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Y. Nishimura
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P2.01 - Poster Session/ Treatment of Advanced Diseases – NSCLC (ID 207)
- Event: WCLC 2015
- Type: Poster
- Track: Treatment of Advanced Diseases - NSCLC
- Presentations: 1
- Moderators:
- Coordinates: 9/08/2015, 09:30 - 17:00, Exhibit Hall (Hall B+C)
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P2.01-075 - Bevacizumab with Docetaxel or S-1 in Non-Squamous NSCLC (HANSHIN 0110) (ID 195)
09:30 - 09:30 | Author(s): Y. Nishimura
- Abstract
Background:
This multicenter, randomized phase II trial investigated the efficacy and safety of docetaxel plus bevacizumab and S-1 plus bevacizumab in the second-line treatment of non-squamous (non-Sq) non-small-cell lung cancer (NSCLC).
Methods:
Patients with non-Sq NSCLC who experienced disease progression after prior platinum-based chemotherapy with or without bevacizumab were randomly assigned (1:1) to receive docetaxel 60 mg/m[2] plus bevacizumab 15 mg/kg (DB) once every 3 weeks or S-1 40 mg/m[2] orally twice daily on days 1–14 plus bevacizumab 15 mg/kg (SB) on day 1 every 3 weeks until disease progression. The primary endpoint was progression-free survival (PFS).
Results:
Ninety patients were randomized. The median PFS was 3.9 months (95% confidence interval [CI] = 3.0–6.5) in the DB arm and 3.5 months (95% CI = 2.9–5.9) in the SB arm. The objective response rate was significantly higher in the DB arm than in the SB arm (22.2% vs. 2.2%; P = 0.004), whereas the disease control rates of the arms were identical (62.2% vs. 62.2%; P = 1.00). Patients receiving DB were more likely to have ≥grade 3 neutropenia (93.4% vs. 4.4%) and febrile neutropenia (33.3% vs. 0%) than SB-treated patients. In the DB arm, PFS and overall survival were significantly longer among bevacizumab-naïve patients than among bevacizumab-experienced patients (median PFS: 7.4 months vs. 2.8 months; P < 0.001; and median OS: 27.4 months vs. 11.7 months; P = 0.002).
Conclusion:
DB and SB produced modest PFS benefits in the second-line treatment of patients with advanced non-Sq NSCLC. Because of the toxicity of DB and the low response rate of SB, neither regimen warrants further investigation, excluding DB in bevacizumab-naïve patients with advanced non-Sq NSCLC.
