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Jianxing He



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    MA11 - Immunotherapy in Special Populations and Predictive Markers (ID 135)

    • Event: WCLC 2019
    • Type: Mini Oral Session
    • Track: Immuno-oncology
    • Presentations: 1
    • Now Available
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      MA11.06 - A PII Study of Toripalimab, a PD-1 mAb, in Combination with Chemotherapy in EGFR+ Advanced NSCLC Patients Failed to Prior EGFR TKI Therapies (Now Available) (ID 1160)

      14:00 - 15:30  |  Author(s): Jianxing He

      • Abstract
      • Presentation
      • Slides

      Background

      EGFR TKI is the standard 1st line therapy for the patients (pts) with advanced NSCLC harboring EGFR mutations. While PD-1 checkpoint blockade has become an integral component of disease management for EGFR wild type NSCLC pts at various settings, platinum-based chemotherapy is still the standard of care for EGFR mutated NSCLC pts who progress after EGFR targeting therapy. Early attempts to combine EGFR TKI with checkpoint blockade had resulted in exacerbated immune related toxicity in the lung. Here we aimed to prospectively evaluate toripalimab, a humanized PD-1 mAb approved for 2nd line treatment of melanoma, in combination with chemotherapy to treat EGFR mutated NSCLC pts after failure of EGFR targeting therapy.

      Method

      This is a phase II, multicenter, open-label, single-arm study for pts with EGFR activating mutations who have failed prior EGFR-TKI therapies without T790M mutation or failed osimertinib treatment. Pts were treated with 240mg or 360mg fixed dose toripalimab once every 3 weeks in combination with carboplatin and pemetrexed for up to 6 cycles, followed by toripalimab plus pemetrexed maintenance therapy until disease progression or intolerable toxicity. Primary endpoint was objective response rate (ORR) at week 12 as assessed by investigator per RECIST v1.1 once every 6 weeks. Secondary endpoints were safety, ORR, DOR, DCR, TTR, PFS, OS, PK and immunogenicity.

      Result

      f14_2_1_3_pub.png

      Forty pts were enrolled from Apr 25, 2018 to March 22, 2019 with 52.5% female pts and a median age of 57.5. 57.5% pts harbored EGFR exon19 deletion while 42.5% pts had exon21 L858R mutation. Only 1 pt had T790M mutation who progressed after osimertinib treatment. In ITT population, 13 confirmed partial response (PR) and 22 stable disease (SD) were observed at week 12 for a 32.5% ORR. As of Jul 25 2019, among 40 pts, 20 confirmed PR and 15 SD were observed for a 50% ORR (95% CI, 33.8% to 66.2%) and an 87.5% DCR (95% CI, 73.2% to 95.8%). Median progression free survival (PFS) was 7.0 months, and median duration of response (DOR) was 7.0 months. Treatment emergent adverse events (TEAE) occurred in 39 (97.5%) of the pts, grade 3 or higher events occurred in 25 (62.5%) of pts including two deaths. Most common AE included leukopenia, neutropenia, thrombocytopenia, anemia, nausea, and loss of appetite. Treatment discontinuation due to AE occurred in 4 (10%) of the pts.

      Conclusion

      Anti-PD-1 mAb, toripalimab in combination with carboplatin and pemetrexed has shown a promising anti-tumor efficacy with a tolerable safety profile for advanced NSCLC patients with EGFR mutated who progressed after EGFR TKI therapies. Pts will be continuously monitored for safety and efficacy readouts (DOR, PFS and OS). A phase III registration study will be initiated in May 2019.

      (Clinical trial information: NCT03513666)

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    MA14 - The Adequate MTarget Is Still the Issue (ID 140)

    • Event: WCLC 2019
    • Type: Mini Oral Session
    • Track: Advanced NSCLC
    • Presentations: 1
    • Now Available
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      MA14.05 - A Randomized Phase III Trial of Fruquintinib Versus Placebo in Patients with Advanced Non-Small Cell Lung Cancer (FALUCA) (Now Available) (ID 1490)

      15:45 - 17:15  |  Author(s): Jianxing He

      • Abstract
      • Presentation
      • Slides

      Background

      Fruquintinib, an orally active kinase inhibitor that selectively targets vascular endothelial growth factor (VEGF) receptor, demonstrated significant benefit in progression-free survival and disease control in a randomized Phase II study in patients with non-small-cell lung cancer (NSCLC) who had failed two lines of chemotherapy. This Phase III FALUCA trial is a randomized, double-blind, placebo-controlled, multicenter trial designed to confirm the efficacy in the same patient population (NCT02691299).

