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Guoguang Shao



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    FP14 - Targeted Therapy - Clinically Focused (ID 252)

    • Event: WCLC 2020
    • Type: Posters (Featured)
    • Track: Targeted Therapy - Clinically Focused
    • Presentations: 1
    • Moderators:
    • Coordinates: 1/28/2021, 00:00 - 00:00, ePoster Hall
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      FP14.11 - Icotinib versus Chemotherapy as Adjuvant Treatment for Stage II–IIIA EGFR-Mutant NSCLC (EVIDENCE): A Randomized, Open-Label, Phase 3 Study (ID 3605)

      00:00 - 00:00  |  Author(s): Guoguang Shao

      • Abstract
      • Slides

      Introduction

      Recent studies have shown significant benefits of EGFR tyrosine kinase inhibitors in the adjuvant setting for patients with EGFR-mutant stage IB–IIIA resected NSCLC. This study aimed to compare the efficacy and safety of icotinib with standard chemotherapy in adjuvant setting in patients with EGFR mutant stage II-IIIA NSCLC.

      Methods

      In this randomized, open-label, phase 3 study, eligible patients aged 18-70 years who had completely resected (R0), stage II-IIIA EGFR-mutant NSCLC (in-frame deletion in exon 19 or Leu858Arg point mutation in exon 21) were randomly assigned, in a 1:1 ratio, to receive either adjuvant icotinib (125 mg thrice daily administered orally for 2 years) or four-cycle chemotherapy (cisplatin plus vinorelbine, or cisplatin plus pemetrexed for non-squamous carcinoma). Patients were stratified by clinical stage (II vs IIIA), EGFR mutation type (exon 19 vs 21), and resection methods (lobectomy vs pneumonectomy). The primary endpoint was disease-free survival (DFS). Secondary endpoints included overall survival (OS) and safety.

      Results

      A total of 365 patients were screened, and 322 patients (161 for each arm) were enrolled from 29 centers across China between June 2015 and July 2019. Thirty-nine patients had major protocol violations and were excluded, leaving 283 patients in full analysis set (151 in icotinib arm and 132 in chemotherapy arm, respectively). 53% and 47% of patients had an EGFR mutation of 19 Del and 21 L858R, respectively. At the data cutoff (March 31, 2020) for the pre-specified interim analysis, 98 out of 196 (50%) events were recorded with a median follow-up of 24.9 months (95% CI, 22.1 to 28.8). In full analysis population, the median DFS (mDFS) was 47.0 months (95% CI, 36.44 to not reached) in the icotinib group and 22.1 months (95% CI, 16.8 to 30.4) in the chemotherapy group (stratified hazard ratio=0.36; 95% CI, 0.24 to 0.55; P < 0.0001). Analyses of DFS based on stratification criteria and vital demographic and prognostic factors showed consistent benefits of icotinib treatment across subgroups. The 3-year DFS was 63.9% in the icotinib group and 32.5% in the chemotherapy group. It is immature to perform OS analysis with14 (9.3%) patients in the icotinib group and 14 (10.6%) patients in the chemotherapy group died, respectively. Adverse events of grade 3 or 4 were observed in 10.9% of the patients in the icotinib group and 61.2% in the chemotherapy group. Treatment-related serious adverse events occurred in 2 (1.3%) patients in the icotinib group and 19 (13.7%) patients in the chemotherapy group. No interstitial pneumonia or treatment-related death was observed in each group.

      Conclusion

      Adjuvant icotinib significantly improved DFS in patients with EGFR mutant stage II-IIIA NSCLC compared with standard chemotherapy and demonstrated a better tolerability profile. Icotinib can provide a new treatment option for stage II-IIIA NSCLC patients with activating EGFR mutation.

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    JICC01 - Joint IASLC-CAALC-CSCO Session: The Truth and Myth of Oral Anti-VEGFR Inhibitors for Advance NSCLC (ID 276)

    • Event: WCLC 2020
    • Type: Workshop
    • Track: N.A.
    • Presentations: 1
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      JICC01.11 - Icotinib versus Chemotherapy as Adjuvant Treatment for Stage II–IIIA EGFR-Mutant NSCLC (EVIDENCE): A Randomized, Open-Label, Phase 3 Study (ID 4275)

      07:00 - 09:00  |  Author(s): Guoguang Shao

      • Abstract

      Introduction
      Recent studies have shown significant benefits of EGFR tyrosine kinase inhibitors in the adjuvant setting for patients with EGFR-mutant stage IB–IIIA resected NSCLC. This study aimed to compare the efficacy and safety of icotinib with standard chemotherapy in adjuvant setting in patients with EGFR mutant stage II-IIIA NSCLC. Methods
      In this randomized, open-label, phase 3 study, eligible patients aged 18-70 years who had completely resected (R0), stage II-IIIA EGFR-mutant NSCLC (in-frame deletion in exon 19 or Leu858Arg point mutation in exon 21) were randomly assigned, in a 1:1 ratio, to receive either adjuvant icotinib (125 mg thrice daily administered orally for 2 years) or four-cycle chemotherapy (cisplatin plus vinorelbine, or cisplatin plus pemetrexed for non-squamous carcinoma). Patients were stratified by clinical stage (II vs IIIA), EGFR mutation type (exon 19 vs 21), and resection methods (lobectomy vs pneumonectomy). The primary endpoint was disease-free survival (DFS). Secondary endpoints included overall survival (OS) and safety. Results
      A total of 365 patients were screened, and 322 patients (161 for each arm) were enrolled from 29 centers across China between June 2015 and July 2019. Thirty-nine patients had major protocol violations and were excluded, leaving 283 patients in full analysis set (151 in icotinib arm and 132 in chemotherapy arm, respectively). 53% and 47% of patients had an EGFR mutation of 19 Del and 21 L858R, respectively. At the data cutoff (March 31, 2020) for the pre-specified interim analysis, 98 out of 196 (50%) events were recorded with a median follow-up of 24.9 months (95% CI, 22.1 to 28.8). In full analysis population, the median DFS (mDFS) was 47.0 months (95% CI, 36.44 to not reached) in the icotinib group and 22.1 months (95% CI, 16.8 to 30.4) in the chemotherapy group (stratified hazard ratio=0.36; 95% CI, 0.24 to 0.55; P < 0.0001). Analyses of DFS based on stratification criteria and vital demographic and prognostic factors showed consistent benefits of icotinib treatment across subgroups. The 3-year DFS was 63.9% in the icotinib group and 32.5% in the chemotherapy group. It is immature to perform OS analysis with14 (9.3%) patients in the icotinib group and 14 (10.6%) patients in the chemotherapy group died, respectively. Adverse events of grade 3 or 4 were observed in 10.9% of the patients in the icotinib group and 61.2% in the chemotherapy group. Treatment-related serious adverse events occurred in 2 (1.3%) patients in the icotinib group and 19 (13.7%) patients in the chemotherapy group. No interstitial pneumonia or treatment-related death was observed in each group. Conclusion
      Adjuvant icotinib significantly improved DFS in patients with EGFR mutant stage II-IIIA NSCLC compared with standard chemotherapy and demonstrated a better tolerability profile. Icotinib can provide a new treatment option for stage II-IIIA NSCLC patients with activating EGFR mutation.

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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): Guoguang Shao

      • 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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    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): Guoguang Shao

      • 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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