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T. Yoshida
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P1.03 - Poster Session/ Treatment of Locoregional Disease – NSCLC (ID 212)
- Event: WCLC 2015
- Type: Poster
- Track: Treatment of Locoregional Disease – NSCLC
- Presentations: 1
- Moderators:
- Coordinates: 9/07/2015, 09:30 - 17:00, Exhibit Hall (Hall B+C)
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P1.03-015 - Safety and Effectiveness of Chemo-Radiotherapy with Weekly Nab Paclitaxel plus Carboplatin in Locally Advanced Non-Small Cell Lung Cancer (ID 2956)
09:30 - 09:30 | Author(s): T. Yoshida
- Abstract
Background:
Combination therapy of carboplatin (CBDCA) and nab-PTX is a useful choice for first-line therapy of patients with advanced non-small cell lung cancer (NSCLC). The efficacy and safety of weekly albumin-bound paclitaxel (nab-PTX) and carboplatin (CBDCA) with concurrent radiotherapy for unresectable locally advanced non-small cell lung cancer was evaluated as a multicenter phase II study of Gifu thoracic oncology group.
Methods:
Patients with stage III NSCLC and an Eastern Cooperative Oncology Group performance status of 0 or 1 were eligible. Concurrent chemoradiotherapy consisted of weekly administration of nab-PTX (40 mg/m[2]) plus CBDCA (area under the plasma concentration time curve (AUC) 2) and thoracic radiotherapy (60 Gy/30 fractions) for a total of 6 weeks. The primary tumor and involved nodal disease received 60 Gy in 2-Gy fractions over 6 weeks. A three dimensional treatment planning system was used in every institute. After concurrent chemoradiotherapy, patients received an additional two cycles of consolidation phase chemotherapy that consisted of 4-week cycles of nab-PTX (100 mg/m[2] on days 1, 8, and 15)/CBDCA (AUC 5 mg/ml/min on day 1). Response was evaluated in accordance with the RECIST. Progression-free and overall survival were estimated using the Kaplan Meier method. Toxicity was graded using the National Cancer Institute Common Terminology Criteria for Adverse Events.
Results:
The study became way canceled for serious adverse events, when the 10 cases were enrolled in this trial between September 2013 and January 2014 from 3 institutes. Patient characteristics are summarized as follow. The median age was 73 years. The ECOG performance status was 0 for 30% of patients and 1 for 70% of patients. Of these patients, 5 cases had squamous cell carcinoma and 5 cases had adenocarcinoma. The overall response rate was 40.0% and the median progression-free survival was 6.7 months. total of 7 patients were unable to complete the consolidation phase chemotherapy because of toxicities (pneumonitis, lung infection, or heart failure), poor PS, or patient preference. The most common grade 3/4 hematological toxicity was leukopenia (8 patients, 80%). Other grade 3/4 hematological toxicities were neutropenia (5 patients, 50%) and anemia (1 patient, 10%). Other grade 3 or worse severe toxicities were anorexia (3 patients, 30%), nausea (2 patients, 20%), diarrhea (1 patient, 10%), pneumonitis (2 patients, 20%), heart failure (2 patients, 20%), and lung infection (1 patient, 10%). Treatment-related death occurred in two patients. Grade 2 or worse severe pneumonitis was observed in all 3 patients that had volume of lung receiving at least 20 Gy (V20) >30%.
Conclusion:
The results of this study indicate that no further investigation is warranted into nab-PTX and CBDCA with concurrent thoracic radiation using three dimensional treatment planning system for stage III NSCLC with V20 >30% due to severe toxicity.