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).

Authors

null

Amit Bahl

Bristol Haematology and Oncology Centre, Bristol, United Kingdom

Amit Bahl , Susan Masson , Zafar I. Malik , Alison J. Birtle , Santhanam Sundar , Robert J. Jones , Nicholas David James , Malcolm David Mason , David Bottomley , Anna Lydon , Simon Chowdhury , James Wylie , Johann Sebastian De Bono

Organizations

Bristol Haematology and Oncology Centre, Bristol, United Kingdom, Clatterbridge Centre for Oncology, Wirral, United Kingdom, Lancashire Teaching Hospitals NHS Foundation Trust, Preston, United Kingdom, Nottingham University Hospitals NHS Trust, Nottingham, United Kingdom, Beatson West of Scotland Cancer Centre, Glasgow, United Kingdom, University of Birmingham, Birmingham, United Kingdom, Velindre Cancer Centre, Cardiff, United Kingdom, St. James's Hospital, Leeds, United Kingdom, South Devon Healthcare NHS Foundation Trust, Torquay, United Kingdom, Guy's and St. Thomas' NHS Foundation Trust, London, United Kingdom, The Christie NHS Foundation Trust, Manchester, United Kingdom, The Institute of Cancer Research and The Royal Marsden NHS Foundation Trust, Sutton, United Kingdom

Research Funding

Pharmaceutical/Biotech Company

Background: 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. Clinical trial information: NCT01254279.

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)

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Abstract Details

Meeting

2013 Genitourinary Cancers Symposium

Session Type

Poster Session

Session Title

General Poster Session A: Prostate Cancer

Track

Prostate Cancer

Sub Track

Prostate Cancer

Clinical Trial Registration Number

NCT01254279

Citation

J Clin Oncol 31, 2013 (suppl 6; abstr 91)

DOI

10.1200/jco.2013.31.6_suppl.91

Abstract #

91

Poster Bd #

F10

Abstract Disclosures