Annals of Oncology Advance Access published online on July 27, 2006
Annals of Oncology, doi:10.1093/annonc/mdl154
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
1 Department of Oncology, Aarhus University Hospital, Denmark
* To whom correspondence should be addressed. Background: Both pemetrexed and gemcitabine have single-agent activity in bladder cancer, but the combination of these two drugs has not been previously evaluated for safety and efficacy in this disease. Thus, the objectives in the current study were to determine overall response rate (ORR), progression-free survival, overall survival and safety and toxicity in chemonaive patients with locally advanced and/or metastatic transitional cell carcinoma of the urothelium. Patients and methods: Gemcitabine 1250 mg/m2 was administered over 30 min i.v. on days 1 and 8, and pemetrexed 500 mg/m2 over 10 min i.v. on day 8 after gemcitabine, every 21 days. Results: Sixty-four patients were enrolled, 11 female and 53 male, median age 65 years (range 38-81), median WHO performance status of 1. Visceral metastases were present in 55% of patients. ORR among 47 patients evaluable for response was 28% (95% CI 16% to 43%) and ORR for the intention-to-treat population was 20% (95% CI 11% to 32%) with three CR and 10 PR. Median response duration was 11.2 months and median overall survival 10.3 months (95% CI 8.1-14.6 months). CTC grade 3/4 hematologic toxicities included anemia (19%), thrombocytopenia (9%), neutropenia (38%), febrile neutropenia (17%) and neutropenic sepsis (3%). Grade 3/4 non-hematologic toxicities included elevated transaminases (12%), dyspnea (8%), fatigue (8%) and stomatitis (5%). There was one toxic death due to neutropenic sepsis. Conclusions: The combination of pemetrexed and gemcitabine had a manageable safety profile. However, efficacy was apparently not superior to that of single-agent gemcitabine.
Received March 20, 2006
Revised May 26, 2006
Accepted May 29, 2006
original article
A phase II trial of pemetrexed plus gemcitabine in locally advanced and/or metastatic transitional cell carcinoma of the urothelium
H. von der Maase 1 *, J. Lehmann 2, G. Gravis 3, H. Joensuu 4, P. F. Geertsen 5, J. Gough 6, G. Chen 6, and M. Kania 6
2 Klinik für Urologie and Kinderurologie, Universität des Saarlandes, Germany
3 Institut Paoli-Calmettes, Marseille, France
4 Department of Oncology, Helsinki University Central Hospital, Finland
5 Department of Oncology, Herlev University Hospital, Denmark
6 Eli Lilly and Company, Indianapolis, IN, USA
H. von der Maase, E-mail: maase{at}as.aaa.dk
Abstract 
CiteULike 
Connotea 
Del.icio.us What's this?
This article has been cited by other articles:
|
|
 |
|
  J. Bellmunt, C. Theodore, T. Demkov, B. Komyakov, L. Sengelov, G. Daugaard, A. Caty, J. Carles, A. Jagiello-Gruszfeld, O. Karyakin, et al. Phase III Trial of Vinflunine Plus Best Supportive Care Compared With Best Supportive Care Alone After a Platinum-Containing Regimen in Patients With Advanced Transitional Cell Carcinoma of the Urothelial Tract J. Clin. Oncol., September 20, 2009; 27(27): 4454 - 4461. [Abstract] [Full Text] [PDF]
|
|
|
|
 |
|
 G. Sonpavde, A. A. Elfiky, and J. E. Rosenberg Review: Novel agents for advanced bladder cancer Therapeutic Advances in Medical Oncology, July 1, 2009; 1(1): 37 - 50. [Abstract] [PDF]
|
|
|
|
 |
|
 C. Sweeney, D. F. Bajorin, and C. N. Sternberg Muscle-invasive Bladder Cancer: What Have We Learned and What's New on the Horizon? ASCO Educational Book, January 1, 2008; 2008(1): 200 - 208. [Abstract] [Full Text] [PDF]
|
|
|
|
 |
|
 G Di Lorenzo and S De Placido Re: Perabo FGE and Muller SC. New agents for treatment of advanced transitional cell carcinoma. Ann Oncol 2007; 18: 835-843. Ann. Onc., June 1, 2007; 18(6): 1118 - 1118. [Full Text] [PDF]
|
|