Phase II evaluation of eribulin mesylate (E7389, NSC 707389) in patients with metastatic or recurrent squamous cell carcinoma of the head and neck: Southwest Oncology Group trial S0618.
OBJECTIVE
Eribulin mesylate, an halichondrin B analog, binds to tubulin and microtubules and possesses broad anti-cancer activity. We conducted a multi-institutional Phase II trial to evaluate the response rate of eribulin mesylate in patients with metastatic or recurrent squamous cell carcinoma of the head and neck (SCCHN).


METHODS
Forty eligible patients who had not received prior chemotherapy for metastatic or recurrent SCCHN were enrolled with the following characteristics: 29 male, 11 female; median age 61.2 years; Zubrod Performance Status of 0 (48%) and 1 (53%). Thirty-three patients (83%) had metastatic disease. Primary tumor sites included: 38% oropharynx, 30% lip/oral cavity, 15% larynx, 10% hypopharynx, 5% other/unknown and 3% nasopharynx. Patients received eribulin mesylate at 1.4 mg/m² on Days 1 and 8 of an every 21-day cycle.


RESULTS
Common Grade 3 and 4 toxicities included: lymphopenia (15%), leukocytopenia (13%), neutropenia (10%), hyponatremia (5%), fatigue (5%), diarrhea (5%) and dyspnea (5%), with one treatment-related death due to pulmonary hemorrhage. Among 40 assessable patients, two confirmed partial responses were observed, for an estimated confirmed response rate of 5% (95% confidence interval: 1-17%). The estimated median progression-free survival is 3 months (95% confidence interval: 1-3 months) and estimated median overall survival is 7 months (95% confidence interval: 5-10 months).


CONCLUSIONS
Eribulin mesylate given on Days 1 and 8 of a twenty-one day cycle in metastatic or recurrent SCCHN was well tolerated, but did not result in a clinically significant median PFS. Studies of other agents should be considered in this setting.
Arnold
Susanne M
SM
University of Kentucky, Lexington, KY, USA. smarno0@uky.edu
Moon
James
J
Williamson
Stephen K
SK
Atkins
James N
JN
Ou
Sai-Hong I
SH
LeBlanc
Michael
M
Urba
Susan G
SG
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000970:Antineoplastic Agents / Q000009:adverse effects / Q000737:chemistry / Q000627:therapeutic use*; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy* / Q000473:pathology*; D018572:Disease-Free Survival; D005260:Female; D005663:Furans / Q000009:adverse effects / Q000737:chemistry / Q000627:therapeutic use*; D006258:Head and Neck Neoplasms / Q000188:drug therapy* / Q000473:pathology*; D006801:Humans; D007659:Ketones / Q000009:adverse effects / Q000737:chemistry / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D009362:Neoplasm Metastasis; D016896:Treatment Outcome; D000095662:Polyether Polyketides
D000970:Antineoplastic Agents; D005663:Furans; D007659:Ketones; C490954:eribulin; D000095662:Polyether Polyketides