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J. He
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MINI 06 - Quality/Prognosis/Survival (ID 111)
- Event: WCLC 2015
- Type: Mini Oral
- Track: Treatment of Localized Disease - NSCLC
- Presentations: 1
- Moderators:R. Meguid, J. Yoshida
- Coordinates: 9/07/2015, 16:45 - 18:15, 605+607
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MINI06.12 - Prognostic Impact of Cancer-involved Lymph Node Ratio in Resected NSCLC Differ between 'N1' or 'N2' Disease (ID 3209)
17:50 - 17:55 | Author(s): J. He
- Abstract
Background:
The extent of lymph nodes (LN) involvement and the adequacy of systematic LN sampling are significantly correlated with the prognosis of cancer patients. The index combing these two factors, cancer-involved LN ratio (LNR), has been proved a strong prognostic factor by extensive previous studies, including non-small cell lung cancer (NSCLC). However, intrapulmonary or mediastinal LNs associate with different examination strategy. It might not be appropriate to apply the LNR indistinguishably to all patients. Therefore, we sought to examine the performance of LNR separately.
Methods:
A consecutive cohort of patients who underwent radical resection with systematic lymph node sampling for NSCLC between Sep 2009 and Dec 2011 were collected. LNR for intrapulmonary and hilar LNs was recorded as LNR1, and LNR for mediastinal LNs was recorded as LNR2. LNR was incorporated in the Cox regression model as a continuous variable. Disease free survival (DFS) was the primary endpoint.
Results:
A total of 681 cases were included for analysis. Overall LNR was a significant prognostic factor in overall population (HR 11.75, 95% CI 6.99 to 19.75; P<0.001). For patients with ‘N2’ disease, overall LNR remained a prognostic factor (HR 3.07, 95% CI 1.22 to 7.74; P=0.02). However, further explorations revealed that LNR2 has prognostic impact (HR 3.59, 95% CI 1.68 to 7.67; P<0.01) but not LNR1 (HR 0.99, 95% CI 0.48 to 2.06; P= 0.99). For those with ‘N1’ disease, LNR1 was not a significant prognostic factor (HR 3.19, 95% CI 0.87 to 11.66; P=0.08) but the prognostic value of overall LNR is strong (HR 36.17, 95% CI 6.23 to 210.13; P<0.01).
Conclusion:
This study suggests that for pathological ‘N1’ NSCLC, overall LNR should be considered a prognostic value while for ‘N2’ disease, only medialstinal LNR should be included in prognostic stratification.
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ORAL 17 - EGFR Mutant Lung Cancer (ID 116)
- Event: WCLC 2015
- Type: Oral Session
- Track: Treatment of Advanced Diseases - NSCLC
- Presentations: 1
- Moderators:P. Meldgaard, E. Felip
- Coordinates: 9/08/2015, 10:45 - 12:15, Four Seasons Ballroom F3+F4
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ORAL17.02 - Randomized Trial of Gefitinib with and without Pemetrexed as First-Line Therapy in East-Asian Patients with Advanced NS NSCLC with EGFR Mutations (ID 1319)
10:56 - 11:07 | Author(s): J. He
- Abstract
- Presentation
Background:
Pemetrexed (P) is the standard of care for non-squamous non-small cell lung cancer (NS NSCLC), whereas epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKIs), such as gefitinib (G), are the standard of care for advanced NSCLC with EGFR mutations. Clinical and nonclinical studies have demonstrated synergistic effects of EGFR TKIs and P. Based on these observations, the efficacy and safety of G+P was compared with G monotherapy in patients with NS NSCLC positive for activating EGFR mutations.
Methods:
The primary objective of this randomized, multicenter, open-label, parallel-arm, phase 2 East-Asian study was to assess whether G+P prolongs progression-free survival (PFS) versus G alone. Secondary endpoints included overall survival (OS), overall response rate, disease control rate, time to progressive disease, duration of response, and treatment-emergent adverse events (TEAEs). Eligible patients had stage IV NS NSCLC with activating EGFR mutations, were chemonaïve, and had an Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1. Patients were randomized in a 2:1 ratio (G+P:G). Dosing schedule was concurrent G (250 mg/day) and P (500 mg/m[2] every 3 weeks) in the G+P arm and G monotherapy (250 mg/day) in the G arm. Treatment continued until progression or unacceptable toxicity. The primary endpoint was analyzed after 144 events, which provided 70% power at a 1-sided 20% significance level, assuming a true hazard ratio (HR) of 0.79.
