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dc.contributor.authorde Morrée, ES
dc.contributor.authorVogelzang, NJ
dc.contributor.authorPetrylak, DP
dc.contributor.authorBudnik, N
dc.contributor.authorWiechno, PJ
dc.contributor.authorSternberg, CN
dc.contributor.authorDoner, K
dc.contributor.authorBellmunt, J
dc.contributor.authorBurke, JM
dc.contributor.authorOchoa de Olza, M
dc.contributor.authorChoudhury, A
dc.contributor.authorGschwend, JE
dc.contributor.authorKopyltsov, E
dc.contributor.authorFlechon, A
dc.contributor.authorvan As, N
dc.contributor.authorHouede, N
dc.contributor.authorBarton, D
dc.contributor.authorFandi, A
dc.contributor.authorJungnelius, U
dc.contributor.authorLi, S
dc.contributor.authorLi, JS
dc.contributor.authorde Wit, R
dc.date.accessioned2018-02-14T09:55:22Z
dc.date.issued2017-01
dc.identifier.citationJAMA oncology, 2017, 3 (1), pp. 68 - 75
dc.identifier.issn2374-2437
dc.identifier.urihttps://repository.icr.ac.uk/handle/internal/1061
dc.identifier.eissn2374-2445
dc.identifier.doi10.1001/jamaoncol.2016.3000
dc.description.abstractImportance The optimal total number of docetaxel cycles in patients with metastatic castration resistant prostate cancer (mCPRC) has not been investigated yet. It is unknown whether it is beneficial for patients to continue treatment upon 6 cycles.Objective To investigate whether the number of docetaxel cycles administered to patients deriving clinical benefit was an independent prognostic factor for overall survival (OS) in a post hoc analysis of the Mainsail trial.Design, setting, and participants The Mainsail trial was a multinational randomized phase 3 study of 1059 patients with mCRPC receiving docetaxel, prednisone, and lenalidomide (DPL) or docetaxel, prednisone, and a placebo (DP). Study patients were treated until progressive disease or unacceptable adverse effects occurred. Median OS was found to be inferior in the DPL arm compared with the DP arm. As a result of increased toxic effects with the DPL combination, patients on DPL received fewer docetaxel cycles (median, 6) vs 8 cycles in the control group. As the dose intensity was comparable in both treatment arms, we investigated whether the number of docetaxel cycles administered to patients deriving clinical benefit on Mainsail was an independent prognostic factor for OS. We conducted primary univariate and multivariate analyses for the intention-to-treat population. Additional sensitivity analyses were done, excluding patients who stopped treatment for reasons of disease progression and those who received 4 or fewer cycles of docetaxel for other reasons, minimizing the effect of confounding factors.Main outcomes and measures Total number of docetaxel cycles delivered as an independent factor for OS.Results Overall, all 1059 patients from the Mainsail trial were included (mean [SD] age, 68.7 [7.89] years). Treatment with 8 or more cycles of docetaxel was associated with superior OS (hazard ratio [HR], 1.909; 95% CI, 1.660-2.194; P < .001), irrespective of lenalidomide treatment (HR, 1.060; 95% CI, 0.924-1.215; P = .41). Likewise, in the sensitivity analysis, patients who received a greater number of docetaxel cycles had superior OS; patients who received more than 10 cycles had a median OS of 33.0 months compared with 26.9 months in patients treated with 8 to 10 cycles; and patients who received 5 to 7 cycles had a median OS of 22.8 months (P < .001).Conclusions and relevance These findings suggest that continuation of docetaxel chemotherapy contributes to the survival benefit. Prospective validation is warranted.
dc.formatPrint
dc.format.extent68 - 75
dc.languageeng
dc.language.isoeng
dc.subjectHumans
dc.subjectThalidomide
dc.subjectTaxoids
dc.subjectPrednisone
dc.subjectAntineoplastic Combined Chemotherapy Protocols
dc.subjectDisease-Free Survival
dc.subjectDrug Administration Schedule
dc.subjectAdult
dc.subjectAged
dc.subjectAged, 80 and over
dc.subjectMiddle Aged
dc.subjectMale
dc.subjectKaplan-Meier Estimate
dc.subjectProstatic Neoplasms, Castration-Resistant
dc.subjectDocetaxel
dc.subjectLenalidomide
dc.titleAssociation of Survival Benefit With Docetaxel in Prostate Cancer and Total Number of Cycles Administered: A Post Hoc Analysis of the Mainsail Study.
dc.typeJournal Article
rioxxterms.versionofrecord10.1001/jamaoncol.2016.3000
rioxxterms.licenseref.startdate2017-01
rioxxterms.typeJournal Article/Review
dc.relation.isPartOfJAMA oncology
pubs.issue1
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/Radiotherapy and Imaging
pubs.organisational-group/ICR/Primary Group/ICR Divisions/Radiotherapy and Imaging/Stereotactic and Precision Body Radiotherapy
pubs.organisational-group/ICR/Primary Group/ICR Divisions/Radiotherapy and Imaging/Stereotactic and Precision Body Radiotherapy/Stereotactic and Precision Body Radiotherapy (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/Radiotherapy and Imaging
pubs.organisational-group/ICR/Primary Group/ICR Divisions/Radiotherapy and Imaging/Stereotactic and Precision Body Radiotherapy
pubs.organisational-group/ICR/Primary Group/ICR Divisions/Radiotherapy and Imaging/Stereotactic and Precision Body Radiotherapy/Stereotactic and Precision Body Radiotherapy (hon.)
pubs.organisational-group/ICR/Primary Group/Royal Marsden Clinical Units
pubs.publication-statusPublished
pubs.volume3
pubs.embargo.termsNot known
icr.researchteamStereotactic and Precision Body Radiotherapyen_US
dc.contributor.icrauthorvan As, Nicken
dc.contributor.icrauthorMarsden,en


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