Eribulin mesylate (halichondrin B analog E7389) in platinum-resistant and platinum-sensitive ovarian cancer: A 2-cohort, phase 2 study Journal Article


Authors: Hensley, M. L.; Kravetz, S.; Jia, X.; Iasonos, A.; Tew, W.; Pereira, L.; Sabbatini, P.; Whalen, C.; Aghajanian, C. A.; Zarwan, C.; Berlin, S.
Article Title: Eribulin mesylate (halichondrin B analog E7389) in platinum-resistant and platinum-sensitive ovarian cancer: A 2-cohort, phase 2 study
Abstract: BACKGROUND: Eribulin mesylate is a tubulin inhibitor with activity superior to paclitaxel in NIH:OVCAR-3 human epithelial ovarian cancer xenograft models. In this study, the authors assessed the efficacy of eribulin in platinum-resistant and platinum-sensitive recurrent ovarian cancer. METHODS: Patients with recurrent, measurable epithelial ovarian cancer who had received ≤2 prior cytotoxic regimens and who had adequate organ function were enrolled into 2 separate cohorts: 1) platinum-resistant patients (who had a progression-free interval <6 months after their last platinum-based therapy) and 2) platinum-sensitive patients (who had a progression-free interval a 6 months after their last platinum-based therapy). Eribulin 1.4 mg/m;b was administered over 15 minutes intravenously on days 1 and 8 every 21 days. Efficacy was determined by objective response on computed tomography studies. RESULTS: In the platinum-resistant cohort, 37 patients enrolled, and 36 patients were evaluable for response and toxicity. Two patients achieved a partial response (5.5%), and 16 patients (44%) had stable disease as their best response. The median progression-free survival was 1.8 months (95% confidence interval, 1.4-2.8 months). In the platinum-sensitive cohort, 37 patients enrolled, and all were evaluable for response. Seven patients achieved a partial response (19%). The median progression-free survival was 4.1 months (95% confidence interval, 2.8-5.8 months). The major toxicity was grade 3 or 4 neutropenia (42% of platinum-resistant patients; 54% of platinum-sensitive patients). CONCLUSIONS: Eribulin produced an objective response in 5.5% of women with platinum-resistant, recurrent ovarian cancer and in 19% of women with platinum-sensitive disease. The median progression-free survival was 1.8 months in the platinum-resistant group and 4.1 months in the platinum-sensitive group. Copyright © 2011 American Cancer Society.
Keywords: adult; cancer survival; clinical article; treatment response; aged; overall survival; neutropenia; cancer recurrence; cisplatin; cancer combination chemotherapy; diarrhea; drug efficacy; hypophosphatemia; side effect; treatment duration; gemcitabine; paclitaxel; topotecan; ovarian cancer; carboplatin; progression free survival; infection; ovary cancer; pain; anemia; leukopenia; clinical assessment; recurrence; docetaxel; febrile neutropenia; hyperglycemia; hypomagnesemia; lymphocytopenia; pneumonia; hypokalemia; hyponatremia; thrombosis; urinary tract infection; muscle weakness; platinum; ca 125 antigen; pemetrexed; ataxia; cytopenia; eribulin; phase 2
Journal Title: Cancer
Volume: 118
Issue: 9
ISSN: 0008-543X
Publisher: Wiley Blackwell  
Date Published: 2012-05-01
Start Page: 2403
End Page: 2410
Language: English
DOI: 10.1002/cncr.26569
PROVIDER: scopus
PMCID: PMC3245795
PUBMED: 21935916
DOI/URL:
Notes: --- - "Export Date: 4 June 2012" - "CODEN: CANCA" - "Source: Scopus"
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MSK Authors
  1. Xiaoyu Jia
    44 Jia
  2. Paul J Sabbatini
    199 Sabbatini
  3. Alexia Elia Iasonos
    179 Iasonos
  4. Martee L Hensley
    220 Hensley
  5. William P Tew
    122 Tew