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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