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Poster Display session (Friday) (ID 65)
- Event: ELCC 2018
- Type: Poster Display session
- Presentations: 1
- Coordinates: 4/13/2018, 12:30 - 13:00, Hall 1
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
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.
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 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.
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.
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
Has not received any funding
All authors have declared no conflicts of interest.
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