A phase II study of intravenous navelbine and doxorubicin combination in previously untreated advanced breast carcinoma.
Oncologist
; 7(3): 205-9, 2002.
Article
in En
| MEDLINE
| ID: mdl-12065792
ABSTRACT
PURPOSE:
The combination of vinorelbine and doxorubicin, two very active drugs in metastatic breast cancer, has demonstrated impressive results in terms of efficacy, at the price of cardiac toxicity (10% grades 2-4) due to the cumulative dose of doxorubicin delivered. This study was designed to divide the dose of doxorubicin into two administrations (day 1 and 8) in order to reduce the toxicity profile, while keeping the same level of efficacy. PATIENTS ANDMETHODS:
Thirty-eight chemotherapy-naïve metastatic breast cancer patients entered into the study and were treated with vinorelbine, 25 mg/m(2), and doxorubicin, 25 mg/m(2), both on days 1 and 8, every 3 weeks. Thirty-seven patients were evaluable for efficacy and 38 for tolerance; 71% of the patients presented with visceral metastases.RESULTS:
Patients received a median of seven cycles and 94.9% of the intended dose intensity of both drugs. Grade 3-4 neutropenia was reported in 10% of cycles. Alopecia was reported in 89.5% of the patients, and grade 2 nausea/vomiting in 9.3% of the cycles. Grade 1-2 cardiac toxicity was noted in 23.7% of the patients. The objective response rate of the patients was 78.4% (nearly 81% for patients with visceral metastases); the median duration of response was 11.6 months, the median survival 21.6 months, and the 1-year survival 75.2%.CONCLUSION:
This schedule of vinorelbine/doxorubicin represents an active and well-tolerated combination.
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Collection:
01-internacional
Database:
MEDLINE
Main subject:
Vinblastine
/
Breast Neoplasms
/
Carcinoma
/
Antineoplastic Combined Chemotherapy Protocols
/
Breast Neoplasms, Male
Limits:
Adult
/
Aged
/
Female
/
Humans
/
Male
/
Middle aged
Language:
En
Journal:
Oncologist
Journal subject:
NEOPLASIAS
Year:
2002
Document type:
Article
Affiliation country:
Poland