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- W2560652414 abstract "302 Background: This investigator initiated phase II trial assessed temsirolimus, an inhibitor of mamalian target of rapamycin (mTOR), as second-line therapy in patients with locally advanced or metastatic TCCU after failure of platinum-containing therapy. Methods: 15 patients were enrolledin this phase II trial from June/2009 to June/2011. Primary endpoint was overall survival, as secondary endpoints we defined time to disease progression, safety and QoL along treatment. Patients with progressive TCCU after prior platinum-based chemotherapy received 25 mg of temsirolimus for 8 weeks. Evaluation for response was acomlished every 8 weeks according to the RECIST criteria, QoL assessment was done every 4 weeks using the QLC-C30 questionnaire, adverse events (AEs) were recorded and graded using NCI-CTC criteria. Results: We enrolled 15 patients in this study, of whom 14 (93%) were available for activity and safety assessment. We treated 10 (71%) male and 4 female (29%) patients median age was 64.7 years (45-76). Patients received on average 13 (3-15) infusions of temsirolimus. Median overall survival was 3.5 months (107 days). Median time to disease prgression was 2.5 months. Four patients with transient stable disease were observed. QoL assessment along treatment revealed a reduction of EORTC-QLQ-C30 (Global Health Status-Subscale) from initial 7.86 to 5.00. Temsirolimus was well tolerated, mostly observed were fatigue (Grade 3-4) in 2 patients, pancytopenia (Grade 3-4) in 2 patients, thrombopenia (Grade 3-4) in 2 patients. All other adverse events were grade 1-2 in nature. Conclusions: The primary endpoint was not met with an overall survival of 3.5 montsh only. Therefore the trial was closed after 14 patients. Temsirolimus seems to have poor activity in patients with progressive metastasized TCCU after platinum-containing first-line therapy." @default.
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- W2560652414 date "2012-02-10" @default.
- W2560652414 modified "2023-09-24" @default.
- W2560652414 title "Temsirolimus in platinum-resistant metastatic urothelial cancer: A phase II trial." @default.
- W2560652414 doi "https://doi.org/10.1200/jco.2012.30.5_suppl.302" @default.
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