Skip Navigation


Annals of Oncology Advance Access originally published online on April 22, 2005
Annals of Oncology 2005 16(7):1087-1093; doi:10.1093/annonc/mdi209
This Article
Right arrow Full Text Freely available
Right arrow FREE Full Text (PDF) Freely available
Right arrow All Versions of this Article:
16/7/1087    most recent
mdi209v1
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 ISI Web of Science
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 arrow Search for citing articles in:
ISI Web of Science (3)
Right arrowRequest Permissions
Right arrow Disclaimer
Google Scholar
Right arrow Articles by Mrózek, E.
Right arrow Articles by Shapiro, C. L.
Right arrow Search for Related Content
PubMed
Right arrow PubMed Citation
Right arrow Articles by Mrózek, E.
Right arrow Articles by Shapiro, C. L.
Social Bookmarking
Add to CiteULike   Add to Connotea   Add to Del.icio.us  
What's this?

© 2005 European Society for Medical Oncology

Phase I trial of liposomal encapsulated doxorubicin (MyocetTM; D-99) and weekly docetaxel in advanced breast cancer patients

E. Mrózek1, C. A. Rhoades1, J. Allen1, E. M. Hade2 and C. L. Shapiro1,*

1 Division of Hematology and Oncology, Ohio State University Medical Center, Arthur G. James Cancer Hospital and Richard J. Solove Research Institute, Columbus, OH; 2 Comprehensive Cancer Center and Center for Biostatistics, Ohio State University, Columbus, OH, USA

* Correspondence to: Dr C. L. Shapiro, B 405 Starling-Loving, 320 West 10th Avenue, Columbus, OH 43210, USA. Tel: +1-614-293-7530; Fax: +1-614-293-7529; Email: shapiro-1{at}medctr.osu.edu

Background:: We conducted a phase I trial to determine the safety and maximum tolerated dose (MTD) of non-pegylated liposome-encapsulated doxorubicin (MyocetTM; D-99) administered with weekly docetaxel in metastatic breast cancer (MBC) patients.

Patients and methods:: Twenty-one patients with no prior chemotherapy for MBC received D-99 (60 or 50 mg/m2) intravenously (i.v.) on day 1 and escalating doses of docetaxel (25, 30 and 35 mg/m2) i.v. on days 1 and 8 in cohorts of three to six patients. Treatment cycles were repeated every 21 days for a maximum of six cycles.

Results:: The maximum tolerated dose (MTD) was 50 mg/m2 of D-99 in combination with 25 mg/m2 of weekly docetaxel. The most common grade 4 toxicity was neutropenia that occurred in 42 (41%) of treatment cycles, with 10 hospitalizations for febrile neutropenia. Serious protocol-defined cardiac events occurred in three (14%) patients, with two (10%; 95% confidence interval [CI] 1% to 30%) developing congestive heart failure (CHF) after a total cumulative anthracycline dose (adjuvant doxorubicin + D-99) of 540 mg/m2.

Conclusions:: D-99 in combination with weekly docetaxel, at the doses and schedule as administered in this trial, is not recommended for phase II testing. Additional trials, using different doses and schedules, are required to evaluate the potential side-effects and efficacy of D-99 and docetaxel.

Key words: liposome encapsulated doxorubicin, cardiotoxicity, breast cancer


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
 Integr Cancer TherHome page
K. Y. Wonders, D. S. Hydock, C. M. Schneider, and R. Hayward
Acute Exercise Protects Against Doxorubicin Cardiotoxicity
Integr Cancer Ther, September 1, 2008; 7(3): 147 - 154.
[Abstract] [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.