Open AccessA Randomized Feasibility Study of Docetaxel Versus Vinorelbine in Advanced Breast Cancer
Author(s) -
Palmieri Carlo,
Alifrangis Constantine,
Shipway David,
Tat Tri,
Watson Vivienne,
Mackie Diane,
Emson Marie,
Coombes R. Charles
Publication year - 2012
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.2012-0161
Subject(s) - medicine , docetaxel , vinorelbine , oncology , breast cancer , randomized controlled trial , cancer , chemotherapy , cisplatin
Background. Docetaxel and vinorelbine have demonstrated efficacy in the treatment of metastatic breast cancer (MBC). This prospective feasibility study compared the efficacy of these two treatments in MBC. Methods. Patients with MBC progressing following anthracycline treatment were randomly assigned to either docetaxel (100 mg/m 2 day 1 q3W) or vinorelbine (25 mg/m 2 day 1 q2W). Patients were eligible to cross over at progression. Objective response rates (ORR), time to progression (TTP), and overall survival (OS) were measured. Results. Thirty‐seven patients were randomized. Two patients were excluded due to protocol violations. Of 35 remaining patients, 17 received docetaxel and 18 received vinorelbine per protocol. ORR was 12.5% and 6.0%, respectively, for docetaxel and vinorelbine. The median time to progression was 10.4 weeks (range, 6–14 weeks) in docetaxel arm and 7.6 weeks (range, 4–11 weeks) in vinorelbine arm ( p = .82). The clinical benefit rate (defined as complete response, partial response plus stable disease) was 44% in the docetaxel arm and 12% in the vinorelbine arm. Based on intent to treat, the median OS in the docetaxel arm was 34 weeks (95% CI, 20.7–48) and 21.2 weeks (95% CI, 17–25.4) in vinorelbine arm ( p = .388). Sixteen patients crossed over, 5 from docetaxel to vinorelbine and 11 from vinorelbine to docetaxel. At crossover, the ORR was 0% and 18% on crossover to vinorelbine and docetaxel, respectively, with a median TTP of 17.3 weeks (95% CI, 16.3–18.1) and 18.7 weeks (95% CI, 13.9–23.4) for those receiving vinorelbine and docetaxel at crossover, respectively. Vinorelbine, however, was much better tolerated with fewer grade 3–4 toxicity events ( n = 4) than docetaxel ( n = 27).