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T. Yana
Author of
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P3.01 - Advanced NSCLC (ID 621)
- Event: WCLC 2017
- Type: Poster Session with Presenters Present
- Track: Advanced NSCLC
- Presentations: 1
- Moderators:
- Coordinates: 10/18/2017, 09:30 - 16:00, Exhibit Hall (Hall B + C)
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P3.01-088a - Phase II Study of Nab-Paclitaxel in Previously Treated Patients with Advanced Non-Small Cell Lung Cancer: SNIPER Study (ID 9803)
09:30 - 09:30 | Author(s): T. Yana
- Abstract
Background:
Nanoparticle albumin-bound paclitaxel (nab-paclitaxel) is an albumin-bound formulation of paclitaxel. This single-arm, phase II trial evaluated nab-paclitaxel monotherapy in pretreated patients with advanced non-small cell lung cancer (NSCLC).
Method:
In this multicentre, single arm phase II trial, we enrolled patients with advanced NSCLC who had previously treated more than one chemotherapy regimen. Patients received nab-paclitaxel 80 mg/m[2] days 1, 8, and 15 (21-day cycle). The primary endpoint was investigator-assessed overall response rate (ORR); secondary endpoints included overall survival (OS), progression-free survival (PFS), the disease control rate (DCR), and safety. The planned enrollment was 30 patients by Simon 2-stage minimax design.
Result:
We enrolled 30 patients. We analyzed endpoints about initially enrolled 24 cases that were available for the evaluation now. Sixty-three % of patients had previous treatment more than 2 regimens. The ORR and DCR were 25% (95% CI 8-42%) and 75%, respectively. Median PFS and OS were 5.8 months and 9.8 months, respectively. No new safety signals were reported; the most common grade ≥3 adverse events included neutropenia (54%), leukopenia (9%), and infection (13%).
Conclusion:
In patients with heavily advanced NSCLC, nab-paclitaxel demonstrated promising antitumor activity; further assessment of nab-paclitaxel monotherapy in this population of patients is supported.
