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 ORCID: https://orcid.org/0000-0003-1505-2869, 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:	31 Oct 2022 09:02
URI:	https://orca.cardiff.ac.uk/id/eprint/79609

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