A Randomized Feasibility Study of Docetaxel Versus Vinorelbine in Advanced Breast Cancer

Abstract

Access the full results at: Palmieri_Alitrangis-12-161.theoncologist.com 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 ϭ .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 ϭ .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

Second-line single-agent chemotherapy in human epidermal growth factor receptor 2-negative metastatic breast cancer: A systematic review

“…Of the 14 second-and/or later-line papers, five [19][20][21][22][23] reported data for a purely second-line patient population, three [24][25][26] reported data from mixed-line treatment but provided results for the second-line subgroup separately, three [27][28][29] had unclear second-line status (i.e. it was unclear whether the previous therapy had been given in the adjuvant or metastatic setting), two [30,31] reported data from second-or later-line patients, and one [32] reported data from a second-or later-line subgroup separately. The categorisation of the other 39 RCTs as first-or later-line (mixed) patients has been tabulated (data not shown, available on request).…”

“…No benefit in terms of TTP was demonstrated for doxorubicin + vinorelbine vs doxorubicin monotherapy (TTP 4.3 vs 5.3 months, respectively) [24], for pegylated liposomal doxorubicin vs vinorelbine or mitomycin C + vinblastine (p>0.05) [31], for 3-weekly docetaxel vs vinorelbine (2.4 vs 1.7 months, respectively; p=0.82) [30], or for epirubicin vs epirubicin + vindesine (TTP 6 months in both treatment arms) [25].…”

“…The primary endpoint was OS in two trials [26,30], PFS in four [19,27,29,31], overall response in three [23,28,32] and not reported in five papers published between 1990 and 2000 [20-22, 24, 25] ( Table 1). Safety/toxicity was typically a secondary endpoint, amongst others.…”

“…Papadimitriou et al, 2009 [23] enrolled unselected patients reporting that 21-24% were HER2+, 29-34% HER2negative, and 34-42% of unknown HER2 status. Palmieri et al, 2012[30] also enrolled unselected patients but did not report their HER2 status. The other nine trials did not report HER2 status[20-22, 24-26, 28, 31, 32].…”

Eribulin mesylate: A new therapeutic option for metastatic breast cancer

“…[12] A recent trial comparing docetaxel with vinorelbine in anthracycline pre-treated disease showed lower response rates with vinorelbine as compared to docetaxel, though hematological adverse effects were ten-fold greater with docetaxel. [13] Most of these chemotherapeutic agents have not demonstrated an impact on survival in patients. [14] A recent trial showed that ixabepilone plus capecitabine significantly improves progression-free survival (PFS) compared with capecitabine alone in anthracycline-, taxane-pre-treated, or resistant patients.…”