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A randomized, phase III multicenter trial of gemcitabine in combination with carboplatin or paclitaxel versus paclitaxel plus carboplatin in patients with advanced or metastatic NSCLC
Annals of Oncology, 10/19/09
Treat JA et al. – Paclitaxel–carboplatin is used as the standard regimen for patients with advanced or metastatic non-small-cell lung cancer (NSCLC). This trial was designed to compare gemcitabine + carboplatin or gemcitabine + paclitaxel to the standard regimen. Non-platinum and non-paclitaxel gemcitabine-containing doublets demonstrate similar overall survival and RR compared with the standard PC regimen. The treatment arms had distinct toxicity profiles.
Methods- 1135 chemonaive patients with stage IIIB or IV NSCLC
- Randomly allocated to receive gemcitabine 1000 mg/m2 on days 1 and 8 plus carboplatin area under concentration–time curve (AUC) 5.5 on day 1 (GC), gemcitabine 1000 mg/m2 on days 1 and 8 plus paclitaxel 200 mg/m2 on day 1 (GP), or paclitaxel 225 mg/m2 plus carboplatin AUC 6.0 on day 1 (PC)
- Stratification based on disease stage, baseline weight loss, and presence or absence of brain metastases
- Cycles repeated every 21 days for up to 6 cycles or disease progression
- Median survival (months) with GC 7.9 compared with 8.5 for GP and 8.7 for PC
- Response rates (RRs) as follows: GC, 25.3%; GP, 32.1%; and PC, 29.8%
- The GC arm associated with greaterincidence of grade 3 or 4 hematologic events but lower rate of neurotoxicity and alopecia when compared with GP and PC
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Targeted proteasome inhibition by Velcade induces apoptosis in human mesothelioma and breast cancer cell lines
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