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Tomoya Fukui



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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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      P76.53 - Impact of Neutrophil-to-Lymphocyte Ratio in Patients with EGFR-Mutant NSCLC Treated with Tyrosine Kinase Inhibitors (ID 3015)

      00:00 - 00:00  |  Author(s): Tomoya Fukui

      • Abstract
      • Slides

      Introduction

      We previously reported that a patient’s smoking status was an independent predictor of progression-free survival (PFS) in gefitinib and erlotinib therapy for patients with non-small cell lung cancer (NSCLC) harboring EGFR mutations. However, other indicators that can elaborate on the clinical efficacy to the EGFR-TKI therapy remain understudied. The inflammatory indicator neutrophil-to-lymphocyte ratio (NLR) in peripheral blood serves as a predictive factor for NSCLC patients treated with anti-cancer agents such as cytotoxic drugs and PD-1 inhibitors. Here, we aimed to evaluate the correlation between NLR and clinical efficacy of EGFR-TKIs in NSCLC patients harboring EGFR mutations.

      Methods

      We retrospectively collected information of 205 patients with advanced NSCLC harboring exon 19 deletion or L858R point mutation and receiving gefitinib or erlotinib, between March 2009 and June 2016, were enrolled. The date cut-off date was March 2019. The clinical outcomes in the NSCLC patients were evaluated based on NLR level before EGFR-TKI therapy. Variables (including gender, age, performance status [PS], NLR, EGFR genotype, smoking status, clinical stage prior to EGFR-TKI treatment [Stage IV vs. postoperative recurrence], the presence or absence of brain metastases, type of EGFR-TKI [gefitinib vs. erlotinib]) were entered into a Cox proportional hazards regression model to estimate the hazards ratios for PFS and overall survival (OS). We used PFS longer or shorter than 10 months as the binary variables for ROC curves.

      Results

      The patient cohort comprised of 60% women, with 70 years median age, and 65% of good PS. An optimal cut-off value of 3.55 was chosen for NLR, with an area under the curve (AUC) value of 0.67 [95% confidence interval (CI): 0.59–0.74, P < 0.0001]. The response rates in the low-NLR and high-NLR groups were 69.2% (95% CI: 60.3–78.1%) and 51.5% (95% CI: 41.8–61.2%). In addition, the mean values of NLR in responders (patients with partial response) and non-responders (patients with stable disease or progressive disease) were 4.8 and 11.3 respectively, indicating a significant difference (P = 0.021). A median follow-up period for the survival analysis was 25.2 months. The median PFS and OS of all the patients together were 10.8 months (95% CI: 8.8– 12.8 months) and 28.0 months (95% CI: 23.5– 32.5 months). The median PFS in the low-NLR and high-NLR groups were 15.7 months (95% CI: 12.7–18.7 months) and 6.7 months (95% CI: 4.6–8.8 months). The median OS in the low-NLR and high-NLR groups were 37.6 months (95% CI: 30.3–44.9 months) and 19.2 months (95% CI: 10.6–27.8 months). The multivariate analysis identified PS, NLR, stage, and smoking status as independent predictors of PFS. Moreover, the PS and NLR were identified as independent predictors of OS.

      Conclusion

      NLR was a significant predictor of clinical efficacy in NSCLC patients harboring EGFR mutations treated with gefitinib or erlotinib.

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      P76.55 - Real-world Experience of the Utility in Afatinib Therapy for Patients with EGFR-Mutant Advanced NSCLC (ID 3128)

      00:00 - 00:00  |  Author(s): Tomoya Fukui

      • Abstract
      • Slides

      Introduction

      We previously reported that a patient’s smoking status and peripheral blood neutrophil-to-lymphocyte ratio (NLR) were independent predictors of progression-free survival (PFS) in gefitinib and erlotinib therapy for patients with NSCLC harboring EGFR mutations. Meanwhile, afatinib is currently one of the available treatment option as well as osimertinib for patients with advanced NSCLC harboring common EGFR mutations, however, the clinicopathological factors that are predictive of this drug’s efficacy have not been sufficiently evaluated in a real-world setting. Hence, we conducted a clinical study to evaluate the predictive factors of afatinib therapy among this patients population.

      Methods

      We retrospectively investigated clinical outcomes in patients with NSCLC who received first-line afatinib between July 2014 and August 2018. Variables (including sex, age, performance status, NLR, EGFR genotype, smoking status, clinical stage prior to treatment [stage IV vs. postoperative recurrence], presence or absence of brain metastases, body surface area, any afatinib dose reductions, and afatinib starting dose [40 vs. 20 or 30 mg]) were subjected to a Cox proportional hazards regression model to estimate PFS. The NLR was calculated based on the absolute neutrophil and lymphocyte counts before commencing afatinib therapy. PFS longer versus shorter than 13 months were used as the binary variables as to determine the optimal NLR cut-off for a plotting of ROC curve.

