PMID- 29202787 OWN - NLM STAT- MEDLINE DCOM- 20180723 LR - 20181113 IS - 1471-2407 (Electronic) IS - 1471-2407 (Linking) VI - 17 IP - 1 DP - 2017 Dec 4 TI - Efficacy and safety of eribulin in patients with locally advanced or metastatic breast cancer not meeting trial eligibility criteria: a retrospective study. PG - 819 LID - 10.1186/s12885-017-3846-8 [doi] LID - 819 AB - BACKGROUND: The efficacy and safety of eribulin in patients with locally advanced or metastatic breast cancer has been demonstrated in phase III trials. However, as patients receiving eribulin in daily practice do not necessarily meet all the eligibility criteria of clinical trials, data for such patients are limited. METHODS: We identified patients with locally advanced or metastatic breast cancer, treated with eribulin monotherapy between July 2011 and December 2015 at the National Cancer Center Hospital, Tokyo, Japan. Patients who would have met the following eligibility criteria from the EMBRACE trial were included in the eligible group, and the rest were included in the ineligible group: 1) Eastern Cooperative Oncology Group Performance status 0-2; 2) adequate function of principal organs; and 3) absence of active infection. We compared the relative dose intensity (RDI), tumor response, progression-free survival (PFS), overall survival (OS), and adverse events between the groups. Nominal and continuous values were compared using the Fisher's exact test and Mann-Whitney U test, respectively. Survival outcomes were determined using Kaplan-Meier estimation, and between-group differences were assessed using the log-rank test. RESULTS: Of the 203 patients included, 34 were classified into the ineligible group and 169 into the eligible group. Initial dose reduction and treatment discontinuation due to adverse events (AEs) were more common in the ineligible group (initial dose reduction: 23.5% in the ineligible group vs. 7.7% in the eligible group, p = 0.011; treatment discontinuation due to AEs: 11.8% vs. 3.0%, p = 0.045). However, RDI (66% vs. 71%, p = 0.130), response rate (15.6% vs. 18.1%, p = 1.000), PFS (3.7 months vs. 4.0 months, p = 0.913), OS (11.5 months vs. 16.1 months, p = 0.743), AEs requiring hospitalization (5.9% vs. 6.5%, p = 1.000), and grade 3/4 AEs were similar in both groups. PFS, OS, AEs requiring hospitalization, and discontinuation due to AEs in the eligible group were comparable to those found in previous phase III trials. CONCLUSION: The safety and efficacy of eribulin monotherapy was demonstrated in a broader patient population than that eligible for clinical trials. Eribulin may be a treatment option in these patients with locally advanced or metastatic breast cancer, considering dose reduction and pre-existing dysfunctions. FAU - Iizumi, Sakura AU - Iizumi S AD - Department of Breast and Medical Oncology, National Cancer Center Hospital, 5-1-1 Tsukiji, Chuo-ku, Tokyo, 104-0045, Japan. AD - Keio University Graduate School of Medicine, 160 Shinanomachi, Shinjuku-ku, Tokyo, 160-8582, Japan. FAU - Shimoi, Tatsunori AU - Shimoi T AUID- ORCID: 0000-0002-3603-8575 AD - Department of Breast and Medical Oncology, National Cancer Center Hospital, 5-1-1 Tsukiji, Chuo-ku, Tokyo, 104-0045, Japan. tshimoi@ncc.go.jp. AD - Course of Advanced Clinical Research of Cancer, Juntendo University Graduate School of Medicine, 3-1-3 Hongoh, bunkyo-ku, Tokyo, 