PMID- 22447503
OWN - NLM
STAT- MEDLINE
DCOM- 20130726
LR  - 20220311
IS  - 1559-131X (Electronic)
IS  - 1357-0560 (Linking)
VI  - 29
IP  - 4
DP  - 2012 Dec
TI  - A phase II trial of temsirolimus in second-line metastatic urothelial cancer.
PG  - 2870-6
LID - 10.1007/s12032-012-0216-x [doi]
AB  - This phase II trial assessed temsirolimus, an inhibitor of mammalian target of 
      rapamycin (mTOR), as second-line therapy in patients with metastatic transitional 
      carcinoma of the urothelium (TCCU) after failure of platinum containing therapy. 
      From June/2009 to June/2011, we enrolled 15 patients in this trial. 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 weekly 25 mg of temsirolimus for 8 
      weeks. Evaluation for response was accomplished every 8 weeks according to the 
      RECIST criteria, QoL assessment was done every 4 weeks using the QLQ-C30 
      questionnaire, adverse events (AEs) were recorded and graded using NCI-CTC 
      criteria. Fifteen patients were enrolled in this study, of whom 14 (93%) were 
      available for activity, safety and QoL 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. As per protocol, no sufficient 
      benefit on overall survival was observed, we early stopped the study after 14 
      patients. Median time to progression was 2.5 months (77 days), median overall 
      survival was 3.5 months (107 days). Four patients with 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. As Grade 3-4 adverse events, we observed fatigue (n=2), leukopenia 
      (n=2) and thrombopenia (n=2). All other adverse events were graded 1-2 in nature. 
      Temsirolimus seems to have poor activity in patients with progressive 
      metastasized TCCU after failure of platinum containing first-line therapy.
FAU - Gerullis, H
AU  - Gerullis H
AD  - Department of Urology, Lukas Hospital, Preussenstrasse 84, 41464, Neuss, Germany. 
      holger.gerullis@gmx.net
FAU - Eimer, C
AU  - Eimer C
FAU - Ecke, T H
AU  - Ecke TH
FAU - Georgas, E
AU  - Georgas E
FAU - Freitas, C
AU  - Freitas C
FAU - Kastenholz, S
AU  - Kastenholz S
FAU - Arndt, C
AU  - Arndt C
FAU - Heusch, C
AU  - Heusch C
FAU - Otto, T
AU  - Otto T
LA  - eng
PT  - Clinical Trial, Phase II
PT  - Journal Article
DEP - 20120325
PL  - United States
TA  - Med Oncol
JT  - Medical oncology (Northwood, London, England)
JID - 9435512
RN  - 0 (Antineoplastic Agents)
RN  - 0 (Protein Kinase Inhibitors)
RN  - 624KN6GM2T (temsirolimus)
RN  - W36ZG6FT64 (Sirolimus)
SB  - IM
MH  - Aged
MH  - Antineoplastic Agents/*therapeutic use
MH  - Carcinoma, Transitional Cell/*drug therapy/mortality/secondary
MH  - Female
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Protein Kinase Inhibitors/*therapeutic use
MH  - Quality of Life
MH  - Sirolimus/*analogs & derivatives/therapeutic use
MH  - Urinary Bladder Neoplasms/*drug therapy/mortality/pathology
EDAT- 2012/03/27 06:00
MHDA- 2013/07/28 06:00
CRDT- 2012/03/27 06:00
PHST- 2011/12/12 00:00 [received]
PHST- 2012/03/10 00:00 [accepted]
PHST- 2012/03/27 06:00 [entrez]
PHST- 2012/03/27 06:00 [pubmed]
PHST- 2013/07/28 06:00 [medline]
AID - 10.1007/s12032-012-0216-x [doi]
PST - ppublish
SO  - Med Oncol. 2012 Dec;29(4):2870-6. doi: 10.1007/s12032-012-0216-x. Epub 2012 Mar 
      25.