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Fei Xu



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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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      JICC01.15 - Pyrotinib Combined with Apatinib for HER2-Mutant Non-Small Cell Lung Cancer: Interim Analysis from a Phase II Clinical Study (ID 4274)

      07:00 - 09:00  |  Author(s): Fei Xu

      • Abstract

      Introduction

      Currently, there has been no approved tyrosine kinase inhibitors (TKIs) for non-small cell lung cancer (NSCLC) harboring HER2 mutations, resulting in an unmet need of this molecular entity. We performed this phase II study to assess the efficacy and safety of pyrotinib combined with apatinib in HER2-mutant advanced NSCLC patients who had failed to prior treatment.

      Methods

      Patients with metastatic HER2-mutant lung adenocarcinomas who had been pretreated with chemotherapy or other TKIs were enrolled to administer pyrotinib (dose of 400mg once daily) in combination with apatinib (dose of 250mg once daily) for 28-day cycles. The primary endpoint was objective response rate (ORR), and the second endpoint included progression-free survival (PFS), duration of response (DoR), disease control rate (DCR), overall survival (OS) and safety. The trial was approved by ethics committee and registered to Chinese Clinical Trial Registry (ChiCTR1900021684). All participants of this study provided written informed consent.

      Results

      Between March 5, 2019, and January 20, 2020, 14 patients were enrolled and received pyrotinib with apatinib combination therapy, and all of them were stage IV at baseline. Seven (50.0%) patients had received first-line platinum-based chemotherapy or afatinib treatment, and the others had received at least 2 lines of prior therapy (range, 2-6). At the last follow-up time July 14, 2020, among these 14 evaluable patients, the ORR was 35.7% (5/14), and it showed no difference between patients with or without brain metastases (ORR, 40.0% vs. 33.3%; median PFS, 6.6 vs. 8.0 months, P = 0.623). All subgroups of patients (10 with exon 20 insertions, 2 with missense mutations and 2 with amplifications) showed disease control with a DCR of 100%. The median PFS, DoR and OS were 8.0 (95%CI: 5.8-10.2), 5.3 (95%CI: 3.6-7.0) and 12.9 (95%CI: 3.8-22.0) months, respectively. The ORR in patients who administered pyrotinib with apatinib as second-line and third- or above-line treatment was 28.6% (2/7) and 42.9% (3/7), respectively; and median PFS did not differ in these two subgroups [8.8 (95%CI: 6.6-11.0) vs. 6.1 (95%CI: 4.0-8.2) months; HR=0.362; P = 0.144]. Common treatment-related adverse events included diarrhea (7.1%, grade 3; 64.3%, grade 2), hypertension (21.4%, grade 2; 50.0%, grade 1) and anorexia (57.1%, grade 1). No treatment-related deaths were reported.

      Patient characteristics at baseline and response for pyrotinib with apatinib

      Parameters

      Groups

      N (%)

      Age

      >60

      2 (14.3)

      ≤60

      12 (85.7)

      Gender

      Male

      7 (50.0)

      Female

      7 (50.0)

      Molecular variant

      A775_G776insYVMA

      9 (64.3)

      P780_Y781insGSP

      1 (7.1)

      G776V

      1 (7.1)

      R811L with Q820K

      1 (7.1)

      HER2 amplification

      2 (14.4)

      Prior lines of treatment

      1

      7 (50.0)

      2

      3 (21.4)

      ≥3

      4 (28.6)

      Brain metastases

      Presence

      5 (35.7)

      Absence

      9 (64.3)

      Partial response

      G766V

      HER2 amplification

      A775_G776insYVMA

      1 (7.1)

      1 (7.1)

      3 (21.4)

      Conclusion

      Pyrotinib in combination with apatinib showed favorable antitumor activity and acceptable safety in heavily pretreated NSCLC patients with diverse HER2 mutations.

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    P04 - Early Stage/Localized Disease - Perioperative Therapy (Neoadjuvant Therapy, Surgery, Adjuvant Therapy) (ID 113)

    • Event: WCLC 2020
    • Type: Posters
    • Track: Early Stage/Localized Disease
    • Presentations: 1
    • Moderators:
    • Coordinates: 1/28/2021, 00:00 - 00:00, ePoster Hall
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      P04.10 - Relapsed or Metastatic Organotropism in Early Stage Lung Cancer after Radical Surgery (ID 3781)

      00:00 - 00:00  |  Presenting Author(s): Fei Xu

      • Abstract

      Introduction

      Malignancies can spread to different sites in the body and the pattern which describes this phenomenon is called metastatic organotropism. Several studies had been tried to illustrate the relation between clinical or pathological features and specific metastatic sties. However, the conclusions remain controversial.

      Methods

      We retrospectively reviewed medical records of 2898 resected early stage non-small cell lung cancer (stage IA-IB, AJCC 7th) patients at Cancer Hospital, Chinese Academy of Medical Sciences from October 2012 to December 2015. To track the recurrence time and status, follow up had been done and the last follow up date was August 5th, 2020. Logistic regression was used to explore the relation between clinicopathological features and metastatic sites in patients who relapsed after radical surgery and especially in those who had not undergone adjuvant therapies.

