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Jianhua Chang



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    JCSE01 - Joint IASLC-CSCO-CAALC Session (ID 63)

    • Event: WCLC 2019
    • Type: Joint IASLC-CSCO-CAALC Session
    • Track:
    • Presentations: 1
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      JCSE01.18 - A CT-Based Radiomics Approach to Predict PD1 Inhibitor Response in Non-Small-Cell Lung Cancer (ID 3432)

      07:00 - 11:15  |  Author(s): Jianhua Chang

      • Abstract
      • Slides

      Abstract
      Background
      The purpose of this study was to investigate the use of radiomics features as predictive parameters of clinical outcomes of non-small-cell lung cancer (NSCLC) patients treated with PD1 inhibitor.

      Methods
      Forty-three stage IIIB/IV NSCLC patients without EGFR mutation or ALK rearrangement who received nivolumab were enrolled between Apr 2016 and Jan 2019. High-dimensional quantitative feature analysis via Pyradiomics was applied to extract 852 radiomics features of pre-anti-PD1 treatment CT. A radiomic score model was constructed from these features with the use of least absolute shrinkage and selection operator (LASSO) Cox regression. The radiomic score for each patient was computed using an equation in which the coefficients were derived from the LASSO Cox model to subgroup patients by progression-free survival (PFS). The median value of radiomic score was used as the cut-off value to cluster patients into high or low score groups.

      Results
      We developed a radiomic signature for PFS that included seven variables. The median value of radiomic score was 0.23. The objective response rate (ORR) was 16.3% (7/43), the median PFS was 2 months and median overall survival (OS) was 3.2 months of all 43 patients. A low radiomic score was associated with a higher ORR (33.7% vs 0%, p= 0.0036), improved PFS (median: 3 months vs 2 months; HR 0.14, 95% CI   0.053-0.39, P < 0.0001) and longer OS (median: 11.2 months vs 7.0 months; HR 0.12, 95%CI 0.04-0.31, p < 0.0001). Multivariate analysis also showed that a low radiomic score was related to better PFS (HR 0.12, 95% CI   0.041-0.32, P < 0.0001) and OS (HR 0.11, 95%CI 0.03-0.28, p < 0.0001).



      Conclusion
      The radiomic signature as an imaging predictor provided a promising way to predict clinical outcomes for NSCLC patients treated with PD-1 inhibitor.

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    MA13 - Going Back to the Roots! (ID 139)

    • Event: WCLC 2019
    • Type: Mini Oral Session
    • Track: Advanced NSCLC
    • Presentations: 1
    • Now Available
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      MA13.11 - A Randomized Phase III Study of Cisplatin-Polymeric Micelle Paclitaxel vs Cisplatin-Solvent-Based Paclitaxel in 1st Line Advanced NSCLC (Now Available) (ID 696)

      14:00 - 15:30  |  Author(s): Jianhua Chang

      • Abstract
      • Presentation
      • Slides

      Background

      Cisplatin-sb-Pac is the one of current standard of chemotherapy in aNSCLC, It produced 15% to 32% objective response rate (ORR) and 7.9 to 10.6 months of median overall survival (OS). Alternative nab-paclitaxel to sb-Pac only increased ORR but not improved progression-free survival (PFS) and OS. Thus the unmet medical need for new chemo regimen remains.

      Method

      From May 2015 to Jan 2018 448 untreated patients (pts) with stage IIIB to IV NSCLC from 24 sites were randomly assigned 2:1 to receive 230 mg/m2 pm-Pac and cisplatin 70 mg/m2 on day 1 of a 3-week cycle, and then dose escalation of pm-Pac to 300 mg/m2 from the second cycle if no prespecified toxic effects observed or 175 mg/m2 sb-Pac plus cisplatin 70 mg/m2 once every 3 weeks. Pts were stratified by stage and histology. The primary end point was ORR by Independent review committee (IRC) and Investigator (INV) in the intent-to-treat population. The second endpoints included PFS, OS and safety. Data cutoff was Jan 26, 2019.

      Result

      300 pts were assigned to pm-Pac and 148 to sb-Pac. Baseline characteristic were balance in both arms. Nonsquamous carcinoma (non-squ) and stage IV were 57.3% and 81.0% in pm-Pac and 58.1% and 81.8% in sb-Pac respectively. 73.2% pts in pm-Pac arm escalated their dose to 300mg/m2, 0.7% down to 184mg/m2. ORR and PFS in pm-Pac were significant better than that in sb-Pac (table 1). OS was immature. For histology subgroup the ORR was 58.6% v 37.1% (P=0.0054) in squamous carcinoma (Squ) and 44.2% v 18.6% (P<0.0001) in non-squ. Grade ≥3 AEs was 80.0% for pm-Pac and 79.7% for sb-Pac. No new safety issues were identified.

