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Katsuhiko Naoki



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    EP1.01 - Advanced NSCLC (ID 150)

    • Event: WCLC 2019
    • Type: E-Poster Viewing in the Exhibit Hall
    • Track: Advanced NSCLC
    • Presentations: 2
    • Now Available
    • Moderators:
    • Coordinates: 9/08/2019, 08:00 - 18:00, Exhibit Hall
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      EP1.01-63 - The Usefulness of “Serum” Samples to Detect EGFR T790M Mutation in EGFR-TKI-Resistant Non-Small Cell Lung Cancer (Now Available) (ID 562)

      08:00 - 18:00  |  Author(s): Katsuhiko Naoki

      • Abstract
      • Slides

      Background

      Osimertinib, a third-generation epidermal growth factor receptor-tyrosine kinase inhibitor, exerts remarkable effects against EGFR T790M resistance mutation-positive NSCLC. Identifying T790M mutation by re-biopsy is essential before prescribing osimertinib. Tissue biopsy is the golden standard for this purpose, but several factors limit its success rate. The liquid biopsy with blood, using circulating tumor DNA, has been an alternative method. However, the true biological meaning and equivalence of liquid biopsy and tumor biopsy are still under investigation. Especially, the usefulness of serum samples to detect T790M mutation is not yet been known.

      Method

      We prospectively evaluated the sensitivity, specificity, and parallelism of the detection of EGFR mutations in tissue re-biopsy and liquid biopsy (plasma and serum), simultaneously, from June 2016 to May 2017. EGFR-mutations in tumor re-biopsy were evaluated by COBAS ver2 and peptide nucleic acid/locked nucleic acid PCR clamp method, and those in liquid biopsy were evaluated with COBAS ver2.

      Result

      Fifteen patients were enrolled. In ten patients whose EGFR mutation was detected in liquid biopsy, the original EGFR mutation (exon 19 del or L858R) was detected in all patients. The detection rate of T790M was lower than that of the original EGFR mutation in liquid biopsy compared to that in tissue re-biopsy. The detection of T790M in serum exhibited a higher specificity (67%) and positive predictive value (50%) than that in plasma (50% and 40%, respectively). The detection sensitivity was similar in plasma and serum. Nine patients were treated with osimertinib. The RR was 77.8% and DCR was 100%. One patient who presented a response was positive for T790M in liquid biopsy (both plasma and serum) and negative in tissue re-biopsy.

      Conclusion

      We suggest serum samples to be more useful than plasma samples for determining the effectiveness of osimertinib against relapse tumor sites because they were more reliable in the detection of T790M mutation at the relapse tumor tissue sites. Repeated tests with different samples and different methods may improve accuracy of T790M detection and will lead to the maximum benefit for the patient.

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      EP1.01-68 - Impact of EGFR Genotype on the Efficacy of Osimertinib in Patients with Non-Small Cell Lung Cancer: A Prospective Observational Study (ID 271)

      08:00 - 18:00  |  Author(s): Katsuhiko Naoki

      • Abstract
      • Slides

      Background

      A T790M of the epidermal growth factor receptor (EGFR) is the most frequently encountered mutation occurring acquired resistance to EGFR tyrosine kinase inhibitors (TKIs) in non-small cell lung cancer (NSCLC). The aim of this study was to assess the differential clinical outcomes of osimertinib therapy in NSCLC patients with T790M according to the type of active EGFR mutation, i.e. exon 19 deletion or L858R point mutation.

      Method

      We conducted a prospective observational cohort study to evaluate the efficacy and safety of osimertinib in patients with major EGFR mutation and T790M-positive advanced NSCLC who had disease progression after first-line EGFR-TKI therapy. The efficacy of osimertinib was evaluated according to the type of EGFR mutation.

      Result

      A total of 51 patients were included in this study. The exon 19 deletion was found in 33 (65%) patients, and the L858R point mutation in 18 patients (35%). An objective response was obtained in 29 patients, indicating an objective response rate of 58.8%. The response rate was 69.7% in patients with exon 19 deletion and 38.9% in patients with L858R point mutation, indicating a statistically significant difference (P =0.033). The median progression-free survival (PFS) and overall survival (OS) of the entire patient population were 7.8 and 15.5 months, respectively. Median PFS in the exon 19 deletion and L858R point mutation groups was 8.0 months and 5.2 months, respectively, indicating a statistically significant difference (P =0.045). Median OS in the exon 19 deletion and L858R point mutation groups was 19.8 months and 12.9 months, respectively, indicating a statistically significant difference (P =0.0015). Multivariate analysis identified exon 19 deletion as a favorable independent predictor of PFS and OS.