Results:
Between February 2012 and August 2013, 191 patients were randomized and treated (G+P: N=126; G: N=65). Patients were mostly female (64.4%) with a mean age of 62 years; most were never-smokers (67.0%), had confirmed stage IV disease (84.8%), and ECOG PS of 1 (68.6%). Overall, 55.0% had exon 19 deletions, 39.3% had exon 21 L858R mutations, and 5.8% had other activating EGFR mutations. Baseline characteristics were balanced between treatment arms. Patients in the G+P arm received 96.3% and 92.9% of the planned mean dose of G and P, respectively; patients in the G arm received 97.9% of the planned mean dose of G. Median PFS for G+P (15.8 months) was significantly longer than for G (10.9 months); HR=0.68; 95% confidence interval 0.48, 0.96; 1-sided P=0.014; 2-sided P=0.029. OS data are immature and will be reported at study completion. The incidence of grade 3/4 study drug-related TEAEs was significantly higher for G+P (42.1%) than for G (18.5%); P=0.001. The most common study drug-related TEAEs for G+P were diarrhea (44.4%), aspartate aminotransferase increased (41.3%), and dermatitis acneiform and alanine aminotransferase increased (38.1% for each), and for G were diarrhea (47.7%), dermatitis acneiform (43.1%), and dry skin (35.4%). The proportion of treatment discontinuations due to TEAEs was 16.7% in the G+P arm and 9.2% in the G arm; 2 patients (G+P arm) died due to study drug-related adverse events.
Conclusion:
The combination of G+P led to a significant improvement in PFS compared with G monotherapy for East-Asian patients with EGFR mutation-positive NS NSCLC, and met the primary study endpoint. The incidence of grade 3/4 study drug-related AEs was higher for G+P than for G. ClinicalTrials.gov identifier: NCT01469000.
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P1.02 - Poster Session/ Treatment of Localized Disease – NSCLC (ID 209)
- Event: WCLC 2015
- Type: Poster
- Track: Treatment of Localized Disease - NSCLC
- Presentations: 1
- Moderators:
- Coordinates: 9/07/2015, 09:30 - 17:00, Exhibit Hall (Hall B+C)
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P1.02-025 - Complete VATS Resection and Reconstruction of Carina and Trachea for Malignant or Benign Disease (ID 1218)
09:30 - 09:30 | Author(s): J. He
- Abstract
Background:
General thoracic surgery involving carinal and/or tracheal reconstruction is technically demanding. The aim of this study is to discuss the feasibility of complete video assisted thoracoscopic surgery (VATS) in the surgical treatment of disease involving the carina and/or trachea.
Methods:
Between May 2012 and April 2015, seven cases of malignant or benign disease involving carina and/or trachea were treated via complete VATS resection and reconstruction of carina and trachea in our hospital. Among the seven patients (median age, 47 years; range, 43-60 years), two patients suffered from a malignant tracheal tumor, one from a main bronchial malignant tumor invading the carina, two from right upper lobe malignant tumor invading the carina, and two from benign bronchial stenosis due to endobronchial tuberculosis. A prospective analysis of clinical characteristics, operative data, and postoperative events was performed. Figure 1
Results:
There were five different types of VATS airway reconstruction in our group, including left main bronchus resection and carinal reconstruction, right main bronchus resection and carinal reconstruction, right upper lobectomy and carinal reconstruction, right upper lobectomy and half carinal reconstruction, and tracheal resection and reconstruction. Median data of surgical outcome are as follows: operative time-200 minutes (range, 50-300 minutes); time of airway reconstruction-50 minutes (range, 19-130 minutes); blood loss-100 mL (range, 30-1000 mL). One patient suffered from endobronchial tuberculosis; during the thoracic procedure we observed complete pleural adhesions which led to large volume of blood loss during pleuropneumonolysis. No conversions to thoracotomy were performed. There was no 30-day mortality. Median data of perioperative outcomes are as follows: postoperative hospital stay-12 days (range, 7-15 days); ICU stay -1 day (range, 0-6 days) and duration of thoracic drainage- 2 days (range, 1-5 days). No patient required postoperative mechanical ventilation. One patient had to be assisted with bronchoscopy as a result of insufficient sputum excretion. Median duration of follow-up was 6 months (range, 0-37 months). Minor anastomotic stenosis(less than 1/4 diameter) was found in two patients during follow-up, but no complaints of significant impact on activity were noted.
