| Title |
|
|
|
UCBG 2-08: 5-year efficacy results from the UNICANCER-PACS08 randomised phase III trial of adjuvant treatment with FEC100 and then either docetaxel or ixabepilone in patients with early-stage, poor prognosis breast cancer
| |
| Author |
|
|
|
| |
| Abstract |
|
|
|
| Purpose: UNICANCER-PACS08 compared adjuvant FEC (5-FU; epirubicin; cyclophosphamide) then docetaxel to FEC then ixabepilone in poor prognosis early breast cancer (BC). We evaluated whether replacing docetaxel with ixabepilone would increase 5-year disease-free survival (DFS). Patients and methods: Triple-negative breast cancer (TNBC) or oestrogen receptor (ER) +/progesterone receptor (PR) -/HER2- BC patients were randomised to receive standard FEC (3 cycles) followed by 3 cycles of either docetaxel (100 mg/m(2)) or ixabepilone (40 mg/m 2). Radiotherapy was mandatory after conservative surgery; ER+ patients received endocrine therapy. Results: Seven hundred sixty-two patients were enrolled between October 2007 and September 2010. Baseline characteristics were balanced between arms. Median follow-up was 66.7 months. Median DFS was not reached; 5-year DFS rate was 76% with docetaxel and 79% with ixabepilone (hazard ratio [HR] = 0.80; 95% confidence interval [CI] = 0.58-1.10; p = 0.175). Median overall survival (OS) was not reached; 5-year OS rate was 86% versus 84% (HR = 0.97; 95% CI = 0.66-1.42; p = 0.897). TNBC patients treated with ixabepilone had a 23% lower risk of relapse compared to docetaxel (HR for DFS = 0.77; 95% CI = 0.53-1.11; p = 0.168). DFS was longer with ixabepilone than docetaxel in patients with grade II-III lymphocytic infiltration (HR = 0.55; 95% CI = 0.29-1.05; p = 0.063). All patients experienced >= 1 adverse events (AEs): 75% reported grade III-IV AEs and two (<1%) had grade V AEs (both with neutropenia and infection receiving ixabepilone). Conclusion: After adjuvant FEC, ixabepilone was comparable to docetaxel for treating poor prognosis early BC patients. The benefit of ixabepilone in subgroups (patients with TNBC and grade II-III lymphocytic infiltration) requires further evaluation. (C) 2018 Elsevier Ltd. All rights reserved. |
| |
| Language |
|
|
|
English
| |
| Source (journal) |
|
|
|
European journal of cancer. - Oxford, 1990, currens | |
| Publication |
|
|
|
Oxford : 2018
| |
| ISSN |
|
|
|
0959-8049 [print]
1879-0852 [online]
| |
| Volume/pages |
|
|
|
103(2018), p. 184-194
| |
| ISI |
|
|
|
000447292100023
| |
| Pubmed ID |
|
|
|
30267987
| |
| Full text (Publisher's DOI) |
|
|
| | |
| Full text (publisher's version - intranet only) |
|
|
| | |
|