      Conclusion

      The phase 3 trial met its primary endpoint. pm-Pac significantly improved ORR and PFS than sb-Pac, and pm-Pac regimen should be a new standard chemo for aNSCLC. (NCT 02667743).

      Tab. Efficacies comparison between pm-Pac and sb-Pac

      pm-Pac

      sb-Pac

      P value

      ORR % (95% CI)

      IRC

      INV

      50.3 (44.5-56.1)

      52.0 (46.2-57.8)

      26.4 (19.5-34.2)

      28.4 (21.3-36.4)

      <0.0001

      <0.0001

      PFS (months)

      6.4 (6.2-6.9)

      5.3 (4.6-6.0)

      HR 0.66 (0.52-0.84), P=0.0006

      OS at 12 months

      67.3%

      61.8%

      -

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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): Jianhua Chang

      • 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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    OA04 - Immuno Combinations and the Role of TMB (ID 126)

    • Event: WCLC 2019
    • Type: Oral Session
    • Track: Immuno-oncology
    • Presentations: 1
    • Now Available
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      OA04.03 - A Randomized Phase 3 Study of Camrelizumab plus Chemotherapy as 1<sup>st</sup> Line Therapy for Advanced/Metastatic Non-Squamous Non-Small Cell Lung Cancer (Now Available) (ID 1682)

      15:15 - 16:45  |  Author(s): Jianhua Chang

      • Abstract
      • Presentation
      • Slides

      Background

      Platinum-based chemotherapy remains 1st line therapy for advanced non-small cell lung cancer (NSCLC) without oncogenic drivers in China. Camrelizumab (SHR-1210, a potent anti‒PD-1 monoclonal antibody) has shown promising activity in multiple malignancies. Here, we report interim analysis results on efficacy and safety of camrelizumab plus carboplatin/pemetrexed as 1st line treatment in Chinese advanced/metastatic non-squamous NSCLC patients with negative oncogenic drivers.

      Method

      In this open-label, randomized, multicenter phase 3 study (SHR-1210-303), patients with advanced/metastatic, non-squamous NSCLC with negative EGFR or ALK were stratified by sex and smoking history (≥ 400/year versus ˂ 400/year) and were randomly assigned (1:1) to receive 4 to 6 cycles of carboplatin (AUC=5) plus pemetrexed (500 mg/m2) with or without camrelizumab (200 mg), followed by pemetrexed with or without camrelizumab as maintenance therapy up to disease progression or intolerable toxicity. Treatment was given every 3 weeks. Crossover to camrelizumab monotherapy was permitted for patients in the chemotherapy arm who had confirmed disease progression. The primary endpoint was PFS per blinded independent central review according to RECIST v1.1. Secondary endpoints included ORR, DCR, DoR and OS. Data of subgroup analysis will be reported. Clinical Trials.gov number: NCT03134872.

      Result

      Between May 12, 2017 and Jun 6, 2018, 419 patients were randomized, among whom 205 received camrelizumab plus chemotherapy and 207 received chemotherapy treatment. After a median follow-up of 11.9 months, median PFS was 11.3 months (95% CI 9.5‒not reached) in camrelizumab plus chemotherapy arm and 8.3 months (95% CI 6.0‒9.7) in chemotherapy arm (HR 0.61 [95% CI 0.46‒0.80], p=0.0002). ORR, DCR, DoR and OS with camrelizumab plus chemotherapy were superior to chemotherapy (Table 1). Grade 3/4 adverse events occurred in 66.8% of patients in camrelizumab plus chemotherapy arm and 51.2% of patients in chemotherapy arm. There were 5 treatment-related deaths in camrelizumab plus chemotherapy arm and 4 in chemotherapy arm.

      Table 1. Responses per blinded independent central review and overall survival in the total study population

      Camrelizumab plus chemotherapy

      (n=205)

      Chemotherapy alone

      (n=207)
      p-value
      Objective response rate 60.0% (53.0‒66.8) 39.1% (32.4‒46.1) p<0.0001
      Disease control rate 87.3% (82.0‒91.6) 74.4% (67.9‒80.2) p=0.0009
      Duration of response (months) 17.6 (11.6‒NR) 9.9 (8.5‒13.8) p=0.0356
      Overall survival (months) NR (17.1‒NR) 20.9 (14.2‒NR) p=0.0272
      Data are shown in % (95% CI) or median (95% CI). NR: not reached.