      Conclusion

      Investigators should consider the proportions of sensitive EGFR mutation types as a stratification factor in designing or reviewing clinical studies involving osimertinib.

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    EP1.12 - Small Cell Lung Cancer/NET (ID 202)

    • Event: WCLC 2019
    • Type: E-Poster Viewing in the Exhibit Hall
    • Track: Small Cell Lung Cancer/NET
    • Presentations: 1
    • Now Available
    • Moderators:
    • Coordinates: 9/08/2019, 08:00 - 18:00, Exhibit Hall
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      EP1.12-36 - Treatment Outcomes and Risk Factors of Limited-Stage Small Cell Lung Cancer Patients Treated with Chemoradiotherapy (Now Available) (ID 442)

      08:00 - 18:00  |  Author(s): Katsuhiko Naoki

      • Abstract
      • Slides

      Background

      The aim of this study was to report clinical outcomes and prognostic factors in limited- stage small cell lung cancer (LD-SCLC) patients treated with chemoradiotherapy (CRT).

      Method

      Data on 107 LD-SCLC patients who received CRT between September 2000 and March 2017 were analyzed retrospectively. The median age of the patients was 66 years (range 42–85 years); 79 (73.8%) patients were male and 28 (26.2%) were female. Seventy-four (69.2%) patients received concurrent CRT (CCRT) with 45 Gy in 30 twice-daily fractions (n=52) or with 54–60 Gy in 27–30 once-daily fractions (n=22). The other 33 patients received sequential CRT (SCRT) with 54–60 Gy in 27–30 once-daily fractions. Prophylactic cranial irradiation was administered to 35 (32.7%) patients. Cisplatin/etoposide or carboplatin/etoposide were mainly selected as chemotherapy regimens. Survival rates were estimated using the Kaplan-Meier method, and univariate and multivariate analysis was performed using the log-rank test and Cox proportional hazard model, respectively.

      Result

      Median follow-up duration was for 28.6 months (range 1.6–147.2 months). Three-year overall survival, progression-free survival and cause-specific survival rates were 51.1%, 38.8% and 51.5%, respectively.

      On univariate analysis metastatic lymph node status (N0 vs N≥1) and timing of CRT (CCRT vs SCRT) were detected as significant prognostic factors for overall survival (3-year overall survival: 100% vs 48.2%, p=0.02; and 56.6% vs 37.7%, p=0.04, respectively). On multivariate analysis, however, these factors did not reach statistical significance.

      Conclusion

      Treatment outcomes in LD-SCLC patients suggested metastatic lymph node status and timing of CRT as prognostic factors for overall survival.

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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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      P1.01-15 - Multicenter, Single-Arm Phase II Study of Nab-Paclitaxel/Carboplatin in Untreated PS2 Patients with Advanced NSCLC: TORG1426 (Now Available) (ID 519)

      09:45 - 18:00  |  Presenting Author(s): Katsuhiko Naoki

      • Abstract
      • Slides

      Background

      Performance Status (PS) has been shown to predict survival in patients with advanced non-small cell lung cancer (NSCLC). To date, PS2 patients have been underrepresented in clinical trials due to concerns about tolerability. Consequently, no standard of care exists for these patients. In CA031 trial, nab-paclitaxel/carboplatin (nab-PTX/CBDCA) demonstrated significantly higher response rate (RR) compared with PTX/CBDCA in PS0-1 patients with advanced NSCLC. Furthermore, in elderly subgroup, nab-PTX/CBDCA tended to show superior progression-free survival (PFS) and overall survival (OS) based on better tolerability compared with PTX/CBDCA. Therefore, this phase II trial was designed to characterize the efficacy, safety, and tolerability of nab-PTX/CBDCA in untreated PS2 patients with advanced NSCLC.

      Method

      Chemotherapy-naive PS2 patients with stage IIIB/IV NSCLC were treated with nab-PTX (70 mg/m2 on day1, 8, and15, q4w) and CBDCA (AUC 5 on day1, q4w) up to 6 cycles if they did not have uncontrolled brain metastasis or pleural effusion. The primary endpoint was PFS rate at 6 months. Its achievement of more than 50% was considered worthy of further development of this regimen, whereas that of less than 30% was considered insufficient for further investigation. The estimated power was 80% with type I error of 0.05, resulting in 35 patients needed. Concurrently, Symptom Score and Charlson Comorbidity Index (CCI) were evaluated.

