SAFETY OF CABAZITAXEL IN SENIORS

Eur J Cancer. 2014 Jan 31. pii: S0959-8049(14)00040-9. doi: 10.1016/j.ejca.2014.01.006. [Epub ahead of print]

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

Heidenreich A1, Bracarda S2, Mason M3, Ozen H4, Sengelov L5, Van Oort I6, Papandreou C7, Fossa S8, Hitier S9, Climent MA10; European investigators.

Author information

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 ⩾70years), are reported.

PATIENTS AND METHODS:

Enrolled patients with progressive mCRPC received cabazitaxel (25mg/m2) plus 10mg oral prednisone/prednisolone every 3weeks until disease progression, death, unacceptable toxicity or physician/patient decision. Safety was analysed by age group (<70 analysed="" analysis.="" and="" complications="" grade="" in="" influence="" multivariate="" neutropenia="" neutropenic="" of="" on="" or="" p="" selected="" the="" variables="" was="" years="">

RESULTS:

746 men were enrolled (<70years 1="" adverse="" age="" aged="" analysis="" and="" any="" cabazitaxel="" cause="" colony-stimulating="" common="" count="" cycle="" cycles="" delays="" dose="" events="" factor="" for="" granulocyte="" groups.="" in="" men="" mm="" more="" multivariate="" n="145)." neutrophil="" number="" of="" possibly="" prophylactic="" reductions="" related="" similar="" span="" style="font-size: 0.8461em; line-height: 1.6363em; position: relative; top: -0.5em; vertical-align: baseline;" the="" three="" to="" tolerability="" treatment="" use="" was="" were="" years.="" years="">3

 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 ⩾75years, is important and improves tolerability in senior adults treated with cabazitaxel.