Randomized phase II study of two intercalated combinations of eribulin mesylate and erlotinib in patients with previously treated advanced non-small-cell lung cancer.
BACKGROUND
This phase II, open-label study investigated intercalated combinations of eribulin and erlotinib in unselected patients with advanced non-small-cell lung cancer previously treated with platinum-based chemotherapies.


METHODS
Eligible patients were randomized to eribulin mesylate 2.0 mg/m(2) on day 1 with erlotinib 150 mg on days 2-16 (21-day regimen) or eribulin mesylate 1.4 mg/m(2) on days 1 and 8 with erlotinib 150 mg on days 15-28 (28-day regimen). The primary end point was objective response rate (ORR).


RESULTS
One hundred and twenty-three patients received ≥ 1 cycle of therapy (63, 21-day regimen; 60, 28-day regimen). ORRs were 13% [95% confidence interval (CI) 6%-24%] and 17% (95% CI 8%-29%), and disease control rates were 48% (95% CI 35%-61%) and 63% (95% CI 50%-75%) for the 21- and 28-day regimens, respectively. The median progression-free survival and overall survival were similar with both regimens. Both regimens were well tolerated with common grade ≥ 3 toxicities being neutropenia, asthenia/fatigue, and dyspnoea. Sequential administration of erlotinib did not interfere with the pharmacokinetic profile of eribulin.


CONCLUSIONS
Intercalated combination of eribulin and erlotinib demonstrated modest activity and the addition of erlotinib did not appear to improve treatment outcome in an unselected population. The 28-day regimen is suitable for further investigation. Clinicaltrials.gov identifier: NCT01104155.
Department of Clinical Oncology, The Chinese University of Hong Kong, Hong Kong, China tony@clo.cuhk.edu.hk.
T S
TS
Mok
Prince of Songkla University, Songkhla, Thailand.
S L
SL
Geater
Hematology Oncology Associates, Port St Lucie, USA.
N
N
Iannotti
Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand.
S
S
Thongprasert
US Oncology Research, Houston Virginia Cancer Specialists, Fairfax.
A
A
Spira
US Oncology Research, Houston Compass Oncology, Vancouver, USA.
D
D
Smith
Department of Clinical Oncology, The University of Hong Kong, Hong Kong, China.
V
V
Lee
Department of Medical Oncology, National Cancer Centre, Singapore, Republic of Singapore.
W T
WT
Lim
Eisai Inc., Woodcliff Lake, USA.
L
L
Reyderman
Eisai Inc., Woodcliff Lake, USA.
B
B
Wang
Eisai Ltd, Hatfield, UK.
P
P
Gopalakrishna
Eisai Inc., Woodcliff Lake, USA.
F
F
Garzon
Eisai Inc., Woodcliff Lake, USA.
L
L
Xu
US Oncology Research, Houston Ocala Oncology, Ocala, USA.
C
C
Reynolds
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000493:pharmacokinetics / Q000627:therapeutic use*; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000473:pathology; D017024:Chemotherapy, Adjuvant; D018450:Disease Progression; D018572:Disease-Free Survival; D004334:Drug Administration Schedule; D000069347:Erlotinib Hydrochloride; D005260:Female; D005663:Furans / Q000008:administration & dosage* / Q000493:pharmacokinetics; D006801:Humans; D007659:Ketones / Q000008:administration & dosage* / Q000493:pharmacokinetics; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000473:pathology; D008297:Male; D008875:Middle Aged; D011799:Quinazolines / Q000008:administration & dosage* / Q000493:pharmacokinetics; D000095662:Polyether Polyketides
D000069347:Erlotinib Hydrochloride; D005663:Furans; D007659:Ketones; D011799:Quinazolines; C490954:eribulin; D000095662:Polyether Polyketides
biomarker; eribulin; erlotinib; non-small-cell lung cancer; platinum-based doublet chemotherapy