Norris Cotton Cancer Center and Dartmouth-Hitchcock Medical Center, Lebanon, NH
Peter Kaufman , Chris Twelves , Javier Cortes , Linda T. Vahdat , Martin Olivo , Yi He , Ahmad Awada
Background: Eribulin (E) has been assessed in two phase 3, open-label trials in pts with locally recurrent or MBC progressing after an anthracycline (A) and taxane (T). E significantly increased overall survival (OS) compared with treatment of physician’s choice (TPC) in one study (EMBRACE) and there was a non-significant trend for improved OS with E vs capecitabine (cape) in the other (Study 301). We present an unplanned pooled analysis of these data. Methods: In the EMBRACE trial, women had received 2–5 lines of chemotherapy for advanced disease. In this ≥ 3rd line setting, pts were randomized 2:1 to E mesylate (1.4 mg/m2 iv on days 1 and 8 every 21 days) or TPC. In study 301, pts who had received 0-2 prior chemotherapies for advanced disease were randomized 1:1 to either E (as above) or cape (1.25 g/m2orally b.i.d. days 1–14 every 21 days). We analysed OS by 2-sided stratified log-rank tests and Cox regression in the overall intent-to-treat population and in the HER2-, triple negative (TNBC) and HER2+ subgroups. Results: 1,864 pts (median age 54 yrs) were included; most had been treated in the 2nd (31.5%) or 3rd line (32.7%) MBC settings. Overall, E provided significantly improved OS vs control; this benefit was also significant in HER2− and TNBC, but not HER2+ pts (Table). E improved progression-free survival overall (4.0 vs 3.4 months, HR = 0.90, 95%CI = 0.81, 0.997, p = 0.046), in HER2– (3.7 vs 3.0 months, HR = 0.84, 95%CI = 0.74, 0.95, p = 0.006) and TNBC pts (2.8 vs 2.6 months, HR = 0.78, 95%CI = 0.63, 0.96, p= 0.018). As reported before, the E safety profile was similar in the studies. Conclusions: E significantly improved OS vs standard therapies in MBC pts with HER2− and TNBC in this pooled analysis; in pts with HER2+ disease the difference did not reach statistical significance but numbers were smaller. Clinical trial information: NCT00337103 and NCT00388726.
Overall |
HER2- |
HER2+ |
TNBC |
|||||
---|---|---|---|---|---|---|---|---|
E | Con | E | Con | E | Con | E | Con | |
n | 1062 | 802 | 748 | 572 | 169 | 123 | 243 | 185 |
Median OSa, months | 15.2 | 12.8 | 15.2 | 12.3 | 13.5 | 12.2 | 12.9 | 8.2 |
HR (95%CI)b | 0.85 (0.77, 0.95) | 0.82 (0.72, 0.93) | 0.82 (0.62, 1.06) | 0.74 (0.60, 0.92) | ||||
pb | 0.003 | 0.002 | 0.135 | 0.006 |
Abbreviations: Con, control; E, eribulin; HR, hazard ratio. aBased on survival curve adjusted by study; bStratified by geographic region, prior cape use and study (plus HER2 status [overall] and TNBC [HER2-]).
Disclaimer
This material on this page is ©2024 American Society of Clinical Oncology, all rights reserved. Licensing available upon request. For more information, please contact licensing@asco.org
Abstract Disclosures
2014 ASCO Annual Meeting
First Author: Chris Twelves
2021 ASCO Annual Meeting
First Author: Kelvin K H Bao
2020 ASCO Virtual Scientific Program
First Author: In Hae Park
2023 ASCO Annual Meeting
First Author: Qamar J. Khan