • Event: WCLC 2013
    • Type: Mini Oral Abstract Session
    • Track: Medical Oncology
    • Presentations: 1
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      MO06.13 - BEYOND: a randomized, double-blind, placebo-controlled, multicentre, phase III study of first-line carboplatin/paclitaxel (CP) plus bevacizumab (Bv) or placebo (Pl) in Chinese patients with advanced or recurrent non-squamous non-small cell lung cancer (NSCLC) (ID 2756)

      17:25 - 17:30  |  Author(s): J. He

      • Abstract
      • Slides

      Background
      Bevacizumab, a monoclonal antibody that inhibits angiogenesis via the vascular endothelial growth factor (VEGF) pathway, has proven efficacy in extending overall survival (OS) (Sandler et al, 2006) and progression-free survival (PFS) (Sandler et al, 2006; Reck et al, 2009) when added to platinum-doublet chemotherapy as first-line treatment for advanced non-squamous NSCLC. These pivotal studies included mainly Caucasian patients, however subgroup analyses in Asian patients also reported efficacy of the first-line Bv+CP regimen (Reck et al, 2009). The BEYOND study was initiated to confirm efficacy in a Chinese population.

      Methods
      Patients aged ≥18 years with histologically or cytologically confirmed, locally advanced, metastatic or recurrent advanced non-squamous NSCLC and an ECOG performance status of 0–1 were randomised 1:1 to receive CP (paclitaxel 175mg/m[2] i.v. and carboplatin AUC6 i.v. on day 1 of each 3-week cycle for up to 6 cycles), plus either Pl or Bv 15mg/kg i.v. on day 1 of each cycle, until progression, unacceptable toxicity, withdrawal of patient consent or death. Patients had no prior treatment for advanced NSCLC. Patients were stratified by gender, smoking status and age. The primary endpoint was PFS in the intent-to-treat (ITT) population; secondary endpoints included objective response rate (ORR), OS, exploratory biomarkers and safety. Collection of blood samples for biomarker analyses was mandatory (at baseline, every two cycles during treatment, at progression, and 4–6 weeks post-progression); tissue samples were optional.

      Results
      276 patients were randomised into the study, 138 to each arm. Baseline characteristics were similar in both treatment groups. PFS was prolonged with Bv+CP versus Pl+CP: hazard ratio 0.40 (95% CI 0.29–0.54); median 9.2 versus 6.5 months; p<0.0001 (ITT population). ORR was also improved with the addition of Bv to CP: 54.4% versus 26.3% with Pl+CP. Disease control rate was 94.4% versus 88.7% with Bv+CP and Pl+CP, respectively. Median duration of response was 8.0 months with Bv+CP versus 5.3 months with Pl+CP. OS data are not yet mature. Safety data were similar to previous studies of Bv+CP in NSCLC; no new safety signals were observed. Treatment discontinuation due to adverse events was 18.4% (Bv+CP) and 15.0% (Pl+CP). Treatment-related deaths were low in both arms (Bv+CP: 2.2%; Pl+CP: 0.0%). Detailed safety data and biomarker analyses will be reported.

      Conclusion
      This study confirms that the addition of bevacizumab to first-line platinum-based chemotherapy appears to provide similar PFS benefits in Chinese patients with advanced non-squamous NSCLC compared with global populations. No new safety concerns were reported.

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    MO22 - Advanced Disease and Outcomes (ID 103)

    • Event: WCLC 2013
    • Type: Mini Oral Abstract Session
    • Track: Surgery
    • Presentations: 1
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      MO22.09 - Thoracoscopic half carina resection and bronchial sleeve resection for central lung cancer (ID 2083)

      11:20 - 11:25  |  Author(s): J. He

      • Abstract
      • Presentation
      • Slides

      Background
      The objectives of this study were to report the surgical techniques and clinical outcome of thoracoscopic half carina resection and thoracoscopic bronchial sleeve resection for central lung cancer.

      Methods
      Between January 2011 and November 2012, 675 patients with lung cancer underwent radical surgery by thoracoscopy, 49 (7.3%) underwent bronchial sleeve resection. Among 49 patients, 20 (41%) received thoracoscopic bronchial sleeve lobectomy. Perioperative variables and postoperative outcomes of these cases were analyzed to evaluate the technical feasibility and safety of this operation.

      Results
      In one patient, right upper lung sleeve resection was combined with half-carinal resection and reconstruction. In another, right medial lung sleeve resection was combined with lower right dorsal segment resection. The average time of surgery was 239 min (range, 142-330 min, 239±51 min), and the average time of airway reconstruction was 44 min (range, 22-75 min, 44±17 min). The intraoperative blood loss averaged 207 ml (range, 80-550 ml, 207±96 min). The median postoperative hospital stay was 10 days (interquartile range, 8-12 days). Postoperatively, extubation was achieved in the recovery room without further need for mechanical ventilation. None of the patients developed anastomotic leak. Perioperative mortality was not observed.

