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Xingxiang Pu



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    FP01 - Early Stage/Localized Disease (ID 111)

    • Event: WCLC 2020
    • Type: Posters (Featured)
    • Track: Early Stage/Localized Disease
    • Presentations: 1
    • Moderators:
    • Coordinates: 1/28/2021, 00:00 - 00:00, ePoster Hall
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      FP01.02 - The Efficacy of Postoperative Radiotherapy in IIIA-N2 Non-Squamous NSCLC with Different EGFR Mutation Status: A Retrospective Analysis (ID 3680)

      00:00 - 00:00  |  Author(s): Xingxiang Pu

      • Abstract

      Introduction

      The effect of postoperative radiotherapy (PORT) on completely resected IIIA-N2 non-squamous non-small cell lung cancer (NSCLC) remains controversial. Growing postoperative therapies for epidermal growth factor receptor (EGFR)-mutant patients make the role of PORT ambiguous. Previous in-vitro studies have indicated that the status of EGFR mutation status can influence the radio-sensitivity of lung cancer, which needs more clinical investigation to verify. In this retrospective study, we aim to assess the efficacy of PORT in IIIA-N2 non-squamous NSCLC with different EGFR mutation status.

      Methods

      We enrolled patients who were diagnosed with completely resected stage IIIA-N2 non-squamous NSCLC, receiving postoperative radiotherapy or not, between April 2011 and May 2017 from the Second Xiangya Hospital and Hunan Cancer Hospital. And we analyzed the influence of PORT on disease-free survival (DFS) and overall survival (OS) in NSCLC patients with different EGFR mutation status.

      Results

      In total, 124 patients were eligible. The median follow-up time was 43.2 months (range 6-103 months). In multivariate analysis, age (>60 years old), cycles of chemotherapy (<4) and multiple-station N2 metastasis were correlated with shorter DFS. Multiple-station N2 metastasis,wild-type EGFR and no PORT were independent risk factors for OS. PORT significantly improved OS (46.40 months vs. 34.17 months, P = 0.021) but not DFS (19.02 months vs. 17.23 months, P = 0.266). In the EGFR wild-type group, PORT prolong OS (43.20 months vs. 28.67 months, P = 0.007), especially in EGFR wild-type group with multiple-station N2 metastasis (39.73 months vs. 24.9 months, P = 0.006) rather than DFS (18.43 months vs. 17.77 months, P = 0.775). There was a trend that PORT improved OS (69.30 months vs. 49.97 months, P = 0.057) and DFS (21.17 months vs. 17.17 months, P = 0.075) in the EGFR-mutant group, although there was no significant difference. In EGFR-mutant patients with multiple-station N2 metastasis, the DFS was significantly prolonged (23.13 months vs. 14.10 months, P = 0.021) in the PORT group. Nevertheless, the OS (72.5 months vs. 60.63 months, P = 0.189) and DFS (13.7 months vs. 24.33 months, P = 0.664) were not improved in EGFR-mutant patients with single-station N2 metastasis(Figure 1).figure 1.jpg

      Comparison of overall survivall (A,C,E) and disease-free survival (B,D,F) between the PORT and the non-PORT group. PORT=postoperative radiotherapy.

      Conclusion

      It is necessary for stage IIIA-N2 non-squamous NSCLC patients to receive PORT,especially for EGFR wild-type patients. Meanwhile, PORT can reduce local recurrence and metastasis in EGFR-mutant group, particularly in EGFR-mutant patients with multiple-station N2 metastasis. More prospective studies are needed to clarify the role of PORT in the EGFR-mutant IIIA-N2 non-squamous NSCLC patients.

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    P48 - Small Cell Lung Cancer/NET - Chemo - IO (ID 236)

    • Event: WCLC 2020
    • Type: Posters
    • Track: Small Cell Lung Cancer/NET
    • Presentations: 1
    • Moderators:
    • Coordinates: 1/28/2021, 00:00 - 00:00, ePoster Hall
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      P48.15 - A Case from a Single-Arm, Phase Two, Open Label Study Assessing Sindilimab Plus Metaformin in Chemotherapy Failed PD-L1 Positive Advanced SCLC (ID 1583)

      00:00 - 00:00  |  Author(s): Xingxiang Pu

      • Abstract

      Introduction

      Small cell lung cancer (SCLC) is relatively difficult in treatment and poor in prognosis. However immune checkpoint inhibitor (ICI) plus platinum based chemotherapy rewrote the SCLC NCCN guideline for the first time in past 2 decades. Metaformin is an oral tablets for type 2 diabete and was found to have potential anticancer effects through regulating T cell function, tumor oxygen consumption and AMPK pathway. Here we evaluated the efficacy and safety of ICI Sindilimab plus metaformin in chemotherapy failed PD-L1 positive SCLC.

      Methods

      This single arm, phase two, open label study aimed to recruit SCLC patients failed standard first-line platinum-based or lines of chemotherapy. Tumor sample was required positive in PD-L1 expression (22C3, both tumor cells and stroma evaluated) . Sindilimab was administrated 200mg Q3w, metaformin was added at 500mg Bid on day 22, escalating to 1000mg Bid on day 29, until progression of disease, unbearable toxicity or receive one year treatment at most. The primary endpoint was objective response rate and second endpoints were progression free survival (PFS), overall survival (OS) and duration of response (DoR). This trial has been registered on ClinicalTrial.gov, NCT03994744 , is ongoing.

