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Atsushi Nakamura



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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: 1
    • Now Available
    • Moderators:
    • Coordinates: 9/08/2019, 08:00 - 18:00, Exhibit Hall
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      EP1.01-04 - Phase I/II Trial of Biweekly Nab-Paclitaxel in Patients with Previously Treated Advanced Non-Small Cell Lung Cancer: NJLCG1402 (Now Available) (ID 795)

      08:00 - 18:00  |  Author(s): Atsushi Nakamura

      • Abstract
      • Slides

      Background

      Nanoparticle albumin-bound paclitaxel (nab-PTX) is a cremophor-free formulation of paclitaxel that can be administered safely as a short infusion without dexamethasone or antihistamine premedication. NJLCG1402 consists of multiple, open-label, single arm, phase I/II trials designed to assess the benefit of biweekly nab-PTX treatment in patients (pts) with previously treated advanced NSCLC (UMIN 000014893).

      Method

      Eligible patients were aged ≥20 years; had histologically or cytologically confirmed, advanced-stage, previously treated NSCLC. Nab-PTX was administered biweekly at dose of 100 to 150 mg/m2 in a 28-day cycle. In the phase I part, we aim to determine the recommended phase II dose of nab-PTX. In the phase II part, pts were assessed for efficacy and tolerability. The primary endpoint for the phase II part is the objective response rate. Secondary endpoints were progression free survival, overall survival, disease control rate, and safety. Assuming an expected the objective response rate of 15% and threshold of 5%, a total of 18 pts were required to have 70% power at a two-tailed alpha of 0.2 at the phase II part.

      Result

      A total of 27 pts (median age 68 years, male 78%) were enrolled. The dose escalation cohort included 15 pts administered biweekly with 100 to 150 mg/m2 across 3 dose levels, and 12 patients in the phase II part were administered with 150mg. No dose-limiting toxicities were observed in the phase I part and 150mg was determined as recommend dose. Of the evaluable pts (n=18) at dose of 150mg/m2, the objective response rate was 22%(4 of 18 pts; 95% CI, 9.5 to 43.5), median progression free survival was 3.6 months (95% CI 1.4 to 5.9), and median overall survival was 7.2 months (95% CI, 0 to 15.0 months). Adverse events (AEs) of grade 3 or higher were observed in 39% of patients. The most common AEs were leukopenia (22%), anemia (22%), and rash (6%).

      Conclusion

      Biweekly nab-PTX monotherapy was well tolerated and exhibits promising systemic antitumor activity in previously treated NSCLC pts.

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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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      MA13.06 - Ph3 Study of Maintenance Therapy with S-1 vs BSC After Induction Therapy with Carboplatin + S-1 for Advanced Squamous Cell Lung Cancer (WJOG7512L) (Now Available) (ID 563)

      14:00 - 15:30  |  Author(s): Atsushi Nakamura

      • Abstract
      • Presentation
      • Slides

      Background

      Our previous phase 3 study established carboplatin plus the oral fluorinated pyrimidine formulation S-1 as a standard option for first-line treatment of advanced non–small cell lung cancer (NSCLC) (J Clin Oncol 2010; 28:5240). The importance of maintenance therapy for patients with advanced squamous NSCLC has been unknown, however.

      Method

      WJOG7512L was designed as a randomized phase 3 study to evaluate whether maintenance therapy with S-1 improves clinical outcome after induction therapy with carboplatin plus S-1 in such patients. Before randomization, patients received carboplatin (AUC of 5 on day 1 every 3 weeks) plus S-1 (40 mg/m2 twice per day on days 1 to 14 every 3 weeks) as induction therapy. Those who did not progress after four cycles of induction therapy were randomized to receive either S-1 plus best supportive care (BSC) or BSC alone. The primary objective was to confirm the superiority of S-1 plus BSC with regard to progression-free survival.

      Result

      Of the 365 patients enrolled, 347 participated in the induction phase and 131 of these individuals were randomized to receive S-1 plus BSC (n = 67) or BSC alone (n = 64). Baseline demographics and clinical characteristics of the subjects, including the response to induction therapy, were well balanced. Patients receiving S-1 plus BSC showed a significantly reduced risk of disease progression compared with those receiving BSC alone (hazard ratio [HR], 0.548; 95% confidence interval [CI], 0.374–0.802; P = 0.0019). Median overall survival from randomization did not differ significantly between the two arms: 17.8 months for BSC alone and 16.7 months for S-1 plus BSC (HR, 0.890; 95% CI, 0.583–1.357). Time to deterioration in quality of life also showed no significant difference (P = 0.8754 for FACT-TOI, P = 0.9016 for FACT-LCS). The incidence of adverse events during maintenance therapy was low, with neutropenia, anemia, and thrombocytopenia of grade 3 or 4 each occurring in ~1% to 4% of patients.

