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Xu Wang



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    FP10 - Small Cell Lung Cancer/NET (ID 231)

    • Event: WCLC 2020
    • Type: Posters (Featured)
    • Track: Small Cell Lung Cancer/NET
    • Presentations: 1
    • Moderators:
    • Coordinates: 1/28/2021, 00:00 - 00:00, ePoster Hall
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      FP10.05 - A Prospective Phase II Study of Apatinib Plus Chemotherapy for Pretreated Patients With Advanced Small Cell Lung Cancer (ID 2045)

      00:00 - 00:00  |  Author(s): Xu Wang

      • Abstract
      • Slides

      Introduction

      Small-cell lung cancer (SCLC), which accounts for ∼15% of all lung cancers, is characterised by its rapid proliferation. The clinical outcomes of second-line and above treatments are unsatisfactory, resulting in a median progression-free survival (PFS) of less than 3 months. There is currently none targeted drugs or new chemotherapeutic drugs that can achieve breakthroughs in advanced SCLC. This study aims to observe whether apatinib in combination with chemotherapy can be a new choice for pretreated patients with advanced SCLC. This clinical trial has presented initial results in 2019 WCLC abstract 1788. This has updated the new data.

      Methods

      This is a prospective, single-center, single-arm clinical study designed to evaluate the efficacy and safety of apatinib plus chemotherapy for second-line and above treatment of advanced SCLC ((NCT03547804)). The dose of apatinib was 500mg per day in the initial protocol, and the treatment plan was adjusted due to tolerance of patients later and lower dose of apatinib 250mg once daily was applied. The dose of apatinib could be further reduced to 250mg every other day if the patient was observed with a grade 3/4 adverse effect. Chemotherapeutic agents were limited to irinotecan or docetaxel alone. The primary endpoint was the progression-free survival (PFS). The secondary endpoints included overall survival (OS), disease control rate (DCR), objective response rate (ORR), and adverse events (AEs).

      Results

      31 patients were enrolled from March 2018 to Oct 2019. 28 patients were available for response evaluation. The ORR and DCR were 25.00% (7/28) and 100% (28/28), respectively. The median PFS and OS were 7.43 months and 12.50 months, respectively (Fig 1a-1b). For subgroup analyses, we found that limited-stage disease had a longer PFS comparied with that of extensive-stage disease (9.17m vs 4.33m, P=0.0013) (Fig 1c). There were no significant differences in efficacy in subgroups of different initial dose (500mg vs 250mg) and age (<60y vs ≥60y). The most common treatment-related AEs were neutropenia, thrombocytopenia, hypertension, hand-foot syndrome, proteinuria, diarrhea, abnormal liver function and mucitis. However, the incidence of grade Ⅲ-Ⅳ adverse reactions was lower and the patients had a better tolerance with an initial dose of apatinib 250mg plus chemotherapy.未标题-1.jpg

      Conclusion

      Apatinib plus single agent chemotherapy showed a promising efficacy and a good tolerance in patients with pretreated SCLC. Especially, apatinib 250mg per day was recommended in this clinical trial.

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    P02 - Diagnostics and Interventional Pulmonology (ID 110)

    • Event: WCLC 2020
    • Type: Posters
    • Track: Diagnostics and Interventional Pulmonology
    • Presentations: 1
    • Moderators:
    • Coordinates: 1/28/2021, 00:00 - 00:00, ePoster Hall
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      P02.25 - Coexistence of Invasive Adenocarcinoma, Minimally Invasive Adenocarcinoma and Atypical Adenomatous Hyperplasia: A Case Report (ID 1726)

      00:00 - 00:00  |  Author(s): Xu Wang

      • Abstract

      Introduction

      Multiple small nodular lung cancer (MSLC) refers to multiple tumor nodules on the same or different lobes of the lungs. These nodules are affected by the same germline characteristics and environmental exposure factors that occur simultaneously in one individual. Invasive adenocarcinoma (inv ADC), minimally invasive adenocarcinoma (MIA) and atypical adenomatous hyperplasia (AAH) are regarded as the “three-steps” in the evolution of lung adenocarcinoma.