      Method

      From December 2015 to February 2018, 45 clinical centers across China participated in the trial. A total of 730 patients aged 18-75 with advanced NSCLC who had failed two lines of chemotherapy were screened and 527 who met the eligibility criteria were enrolled into the study. Patients were stratified based on epidermal growth factor receptor mutation status and prior use of VEGF inhibitor therapy, and were randomized in a 2:1 ratio to receive fruquintinib (n=354) or placebo (n=173) once daily in a 3 weeks on/1 week off 4-week cycle. The primary end point was overall survival (OS). Secondary end points included progression-free survival (PFS), objective response rate (ORR), disease control rate (DCR), duration of response. The final data cutoff was on September 21, 2018.

      Result

      Median OS was 8.94 months for fruquintinib and 10.38 months for placebo (hazard ratio, 1.02; 95% CI, 0.816 to 1.283; p=0.841). Median PFS was 3.68 months for fruquintinib comparing to 0.99 months for placebo, respectively (hazard ratio, 0.34; 95%CI, 0.279 to 0.425; p<0.001). The ORR and DCR were 13.8% and 66.7% for fruquintinib, compared with 0.6% and 24.9% for placebo (both p<0.001), respectively. The most frequent treatment-emergent adverse events with fruquintinib (≥grade 3) were hypertension (20.7%), hand-foot syndrome (11.0%), and proteinuria (1.4%). A sensitivity analysis revealed that median OS was significantly prolonged with fruquintinib compared with placebo in patients who received no subsequent systemic anti-tumor therapies (7.00 months versus 5.06 months ; hazard ratio, 0.64; 95%CI, 0.453 to 0.903; p=0.010).

      Conclusion

      The FALUCA trial failed to meet the primary end point of OS while confirming significant benefit in secondary end points including PFS, ORR and DCR. The safety profile of fruquintinib in this patient population was acceptable and consistent with that identified in the Phase II study. A post-hoc sensitivity analysis revealed that the anti-tumor therapies that patients received post disease progression probably contributed to the failure of this study on the primary end point.

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    OA02 - A New Vision of Targets and Strategies (ID 120)

    • Event: WCLC 2019
    • Type: Oral Session
    • Track: Targeted Therapy
    • Presentations: 1
    • Now Available
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      OA02.03 - The Third Generation EGFR Inhibitor (EGFR-TKI) HS-10296 in Advanced NSCLC Patients with Resistance to First Generation EGFR-TKI (Now Available) (ID 766)

      10:30 - 12:00  |  Author(s): Jianxing He

      • Abstract
      • Presentation
      • Slides

      Background

      HS-10296 is an oral, potent, high selective third generation EGFR tyrosine-kinase inhibitor (EGFR-TKI) for sensitizing mutations, and the EGFR Thr790Met (T790M) resistance mutation which has been demonstrated by phase I study. This phase II, open-label, multicenter single-arm study was designed to confirm the efficacy and safety of HS-10296 in a large population of non-small-cell lung cancer (NSCLC) patients with EGFR T790M mutation, who had progressed after first generation EGFR-TKI treatment.

      Method

      Patients aged at least 18 years with centrally confirmed EGFR T790M-positive mutations, locally advanced or metastatic (stage IIIB/IV) NSCLC after first generation EGFR-TKI treatment received HS-10296 110 mg orally once daily until disease progression, or intolerable toxicity, or patient withdrawal. Patients with asymptomatic, stable brain metastases not requiring steroids were allowed to enroll. The primary endpoint was the objective response rate (ORR) by independent central review using Response Evaluation Criteria in Solid Tumors, version 1.1 every 6 weeks. Response endpoints (ORR and disease control rate [DCR]) were assessed in response analysis set. Secondary end points including progression-free survival (PFS), duration of response (DoR), depth of response (DepOR), overall survival (OS) and safety were evaluated in full analysis set. The final data cutoff was on Jan 5, 2019. The study is still ongoing.

