Please use this identifier to cite or link to this item: https://doi.org/10.1371/journal.pone.0154316
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dc.titlePhase I study of oral vinorelbine in combination with erlotinib in advanced non-small cell lung cancer (NSCLC) using two different schedules
dc.contributor.authorSutiman N.
dc.contributor.authorZhang Z.
dc.contributor.authorAng M.K.
dc.contributor.authorTan S.-W.D.
dc.contributor.authorToh C.K.
dc.contributor.authorNg Q.S.
dc.contributor.authorChowbay B.
dc.contributor.authorLim W.-T.
dc.date.accessioned2019-11-06T07:57:34Z
dc.date.available2019-11-06T07:57:34Z
dc.date.issued2016
dc.identifier.citationSutiman N., Zhang Z., Ang M.K., Tan S.-W.D., Toh C.K., Ng Q.S., Chowbay B., Lim W.-T. (2016). Phase I study of oral vinorelbine in combination with erlotinib in advanced non-small cell lung cancer (NSCLC) using two different schedules. PLoS ONE 11 (5) : e0154316. ScholarBank@NUS Repository. https://doi.org/10.1371/journal.pone.0154316
dc.identifier.issn19326203
dc.identifier.urihttps://scholarbank.nus.edu.sg/handle/10635/161571
dc.description.abstractPurpose: This study aimed to evaluate the safety, tolerability and pharmacokinetics of the combination of oral vinorelbine with erlotinib using the conventional (CSV) and metronomic (MSV) dosing schedules in patients with advanced non-small cell lung cancer (NSCLC). Methods: This was an open-label, multiple dose-escalation phase I study. An alternating 3+3 phase I design was employed to allow each schedule to enroll three patients sequentially at each dose level. Thirty patients with Stage IIIB/IV NSCLC were treated with escalating doses of oral vinorelbine starting at 40 mg/m 2 on day 1 and 8 in the CSV group (N = 16) and at 100 mg/week in the MSV group (N = 14). Erlotinib was administered orally daily. Results: The maximum tolerated dose was vinorelbine 80 mg/m 2 with erlotinib 100 mg in the CSV group and vinorelbine 120 mg/week with erlotinib 100 mg in the MSV group. Grade 3/4 toxicities included neutropenia (N = 2; 13%) and hyponatremia (N = 1; 6%) in the CSV group, and neutropenia (N = 5; 36%) in the MSV group. Objective response was achieved in 38% and 29% in the CSV and MSV groups respectively. Vinorelbine co-administration did not significantly affect the pharmacokinetics of erlotinib and OSI-420 after initial dose. However, at steady-state, significantly higher C max , higher C min and lower CL/F of erlotinib were observed with increasing dose levels of vinorelbine in the CSV group. Significantly higher steady-state C min , C avg and AUC ss of erlotinib were observed with increasing dose levels of vinorelbine in the MSV group. Conclusions: Combination of oral vinorelbine with erlotinib is feasible and tolerable in both the CSV and MSV groups. Trial Registration: ClinicalTrials.gov NCT00702182. © 2016 Sutiman et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
dc.rightsAttribution 4.0 International
dc.rights.urihttp://creativecommons.org/licenses/by/4.0/
dc.sourceUnpaywall 20191101
dc.subjecterlotinib
dc.subjectnavelbine
dc.subjectantineoplastic agent
dc.subjecterlotinib
dc.subjectOSI-420
dc.subjectquinazoline derivative
dc.subjectvinblastine
dc.subjectvinorelbine tartrate
dc.subjectadult
dc.subjectadvanced cancer
dc.subjectaged
dc.subjectalopecia
dc.subjectanemia
dc.subjectanorexia
dc.subjectarea under the curve
dc.subjectarthralgia
dc.subjectArticle
dc.subjectcancer fatigue
dc.subjectclinical article
dc.subjectclinical effectiveness
dc.subjectconstipation
dc.subjectcontrolled study
dc.subjectdiarrhea
dc.subjectdizziness
dc.subjectdrug dose escalation
dc.subjectdrug efficacy
dc.subjectdrug response
dc.subjectdrug safety
dc.subjectdrug tolerability
dc.subjectdry eye
dc.subjectdry skin
dc.subjectdysphagia
dc.subjectface pain
dc.subjectfebrile neutropenia
dc.subjectfemale
dc.subjectheartburn
dc.subjecthuman
dc.subjecthyponatremia
dc.subjectinfection
dc.subjectkeratitis
dc.subjectloss of appetite
dc.subjectmale
dc.subjectmaximum plasma concentration
dc.subjectmyalgia
dc.subjectnail disease
dc.subjectnausea
dc.subjectneuropathy
dc.subjectneutropenia
dc.subjectnon small cell lung cancer
dc.subjectnose disease
dc.subjectoutcome assessment
dc.subjectparonychia
dc.subjectphase 1 clinical trial
dc.subjectpruritus
dc.subjectrash
dc.subjectsteady state
dc.subjectstomatitis
dc.subjectvomiting
dc.subjectanalogs and derivatives
dc.subjectCarcinoma, Non-Small-Cell Lung
dc.subjectclinical trial
dc.subjectdrug administration
dc.subjectmiddle aged
dc.subjecttreatment outcome
dc.subjectAdult
dc.subjectAged
dc.subjectAntineoplastic Combined Chemotherapy Protocols
dc.subjectCarcinoma, Non-Small-Cell Lung
dc.subjectDrug Administration Schedule
dc.subjectErlotinib Hydrochloride
dc.subjectFemale
dc.subjectHumans
dc.subjectMale
dc.subjectMiddle Aged
dc.subjectQuinazolines
dc.subjectTreatment Outcome
dc.subjectVinblastine
dc.typeArticle
dc.contributor.departmentDUKE-NUS MEDICAL SCHOOL
dc.contributor.departmentDEAN'S OFFICE (DUKE-NUS MEDICAL SCHOOL)
dc.description.doi10.1371/journal.pone.0154316
dc.description.sourcetitlePLoS ONE
dc.description.volume11
dc.description.issue5
dc.description.pagee0154316
dc.published.statePublished
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This item is licensed under a Creative Commons License Creative Commons