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dc.contributor.authorMichael, Michael
dc.contributor.authorWhite, Shane C
dc.contributor.authorAbdi, Ehtesham
dc.contributor.authorNott, Louise
dc.contributor.authorClingan, Phillip
dc.contributor.authorZimet, Allan
dc.contributor.authorButton, Peter
dc.contributor.authorGregory, Daniel
dc.contributor.authorSolomon, Benjamin
dc.contributor.authorDobrovic, Alexander
dc.contributor.authorDo, Hongdo
dc.contributor.authorClarke, Stephen
dc.date.accessioned2017-05-03T15:25:58Z
dc.date.available2017-05-03T15:25:58Z
dc.date.issued2015
dc.identifier.issn1743-7555
dc.identifier.doi10.1111/ajco.12178
dc.identifier.urihttp://hdl.handle.net/10072/65660
dc.description.abstractAim The potential beneficial interaction between erlotinib and chemotherapy may require sequencing or pharmacodynamic separation. The aim of this study was to evaluate the efficacy and tolerance of sequential erlotinib and gemcitabine versus gemcitabine monotherapy as first-line therapy in elderly or ECOG PS-2 patients with advanced non-small cell lung carcinoma. Methods The primary objective of this multicenter randomized Phase II study was progression-free survival (PFS). Secondary objectives were overall response rate (ORR), disease control rate, response duration, overall survival and safety. Patients were randomized to either gemcitabine (1250?mg/m2 Day 1, 8 q28 days) followed by erlotinib (150?mg/day on day 15 through day 28), (EG-arm), or gemcitabine monotherapy (1000?mg/m2 Days 1, 8, 15 q28 days), (G-arm) for up to six cycles. Results Fifty-four patients were recruited, 28 G-arm and 26 EG-arm. Overall, efficacy results were not significantly different between study arms. Median PFS and ORR for the G- versus EG-arms were 8.0 versus 10.3 weeks (hazard ratio 1.3; 95% confidence interval [0.63;2.68]; P?=?0.48) and 7.1 versus 3.8 percent respectively (difference -3.30; 95% confidence interval [-17.5;10.9]). The majority of adverse events (AEs) in both arms were Grade 1-2. The commonest AEs recorded in the EG- and G-arms were rash-like events (65 percent) and nausea (42 percent) respectively. Four patients (17 percent) in EG-arm and five (16 percent) in G-arm experienced at least one treatment-related serious AE. Conclusions In this study, patients with non-small cell lung carcinoma at ECOG PS-2 or aged =70 years derived no efficacy advantage from sequential erlotinib in combination with gemcitabine relative to gemcitabine alone. No unexpected safety findings were noted.
dc.description.peerreviewedYes
dc.description.publicationstatusYes
dc.languageEnglish
dc.language.isoeng
dc.publisherWiley-Blackwell
dc.publisher.placeUnited Kingdom
dc.relation.ispartofstudentpublicationN
dc.relation.ispartofpagefrom1
dc.relation.ispartofpageto11
dc.relation.ispartofjournalAsia-Pacific Journal of Clinical Oncology
dc.rights.retentionY
dc.subject.fieldofresearchOncology and Carcinogenesis not elsewhere classified
dc.subject.fieldofresearchOncology and Carcinogenesis
dc.subject.fieldofresearchcode111299
dc.subject.fieldofresearchcode1112
dc.titleMulticenter randomized, open-label phase II trial of sequential erlotinib and gemcitabine compared with gemcitabine monotherapy as first-line therapy in elderly or ECOG PS two patients with advanced NSCLC
dc.typeJournal article
dc.type.descriptionC1 - Articles
dc.type.codeC - Journal Articles
gro.hasfulltextNo Full Text
gro.griffith.authorAbdi, Ehtesham


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