title: Efficacy, quality of life, and safety of cabazitaxel in Canadian metastatic castration-resistant prostate cancer patients treated or not with prior abiraterone.
abstract: BACKGROUND
  In the TROPIC study, cabazitaxel improved overall survival in abiraterone-naïve metastatic castration-resistant prostate cancer (mCRPC) patients post-docetaxel. To evaluate cabazitaxel in routine clinical practice, an international, single-arm trial was conducted. Efficacy, safety, and quality of life (QoL) data were collected from Canadian patients enrolled. Overall survival and progression-free survival were not collected as part of this study. Importantly, prior abiraterone use was obtained and its impact on clinical parameters was examined.
  
  
  METHODS
  Sixty-one patients from nine Canadian centres were enrolled, with prior abiraterone use known for 60 patients. Prostate-specific antigen (PSA) response rate, safety, and impact on QoL life were analyzed as a function of prior abiraterone use.
  
  
  RESULTS
  Overall, 92% of patients were ECOG 0/1, 88% had bone metastases, and 25% visceral metastases. Patients treated without prior abiraterone (NoPriorAbi) (n=35, 58%) and with prior abiraterone (PriorAbi) (n=25, 42%) had similar baseline characteristics, except for age and prior cumulative docetaxel dose. Median number of cabazitaxel cycles received was similar between groups (NoPriorAbi=6, PriorAbi=7), as was PSA response rate (NoPriorAbi=36.4%, PriorAbi=45.0%, p=0.54). Almost one-third (31%) of patients received prophylactic granulocyte colony-stimulating factors. Most frequent Grade 3/4 toxicities were neutropenia (14.8%); anemia, febrile neutropenia, fatigue (each at 9.8%); and diarrhea (8.2%). No treatment-related adverse event leading to death was observed. QoL and pain were improved with no difference seen between groups. Treatment discontinuation was mainly due to disease progression (45.9%) and adverse events (32.8%).
  
  
  CONCLUSIONS
  In routine clinical practice, cabazitaxel's risk-benefit ratio in mCRPC patients previously treated with docetaxel seems to be maintained independent of prior abiraterone use.
authors.affiliation: CRCHUM/Université de Montréal, Montreal, QC, Canada;
authors.forename: Fred
authors.initials: F
authors.lastname: Saad
authors.affiliation: London Health Sciences Centre, London, ON, Canada;
authors.forename: Eric
authors.initials: E
authors.lastname: Winquist
authors.affiliation: Grand River Regional Cancer Centre, Kitchener, ON, Canada;
authors.forename: Stacey
authors.initials: S
authors.lastname: Hubay
authors.affiliation: Sunnybrook, Odette Cancer Centre, Toronto, ON, Canada;
authors.forename: Scott
authors.initials: S
authors.lastname: Berry
authors.affiliation: Horizon Health Network, Moncton, NB, Canada;
authors.forename: Hazem
authors.initials: H
authors.lastname: Assi
authors.affiliation: CHUQ Hôtel-Dieu de Québec, Quebec City, QC, Canada;
authors.forename: Eric
authors.initials: E
authors.lastname: Levesque
authors.affiliation: Cité-de-la-Santé Hospital, Laval, QC, Canada;
authors.forename: Nathalie
authors.initials: N
authors.lastname: Aucoin
authors.affiliation: CancerCare Manitoba, Winnipeg, MB, Canada;
authors.forename: Piotr
authors.initials: P
authors.lastname: Czaykowski
authors.affiliation: CRCHUM/Université de Montréal, Montreal, QC, Canada;
authors.forename: Jean-Baptiste
authors.initials: JB
authors.lastname: Lattouf
authors.affiliation: Sanofi-aventis Canada Inc., Montreal, QC, Canada;
authors.forename: Karine
authors.initials: K
authors.lastname: Alloul
authors.affiliation: Sanofi-aventis Canada Inc., Montreal, QC, Canada;
authors.forename: John
authors.initials: J
authors.lastname: Stewart
authors.affiliation: Princess Margaret Hospital, Toronto, ON, Canada.
authors.forename: Srikala S
authors.initials: SS
authors.lastname: Sridhar