      Results

      Forty-eight patients with a median age of 67 years were included. All of them had good performance status. The majority of patients had stage IV disease (75%); the optimal NLR cut-off value was 2.65, which had an area under the curve of 0.67 (95% confidence interval [CI]: 0.51–0.82, P=0.048). The objective response was observed in 30 patients, indicating an objective response rate of 62.5% (95% CI: 47.1–77.9%); the response rates were 54.8% (95%CI 39.0–70.7) and 76.5% (95%CI: 63.0–90.0%) for patients receiving 40 mg versus 20–30 mg of afatinib (P=0.34), and were 61.9% (95%CI: 46.5–77.3%) and 63.0% (95%CI: 47.6–78.3%) for patients who required afatinib dose reduction and those who did not (P=0.59), respectively. The patients were followed for a median of 25.3 months for the survival analysis. The median PFS of all patients was 14.1 months (95% CI: 7.7–20.5 months); the PFS were 11.8 (95% CI 5.1–18.5 months) and 15.9 months (95%CI 8.6–23.2 months) for patients receiving 40 mg versus 20–30 mg of afatinib (P=0.41), respectively, and were 14.5 (95% CI 6.4–22.6 months) and 13.8 months (95% CI 6.2–2 1.4 months) for patients who required afatinib dose reduction and those who did not (P=0.80). A multivariate analysis did not identify significant predictive value for PFS ultimately, indicating that PFS can be expected irrespective of the starting dose of afatinib, dose reduction, smoking status and NLR level.

      Conclusion

      Afatinib is effective for patients with NSCLC harboring common EGFR mutations irrespective of their clinicopathological backgrounds unlike gefitinib and erlotinib.

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    P78 - Immunotherapy (Phase II/III Trials) - Immune Checkpoint Inhibitor Single Agent (ID 255)

    • 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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      P78.06 - Dynamic Risk Prediction for Disease Control With Nivolumab in Advanced or Recurrent Non-Small Cell Lung Cancer Patients (NewEpoch) (ID 3121)

      00:00 - 00:00  |  Presenting Author(s): Tomoya Fukui

      • Abstract
      • Slides

      Introduction

      Immune checkpoint inhibitors (ICI) have been widely used for treatment of advanced or recurrent non-small cell lung cancer (NSCLC), but prediction of their efficacy remains difficult before and at early phases of therapy. Here, we aimed to clarify early clinical predictors for disease control with nivolumab in patients with NSCLC.

      Methods

      We prospectively collected a cohort of patients with advanced or recurrent NSCLC who received nivolumab every 2 weeks as second or third-line treatment from Aug 2016 to Dec 2017. Disease control was defined as continuing CR/PR/SD according to the RECIST at 25 weeks after the start of nivolumab. QOL score by EQ-5D-5L was collected at baseline and at weeks 5, 9, 13 and 25 (after 12 cycles). Potential clinical biomarkers included patient characteristics, laboratory data, performance status (PS) and QOL score before and at nivolumab week 9 (after 4 cycles), and immune-related adverse event (irAE) at week 9.

      Results

      243 patient cohort comprised of 50 (21%) females, with mean age of 67.7 years old, 91% good PS. 33% had squamous cell carcinoma, 67% had non-squamous NSCLC. 66% had PD-L1 1% or more expression and 88% were current or past smokers. At this data cutoff, the disease control rate (DCR) and the objective response rate (ORR) at week 25 were 41.2% (95% CI, 34.9%–47.6%) and 18.5% (95% CI, 13.8–24.0), respectively. Median progression-free survival (PFS) was 3.9 months (95% CI, 3.3–5.5) and overall survival (OS) was 13.0 months (95% CI, 11.4–16.5). 9% (22/243) experienced grade 3 or more irAE at week 9, including 5% (12/243) pulmonary toxicity. The multivariate analyses identified male gender [odds ratio (OR), 0.29; 95% CI, 0.13–0.65, p=0.0027] and disease control at week 9 (OR, 11.8; 95% CI, 3.4–40.7; p<0.0001) as predictors for disease control at week 25. Similarly, high lymphocyte count at baseline (p=0.03) and at week 9 (p=0.016) and low serum creatinine value at week 9 (p=0.028) were associated with overall response at week 25. Grade 3 or more irAE at week 9 was not associated with disease control (OR, 1.45; 95% CI, 0.85–2.45; p=0.17) and overall response (OR, 1.16; 95% CI, 0.59–2.27; p=0.66) at week 25. Landmark analysis of overall survival starting from week 25 (n=152) showed that status of disease control, PS (0, 1 vs. 2 or more, p=0.0051) and QOL score such as pain (p=0.0086) or anxiety (p=0.0039) at week 25 were independent prognostic factors as well as gender (p=0.012), nivolumab as the third line therapy (p=0.0042). Body mass index (p=0.017) and co-morbidity such as interstitial lung disease, chronic obstructive pulmonary disease and liver disease at baseline (p=0.0028) were independently associated with pulmonary toxicity by nivolumab.

      Conclusion

      Gender, lymphocyte count and serum creatinine at week 9 may be clinical predictors for nivolumab efficacy in patients with advanced or recurrent NSCLC. In addition, patient reported outcomes may be independent prognostic factors.

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