Phase I Trial of Radiation With Concurrent and Consolidation Pemetrexed and Cisplatin in Patients With Unresectable Stage IIIA/B Non-Small-Cell Lung Cancer
Journal Article
·
· International Journal of Radiation Oncology, Biology and Physics
- Department of Radiation Oncology, Princess Margaret Hospital, University of Toronto, Toronto, ON (Canada)
- Department of Radiation Oncology, Ottawa Regional Cancer Centre, Ottowa, ON (Canada)
- Department of Medical Oncology, Ottawa Regional Cancer Centre, Ottawa, ON (Canada)
- Department of Medical Oncology, Princess Margaret Hospital, University of Toronto, Toronto, ON (Canada)
- Department of Biostatistics, Princess Margaret Hospital, University of Toronto, Toronto, ON (Canada)
- Eli Lilly Canada, Toronto, ON (Canada)
Purpose: To evaluate the feasibility and safety of concurrent pemetrexed/cisplatin/thoracic radiotherapy followed by consolidation pemetrexed/cisplatin for unresectable Stage IIIA/B non-small-cell lung cancer (NSCLC). Methods and Materials: Eligible patients with <5% weight loss and good performance status received two cycles of pemetrexed (300, 400, or 500 mg/m{sup 2} on Days 1 and 22 for Dose Levels 1, 2, and 3/4, respectively) and cisplatin (25 mg/m{sup 2} Days 1-3 for Dose Levels 1-3; 20 mg/m{sup 2} Days 1-5 for Dose Level 4) concurrent with thoracic radiation (61-66 Gy in 31-35 fractions). Consolidation consisted of two cycles of pemetrexed/cisplatin (500 mg/m{sup 2}, 75 mg/m{sup 2}) 21 days apart, after concurrent therapy. Results: Between January 2006 and October 2007, 16 patients entered the study. Median follow-up was 17.2 months. No dose-limiting toxicities were observed. Median radiation dose was 64 Gy (range, 45-66 Gy). Rates of significant Grade 3/4 hematologic toxicity were 38% and 7%, respectively. One patient experienced Grade 3 acute esophagitis, and 2 experienced late (Grade 3) esophageal stricture, successfully managed with dilation. One patient experienced Grade 3 pneumonitis. The overall response rate was 88%. One-year overall survival was 81%. Conclusions: Full systemic dose pemetrexed seems to be safe with full-dose cisplatin and thoracic radiation in Stage IIIA/B NSCLC. Pemetrexed is the first third-generation cytotoxic agent tolerable at full dose in this setting. A Phase II study evaluating Dose Level 4 is ongoing.
- OSTI ID:
- 21491696
- Journal Information:
- International Journal of Radiation Oncology, Biology and Physics, Journal Name: International Journal of Radiation Oncology, Biology and Physics Journal Issue: 5 Vol. 79; ISSN IOBPD3; ISSN 0360-3016
- Country of Publication:
- United States
- Language:
- English
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