Ireland RH, et al. Feasibility of image registration and IMRT planning with hyperpolarized helium-3 MRI for non-small cell lung cancer. Int J Radiat Oncol Biol Phys 2007 [In press] [2] de Zanche N, et al. Optimized quadrature elliptical birdcage coil for hyperpolarized 3He lung MRI at 1.5T. Proc. 23rd Ann. Sci. ESMRMB Meeting, Warsaw 21-23 Sept.
To evaluate the efficacy of the pan-erbB inhibitor, CI-1033, in platinum-refractory or recurrent advanced stage non-small cell lung cancer.
Patients and Methods:This open label randomized phase II trial evaluated CI-1033 in patients with advanced stage NSCLC who failed or were refractory to platinum-based chemotherapy. Three oral CI-1033 doses were evaluated in 21-day dosing cycles -50 mg daily for 21 consecutive days; 150 mg daily for 21 consecutive days; and 450 mg daily for 14 consecutive days followed by 7 days of no treatment. The primary efficacy endpoint was the 1-year survival rate. Results: One hundred sixty six patients were randomized. Baseline patient demographics were well balanced. The most common drug related adverse events were rash and diarrhea. The 450 mg arm (14 days on/7 days off) was closed early due to an excessive rate of adverse events. The 1-year survival rates were 29%, 26% and 29%, respectively in the 3 arms. The response rates were 2%, 2% and 4% and stable disease was confirmed in 16, 23% and 18% of patients, respectively in the 3 study arms. Exploratory analyses demonstrated a prolonged survival in patients who developed a rash and in those with baseline tumor ErbB-2 expression. Conclusions: CI-1033 had modest activity in unselected NSCLC patients but did not meet its primary endpoint. Future studies should focus on identifying methods of patient selection.
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