      Results

      Among 2898 stage I non-small cell lung cancer(NSCLC) patients with surgical resection, 212(7.3%) patients relapsed, including 146 patients who had not undergone adjuvant therapies. Clinical features such as age, sex, smoking history, tumor size, tumor location, pathological factors such as pathologic type, differentiation, predominant subtype, lymphovascular space invasion(LVSI), pleural invasion and molecular mutations were included in the regression model. Distant organs were defined as metastases to bone, brain, liver and other sites except for metastases within lung and pleura. Patients with tumors in left lobes had more probabilities to metastasize to distant organs than those with tumors located in right lobes (OR=2.030, p=0.012). Among patients without adjuvant therapies, compared to lung metastases, patients with LVSI were more inclined to have brain as their first metastatic site than those without LVSI (OR=10.290, p=0.025). And compared to bone metastases, patients with pleural invasion had more tendency toward lung metastases than patients without pleural invasion (OR=5.327, p=0.026). Driver mutations, pathologic predominant subtype and adjuvant chemotherapy did not show correlation with relapsed organotropism of early stage NSCLC in our cohort.

      Conclusion

      We found 7.3% of stage I non-small cell lung cancer patients relapsed after radical surgery. Patients with tumors in left lobes were more likely to metastasize to distant organs. For patients who had not undergone adjuvant therapies, patients with lymphovascular space invasion of their tumors tended to metastasize to the brain and patients with pleural invasion of primary tumors tended to metastasize within the lung.

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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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      P86.02 - Pyrotinib Combined with Apatinib for HER2-Mutant Non-Small Cell Lung Cancer: Interim Analysis from a Phase II Clinical Study (ID 3019)

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

      • Abstract

      Introduction

      Currently, there has been no approved tyrosine kinase inhibitors (TKIs) for non-small cell lung cancer (NSCLC) harboring HER2 mutations, resulting in an unmet need of this molecular entity. We performed this phase II study to assess the efficacy and safety of pyrotinib combined with apatinib in HER2-mutant advanced NSCLC patients who had failed to prior treatment.

      Methods

      Patients with metastatic HER2-mutant lung adenocarcinomas who had been pretreated with chemotherapy or other TKIs were enrolled to administer pyrotinib (dose of 400mg once daily) in combination with apatinib (dose of 250mg once daily) for 28-day cycles. The primary endpoint was objective response rate (ORR), and the second endpoint included progression-free survival (PFS), duration of response (DoR), disease control rate (DCR), overall survival (OS) and safety. The trial was approved by ethics committee and registered to Chinese Clinical Trial Registry (ChiCTR1900021684). All participants of this study provided written informed consent.

      Results

      Between March 5, 2019, and January 20, 2020, 14 patients were enrolled and received pyrotinib with apatinib combination therapy, and all of them were stage IV at baseline. Seven (50.0%) patients had received first-line platinum-based chemotherapy or afatinib treatment, and the others had received at least 2 lines of prior therapy (range, 2-6). At the last follow-up time July 14, 2020, among these 14 evaluable patients, the ORR was 35.7% (5/14), and it showed no difference between patients with or without brain metastases (ORR, 40.0% vs. 33.3%; median PFS, 6.6 vs. 8.0 months, P = 0.623). All subgroups of patients (10 with exon 20 insertions, 2 with missense mutations and 2 with amplifications) showed disease control with a DCR of 100%. The median PFS, DoR and OS were 8.0 (95%CI: 5.8-10.2), 5.3 (95%CI: 3.6-7.0) and 12.9 (95%CI: 3.8-22.0) months, respectively. The ORR in patients who administered pyrotinib with apatinib as second-line and third- or above-line treatment was 28.6% (2/7) and 42.9% (3/7), respectively; and median PFS did not differ in these two subgroups [8.8 (95%CI: 6.6-11.0) vs. 6.1 (95%CI: 4.0-8.2) months; HR=0.362; P = 0.144]. Common treatment-related adverse events included diarrhea (7.1%, grade 3; 64.3%, grade 2), hypertension (21.4%, grade 2; 50.0%, grade 1) and anorexia (57.1%, grade 1). No treatment-related deaths were reported.

      Patient characteristics at baseline and response for pyrotinib with apatinib

      Parameters

      Groups

      N (%)

      Age

      >60

      2 (14.3)

      ≤60

      12 (85.7)

      Gender

      Male

      7 (50.0)

      Female

      7 (50.0)

      Molecular variant

      A775_G776insYVMA

      9 (64.3)

      P780_Y781insGSP

      1 (7.1)

      G776V

      1 (7.1)

      R811L with Q820K

      1 (7.1)

      HER2 amplification

      2 (14.4)

      Prior lines of treatment

      1

      7 (50.0)

      2

      3 (21.4)

      ≥3

      4 (28.6)

      Brain metastases

      Presence

      5 (35.7)

      Absence

      9 (64.3)

      Partial response

      G766V

      HER2 amplification

      A775_G776insYVMA

      1 (7.1)

      1 (7.1)

      3 (21.4)

      Conclusion

      Pyrotinib in combination with apatinib showed favorable antitumor activity and acceptable safety in heavily pretreated NSCLC patients with diverse HER2 mutations.