Author of

• 17556

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  P2.03a - Poster Session with Presenters Present (ID 464)

  • Event: WCLC 2016
  • Type: Poster Presenters Present
  • Track: Advanced NSCLC
  • Presentations: 1
  • Moderators:
  • Coordinates: 12/06/2016, 14:30 - 15:45, Hall B (Poster Area)

  • 17612

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    P2.03a-056 - Phase II Trial of Weekly Nab-Paclitaxel for Previously Treated Advanced Non–Small Cell Lung Cancer: KTOSG Trial 1301 (ID 4004)

    14:30 - 14:30  |  Author(s): Y. Yoneshima
    • Abstract

    Background:
    We performed an open-label, multicenter, single-arm phase II study (UMIN ID 000010532) to prospectively evaluate the efficacy and safety of nab-paclitaxel for previously treated patients with advanced non–small cell lung cancer (NSCLC).
    
    Methods:
    Patients with advanced NSCLC who experienced failure of prior platinum-doublet chemotherapy received weekly nab-paclitaxel (100 mg/m[2]) on days 1, 8, and 15 of a 21-day cycle until disease progression or the development of unacceptable toxicity. The primary end point of the study was objective response rate (ORR).
    
    Results:
    Forty-one patients were enrolled between September 2013 and April 2015. The ORR was 31.7 % (90% confidence interval, 19.3% to 44.1%), which met the primary objective of the study. Median progression-free survival was 4.9 months (95% confidence interval, 2.4 to 7.4 months) and median overall survival was 13.0 (95% confidence interval, 8.0 to 18.0 months) months. The median number of treatment cycles was four (range, 1 to 17) over the entire study period, and the median dose intensity was 89.1 mg/m[2] per week. Hematologic toxicities of grade 3 or 4 included neutropenia (19.5%) and leukopenia (17.1%), with no cases of febrile neutropenia being observed. Individual nonhematologic toxicities of grade 3 or higher occurred with a frequency of <5%.
    
    Conclusion:
    Weekly nab-paclitaxel was associated with acceptable toxicity and a favorable ORR in previously treated patients with advanced NSCLC. Our results justify the undertaking of a phase III trial comparing nab-paclitaxel with docetaxel in this patient population.