      Result

      Totally, 244 patients (median age 60.8) entered study in 36 sites in mainland China (189 patients) and Taiwan (55 patients) between May 16, 2018 to Oct 23, 2018. 2 patients were excluded from the evaluable for response analysis set (n=242) due to absence of measurable disease at baseline by independent central review. At data cutoff, 182 (74.6%) patients remained on treatment. The median duration of follow-up was 4.7 months. 160 of 242 patients achieved confirmed partial responses by independent central review. The ORR was 66.1% (95% CI: 59.8-72.1). The DCR was 93.4% (95% CI: 89.5-96.2). The most common adverse reactions (≥ 10%) were blood creatine phosphokinase increased (43 [17.6%]), aspartate aminotransferase increased (29 [11.9%]), pruritus (28 [11.5%]), rash (28 [11.5%]) and alanine aminotransferase increased (26 [10.7%]). The most common all-causality grade 3 and 4 adverse events were blood creatine phosphokinase increased (14 [5.7%]) and hyponatraemia (4 [1.6%]). Serious adverse events were reported in 30 (12.3%) patients, of which 19 (7.8%) were investigator assessed as possibly treatment-related to HS-10296. Three deaths were due to adverse events; one was related to cardiopulmonary failure, other two events occurred after disease progression. There was no interstitial lung disease during study treatment.

      Conclusion

      HS-10296 has demonstrated good clinical benefit with minimal toxicity in patients with EGFR T790M-positive NSCLC patients who have progressed after first generation EGFR-TKI treatment. The Phase III study has already launched comparing HS-10296 with gefinitib in advanced NSCLC patients with EGFR sensitizing mutations. (The study was sponsored by Jiangsu Hansoh Pharmaceutical Co., Ltd.; ClinicalTrials.gov number, NCT02981108)

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    OA03 - Systemic Therapies for SCLC: Novel Targets and Patients' Selection (ID 121)

    • Event: WCLC 2019
    • Type: Oral Session
    • Track: Small Cell Lung Cancer/NET
    • Presentations: 1
    • Now Available
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      OA03.02 - Effect of Anlotinib in Advanced Small Cell Lung Cancer Patients Previously Received Chemoradiotherapy: A Subgroup Analysis in ALTER 1202 Trial (Now Available) (ID 1698)

      13:30 - 15:00  |  Author(s): Jianxing He

      • Abstract
      • Presentation
      • Slides

      Background

      The ALTER 1202 trial showed significant improvement in progress-free survival and well tolerant with anlotinib in advanced small cell lung cancer (SCLC) patients received at least two lines chemotherapy. Here, we reported the effect of anlotinib in patients previously received chemoradiotherapy.

      Method

      The ALTER 1202 was a randomized, double-blind phase 2 trial conducted at 11 centers in China. Patients with advanced SCLC that received at least two previous lines of chemotherapy were enrolled and randomized in a 2:1 ratio to receive either anlotinib or placebo until tumor progression or unacceptable toxicity. The subgroup analysis assessed the effect of anlotinib in patients with previous concurrent, sequential and alternate chemoradiotherapy. The primary outcome was progressive-free survival (PFS). The secondary outcomes were overall survival (OS), objective response rate, disease control rate and safety. Data are reported as per the 30 June 2018, data cutoff date. This trial is registered with ClinicalTrials.gov, number NCT03059797.