      Conclusion

      Maintenance with S-1 plus BSC is an effective and well-tolerated treatment option for patients with advanced squamous NSCLC.

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    OA02 - A New Vision of Targets and Strategies (ID 120)

    • Event: WCLC 2019
    • Type: Oral Session
    • Track: Targeted Therapy
    • Presentations: 1
    • Now Available
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      OA02.06 - The Sequential Therapy of Crizotinib Followed by Alectinib: Real World Data of 840 Patients with NSCLC Harboring ALK-Rearrangement (WJOG9516L) (Now Available) (ID 2145)

      10:30 - 12:00  |  Author(s): Atsushi Nakamura

      • Abstract
      • Presentation
      • Slides

      Background

      Previous clinical trials demonstrated that alectinib (ALEC) had a longer time-to-progression than crizotinib (CRZ) in 1st-line settings. Information on long-term overall survival (OS), however, is still limited with a few studies having reported that the sequential strategy of CRZ followed by other ALK-inhibitorcan provide extended OS. In Japan, ALEC was approved for a 1st-line setting earlier than in other countries.

      Method

      We reviewed the clinical data of ALK-rearranged NSCLC patients who received CRZ or ALEC between May 2012 and Dec 2016. Patients were divided into two groups according to the first-administered ALK inhibitor, the CRZ or ALEC group. In order to evaluate the efficacy of the sequential strategy of CRZ followed by ALEC, the combined time to treatment failure (TTF) was calculated in the CRZ group as defined by the sum of the TTF of CRZ plus the TTF of ALEC if patients were treated with ALEC followed by CRZ. In the ALEC group, the TTF of ALEC was calculated. The primary endpoint is the comparison between the combined TTF in the CRZ group with the TTF in the ALEC group.

      Result

      Of 864 patients enrolled from 61 institutions, 840 patients were analyzed. Median age was 61 (range, 20-94); 56% were female; and 95% had adenocarcinoma. There were 535/305 patients in the CRZ/ALEC group. In the CRZ group, 282 patients received ALEC after CRZ failure. The combined TTF in the CRZ group was significantly longer than TTF in the ALEC group; median, 34.4 vs 27.2 months (mo); hazard ratio (HR), 0.709 [95%CI;0.559- 0.899]; P=0.0044. However, there was no significant difference in OS between the patients who received ALEC after CRZ in the CRZ group and the patients in the ALEC group; median, 88.4 months vs. not reached; HR 1.048 [95%CI;0.758-1.451]; P=0.7770. In the whole population, the CRZ group had a significantly shorter OS than the ALEC group; median, 53.6 mo vs not reached HR, 1.821 [95%CI;1.372-2.415]; P<0.0001.

      Conclusion

      The combined TTF in the CRZ group was significantly longer than TTF in the ALEC group, however, OS benefit of sequential therapy of CRZ followed by ALEC was not shown.

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    P1.16 - Treatment in the Real World - Support, Survivorship, Systems Research (ID 186)

    • Event: WCLC 2019
    • Type: Poster Viewing in the Exhibit Hall
    • Track: Treatment in the Real World - Support, Survivorship, Systems Research
    • Presentations: 2
    • Now Available
    • Moderators:
    • Coordinates: 9/08/2019, 09:45 - 18:00, Exhibit Hall
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      P1.16-29 - Profiling Immune-Related Adverse Events (irAEs) in Patients with Anti-PD-1 for Advanced Non-Small Cell Lung Cancer (ID 416)

      09:45 - 18:00  |  Author(s): Atsushi Nakamura

      • Abstract
      • Slides

      Background

      Immune-related adverse events (irAEs) are frequently observed during anti-programmed death-1 antibody therapy. We previously reported that patients with irAEs were associated with clinical efficacy. However, little is known about which irAEs are related with clinical efficacy in patients with non-small cell lung cancer (NSCLC). This study aimed to evaluate the correlations between different irAEs and treatment response.

      Method

      Patients with advanced NSCLC who received nivolumab or pembrolizumab monotherapy at our hospital (n=154) from January 2016 to April 2018 were included in this study. Subjects were categorized into the irAE-incident group (with irAEs group) or non-irAE-incident group (without irAEs group), specific for each irAE. We evaluated the objective response rate (ORR), time to treatment failure (TTF), progression-free survival (PFS), and overall survival (OS) in each group.

