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K. Takahashi
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P3.01 - Poster Session/ Treatment of Advanced Diseases – NSCLC (ID 208)
- Event: WCLC 2015
- Type: Poster
- Track: Treatment of Advanced Diseases - NSCLC
- Presentations: 1
- Moderators:
- Coordinates: 9/09/2015, 09:30 - 17:00, Exhibit Hall (Hall B+C)
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P3.01-068 - Phase II Study of S-1 plus Bevacizumab for Pretreated Patients with Non-Squamous NSCLC (ID 677)
09:30 - 09:30 | Author(s): K. Takahashi
- Abstract
Background:
The additional effects of bevacizumab (B) as first-line chemotherapy for non-squamous non-small cell lung cancer (Non-sq NSCLC) have been established. However, the efficacy of B in a second-line setting or further has not been clarified. It has recently become clear that S-1 (S), an oral fluoropyrimidine, is effective for advanced NSCLC, and S is now used with platinum as one of the standard forms of first-line chemotherapy. Furthermore, preclinical findings have suggested that the combination of S plus B is a promising treatment option.
Methods:
Non-sq NSCLC patients with an ECOG performance status of 0-2, and who had undergone prior platinum-based chemotherapy regardless of the use of B, were eligible for the study. S (80 mg/m[2]) was administered orally twice daily for 14 days, and B (15 mg/kg) on day 1 every 3 weeks until disease progression or unacceptable toxicity occurred. The primary endpoint was progression-free survival (PFS), and the planned sample size was 28 patients.
Results:
Between March 2012 and June 2014, 28 patients (14 males and 14 females; median age 62 years; PS 0/1/2: 21/7/0; Ad/Other: 26/2, EGFR mutation positive/wild type 12/16) were accrued from 4 centers in Japan. All 28 patients were included in analysis of efficacy and toxicity. With a median follow-up of 9.3 months, the median PFS was 3.2 months (95% CI: 2.2-4.0 months). Patients who had not received prior pemetrexed or who had shown a good response to prior chemotherapy tended to have a longer PFS (5.3 and 5.0 months, respectively), although this was not statistically significant. An objective response was observed in 4 patients (PR; 4, SD; 20, PD 4), the response rate and disease control rate being 14.3% and 85.7%, respectively. The treatment was well tolerated, the most common treatment-related side effects being anorexia (75%) and fatigue (68%).
Conclusion:
This is the first report to evaluate the efficacy and safety of SB. Although SB seems to have a higher tumor reduction effect than S alone for previously treated Non-sq NSCLC, this study failed to meet its primary endpoint. SB is well tolerated and no new toxicities were observed.