      Conclusion

      First-line camrelizumab plus chemotherapy shows substantial clinical benefit in patients with advanced/metastatic non-squamous NSCLC with negative EGFR or ALK in terms of PFS, ORR, and OS and acceptable safety profiles. The combination should become novel standard 1st line therapy for this population.

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    P1.01 - Advanced NSCLC (ID 158)

    • Event: WCLC 2019
    • Type: Poster Viewing in the Exhibit Hall
    • Track: Advanced NSCLC
    • Presentations: 1
    • Now Available
    • Moderators:
    • Coordinates: 9/08/2019, 09:45 - 18:00, Exhibit Hall
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      P1.01-66 - A CT-Based Radiomics Approach to Predict PD1 Inhibitor Response in Non-Small-Cell Lung Cancer (Now Available) (ID 565)

      09:45 - 18:00  |  Author(s): Jianhua Chang

      • Abstract
      • Slides

      Background

      The purpose of this study was to investigate the use of radiomics features as predictive parameters of clinical outcomes of non-small-cell lung cancer (NSCLC) patients treated with PD1 inhibitor.

      Method

      Forty-three stage IIIB/IV NSCLC patients without EGFR mutation or ALK rearrangement who received nivolumab were enrolled between Apr 2016 and Jan 2019. High-dimensional quantitative feature analysis via Pyradiomics was applied to extract 852 radiomics features of pre-anti-PD1 treatment CT. A radiomic score model was constructed from these features with the use of least absolute shrinkage and selection operator (LASSO) Cox regression. The radiomic score for each patient was computed using an equation in which the coefficients were derived from the LASSO Cox model to subgroup patients by progression-free survival (PFS). The median value of radiomic score was used as the cut-off value to cluster patients into high or low score groups.

      Result

      We developed a radiomic signature for PFS that included seven variables. The median value of radiomic score was 0.23. The objective response rate (ORR) was 16.3% (7/43), the median PFS was 2 months and median overall survival (OS) was 3.2 months of all 43 patients. A low radiomic score was associated with a higher ORR (33.7% vs 0%, p= 0.0036), improved PFS (median: 3 months vs 2 months; HR 0.14, 95% CI   0.053-0.39, P < 0.0001) and longer OS (median: 11.2 months vs 7.0 months; HR 0.12, 95%CI 0.04-0.31, p < 0.0001). Multivariate analysis also showed that a low radiomic score was related to better PFS (HR 0.12, 95% CI   0.041-0.32, P < 0.0001) and OS (HR 0.11, 95%CI 0.03-0.28, p < 0.0001).

      8.pic_hd.jpg

      Conclusion

      The radiomic signature as an imaging predictor provided a promising way to predict clinical outcomes for NSCLC patients treated with PD-1 inhibitor.

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    P1.04 - Immuno-oncology (ID 164)

    • Event: WCLC 2019
    • Type: Poster Viewing in the Exhibit Hall
    • Track: Immuno-oncology
    • Presentations: 1
    • Moderators:
    • Coordinates: 9/08/2019, 09:45 - 18:00, Exhibit Hall
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      P1.04-20 - PD-L1 mRNA Derived from Tumor-Educated Platelets Predicts the Clinical Outcome of Immunotherapy in Non-Small Cell Lung Cancer (ID 2982)

      09:45 - 18:00  |  Presenting Author(s): Jianhua Chang

      • Abstract

      Background

      Immunotherapy was promising treatment of advanced non-small cell lung cancer (NSCLC), but only a small part of patients could benefit from the immune checkpoint inhibitors (ICIs). Development of novel biomarkers was of great importance to improve the selection of patients and to avoid unnecessary toxicity.

      Method

      We collected data from advanced NSCLC patients who received immunotherapy alone or in combination with chemotherapy as first- or second-line treatment at a single institution. All the patients were wild type of EGFR/ALK and enrolled into clinical trials on ICIs, including nivolumab, pembrolizumab, atezolizumab, durvalumab, tremelimumab and camrelizumab. PD-L1 messenger RNA (mRNA) was detected from tumor-educated platelets before ICIs treatment. Meanwhile, tumoral PD-L1 expression was also determined by immunohistochemistry in archived tissue samples to explore its predictive value and association with TEPs- derived PD-L1 mRNA expression.

