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K. Okudera
Author of
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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)
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P2.03a-054 - A Single-Arm Phase II Study of Nab-Paclitaxel for Patients with Chemorefractory Non-Small Cell Lung Cancer (ID 4886)
14:30 - 14:30 | Author(s): K. Okudera
- Abstract
Background:
Background: Albumin-bound paclitaxel (nab-PTX) is a paclitaxel formulation in which nanoparticles of PTX are bound to human serum albumin. We conducted this study to evaluate the efficacy and safety of nab-PTX in patients with advanced non-small cell lung cancer (NSCLC) who failed previous chemotherapy.
Methods:
Methods: Eligible patients had refractory advanced NSCLC. Patients were required to have an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-2 and adequate organ function. Patients received nab-paclitaxel, 100 mg/m[2] i.v. on days 1, 8 and 15 every 4 weeks. The primary endpoint was the overall response rate (ORR).
Results:
Results: From July 2013 to July 2015, 31 patients enrolled, 14 patients received nab-paclitaxel as a second-line and 17 received it as an over third-line therapy. The median number of treatment cycles was 5 (range, 1-11). The overall response rate was 19.3% (95% confidence interval, 9.1%-36.2%) (compleate response (n = 0), partial response (n = 6), stable disease (n = 17), and progressive disease (n = 8)). The median progression-free survival time was 4.5 months (95% confidence interval 3.5- 6.3 months), median overall survival time was 15.7 months, and 1-year survival rate was 54.8%. Grade 3 or 4 hematological toxicities included neutropenia (38.6%), anemia (3.2%), and thrombocytopenia (0%). Grade 3 or 4 non-hematological toxicities were elevated aspartate transaminase level (3.2%) and sensory neuropathy (9.6%). Febrile neutropenia developed in 12.9% patients. No treatment-related deaths were observed in this study.
Conclusion:
Conclusions: Single agent nab-paclitaxel showed significant clinical activity with manageable toxicities for patients with chemorefractory advanced NSCLC. This study provides relevant data for routine practice and future prospective trials evaluating treatment strategies for patients with advanced NSCLC. Clinical trial information: UMIN000011696.
