Skip Navigation



Annals of Oncology Advance Access published online on April 2, 2008
Annals of Oncology, doi:10.1093/annonc/mdn066
This Article
Right arrow Full Text
Right arrow Full Text (PDF)
Right arrow All Versions of this Article:
19/8/1387    most recent
mdn066v1
Right arrow E-letters: Submit a response
Right arrow Alert me when this article is cited
Right arrow Alert me when E-letters are posted
Right arrow Alert me if a correction is posted
Services
Right arrow Email this article to a friend
Right arrow Similar articles in this journal
Right arrow Similar articles in PubMed
Right arrow Alert me to new issues of the journal
Right arrow Add to My Personal Archive
Right arrow Download to citation manager
Right arrowRequest Permissions
Right arrow Disclaimer
Google Scholar
Right arrow Articles by Bellmunt, J.
Right arrow Articles by Berkenblit, A.
PubMed
Right arrow PubMed Citation
Right arrow Articles by Bellmunt, J.
Right arrow Articles by Berkenblit, A.
Social Bookmarking
Add to CiteULike   Add to Connotea   Add to Del.icio.us  
What's this?

© The Author 2008. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. For permissions, please email: journals.permissions@oxfordjournals.org

Temsirolimus safety profile and management of toxic effects in patients with advanced renal cell carcinoma and poor prognostic features

J. Bellmunt1,*, C. Szczylik2, J. Feingold3, A. Strahs3 and A. Berkenblit3

1 Oncology Department, University Hospital del Mar, Barcelona, Spain
2 Klinika Onkologii Wojskowy Instytut Medyczny, Warszawa, Poland
3 Wyeth Research, Cambridge, MA, 02140 USA

* Correspondence to: Dr J. Bellmunt, Solid Tumor Oncology (Genitourinary & Gastrointestinal), Medical Oncology Service, Hospital del Mar, Paseo Maritimo 25–29, Barcelona 08003, Spain. Tel: +34-93-2483137; Fax: +34-93-2483366; E-mail: jbellmunt{at}imas.imim.es

Background: Temsirolimus, a novel inhibitor of mammalian target of rapamycin, has demonstrated prolonged overall survival and progression-free survival compared with interferon alfa (IFN) in patients with advanced renal cell carcinoma (RCC) and poor prognostic features. Adverse events (AEs) of any causality were previously reported, but AEs that were deemed temsirolimus related are of particular relevance for poor-risk patients and for defining mammalian target of rapamycin inhibitor-specific side-effects.

Patients and methods: Patients with advanced RCC, no prior systemic therapy, and three or more of six poor-risk factors were randomly assigned to one of three groups: (i) IFN s.c. up to 18 MU thrice weekly, (ii) temsirolimus i.v. 25 mg weekly, or (iii) temsirolimus i.v. 15 mg weekly plus interferon s.c. 6 MU thrice weekly.

Results: Among 208 patients, the most common temsirolimus-related grades 3–4 AEs were anemia (13%), hyperglycemia (9%), and asthenia (8%). Grades 3–4 hypercholesterolemia (1%), hypertriglyceridemia (3%), and hypophosphatemia (4%) were also seen. Although pneumonitis occurred infrequently, vigilance for its development is needed. Guidelines for management of toxic effects are presented on the basis of available clinical experience.

Conclusions: Temsirolimus-related grades 3–4 AEs were primarily metabolic in nature and easily controlled medically. In general, these did not negatively impact patient quality of life.

interferon, mammalian target of rapamycin (mTOR), renal cell carcinoma, safety, temsirolimus

Received for publication October 11, 2007. Revision received January 7, 2008. Accepted for publication February 20, 2008.


Add to CiteULike CiteULike   Add to Connotea Connotea   Add to Del.icio.us Del.icio.us    What's this?


This article has been cited by other articles:


Home page
 Ann OncolHome page
S. Negrier
Temsirolimus in metastatic renal cell carcinoma
Ann. Onc., August 1, 2008; 19(8): 1369 - 1370.
[Full Text] [PDF]


Disclaimer:
Please note that abstracts for content published before 1996 were created through digital scanning and may therefore not exactly replicate the text of the original print issues. All efforts have been made to ensure accuracy, but the Publisher will not be held responsible for any remaining inaccuracies. If you require any further clarification, please contact our Customer Services Department.