Phase II trial of PTK787/ZK 222584 (vatalanib) administered orally once-daily or in two divided daily doses as second-line monotherapy in relapsed or progressing patients with stage IIIB/IV non-small-cell lung cancer (NSCLC).

BACKGROUND: The objective of this multicenter, prospective uncontrolled phase II trial was to determine efficacy, safety and tolerability of vatalanib, an oral angiogenesis inhibitor targeting all known vascular endothelial growth factor receptors, in the second-line treatment of non-small-cell lung cancer (NSCLC). PATIENTS AND METHODS: Patients with stage IIIB/IV NSCLC-proven tumor progression during or after one platinum-based chemotherapy regimen received a fixed dose of 1250 mg vatalanib either once-daily dosing (QD) or two divided daily dosing (TDD: 500 mg a.m. + 750 mg p.m.) until disease progression or unacceptable toxicity. Primary end point was the disease control rate (DCR) at 12 weeks. RESULTS: Fifty-four and 58 patients were enrolled to the QD and TDD arms. DCR at 12 weeks was 35% in the QD and 37% in the TDD arm. The best overall response included one (2%) patient with confirmed partial response with QD and three (5%) with TDD. Median progression-free survival and overall survival were 2.1/7.3 months in the QD arm and 2.8/9.0 months with TDD arm. This therapy showed a moderate toxicity profile for the majority of patients. CONCLUSIONS: In the chosen patient population, vatalanib QD and TDD dosing demonstrated potential benefits in tumor size reduction, DCR, and survival.

Detection of pulmonary nodules at spiral CT: comparison of maximum intensity projection sliding slabs and single-image reporting.

The aim of this study was to compare numbers of pulmonary nodules detected with maximum intensity projections using a slab thickness of 15 mm (MIP 15) and 30 mm (MIP 30) with single image (SI) presentation of chest CT scans. Two readers reviewed MIP 15, MIP 30, and SI presentations of 10-mm (n = 8) and 5-mm collimation (n = 10) helical CT scans and recorded size, location, and diagnostic confidence (definite, probable) of pulmonary nodules. Readers 1 and 2 recorded more nodules with MIP 15 than with SI: 10-mm collimation, 77/64 and 60/56; 5-mm collimation, 64/60 and 40/36; and more "definite" nodules (10-mm collimation: 68/57 and 51/42; 5-mm collimation: 43/36 and 34/30). MIP 15 also detected more nodules than MIP 30 at 10-mm collimation: 77/72 and 60/50; with no major differences at 5-mm collimation: 64/66 and 40/38; and more "definite" nodules (10-mm collimation: 68/58 and 51/36; 5-mm collimation: 43/39 and 34/29). There were only minor differences between SI and MIP 30. Reading time and image number per study were reduced with MIP presentations by a factor of 1.4-5.3. There were no significant differences in the number of nodules detected with SI, MIP 15, and MIP 30, but MIP presentation reduced reporting time and filming cost when compared with SI reporting. For detection of nodules MIP 15 was slightly superior to MIP 30.