      Conclusion
      Thoracoscopic bronchial sleeve resection can be considered a feasible and safe operation for selected patients with central lung cancer. The complicated anastomosis technique of half carina resection was feasible.

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    P1.07 - Poster Session 1 - Surgery (ID 184)

    • Event: WCLC 2013
    • Type: Poster Session
    • Track: Surgery
    • Presentations: 4
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      P1.07-027 - VATS lobectomy for non-small cell lung cancer in patients with severe COPD (ID 2127)

      09:30 - 09:30  |  Author(s): J. He

      • Abstract

      Background
      To assess the feasibility, safety and long-term outcomes of video-assisted thoracic surgery (VATS) lobectomy for the treatment of non-small cell lung cancer (NSCLC) in patients with severe COPD.

      Methods
      The clinical data of patients with NSCLC and severe COPD (preoperative FEV1% <50%) who underwent VATS lobectomy from January 2000 to January 2011 were retrospectively analyzed to identify their demographic parameters, postoperative complications and outcomes.

      Results
      The preoperative FEV1/FVC was <70% and FEV1% <50% in all 61 patients in this study, with a mean preoperative FEV1 of 0.99 L (0.54-1.58 L) and mean FEV1% of 38.4% (22-49.82%). All of the 61 patients underwent the VATS lobectomy or sleeve resection plus systemic lymph node dissection. The mean operative time was 218 minutes (120-355 minutes), with a mean intraoperative blood loss of 342 ml (50-1600 ml). None of the patients converted to thoracotomy. Multivariate statistical analysis revealed that age and TNM staging after tumor resection were independent predictive factors for the 5-year survival in those patients (p=0.014 and 0.013).

      Conclusion
      With preoperative imaging studies, pulmonary function assessment and target positioning, VATS leboectomy can be safely and effectively performed for patients with NSCLC and severe COPD to achieve a satisfying long-term survival outcome.

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      P1.07-028 - Thoracoscopic minimally invasive surgery for non-small cell lung cancer in patients with chronic obstructive pulmonary disease (ID 2148)

      09:30 - 09:30  |  Author(s): J. He

      • Abstract

      Background
      To determine the incidence of peri-operative complications in non-small cell lung cancer (NSCLC) patients with co-existent chronic obstructive pulmonary disease (COPD) who undergo lung resection via traditional and minimally invasive techniques.

      Methods
      A retrospective analysis was conducted of 152 NSCLC patients with COPD who underwent thoracoscopic minimally invasive surgery. Particular attention is given to the relationship between disease severity or surgical approach and the incidence of complications.

      Results
      The prevalence of respiratory and cardiac complications was significantly higher in patients with severe/extremely severe COPD than those with mild to moderate COPD (respiratory compications: 37.3% vs. 20.4%, P=0.022; cardiac complictions: 16.9% vs. 6.5%, P=0.040). Patients who underwent complete-video assisted thoracoscopic surgery (c-VATS) had a significantly lower overall morbidity of adverse reactions than those who had undergone VATS major resection surgery (26.3% vs. 42.1%, P=0.044). Among patients with severe/extremely severe COPD, there was no significant difference in the incidence of any complication between the lobectomy group and wedge resection group (38.8% vs. 70.0%, P=0.072). Overall, the occurrence of adverse reactions was significantly lower in patients who underwent c-VATS than in those who had undergone VATS major resection surgery (34.2% vs. 61.9%, P=0.038).

      Conclusion
      VATS techniques are suitable for COPD patients and are demonstrated here to lower the incidence of post-operative complications when compared with more invasive approaches. Minimally invasive approaches should be considered in patients with COPD who are deemed high risk for curative surgery by traditional techniques.

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      P1.07-029 - Nomogram for predicting survival in patients with resected non-small cell lung cancer (ID 2979)

      09:30 - 09:30  |  Author(s): J. He

      • Abstract

      Background
      Nomogram is a widely used tool for cancer prognosis due to its improved individual prediction of survival through combining various significant prognostic factors. The objective of this study was to develop a clinical nomogram for predicting survival for patient with resected non-small cell lung cancer (NSCLC).

      Methods
      Based on data from a multi-institutional registry for 6111 patients with resected NSCLC at China between January 2001 and December 2008, we performed univariate and multivariate stepwise Cox regression analyses to identify survival prognostic factors, which were then integrated to build the nomogram. Seventy-five percents of randomly sampled data were used to build the nomogram while the remaining data were used to validate the model. The predictive accuracy and discriminative ability of the nomogram was determined by concordance index (C-index). Risk group stratification within a certain stage was proposed for the nomograms.

