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S. Minami
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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: 2
- Moderators:
- Coordinates: 10/16/2017, 09:30 - 16:00, Exhibit Hall (Hall B + C)
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P1.03-047 - Carboplatin/ Weekly Nab-PTX in Elderly Patients with Previously Untreated Advanced Squamous NSCLC Selected Based on MNA-SF (ID 7582)
09:30 - 09:30 | Author(s): S. Minami
- Abstract
Background:
This multicenter, single-arm, open-label, phase 2 study assessed the efficacy and safety of carboplatin plus weekly nanoparticle albumin-bound paclitaxel in elderly patients with previously untreated advanced squamous non-small-cell lung cancer, selected based on the Mini Nutritional Assessment short-form scores (MNA-SF).
Method:
Patients received carboplatin (area under the curve: 6) on Day 1, and nanoparticle albumin-bound paclitaxel (100 mg/m[2]) on Days 1, 8, and 15, every 28 days for ≤4 cycles. Eligibility criteria included an MNA-SF score of ≥8 points. The primary endpoint was the objective response rate.
Result:
Thirty patients with a median age of 76 (range, 70–83) years were enrolled. The objective response rate was 50.0% (95% confidence interval: 31.3–68.7%), which met the primary objective of this study. The disease control rate was 73.3% (95% confidence interval: 54.1–87.7%). At a median follow-up of 15.0 months, the median progression-free and overall survival was 7.1 and 19.1 months, respectively. The most common treatment-related adverse event of Grade ≥3 was neutropenia (66.7%). Non-hematological adverse events of Grade ≥3 were minor. Well-nourished patients, based on the MNA-SF, experienced fewer adverse events of Grade ≥3 compared to patients at risk of malnutrition. All treatment-related adverse events were tolerable and reversible. There were no treatment-related deaths.
Conclusion:
Carboplatin plus weekly nanoparticle albumin-bound paclitaxel is effective and well tolerated as a first-line treatment for elderly patients with advanced squamous non-small-cell lung cancer. Eligibility based on MNA-SF screening may be useful in determining acceptable toxicity.
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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): S. Minami
- 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.
