This Article Full Text Full Text (PDF) eLetters: Submit a response to this article Alert me when this article is cited Alert me when eLetters are posted Alert me if a correction is posted Citation Map Services E-mail this article link to a friend Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Download to citation manager Reprints/Permissions Citing Articles Citing Articles via Google Scholar Google Scholar Articles by Pawlicki, M. Articles by Tomzak, P. Search for Related Content PubMed PubMed Citation Articles by Pawlicki, M. Articles by Tomzak, P.

A Phase II Study of Intravenous Navelbine and Doxorubicin Combination in Previously Untreated Advanced Breast Carcinoma

^a Cancer Institute, Krakow, Poland; ^b Oncology Centre, Krakow, Poland; ^c Oncology Centre, Poznan, Poland; ^d Oncology Centre, Warsaw, Poland; ^e Chorob Pluc i Gruzlicy, Poznan, Poland; ^f Medical Academy, Poznan, Poland

Correspondence: M. Pawlicki, M.D., Medical Oncology Department, Cancer Institute, Garncarska 11, 31-115 Krakow, Poland. Telephone: 48-12-423-10-34; Fax: 48-12-423-15-89.

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/m², and doxorubicin, 25 mg/m², 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.

Key Words. Vinorelbine • Fractionated doxorubicin • First-line • Advanced breast cancer