Open AccessA Phase II Study of Intravenous Navelbine and Doxorubicin Combination in Previously Untreated Advanced Breast Carcinoma
Author(s) -
Pawlicki M.,
Rolski J.,
Zaluski J.,
Siedlecki P.,
Ramlau C.,
Tomzak P.
Publication year - 2002
Publication title -
the oncologist
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.176
H-Index - 164
eISSN - 1549-490X
pISSN - 1083-7159
DOI - 10.1634/theoncologist.7-3-205
Subject(s) - medicine , vinorelbine , doxorubicin , neutropenia , nausea , metastatic breast cancer , vomiting , cumulative dose , breast cancer , toxicity , chemotherapy , phases of clinical research , oncology , cancer , gastroenterology , surgery , cisplatin
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 and Methods . 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.