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Phase III trial comparing three doses of docetaxel for second-line treatment of advanced breast cancer.
- Source :
-
Journal of clinical oncology : official journal of the American Society of Clinical Oncology [J Clin Oncol] 2006 Nov 01; Vol. 24 (31), pp. 4963-70. Date of Electronic Publication: 2006 Oct 10. - Publication Year :
- 2006
-
Abstract
- Purpose: To evaluate whether a relationship exists between docetaxel dose and clinical response in the treatment of patients with advanced breast cancer.<br />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.<br />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.<br />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.
- Subjects :
- Adult
Aged
Aged, 80 and over
Antineoplastic Agents, Phytogenic adverse effects
Antineoplastic Agents, Phytogenic pharmacokinetics
Area Under Curve
Breast Neoplasms pathology
Docetaxel
Dose-Response Relationship, Drug
Female
Humans
Logistic Models
Male
Middle Aged
Proportional Hazards Models
Survival Analysis
Taxoids adverse effects
Taxoids pharmacokinetics
Treatment Outcome
Antineoplastic Agents, Phytogenic administration & dosage
Breast Neoplasms drug therapy
Taxoids administration & dosage
Subjects
Details
- Language :
- English
- ISSN :
- 1527-7755
- Volume :
- 24
- Issue :
- 31
- Database :
- MEDLINE
- Journal :
- Journal of clinical oncology : official journal of the American Society of Clinical Oncology
- Publication Type :
- Academic Journal
- Accession number :
- 17033039
- Full Text :
- https://doi.org/10.1200/JCO.2005.05.0294