      Results

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      From Aug. 2019 to Mar. 2020, 8 in 40 (20%) SCLC patients were positive for PD-L1 expression, only two patients met the inclusion criteria and received Sindilimab and metaformin (S+M) treatment. One of these two patient (P004) showed favorable response. P004 was diagnosed with stage IVb SCLC and received EP chemotherapy with 8 month PFS. When assessed PD, he complained of back pain and CT scan showed a mass on right upper lobe of lung, multi-lymph nodes metastasis on several sites, new lesions on brain and right rib. Then he was enrolled in this trial and at data sutoff he received 15 cycles of Sindilimab and 10 months metafomin tablets. The review showed the targeted lesion met and remained PR through treatment, even for the brain metastasis. The latest CT review (19th Aug 2020) indicated a 84% (96.2-15.8mm) shrinkage according to RECIST 1.1. Back pain vanished during treatment. Now treatment is ongoing and until data cutoff the second-line PFS was 10 months. So far no adverse event was observed in recruited cases.

      Conclusion

      The combination of Sindilimab plus metaformin showed potential efficacy on second line treatment in this PD-L1 positive SCLC case, though limited patients included so far. More data are required to confirm the efficacy and the underlying mechanism of heterogeneous response.

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    P76 - Targeted Therapy - Clinically Focused - EGFR (ID 253)

    • Event: WCLC 2020
    • Type: Posters
    • Track: Targeted Therapy - Clinically Focused
    • Presentations: 2
    • Moderators:
    • Coordinates: 1/28/2021, 00:00 - 00:00, ePoster Hall
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      P76.48 - A CT-Based Radiomic Feature Predicts EGFR Mutation and Response to Targeted Therapy in NSCLC (ID 2211)

      00:00 - 00:00  |  Author(s): Xingxiang Pu

      • Abstract

      Introduction

      Biomarkers that predict response to epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKI) is critical in NSCLC. EGFR mutation is a common and common use biomarker, but it is still constrained by tumor or liquid biopsy and tumor heterogeneity. Medical imaging-based biomarkers are research hotspots in certain anticancer therapy. Since computer tomography (CT) imaging is less costly and much easier for clinical application, several radiomics bio-markers have been proposed in lung cancer. The aim of this study is to identify radiomic signatures that distinguish the EGFR mutational status and explore feature related biomarkers associated with response in lung adenocarcinoma patients treated with first-line EGFR TKI.

      Methods

      CT imaging before treatment from 692 Lung adenocarcinoma patients with certain EGFR mutational status at Hunan Cancer Hospital were analyzed retrospectively. The features were quantified by radiomic features and enrolled into the support vector machine (SVM) classifier to build a radiomic model for predicting EGFR status. The performance was evaluated by the area under the curve (AUC) of the receiver operating characteristic (ROC) curve. We included top-ranked features to evaluate the relationship between survival and CT features using COX regression survival analysis.

      Results

      In this cohort, 355 patients were EGFR mutant while 337 patients was EGFR wild type. Two hundred and twenty-five EGFR-mutant patients suffered disease progression after first-line EGFR TKI therapy. The 13 features were input to the SVM classifier to build a radiomic model trained on the training cohort with 514 patients. The predictive performance was evaluated on an independent validation cohort and achieved an AUC of 74.13%. We found that higher value of skewness feature (HR=1.722,95%CI:1.261–2.352,P=0.001) and higher 10percentile feature (HR=1.466, 95% CI: 1.085-1.981, P=0.013) before treatment were significantly correlated with shorter PFS.

      Conclusion

      The radiomics signature based on CT imaging features in addition with clinical variables can be used to predict EGFR mutational status of lung adenocarcinomas. Skewness and 10percentile features may help the stratification of progression of advanced lung adenocarcinoma patients treated EGFR targeted therapy.

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      P76.63 - Dacomitinib Induces a Drastic Response in Metastatic Brain Lesions of Patients with EGFR-mutant Non-small-cell Lung Cancer: A Brief Report (ID 3280)

      00:00 - 00:00  |  Author(s): Xingxiang Pu

      • Abstract

      Introduction

      Dacomitinib is a potent, irreversible and pan-HER tyrosine kinase inhibitor (TKI) of EGFR-mutant NSCLC lacking evidence about its activity on brain metastasis. In this retrospective realworld cohort, we evaluated the intracranial efficacy and tolerability of dacomitinib in treatment-naïve NSCLC patients with EGFR-mutation and brain metastases.

      Methods

      Between July, 2019 and July, 2020, patients diagnosed of EGFR mutatant stage IV NSCLC with brain metastasis from Hunan Cancer hospital were reviewed. Paitents treated with Dacomitinib were enrolled. Objective response rate (ORR) and depth of response in brain metastasis was assessed with RECIST 1.1 criteria or RANO-LM.

      Results

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      Brain radiographic review of patients.

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      Response assesment of patients

      In total, 59 EGFR-mutant NSCLC patients were prescribed first-line Dacomitinib and 14 had brain metastasis before treatment. In 14 patietns, starting dose of 45 mg once daily was given to 5 patients while the remaining 9 patients received 30 mg until progression of disease or unbearable toxity. In this cohort, 7 (50%) were male. Eight patients harbored EGFR 19del, 5 with L858R and one patient had EGFR G719A and I706T. All patients received at least one radiographic review. At the data cut-off, the median follow up duration was 5 months. The ORR was 92.9% (13/14) and the DCR was 100% according to RECIST 1.1 criteria. A measurable response of intracranial metastases was observed in 12 of the 14 patients (85.7%), including 12 of 13 (92.3%) with brain parenchymal metastasis, but the one patient with meningeal metastasis did not respond well (RANO-LM criteria). All patients (100%) had grade 1-2 adverse effects, but none discontinued treatment or required a dosage adjustment.

      Conclusion

      This real-world cohort study with 14 patients has shown for the first time that dacomitinib have potent efficacy for CNS metastasis in both L858R and 19del EGFR-positive patients with NSCLC. More data are required to confirm its advantages and optimize its clinical application.