Conclusion:
Complete VATS for carina and trachea resection and reconstruction is a technically challenging, but feasible procedure for both benign and malignant disease and should be restricted to skilled VATS surgeons.
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P2.04 - Poster Session/ Biology, Pathology, and Molecular Testing (ID 234)
- Event: WCLC 2015
- Type: Poster
- Track: Biology, Pathology, and Molecular Testing
- Presentations: 1
- Moderators:
- Coordinates: 9/08/2015, 09:30 - 17:00, Exhibit Hall (Hall B+C)
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P2.04-071 - PD-L1 Expression Is Not Associated with Disease-Free Survival in NSCLC Patients Who Underwent Radical Resection (ID 2856)
09:30 - 09:30 | Author(s): J. He
- Abstract
Background:
The expression of Programmed Cell Death Ligand 1 (PD-L1), as a major mechanism of immune escape, has been observed in various malignancies. However, its prognostic impact on non-small cell lung cancer (NSCLC) patients remains controversial, especially those in early stage when theoretically all tumors have been removed. We sought to examine the correlation between PD-L1 expression and prognosis of NSCLC patients after radical resection.
Methods:
A consecutive cohort of 681 patients who underwent radical resection for stage I to III NSCLC in our center between Sep 2009 and Dec 2011 was collected. All available cancerous tissues were collected and were made into tissue arrays. Immunohistochemistry staining using PD-L1 (E1L3N ®) XP ® Rabbit mAb was performed to detect the PD-L1 expression. PD-L1 positive expression was denoted as more than 10% tumor cells with PD-L1 staining, while PD-L1 high expression was denoted as H score≥100. The primary endpoint was disease-free survival (DFS).
Results:
Tissues of 670 patients were available and all of them were eligible for PD-L1 staining. There were 222 events (recurrence/death) and the median follow-up was 3.1 year (range, 0.1 to 5.6). Neither positive expression (HR 0.93, 95%CI 0.69 to 1.25; P=0.61) nor high expression of PD-L1 (HR 0.88, 95% CI 0.59 to 1.31; P=0.54) was associated with DFS (Figure 1). The absence of discrepancies in prognosis did not differ in each stage and histology (Table 1). Figure 1 Figure 1. Kaplan-Meier curve. Table 1. Subgroup analysesSubgroup No. HR 95% CI Sig. Stage I 340 0.754 0.299 1.897 0.548 II 139 0.827 0.406 1.683 0.600 III 162 0.669 0.355 1.259 0.213 Histology Non-squamous without neuroendocrine differentiation 473 0.840 0.483 1.461 0.537 Squamous 146 0.867 0.445 1.690 0.675 Other or mix 49 0.763 0.225 2.585 0.664
Conclusion:
This large scale study showed that PD-L1 is not a prognostic factor in early stage NSCLC after radical resection. These results encourage us to investigate whether the nature of the disease especially regarding immune escape will change after radical resection.
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P2.06 - Poster Session/ Screening and Early Detection (ID 219)
- Event: WCLC 2015
- Type: Poster
- Track: Screening and Early Detection
- Presentations: 1
- Moderators:
- Coordinates: 9/08/2015, 09:30 - 17:00, Exhibit Hall (Hall B+C)
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P2.06-026 - Advanced Bronchoscopies for Diagnosing Precancerous or Cancerous Lesions: A Meta-Analysis (ID 2694)
09:30 - 09:30 | Author(s): J. He
- Abstract
Background:
Conventional white light bronchoscopy (WLB) has been used for decades. Some technical advances in bronchoscopies are available for detecting lung precancerous and cancerous lesions currently. Our aim was to investigate the performance of autofluorescence bronchoscopy (AFB), AFB combined with white light bronchoscopy (AFB+WLB), narrow-band imaging bronchoscopy (NBI) and, additionally, to directly compare these new techniques with WLB alone.