      Result

      Between March 30, 2017 and June 8, 2018, a total of 120 patients who met all eligibility criteria were randomly assigned to the anlotinib group (82 patients) or placebo group (38 patients). And 46 patients in anlotinib group and 22 patients in placebo group previously received chemoradiotherapy. Among them, the median PFS was 5.49 months (95% confidence interval [CI], 2.83 to 6.47) with anlotinib versus 0.69 months (95% CI, 0.66 to 0.76) with placebo (hazard ratio [HR], 0.14; 95% CI, 0.07 to 0.28; P<0.0001). Meanwhile, anlotinib significantly prolonged OS compared with placebo (9.49 months [95% CI, 7.29 to 12.68] versus 2.56 months [95% CI, 0.49 to 5.22]; HR, 0.46 [95% CI, 0.22 to 0.98]; P=0.0388) in patients previously received chemoradiotherapy. The most common adverse events were hypertension (39.13%), weight loss (39.13%), hypertriglyceridemia (36.96%) and leukopenia (30.43%). While, the most common grade 3 or worse adverse events were hypertension (15.22%), hypertriglyceridemia (10.87%), γ-glutamyl-transferase increased (8.70%).

      Conclusion

      Anlotinib improved PFS and OS in advanced SCLC patients previously received chemoradiotherapy and was well tolerated.

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    P1.03 - Biology (ID 161)

    • Event: WCLC 2019
    • Type: Poster Viewing in the Exhibit Hall
    • Track: Biology
    • Presentations: 1
    • Moderators:
    • Coordinates: 9/08/2019, 09:45 - 18:00, Exhibit Hall
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      P1.03-39 - Intra-Tumoral CD61+ Megakaryocytes Predicts Poor Prognosis in Non-Small Cell Lung Cancer (ID 1663)

      09:45 - 18:00  |  Author(s): Jianxing He

      • Abstract

      Background

      Lung is a reservoir for MKs to produce platelets. The aim is to investigate relationship between intra-tumoral MK with the recurrence of NSCLC.

      Method

      The tissue sections of 629 patients with resected NSCLC were stained with hematoxylin, anti-CD61, anti-CD34 and stromal cell-derived factor-1 (SDF-1). CD61+ giant cells localized in CD34+ capillaries were identified as MKs. The impact of MKs and DFS was investigated.

      Result

      Overall, 18.9% of patients were positive for the presence of MKs. In univariate analysis, the median DFS of the MK+ group was shorter than the median DFS of the MK- group (69.1 vs. 80.5 months; P=0.021). Multivariate analysis indicated that MKs in tumor tissue was an unfavorable prognostic factor for DFS (HR 1.351, P=0.065), the impact of which was more significant in non-squamous cell carcinoma (NSCC) (HR 1.710, P=0.008) and in patients with N0 (HR 1.883, P=0.009). Although systemic platelet count of the MK+ group was significantly higher than the MK- group (270.6 vs. 243.6 ×109/L, P=0.007), the stratified subgroup DFS curves (P=0.003) showed that the effect of MKs on prognosis was independent of the blood platelet count. In addition, the positive association of SDF-1, CD61 and microthrombi indicated a potential mechanism by which increased MKs facilitate blood metastasis.

      figure-2.jpgfigure-3.jpg

      Conclusion

      CD61+ MKs in tumor tissue predict unfavorable prognosis in NSCLC. The prognostic impact of MKs in addition to that of systemic platelet count implies that regional MK-producing platelets in tumors might contribute to NSCLC metastasis.

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    P1.11 - Screening and Early Detection (ID 177)

    • Event: WCLC 2019
    • Type: Poster Viewing in the Exhibit Hall
    • Track: Screening and Early Detection
    • Presentations: 1
    • Moderators:
    • Coordinates: 9/08/2019, 09:45 - 18:00, Exhibit Hall
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      P1.11-23 - The Impact of the Family History of Different Cancers on Lung Cancer (ID 2542)

      09:45 - 18:00  |  Author(s): Jianxing He

      • Abstract

      Background

      The definition of the high-risk population of lung cancer screening remains controversial. People with a family history of lung cancer will have a distinctly increase risk of lung cancer, but the influence of family history of other cancers it is still unclear.

      Method

      We performed a case-control study to compare the exposure of different cancer family history between lung cancer and other cancers. All cancer patients who were hospitalized in our center between 2007 and 2018 were included and records of each patient’s family history were retrieved. Logistic regression analysis was conducted after excluding the patients with a family history of non-lung cancer who had diagnosed the corresponding system cancer.

