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dc.contributor.authorMoreno, L
dc.contributor.authorCasanova, M
dc.contributor.authorChisholm, JC
dc.contributor.authorBerlanga, P
dc.contributor.authorChastagner, PB
dc.contributor.authorBaruchel, S
dc.contributor.authorAmoroso, L
dc.contributor.authorGallego Melcón, S
dc.contributor.authorGerber, NU
dc.contributor.authorBisogno, G
dc.contributor.authorFagioli, F
dc.contributor.authorGeoerger, B
dc.contributor.authorGlade Bender, JL
dc.contributor.authorAerts, I
dc.contributor.authorBergeron, C
dc.contributor.authorHingorani, P
dc.contributor.authorElias, I
dc.contributor.authorSimcock, M
dc.contributor.authorFerrara, S
dc.contributor.authorLe Bruchec, Y
dc.contributor.authorSlepetis, R
dc.contributor.authorChen, N
dc.contributor.authorVassal, G
dc.date.accessioned2018-12-18T09:13:10Z
dc.date.issued2018-09
dc.identifier.citationEuropean journal of cancer (Oxford, England : 1990), 2018, 100 pp. 27 - 34
dc.identifier.issn0959-8049
dc.identifier.urihttps://repository.icr.ac.uk/handle/internal/2979
dc.identifier.eissn1879-0852
dc.identifier.doi10.1016/j.ejca.2018.05.002
dc.description.abstractBackground nab-Paclitaxel has demonstrated efficacy in adults with solid tumours and preclinical activity in paediatric solid tumour models. Results from phase I of a phase I/II study in paediatric patients with recurrent/refractory solid tumours treated with nab-paclitaxel are reported.Patients and methods Patients with recurrent/refractory extracranial solid tumours received nab-paclitaxel on days 1, 8 and 15 every 4 weeks at 120, 150, 180, 210, 240, or 270 mg/m 2 (rolling-6 dose-escalation) to establish the maximum tolerated dose (MTD) and recommended phase II dose (RP2D).Results Sixty-four patients were treated. Dose-limiting toxicities were grade 3 dizziness at 120 mg/m 2 and grade 4 neutropenia >7 days at 270 mg/m 2 . The most frequent grade 3/4 adverse events were haematologic, including neutropenia (36%), leukopenia (36%) and lymphopenia (25%). Although the MTD was not reached, 270 mg/m 2 was declared non-tolerable due to grade 3/4 toxicities during cycles 1-2 (neutropenia, n = 5/7; skin toxicity, n = 2/7; peripheral neuropathy, n = 1/7). Of 58 efficacy-evaluable patients, complete response occurred in one patient (2%; Ewing sarcoma) and partial responses in four patients (7%; rhabdomyosarcoma, Ewing sarcoma, renal tumour with pulmonary metastases [high-grade, malignant] and sarcoma not otherwise specified); all responses occurred at ≥210 mg/m 2 . Thirteen patients (22%) had stable disease (5 lasting ≥16 weeks) per RECIST.Conclusions nab-Paclitaxel 240 mg/m 2 qw3/4 (nearly double the adult recommended monotherapy dose for this schedule in metastatic breast cancer) was selected as the RP2D based on the tolerability profile, pharmacokinetics and antitumour activity. Phase II is currently enrolling patients with recurrent/refractory neuroblastoma, rhabdomyosarcoma and Ewing sarcoma. CLINICALTRIALS.GOV: NCT01962103.Eudract 2013-000144-26.
dc.formatPrint-Electronic
dc.format.extent27 - 34
dc.languageeng
dc.language.isoeng
dc.rights.urihttps://www.rioxx.net/licenses/under-embargo-all-rights-reserved
dc.subjectHumans
dc.subjectNeoplasms
dc.subjectPaclitaxel
dc.subjectAlbumins
dc.subjectAntineoplastic Agents, Phytogenic
dc.subjectTreatment Outcome
dc.subjectDrug Administration Schedule
dc.subjectMaximum Tolerated Dose
dc.subjectAge Factors
dc.subjectTime Factors
dc.subjectAdolescent
dc.subjectChild
dc.subjectChild, Preschool
dc.subjectCanada
dc.subjectUnited States
dc.subjectEurope
dc.subjectFemale
dc.subjectMale
dc.subjectDrug Dosage Calculations
dc.titlePhase I results of a phase I/II study of weekly nab-paclitaxel in paediatric patients with recurrent/refractory solid tumours: A collaboration with innovative therapies for children with cancer.
dc.typeJournal Article
dcterms.dateAccepted2018-05-01
rioxxterms.versionofrecord10.1016/j.ejca.2018.05.002
rioxxterms.licenseref.urihttps://www.rioxx.net/licenses/under-embargo-all-rights-reserved
rioxxterms.licenseref.startdate2018-09
rioxxterms.typeJournal Article/Review
dc.relation.isPartOfEuropean journal of cancer (Oxford, England : 1990)
pubs.notesNot known
pubs.organisational-group/ICR
pubs.organisational-group/ICR/Primary Group
pubs.organisational-group/ICR/Primary Group/ICR Divisions
pubs.organisational-group/ICR/Primary Group/ICR Divisions/Clinical Studies
pubs.organisational-group/ICR/Primary Group/ICR Divisions/Clinical Studies/Sarcoma Clinical Trials in Children and Young People
pubs.organisational-group/ICR/Primary Group/ICR Divisions/Clinical Studies/Sarcoma Clinical Trials in Children and Young People/Sarcoma Clinical Trials in Children and Young People (hon.)
pubs.organisational-group/ICR/Primary Group/ICR Divisions/Molecular Pathology
pubs.organisational-group/ICR/Primary Group/ICR Divisions/Molecular Pathology/Sarcoma Clinical Trials in children and young people
pubs.organisational-group/ICR/Primary Group/ICR Divisions/Molecular Pathology/Sarcoma Clinical Trials in children and young people/Sarcoma Clinical Trials in Children and Young People (hon.)
pubs.organisational-group/ICR/Primary Group/Royal Marsden Clinical Units
pubs.organisational-group/ICR
pubs.organisational-group/ICR/Primary Group
pubs.organisational-group/ICR/Primary Group/ICR Divisions
pubs.organisational-group/ICR/Primary Group/ICR Divisions/Clinical Studies
pubs.organisational-group/ICR/Primary Group/ICR Divisions/Clinical Studies/Sarcoma Clinical Trials in Children and Young People
pubs.organisational-group/ICR/Primary Group/ICR Divisions/Clinical Studies/Sarcoma Clinical Trials in Children and Young People/Sarcoma Clinical Trials in Children and Young People (hon.)
pubs.organisational-group/ICR/Primary Group/ICR Divisions/Molecular Pathology
pubs.organisational-group/ICR/Primary Group/ICR Divisions/Molecular Pathology/Sarcoma Clinical Trials in children and young people
pubs.organisational-group/ICR/Primary Group/ICR Divisions/Molecular Pathology/Sarcoma Clinical Trials in children and young people/Sarcoma Clinical Trials in Children and Young People (hon.)
pubs.organisational-group/ICR/Primary Group/Royal Marsden Clinical Units
pubs.publication-statusPublished
pubs.volume100
pubs.embargo.termsNot known
icr.researchteamSarcoma Clinical Trials in children and young peopleen_US
dc.contributor.icrauthorChisholm, Juliaen


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