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Safety of cabazitaxel in senior adults with metastatic castration-resistant prostate cancer: results of the European compassionate-use programme

Heidenreich, Axel, Bracarda, Sergio, Mason, Malcolm David, Ozen, Haluk, Sengelov, Lisa, Van Oort, Inge, Papandreou, Christos, Fossa, Sophie, Hitier, Simon and Climent, Miguel Angel 2014. Safety of cabazitaxel in senior adults with metastatic castration-resistant prostate cancer: results of the European compassionate-use programme. European Journal of Cancer 50 (6) , pp. 1090-1099. 10.1016/j.ejca.2014.01.006

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Abstract

Background: Cabazitaxel/prednisone has been shown to prolong survival versus mitoxantrone/prednisone in patients with metastatic castration-resistant prostate cancer (mCRPC) that has progressed during or after docetaxel. Subsequently, compassionate-use programmes (CUPs) and expanded-access programmes (EAPs) were established worldwide, allowing access to cabazitaxel before its commercial availability. Preliminary results of the European CUP/EAP, focusing on the elderly population (aged ⩾70 years), are reported. Patients and methods: Enrolled patients with progressive mCRPC received cabazitaxel (25 mg/m2) plus 10 mg oral prednisone/prednisolone every 3 weeks until disease progression, death, unacceptable toxicity or physician/patient decision. Safety was analysed by age group (<70, 70–74 and ⩾75 years). The influence of selected variables on grade ⩾3 neutropenia and/or neutropenic complications was analysed in multivariate analysis. Results: 746 men were enrolled (<70 years, n = 421; 70–74, n = 180, ⩾75 years, n = 145). Number of cabazitaxel cycles, dose reductions for any cause, dose delays possibly related to cabazitaxel adverse events, and tolerability were similar in the three age groups. Prophylactic granulocyte colony-stimulating factor (G-CSF) use was more common in men aged ⩾70 years. In multivariate analysis, age ⩾75 years, treatment cycle 1, and neutrophil count <4000/mm3 before cabazitaxel injection were associated with increased risk of developing grade ⩾3 neutropenia and/or neutropenic complications. Prophylactic use of G-CSF at a given cycle significantly reduced this risk by 30% (odds ratio 0.70, p = 0.04). Conclusion: The results suggest that cabazitaxel has a manageable safety profile in everyday clinical practice. Prophylactic use of G-CSF, especially at cycle 1 and in men aged ⩾75 years, is important and improves tolerability in senior adults treated with cabazitaxel.

Item Type: Article
Date Type: Publication
Status: Published
Schools: Medicine
Subjects: R Medicine > RC Internal medicine > RC0254 Neoplasms. Tumors. Oncology (including Cancer)
Publisher: Elsevier
ISSN: 0959-8049
Last Modified: 07 Feb 2019 11:03
URI: http://orca-mwe.cf.ac.uk/id/eprint/79609

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