      Result

      This study enrolled 23,977 cancer patients including 15,120 lung cancer and 8,857 non-lung cancer. Lung cancer patients had a higher exposure to a family history of lung cancer compared with non-lung cancer patients(OR=2.418, P< 0.001), and had a potential higher exposure to the patients with the family history of pancreatic cancer(OR=1.769,P=0.597)and kidney cancer(OR=1.326,P=0.596)without statistical difference. Sex had no significantly impact on the association between cancer family history and lung cancer risk (interaction P >0.05).table 1.png

      Conclusion

      Patients with a family history of lung cancer should be considered a high-risk population for lung cancer screening, whereas there is no strong evidence to support that family history of other cancer will influence the risk of lung cancer. More researches are required to determine the relationship between lung cancer risk and family history of pancreatic and kidney cancers.

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    P2.03 - Biology (ID 162)

    • Event: WCLC 2019
    • Type: Poster Viewing in the Exhibit Hall
    • Track: Biology
    • Presentations: 1
    • Moderators:
    • Coordinates: 9/09/2019, 10:15 - 18:15, Exhibit Hall
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      P2.03-50 - Stromal BTK Expression Predicts Poor Prognosis in NSCLC Patients (ID 1665)

      10:15 - 18:15  |  Author(s): Jianxing He

      • Abstract

      Background

      Bruton's tyrosine kinase (BTK) is a kinase that plays a crucial role in B-cell development and widely involves cancer biology. We sought to explore the relationship between BTK expression and NSCLC.

      Method

      We firstly used a cohort of 1,249 consecutive NSCLC patients who underwent surgical resection in our center between Apr 2018 and Sep 2018 with fresh tissue to examine the presence of BTK (cohort 1). Another cohort of 681 patients with resected NSCLC between 2009-2014 with stored paraffin sections and survival information were also retrieved to assess the prognostic value of BTK (cohort 2). All samples were stained by IHC for BTK (EPR20445) and PD-L1 (SP142).

      Result

      The overall expression rates of BTK expression on tumor and stromal cells were 11.9% and 87.1% respectively in cohort 1, which did not differ across histological types or other clinical features. Both tumoral expression (Chi2=8.84, P<0.01) and stromal expression (Chi2=3.96, P=0.047) of BTK were positively correlated with tumoral PDL1 expression. In cohort 2, we found that the stromal (HR=1.49, P=0.03) but not tumoral (HR=0.74, P=0.20) BTK expression was significantly correlated with poorer prognosis, after adjusting for tumoral PDL1 expression (HR=0.58, P<0.01) and other covariates.

      18200172 (2).jpg

      Conclusion

      This is the first study showing the presence of BTK expression and its positive correlation with PDL1 expression in NSCLC. Stromal BTK expression predicts poor prognosis in NSCLC patients. This study shed light on the biological effect of BTK-expressing cells and treatment potential of targeting relevant pathways.

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    P2.09 - Pathology (ID 174)

    • Event: WCLC 2019
    • Type: Poster Viewing in the Exhibit Hall
    • Track: Pathology
    • Presentations: 2
    • Now Available
    • Moderators:
    • Coordinates: 9/09/2019, 10:15 - 18:15, Exhibit Hall
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      P2.09-01 - Characteristics of Driver Mutations in Early Lung Adenocarcinoma: From Preinvasive/Minimally invasive to Invasive Adenocarcinoma (Now Available) (ID 1743)

      10:15 - 18:15  |  Author(s): Jianxing He

      • Abstract
      • Slides

      Background

      It is still unclear when the gene mutation occurs during the carcinogenetic process, which progresses from preinvasive to invasive adenocarcinoma. We aim to investigate the driver gene alterations profile of adenocarcinoma in situ (AIS), minimally invasive adenocarcinoma (MIA) and invasive adenocarcinoma (IAC).