      Methods

      A fifty-year-old Asian female patient without a history of smoking was hospitalized due to three ground-glass nodules (GGNs) in the right upper lobe of the lung, which were detected in March 2017. Three nodules revealed by chest CT were each pathologically diagnosed as ADC, MIA and AAH. To further confirm the correlations and differences among these types, we performed whole-exome sequencing on the three lesions followed by a comparative analysis at the genetic level to determine the major genes that may play an important role in the progression of these “three-steps” in lung adenocarcinoma.p1.png

      Results

      The TMB of the three lesions was relatively low, especially in AAH.(Fig 2C) The three lesions were found to share a common gene (BAGE2).(Fig 2B) We found that MAP3K14, MAP2K1, and EGFR, which are three major genes of the EGFR-MAPK pathway, may play an important role in AAH, MIA and inv ADC, respectively.(Fig 2D) The C>T alteration was the primary change observed in the three nodules of the patient. C>A was increased in the ADC nodule and decreased in the MIA nodule, but was rare in AAH.(Fig 2E, F)p2.png

      Conclusion

      We found that MAP3K14, MAP2K1, and EGFR were three dominant factors that exist as part of “three-steps” and that might act as new specific targets for the treatment of this disease type. However, the relationship among MAP2K1, MAP3K14 and EGFR still requires more verification in more samples.

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    P75 - Immunotherapy (Phase II/III Trials) - Misc. Topics (ID 248)

    • Event: WCLC 2020
    • Type: Posters
    • Track: Immunotherapy (Phase II/III Trials)
    • Presentations: 1
    • Moderators:
    • Coordinates: 1/28/2021, 00:00 - 00:00, ePoster Hall
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      P75.22 - Efficacy of PD-1/PD-L1 Immune Checkpoint Inhibitors for Advanced NSCLC According to PD-L1 Expression: A Meta-Analysis (ID 2064)

      00:00 - 00:00  |  Author(s): Xu Wang

      • Abstract
      • Slides

      Introduction

      Programmed death 1(PD-1)/programmed death ligand 1 (PD-L1) immune checkpoint inhibitors (ICIs) has shown remarkable efficacy in the treatment of cancer. The predictive value of PD-L1 expression for ICIs in the treatment of advanced non-small cell lung cancer (NSCLC) has raise wide attention, also with some controversies. We combined existing data by meta-analysis to analyze the efficacy of immune checkpoint inhibitors (ICIs) in patients with advanced non-small cell lung cancer (NSCLC) with different PD-L1 expression levels, and to provide a basis for the selection of the best benefited patients.

      Methods

      Databases such as PubMed, Cochrane Library, Embase database, clinicaltrial.gov and the major international conferences such as ASCO, ESMO, WCLC were searched to select the qualified literatures according to the inclusion and exclusion criteria. We divided all patients into three groups of PD-L1≥50%, PD-L1 1%~49% and PD-L1<1%. All analyses were used the program RevMan5.3, to analyze the efficacy of ICIs in patients with different PD-L1 expression levels compared with chemotherapy by outcome measures of OS, PFS and ORR.

      Results

      Finally, 11 literatures from 10 randomized controlled trials and a total of 6122 patients were included in the study, including 3349 in the ICIs group and 2828 in the chemotherapy group. The results were as follows:

      1. In patients with advanced NSCLC with PD-L1≥50%, ICIs therapy improved OS(P<0.00001), PFS(P<0.0001), and ORR(P=0.003) compared with chemotherapy.

      2. In patients with advanced NSCLC with PD-L1 1%~49%, ICIs were associated with longer OS than chemotherapy (P=0.002), consistent with the results of second or later line therapy but not first line therapy. But the PFS (P=0.8) and ORR (P=0.05) were no statistical significances in these patients.

      3. In patients with advanced NSCLC with PD-L1<1%, ICIs improved OS (P=0.001) compared with chemotherapy, but the PFS (P=0.97) and ORR (P=0.34) were no statistical significances.

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      Conclusion

      1. The PD-L1 expression level may have predictive value for the treatment of ICIs in advanced NSCLC. Patients with PD-L1≥50% could be the best recipients of ICIs.

      2. Patients with PD-L1 1%~49% and PD-L1<1% also had OS benefits from ICIs in second or later line therapy, but not PFS or ORR benefit, and more evidence is needed for first-line treatment.

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    P79 - Immunotherapy (Phase II/III Trials) - Immunotherapy Plus Chemotherapy (ID 256)

    • Event: WCLC 2020
    • Type: Posters
    • Track: Immunotherapy (Phase II/III Trials)
    • Presentations: 1
    • Moderators:
    • Coordinates: 1/28/2021, 00:00 - 00:00, ePoster Hall
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      P79.09 - Neoadjuvant Combination Sintilimab plus Chemotherapy in Patients with Resectable Stage IIIA Non-Small Cell Lung Cancer. (ID 2013)