      Result

      The categorization of irAEs identified 51 cases of skin reactions (31%), 16 of infusion reactions (10%), 19 of pneumonitis (12%), 21 of thyroid dysfunction (14%), and 10 of hepatitis (6%). In the with/without skin reaction groups, the ORRs were 57% (29 cases)/19% (20 cases) (p<.001), median TTFs (months) were 8.7/2.8 (p<.001), median PFSs were 12.9/3.4 months (p<.001), and median OSs were NR/11.4 months (p<.001), respectively. In the with/without infusion reaction groups, the ORRs were 56% (9 cases)/29% (40 cases) (p=.05), median TTFs were 7.6/3.7 months (p=.11), median PFSs were 11.1/4.1 months (p=.045), and median OSs were NR/14.8 months (p<.001), respectively. In the with/without pneumonitis groups, the ORRs were 63% (12 cases)/27% (37 cases) (p=.004), median TTFs were 4.4/3.7 months (p=.44), median PFSs were 18.9/4.1 months (p=.02), and median OSs were NR/14.8 months (p=.09), respectively. In the with/without thyroid dysfunction groups, the ORRs were 52% (11 cases)/29% (38 cases) (p=.08), median TTFs were 7.4/3.7 months (p=.63), median PFSs were 8.7/4.2 months (p=0.22), and median OSs were 11.8/15.9 months (p=.84), respectively. In the with/without hepatitis groups, the ORRs were 40% (4 cases)/31% (45 cases) (p=.82), median TTFs were 2.7/4.1 months (p=.42), median PFSs were 6.4/4.20 months (p=.70), and median OSs were NR/15.6 months (p=.43). The PFS was significantly longer in patients with skin reactions, infusion reactions, and pneumonitis than that in those without, whereas the OS was significantly longer in patients with skin and infusion reactions than that in those without.

      Conclusion

      The development of skin and infusion reactions during nivolumab or pembrolizumab monotherapy for NSCLC might be strongly associated with improved clinical efficacy, and clinical benefits should be validated through large-scale prospective analysis.

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      P1.16-34 - Association Between Skin Reactions and Clinical Benefit in Patients Treated with Anti-PD-1 Treatment for Advanced Non-Small Cell Lung Cancer (Now Available) (ID 420)

      09:45 - 18:00  |  Author(s): Atsushi Nakamura

      • Abstract
      • Slides

      Background

      Anti-Programmed death-1 antibody is now standard therapy for advanced non-small cell lung cancer (NSCLC). However, immune-related adverse events (irAEs) including skin reactions are frequently observed. In melanoma, skin reactions and clinical efficacy are reportedly associated. However, little is known about this association in NSCLC. In addition, predictive markers of irAEs remain unknown. This study aimed to evaluate whether skin reactions correlate with clinical efficacy and identify potential clinical biomarkers that may meaningfully and conveniently predict skin reactions following treatment.

      Method

      We retrospectively surveyed patients with advanced NSCLC who received nivolumab or pembrolizumab monotherapy at Sendai Kousei Hospital (n=155) between January 2016 and April 2018. The patients were categorized into two groups based on the development of skin reactions during treatment. Treatment efficacy was evaluated in each group, and predictive markers of skin reactions were determined. Furthermore, we also conducted 6-week landmark analysis to assess the association between early skin reactions and clinical benefit.

      Result

      In the cohort of 155 patients (median [range] age, 68 [31-88] years; 117 men [75%], 38 women [25%]), skin reactions were observed in 52 (33%) patients. The median duration of onset of skin reactions was 6.4 weeks. The overall response rate (ORR) was significantly higher in patients with skin reactions than that in those without (57% vs. 19%; P<.001). The median progression free survivals (PFSs) were 12.9(95% confidence interval (CI), 8.5–not reached(NR)) and 3.4 (95% CI, 2.5-4.1) (P<.001) months, whereas the median overall survivals (OS) were NR (95% CI, 17.4-NR) and 11.4 months (95% CI, 8.8-15.6) (P<.001) in patients with and without skin reactions, respectively. In 6-week landmark analysis, the ORR was significantly higher in patients with skin reactions than that in those without (28 of 49 patients [57.1%] vs. 20 of 106 patients [18.9%]; P <.001), and the development of skin reactions was significantly associated with increased PFS (with skin reactions median PFS = 10.3 months, 95% CI, 5.6-NR ; without, median PFS = 4.2 months, 95% CI, 3.6-5.9; P=.045). Furthermore, multivariate analysis revealed that pre-existing rheumatoid factor (RF) was an independent predictor of skin reactions (odds ratio, 3.39; 95% CI, 1.56–7.33; P=.003).

      Conclusion

      The development of skin reactions was associated with clinical benefit in patients treated with nivolumab and pembrolizumab for NSCLC. Pre-existing RF also served as an independent predictor of skin reactions. Further studies with large patient samples are necessary to validate these findings.

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