      Method

      A total of 1219 patients with pulmonary nodes smaller than 3 cm were selected for this study. Driver mutation testing was performed with NGS in all resected tumor tissues. The incidence of mutations was calculated and compared among different subtypes. Logistic regression was used to further identify factors that may independently correlate with IAC.

      Result

      In all 1219 patients with lung adenocarcinoma, 62 were diagnosed as AIS, 208 as MIA and 949 as IAC. Mutations were found in 809 (66.4%) patients. The frequency of mutations increased with the progression of tumor invasiveness: AIS (32.3%), MIA (45.2%) and IAC (73.2%)(P<0.001 between IAC and AIS, P<0.001 between IAC and MIA). The results (Figure 1) also showed an increasing trend towards more driver mutations from AIS to MIA, and to IAC. Multivariate analysis revealed that driver mutations was a factor associated with IAC (OR: 2.39, P<0.001). Of the genetic factors, EGFR, KRAS and ALK alterations were significant indicators of IAC (all P<0.020), and were found increased in IAC compared with AIS/MIA.

      figure 1.jpg

      Conclusion

      Genetic alterations occurs early in the development of lung adenocarcinoma and can be detected even before tumor have acquired malignant potential. Driver mutations gradually increase in tumorigenesis and progression from AIS to MIA, and finally to overt IAC. A better understanding of carcinogenesis in preinvasive/minimally invasive cases may allow the development of effective preventive, screening, and treatment strategies.

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      P2.09-04 - The Clinicopathological Characteristics and Prognosis of Lung Cancer with Tumor Spread Through Air Spaces: A Meta-Analysis (Now Available) (ID 1652)

      10:15 - 18:15  |  Author(s): Jianxing He

      • Abstract
      • Slides

      Background

      Background: The clinicopathological characteristics of lung cancer with tumor spread through air spaces (STAS) has not been clearly characterized yet. Also, it is still not clear whether the presence of STAS correlated with worse prognosis in patients with lung cancer. Thus, we aim to systematically evaluate the clinicopathological characteristics and prognosis of the patients with or without STAS undergoing surgical resection for lung cancer.

      Method

      Materials and Methods: A comprehensive search of online databases was performed. Clinicopathological characteristics, 5-year RFS and OS rate were compared between 2 groups. Cumulative meta-analysis was performed to evaluate the temporal trend of pooled outcomes. Specific subgroups according to different types of lung cancer are examined.

      Result

      Results: A total of 25 eligible studies including 8494 patients were recruited. STAS occurred in 2881 patients (34%) while non-STAS occurred in 5613 patients (66%). Overall, patients with STAS manifested significantly more aggressive characteristics, including lymphatic invasion (SMD=2.935; P=0.000), pleural invasion (SMD=2.329; P=0.000), vascular invasion (SMD=2.306; P=0.000) as well as lymph node metastasis (OR=3.510; P=0.000). Patients with STAS also correlated with significantly higher pathological stage (OR=2.216; P=0.003), T stage (OR=1.756; P=0.000), N stage (OR=2.395; P=0.000) and larger tumor size (OR=0.275; P=0.001). Meanwhile, the incidence of STAS was significantly associated with the micropapillary (OR=9.792; P=0.000) and solid patterns (OR=2.451; P=0.000). Moreover, the presence of STAS was related to male sex (OR=1.493; P=0.000), smoking history (OR=1.637; P=0.000) and necrosis (OR=2.300; P=0.000). As for the outcomes of the prognosis, patients with STAS linked with significant worse prognosis than those without STAS, including both 5-year RFS (HR=0.585; 95% CI: 0.486–0.684; P=0.000) and 5-year OS rate (HR=0.788; 95% CI: 0.596–0.980; P=0.000).

      Conclusion

      Conclusions: The presence of STAS was associated with several invasive pathological characteristics, which might explain the worse prognosis in patients with STAS compared with those without STAS.

