960 - Cabazitaxel early access program (EAP) - Canadian interim results: safety, QOL, and utility values in metastatic castration resistant prostate cance...

Date 28 September 2012
Event ESMO Congress 2012
Session Publication Only
Topics Anticancer agents
Prostate Cancer
Therapy
Biological therapy
Presenter Srikala Sridhar
Authors S.S. Sridhar1, E. Winquist2, S. Hubay3, C. St.-Laurent Thibault4, H. Assi5, S. Berry6, E. Levesque7, N. Aucoin8, P. Czaykowski9, F. Saad10
  • 1Medical Oncology, Princess Margaret Hospital, Toronto/CA
  • 2University of Western OntarioLondon Regional Cancer Center, CA-N6A 4L6 - London/CA
  • 3Medical Oncology, Grand River Regional Cancer Centre, Kitchener/CA
  • 4Oncology, Sanofi Inc. Canada, Montreal/CA
  • 5Medical Oncology, The Moncton Hospital, Moncton/CA
  • 6Medical Oncology, Odette Cancer Centre, Toronto/CA
  • 7Medical Oncology, CHUQ-L'Hotel-Dieu de Quebec, Quebec City/CA
  • 8Medical Oncology, Cité-de-la-Santé Hospital, Laval/CA
  • 9Medical Oncology, Cancer Care Manitoba, Winnipeg/CA
  • 10CHUM, Notre-Dame Hospital, Montreal/CA

Abstract

Background

Cabazitaxel/Prednisone (CbzP) improves survival in docetaxel resistant mCRPC. Canadian investigators collected safety and QoL data for patients (pts) participating in a global single-arm multicenter EAP.

Methods

Between May 2011 and Feb 2012, 61 evaluable pts were enrolled at 9 centers. Safety and QoL data were collected at baseline and at each cycle. QoL was assessed using the FACT-P and its subscales, EQ 5D-3L, and ESAS questionnaires. Utility values were derived from the EQ 5D-3L. Present pain intensity (PPI) and analgesic scores were assessed using the McGill-Melzack questionnaire. The change from baseline QoL in individual patients was analyzed.

Results

At the time of analysis, baseline characteristics and safety data were available for the first 33 pts. Median age was 65; 94% were ECOG 0/1; 85% had bone metastases; and 76% had progressed within 3 months of prior docetaxel. Over half (56%) received at least 5 cycles of CbzP. Main grade 3+ toxicities were anemia 3%, leukopenia 3%, and febrile neutropenia 3% (prophylactic and therapeutic G-CSF use was permitted). Incidence of diarrhea (all grades) was 52%, and grade 3+ diarrhea was 3%. No treatment related deaths were reported. Preliminary analyses showed stable QoL and derived utility values over time. A pain subscale of FACT-P, showed improvements in the first 4 cycles; PPI scores improved despite stable analgesic use.

Conclusions

In this EAP, reflecting routine clinical practice, the main toxicities of CbzP were similar to the TROPIC trial (neutropenia and diarrhea) emphasizing the need for close toxicity monitoring. Preliminary QoL and PPI data support a palliative benefit of CbzP not reported in TROPIC. Updated data with all evaluable pts and percentages of pts meeting important response thresholds will be presented.

Disclosure

S.S. Sridhar: Dr. Sridhar has served on the advisory board for and is involved in research projects with Sanofi Aventis Canada.

E. Winquist: Dr Winquist has received travel funding and consultant's honoraria from Sanofi Canada. He is involved in research projects with Sanofi Canada.

C. St.-Laurent Thibault: Catherine Saint-Laurent Thibault is an employee of Sanofi Canada Inc.

H. Assi: Membership on an Advisory board,

S. Berry: Membership on an advisory board,

N. Aucoin: Membership on an advisory board,

F. Saad: Dr Fred Saad sits on the advisory board for Sanofi Aventis Canada and has received consultant's honoraria from Sanofi Canada. He is involved in research projects with Sanofi Canada.

All other authors have declared no conflicts of interest.