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Kuda Tomoya



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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): Kuda Tomoya

      • 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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    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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      P1.01-08 - Randomized Phase II Trial of CBDCA+nab-PTX vs CDDP+GEM in Patients with Chemo-Naïve Squamous Cell Lung Cancer: NJLCG1302 (Now Available) (ID 971)

      09:45 - 18:00  |  Author(s): Kuda Tomoya

      • Abstract
      • Slides

      Background

      The subset analysis of CA031 trial showed a significant improvement of overall response rate (ORR) for carboplatin (CBDCA) plus weekly nab-PTX versus CBDCA plus PTX in patients (pts) with squamous cell histology (41% vs 24%). We conducted a phase II study comparing CBDCA plus weekly nab-PTX (CnP) to cisplatin plus gemcitabine (CG), one of the standard regimens in pts with squamous cell lung cancer (SCC).

      Method

      Chemo-naïve stage IIIB/IV or postoperative recurrent SCC pts were randomly assigned to receive either cisplatin (80 mg/m2) on day 1 plus gemcitabine (1000 mg/m2) on days 1, 8 every 3 weeks or CBDCA (area under the curve [AUC] 6 mg/ml/min) on day 1 plus nab-PTX (75 mg/m2) on days 1, 8, 15 every 3 weeks. The primary endpoint was ORR. Secondary endpoints were progression-free survival (PFS), overall survival (OS), disease control rate (DCR) and toxicity. Assuming that an ORR of 40% in eligible pts indicates potential usefulness and ORR of 20% is the lower limit of interest, the estimated accrual was 32 pts in each arm. Allowing for dropouts, the accrual goal was determined to be 35 pts in each arm (alpha, 0.05; beta, 0.20).Thisstudy was planned to enroll 70 pts in total.

      Result

      Between June 2013 and October 2018, 71 pts were enrolled and assigned to CG arm (n=35) and CnP arm (n=36). The median follow-up time was 10.8months. At data cutoff (March 31, 2019), ORR was 43% (95% confidence interval [CI]: 27.3-58.5) in CG arm and 47% (95%CI: 31.7-62.7) in CnP arm. DCR was 77% in CG arm and 80% in CnP arm. Median PFS was 4.6 months in CG arm and 4.1months in CnP arm. Median OS was 15.2months in CG arm and 10.2months in CnP arm. Of the grade 3 or higher adverse events, anemia was more common in CnP arm (CG, 17% and CnP, 53%). There was one treatment-related death in CG arm and no treatment-related death in CnP arm.

      Conclusion

      In this study, CBDCA plus weekly nab-PTX was likely to be equivalent to cisplatin plus gemcitabine despite carboplatin-based regimen. CBDCA plus weekly nab-PTX could be a promising regimen for SCC.

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