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    P2.11 - Screening and Early Detection (ID 178)

    • Event: WCLC 2019
    • Type: Poster Viewing in the Exhibit Hall
    • Track: Screening and Early Detection
    • Presentations: 1
    • Moderators:
    • Coordinates: 9/09/2019, 10:15 - 18:15, Exhibit Hall
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      P2.11-29 - Diagnosis and Surveillance of Solitary Pulmonary Nodules with ctDNA Methylation Sequencing: Protocol for a Prospective Multicenter Study (ID 1666)

      10:15 - 18:15  |  Author(s): Jianxing He

      • Abstract

      Background

      LDCT screening can identify early-stage lung cancers yet introduces excessive false positives , which calls for better non-invasive diagnostic tools. We previously established a diagnostic model of early stage lung cancer based on high-throughput DNA methylation sequencing of ctDNA (Theranostics 2019; 9(7)). The aim of the present study is to assess the role of ctDNA methylation markers in differential diagnosis and surveillance of pulmonary nodules.

      Method

      A prospective cohort of 10,560 patients from 20 centers in China with non-calcified nodules range from 0.5 to 3 cm in diameter indicated by LDCT or CT will be included and followed up for 2 to 3 years. Each patient will undergo LDCT/CT follow-up and their information as well as blood sample will be collected at baseline, 3, 6, 12, 24 and 36 months. Blood samples will be subjected to ctDNA methylation test. Sensitivity, specificity, positive predictive value and negative predictive value are used to measure the diagnostic value of ctDNA methylation test in differentiating benign and malignant pulmonary nodules.

      Result

      This study is registered in clinicaltrials.gov (NCT03651986, BELL study) and has launched since Oct 2018. Upon submission, 975 cases had been enrolled from 13 centers who had begun recruiment. Completion of data collection is anticipated by March 2023.

      Conclusion

      To the best of our knowledge, this is the first and largest study worldwide to test the efficacy of ctDNA methylation markers in differential diagnosis and surveillance of pulmonary nodules.

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    P2.12 - Small Cell Lung Cancer/NET (ID 180)

    • Event: WCLC 2019
    • Type: Poster Viewing in the Exhibit Hall
    • Track: Small Cell Lung Cancer/NET
    • Presentations: 2
    • Moderators:
    • Coordinates: 9/09/2019, 10:15 - 18:15, Exhibit Hall
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      P2.12-11 - Quality of Life in ALTER1202 Trial of Anlotinib as Third-or Further Line Therapy for Advanced Small Cell Lung Cancer (SCLC): A Post-Hoc Analysis (ID 1300)

      10:15 - 18:15  |  Author(s): Jianxing He

      • Abstract
      • Slides

      Background

      Anlotinib significantly improved progress-free survival of advanced small cell lung cancer (SCLC) patients in ALTER1202 trial. In this post-hoc analysis, we assessed the effect of anlotinib on health-related quality of life in ALTER1202 trial.

      Method

      In the randomised, phase 2, multicentre ALTER1202 trial, patients with advanced SCLC that received at least two previous lines of chemotherapy were enrolled from 11 centers in China. Eligible patients were randomly assign (2:1) to receive anlotinib or placebo. Health-related quality of life was assessed by EQ-5D scores. Patients filled out questionnaires at screening period and the end of each treatment cycle.

      Result

      Between March 30, 2017 and June 8, 2018, a total of 120 patients were enrolled. There were 119 patients with completed questionnaires at screening period, and 106 patients completed questionnaires at the end of the first treatment cycle (76 in anlotinib group, 30 in placebo group). EQ-5D scores had no significant difference between baseline and the end of the first treatment cycle in patients with anlotinib (0.85 versus 0.85, P=0.706). The median EQ-5D VASscores were 80.0 versus 85.0 in anlotinib and placebo group respectively (P=0.323) at screening period, and 90.0 versus 82.5 at the end of the first treatment cycle (P=0.273). The change of EQ-5D VAS scores from baseline to the end of the first treatment cycle was statistically significant (P=0.001) in patients with anlotinib compared to patients with placebo.

      Conclusion

      This post-hoc analysis showed that anlotinib maintained health-related quality of life in advanced SCLC patients.

