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Conference Paper: Phase II study of two eribulin regimens in combination with erlotinib in patients (PTS) with previously treated advanced non-small cell lung cancer (NSCLC)

TitlePhase II study of two eribulin regimens in combination with erlotinib in patients (PTS) with previously treated advanced non-small cell lung cancer (NSCLC)
Authors
KeywordsMedical sciences
Oncology
Issue Date2012
PublisherOxford University Press. The Journal's web site is located at http://annonc.oxfordjournals.org/
Citation
The 37th Congress of the European Society for Medical Oncology (ESMO 2012), Vienna, Austria, 28 September-2 October 2012. In Annals of Oncology, 2012, v. 23 suppl. 9, p. ix393, abstract no. 1205P How to Cite?
AbstractBACKGROUND: Eribulin, a microtubule dynamics inhibitor, is approved for pts with locally advanced/metastatic breast cancer that progressed after ≥2 chemotherapeutic regimens for advanced disease. Prior therapy should have included an anthracycline and taxane unless not suitable. This randomized, multicenter study compared efficacy and tolerability of two eribulin regimens administered sequentially with erlotinib in pts with advanced NSCLC to establish an optimal dosing schedule. METHODS: Pts (ECOG ≤2; ≥1 prior anti-cancer therapy for advanced NSCLC including ≥1 platinum-based therapy) received 2.0 mg/m2 eribulin mesilate (2-5 min IV) on Day (D) 1 and 150 mg oral erlotinib on D2-16 (21D cycle), or 1.4 mg/m2 eribulin mesilate on D1 and D8 and 150 mg erlotinib on D15-28 (28D cycle). Primary endpoint was objective response rate (ORR); secondary endpoints were progression-free survival (PFS), overall survival (OS), disease control rate (DCR), safety, pharmacokinetics and biomarker (BM) assessment. RESULTS: 123 pts were treated (63 pts 21D cycle, 60 pts 28D cycle). Median age was 63 years (range 35-87), 53.7% male, 75.6% smokers, 65.9% stage IV disease and 91.1% ≥2 prior therapy for advanced NSCLC. ORR was 12.7% (21D) and 16.7% (28D); other efficacy parameters were also greater with the 28D cycle. Concomitant administration of erlotinib did not affect eribulin exposure and was well tolerated with no unexpected toxicities. BM analysis supported overall results. CONCLUSIONS: Both regimens were associated with moderate activity in this heavily pre-treated population. The 28D regimen appears to have greater activity and less toxicity than the 21D. Disclosure: S. Thongprasert: The author declares the following conflicts of interest: consultant/advisory role (Novartis/Pfizer/Eli Lilly), honoraria (AstraZeneca/Roche), and research funding (Novartis/Pfizer/Roche). D. Smith: The author declares the following conflicts of interest: research funding (Eisai). P. Gopalakrishna: The author declares the following conflicts of interest: employee (Eisai Ltd. C. Reynolds: The author declares the following conflicts of interest: honoraria/speakers bureau (Eisai). T.S.K. Mok: Consultant/advisory role (AstraZeneca /Pfizer/Eli Lilly/Roche/Merck Serono/Eisai/BMS/BeiGene/AVEO/Taiho/BI), honoraria (AstraZeneca/Roche Pfizer/Eli Lilly/ Merck Serono/Eisai/BMS/BeiGene/AVEO /Taiho/BI), research funding (AstraZeneca). All other authors have declared no conflicts of interest.
DescriptionThis journal suppl. entitled: Abstract Book of the 37th ESMO Congress ... 2012
Persistent Identifierhttp://hdl.handle.net/10722/194785
ISSN
2015 Impact Factor: 9.269
2015 SCImago Journal Rankings: 4.362

 