      00:00 - 00:00  |  Author(s): Xu Wang

      • Abstract
      • Slides

      Introduction

      Patients with stage IIIA non-small cell lung cancers (NSCLC) are potentially curable, however 5-year survival rate remains disappointing of 40%. The median overall survival(OS) of stage Ⅲ resectable NSCLC was only 31months, and 22 months for N2. At present, the standard treatment of neoadjuvant therapy is still platinum dual-drug chemotherapy. Antibodies that block programmed death 1 (PD-1) protein combined with chemotherapy improves survival in patients with advanced NSCLC. Sintilimab, a highly selective, fully human monoclonal antibody (mAb), blocks the interaction of PD-1 and its ligands and has demonstrated clinical benefit in various clinical studies. Therefore,it is still a question to be explored whether immunochemotherapy combined with chemotherapy can improve the pathological response rate, the disease-free survival(DFS) and OS. This study assessed the effects of the addition of Sintilimab to traditionnal neoadjuvant chemotherapy in resecrable NSCLC, aims to observe whether Sintilimab in combination with chemotherapy can be a new choice for treatment of resectable NSCLC.

      Methods

      This is a prospective, single-center, single-arm Phase Ⅱ clinical trial(NCT04326153). In this pilot study, patients with resectable stage ⅢA NSCLC received 2 cycles of neoadjuvant treatment (Sintilimab+Nab-paclitaxel+carboplatin) prior to surgery. Surgery must be done within the 3rd-4th week. Patients that are R0 confirmed by surgical pathology evaluation will receive 2 cycles of adjuvant treatment (Sintilimab+Nab-paclitaxel+carboplatin), and treatment of Sintilimab for six months. The primary endpoint is the rate of 24-month DFS. Secondary endpoints included major pathological response(mPR), the pathological complete response (pCR), OS, and adverse events(AEs).

      Results

      The ongoing trial has not reached pre-specified endpoints for analysis. At present, there are 2 patients who meet the standard have completed the operation after neoadjuvant. Patient A was diagnosed as large cell lung cancer with clinical stage ⅢA(T4N1M0). The evaluation of CT was patial response(PR)(Fig.1(a)(b)(c)(d)). The pathological response rate was 60%. Pathological stage reduced to stageⅠB(pT2aN0M0). Treat-related AE was increase of aspartate transaminase and alanine aminotransferase(grade Ⅱ CTCAE5.0 ). Patient B was diagnosed as adenocarcimoma with clinical stage ⅢA(T1bN2M0). The evaluation of CT was stable disease(SD)(Fig.1(e)(f)(g)(h)). The pathological response rate was 30%. Pathological stage reduced to stageⅡB(pT1cN1M0). Treat-related AE was leukopenia(grade Ⅱ CTCAE5.0). All adverse reactions can be returned to normal after symptomatic treatment.

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      Conclusion

      Neoadjuvant Sintilimab plus chemotherapy showed a bright efficacy with no intolerable adverses. It may improve the downstage rate and pathologic remission rate of patients with NSCLC. Whether it can improve the DFS and OS of patients remains to be further observed with experimental data.

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    P84 - Targeted Therapy - Clinically Focused - ALK (ID 261)

    • Event: WCLC 2020
    • Type: Posters
    • Track: Targeted Therapy - Clinically Focused
    • Presentations: 1
    • Moderators:
    • Coordinates: 1/28/2021, 00:00 - 00:00, ePoster Hall
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      P84.23 - The Safety and Toxicities of ALK -TKIs in ALK-Positive NSCLC: A Systematic Review and Pool Analysis (ID 2155)

      00:00 - 00:00  |  Author(s): Xu Wang

      • Abstract
      • Slides

      Introduction

      The anaplastic lymphoma kinase tyrosine kinase inhibitors (ALK-TKIs) including crizotinib, alectinib, ceritinib and brigatinib are available for the first-line treatment of patients with positive non-small cell lung cancer (NSCLC) and show a promising response. Selecting a treatment with acceptable toxicities and has a lower influence on the quality of life of the patient is essential. However, the analysis of the toxicity and safety profiles among different first line ALK TKIs is lacking. We performed a systemetic review to evaluate the safety and tolerability profiles of the first-line ALK inhibitors according to ALK -TKI type.

      Methods

      We extracted the data from prospective clinical trials searched in database and conducted a pooled analysis of severe AEs according to the type of ALK-TKIs. All statistical analyses were performed with the SPSS software.

