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EP1.01 - Advanced NSCLC (ID 150)
- Event: WCLC 2019
- Type: E-Poster Viewing in the Exhibit Hall
- Track: Advanced NSCLC
- Presentations: 1
- Now Available
- Coordinates: 9/08/2019, 08:00 - 18:00, Exhibit Hall
EP1.01-04 - Phase I/II Trial of Biweekly Nab-Paclitaxel in Patients with Previously Treated Advanced Non-Small Cell Lung Cancer: NJLCG1402 (Now Available) (ID 795)
08:00 - 18:00 | Author(s): Shunichi Gamou
Nanoparticle albumin-bound paclitaxel (nab-PTX) is a cremophor-free formulation of paclitaxel that can be administered safely as a short infusion without dexamethasone or antihistamine premedication. NJLCG1402 consists of multiple, open-label, single arm, phase I/II trials designed to assess the benefit of biweekly nab-PTX treatment in patients (pts) with previously treated advanced NSCLC (UMIN 000014893).Method
Eligible patients were aged ≥20 years; had histologically or cytologically confirmed, advanced-stage, previously treated NSCLC. Nab-PTX was administered biweekly at dose of 100 to 150 mg/m2 in a 28-day cycle. In the phase I part, we aim to determine the recommended phase II dose of nab-PTX. In the phase II part, pts were assessed for efficacy and tolerability. The primary endpoint for the phase II part is the objective response rate. Secondary endpoints were progression free survival, overall survival, disease control rate, and safety. Assuming an expected the objective response rate of 15% and threshold of 5%, a total of 18 pts were required to have 70% power at a two-tailed alpha of 0.2 at the phase II part.Result
A total of 27 pts (median age 68 years, male 78%) were enrolled. The dose escalation cohort included 15 pts administered biweekly with 100 to 150 mg/m2 across 3 dose levels, and 12 patients in the phase II part were administered with 150mg. No dose-limiting toxicities were observed in the phase I part and 150mg was determined as recommend dose. Of the evaluable pts (n=18) at dose of 150mg/m2, the objective response rate was 22%(4 of 18 pts; 95% CI, 9.5 to 43.5), median progression free survival was 3.6 months (95% CI 1.4 to 5.9), and median overall survival was 7.2 months (95% CI, 0 to 15.0 months). Adverse events (AEs) of grade 3 or higher were observed in 39% of patients. The most common AEs were leukopenia (22%), anemia (22%), and rash (6%).Conclusion
Biweekly nab-PTX monotherapy was well tolerated and exhibits promising systemic antitumor activity in previously treated NSCLC pts.
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