      Result

      Of 76 patients enrolled into this study, 68 patients (89.5%) received only immunotherapy and 23 patients (30.3%) responded to the treatment, and the median PFS was 3.81 months. There was no correlation between tumoral PD-L1 expression and TEPs-derived mRNA of PD-L1 by Pearson Correlation test (P=0.32). Based on the median of PD-L1 mRNA, 19 patients (44.4%) responded to immunotherapy in high PD-L1 group compared to 5 patients (13.9%) in low PD-L1 group (P<0.01). The median PFS were 2.76 months in low PD-L1 group, compared to 8.28 months in high PD-L1 group (P<0.001), respectively. For the 64 patients who received only immunotherapy, the PFS advantage was persistent in high PD-L1 group (2.76 vs 8.02 months, p=0.002). The median OS was not reached in high PD-L1 group, while it was 13.47 months in low PD-L1 group (P<0.01).

      Conclusion

      Tumor-educated platelets derived PD-L1 mRNA could be a surrogate biomarker predicting the PFS and OS of immunotherapy in patients with advanced non-small cell lung cancer.

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    P1.12 - Small Cell Lung Cancer/NET (ID 179)

    • Event: WCLC 2019
    • Type: Poster Viewing in the Exhibit Hall
    • Track: Small Cell Lung Cancer/NET
    • Presentations: 1
    • Now Available
    • Moderators:
    • Coordinates: 9/08/2019, 09:45 - 18:00, Exhibit Hall
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      P1.12-19 - Identification and Potential Application of Human Blood Exosomal RNA in Small Cell Lung Cancer (Now Available) (ID 423)

      09:45 - 18:00  |  Author(s): Jianhua Chang

      • Abstract
      • Slides

      Background

      Plasma exosomes­, which are nanosized endocytic vesicles that have been implicated as non-invasive diagnostic, prognostic sources, contain an abundant cargo of different RNA species that may be used as biomarkers for human cancers. Little research has been done on small cell lung cancer (SCLC) blood exosomal RNA. The aim of this study is to explore SCLC exosomal specific transcriptional profiles and to further predict efficacy of first-line chemotherapy.

      Method

      Pre-chemotherapy and paired post-chemotherapy plasma samples (8ml whole blood) from patients with limited or extensive disease SCLC and healthy volunteers were prospectively collected. We used exoRNeasy Serum/Plasma Kit (Qiagen, Hilden, Germany) to purify exosomes and isolate total exosomal RNAs. Exosomal RNA profiling was performed using RNA-seq. RNA-seq libraries were generated using SMART technology (Clontech). We conducted pre-experimental analysis of 8 samples from healthy volunteers and 8 samples of 4 SCLC patients before and after chemotherapy.

      Result

      The heat map showed that the exosomal mRNA expression profile of SCLC was significantly up-regulated compared to healthy volunteers and that the mRNA profiles before and after chemotherapy were also significantly different. Compared with healthy volunteers, SCLC had a significant up-regulation of 499 genes including the most differential gene ZNF805 (p=2.82E-05), COPS8 (p=3.20E-05), LRRC47 (p=3.54E-05), FANCE (p=1.02E-04), PGM3 (p=1.47E-04). Before and after chemotherapy, up-regulated genes with the greatest difference included KCNN4, HBB, TRAK2, TMUB2, ELF3; down-regulated genes with the greatest difference included ZBTB7C, LHFP, WNT11, VPS33B, STON1.

      1.jpg2.jpg

      Conclusion

      This preliminary analysis firstly identified blood exosomal RNA profiles in SCLC and highlighted the potential application of exosomal RNA based non-invasive liquid biopsy in SCLC.

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    P2.01 - Advanced NSCLC (ID 159)

    • Event: WCLC 2019
    • Type: Poster Viewing in the Exhibit Hall
    • Track: Advanced NSCLC
    • Presentations: 1
    • Moderators:
    • Coordinates: 9/09/2019, 10:15 - 18:15, Exhibit Hall
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      P2.01-99 - A Phase IIIb Open-Label Study of Afatinib in EGFR TKI-Naïve Patients with EGFR Mutation-Positive NSCLC: Final Analysis (ID 1671)

      10:15 - 18:15  |  Author(s): Jianhua Chang

      • Abstract
      • Slides

      Background

      The safety and efficacy of afatinib, an orally administered irreversible EGFR TKI, have been demonstrated in patients with EGFR mutation-positive (EGFRm+) NSCLC in several Phase III clinical trials. However, prospective evidence supporting the clinical benefit of afatinib in the real-world setting is limited. Here, we report final data from a Phase IIIb open-label, multicenter trial evaluating safety and efficacy of afatinib in EGFR TKI-naïve Asian patients with locally advanced/metastatic EGFRm+ NSCLC, in a setting similar to real-world practice.