DC FieldValueLanguage
dc.contributor.authorGeater, SLen_US
dc.contributor.authorIanotti, Nen_US
dc.contributor.authorThongprasert, Sen_US
dc.contributor.authorSpira, Aen_US
dc.contributor.authorSmith, Den_US
dc.contributor.authorLee, Ven_US
dc.contributor.authorLim, WTen_US
dc.contributor.authorGopalakrishna, Pen_US
dc.contributor.authorReynolds, Cen_US
dc.contributor.authorMok, TSKen_US
dc.date.accessioned2014-02-17T02:09:50Z-
dc.date.available2014-02-17T02:09:50Z-
dc.date.issued2012en_US
dc.identifier.citationThe 37th Congress of the European Society for Medical Oncology (ESMO 2012), Vienna, Austria, 28 September-2 October 2012. In Annals of Oncology, 2012, v. 23 suppl. 9, p. ix393, abstract no. 1205Pen_US
dc.identifier.issn0923-7534-
dc.identifier.urihttp://hdl.handle.net/10722/194785-
dc.descriptionThis journal suppl. entitled: Abstract Book of the 37th ESMO Congress ... 2012-
dc.description.abstractBACKGROUND: Eribulin, a microtubule dynamics inhibitor, is approved for pts with locally advanced/metastatic breast cancer that progressed after ≥2 chemotherapeutic regimens for advanced disease. Prior therapy should have included an anthracycline and taxane unless not suitable. This randomized, multicenter study compared efficacy and tolerability of two eribulin regimens administered sequentially with erlotinib in pts with advanced NSCLC to establish an optimal dosing schedule. METHODS: Pts (ECOG ≤2; ≥1 prior anti-cancer therapy for advanced NSCLC including ≥1 platinum-based therapy) received 2.0 mg/m2 eribulin mesilate (2-5 min IV) on Day (D) 1 and 150 mg oral erlotinib on D2-16 (21D cycle), or 1.4 mg/m2 eribulin mesilate on D1 and D8 and 150 mg erlotinib on D15-28 (28D cycle). Primary endpoint was objective response rate (ORR); secondary endpoints were progression-free survival (PFS), overall survival (OS), disease control rate (DCR), safety, pharmacokinetics and biomarker (BM) assessment. RESULTS: 123 pts were treated (63 pts 21D cycle, 60 pts 28D cycle). Median age was 63 years (range 35-87), 53.7% male, 75.6% smokers, 65.9% stage IV disease and 91.1% ≥2 prior therapy for advanced NSCLC. ORR was 12.7% (21D) and 16.7% (28D); other efficacy parameters were also greater with the 28D cycle. Concomitant administration of erlotinib did not affect eribulin exposure and was well tolerated with no unexpected toxicities. BM analysis supported overall results. CONCLUSIONS: Both regimens were associated with moderate activity in this heavily pre-treated population. The 28D regimen appears to have greater activity and less toxicity than the 21D. Disclosure: S. Thongprasert: The author declares the following conflicts of interest: consultant/advisory role (Novartis/Pfizer/Eli Lilly), honoraria (AstraZeneca/Roche), and research funding (Novartis/Pfizer/Roche). D. Smith: The author declares the following conflicts of interest: research funding (Eisai). P. Gopalakrishna: The author declares the following conflicts of interest: employee (Eisai Ltd. C. Reynolds: The author declares the following conflicts of interest: honoraria/speakers bureau (Eisai). T.S.K. Mok: Consultant/advisory role (AstraZeneca /Pfizer/Eli Lilly/Roche/Merck Serono/Eisai/BMS/BeiGene/AVEO/Taiho/BI), honoraria (AstraZeneca/Roche Pfizer/Eli Lilly/ Merck Serono/Eisai/BMS/BeiGene/AVEO /Taiho/BI), research funding (AstraZeneca). All other authors have declared no conflicts of interest.en_US
dc.languageengen_US
dc.publisherOxford University Press. The Journal's web site is located at http://annonc.oxfordjournals.org/en_US
dc.relation.ispartofAnnals of Oncologyen_US
dc.subjectMedical sciences-
dc.subjectOncology-
dc.titlePhase II study of two eribulin regimens in combination with erlotinib in patients (PTS) with previously treated advanced non-small cell lung cancer (NSCLC)en_US
dc.typeConference_Paperen_US
dc.identifier.emailLee, V: vhflee@hku.hken_US
dc.identifier.authorityLee, V=rp00264en_US
dc.identifier.doi10.1093/annonc/mds408en_US
dc.identifier.hkuros227946en_US
dc.identifier.volume23-
dc.identifier.issuesuppl. 9en_US
dc.identifier.spageix393en_US
dc.identifier.epageix393en_US
dc.publisher.placeUnited Kingdomen_US

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