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M. Higashiguchi
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P1.03 - Chemotherapy/Targeted Therapy (ID 689)
- Event: WCLC 2017
- Type: Poster Session with Presenters Present
- Track: Chemotherapy/Targeted Therapy
- Presentations: 1
- Moderators:
- Coordinates: 10/16/2017, 09:30 - 16:00, Exhibit Hall (Hall B + C)
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P1.03-049 - Phase II Study of S-1 plus Bevacizumab Combination Therapy for Patients Previously Treated for Non-Squamous Non–Small Cell Lung Cancer (ID 8008)
09:30 - 09:30 | Author(s): M. Higashiguchi
- Abstract
Background:
The combination of platinum plus third-generation cytotoxic drugs has been the gold standard first-line chemotherapy for patients with advanced NSCLC. However, most patients experience disease progression during or after first-line treatment. The survival benefit of S-1 monotherapy as second-line therapy is not satisfactory. Bevacizumab conferred a survival benefit when combined with carboplatin and paclitaxel as first-line treatment in non-squamous NSCLC. The benefit of adding bevacizumab to non-platinum cytotoxic monotherapy such as S-1 is not clear as subsequent treatment. Therefore, we conducted a multi-center, a single-arm phase II study to evaluate the safety and efficacy of combination therapy of tailored-dose S-1 plus bevacizumab in patients with recurrent non-squamous NSCLC.
Method:
This was a prospective, multi-center, single-arm phase II study. Patients with non-squamous NSCLC who had experienced progression after cytotoxic chemotherapy were enrolled. Oral S-1 was administered on days 1–14 of a 21-day cycle, and bevacizumab (15 mg/kg) was given intravenously on day 1. Patients received S-1 adjusted on the basis of their creatinine clearance and body surface area. The primary endpoint was response rate (RR); secondary endpoints were progression-free survival (PFS), overall survival (OS), and safety.
Result:
We enrolled 30 patients. One patient had never received platinum-based therapy. Five patients had activating mutations of the epidermal growth factor receptor gene, of whom four had received tyrosine kinase inhibitors before this study. The RR was 6.7% (95% confidence interval (CI) 1.8–21.3%), and the disease control rate (DCR) was 80% (95% CI 62.7–90.5%). Median PFS was 4.8 months (95% CI 2.7–6.4 months], and median OS was 13.8 months (95% CI 8.4 months – not applicable). Patients did not experience any Grade 4 toxicity or treatment-related death. Grade 3 hematologic toxicity (anemia) occurred in one patient (3.3%). The main Grade 3 non-hematologic toxicities were anorexia (10%), infection (10%), and diarrhea (6.7%).
Conclusion:
The addition of bevacizumab to S-1 was tolerable, but not beneficial for patients with previously treated non-squamous NSCLC. We do not recommend further study of this regimen.
