In:
Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 35, No. 15_suppl ( 2017-05-20), p. 1082-1082
Abstract:
1082 Background: PG chemotherapy is one of the preferred chemotherapeutic regimens for patients with MBC. Eribulin mesylate is a non-taxane inhibitor of microtubule dynamics of the halichondrin class. A recent pooled analysis with eribulin showed improved overall survival (OS) in various patient subgroups. Furthermore, eribulin may have rational benefit compared with paclitaxel in terms of neurotoxicity. Methods: This study was a prospective randomized phase 2, open-label, two-arm, multi-center study comparing EG with PG chemotherapy for patients with HER-2 negative MBC as first-line treatment. Histologically confirmed breast cancer patients, at least 19 years of age, with no prior history of chemotherapy for MBC with evaluable lesions were included. Prior hormonal therapy as a treatment of Hormone Receptor (HR)-positive MBC was allowed. This design was hypothesized that EG chemotherapy would not be inferior to PG chemotherapy. The primary endpoint was Progression-Free Survival (PFS). Estimated 6 mo. PFS rate for each arm was 70%. The secondary endpoints were: Time to Treatment Failure (TTF); OS; neuropathic scale; toxicity; clinical benefit rate. Results: A total of 118 patients (median age: 50, 24-66) were enrolled between 2015 and 2016, and were randomly assigned to PG (n = 59) or EG (n = 59) chemotherapy. Mean number of metastatic sites was 3 (1-8). Six month PFS rates for both arms were 72% for EG and 73% for PG arm (p = 0.457). PFS in PG arm tends to be longer than in EG group (median PFS 12.6 for PG vs. 9.6 months for EG) without statistical significance. In addition, there was no significant difference in OS between the two groups (not reached vs. 21.2 months, p = 0.223). The median numbers of chemotherapy cycles of both groups were 8 for EG and 10 for PG (range 2-32). CBRs were 44% for EG and 45% for PG arm. Major toxicities were neutropenia and neurotoxicity. Grade II or more neurotoxicity was more common in PG than in EG group (40% vs.25%). Conclusions: EG chemotherapy showed similar clinical benefit with PG chemotherapy in terms of PFS but, more favorable neurotoxicity than PG chemotherapy. Clinical trial information: NCT02263495.
Type of Medium:
Online Resource
ISSN:
0732-183X
,
1527-7755
DOI:
10.1200/JCO.2017.35.15_suppl.1082
Language:
English
Publisher:
American Society of Clinical Oncology (ASCO)
Publication Date:
2017
detail.hit.zdb_id:
2005181-5
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