Journal
LUNG CANCER
Volume 68, Issue 1, Pages 89-93Publisher
ELSEVIER IRELAND LTD
DOI: 10.1016/j.lungcan.2009.05.009
Keywords
Bortezomib; Proteasome inhibitor; Metastatic; Non-small cell lung cancer; First-line therapy; Phase II Study; Monotherapy
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Funding
- Millennium: The Takeda Oncology Company
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The primary objective of this study was to determine the objective response rate of bortezomib as a first-line therapy in patients advanced stage NSCLC. Advanced/metastatic NSCLC patients with measurable disease, adequate organ function, ECOG performance status of 0-2, and no prior chemotherapy for metastatic disease were eligible. Patients received intravenously bolus bortezomib 1.3 mg/m(2)/day on days 1, 4, 8 and 11 every 21 days for a maximum of 8 cycles, or until disease progression, or unacceptable toxicity. Tumor response was evaluated after every 2 cycles of therapy. This single-arm phase II study employed the Simon's two-stage design. The study was terminated in the first stage after 14 patients enrolled at 4 institutions. No objective response was observed. Three patients (21%) had stable disease and received 8,6 and 4 cycles of treatment; the duration of stable disease was 11.5, 4.2 and 3.4 months, respectively. Median time to progression was 1.3 months (95% Cl, 0.6-3.0 months); median overall survival (OS) was 9.9 months (95% Cl, 2.2-27.0 months). Twelve patients received at least one dose of bortezomib. There were no grade 4 toxicities or treatment related deaths. Grade 3 toxicities included fatigue (N = 1, 8%), deep vein thrombosis (N = 1,8%) and thrombocytopenia (N = 1, 8%). Although well tolerated, bortezomib monotherapy is not active in this cohort of chemotherapy-naive, metastatic NSCLC. (C) 2009 Elsevier Ireland Ltd. All rights reserved.
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