Cabazitaxel for metastatic castration-resistant prostate cancer (mCRPC): Interim safety and quality-of-life (QOL) data from the U.K. early access program (NCT01254279).

Authors

null

Amit Bahl

Bristol Haematology and Oncology Centre, Bristol, United Kingdom

Amit Bahl , Susan Masson , Zafar Malik , Alison J Birtle , Santhanam Sundar , Robert J Jones , Nicholas David James , Malcolm David Mason , Satish Kumar , 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, Rosemere Cancer Centre, Royal Preston Hospital, Preston, United Kingdom, Nottingham University Hospitals NHS Trust, Nottingham, United Kingdom, Beatson West of Scotland Cancer Centre, Glasgow, United Kingdom, School of Cancer Sciences, University of Birmingham, Birmingham, United Kingdom, Velindre Hospital, Cardiff, United Kingdom, St. James's University 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 for Cancer Research and Royal Marsden Hospital, Sutton, United Kingdom

Research Funding

Pharmaceutical/Biotech Company

Background: Cabazitaxel, a tubulin-binding taxane, improved survival in mCRPC in the TROPIC trial. Notable toxicities were neutropenia and diarrhoea. We report interim safety and QOL data from a single arm multicentre open label study providing early access to cabazitaxel in the UK. Methods: Patients recruited from 12 centres received cabazitaxel 25mg/m2 intravenously every 3 weeks and prednisolone 10mg daily. Safety assessments were performed before each cycle. Patients completed the EQ-5D questionnaire and health state visual analogue scale (VAS) at baseline and at alternate cycles. Patients recruited before March 31st 2011 are included in the safety analysis. QOL data collected before July 31st 2011 at baseline (n=62), cycle 2 (n=50) and cycle 4 (n=26) are included. Results: Median age was 68 years; 24% were aged over 75 years. 93% had bone metastases. 50% had experienced disease progression during or within 3 months of docetaxel and the remaining 50% within 3-6 months. A median of 3 cycles of cabazitaxel were completed with 99% relative dose intensity. 83% continued cabazitaxel at the time of safety analysis. 7 patients stopped before completing the full course, 5 of these were due to disease progression. One treatment related death occurred within 30 days of the last cabazitaxel infusion (2.4%). 85% of patients received granulocyte-colony stimulating factor prophylaxis from cycle 1. The proportion of patients reporting no pain or discomfort increased between baseline, cycle 2 and cycle 4 (22.6% to 38% to 50%). Anxiety and depression, mobility and self-care scores from EQ-5D were stable. Median VAS health state increased from baseline (75%) to cycle 4 (79%). Conclusions: Improvements in pain control and health states were reported during early stages of cabazitaxel treatment. Other EQ-5D QOL measures were stable. Severe toxicity was rare. Results will be updated from final analysis in late 2011.


Total n=41
Side effect Grade 3/4
n (%)
All grades
n (%)

Diarrhea 1 (2.4%) 23 (56.1%)
Fatigue 4 (9.8%) 19 (46.3%)
Neutropenia >7 days 2 (4.9%) 2 (4.9%)
Neutropenic sepsis 2 (4.9%) 2 (4.9%)
Peripheral neuropathy 0 (0%) 2 (4.9%)
Cardiac toxicity 0 (0%) 0 (0%)

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Abstract Details

Meeting

2012 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 30, 2012 (suppl 5; abstr 44)

DOI

10.1200/jco.2012.30.5_suppl.44

Abstract #

44

Poster Bd #

C10

Abstract Disclosures