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Randomized phase II trial of docetaxel plus cetuximab or docetaxel plus bortezomib in patients with advanced non-small-cell lung cancer and a performance status of 2: CALGB 30402
Journal of Clinical Oncology, 08/28/09
Lilenbaum R et al. – The prognosis is poor in patients with advanced NSCLC and a PS of 2. Neither docetaxel + cetuximab nor docetaxel + bortezomib met the PFS end point.
Methods- Randomized phase II trial
- 59 patients with advanced NSCLC received docetaxel (30 mg/m2 on d1, 8, and 15 q28 d) in combination with cetuximab (400 mg/m2 load and 250 mg/m2 qw) or bortezomib (1.6 mm2 on d1, 8, and 15 q28d x 4 cycles)
- CR or PR rates were 13.3% and 10.3% for the D + C and D + B groups, respectively
- The median PFS was 3.4 mos in the D + C group and 1.9 mos in the D + B group
- T 6-mos PFS was 27.8% for the D + C group and 21% for the D + B group
- Grade 3/4 hematologic toxicity was 16% for D + C and 21% for D + B, whereas non-hematologic toxicities were 63% and 44%, respectively
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