Originally published as JCO Early Release 10.1200/JCO.2005.05.0294 on October 10 2006
Journal of Clinical Oncology, Vol 24, No 31 (November 1), 2006: pp. 4963-4970
© 2006 American Society of Clinical Oncology.
Phase III Trial Comparing Three Doses of Docetaxel for Second-Line Treatment of Advanced Breast Cancer
Vernon Harvey,
Henning Mouridsen,
Vladimir Semiglazov,
Erik Jakobsen,
Edouard Voznyi,
Bridget A. Robinson,
Vanina Groult,
Michael Murawsky,
Soeren Cold
From the Department of Oncology, Auckland Hospital, Auckland; Department of Oncology, Christchurch Hospital, Christchurch, New Zealand; Department of Oncology, Rigshospitalet, Copenhagen; Department of Oncology, Vejle Sygehus, Vejle; Department of Oncology, Odense Universitetssygehus, Odense, Denmark; Department of Oncology, Petrov Research Institute of Oncology, St Petersburg; Department of Oncology, Research Institute of Diagnostics and Surgery, Moscow, Russian Federation; and Sanofi-Aventis, Antony, France; Sanofi-Aventis, Antony, France
Address reprint requests to Vernon Harvey, MD, Department of Oncology, Auckland Hospital, Private Bag 92-024, Auckland, New Zealand; e-mail: vernonh{at}adhb.govt.nz
Purpose To evaluate whether a relationship exists between docetaxel dose and clinical response in the treatment of patients with advanced breast cancer.
Patients and Methods Patients whose cancer had progressed after one prior chemotherapy regimen for advanced breast cancer or had recurred during or within 6 months of adjuvant chemotherapy were randomly assigned to docetaxel 60, 75, or 100 mg/m2 intravenously every 3 weeks.
Results Five hundred twenty-seven patients were randomly assigned (intent to treat [ITT]), and 524 were assessable for toxicity. In the population assessable for efficacy (n = 407), logistic regression analysis showed that increasing docetaxel dose was significantly associated with higher response rate (P = .007) and improved time to progression (TTP; P = .014). In the ITT analysis, a significant dose-response relationship was observed for tumor response (P = .026) but not for TTP (P = .067). The incidences of most hematologic and nonhematologic toxicities were related to increasing dose, with grade 3 to 4 neutropenia occurring in 76.4%, 83.7%, and 93.4% and febrile neutropenia occurring in 4.7%, 7.4%, and 14.1% of patients administered the 60, 75, and 100 mg/m2 doses, respectively. One death was considered treatment related.
Conclusion A relationship between increasing dose of docetaxel and increased tumor response was observed across the dose range of 60 to 100 mg/m2 every 3 weeks. Toxicities were related to increasing dose. Depending on the therapy goal, any of the doses studied may be appropriate for second-line treatment of advanced breast cancer.
published online ahead of print at www.jco.org on October 10, 2006.
Supported by Sanofi-Aventis, Paris, France.
Authors' disclosures of potential conflicts of interest and author contributions are found at the end of this article.

CiteULike Complore Connotea Del.icio.us Digg Facebook Reddit Technorati Twitter What's this?
This article has been cited by other articles:

|
 |

|
 |
 
J. A. Sparano, A. N. Makhson, V. F. Semiglazov, S. A. Tjulandin, O. I. Balashova, I. N. Bondarenko, N. V. Bogdanova, G. M. Manikhas, G. P. Oliynychenko, V. A. Chatikhine, et al.
Pegylated Liposomal Doxorubicin Plus Docetaxel Significantly Improves Time to Progression Without Additive Cardiotoxicity Compared With Docetaxel Monotherapy in Patients With Advanced Breast Cancer Previously Treated With Neoadjuvant-Adjuvant Anthracycline Therapy: Results From a Randomized Phase III Study
J. Clin. Oncol.,
September 20, 2009;
27(27):
4522 - 4529.
[Abstract]
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
N. Katsumata, T. Watanabe, H. Minami, K. Aogi, T. Tabei, M. Sano, N. Masuda, J. Andoh, T. Ikeda, T. Shibata, et al.
Phase III trial of doxorubicin plus cyclophosphamide (AC), docetaxel, and alternating AC and docetaxel as front-line chemotherapy for metastatic breast cancer: Japan Clinical Oncology Group trial (JCOG9802)
Ann. Onc.,
July 1, 2009;
20(7):
1210 - 1215.
[Abstract]
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
S. Chan, G. Romieu, J. Huober, T. Delozier, M. Tubiana-Hulin, A. Schneeweiss, A. Lluch, A. Llombart, A. du Bois, R. Kreienberg, et al.
Phase III Study of Gemcitabine Plus Docetaxel Compared With Capecitabine Plus Docetaxel for Anthracycline-Pretreated Patients With Metastatic Breast Cancer
J. Clin. Oncol.,
April 10, 2009;
27(11):
1753 - 1760.
[Abstract]
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
P. Bono, P.-L. Kellokumpu-Lehtinen, T. Alanko, R. Kokko, R. Asola, T. Turpeenniemi-Hujanen, S. Jyrkkio, V. Kataja, M. Leinonen, and H. Joensuu
Docetaxel 100 versus 80 mg/m2 as adjuvant treatments of early breast cancer: an exploratory analysis of a randomised trial
Ann. Onc.,
March 1, 2009;
20(3):
595 - 596.
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
S. Chia, S. Dent, S. Ellard, P. M. Ellis, T. Vandenberg, K. Gelmon, J. Powers, W. Walsh, L. Seymour, and E. A. Eisenhauer
Phase II Trial of OGX-011 in Combination with Docetaxel in Metastatic Breast Cancer
Clin. Cancer Res.,
January 15, 2009;
15(2):
708 - 713.
[Abstract]
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
L. J. Goldstein, A. O'Neill, J. A. Sparano, E. A. Perez, L. N. Shulman, S. Martino, and N. E. Davidson
Concurrent Doxorubicin Plus Docetaxel Is Not More Effective Than Concurrent Doxorubicin Plus Cyclophosphamide in Operable Breast Cancer With 0 to 3 Positive Axillary Nodes: North American Breast Cancer Intergroup Trial E 2197
J. Clin. Oncol.,
September 1, 2008;
26(25):
4092 - 4099.
[Abstract]
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
P. Francis, J. Crown, A. Di Leo, M. Buyse, A. Balil, M. Andersson, B. Nordenskjold, I. Lang, R. Jakesz, D. Vorobiof, et al.
Adjuvant Chemotherapy With Sequential or Concurrent Anthracycline and Docetaxel: Breast International Group 02 98 Randomized Trial
J Natl Cancer Inst,
January 16, 2008;
100(2):
121 - 133.
[Abstract]
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
K. W. Rahman, S. Ali, A. Aboukameel, S. H. Sarkar, Z. Wang, P. A. Philip, W. A. Sakr, and A. Raz
Inactivation of NF-{kappa}B by 3,3'-diindolylmethane contributes to increased apoptosis induced by chemotherapeutic agent in breast cancer cells
Mol. Cancer Ther.,
October 1, 2007;
6(10):
2757 - 2765.
[Abstract]
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
M. Colozza, E. de Azambuja, N. Personeni, F. Lebrun, M. J. Piccart, and F. Cardoso
Achievements in Systemic Therapies in the Pregenomic Era in Metastatic Breast Cancer
Oncologist,
March 1, 2007;
12(3):
253 - 270.
[Abstract]
[Full Text]
[PDF]
|
 |
|
|