      Results
      Among 26 clinical variables, 13 independent prognostic factors finally entered the nomogram (Figure 1), including age, sex, histology, tumor location, operation type, assess to complete video-assisted thoracoscopic surgery (VATS), primary tumor (T) stage, lymph nodes (N) stage, TN stage, number of dissected lymph nodes, blood loss volume, and complications. The calibration curves for probability of 1, 3, 5, 10-year overall survival (OS) represented good agreement between prediction by nomogram and actual observation in the validation set. The C-index of the nomogram was statistically higher than that of the 7[th] edition TNM stage for predicting survival (0.71 vs 0.66, P=0.01). The stratification into different risk groups allows significant distinction between Kaplan-Meier curves for survival outcomes in each TNM stage respectively (P<0.01 for all stages, Figure 2).Figure 1

      Conclusion
      We developed a novel and validated clinical nomogram that could provide individual and more accurate predictions for OS of resected NSCLC patients compared with the TNM staging system. This prognostic model may support clinicians and patients in decision making, such as to identify those with higher risk for poor prognosis.

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      P1.07-033 - Video-Assisted Thoracoscopic Surgery (VATS) Lobectomy: A Consensus Statement (ID 2246)

      09:30 - 09:30  |  Author(s): J. He

      • Abstract

      Background
      Video-assisted thoracoscopic surgery (VATS) lobectomy has been gradually accepted as an alternative surgical approach to open thoracotomy for selected patients with non-small cell lung cancer (NSCLC) over the past 20 years. The aim of this project was to standardize the perioperative management of VATS lobectomy patients through expert consensus and to provide insightful guidance to clinical practice.

      Methods
      A panel of 55 experts on VATS lobectomy was identified by the Scientific Secretariat and the International Scientific Committee of the ‘20[th] Anniversary of VATS Lobectomy Conference – The Consensus Meeting’. The Delphi methodology consisting of two rounds of voting was implemented to facilitate the development of consensus. Results from the second-round voting formed the basis of the current Consensus Statement. Consensus was defined a priori as more than 50% agreement amongst the panel of experts. Clinical practice was deemed ‘recommended’ if 50-74% of experts reached agreement and ‘highly recommended’ if 75% or more of experts reached agreement.

      Results
      Fifty VATS lobectomy experts (91%) from 16 countries completed both rounds of standardized questionnaires. No statistically significant differences in the responses between the two rounds of questioning were identified. Consensus was reached on 21 controversial points, outlining the current accepted definition of VATS lobectomy, its indications and contraindications, perioperative clinical management, as well as recommendations for training and future research directions. Figure 1 Figure 2

      Conclusion
      The present Consensus Statement represents a collective agreement amongst 50 international experts to establish a standardized practice of VATS lobectomy for the thoracic surgical community after 20 years of clinical experience.

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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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      P3.07-020 - Nonintubated Thoracoscopic Lobectomy for Lung Cancer: Experience of Two Medical Centers from Taiwan and China (ID 1783)

      09:30 - 09:30  |  Author(s): J. He

      • Abstract

      Background
      General anesthesia with single-lung ventilation is considered mandatory for thoracoscopic lobectomy for non-small cell lung cancer (NSCLC). Nonintubated thoracoscopic lobectomy has rarely been reported previously. The objective of this study was to evaluate the feasibility and safety of thoracoscopic lobectomy without endotracheal intubation.

      Methods
      From August 2009 through March 2013, 196 patients with clinical stage I or II NSCLC were treated by non-intubated thoracoscopic lobectomy using epidural anesthesia, intrathoracic vagal blockade, and sedation at National Taiwan University Hospital, Taiwan, and The First Affiliated Hospital of Guangzhou Medical College, China.

      Results
      The mean age of the patients were 59 years and 128 (65.3%) were female. Collapse of the operative lung and inhibition of coughing were satisfactory in the non-intubated patients, induced by spontaneous breathing and vagal blockade. Sixteen patients (8.2%) required conversion to intubated-single lung ventilation because of significant mediastinal movement, persistent hypoxemia, dense pleural adhesions, and bleeding. Two patients were converted to standard thoracotomy because of bleeding. The mean postoperative chest tube drainage and postoperative hospital stay were 3.6 days and 6.8 days, respectively. Postoperative complications were noted in 23 (11.7%) patients, including prolonged air leaks, arrhythmia, pneumonia, and bleeding. No operation mortalities were noted.

      Conclusion
      Non-intubated thoracoscopic lobectomy is technically feasible and safe. It can be a valid alternative of single-lung ventilated thoracoscopic lobectomy in managing selected patients with early-stage NSCLC.