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dc.contributor.authorMassard, C
dc.contributor.authorMateo, J
dc.contributor.authorLoriot, Y
dc.contributor.authorPezaro, C
dc.contributor.authorAlbiges, L
dc.contributor.authorMehra, N
dc.contributor.authorVarga, A
dc.contributor.authorBianchini, D
dc.contributor.authorRyan, CJ
dc.contributor.authorPetrylak, DP
dc.contributor.authorAttard, G
dc.contributor.authorShen, L
dc.contributor.authorFizazi, K
dc.contributor.authorde Bono, J
dc.date.accessioned2017-03-01T12:16:23Z
dc.date.issued2017-01
dc.identifier.citationAnnals of oncology : official journal of the European Society for Medical Oncology, 2017, 28 (1), pp. 90 - 95
dc.identifier.issn0923-7534
dc.identifier.urihttps://repository.icr.ac.uk/handle/internal/440
dc.identifier.eissn1569-8041
dc.identifier.doi10.1093/annonc/mdw441
dc.description.abstractBackground Abiraterone and cabazitaxel improve survival in patients with metastatic castration-resistant prostate cancer (mCRPC). We conducted an open-label phase I/II trial of cabazitaxel plus abiraterone to assess the antitumor activity and tolerability in patients with progressive mCRPC after docetaxel (phase I), and after docetaxel and abiraterone (phase II) (NCT01511536).Patients and methods The primary objectives were to determine the maximum tolerated dose (MTD) and dose-limiting toxicities (DLTs) of cabazitaxel plus abiraterone (phase I), and the prostate-specific antigen (PSA) response defined as a ≥ 50% decrease confirmed ≥3 weeks later with this combination (phase II).Results Ten patients were enrolled in the phase I component; nine were evaluable. No DLTs were identified. The MTD was established as the approved doses for both drugs (cabazitaxel 25 mg/m2 every 3 weeks and abiraterone 1000 mg once daily). Daily abiraterone treatment did not impact on cabazitaxel clearance. Twenty-seven patients received cabazitaxel plus abiraterone plus prednisone (5 mg twice daily) in phase II. The median number of cycles administered (cabazitaxel) was seven (range: 1-28). Grade 3-4 treatment-emergent adverse events included asthenia (in 5 patients; 14%), neutropenia (in 5 patients; 14%) and diarrhea (in 3 patients; 8%). Nine patients (24%) required dose reductions of cabazitaxel. Of 26 evaluable patients, 12 achieved a PSA response [46%; 95% confidence interval (CI): 26.6-66.6%]. Median PSA-progression-free survival was 6.9 months (95% CI: 4.1-10.3 months). Of 14 patients with measurable disease at baseline, 3 (21%) achieved a partial response per response evaluation criteria in solid tumors.Conclusions The combination of cabazitaxel and abiraterone has a manageable safety profile and shows antitumor activity in patients previously treated with docetaxel and abiraterone.
dc.formatPrint
dc.format.extent90 - 95
dc.languageeng
dc.language.isoeng
dc.rights.urihttps://creativecommons.org/licenses/by/4.0
dc.subjectHumans
dc.subjectNeoplasm Metastasis
dc.subjectNeoplasm Recurrence, Local
dc.subjectDisease Progression
dc.subjectTaxoids
dc.subjectAndrostenes
dc.subjectProstate-Specific Antigen
dc.subjectAntineoplastic Combined Chemotherapy Protocols
dc.subjectDisease-Free Survival
dc.subjectTreatment Outcome
dc.subjectMaximum Tolerated Dose
dc.subjectAged
dc.subjectMiddle Aged
dc.subjectMale
dc.subjectKaplan-Meier Estimate
dc.subjectProstatic Neoplasms, Castration-Resistant
dc.subjectDocetaxel
dc.titlePhase I/II trial of cabazitaxel plus abiraterone in patients with metastatic castration-resistant prostate cancer (mCRPC) progressing after docetaxel and abiraterone.
dc.typeJournal Article
rioxxterms.versionofrecord10.1093/annonc/mdw441
rioxxterms.licenseref.urihttps://creativecommons.org/licenses/by-nc/4.0
rioxxterms.licenseref.startdate2017-01
rioxxterms.typeJournal Article/Review
dc.relation.isPartOfAnnals of oncology : official journal of the European Society for Medical Oncology
pubs.issue1
pubs.notesNo embargo
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/Prostate Cancer Targeted Therapy Group
pubs.organisational-group/ICR/Primary Group/ICR Divisions/Molecular Pathology
pubs.organisational-group/ICR/Primary Group/ICR Divisions/Molecular Pathology/Treatment Resistance
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/Prostate Cancer Targeted Therapy Group
pubs.organisational-group/ICR/Primary Group/ICR Divisions/Molecular Pathology
pubs.organisational-group/ICR/Primary Group/ICR Divisions/Molecular Pathology/Treatment Resistance
pubs.organisational-group/ICR/Primary Group/Royal Marsden Clinical Units
pubs.publication-statusPublished
pubs.volume28
pubs.embargo.termsNo embargo
icr.researchteamProstate Cancer Targeted Therapy Groupen_US
icr.researchteamTreatment Resistanceen_US
dc.contributor.icrauthorAttard, Gerhardten
dc.contributor.icrauthorDe Bono, Johannen
dc.contributor.icrauthorMarsden,en
dc.contributor.icrauthorMateo Valderrama, Joaquinen


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