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      P2.12-26 - The Impact of Anlotinib for Relapsed SCLC Patients with Brain Metastases: A Subgroup Analysis of ALTER 1202 (ID 489)

      10:15 - 18:15  |  Author(s): Jianxing He

      • Abstract
      • Slides

      Background

      ALTER1202 trial (NCT03059797), a multicentre, randomized, double-blind phase II study has demonstrated that anlotinib significantly prolonged progress-free survival (PFS) in relapsed SCLC patients as 3rdor further line treatment. Here, we performed a comparative analysis for patients with brain metastases in the placebo and anlotinib arms.

      Method

      Eligible either limited- or extensive-stage SCLC pts who failed ≥2 lines of chemotherapy (n=120) were randomized 2:1 to receive anlotinib or placebo (12 mg QD from day 1 to 14 of a 21-day cycle) till progression or intolerable toxicity. The primary endpoint was PFS. This subgroup analysis was based on patients with brain metastases at baseline.

      Result

      There are 30 pts with brain metastases in anlotinib and placebo groups (n=21 vs 9). Anlotinib significantly improved PFS (3.84 vs 0.76 months; HR = 0.15; 95% CI, 0.04–0.51; P = 0.0005) and OS (6.08 vs 2.56 months; HR = 0.26; 95% CI, 0.09–0.73; P = 0.0061) comparing to placebo in patients with brain metastases at baseline. In anlotinib group, loss of appetite (47.62%), loss of weight (42.86 %), leukopenia (38.10%) and hypertriglyceridemia (38.10%) were the most common adverse events (AEs); then, in placebo group were emesis (44.44%) and loss of appetite (33.33 %).

      Conclusion

      For patients with brain metastases in ALTER1202 trial, significant improvement in OS and PFS were found in anlotinib treated group with a manageable safety profile.

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    P2.17 - Treatment of Early Stage/Localized Disease (ID 189)

    • Event: WCLC 2019
    • Type: Poster Viewing in the Exhibit Hall
    • Track: Treatment of Early Stage/Localized Disease
    • Presentations: 1
    • Moderators:
    • Coordinates: 9/09/2019, 10:15 - 18:15, Exhibit Hall
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      P2.17-36 - Molecular Markers, Therapeutic and Prognostic Analysis of Lung Sarcomatoid Carcinomas (ID 2973)

      10:15 - 18:15  |  Author(s): Jianxing He

      • Abstract

      Background

      Several molecular markers have been established for therapeutic intervention and prognostic prediction of lung cancer. Less is known about their therapeutic potential and prognostic significance in less common lung cancer subtypes. The present study was therefore designed to assess a set of well-defined molecular markers in patients with lung sarcomatoid carcinomas and their therapeutic and prognostic significance.

      Method

      This is a single-center retrospective study of lung cancer patients with histologic types of the sarcomatoid carcinomas who underwent surgical resection at our center during August 2008 to August 2018. The molecular markers analyzed were driver mutations in EGFR, ERBB2, PIK3CA, C-MET, RAS, BRAF, EML4-ALK, RET and ROS1 by ARMS-PCR or NGS, protein expressions of PD-L1 (clone SP-142) in tumors and/or associated lymphocytes by immunohistochemistry. Log-rank test was used to compare the overall survival of patients.

      Result

      A total of 74 (1.18%) patients with sarcomatoid carcinomas were identified from 6,285 patients underwent surgical resection. Of the 35 patients underwent mutation testing (including 14 test EGFR and RAS by ARMS), 17 (48.57%) harbored driver mutations (12 RAS, 4 EGFR L859R and 4 EGFR 19del). Proteins expressions of PD-L1 were found in 67.86% of patients. No prognostic significance (DFS and OS) was noted regarding to any driver mutations and PD-L1 expression. Half of the patients (37/74, 50.00%) received adjuvant therapy, 27 of whom used platinum-based chemotherapy (72.97%). Platinum-based adjuvant chemotherapy showed improved DFS (P=0.011) but similar OS (P=0.079).

      Conclusion

      A part of lung sarcomatoid carcinomas harbor driver mutation or PD-L1 expression, although they are not prognostic. Platinum-based chemotherapy was preferable in these patients. The role of targeted or immune agents as adjuvant therapy needs further study.