113-0033, Japan. tshimoi@ncc.go.jp. FAU - Tsushita, Natsuko AU - Tsushita N AD - Department of Breast and Medical Oncology, National Cancer Center Hospital, 5-1-1 Tsukiji, Chuo-ku, Tokyo, 104-0045, Japan. FAU - Bun, Seiko AU - Bun S AD - Department of Pharmacy, National Cancer Center Hospital, 5-1-1 Tsukiji, Chuo-ku, Tokyo, 104-0045, Japan. FAU - Shimomura, Akihiko AU - Shimomura A AD - Department of Breast and Medical Oncology, National Cancer Center Hospital, 5-1-1 Tsukiji, Chuo-ku, Tokyo, 104-0045, Japan. FAU - Noguchi, Emi AU - Noguchi E AD - Department of Breast and Medical Oncology, National Cancer Center Hospital, 5-1-1 Tsukiji, Chuo-ku, Tokyo, 104-0045, Japan. FAU - Kodaira, Makoto AU - Kodaira M AD - Department of Medical Oncology, Kodaira Hospital, 20-16 Sasameminamicho, Toda city, Saitama, 335-0035, Japan. FAU - Yunokawa, Mayu AU - Yunokawa M AD - Department of Breast and Medical Oncology, National Cancer Center Hospital, 5-1-1 Tsukiji, Chuo-ku, Tokyo, 104-0045, Japan. FAU - Yonemori, Kan AU - Yonemori K AD - Department of Breast and Medical Oncology, National Cancer Center Hospital, 5-1-1 Tsukiji, Chuo-ku, Tokyo, 104-0045, Japan. FAU - Shimizu, Chikako AU - Shimizu C AD - Department of Breast and Medical Oncology, National Cancer Center Hospital, 5-1-1 Tsukiji, Chuo-ku, Tokyo, 104-0045, Japan. FAU - Fujiwara, Yasuhiro AU - Fujiwara Y AD - Department of Breast and Medical Oncology, National Cancer Center Hospital, 5-1-1 Tsukiji, Chuo-ku, Tokyo, 104-0045, Japan. FAU - Tamura, Kenji AU - Tamura K AD - Department of Breast and Medical Oncology, National Cancer Center Hospital, 5-1-1 Tsukiji, Chuo-ku, Tokyo, 104-0045, Japan. LA - eng PT - Journal Article DEP - 20171204 PL - England TA - BMC Cancer JT - BMC cancer JID - 100967800 RN - 0 (Antineoplastic Agents) RN - 0 (Furans) RN - 0 (Ketones) RN - LR24G6354G (eribulin) SB - IM MH - Adult MH - Aged MH - Aged, 80 and over MH - Antineoplastic Agents/adverse effects/*therapeutic use MH - Breast Neoplasms/*drug therapy/mortality/pathology MH - Disease-Free Survival MH - Furans/adverse effects/*therapeutic use MH - Humans MH - Kaplan-Meier Estimate MH - Ketones/adverse effects/*therapeutic use MH - Liver Neoplasms/*drug therapy/mortality/pathology MH - Middle Aged MH - Patient Selection MH - Retrospective Studies MH - Treatment Outcome PMC - PMC5716387 OTO - NOTNLM OT - Breast cancer OT - Efficacy OT - Eribulin OT - Safety COIS- ETHICS APPROVAL AND CONSENT TO PARTICIPATE: This study was approved by the National Cancer Center Institutional Review Board (No. 2016-122). Written informed consent was not obtained because of the retrospective nature of this study. This study was publicized via the web page of the hospital. CONSENT FOR PUBLICATION: Not applicable. COMPETING INTERESTS: The authors declare that they have no competing interests. PUBLISHER'S NOTE: Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations. EDAT- 2017/12/06 06:00 MHDA- 2018/07/24 06:00 PMCR- 2017/12/04 CRDT- 2017/12/06 06:00 PHST- 2017/04/02 00:00 [received] PHST- 2017/11/24 00:00 [accepted] PHST- 2017/12/06 06:00 [entrez] PHST- 2017/12/06 06:00 [pubmed] PHST- 2018/07/24 06:00 [medline] PHST- 2017/12/04 00:00 [pmc-release] AID - 10.1186/s12885-017-3846-8 [pii] AID - 3846 [pii] AID - 10.1186/s12885-017-3846-8 [doi] PST - epublish SO - BMC Cancer. 2017 Dec 4;17(1):819. doi: 10.1186/s12885-017-3846-8.