T S Mok1, S L Geater2, N Iannotti3, S Thongprasert4, A Spira5, D Smith6, V Lee7, W T Lim8, L Reyderman9, B Wang9, P Gopalakrishna10, F Garzon9, L Xu9, C Reynolds11. 1. Department of Clinical Oncology, The Chinese University of Hong Kong, Hong Kong, China tony@clo.cuhk.edu.hk. 2. Prince of Songkla University, Songkhla, Thailand. 3. Hematology Oncology Associates, Port St Lucie, USA. 4. Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand. 5. US Oncology Research, Houston Virginia Cancer Specialists, Fairfax. 6. US Oncology Research, Houston Compass Oncology, Vancouver, USA. 7. Department of Clinical Oncology, The University of Hong Kong, Hong Kong, China. 8. Department of Medical Oncology, National Cancer Centre, Singapore, Republic of Singapore. 9. Eisai Inc., Woodcliff Lake, USA. 10. Eisai Ltd, Hatfield, UK. 11. US Oncology Research, Houston Ocala Oncology, Ocala, USA.
Abstract
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 withplatinum-based chemotherapies. PATIENTS AND 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. CONCLUSION: 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.
RCT Entities:
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. PATIENTS AND 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. CONCLUSION: 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.
Authors: N Katakami; E Felip; D R Spigel; J-H Kim; M Olivo; M Guo; H Nokihara; J C-H Yang; N Iannotti; M Satouchi; F Barlesi Journal: Ann Oncol Date: 2017-09-01 Impact factor: 32.976