Methods:
Pubmed, Embase, Web of Science, Ovid, ProQuest, Scopus and the Cochrane Library were searched for relevant articles. Eligible studies should study any of the new techniques with histopathology as a golden standard, and should have sufficient data to construct 2×2 contingency tables. We used random-effects bivariate models to pool sensitivity, specificity, diagnostic odds ratio (DOR) and the area under the receiver operating curve (AUC) with 95% confidence interval.
Results:
Fifty-three studies involving a total of 6543 patients and 18458 biopsy specimens were included. Single arm synthesis of the new techniques showed that the overall sensitivity of AFB, AFB+WLB, NBI and WLB was 87% (82%-90%), 88% (82%-93%), 96% (78%-99%) and 54% (46%-61%); overall specificity was 65% (58%-72%), 59% (48%-68%), 84% (70%-92%) and 79% (73%-84%); and AUC was 85% (81%-87%), 82% (78%-85%), 94% (91%-96%) and 72% (68%-76%) respectively. In direct comparison, AFB, AFB+WLB and NBI had higher overall sensitivity, DOR and AUC, but lower specificity than WLB alone, regardless of precancerous or cancerous lesions (see in Table 1). In exploratory subgroup analysis, the sensitivities of all techniques were relatively higher in studies with higher proportion of elder patients, or in those with higher proportion of ‘high risk’ patients who had prior/suspected lung cancer or head & neck cancer. Figure 1
Conclusion:
Based on this pooled analysis, the performance of AFB, AFB+WLB or NBI is superior to WLB alone for diagnosing both lung precancerous and cancerous lesions. Its application might be preferably encouraged in populations with higher risk for non-benign lesions.
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P3.03 - Poster Session/ Treatment of Locoregional Disease – NSCLC (ID 214)
- Event: WCLC 2015
- Type: Poster
- Track: Treatment of Locoregional Disease – NSCLC
- Presentations: 1
- Moderators:
- Coordinates: 9/09/2015, 09:30 - 17:00, Exhibit Hall (Hall B+C)
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P3.03-014 - The Impact of Post-Operative Adjuvant Chemotherapy for Resected NSCLC in the Real-World Setting: Single Center Experience (ID 2905)
09:30 - 09:30 | Author(s): J. He
- Abstract
Background:
Recent evidence argues against the benefits from adjuvant chemotherapy (ad-chemo) for resected NSCLC in the real world setting. We sought to examine the impact of ad-chemo based on the data from our center.
Methods:
A consecutive cohort of 681 patients who underwent radical resection for stage I to III NSCLC in our center between Sep 2009 and Dec 2011 was collected. Patients who received adjuvant EGFR-TKIs were excluded. Patients lost follow-up upon discharge (uncertain history of ad-chemo) were included in sensitivity analyses. The primary endpoint was disease-free survival (DFS).
Results:
372 patients received ad-chemo whereas 224 did not, and the remaining 85 had no certain record of ad-chemo. There were 222 events (175 recurrence and 47 deaths). Univariate analysis showed that patients who received ad-chemo had shorter DFS than those who did not (HR 1.94, 95%CI 1.40 to 2.67; P<0.001). Incorporation of those without certain record of ad-chemo (HR 1.88; P<0.001) or excluding patients with stage I disease (HR 1.36; P=0.17) did not alter the trend. After adjusting for some important prognostic factors, such as stage, histology, visceral-pleural invasion, the inferiority of ad-chemo remained. In ad-chemo arm, we observed potentially better DFS in patients receiving platinum-based regimen (HR 0.64, 95% CI 0.38 to 1.07; P=0.09) and patients complete 4 or more cycles of ad-chemo (HR 0.73, 95% CI 0.52 to 1.01; P=0.05).
Conclusion:
Current results suggested that applying adjuvant chemotherapy should be based on strict patient selection. Establishment of selection criteria regarding recurrence risk and physical status is highly encouraged.