      Results

      A total of 21 studies including 3418 patients were considered eligible for analysis. The frequencies of treatment-related death and AEs due to treatment withdrawn were 0.7% (24/3418) and 7.8 % (258/3308), respectively. The frequency of severe AEs in patients treated with ceritinib was significantly higher than patients treated with crizotinib, alectinib and brigatinib. One of the most common adverse events (AEs) observed with ALK inhibitors were gastrointestinal (GI) toxicities, such as nausea,vomiting and diarrhea. The frenquency of GI toxicities grade ≥ 3 in ceritinib group is significantly higher than in crizotinib group (5.6% vs. 1.2%, OR 4.825, 95% CI 2.907–8.008, P < 0.001) alectinib cohort (5.6% vs. 0.3%, OR 22.148, 95% CI 3.038–161.462, P < 0.001) and brigatinib group (5.6% vs 0.7%, OR 8.129, 95% CI 1.956–33.782, P=0.001). Hepatotoxicity of grade≥3 was significantly more frequent in patients treated with ceritinib, occured up to 24.1%(24.1% vs. 3.7%, OR 0.122, 95% CI 0.07–0.21, P < 0.001; 24.1% vs. 1.4%, OR 21.70, 95% CI 7.98–59.05, P < 0.001; 24.1% vs. 9.6%, OR 0.34 95% CI 0.27–0.42, P < 0.001). Significant difference of fatigue of grade ≥3 between ceritinib and other TKIs were detected(4.9% vs 0.9% OR 0.176, 95% CI 0.042–0.736, P=0.007; 4.9% vs0.7% OR 7.19, 95% CI 0.978–52.872, P=0.024; 4.9% vs 2.3% OR 0.46, 95% CI 0.29–0.74, P=0.001). It is more frequently in patients treated with crizotinib that occured neutropenia than any other group(12% vs 0.6% OR 21.07, 95% CI 5.2–85.2, P< 0.001; 12% vs1.1% OR 0.08, 95% CI 0.012–0.616, P=0.002; 12% vs 0% OR 1.09, 95% CI 1.08–1.11,P<0.001). Lung toxicity of grade ≥3 occured more often in brigatinib(6.1% vs 0% OR 2.46, 95% CI 2.22–2.71, P< 0.001; 6.1% vs2.8% OR 2.26, 95% CI 1.06–4.83, P=0.031; 6.1% vs 2.6% OR 2.46, 95%CI 1.33-4.54,P=0.003).

      Conclusion

      Attention should be focused on ALK inhibitor-related SAEs although ALK inhibitors have an acceptable safety profile with a low risk of treatment-related deaths. Statistically significant differences in some severe AEs among ceritinib, crizotinib alectinib and brigatinib were detected in this pool analysis.

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    P86 - Targeted Therapy - Clinically Focused - New Target (ID 263)

    • Event: WCLC 2020
    • Type: Posters
    • Track: Targeted Therapy - Clinically Focused
    • Presentations: 1
    • Moderators:
    • Coordinates: 1/28/2021, 00:00 - 00:00, ePoster Hall
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      P86.23 - Clinical Efficacy Analysis of Apatinib as a Second-Or Further-Line Treatment in Patients With Advanced NSCLC (ID 2072)

      00:00 - 00:00  |  Author(s): Xu Wang

      • Abstract
      • Slides

      Introduction

      Angiogenic agents play an important role in the therapeutic strategy for advanced NSCLC. Apatinib is a novel tyrosine kinase inhibitor that targets vascular endothelial growth factor receptor-2. The purpose of this study was to collect data on the clinical efficacy and side effects of oral apatinib as a second-or further-line in patients with advanced NSCLC in the first hospital of Jilin University.

      Methods

      A total of 43 patients with advanced NSCLC who were hospitalized in the Cancer Center of the First Hospital of Jilin University from January 1, 2017 to December 31, 2018 were enrolled. This study included patients whose initial dose was apatinib 500mg per day. Statistical analysis was performed using the SPSS19.0 system. The Kaplan-Meier method was used for survival analysis and the COX proportional hazard model was used for single factor analysis. The difference was statistically significant at p<0.05.

      Results

      Among all patients, the objective response rate (ORR) is 11.6% and the disease control rate (DCR) is 72.1%. The median progression-free survival (PFS) was 3.7 months. The ORR and DCR of 30 patients with Eastern Cooperative Oncology Group (ECOG) score of 0-1 were 16.7% and 83.3%, respectively, and the median PFS was 5.4 months (95% CI 3.1-7.7 months). The ORR and DCR of 13 patients with ECOG score of 2 were 0 and 4.6%, respectively, and the median PFS was 2.7 months (95% CI 2.1-3.3 months). The difference between the two groups was statistically significant (P=0.012). The most common treatment-related AEs were hypertension (48.8%), hand-foot syndrome (39.5%), diarrhea was (18.6%), nausea and vomiting (18.6%), and the incidence of grade 3 to 4 adverse reactions was 9.3%.

      Conclusion

      Apatinib is convenient, effective and safe in the treatment of advanced NSCLC patients, and the incidence of adverse reactions is low and controllable. ECOG score is the influencing factor of median PFS. For patients with ECOG score of 0-1, oral apatinib 250mg per day therapy can show a better therapeutic effect.

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