      Method

      EGFR TKI-naïve patients with locally advanced/metastatic EGFRm+ NSCLC were recruited from 34 sites in China, Hong Kong, India, Singapore, and Taiwan. Patients received 40 mg/day afatinib. Dose reduction to minimum 20 mg/day was permitted. Treatment continued until lack of clinical benefit as determined by the investigator. The primary and secondary safety endpoints were number of patients with serious adverse events (SAEs), and number of patients with drug-related AEs, respectively. The secondary efficacy endpoint was time to symptomatic progression (TTSP). Further endpoints included progression free survival (PFS), objective response, and duration of disease control.

      Result

      In total, 541 patients received afatinib. Baseline characteristics were representative of patients with EGFRm+ NSCLC (median age, 59 years; female, 52.9%; never smoked, 69.3%; EGFR mutations, common [Del19/L858R]/uncommon: 88.2% [48.2%/40.5%]/11.8%; ECOG performance status 0/1, 18.3%/79.7%; brain metastases, 19%). SAEs were reported in 164 patients (30.3%). 34 patients (6.3%) had drug-related SAEs, most commonly (grouped terms): diarrhea (1.8%), stomatitis (0.7%), and vomiting (0.7%). Drug-related AEs (DRAEs) of any grade were reported in 528 patients (97.6%). AEs leading to dose reduction occurred in 154 patients (28.5%); TRAEs leading to treatment discontinuation were reported in 17 patients (3.1%). Three patients experienced DRAEs leading to death (decreased appetite, dyspnea, and respiratory failure). Median TTSP was 14.0 months (95% confidence interval [CI]: 12.9, 15.9) and median PFS was 12.1 months (95% CI: 11.0, 13.6). Objective responses were reported in 312 patients (57.7%) by week 52; the median duration of response was 12.2 months (95% CI: 11.0, 13.5). 483 patients (89.3%) achieved disease control of median duration 13.6 months (95% CI: 12.1, 14.4).

      Conclusion

      Safety data for afatinib in this patient population were consistent with previously reported data, with no new safety signals. AEs were manageable and did not lead to discontinuation in most patients. This study also demonstrated the efficacy and clinical benefit of afatinib in Asian patients with locally advanced or metastatic EGFRm+ NSCLC in a near real-world setting.

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    P2.09 - Pathology (ID 174)

    • Event: WCLC 2019
    • Type: Poster Viewing in the Exhibit Hall
    • Track: Pathology
    • Presentations: 1
    • Moderators:
    • Coordinates: 9/09/2019, 10:15 - 18:15, Exhibit Hall
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      P2.09-08 - Correlation Between Hormone Receptor Expression and EGFR Gene Mutation in Lung Cancer Patients with Simultaneous Primary Breast Cancer (ID 2968)

      10:15 - 18:15  |  Presenting Author(s): Jianhua Chang

      • Abstract

      Background

      Double primary breast cancer (BC) and lung cancer (LC) is not uncommon but research is limited. To decipher the inner pathogenesis, relationship between hormone receptor (HR) protein expression and EGFR gene mutation was explored in the present study.

      Method

      Clinicopathological characteristics of 400 female patients with double primary BC and LC were analyzed, while another 114 patients with single LC were compared correspondingly. Tissue samples were obtained from enrolled subjects to detect EGFR mutation status by gene sequencing analysis, and estrogen receptor (ER) and progesterone receptor (PR) expression was determined by immunohistochemistry.

      Result

      Among 169 patients, synchronous and metachronous double primary BC-LC cases accounted for 39.1% and 61.0%, respectively. For most female LC patients with simultaneous primary BC, adenocarcinoma was the dominant subtype (95.1%). The positivity rates were 13% for ER and 13% for PR in lung tumor tissues of 200 double BC-LC patients, slightly higher than those in single LC patients. Among BC-LC patients with mutant EGFR, 48.2% were either ER-positive (30.6%) or PR-positive (30.6%). But for those without EGFR mutation, both ER and PR could not be detected in lung tumor tissue samples. χ2 testfurther confirmed a significantly positive correlation between ER, PR expression and EGFR mutation in lung tumor tissues in double primary patients (P < 0.05). However, such relationship could not be similarly observed in single LC cases. Besides, the presence of family tumor history was associated with the onset time of the two primary cancers.

      Conclusion

      Double primary BC-LC patients have distinctive clinicopathological features. Expression of HRs (both ER and PR) significantly correlated with EGFR mutation status in their lung tumor tissues.