715 CABAZITAXEL FOR METASTATIC CASTRATION RESISTANT PROSTATE CANCER (MCRPC): FINAL QUALITY OF LIFE (QOL) RESULTS WITH SAFETY DATA FROM THE UNITED KINGDOM (UK) EARLY ACCESS PROGRAMME (EAP) (NCT01254279)

Field: Medicine (Health Sciences)

You have accessJournal of UrologyProstate Cancer: Advanced (I)1 Apr 2013715 CABAZITAXEL FOR METASTATIC CASTRATION RESISTANT PROSTATE CANCER (MCRPC): FINAL QUALITY OF LIFE (QOL) RESULTS WITH SAFETY DATA FROM THE UNITED KINGDOM (UK) EARLY ACCESS PROGRAMME (EAP) (NCT01254279) Amit Bahl, Susan Masson, Zafar Malik, Alison Birtle, Santhanam Sundar, Robert Jones, Nicholas James, Malcolm Mason, David Bottomley, Anna Lydon, Simon Chowdhury, James Wylie, and Johann De Bono Amit BahlAmit Bahl Bristol, United Kingdom More articles by this author , Susan MassonSusan Masson Bristol, United Kingdom More articles by this author , Zafar MalikZafar Malik Bebington, United Kingdom More articles by this author , Alison BirtleAlison Birtle Preston, United Kingdom More articles by this author , Santhanam SundarSanthanam Sundar Nottingham, United Kingdom More articles by this author , Robert JonesRobert Jones Glasgow, United Kingdom More articles by this author , Nicholas JamesNicholas James Birmingham, United Kingdom More articles by this author , Malcolm MasonMalcolm Mason Cardiff, United Kingdom More articles by this author , David BottomleyDavid Bottomley Leeds, United Kingdom More articles by this author , Anna LydonAnna Lydon Exeter, United Kingdom More articles by this author , Simon ChowdhurySimon Chowdhury London, United Kingdom More articles by this author , James WylieJames Wylie Manchester, United Kingdom More articles by this author , and Johann De BonoJohann De Bono London, United Kingdom More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2013.02.274AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES Several drugs can now improve survival in mCRPC after docetaxel, including cabazitaxel, a next generation taxane. TROPIC (NCT00417079) showed an overall survival benefit of 2.4 months for cabazitaxel compared with mitoxantrone for mCRPC. The UK EAP provided patients access to cabazitaxel; detailed QOL and safety data were recorded. Interim analysis suggested improvements in QOL, particularly pain scores and a good safety profile. We report final QOL and updated safety data. METHODS 108 patients recruited at 12 centres received cabazitaxel 25mg/m2intravenously every 3 weeks with oral prednisolone 10mg daily. EQ-5D questionnaires and health state visual analogue scale (VAS) were completed at baseline, at alternate cycles and at 30 days post treatment. Safety assessments followed each cycle. RESULTS According to EQ-5D and VAS scores, QOL was stable with an overall trend towards improvement in patients who continued treatment. Paired ?within patient? analyses also support this trend. Improved pain was noted more frequently than deterioration at all time points and pain scores were at least stable in 96% of patients at cycle 10. A median of 6 cycles were given. 34 patients (31%) received 10 or more cycles. Grade 3/4 adverse events were uncommon, the most frequent being fatigue (9.3%), diarrhoea (2.8%) and neutropenic sepsis (1.9%). 85% received prophylactic granulocyte colony stimulating factor. CONCLUSIONS Almost 1/3 of patients completed 10 or more cycles in the UK EAP. QOL was stable with trends to improved EQ-5D and VAS scores. Improved or stable pain was observed in the majority of patients continuing therapy. The UK EAP provides the first data on QOL benefit with cabazitaxel in mCRPC post docetaxel and demonstrates manageable toxicity. Final safety data will be available for presentation. Mean EQ-5D QOL Scores showing trend to improvement during treatment N Mean Score (range 0-1) Baseline 100 0.698 (0.654 - 0.741) Cycle 2 97 0.730 (0.689 - 0.770) Cycle 4 74 0.765 (0.719 - 0.812) Cycle 6 63 0.761 (0.716 - 0.805) Cycle 8 37 0.781 (0.711 - 0.851) Cycle 10 28 0.817 (0.743 - 0.891) Post treatment 62 0.695 (0.633 - 0.756) © 2013 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetailsCited byLee D, Nielsen S, van Keep M, Andersson F and Greene D (2018) Quality of Life Improvement in Patients Treated with Degarelix versus Leuprorelin for Advanced Prostate CancerJournal of Urology, VOL. 193, NO. 3, (839-846), Online publication date: 1-Mar-2015. Volume 189Issue 4SApril 2013Page: e294 Advertisement Copyright & Permissions© 2013 by American Urological Association Education and Research, Inc.MetricsAuthor Information Amit Bahl Bristol, United Kingdom More articles by this author Susan Masson Bristol, United Kingdom More articles by this author Zafar Malik Bebington, United Kingdom More articles by this author Alison Birtle Preston, United Kingdom More articles by this author Santhanam Sundar Nottingham, United Kingdom More articles by this author Robert Jones Glasgow, United Kingdom More articles by this author Nicholas James Birmingham, United Kingdom More articles by this author Malcolm Mason Cardiff, United Kingdom More articles by this author David Bottomley Leeds, United Kingdom More articles by this author Anna Lydon Exeter, United Kingdom More articles by this author Simon Chowdhury London, United Kingdom More articles by this author James Wylie Manchester, United Kingdom More articles by this author Johann De Bono London, United Kingdom More articles by this author Expand All Advertisement Advertisement PDF downloadLoading ...