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M. Fujita



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    Poster Display session (Friday) (ID 65)

    • Event: ELCC 2018
    • Type: Poster Display session
    • Track:
    • Presentations: 1
    • Moderators:
    • Coordinates: 4/13/2018, 12:30 - 13:00, Hall 1
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      172P - Safety and efficacy phase 2 study of nab-paclitaxel maintenance treatment after nab-paclitaxel plus carboplatin in stage IIIB/IV non-small cell lung cancer (ID 313)

      12:30 - 13:00  |  Author(s): M. Fujita

      • Abstract
      • Slides

      Background:
      Maintenance chemotherapy is being approved as a new treatment paradigm to improve the outcome of advanced NSCLC. Pemetrexed has become recognized as the most promising drug for maintenance therapy, and demonstrated benefits both in progression-free survival (PFS) and overall survival (OS) in the PARAMOUNT study. Since carboplatin plus nab-paclitaxel is also a less toxic regimen, nab-paclitaxel could be a candidate for better maintenance chemotherapy. Therefore, we conducted a phase II study to evaluate the nab-paclitaxel maintenance treatment after nab-paclitaxel plus carboplatin, in terms of safety and efficacy for advanced NSCLC.

      Methods:
      This trial was an open-label, single-arm, multi-center, phase II study. Patients with advanced NSCLC, with no previous systemic chemotherapy (TKIs were allowed), with measurable lesion, and an ECOG PS 0 or 1 participated. Patients received nab-paclitaxel 100 mg/m[2] on days 1, 8, and 15, every 4 weeks in combination with carboplatin at AUC 6 on day 1 of each 4-week cycle for induction. Patients, with no detected disease progression in induction chemotherapy, received nab-paclitaxel monotherapy maintenance until disease progression. The primary endpoint was the PFS. Secondary endpoints were the objective response rate (ORR), OS, safety including peripheral neuropathy, and maintenance therapy transition rate.

      Results:
      A total of 39 patients were enrolled to receive induction therapy, and 15 patients were treated with maintenance nab-paclitaxel; the transition rate was 38.5%. The median PFS, measured from the transition of maintenance therapy, was 6.5 (90%CI: 1.4–11.4) months among 15 patients. PFS was superior to that of the PARAMOUNT study. However, the lower limit of the 90% confidence interval, 1.4 months, was lower than the threshold 3.0 months. Therefore, it was not statistically significant. The most common grade ≥ 3 toxicities observed were hematologic; neutropenia (55.0%), anemia (15.0%), and febrile neutropenia (5.0%), with no increase in the maintenance therapy.

      Conclusions:
      The rate of transition to maintenance therapy was lower than expected. Although nab-paclitaxel may become a candidate regimen for maintenance therapy, this study did not demonstrate statistically significant results because of the small number of enrolments.

      Clinical trial identification:


      Legal entity responsible for the study:
      Department of Respiratory Medicine, Faculty of Medicine, Fukuoka University

      Funding:
      Has not received any funding

      Disclosure:
      All authors have declared no conflicts of interest.

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