Abstract | BACKGROUND: Combination therapy with doxorubicin (DOX) and docetaxel (DOC), given 3 weeks apart, is one of the standard regimens used for treating metastatic breast cancer, but it frequently generates febrile neutropenia. To find a safer regimen with less myelotoxicity and the appropriate dose intensity, we conducted a phase I study of simultaneous weekly infusion with DOX and DOC. METHODS: Twenty-five patients with advanced breast cancer were treated with an intravenous push-injection of DOX that was immediately followed by a 1-h infusion of DOC. This was repeated every week for at least 6 weeks. The premedication employed was three 4-mg doses of dexamethasone every week. Patients were divided into four groups for which the doses of DOX and DOC were escalated in 5-mg/m2 increments. RESULTS: In the 18 patients who were treated with DOX 15 or 20 mg/m2 and DOC 25 mg/m2, or lower, the regimen was found to be tolerable, without febrile episodes. The regimen with 20 mg/m2 of DOX and 30 mg/m2 of DOC was the maximum tolerated dose. Other indications of grade 3 toxicity included asthenia in 4% of patients, anorexia in 8%, and vomiting in 8%. Of the 25 patients, 14 had a partial response. The overall response rate was 56% (95% confidence interval [CI], 35% to 77%). The recommended dose for further trial was 20 mg/m2 of DOX and 25 mg/m2 of DOC. CONCLUSION: Simultaneous weekly infusion with DOX and DOC was feasible, with modest neutropenia and preserved dose intensity. This regimen may be helpful in the management of patients with advanced breast cancer.
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Authors | Y Ito, K Aiba, N Horikoshi, T Saotome, T Irie, K Sugiyama, M Nakane, D Hashimoto, N Yoshida, N Mizunuma, S Takahashi, Y Tanigawara |
Journal | International journal of clinical oncology
(Int J Clin Oncol)
Vol. 6
Issue 5
Pg. 242-7
(Oct 2001)
ISSN: 1341-9625 [Print] Japan |
PMID | 11723746
(Publication Type: Clinical Trial, Clinical Trial, Phase I, Journal Article)
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Chemical References |
- Taxoids
- Docetaxel
- Doxorubicin
- Paclitaxel
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Topics |
- Adult
- Aged
- Antineoplastic Combined Chemotherapy Protocols
(administration & dosage, adverse effects)
- Breast Neoplasms
(drug therapy)
- Docetaxel
- Doxorubicin
(administration & dosage, adverse effects)
- Drug Administration Schedule
- Female
- Humans
- Middle Aged
- Paclitaxel
(administration & dosage, adverse effects, analogs & derivatives)
- Taxoids
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