      Result

      This trial was terminated due to slow accrual. Between September 2015 and August 2018, 17 patients (median age, 68 years [range, 50-73]) were enrolled and received a median of 3 cycles. The reasons for PS2 were tumor progression (71%), comorbidities (12%), or both (17%). The PFS rate at 6 months was 20.8% (95% confidence interval, 0%-41.6%). The median PFS, OS, RR, and disease control rate (DCR) were 3.0 months, 9.5 months, 17.4%, and 70.6%, respectively. Grade 3-5 adverse events (AE) included fatigue (24%), lung infection (24%, including 6% of grade 5), neutropenia (18%), and anemia (18%), resulting in trial withdrawal rate of 24%. The median PFSs of 11 patients with and 6 patients without 2nd line chemotherapy were 5 months and 1.7 months, respectively (p = 0.009). Symptom Score was improved by chemotherapy (p = 0.004), whereas comparison between lower and higher CCI values demonstrated no difference regarding chemotherapy cycles administered (p = 0.5) and regarding chemotherapy efficacy (p = 0.268).

      Conclusion

      Nab-PTX/CBDCA did not meet its primary endpoint, but could be a feasible treatment option for untreated PS2 patients with advanced NSCLC. Clinical trial information: UMIN000019458

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    P2.04 - Immuno-oncology (ID 167)

    • Event: WCLC 2019
    • Type: Poster Viewing in the Exhibit Hall
    • Track: Immuno-oncology
    • Presentations: 1
    • Now Available
    • Moderators:
    • Coordinates: 9/09/2019, 10:15 - 18:15, Exhibit Hall
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      P2.04-87 - Efficacy of Immune Checkpoint Inhibitors for Locally Advanced Non-Small Cell Lung Cancer Patients Before Durvalumab Approval (Now Available) (ID 878)

      10:15 - 18:15  |  Author(s): Katsuhiko Naoki

      • Abstract
      • Slides

      Background

      Standard treatment for patients with locally advanced (LA) non-small cell lung cancer (NSCLC) was concurrent chemoradiotherapy (CRT) with 40-70% of 2-year overall survival (OS). Immune checkpoint inhibitors (ICIs) have been shown efficacy in advanced or recurrent NSCLC and approved on December 2015 in Japan. After that, the ICI durvalumab was approved as maintenance therapy after concurrent CRT even in unresectable LA-NSCLC on July 2018 in Japan.

      Method

      To investigate the feasibility of concurrent CRT for LA-NSCLC patients and efficacy of ICI treatment for the relapsed patients after CRT, we assessed consecutive LA-NSCLC patients treated with concurrent CRT between July 2013 and June 2018 (before durvalumab approval), retrospectively.

      Result

      108 eligible patients (81 males and 27 females with median age of 65 years old, including 7 patients with targeted mutations; 2 EGFR, 4 ALK and 1 ROS1) were analyzed. All patients received radical thoracic radiotherapy using 3D planning system and concurrent with platinum-based chemotherapy. 79 (73%) received one or two cycles of consolidation chemotherapy of same regimen. 105 (97%) patients completed planned radiotherapy, and radiation pneumonitis was observed in 93 (85%) patients with median 130 (range, 41-317) days from initiation of radiation to onset. 74 (69%) patients met the PACIFIC criteria and were considered to be eligible for durvalumab. The overall response rate was 64% and the progression free survival was 10.3 (95% CI, 8.4–12.2) months. The OS was 41.8 (95%CI, 20.1-63.5) months and 2-year OS were 63%. Of the 82 patients who relapsed after CRT, 18 patients received ICI treatment (14 nivolumab, 3 pembrolizumab, 1 atezolizumab) in the course of treatment. Patients who received ICI after relapse had significantly better survival than those who did not receive ICI (2-year OS, 87% vs. 41%; p=0.001).

      Conclusion

      Concurrent CRT using platinum-based regimen was considered effective treatment with acceptable toxicity for LA-NSCLC patients. The efficacy of ICI treatment has been shown in patients with relapse after concurrent CRT in LA-NSCLC, and indication with durvalumab maintenance therapy is expected to further improve the prognosis in patients with LA-NSCLC. The optimal use timing of ICI treatment for patients with LA-NSCLC should be considered.

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