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Ryota Saito



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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): Ryota Saito

      • 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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      MA13.02 - Incidence of Venous Thromboembolism at the Time of Lung Cancer Diagnosis: A Multicenter, Prospective Observational Trial (Rising-VTE/NEJ037) (Now Available) (ID 1195)

      14:00 - 15:30  |  Author(s): Ryota Saito

      • Abstract
      • Presentation
      • Slides

      Background

      Venous thromboembolism (VTE) is a most well-known kind of cancer associated thrombosis, and a common complication of malignancy. However, little is known about the incidence of VTE at the time of lung cancer diagnosis. This information is important for clinicians and patients to inform their decision-making about cancer treatment.

      Method

      The Rising-VTE/NEJ037 study was a multicenter, prospective, observational study with 40 participating Japanese institutions. It included 1,021 patients diagnosed with lung cancer unsuitable for radical resection or radiation between June 2016 and August 2018. The incidence of VTE and characteristics of patients diagnosed with VTE based on contrast-enhanced computed tomography or ultrasonography of the leg are described. Diagnosis of VTE was confirmed via central review by two radiologists.

      Result

      Baseline data was available for 1,013 patients. The median age was 71 years (range 30-94). Eighty-six percent of patients had non-small cell lung cancer and 13.5% had small cell lung cancer. Histological types included adenocarcinoma (N=645, 63.7%), squamous cell carcinoma (N=180, 17.8%), small-cell lung cancer (N=137, 13.5%) and others (N=42, 4.1%). There were 59 patients (5.8%) diagnosed with VTE, of whom 53.9% had deep vein thrombosis (DVT), 28.7% had pulmonary embolism (PE) and 24.6% had both DVT and PE. Most patients with VTE had adenocarcinomas (89.1%).

      Conclusion

      The incidence of VTE in this study seems to be higher than in the clinical setting, suggesting that screening may be desirable. Adenocarcinoma of the lung seems to be a risk factor for VTE that we should consider more carefully. The primary endpoint of this trial is the rate of symptomatic or asymptomatic recurrence or newly diagnosed VTE during 2 years after registration. Follow-up is ongoing, with a report of final findings planned for 2021. Clinical trial information: UMIN000020194. Funding: Daiichi Sankyo Company.

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    P2.14 - Targeted Therapy (ID 183)

    • Event: WCLC 2019
    • Type: Poster Viewing in the Exhibit Hall
    • Track: Targeted Therapy
    • Presentations: 1
    • Now Available
    • Moderators:
    • Coordinates: 9/09/2019, 10:15 - 18:15, Exhibit Hall
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      P2.14-23 - Initial Analysis in NSCLC Part of Randomized Trial Evaluating Topical Corticosteroid for the Facial Acneiform Rash by EGFR Inhibitors (Now Available) (ID 551)

      10:15 - 18:15  |  Author(s): Ryota Saito

      • Abstract
      • Slides

      Background

      Epidermal growth factor receptor (EGFR) inhibitors commonly induce skin toxicities including facial acneiform rash. The incidence of facial acneiform rash with any grade estimetes 60-90% in previous clinical trials. This FAEISS study, NCCH1512, is designed to evaluate the effects of reactive topical corticosteroid therapies with serially ranking down from very strong levels compared with that with serially ranking up from weak levels for facial acneiform rash induced by EGFR inhibitors.

      Method

      Patients with EGFR-mutated non-small cell lung cancer (NSCLC) and RAS wild-type colorectal cancer who started treatment with EGFR inhibitors were enrolled first in this study (first-phase). All patients received pre-emptive therapy of oral minocycline 100 mg/day and heparinoid moisturizer from the initiation of EGFR inhibitors. Enrolled patients who developed facial acneiform rash within two weeks were randomised either to group A (ranking-up) and group B (ranking-down) (second-phase) by minimization method for balancing institution, type of EGFR inhibitors, and sex. Primary endpoint in this study was incidence of grade 2 (moderate) or higher facial acneiform rash during the 10-week skin treatment period. Here, we present the initial analysis in NSCLC patients who received EGFR tyrosine kinase inhibitors of afatinib and erlotinib. This study was registered with UMIN-CTR as UMIN000024113 (www.umin.ac.jp/ctr/).

      Result

      From November 2016 to August 2018, 51 NSCLC patients treated with afatinib (n=30) and erlotinib (n=21) were enrolled in first-phase. Thirty four patients were female and 17 were male, with a median age of 66 years (range 39-79). Thirty five patients (68.6%) didn’t develop facial acneiform rash within two weeks. While facial acneiform rash occurred in 16 patients (grade 1 [n=14, 27.4%] and grade 2 [n=2, 3.9%]). No patients developed severe facial acneiform rash (grade 3 or higher). Nine (30.0%) patients who received afatinib and seven (33.3%) who received erlotinib developed facial acneiform rash within two weeks. One patient treated with erlotinib was excluded due to hepatotoxicity by minocycline and 15 (29.4%) were assigned to second-phase (9 in group A and 6 in group B). Skin adverse events in second-phase (n=15) were non-facial acneiform rash (n=14), pruritus (n=8), paronychia (n=5), and dry skin (n=3). Major non-skin adverse events related to EGFR inhibitors were diarrhea (grade 3 [n=2]), ALT increased (grade 2 [n=2]), stomatitis (grade 3 [n=1]), and pneumonitis (grade 1 [n=1]).

      Conclusion

      In NSCLC patients who received EGFR tyrosine kinase inhibitors, pre-emptive therapy of oral minocycline and heparinoid moisturizer could be effective for prevention of facial acneiform rash.

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