title: Phase II, Multicenter, Single-Arm, Feasibility Study of Eribulin Combined With Capecitabine for Adjuvant Treatment in Estrogen Receptor-Positive, Early-Stage Breast Cancer.
abstract: BACKGROUND
  The present phase II, open-label, multicenter study explored the feasibility, safety, and tolerability of eribulin, a novel non-taxane microtubule inhibitor, plus capecitabine as adjuvant therapy.
  
  
  METHODS
  Postmenopausal women with early-stage, human epidermal growth factor receptor 2 (HER2)-negative, estrogen-receptor (ER)-positive breast cancer received four 21-day cycles of treatment with eribulin mesylate (1.4 mg/m(2) intravenously on days 1 and 8 of each cycle) combined with capecitabine (900 mg/m(2) orally twice daily on days 1-14 of each cycle [standard schedule] or 1500 mg orally twice daily using a 7-days on/7-days off schedule [weekly schedule]). Feasibility was determined by the relative dose intensity (RDI) of the combination using prespecified criteria for 80% of patients achieving an RDI of ≥ 85%, with a lower 95% confidence boundary > 70%.
  
  
  RESULTS
  The mean RDI was 90.6%, and the feasibility rate was 81.3% among women (n = 67, mean age, 61.3 years) receiving the standard schedule and 95.6% and 100% among women (n = 10, mean age 62.3 years) receiving the weekly schedule. Dose reductions, missed doses, and withdrawals due to adverse events (most commonly hand-foot syndrome) ascribed to capecitabine led to a higher RDI (93.5% vs. 87.8%) and feasibility rate (82.8% vs. 71.9%) for eribulin than for capecitabine using the standard dosing schedule. The most common adverse events were alopecia and fatigue.
  
  
  CONCLUSIONS
  Eribulin plus capecitabine with standard or weekly dosing schedules is feasible in patients with early-stage, HER2-negative, ER-positive breast cancer. Full-dose eribulin (1.4 mg/m(2) on days 1 and 8) with capecitabine (1500 mg orally twice daily, 7 days on/7 days off) is recommended as a regimen for further evaluation.
authors.affiliation: Compass Oncology, The US Oncology Network, Portland, OR. Electronic address: john.smith@usoncology.com.
authors.forename: John W
authors.initials: JW
authors.lastname: Smith
authors.affiliation: Texas Oncology-Tyler, The US Oncology Network, Tyler, TX.
authors.forename: Svetislava
authors.initials: S
authors.lastname: Vukelja
authors.affiliation: Eastchester Center for Cancer Care, Bronx, NY.
authors.forename: Anthony D
authors.initials: AD
authors.lastname: Hoffman
authors.affiliation: Yakima Valley Memorial Hospital-North Star Lodge Cancer Center, Yakima, WA.
authors.forename: Vicky E
authors.initials: VE
authors.lastname: Jones
authors.affiliation: Texas Oncology-Dallas Presbyterian Hospital, The US Oncology Network, Dallas, TX.
authors.forename: Kristi
authors.initials: K
authors.lastname: McIntyre
authors.affiliation: Eisai Inc., Woodcliff Lake, NJ.
authors.forename: Erhan
authors.initials: E
authors.lastname: Berrak
authors.affiliation: Eisai Inc., Woodcliff Lake, NJ.
authors.forename: James X
authors.initials: JX
authors.lastname: Song
authors.affiliation: Texas Oncology-Baylor Charles A. Sammons Cancer Center, The US Oncology Network, Dallas, TX.
authors.forename: Joyce
authors.initials: J
authors.lastname: O'Shaughnessy
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy*; D000069287:Capecitabine / Q000008:administration & dosage / Q000009:adverse effects; D017024:Chemotherapy, Adjuvant / Q000379:methods*; D005240:Feasibility Studies; D005260:Female; D005663:Furans / Q000008:administration & dosage / Q000009:adverse effects; D006801:Humans; D007659:Ketones / Q000008:administration & dosage / Q000009:adverse effects; D008875:Middle Aged; D009367:Neoplasm Staging; D017698:Postmenopause; D000095662:Polyether Polyketides
chemical_list: D000069287:Capecitabine; D005663:Furans; D007659:Ketones; C490954:eribulin; D000095662:Polyether Polyketides
keywords: Adjuvant therapy; Chemotherapy; ER-positive; HER2-negative; Halaven